Whitepaper: How to Model Scientific Data for Analysis in Drug Discovery
Data modeling is an important but frequently ignored step of drug discovery. In a new whitepaper, PerkinsElmer Informatics shows how Signals Inventa can help companies develop data models that facilitate robust data analysis. The platform can integrate and compare data from early chemical surveying to in vivo experiments.
Podcast Q&A: Evidence Generation Planning
This podcast segment from Syneos Health's July 26, 2022 webinar features the Q&A with Colin Oliver, Anila Dede, Erwin De [...]
1st Zantac Case Against GSK Dropped by Plaintiff
Joseph Bayer, the plaintiff in the first case surrounding GSK’s Zantac has voluntarily dismissed his case against the company, citing personal health reasons. Bayer sued GSK and several others for esophageal cancer he developed that he and his care team attributed to the drug. So far, he has gotten a combined settlement of half a million dollars from the other companies. The dismissal isn’t a true win for GSK, however, as Bayer has a year to refile the case.
Gilead Spends $455 Million for Rights to New Breast Cancer Drug in Asia
Hot off the heels of Gilead’s June approval for Troldelvy for metastatic triple-negative breast cancer (TNBC) drug in China, the company has agreed to a deal buying exclusive rights to sell the drug in Asia from the China-based Everest Medicines. This agreement gives Gilead global control of Troldelvy’s distribution. Gilead got the drug in its $21 billion acquisition of Immunomedics, which previously sold the rights to the drug to Everest.
US Drug Launch Prices Higher Than Ever in 2022
A Reuters analysis has found that US launch prices for new drugs are approaching record highs. The study found this year’s median annual price of 13 drugs recently approved by the Food and Drug Administration (FDA) for chronic conditions is $257,000, with seven other drugs reaching the $200,000+ range. The report comes as the Democrat’s signature Inflation Reduction Act is signed into law, which would let Medicare negotiate the prices of a small number of expensive drugs.
Carlyle and Abingworth Make First Major Biotech Investment
Launch Therapeutics, a joint project between the Carlyle Group and its recently acquired Abingworth, is funding the Australian biotech Opthea to the tune of $170 million. The deal will also provide clinical, regulatory, and commercial services. The deal is intended to help develop and launch OPT-302, a drug for age-related macular degeneration that is currently in a Phase II trial.
Real-World Evidence and Real-world Data: Beyond Payer Decisionmaking
Although payer decision-making has been a key use of real-world evidence (RWE) and real-world data (RWD) in the healthcare space, there are far more avenues in which these resources can advance medicine. Agencies like the US Food and Drug Administration (FDA) are increasingly using RWE and RWD to make regulatory decisions, while market access teams implement strategies based on the perspectives they inform.
Analysts Suggest Impact of Drug Pricing Reforms Would be Limited
Despite a litany of complaints and concerns from the industry, the new US drug pricing reform passed by the Democrats would have a marginal impact on pharma, according to analysts from the Bank of America and UBS. The legislation will allow Medicare to set Part D prices for some medications, 10 by 2026 and 60 by 2029. In addition, the Centers for Medicare and Medicaid Services (CMS) will be able to negotiate part B prices.
Endo Will File for Bankruptcy Due to Opioid Lawsuits “Imminently”
Endo International signaled on Tuesday, August 11th, that bankruptcy is in the company’s immediate future. The announcement comes as the company faces thousands of lawsuits related to its role in the US opioid epidemic. The suits center around its drug Opana ER, which was pulled from the market in 2017 by the US Food and Drug Administration.
Essential Terms for UK Quality Regulations Post-Brexit
Many biotechs are struggling with the uncertain state of quality regulations in the Post-Brexit UK. Understanding the new regulatory processes and requirements begins with understanding the key terms in a new MasterControl article, Joanna Blair breaks down the top 11 terms you need to know to navigate the current regulatory landscape to ensure compliance. To start, companies must know the importance of UKCA and CE markings.
Pharma Preps Legal Strategy Against New US Drug Pricing Regulation
The US Senate’s newly passed drug pricing regulation will allow Medicare to cut the prices of a select number of drugs over the course of the decade. In response, pharma companies have begun prepping their legal objections to the rule. The industry will likely sue the Center for Medicare and Medicaid Service (CMS) as regulations begin, affect the rulemaking deliberations, and shift the price negotiation process in its favor.
Pharma Marketing USA 2022 Article: Pharma Needs a Digital Reset Same as Above
Reaching the most important stakeholders in pharma, patients and their HCPs, requires breaking down operational silos and creating cross-functional teams. Doing so can help companies condense the science to actionable content that’s tailored for their audience. Building such teams starts with inter-departmental training programs.
