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Patent Office Accelerates Patent Review For Cancer Drugs in Pilot Program
Patent Office Accelerates Patent Review For Cancer Drugs in Pilot Program
The Patent Offices estimates it receives approximately 900 cancer immuno-therapy applications annually. "Patents for Patients" will accelerate the intellectual property protection process so new cancer immunotherapies can reach the clinics as soon as p...
Cancer Drug Shows Potential in Treating Severe Asthma
Cancer Drug Shows Potential in Treating Severe Asthma
Mast cells are associated with severe asthma and airway hyperresponsiveness and in some patients they persist in the airway despite high doses of glucocorticoids.
Compatibility And Testing of Nested Container And Closure Systems To Help Pharmaceutical Companie...
Compatibility And Testing of Nested Container And Closure Systems To Help Pharmaceutical Companie...
As next-generation drugs require perfectly aligned manufacturing processes and packaging solutions, leading suppliers have announced the creation of the Matrix Alliance. Their mission is to bring to market complete and compelling solutions for aseptic ...
Zika Crisis Stresses Need for Pharma Industry
Zika Crisis Stresses Need for Pharma Industry
Do police departments and phar­maceutical companies have anything in common? Correct: Both are routinely vilified until a crisis occurs. Case in point? By now every­­one is aware that the Zika virus — spread initially by mosquitoes...
How to Stop Drug Price Gouging
How to Stop Drug Price Gouging
One of Donald Trump's few universally welcomed campaign promises was to do something about the prices of pharmaceutical drugs.
Making Drugs Work Better: Four New Drug Delivery Methods
Making Drugs Work Better: Four New Drug Delivery Methods
Inside tiny wells that are able to hold liquid around a third of the volume of a raindrop, scientists use human cells to examine the potential of a compound to become a drug. Thousands of these drug candidates can be tested each day for the desired bio...
Will Organs on Chips Revolutionize Drug Trials?
Will Organs on Chips Revolutionize Drug Trials?
In a laboratory at Harvard University, there is a small plastic chip that can breathe like a human lung. There are also chips that function like mini hearts, livers, kidneys, and intestines.
Value Pricing For Drugs: Whose Value, What Price?
Value Pricing For Drugs: Whose Value, What Price?
It is hard to read a newspaper these days without coming across a story about the high and ever increasing cost of drugs. The Wall Street Journal named drug prices the top health story of 2015. Stories about drug prices fall into two general categories...
Cannabis Drug Succeeds in Epilepsy, Doubling Value of GW Pharma
Cannabis Drug Succeeds in Epilepsy, Doubling Value of GW Pharma
An experimental cannabis-based drug has successfully treated children with a rare form of severe epilepsy in a keenly anticipated clinical trial, more than doubling the value of its maker GW Pharmaceuticals. The study of GW's Epidiolex in Dravet syndro...
Researchers Develop Versatile Building Blocks That Could Be Useful in Pharmaceutical Research
Researchers Develop Versatile Building Blocks That Could Be Useful in Pharmaceutical Research
Researchers in the Doyle lab at Princeton have developed a direct cross-coupling reaction to produce nitrogen-containing compounds called 1,2-dihydropyridines, versatile building blocks that are highly useful in pharmaceutical research. Published in Ch...
Impact of GST On Pharmaceutical Industry
Impact of GST On Pharmaceutical Industry
2016-17 has been tenure of prolific significance, as India saw a plethora of reforms, set to change how the market functions. Amongst the lot, GST is the single biggest tax reform which all industries are witnessing today. Yet, there is a great deal of...
Supreme Court Patent Case Has Major Implications For Drugmakers
Supreme Court Patent Case Has Major Implications For Drugmakers
The pharmaceutical industry is closely watching a case that went before the U.S. Supreme Court over who should potentially have the upper hand in many patent battles between generic and brand-name drug makers. The case, Cuozzo Speed Technologies v. ...
Groups Challenge Explanation of Drug Price Cap Initiative
Groups Challenge Explanation of Drug Price Cap Initiative
Industry groups have filed a court challenge to the South Dakota attorney general's explanation of a ballot question that would cap how much state agencies could pay for prescription drugs.
Report: Nearly 80 Percent of US Prescriptions Are For Generic Drugs
Report: Nearly 80 Percent of US Prescriptions Are For Generic Drugs
The United States is the biggest generic drugs market in the world, with nearly 80 percent of prescriptions in American written for generics, according to Research and Markets' "Analyzing the Generic Drugs Sector of the U.S. Pharmaceutical Industry 2017."
Orphan Drugs: Pursuing Value And Avoiding Unintended Effects Of Regulations
Orphan Drugs: Pursuing Value And Avoiding Unintended Effects Of Regulations
Amid ongoing scrutiny of high pharmaceutical drug prices, debate about the value of "orphan drugs" - those designed to treat rare conditions that affect fewer than 200,000 individuals - continues to capture public and policy maker attention.
What Can Scott Gottlieb Do To Advance The FDA & Clinical Trials?
What Can Scott Gottlieb Do To Advance The FDA & Clinical Trials?
On May 11, Scott Gottlieb, M.D., officially became the 23rd commissioner of the U.S. Food and Drug Administration (FDA). Dr. Gottlieb has previous FDA experience, having served as deputy commissioner for medical and scientific affairs, among other posi...
The Effects of the Trans-Pacific Partnership On Pharmaceutical Innovation
The Effects of the Trans-Pacific Partnership On Pharmaceutical Innovation
According to author Robert A. Freeman, PhD, there are three main areas of controversy. First, pharmaceutical prices will be driven up, with especially negative effects on low-income countries. Second, there is potential for litigation for individual co...
Pharmaceuticals Represent the Fastest-Growing Thermoform Packaging Segment
Pharmaceuticals Represent the Fastest-Growing Thermoform Packaging Segment
The pharmaceutical segment is estimated to be the fastest-growing thermoform segment in 2016, experiencing a higher growth rate than the food and beverage and electronics industries, primarily due to rising disposable incomes and an aging population.
