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Contract Manufacturing Raises Regulatory Concerns
Contract Manufacturing Raises Regulatory Concerns
FDA officials continue to be alarmed about violative production practices and inadquate quality control at drug outsourcers, as seen in a rise in warning letters and citations to contractors and their pharma clients.
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.
How AI, Blockchain, And Big Data Can Reduce Drug Development Costs
How AI, Blockchain, And Big Data Can Reduce Drug Development Costs
It's no secret that drug prices are a controversial issue.
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.
President Trump's Plan to Lower Drug Prices Spares Pharma Industry
President Trump's Plan to Lower Drug Prices Spares Pharma Industry
President Donald Trump's long-promised plan to bring down drug prices would mostly spare the pharmaceutical industry he previously accused of "getting away with murder." Instead he focuses on private competition and more openness to reduce America's pr...
NIH Abruptly Changes Course On Industry Opioids Partnership After Ethics Flags Raised
NIH Abruptly Changes Course On Industry Opioids Partnership After Ethics Flags Raised
It's been touted by health officials for almost a year: a planned opioids research partnership worth roughly $400 million.
New Tool To Assess Largely Ignored Risk in Pharmaceutical Industry
New Tool To Assess Largely Ignored Risk in Pharmaceutical Industry
A new method to test the likelihood of a drug turning into a potentially harmful version of itself when it enters the body has been developed by researchers at Cardiff University.
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 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...
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.
FDA Lays Groundwork For Regulating 3D-Printed Drugs
FDA Lays Groundwork For Regulating 3D-Printed Drugs
The pharmaceutical industry tends to attract disruptive technology, as drug and device makers look to make therapeutic advances. But manufacturing - at least for the medicines themselves - has largely stuck to its tried-and-true ways, moving more slowl...
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...
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.
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...
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.
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.
Trump Hasn't Attacked Drug Prices, As He Promised He Would, During His First Year in Office
Trump Hasn't Attacked Drug Prices, As He Promised He Would, During His First Year in Office
Donald Trump raged against the pharmaceutical industry as a candidate. He accused drug companies of "getting away with murder" as president-elect. But he hasn't done too much to tackle prices as president yet.
AMR And Diagnostics: Pointing the Way To Better Infection Control
AMR And Diagnostics: Pointing the Way To Better Infection Control
Antimicrobial resistance - the ability of previously sensitive microorganisms to resist the effects of an antimicrobial agent - is a growing problem.
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...
Is It Time To Say Goodbye To ClinicalTrials.Gov?
Is It Time To Say Goodbye To ClinicalTrials.Gov?
It is an exciting time in the pharmaceutical industry. According to industry organization PHRMA, there are currently more than 7,000 new medicines under development with many being first in class treatments. Digital technology combined with medicine, g...
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...
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.
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.
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...
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.
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.
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...
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...
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.
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 ...
Drugmakers Can Give Free Drugs to Patients Losing Aid, US Says
Drugmakers Can Give Free Drugs to Patients Losing Aid, US Says
Drugmakers can provide free medication to patients who can't afford their prescriptions after a major industry-funded charity said it wouldn't offer patients assistance in 2018, the federal government said.
Most of House Panel against Cuts in NIH Research Overhead Costs
Most of House Panel against Cuts in NIH Research Overhead Costs
The Trump administration's proposed 10 percent cap on paying overhead costs for National Institutes of Health-funded projects would stifle vital research efforts and leave institutions scrambling to cover shortfalls, grant recipients told House appropr...
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 ...
FDA, EMA and PMDA Plot Harmonized Path for Antibiotics
FDA, EMA and PMDA Plot Harmonized Path for Antibiotics
Regulators from the U.S. Food and Drug Administration, European Medicines Agency and Japan's Pharmaceuticals and Medical Devices Agency, met in Tokyo last month to plot out an approach that would allow drugmakers to conduct a single development plan fo...
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...
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...
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...
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.
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.
The US Has A Fentanyl Shortage ... In The Clinic, Not On The Streets
The US Has A Fentanyl Shortage ... In The Clinic, Not On The Streets
My pharmaceutical irony meter exploded earlier this month when I learned that the U.S. Food and Drug Administration declared a nationwide shortage of many forms of injectable fentanyl citrate. This dosage form of the highly-potent opioid is often used ...
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.
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.
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.
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.
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.
