Twelve European Countries Getting Influenza Pandemic Prep from GSK
GSK has signed an agreement with the European Commission’s Health Emergency Preparedness and Response Authority (HERA) to help prepare 12 European countries for future influenza pandemics. The agreement is another win for the pharma giant, which signed similar deals with the US, Canada, and the World Health Organization. The total amount of pandemic influenza vaccines promised in the deals reaches 200 million.
Takeda Partner BridGene Biosciences Brings in $38.5 Million Series B
The small biotech Bridgene Biosciences has scored another funding win, this time to the tune of $38.5 million in a Series B. Last year, the company netted $12 million in a Series A and secured a partnership with Takeda that could amount to half a billion dollars. BridGene intends to use the money to develop it’s IMTAC platform, a small molecule screening tool for oncology research.
US Department of Justice Opens Investigation into Cassava Alzheimer’s Drug Data Manipulation Controversy
Late last year, reports surfaced that Cassava Sciences had falsified trial data regarding its experimental drug for Alzheimer’s disease. Now, the US Department of Justice (DOJ) has launched a probe into the allegations, sending the company’s share prices down by 30%. The claims originated from two doctors, represented by the law firm Labaton Sucharow, who found irregularities in data coming from Hoau-yan Wang, an Associate Medical Professor at City University of New York, and Lindsay Burns, Cassava’s VP of neurosciences.
Reuters Events: Pharma Marketing USA 2022 – November 8-9 – Philadelphia, US
This November, Reuters Events is hosting Pharma Marketing USA 2022 in Philadelphia, PA. The event, taking place November 8th-9th, will bring together professionals from pharma marketing, data, commercial, IT, analytics and more. Speakers will come from industry leaders like Bristol Myers Squibb, GSK, Astrazeneca, Teva, Takeda, Zimmer Biomet, and Alnylam. Register by Friday, July 29th with the code “FLASH200” to save $200.
Webinar: Planning for the Pivot to Commercialization – August 25th
Achieving commercial success in cell and gene therapy requires careful planning from the early stages of preclinical development. On August [...]
US Court Rejects Novartis’s Appeal in Whistleblower Case
New Jersey’s Superior Court, Appellate Division, has rejected Novartis’s appeal of a 2019 verdict in a case against a former executive turned whistleblower. Min Amy Guo, then executive director of the company’s health economics and outcomes research team, was fired in 2013 after expressing concerns that a cancer drug study would violate laws preventing kickbacks. She filed suit the following year and five years later a New Jersey court ruled Novartis was guilty of retaliation and must pay Guo $1.8 million in damages.
UK Life Sciences Sector at Risk of Slipping Behind Rivals
Although the United Kingdom’s life sciences industry ranks third among industrialized nations in terms of spending, a recently released report shows that the nation is lagging behind on other important measures. For example, trial setup in the UK takes longer than the approval process, putting the nation behind other European countries like Germany and Switzerland in the number of therapeutics approved.
UK CMA Fines Pfizer and Flynn Pharma £70M in Epilepsy Drug Pricing Case
The United Kingdom’s Competition and Markets Authority (CMA) has issued a preliminary judgment fining Pfizer and Flynn Pharma £70 million for abusing their status as the UK’s only suppliers of the epilepsy drug phenytoin. Pfizer and Flynn jacked up the prices of the life-saving drug between 780% and 2,600%, a move deemed by the courts as anti-competitive and exploitative. Pfizer will pay £63 million and Flynn will pay £6.7 million.
EU Committee Supports New Roche and Eli Lilly Meds as Clovis’ Ovarian Cancer Drug is Rejected
The European Committee for Medicinal Products for Human Use (CHMP) has given the nod to Eli Lilly for its type 2 diabetes drug Mounjaro and Roche’s macular degeneration drug Vabysmo. Clovis’ Rubraca, a third-line treatment for ovarian cancer, was not reccomended by the committee based on the manufacturer’s request. The drugmaker had already voluntarily pulled the drug in the US due to data linking the drug to increased mortality risk.
Medicines for Europe: Improving Europe’s Health Systems with Off-Patent Medicines
Strengthening European health systems by promoting the use of off-patent medicines was the topic of several speakers during a presentation the recent Medicines for Europe Conference, held in Sitges, Barcelona, Spain from June 29th to July 1st. The speakers noted that 70% of the drugs dispensed throughout the region are off-patent, and that policies favoring these and biosimilars should be prioritized.
Biogen Writes Off Aduhelm Stock
Biogen has written off its remaining Aduhelm inventory in a filing to the Securities and Exchange Commission (SEC) filing. The company declared that its stock of the failed Alzheimer’s drug was functionally worthless, in contrast with a $233 million valuation towards the end of 2021. The remaining stock will be available to patients that are already using the drug, such as those in clinical trials.