FDA Approves Briviact To Treat Partial Onset Seizures
FDA Approves Briviact To Treat Partial Onset Seizures
The U.S. Food and Drug Administration recently approved Briviact as an add-on treatment to other medications to treat partial onset seizures in patients aged 16 years and older with epilepsy.
FDA Releases Guidance to Assist Development of Advanced Technology to Modernize Pharmaceutical Ma...
FDA Releases Guidance to Assist Development of Advanced Technology to Modernize Pharmaceutical Ma...
On Dec. 23, 2015, the Food and Drug Administration (FDA) released draft guidance on the Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base. This was a positive step towards helping pharmaceutical companie...
Will There Be a Brexit Boom?
Will There Be a Brexit Boom?
While some analysts have warned that U.K.-based pharmaceutical companies may lose access to European Union markets once the country falls out of the bloc’s system and loses access to central marketing authorization for new drugs, such dangers are...
Ovarian Cancer And Talc: Did Junk Science Cost J&J?
Ovarian Cancer And Talc: Did Junk Science Cost J&J?
Johnson & Johnson is an immense pharmaceutical and consumer products company of the type that the public loves to hate. Recently, it's been getting absolutely killed by juries holding its baby powder responsible for causing several women's ovarian canc...
FDA Announces Sweeping Review of Policies Related To Opioid Drugs
FDA Announces Sweeping Review of Policies Related To Opioid Drugs
The U.S. Food and Drug Administration has launched a review into its policies involving opioid drugs, prompted by figures showing that overdose from an opioid drug is now the leading cause of death by injury in the United States.
Tackling the Prior Authorization Challenge: A Critical Task for Pharma
Tackling the Prior Authorization Challenge: A Critical Task for Pharma
Talk with busy physicians and you'll soon hear about the ever-increasing difficulty in getting approval for the medications that they believe are most appropriate for their patients.
Synthetic Biology Bites Back at Global Snake Antivenom Shortage
Synthetic Biology Bites Back at Global Snake Antivenom Shortage
When the medical charity Médecins Sans Frontières called the worldwide shortage of snake antivenom a public-health crisis last September, Brazilian biochemist Paulo Lee Ho wasn’t surprised. He has spent his career at São Paulo̵...
Drug Shortages in American Emergency Rooms Have Increased More Than 400 Percent
Drug Shortages in American Emergency Rooms Have Increased More Than 400 Percent
Emergency rooms are healthcare's front line — in the United States, nearly 45 out of 100 people visit an ER in any given year. But there's an issue brewing behind the scenes in emergency medical facilities, one that can't be fixed by a simple sti...
WHO Suspends Tuberculosis Drugs From Major Indian Supplier
WHO Suspends Tuberculosis Drugs From Major Indian Supplier
The World Health Organization (WHO) reportedly suspended its approval of all tuberculosis products made at India’s Svizera Labs citing unreliable manufacturing standards and quality management. The company is one of the largest suppliers of gener...
Pharmaceutical Industry-Sponsored Meals Associated With Higher Prescribing Rates
Pharmaceutical Industry-Sponsored Meals Associated With Higher Prescribing Rates
Accepting a single pharmaceutical industry-sponsored meal was associated with higher rates of prescribing certain drugs to Medicare patients by physicians, with more, and costlier, meals associated with greater increases in prescribing, according to an...
A Tale of Two Drug Bills - One Proposed Bill Will Worsen the Drug Prices Crisis
A Tale of Two Drug Bills - One Proposed Bill Will Worsen the Drug Prices Crisis
Both opioid abuse and the high price of medication have wreaked hell on Americans and their families, and now two very different bills in Congress that affect drug importation aim to alleviate these crises. However, if the pharmaceutical industry has i...
As Drug Prices Soar, Value-Based Pay Hits Pharmaceutical Industry
As Drug Prices Soar, Value-Based Pay Hits Pharmaceutical Industry
More health insurance companies are deciding to pay for a drug based on whether it's effective and provides the patient a good outcome as value-based care inches toward the pharmaceutical industry, insurers and a new analysis indicate.
Ten Hot-Button Issues FDA's New Commissioner Will Face
Ten Hot-Button Issues FDA's New Commissioner Will Face
Like his predecessors, Scott Gottlieb, the newly sworn-in commissioner of the U.S. Food and Drug Administration (FDA), will have a full plate to tackle as he takes the reins of the short-staffed agency.
Can AI Improve Sales Productivity in Pharma?
Can AI Improve Sales Productivity in Pharma?
For years, pharmaceutical sales representatives have been dealing with access challenges and shrinking availability of prescribers, stemming from a more restrictive regulatory environment, changing economic conditions and new healthcare business models...
Watch For These Red Flags When Dispensing Opioid Prescriptions
Watch For These Red Flags When Dispensing Opioid Prescriptions
When I graduated from pharmacy school almost 25 years ago, filling prescriptions for opioids in a community setting wasn't a topic of great concern. We did it. We made sure the dosing was appropriate and counseled the patients about side effects such a...
A Faster, More Flexible, and Frugal FDA?
A Faster, More Flexible, and Frugal FDA?
A top priority for FDA this year has been to gain speedy Congressional approval of new user fee reauthorization bills. Now, White House proposals to slash funding for federal health agencies and to boost FDA reliance on medical product fees makes that ...
The Impact of a 'Hard Brexit'
The Impact of a 'Hard Brexit'
In January, the prime minister, Theresa May, warned the E.U. that "no deal for Britain is better than a bad deal" when it comes to Brexit. Although her government is now edging away from that position, the statement raised the question of what no deal ...
A Drug That's 100 Times More Potent Than Fentanyl Surfaces in North America
A Drug That's 100 Times More Potent Than Fentanyl Surfaces in North America
A powerful drug has been found by police in Canada and is raising concerns that a deadly new trend is emerging in North America’s drug scene. Called W-18, the drug is a synthetic opioid that officials say is 100 times more powerful than fentanyl ...