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.
Study Yields More Than a Million New Cyclic Compounds, Some with Pharmaceutical Potential
Study Yields More Than a Million New Cyclic Compounds, Some with Pharmaceutical Potential
Researchers say they can now produce a vast library of unique cyclic compounds, some with the capacity to interrupt specific protein-protein interactions that play a role in disease. The new compounds have cyclic structures that give them stability and...
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...
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.
Pfizer Considers Sale of Consumer Healthcare Business
Pfizer Considers Sale of Consumer Healthcare Business
Pfizer is mulling over strategic alternatives for its consumer healthcare business including a sale in a move to allocate resources and capital to best serve patients and maximize share value. The U.S.-based pharma giant said that it may consider a ful...
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 ...
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.
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...
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.
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.
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."
Pharmaceutical Companies Face Harsher Antitrust Compliance Challenges
Pharmaceutical Companies Face Harsher Antitrust Compliance Challenges
On Nov. 16 2017, four months after seeking comments, the National Development and Reform Commission (NDRC) released its Price Conduct Guidelines for Operators of Drugs Prone to Shortages and APIs. These are the first price-related anti-monopoly guideli...
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.
Artificial Intelligence: Will It Change the Way Drugs Are Discovered?
Artificial Intelligence: Will It Change the Way Drugs Are Discovered?
The pharmaceutical industry is beginning to invest in artificial intelligence (AI), with many large pharmaceutical companies partnering with AI start-ups in 2017 in order to develop better diagnostics or biomarkers, to identify drug targets and to desi...
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.
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...
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...
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...
Adalimumab Tops List for Drug Spending, But Biosimilars Impact Impending
Adalimumab Tops List for Drug Spending, But Biosimilars Impact Impending
Adalimumab (Humira, AbbVie) a treatment for rheumatoid arthritis (RA), once again led the pack in drug invoice spending in 2016, with $13.6 billion spent, an excess of $3 billion more than the next highest spend, according to new data from the ...
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.
The Outsourcing of Pharmaceuticals
The Outsourcing of Pharmaceuticals
Patent expirations, growth of disease prevalence, and the greater availability of advanced diagnostic procedures have increased the discovery and development of new biopharmaceutical compounds at an exponential rate. Pharmaceutical outsourcing has beco...
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.
What Gilead Taught Pharma About Pricing a Cure
What Gilead Taught Pharma About Pricing a Cure
Debate over 'how to price a cure' entered the pharma industry lexicon when Gilead Sciences Inc. priced its highly effective hepatitis C drug Sovaldi (sofosbuvir) at $84,000 per treatment course.
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.
FDA Releases Resources Planning Report
FDA Releases Resources Planning Report
On April 4, 2018, FDA released a report, developed in consultation with PricewaterhouseCoopers LLP, that outlines the agency’s use of user-fee funding, its plan to modernize its time-reporting approach, and the development of its resource forecas...
Pharma Supply Chains To Become More Reliant on Holography
Pharma Supply Chains To Become More Reliant on Holography
Regulation is currently driving concerns for those involved in pharmaceutical manufacturing, production and distribution with governments, national agencies and those with responsibility for law enforcement moving to protect the sector from criminals a...
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?
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.
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.
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.
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...
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...
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.
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.
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...
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.
Could This Drug Help the Brain Recover After a Stroke?
Could This Drug Help the Brain Recover After a Stroke?
Despite years of effort, researchers have so far failed to find a pill you could take or a food you could eat to harden your brain against the injury that could be caused by a stroke.
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...
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...
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...
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.
The Why, How And When Of AI In The Pharmaceutical Industry
The Why, How And When Of AI In The Pharmaceutical Industry
Recently, pharmaceutical companies have been demonstrating a vivid interest in artificial intelligence (AI) applications for various research needs, catalyzed by the illustrative practical achievements of AI in solving more "traditional" tasks - overco...
'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...
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.
California Governor Signs Law To Make Drug Pricing More Transparent
California Governor Signs Law To Make Drug Pricing More Transparent
California Gov. Jerry Brown defied the drug industry Monday, signing the most comprehensive drug price transparency bill in the nation that will force drug makers to publicly justify big price hikes.
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.
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.
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...
Scientists Develop New Method To Make Drugs Smarter
Scientists Develop New Method To Make Drugs Smarter
Scientists from the University of Lincoln in the U.K. have created a new technique using nanotechnology which can make drugs more effective at reaching their target.
