omni
aaps
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...
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...
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.
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 ̶...
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...
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.
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...
AI in Medicine Gets Closer To Making Regular Rounds
AI in Medicine Gets Closer To Making Regular Rounds
The Food and Drug Administration recently approved a software algorithm that helps doctors identify hand fractures in X-rays.
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.
Pharma And Biotech Leaders Back 'No Deal' Brexit Warning
Pharma And Biotech Leaders Back 'No Deal' Brexit Warning
A cross-party committee of MPs has urged the Government to secure a post-Brexit deal with Europe to protect patients and the UK's pharma and biotech sectors.
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...
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 ...
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.
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.
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.
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.
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.
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.
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.
FDA Prepping for Push of New Gene and Cell Therapies
FDA Prepping for Push of New Gene and Cell Therapies
In addition to new draft guidance documents on gene therapy-related issues, the U.S. Food and Drug Administration (FDA) will also release guidance on the clinical development of gene and cell therapies, FDA Commissioner Scott Gottlieb said at the Allia...
Cloud Pharmaceuticals Enters Into Drug Discovery Collaboration With GSK
Cloud Pharmaceuticals Enters Into Drug Discovery Collaboration With GSK
Cloud Pharmaceuticals, Inc., an Artificial Intelligence-driven drug design and development company, announced they have entered into drug discovery collaboration with GlaxoSmithKline (GSK). Cloud will design novel small-molecule agents to GSK specified...
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...
High-Throughput Flow Cytometry And Phenotypic Drug Discovery
High-Throughput Flow Cytometry And Phenotypic Drug Discovery
Researchers from the Genomics Institute of the Novartis Research Foundation (GNF) highlight a diversity of approaches that their automated high-throughput flow cytometry has enabled for phenotypic drug discovery.
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...
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...
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.
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.
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...
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.
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.
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.
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...
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...
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...
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...
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.
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.
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.
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.
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...
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.
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.
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.
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 ...
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.
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.
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.
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.
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...
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...
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...
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.
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...
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.
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...
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.
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.
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...
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.
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...
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...
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...
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.
How Might Biopharma Manufacturing Differ In The Next Decade?
How Might Biopharma Manufacturing Differ In The Next Decade?
When embarking on our pulling together the manufacturing outlook article for our December 2017 issue, we faced what many might describe as a good problem to have - too much content and not enough pages.
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...
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.
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.
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...
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...
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...
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.