Fast-Tracking Drug Development One Robot At a Time
Fast-Tracking Drug Development One Robot At a Time
The pharmaceutical industry is going through a tough phase as it strives to manage high R&D costs and skyrocketing drug prices, along with the spike in regulatory controls.
How a Painkiller Designed To Deter Abuse Helped Spark an HIV Outbreak
How a Painkiller Designed To Deter Abuse Helped Spark an HIV Outbreak
When Kevin Polly first started abusing Opana ER, a potent prescription opioid painkiller, he took pills — or fractions of pills — and crushed them into a fine powder, then snorted it. When Opana pills are swallowed, they release their paink...
Fast-Rising Drug Prices Hit Hospitals Hard in Bottom Lines
Fast-Rising Drug Prices Hit Hospitals Hard in Bottom Lines
When drug costs rose $20 million in one year for Beaumont Health in suburban Detroit, CEO John Fox asked executives like Kathy Pawlicki, vice president for pharmacy, why and what could be done about it.
The Gender Diversity Dearth in Pharma
The Gender Diversity Dearth in Pharma
Yahoo CEO Marissa Mayer is pregnant again, this time with twin girls. And once again, her pregnancy is newsworthy. Some sources are critical of her plan to take only two weeks of maternity leave as she did with her first child, rather than take advanta...
New Study Highlights Current Trends And Challenges Facing Pharmaceutical Industry Collaborations ...
New Study Highlights Current Trends And Challenges Facing Pharmaceutical Industry Collaborations ...
Patient advocacy groups are a trusted source for patients seeking information on a disease or new therapies. For pharmaceutical companies, strong relationships with advocacy groups are an effective way to reach patients.
Artificial Intelligence To Usher in New Era of Drug Safety Automation
Artificial Intelligence To Usher in New Era of Drug Safety Automation
Genpact is investing in leading digital technologies that are transforming industries. Genpact’s Pharmacovigilance Artificial Intelligence (PVAI) will be the life sciences industry's first fully-integrated, end-to-end adverse event (AE) processin...
Policy Policymakers Face Pressure to Act on Drug Pricing
Policy Policymakers Face Pressure to Act on Drug Pricing
A proposal that would open the door for the import of low-cost prescription drugs from Canada was defeated at a Senate markup, but the proposal is unlikely to be gone for good. Lawmakers from both parties seem to want to demonstrate concern about drug ...
Can FDA Control Drug Prices?
Can FDA Control Drug Prices?
Economists and policymakers agree that more competitive pharmaceutical markets can yield lower-cost drugs. FDA approval of generics following the loss of patent protection can send brand prices plummeting, particularly after multiple copycats gain entr...
In Development: New Generation of Superbug Drugs
In Development: New Generation of Superbug Drugs
New research published in the journal Nature reveals the mechanism by which drug-resistant bacterial cells maintain a defensive barrier. The findings pave the way for a new wave of drugs that kill superbugs by bringing down their defensive walls rather...
New Genetic Research Can Significantly Improve Drug Development
New Genetic Research Can Significantly Improve Drug Development
According to a new study published in the International Journal of Epidemiology, genetic research in large-scale prospective biobank studies can significantly improve the drug development pipeline and reduce costs.
How the Pharmaceutical War On the 'Superbug' Is Really Playing Out
How the Pharmaceutical War On the 'Superbug' Is Really Playing Out
Will the recent drug developments in fighting MRSA give rise to new, worse superbugs instead? Originally appeared on Quora — the knowledge sharing network where compelling questions are answered by people with unique insights.
Will Pharmaceutical Companies Kill the Death Penalty?
Will Pharmaceutical Companies Kill the Death Penalty?
Recently, Pfizer became the latest and largest pharmaceutical company to ban the use of its products in lethal injections.
Using Real-World Evidence to Propel Personalized Treatments, Improve Clinical Trial Outcomes
Using Real-World Evidence to Propel Personalized Treatments, Improve Clinical Trial Outcomes
Compared to 2006 when approximately 13 personalized treatment options were available, in 2014 that number increased to 113 personalized medicine drugs, treatments, and diagnostic products, according to the Personalized Medicine Coalition.
Prescribed Reading: Pharma Marked By Restructuring And Failures
Prescribed Reading: Pharma Marked By Restructuring And Failures
Biopharma is a complex, rapidly evolving industry that is highly regulated and closely watched - and that means there is constant news. Here's a closer look at the clinical trials, M&A, cool science and regulations that are driving the industry this week.
Authentic Drugs Tagged with Plant DNA Could Help Snare Fake Meds
Authentic Drugs Tagged with Plant DNA Could Help Snare Fake Meds
In the U.S. it’s uncommon to encounter counterfeit pharmaceuticals, drugs that are manufactured illegally and passed off as the genuine articles. But in countries with weaker regulatory systems such as India and Nigeria these drugs make up 25 to ...
Complicated vs Complex Challenges in Pharma
Complicated vs Complex Challenges in Pharma
The pace, scope, and variety of challenges we face as executives in Pharma are both invigorating and overwhelming. They span macro trends such as personalized medicine, real-world-evidence (RWE), onerous regulatory pressures, collaborative R&D and Digi...
Can We Find New Uses For Old Drugs?
Can We Find New Uses For Old Drugs?
Humans have been “repurposing” for centuries. Today we turn old churches into museums, schoolhouses into condos, old tires into artificial turf, and plastic bottles into dress pants. Drugs have become a new and exciting target for this acti...
Solving And Satisfying All of the Complex Regulatory And Compliance Rules
Solving And Satisfying All of the Complex Regulatory And Compliance Rules
The pharmaceutical industry operates under a plethora of regulations and organizations have to comply with the intricate regulatory system for a very good reason: protecting patient safety.
Another Fatal-Disease Drug in Limbo
Another Fatal-Disease Drug in Limbo
An advisory panel for the U.S. Food and Drug Administration (FDA) voted that Sarepta Therapeutics’s eteplirsen has not been proven effective in the treatment of Duchenne muscular dystrophy (DMD), a rare and fatal disease for which there is curren...