J&J Head of R&D Steps Down Unexpectedly
Mathai Mammen, MD, PhD, has stepped down from his role as head of research and development at Johnson & Johnson. Mammen, who joined the company in 2017, was appointed VP of pharmaceuticals R&D just last year. According to an announcement made yesterday, August 8th, his departure is based on his plans to “pursue other opportunities.”
UK Lord’s Committee Share Worries Over Nation’s Goal to Become ‘Science Superpower”
The UK Lord’s Committee has released a report that casts doubts over the UK government’s goal of ‘science and technology superpower’. Last year, the government released its 2021 Integrated Review of Security, Defence, Development and Foreign Policy report that solidified these ambitions. The statement from the Lord’s committee lays out areas of improvement and proposes an actionable means to tackle these issues.
US FDA Gives Quick Approval for First Low-HER2 Breast Cancer Drug
The US Food and Drug Administration (FDA) has approved Enhurtu, the first drug to treat metastatic or unresectable low-HER2 breast cancer, a recently defined category of the disease. The drug, developed by AstraZeneca and Daiichi Sankyo, received expedited approval from the agency, in part because of the potential for the breast cancer category, which covers over half of cases previously defined as HER2-negative.
US Senate Passes Democrat’s Flagship Climate, Drug Pricing, and Tax Bill
After months of negotiations and setbacks, Democrats in the US Senate have passed a pared-down version of their tax, climate, and drug pricing reform bill. Included in the bill is a provision that would limit the price of Insulin to $35 a month for Medicare recipients. Previous iterations of the bill that would have capped prices for patients on private care plans were struck down by Senate Republicans. The passage of the bill comes after Sen. Joe Manchin (D-W.V.) reached a last-minute agreement with Senate Majority Leader Chuck Schumer.
Calling Them “Vanity Drugs,” Some Insurers Refuse to Cover New Anti-Obesity Drugs
In an interview with Pharmacy Times, Ron Lanton III, Esq., principal at Lanton Law, discussed why insurers are refusing to [...]
A New Covid Vaccine That’s Effective Against Omicron Could Hit The Market This Year
Sanofi and GlaxoSmithKline are hoping to launch their latest Covid vaccine later this year after trials found it to be [...]
Webinar: Make Market Access Your Brand’s Super Power
Accessibility is a key deciding factor for clinicians when prescribing medicine. At an upcoming webinar on August 23rd, Jon Bambalas [...]
Bristol Meyer Squibb Eyes More Major M&As
Last Wednesday, July 27th, Bristol Meyer Squibb’s CEO Giovanni Caforio signaled that the company has the resources to grow its holdings and it intends to do so. The company’s sales this Q2 were more than double the same period last year, giving the company more than enough funds to build off recent acquisitions.
Master Control: Your Guide to Connecting Pharma Quality Data
Achieving success in the pharma landscape requires a modern quality management system (QMS). Master Control has released a new guide [...]
Patrice Matchaba of Novartis Speaks About Company’s Initiative for Inclusion and Diversity
Novartis recently stepped up its efforts toward diversity and inclusion by launching the Beacon of Hope program, an initiative that works to create fruitful partnerships with 26 historically Black colleges and universities (HBCU). Late last month, Ed Miseta, Chief Editor of Clinical leader, discussed the program with Patrice Matchaba, MD, Head of US Corporate Responsibility at Novartis, and President of the Novartis US Foundation.
The UK market access has always been complex, now even more than before, Graham Foxon and Paul Craddy?
The UK has always been on the forefront of market access with its unique pathways within England, but especially also considering Wales, [...]
Sanofi at Least Risk of Generic Competition, CEO Says
Paul Hudson, CEO of Sanofi, told investors on Thursday, July 28th, that the company’s stock was the “least exposed” to competition from generics for the next decade. According to Hudson, the company’s only upcoming loss of exclusivity through 2030 is Aubagio. The company’s biggest seller, Dupixent, is still growing in sales and a generic is nowhere in sight in the 2020’s.
Merck Keeps a Tight Lid on Potential Seagen Merger
Despite weeks of speculation about the company’s plans to acquire Seagen, Merck was tightlipped about the rumors during a conference call this Thursday, July 28th. Sales of Merck’s cancer blockbuster Keytruda totalled $5.3 billion, over a third of the company’s total revenue for the quarter. As a result, it is seeking to widen its offerings.