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.
How Data Science & Network Analytics Can Help Pharma Shift from Brand Centricity to Customer Cent...
How Data Science & Network Analytics Can Help Pharma Shift from Brand Centricity to Customer Cent...
Healthcare practitioners are getting sick of pharma sales reps. Over the past decade, many HCPs have significantly reduced the access they grant to pharmaceutical sales representatives: in 2008, roughly 80 percent of physicians were classified as ̶...
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.
Senate Plans 340B Oversight Hearings As Transparency Push Mounts
Senate Plans 340B Oversight Hearings As Transparency Push Mounts
The Senate health committee is planning an oversight hearing for the 340B drug discount program, signaling the first significant move in the upper chamber to follow the U.S. House of Representatives' push for 340B reforms.
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."
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).
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.
Fight Over Federal Drug Discount Program Continues in 2018
Fight Over Federal Drug Discount Program Continues in 2018
The battle over the fate of a 25-year-old federal drug discount program could heat up on Capitol Hill this year. At issue is the 340B discount program, which safety-net providers such as hospitals use to obtain often steep discounts on medications from...
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.
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...
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.
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...
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. ...
FDA Unveils Draft Guidance on Track and Trace
FDA Unveils Draft Guidance on Track and Trace
The FDA unveiled two new draft guidances to interpret certain terms and elaborate on the standards for the exchange of certain transaction information, history and statements.
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.
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...
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.
Drug Policy: The Year In Review, And The Year Ahead
Drug Policy: The Year In Review, And The Year Ahead
Last year was an unquestionably busy time for health care news of all kinds.
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.
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...
Why Pharma Strategic Planning Reduces Productivity And How To Fix It
Why Pharma Strategic Planning Reduces Productivity And How To Fix It
As is often the case in pharma, Emma Walmsley, the CEO of Glaxo, soon after taking office announced a reorganization of R&D, no doubt the product of a thoughtful strategic plan.
Can Taxing Pain Pills Alleviate the Opioid Epidemic?
Can Taxing Pain Pills Alleviate the Opioid Epidemic?
The opioid epidemic, which killed 64,000 Americans in 2016, is making governments resort to unprecedented policies for saving lives and preventing addiction in the first place.
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...
New Efforts Taking Root to Ease Off-Label Drug Promotion
New Efforts Taking Root to Ease Off-Label Drug Promotion
Legislative campaigns to ease restrictions on the off-label promotion of medicines could put patients' health at risk and leave them paying for costly drugs for which there is little evidence in support of their use, researchers said in a recent article.
Physicists Bring Order To Liquid Droplets, Offering Promise For Pharmaceutical Development
Physicists Bring Order To Liquid Droplets, Offering Promise For Pharmaceutical Development
A team of physicists has developed a method to generate and self-organize liquids into well-defined patterns, a breakthrough that offers potential new pathways for the development of more sophisticated pharmaceuticals and other consumer products.
Probe Into Generic Drug Price Fixing Set To Widen
Probe Into Generic Drug Price Fixing Set To Widen
Forty-five states and the Department of Justice are claiming that generic drug prices are fixed, and the alleged collusion may have cost U.S. business and consumers more than $1 billion.
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.
3 Trends in Pharma Globalization
3 Trends in Pharma Globalization
Nearly 60 to 70 percent of the healthcare market is still dominated by North America, and many smaller biopharma companies are reluctant to move beyond the established markets of the U.S., Europe and Japan.
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.
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 ...
These New Pharma Bros Are Wreaking Havoc on Prescription Drug Prices
These New Pharma Bros Are Wreaking Havoc on Prescription Drug Prices
For at least the past three years, Todd Smith and Benjamin Bove have crisscrossed the U.S., offering a sure-fire fix for struggling pharmaceutical companies. And wherever they go, the price of prescription drugs tends to skyrocket.
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.
How Digital Sensors Could Change the Face of Pharma
How Digital Sensors Could Change the Face of Pharma
Earlier this week, Proteus Digital Health and Otsuka Pharmaceuticals announced that Abilify MyCite, a new, sensor-enabled version of Otsuka’s drug for schizophrenia, had received FDA approval for mental health conditions including schizophrenia a...
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.
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...
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 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 ...
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...
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.
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...