US Approves First Drug for Psychosis Linked to Parkinson's
US Approves First Drug for Psychosis Linked to Parkinson's
Acadia Pharmaceuticals’s drug for psychosis linked to Parkinson’s disease was approved in the United States on Friday, becoming the first treatment for the condition to get a nod in the country. The U.S. Food and Drug Administration, howeve...
FDA Guidance Unlocks Pharma Opportunities
FDA Guidance Unlocks Pharma Opportunities
In response to the hundreds of drug shortages that have been reported in recent years, the U.S. Food and Drug Administration (FDA) is working with pharmaceutical manufacturers to help them identify and implement new, scientifically sound technologies. ...
Facing Cancer Drug Shortage, US Relies On Banned Chinese Plant
Facing Cancer Drug Shortage, US Relies On Banned Chinese Plant
Last September, U.S. regulators faced a dilemma: whether to allow importation of drug ingredients from a Chinese factory with a history of poor quality controls, or face shortages of treatments for American cancer patients.
Technology And Medicine: New Treatments For Diabetes Patients
Technology And Medicine: New Treatments For Diabetes Patients
The technological revolution continues to foster advances in medicine at an increasingly rapid rate. In diabetes treatment, monitoring and care, state-of-the-art "gadgets" have made the management of this disease easier and allowed and encouraged more ...
Precision Medicine and the 21st Century Cures Act
Precision Medicine and the 21st Century Cures Act
On July 10, 2015, a bill for the 21st Century Cures Act passed the House of Representatives by a very large margin: 344 to 77. The bill is currently before the Senate, and although nothing in life is certain but death and taxes, the bill is expected to...
HHS Rule Agenda Delays 340B Rules, Guidance
HHS Rule Agenda Delays 340B Rules, Guidance
The latest HHS regulatory agenda pushes back the expected release dates for rules and a guidance that would affect pharmaceutical companies participating in the federal 340B drug discount program.
Why Big Pharma Is Struggling to Profit From the Obesity Epidemic
Why Big Pharma Is Struggling to Profit From the Obesity Epidemic
Drugmakers such as Novartis AG, Novo and Sanofi are pushing ahead, testing even more advanced medicines they hope will deliver greater weight loss than the drugs available today. Once seen as a problem only in wealthier countries, obesity is on the ris...
Drug Treatment Reduces Risk of Skin Cancer in Transplant Patients
Drug Treatment Reduces Risk of Skin Cancer in Transplant Patients
It is well documented that solid organ transplant recipients (OTRs) are at greater risk of developing skin cancer following transplant surgery. However, a new study conducted by Harvard Medical School researchers found that an immunosuppressive drug lo...
Generic Drugs: A Bargain Or Sticker Shock?
Generic Drugs: A Bargain Or Sticker Shock?
Generic drugs, normally a bargain alternative to name-brand pharmaceuticals, are providing some sticker shock of their own. Prices of generic drugs rose more steeply than inflation for 22 percent of the top-selling generics on the market, according to ...
Too Many 'Me-Too' Cancer Drugs? FDA Official Asks
Too Many 'Me-Too' Cancer Drugs? FDA Official Asks
A new type of cancer drug that takes the brakes off the body's immune system has given drugmakers some remarkable wins against the deadly disease, but a top U.S. regulator says too many companies are focused on the same approach.
Clinical Testing And Scale-Up of Affordable Hep C Drug
Clinical Testing And Scale-Up of Affordable Hep C Drug
The Drugs for Neglected Diseases initiative (DNDi) and the Egyptian drug manufacturer Pharco Pharmaceuticals have signed agreements covering the clinical testing and scale-up of a hepatitis C treatment regimen at a price of just under $300. If our ...
FDA Calls For Industry Input On Continuous Manufacturing Guidelines
FDA Calls For Industry Input On Continuous Manufacturing Guidelines
The FDA clearly wants more companies to transition to continuous manufacturing (CM), highlighting the approach's benefits in a blog post published.
How Is the Draft Pharma Policy Revamping Drug Price Regulation?
How Is the Draft Pharma Policy Revamping Drug Price Regulation?
The draft pharmaceutical policy has been recently circulated by the Department of Pharmaceuticals (DOP) to a select group of organizations.
In an Overlooked Corner of Pharma, Drastic Price Hikes Hit Medicines For Radiology Scans
In an Overlooked Corner of Pharma, Drastic Price Hikes Hit Medicines For Radiology Scans
Three years ago, pharmacist Dennis McClure was stunned by news from a key supplier.
Is There a Cure for High Drug Prices?
Is There a Cure for High Drug Prices?
The cost of prescription drugs for tens of millions of Americans rose $2 billion last year, and all signs point to a continued rise. At stake is nothing less than the ability of Americans to afford the medicines they need. Can we stop the madness?
FDA Asks Teva Pharmaceutical For Further Study On Huntington's Drug
FDA Asks Teva Pharmaceutical For Further Study On Huntington's Drug
Approval for Israel-based Teva Pharmaceutical Industries' drug to treat the neurological disorder chorea has been held up by U.S. regulators seeking further blood studies, the company said.
Zika Fears Spur Pharmaceutical Gold Rush Amid Vaccine Vacuum
Zika Fears Spur Pharmaceutical Gold Rush Amid Vaccine Vacuum
Before it became known as a deadly virus, Zika was just a lush forest on the north shores of Lake Victoria, a quiet sanctuary across from Tanzania and its gold mines. These days, the virus has sparked a gold rush of its own: companies are touting produ...
Serialization Will Be Good For Business, Pharma Says
Serialization Will Be Good For Business, Pharma Says
More than 70 percent of drugmakers believe serialization requirements in the U.S. will positively transform their business processes, according to a new report.
New Study Outlines Pharmaceutical Industry Spending for New Product Launch Activities Before and ...
New Study Outlines Pharmaceutical Industry Spending for New Product Launch Activities Before and ...