Webinar – Pain R&D: Plenty of Pain to Go Around, But Who’s Making Gains?
Despite a growing need for safe, effective pain drugs, the drug development pipeline is sparsely populated. Recent setbacks like those facing Lilly and Pfizer’s anti-NGF drug have chilled the atmosphere for new lines of research. In an Endpoints webinar on August 11th, Lei Lei Wu of Endpoints will sit down with Jan Adams of Grünenthal to discuss the situation and how to improve access to patients.
R-S-S Course: Economic Evalulation of Cancer Drugs – October 3rd
Regulatory Scientific and Health Solutions (R-S-S) is hosting a course entitled, “Economic Evaluation of Cancer Drugs.” The course is aimed towards professionals in health economics and outcomes research (HEOR), market access, and clinical oncology. Attendees will learn about the development, application, and interpretation of economic models for cancer drugs. The course takes place at the Hilton London Watford, Watford, UK on Monday 3rd October 2022. Register by 1st August 2022 for an early bird discount.
Biogen Settles MS Kickback Suit for $900M
Biogen has settled a whistleblower suit regarding kickbacks for its line of multiple sclerosis (MS) drugs. The company was sued for allegedly paying clinicians kickbacks when they prescribed its drugs Tecfidera, Tysabri, and Avonex. The settlement comes as competition from Novartis and Ocrevus closes in on Biogen’s MS drugs
J&J Tamps Down M&A Ambitions
Johnson & Johnson’s new CEO Joaquin Duato has repeatedly told analysts and investors that the company was going to pursue an aggressive M&A campaign. In a call earlier today, July 19th, Duato signalled a shift and toned down those ambitions as the company’s expected 2022 sales growth dropped from 4-5% to 3%. However, this does not mean that J&J has completely written off any acquisitions.
Abbvie Applies for EMA Marketing Authorization for Migraine Drug Atogepant
The drugmaker Abbvie has applied to the European Medicines Agency (EMA) for marketing authorization for Atogepant, its prophylactic migrain treatment. Data supporting the application comes from two phase three studies, which showed the drug was well tolerated and was effective at reducing the occurrence of migraines.
Bavarian Nordic Makes Deal to Provide 1.5M Monkeypox Vaccine Doses to Unnamed European Country
The Danish drugmaker Bavarian Nordic has signed a deal with another unnamed European nation, this time promising 1.5 million doses of its monkeypox vaccine. This is the second deal with undisclosed European countries and comes hot off the heels of a deal with the US govt for 2.5 million.
CBO: Senate Drug Price Cuts Would Curb Development of 10 Drugs Over 30 Years
Despite fears that drug pricing regulations would dampen innovation, an analysis by the US Congressional Budget Office found that the drug pricing proposal put forward by Senate Democrats would stifle development of 10 drugs in the next 30 years. This amounts to just shy of 1% of the estimated 1,300 approvals in that time period. The projected losses are much less than previous bills.
Teva Asks US Supreme Court to Reverse Loss in “Skinny Label” Patent Suit, Says Decision is Competition-Killing for Generics
According to Teva Pharmaceuticals, the company’s legal battle with GSK over “skinny labels” portends a greater threat to the generic drug market. Skinny labeling is a practice where a manufacturer can get its generic approved by applying for some of the original drug’s indications, but not all. GSK and others argue that the practice is infringement because the generics are often prescribed off-label for the original drug’s indications. Teva has asked the US Supreme Court to reverse the decision, which ordered the company to pay GSK $235 million.
Royalty Pharma Buys Theravance to Get Royalties on GSK COPD Drug Trelegy Ellipta
Royalty Pharma has bought 85% of Theravance Biopharma to access royalty rights to its chronic obstructive pulmonary disease (COPD) drug [...]
China Announces Price Cuts, Hitting Astrazeneca, Pfizer, and Novartis’s Profits
China’s latest round of price cuts dinged profits of many major pharma companies, especially Astrazeneca, Pfizer, and Novartis. The companies [...]
HRA Pharma Files FDA Application for First Over-the-Counter Oral Contraceptive
HRA Pharma has submitted its application for the US’s first over-the-counter (OTC) birth control pill. The company, a subsidiary of [...]
US Senate Finance Committee Report Targets Trump Tax Laws that Benefited AbbVie
Democrats in the US Senate Finance Committee has called out the tax practices of AbbVie. The company and others used [...]
Sinopharm Looking to Acquire DNA Synthesis Biotech for $1B
Sinopharm, a Chinese pharma company responsible for the country’s inactivated COVID-19 vaccine, is considering purchasing the China-based DNA synthesis firm [...]
Webinar: Modernize Your Patient Support Programs (PSPs) to Ensure a Seamless Patient Experience
Patient support programs (PSPs) have historically underdelivered for patients, in part because they fail to include patients in the development [...]