The launch landscape for new pharmaceutical products continues to evolve. To keep up with market and technology changes, the pharmaceutical industry has to continually shift its investment patterns for the activities that support a new product launch.
Generic Drugs: Revolutionary Change in the Global Pharmaceutical Industry
Generic Drugs: Revolutionary Change in the Global Pharmaceutical Industry
Over the last few years, generic drugs — low-cost copies of branded drugs — have been gaining in volume and market share. Typically priced at significant discounts (50-70 percent) to their branded counterparts, health plans and governments ...
Creation of New Molecules For New Formulas Results Into New Fuels & Medications
Creation of New Molecules For New Formulas Results Into New Fuels & Medications
A research at the University of California, LA led to the creation of new molecules essential to formulate new forms of fuel and will cause an impact to the pharmaceutical industry. The new molecules will be building blocks when fused with elements tha...
The Next Pharmaceutical Revolution Could Be 3-D Bioprinted
The Next Pharmaceutical Revolution Could Be 3-D Bioprinted
Body organs such as kidneys, livers and hearts are incredibly complex tissues. Each is made up of many different cell types, plus other components that give the organs their structure and allow them to function as we need them to.
Ibuprofen Patch Heralds Side Effect Free Drug Future
Ibuprofen Patch Heralds Side Effect Free Drug Future
An ibuprofen patch that delivers the painkiller directly through the skin to the site of pain, at a consistent dose for up to 24 hours, has been developed by U.K. researchers. University of Warwick research chemist Professor David Haddleton told Reuter...
China's War On Big Pharma Exposes The Mirage Of Market Access
China's War On Big Pharma Exposes The Mirage Of Market Access
A recent ChinaFile report makes pretty bleak reading for “Big Pharma.” Long regarded as the next great hope for market expansion, the mirage of China keeps receding into the middle distance. Always there, always out of reach. This time the ...
The War On Drugs Is Over. Big Pharma Won
The War On Drugs Is Over. Big Pharma Won
For years the government's "war on drugs" focused on stopping the production of illegal drugs in countries like Bolivia, Peru, Mexico and Afghanistan.
Some Popular Heartburn Drugs Have Been Linked to Dementia
Some Popular Heartburn Drugs Have Been Linked to Dementia
A popular group of heartburn drugs may be linked to dementia in seniors. A German study published in the medical journal JAMA Neurology found that seniors who regularly took proton-pump inhibitors like Nexium, Prilosec, and Prevacid were 44 percent mor...
Modernizing And Strengthening Existing Laws To Control Drug Costs
Modernizing And Strengthening Existing Laws To Control Drug Costs
In his first pre-inaugural press conference on Jan. 11, President Trump stated the pharmaceutical industry has been "disastrous" and is "getting away with murder."
First 6-Month Implant to Treat Opioid Addiction
First 6-Month Implant to Treat Opioid Addiction
Titan Pharmaceuticals, Inc., and partner Braeburn Pharmaceuticals today announced that the Psychopharmacologic Drugs Advisory Committee (PDAC) of the FDA voted 12 to 5 in favor of approving Probuphine, the first long-acting, subdermal buprenorphine imp...
Senate Clears Hurdle To Open Debate On Healthcare
Senate Clears Hurdle To Open Debate On Healthcare
Senators voted, 51-50, Tuesday afternoon on a motion to proceed with debate on a healthcare bill when Vice President Mike Pence broke a tie with the decisive vote.
The Road Ahead For Innovative Medical Plastics Packaging
The Road Ahead For Innovative Medical Plastics Packaging
Within the broad expanse of medical package development there are several simultaneous medical packaging challenges that always need to be taken into account. The development of innovative packaging starts with a complete understanding of the device or...
Patient Involvement Could Improve Medicines R&D, Industry Personnel Suggest
Patient Involvement Could Improve Medicines R&D, Industry Personnel Suggest
A new study has revealed a belief among pharmaceutical industry personnel that greater involvement of patients and the public could improve medicines research and development (R&D). The study, which is one of the first of its kind and part of the wider...
FDA OKs First New Treatment for Sickle Cell in Almost 20 Years
FDA OKs First New Treatment for Sickle Cell in Almost 20 Years
The U.S. Food and Drug Administration has approved L-glutamine oral powder (Endari) to reduce severe complications of sickle cell disease in patients aged 5 years and older with the disorder. This is the first approval for the rare disorder in almost 2...
Trump Needs To Back Bioscience To Boost US Drug Making Say Experts
Trump Needs To Back Bioscience To Boost US Drug Making Say Experts
President Donald Trump should foster biotech investment if he wants more U.S.-made pharmaceuticals say experts who argue that cutting regulations to attract small molecule drug manufacturers will only have a limited effect.
FDA Releases Annual Report on Generics
FDA Releases Annual Report on Generics
On April 13, 2016, FDA’s Office of Generic Drugs (OGD) in the Center for Drug Evaluation and Research (CDER) released their first annual report. The report states that FDA met or exceeded their performance goals for 2015. According to OGD, more t...
Medicare's Drug-Pricing Experiment Stirs Opposition
Medicare's Drug-Pricing Experiment Stirs Opposition
A broad proposal by Medicare to change the way it pays for some drugs has drawn intense reaction and lobbying, with much of the debate centering on whether the plan gives too much power over drug prices to government regulators.
Novel Antibiotic Isolated From Human Nose
Novel Antibiotic Isolated From Human Nose
A new antibiotic that can kill meticillin-resistant Staphylococcus aureus (MRSA) has been discovered in the human nose by researchers at the University of Tubingen in Germany.
US FDA Sounds Alert On Quality Issues in Indian Pharma
US FDA Sounds Alert On Quality Issues in Indian Pharma
Quality is a challenge for the Indian pharmaceutical sector, the largest supplier of drugs to the United States, according to a recent blog by the U.S. Food and Drug Administration.
'Drug Transparency': Each Bill Needs Careful Evaluation
'Drug Transparency': Each Bill Needs Careful Evaluation
Author Tom Norton writes: About a month ago, I received a breathless email from a colleague who was following the Vermont Drug Transparency debate in Montpelier. The measure was signed into law on June 2, 2016, and he felt it would "lead the U.S. Pharm...
Gottlieb Vows To Uphold FDA's 'Gold Standard'
Gottlieb Vows To Uphold FDA's 'Gold Standard'
Ever since President Donald Trump was inaugurated in January, he has pledged to cut burdensome regulations on businesses and industry. When it comes to the pharmaceutical industry, Trump vowed to "slash the restraints" on drug development.
AI Provides New Insights for Accelerated Drug Development
AI Provides New Insights for Accelerated Drug Development
The enormous cost associated with drug development is one of the biggest challenges for pharmaceutical manufacturers. With an estimated cost of $2.6 billion and more than 10 years (1) to develop and test a drug candidate, the pharmaceutical industr...
DEA Steps in To Help Curb Opioid Crisis
DEA Steps in To Help Curb Opioid Crisis
The use of opioids in the United States has reached a point at which it is now considered to be a major public health concern due to the alarming rates of overdose and death. President Donald Trump also recognizes that the opioid crisis is one that req...
The False Drug Pricing Problem
The False Drug Pricing Problem
Where would you want to live if you had cancer? If you worried about high drug prices, you would avoid the U.S. But a new study presented at the annual meeting of the American Society of Clinical Oncology suggests that cancer drugs are actually more af...
Handling of Injectable Powders with Vacuum-Pressure Dosing Systems
Handling of Injectable Powders with Vacuum-Pressure Dosing Systems
The unpredictable nature of injectable pharmaceutical powders makes it imperative for the packaging sector to use machines that deliver tight dose control. For this particularly volatile — and understandably stringently-controlled — subset ...
How the FDA Boosts the Costs of New Drugs
How the FDA Boosts the Costs of New Drugs
Many aspects of the GOP's newly proposed A Better Way healthcare plan would improve the health system. But "A Better Way" seems to mean "Much of the Same" when dealing with Food and Drug Administration regulation.
The Past, Present, and Future of Government Regulation of Off-Label Communications
The Past, Present, and Future of Government Regulation of Off-Label Communications
In 1998, the U.S. District Court for the District of Columbia ruled that FDA’s guidance documents Industry-Supported Scientific and Educational Activities and Advertising and Promotion were unconstitutional because they unduly burdened manufactur...
Drug Spending May Be Slowing Down in US
Drug Spending May Be Slowing Down in US
The high costs of prescription drugs in the United States has been a prevalent topic of conversation within the last few years, and this largely aligns with the United States being recognized for paying the highest prices for drugs in the world.
Antiretroviral Therapy Virtually Eliminates HIV Transmission Within Couples
Antiretroviral Therapy Virtually Eliminates HIV Transmission Within Couples
Effective antiretroviral therapy (ART) virtually eliminates the risk of HIV transmission to an uninfected partner, according to a study of serodiscordant couples.
Avoiding a CIA: Analytics And the Search For Dangerous Data
Avoiding a CIA: Analytics And the Search For Dangerous Data
When it comes to promoting compliance in the pharmaceutical industry, corporate integrity agreement may be the most important - and most onerous - tools in the government's toolbox.
FDA Approves First Cancer Treatment For Any Solid Tumor With a Specific Genetic Feature
FDA Approves First Cancer Treatment For Any Solid Tumor With a Specific Genetic Feature
The U.S. Food and Drug Administration granted accelerated approval to a treatment for patients whose cancers have a specific genetic feature (biomarker).
Damages For Pharmaceutical Patent Infringement: Federal Court Gives Long Awaited Guidance
Damages For Pharmaceutical Patent Infringement: Federal Court Gives Long Awaited Guidance
Last week, the Federal Court handed down the important decision in Bayer Pharma Aktiengesellschaft v Generic Health Pty Ltd [2017] FCA 2501 regarding the assessment of damages for pharmaceutical patent infringement. Being the first reported Australian ...
USDA Considering Changes in Biotechnology Regulations
USDA Considering Changes in Biotechnology Regulations
USDA is seeking public comment on whether the agency should draw up new rules to regulate biotechnology products. This comes after heavy criticism for not conducting environmental assessments on the potential effects of biotech crops. The agency is als...
The State of the Biosimilars Industry
The State of the Biosimilars Industry
Biosimilars continue to gain momentum in the U.S. To date, two biosimilars have been approved in the U.S., with many more in production and going through clinical trials.
FDA Warns About Serious Heart Problems With High Doses of the Antidiarrheal Medicine Loperamide (...
FDA Warns About Serious Heart Problems With High Doses of the Antidiarrheal Medicine Loperamide (...
The U.S. Food and Drug Administration is warning that taking higher than recommended doses of the common over-the-counter (OTC) and prescription diarrhea medicine loperamide (Imodium), including through abuse or misuse of the product, can cause serious...
How To Reduce Medicare Drug Costs
How To Reduce Medicare Drug Costs
Prescription drug spending in Medicare has been rising fast, but it is not completely clear what policies are driving the increases. The Obama administration hopes to find ways to control costs by testing different approaches to paying for the drugs. T...
Can Better Modeling Reduce Pharmaceutical Development and Manufacturing Costs?
Can Better Modeling Reduce Pharmaceutical Development and Manufacturing Costs?
In the U.K., a new four-year initiative has been launched to streamline drug development and manufacturing by leveraging better computer-based process modeling and simulation. Dubbed Advanced Digital Design of Pharmaceutical Therapeutics (ADDoPT), the ...
CDC, FDA Take Action To Curb Opioid Abuse
CDC, FDA Take Action To Curb Opioid Abuse
The Centers for Disease Control and Prevention (CDC) has released new guidance on the prescribing of opioids for chronic pain in an effort to combat the national prescription painkiller epidemic. The new guidelines mark the first time the CDC has made ...
Texas Joins Multistate Investigation Into Opioid Manufacturers' Role in Nationwide Epidemic
Texas Joins Multistate Investigation Into Opioid Manufacturers' Role in Nationwide Epidemic
Texas Attorney General Ken Paxton last week joined a coalition of state attorneys general who are investigating opioid manufacturers' marketing and sales practices to determine whether the companies have broken any laws, according to The Texas Tribune.
A Hard or Soft Brexit? More Uncertainty for the Life Sciences Industry
A Hard or Soft Brexit? More Uncertainty for the Life Sciences Industry
No-one thought Brexit would be easy and so far, the going has only gotten tougher. UK Prime Minister Theresa May had hoped that by calling an early election that she would have a stronger negotiating position with the European Union (EU). She was wrong.
How Big Pharma Uses Charity Programs to Cover for Drug Price Hikes
How Big Pharma Uses Charity Programs to Cover for Drug Price Hikes
In August 2015, Turing Pharmaceuticals and its then-chief executive, Martin Shkreli, purchased a drug called Daraprim and immediately raised its price more than 5,000 percent. Within days, Turing contacted Patient Services Inc., or PSI, a charity that ...
Sanders To Unveil Rule Requiring Drug Companies To Set Fair Prices
Sanders To Unveil Rule Requiring Drug Companies To Set Fair Prices
Sen. Bernie Sanders (I-Vt.) will unveil a new rule forcing pharmaceutical companies to set reasonable prices for drugs developed using research funded by federal research dollars, Huffington Post reported.
Decoding Big Pharma's Secret Drug Pricing Practices
Decoding Big Pharma's Secret Drug Pricing Practices
Health insurance companies buy prescription drugs the way U.S. consumers buy cars: There's the sticker price (which few people actually pay) and there's the negotiated price.
Martin Shkreli's Trial Shows Just How Angry People Are About Drug Prices
Martin Shkreli's Trial Shows Just How Angry People Are About Drug Prices
Martin Shkreli isn't actually on trial for buying an obscure antiparasitic drug used by AIDS patients and jacking up the price astronomically, but he might as well be.
Continuous Manufacturing: A Generic Industry Perspective
Continuous Manufacturing: A Generic Industry Perspective
The continuous manufacturing concept originated from pig iron production using a blast furnace, where the process operates for multiple years without shutdown. The approach is followed in production processes for oil refining, chemicals, synthetic fib...
Certain Steroids Raise Risk For Serious Staph Infections
Certain Steroids Raise Risk For Serious Staph Infections
People who use powerful drugs called systemic glucocorticoids are at higher risk for life-threatening staph blood infections, a new study finds. The findings are "a reminder for clinicians to weigh carefully the elevated risk against the potential bene...
Technology, Innovation Transforming Healthcare Packaging Market
Technology, Innovation Transforming Healthcare Packaging Market
Rising healthcare awareness and continuous innovation and technological developments in both pharmaceutical and medical industries are transforming the healthcare packaging industry, thereby driving the growth of the sterile medical packaging market. T...
Great Expectations: The Psychology of Switching From Brand Drugs To Generics
Great Expectations: The Psychology of Switching From Brand Drugs To Generics
The late Canadian novelist Robertson Davies once remarked that the eye sees only what the mind is prepared to comprehend. He could almost have been referring to oft-reported negative experiences of patients switching from branded to generic drugs.
Why Identity is Imperative for Pharma Companies
Why Identity is Imperative for Pharma Companies
Pharmaceutical companies are working hard to keep pace with the disruptions brought about by digital technology and a shifting health care landscape.
Drug Industry Overstates Impact of Patent Reviews On Innovation
Drug Industry Overstates Impact of Patent Reviews On Innovation
Drug makers complained bitterly last week after the U.S. Supreme Court left intact a controversial procedure for reviewing patent disputes, arguing that the decision threatens valuable research efforts and that patients will eventually suffer. But the ...
Medicinal Cannabis Treatments Coming, Experts Say
Medicinal Cannabis Treatments Coming, Experts Say
Medicinal cannabis industry officials and scholars here touted potential breakthroughs to treat health problems and questioned why cannabidiol (CBD) is not mandatory for athletes to address traumatic brain injury (TBI). Others, meanwhile, cautioned the...
Brexit Creates Supply Chain Uncertainty
Brexit Creates Supply Chain Uncertainty
For organizations operating in the EU, Britain's pending withdrawal, known as Brexit, may disrupt both physical supply chains as well as the information systems required to manage those supply chains. Depending on the final Brexit terms, organizations...
Prescription Drug Prices in America Are Rising Like No Other Industry
Prescription Drug Prices in America Are Rising Like No Other Industry
The high cost of prescription drugs has been causing pain and hardships for millions of Americans for years.
CDC Issues Guidelines To Limit Opioid Painkiller Prescriptions
CDC Issues Guidelines To Limit Opioid Painkiller Prescriptions
The Centers for Disease Control and Prevention released long-awaited guidelines to limit prescribing of opioid painkillers, the overuse of which has contributed to a pervasive and deadly epidemic in the U.S., the agency’s director said. The guide...
Vaccination During Pregnancy Protects Infants Against Flu
Vaccination During Pregnancy Protects Infants Against Flu
In children born to women given the flu vaccination during pregnancy, the risk of influenza is much lower. Vaccinating babies against influenza in the first six months of life is not effective. Passive protection via maternal immunisation may offer an ...
Industry Asks US FDA To 'Pause' Data Quality Reporting Plan
Industry Asks US FDA To 'Pause' Data Quality Reporting Plan
The U.S. regulator mooted the idea of quality metrics reporting in 2015, arguing the data would help it target inspection resources and more accurately predict shortages. The agency also said it would encourage manufacturers to adopt robust quality man...
How Will Brexit Impact The International Clinical Research Industry?
How Will Brexit Impact The International Clinical Research Industry?
Though the statement "we live in a global world" typically refers to healthcare and the environment, it truly applies to science, which spans country borders and languages. This is why the 2016 decision by the British electorate to leave the European U...
How Do Policies on Detailing Affect Branded Drug Rx?
How Do Policies on Detailing Affect Branded Drug Rx?
In recent years, many academic centers have enforced strict policies limiting access of pharmaceutical representatives to physicians.
Opening the Door For Medical Innovation
Opening the Door For Medical Innovation
The Food and Drug Administration announced on April 6 that it will allow the California-based genomics and biotechnology company 23andMe to sell direct-to-consumer tests for 10 genetic risks, including Parkinson's, late-onset Alzheimer's, Celiac and Ga...
FDA Finalizes Compounding Guidance
FDA Finalizes Compounding Guidance
The FDA recently published three final guidance documents regarding the compounding of drug products. The guidance documents address the regulation of firms that compound drugs and the compounding of bulk drug substances by FDA-registered outsourcing f...
Why Pharma Companies Prefer Drugs Over Vaccines
Why Pharma Companies Prefer Drugs Over Vaccines
When it comes to addressing disease, many industry observers and public health advocates believe that pharmaceutical companies prefer to invest in drugs rather than vaccines, as preventives are perceived to be inherently less profitable. A Harvard-Dart...
Modernizing the Pharmaceutical Manufacturing Base
Modernizing the Pharmaceutical Manufacturing Base
If we used a time machine to transport a pharmaceutical scientist from the 1960s into a current pharmaceutical production plant, it might be surprising to learn that he would already be familiar with most of the processes and production techniques bein...
Drug Companies Boosted Their Prices, Analysis Finds
Drug Companies Boosted Their Prices, Analysis Finds
Major drug companies have raised prices over the past five years, sometimes doubling them, a Reuters analysis found. Prices for four of the nation's top 10 drugs increased more than 100 percent since 2011, Reuters found. Six others went up more than 50...
Pharmaceutical Industry Under US Anti-Corruption Regulatory Spotlight
Pharmaceutical Industry Under US Anti-Corruption Regulatory Spotlight
While no industry is immune to corruption, the pharma industry has been the focus of both the SEC and DOJ for several years now. As the SEC’s enforcement chief, Andrew Cerezny, explained in his remarks at CBI’s Pharmaceutical Compliance Co...
How 3-D Printing Will Change the Pharmaceutical World Forever
How 3-D Printing Will Change the Pharmaceutical World Forever
New possibilities in 3-D printing may open up a whole new chapter of opportunities for pharmaceutical research and bio-technology applications. There are a number of ways it could be used — drug dosage forms, supporting delivery, or helping to re...
Challenging the Current Compliance Paradigm
Challenging the Current Compliance Paradigm
The compliance paradigm in pharma is flawed. My evidence, I confess, is largely anecdotal but as in medicine, a weight of anecdotal evidence does warrant further investigation and these are not simply my own observations.
Pharmacists And the Prescription Prior Authorization Process
Pharmacists And the Prescription Prior Authorization Process
Pharmacists working in the community pharmacy setting know the situation all too well. A patient brings in a prescription for a new medication.
FDA Approves Selexipag For Pulmonary Arterial Hypertension
FDA Approves Selexipag For Pulmonary Arterial Hypertension
The U.S. Food and Drug Administration (FDA) has approved selexipag to treat adults with pulmonary arterial hypertension (PAH), a chronic and progressive lung disease that causes high pressure in the arteries that connect the heart to the lungs. The dru...
Value-Based Pricing For Pharmaceuticals In The Trump Administration
Value-Based Pricing For Pharmaceuticals In The Trump Administration
Everyone seems to agree: Drug prices are too damn high. Scandalous prices for new drugs and enormous price hikes on old drugs have focused public ire on the pharmaceutical industry. A bipartisan consensus has emerged that something must be done to tack...
Pharmaceutical Applications of Supercritical Fluid Chromatography
Pharmaceutical Applications of Supercritical Fluid Chromatography
Although supercritical fluids were used as eluents for chromatographic separations in 1962, the term supercritical fluid chromatography (SFC) was first used only five years later. Since then, the technique has come a long way, particularly in the pharm...
Technology Selection Marked as the Biggest Hurdle in Serialization Compliance
Technology Selection Marked as the Biggest Hurdle in Serialization Compliance
A research, conducted by serialization system provider SEA Vision and life-science technology specialist Zenith Technologies, identified technology selection as the biggest challenge currently faced by the industry in the race to serialization complian...
High Drug Prices Prompt Demands for Transparency
High Drug Prices Prompt Demands for Transparency
Outraged by exorbitant prices for certain prescription drugs, lawmakers in at least 11 states have introduced legislation that would require pharmaceutical companies to justify their prices by disclosing how much they spend on research, manufacturing a...
Brand-Name Drug Makers Wary of Letting Generic Rival Join Their Club
Brand-Name Drug Makers Wary of Letting Generic Rival Join Their Club
For decades, brand-name and generic drug companies have fought each other in Congress, at international trade negotiations and in court.
Zika: Why Biotechnology Is Imperative To National Security
Zika: Why Biotechnology Is Imperative To National Security
When we think of national security, we think of tanks, jets, missile defense systems and more recently, information space. But what about the realm of the microscopic, the biological or the genetic? Whether you think biotechnology, genetics and microbe...
Best Practices for Pharmaceutical Waste
Best Practices for Pharmaceutical Waste
As more and more pharmaceutical companies launch into new projects, an even greater amount of pharmaceuticals are secreted into the environment. "Sustainability" has become commonplace in operational discussions; however, companies are still working to...
Life Sciences Regulation in India: The Need For Evolution
Life Sciences Regulation in India: The Need For Evolution
The life sciences industry has traditionally been classified as consisting of pharmaceuticals and healthcare.
Dementia Drug Could Help Prevent Falls in Parkinson's Disease Patients
Dementia Drug Could Help Prevent Falls in Parkinson's Disease Patients
A drug commonly prescribed to treat dementia could help prevent falls in patients with Parkinson’s disease, according to research published in The Lancet Neurology. Researchers from the University of Bristol found that patients with ParkinsonR...