Mar 17, 2023

The big biotech signed a licensing deal with Gracell Biotechnologies last week, granting the smaller partner rights to certain patents, SEC documents show . Gracell will conduct preclinical and clinical research on the unnamed cell therapy programs and be able to bring up to five to the market. The scope of Thursday’s deal and content of the Seagen patents, however, remain a mystery for now. Neither company issued a press release about the deal and no financial terms were disclosed in the SEC filings. Representatives for Seagen and Gracell did not immediately respond to requests for comment. Keep reading Endpoints with a free subscription Unlock this story instantly and join 163,000+ biopharma pros reading Endpoints daily — and it's free. SIGN UP Zachary Brennan Senior Editor The Centers for Medicare and Medicaid Services (CMS) late Wednesday published its first long-awaited guidance on how exactly biopharma companies will have to negotiate with the federal government when it comes to the most expensive of drugs, beginning in 2026. The 91-page guidance document sets the requirements for manufacturers of Medicare Part D and B drugs that are selected for negotiations, and CMS is soliciting feedback, before April 14, on everything from the initial offer and counteroffer exchanges between CMS and manufacturers, how the maximum fair price (i.e. the negotiated price) will be applied across different dosage forms and strengths of a drug chosen for negotiations, as well as the process for issuing monetary penalties to those violating the new law. Keep reading Endpoints with a free subscription Unlock this story instantly and join 163,000+ biopharma pros reading Endpoints daily — and it's free. SIGN UP Senior Editor As Ultragenyx looks to use the accelerated approval pathway for an increasing number of rare disease drugs, the company has promoted Eric Crombez to EVP and chief medical officer, effective May 1. Crombez, who previously served as CMO for gene therapy and inborn errors of metabolism, joined Ultragenyx following its $138 million acquisition of Dimension Therapeutics in November 2017. Since January 2020, he’s also served in a non-voting role as industry representative on the FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee. Keep reading Endpoints with a free subscription Unlock this story instantly and join 163,000+ biopharma pros reading Endpoints daily — and it's free. SIGN UP Katherine Lewin News Reporter The FDA’s Antimicrobial Drugs Advisory Committee voted 16-1 that the benefits of Pfizer’s Covid-19 pill Paxlovid outweigh the risks in adults with mild-to-moderate illness. The vote followed hours of discussion on topics ranging from efficacy in people who have already been vaccinated or infected to drug-drug interactions (DDIs). Pfizer submitted a request to convert its EUA to a full approval back in June, but the FDA extended its review period by three months to consider additional data submitted, the company announced in December. The current PDUFA action date for a decision by the FDA is May 2023. Read More March 16, 2023 04:30 PM EDT Max Gelman Senior Editor Ahead of Keytruda’s patent cliff in 2028, Merck is trying to develop a variety of combination therapies that can extend the megablockbuster’s potential. But one of those combos just hit a snag, and it’s putting the company in damage control mode. MK-7684A, a brew of pembrolizumab (Keytruda’s chemical name) and Merck’s in-house anti-TIGIT compound vibostolimab, failed the open-label portion of a Phase II study measuring it against chemotherapy in metastatic non-small cell lung cancer, the Big Pharma announced Thursday afternoon. The regimen did not improve patients’ progression-free survival odds compared to the control and was less effective than chemo. Keep reading Endpoints with a free subscription Unlock this story instantly and join 163,000+ biopharma pros reading Endpoints daily — and it's free. SIGN UP Beth Snyder Bulik Senior Editor GSK’s ViiV Healthcare wants to help people talk about sex. Specifically, it’s aiming to help Black women feel empowered to have sex-positive conversations and reframe discussions around HIV prevention and services in their doctor’s offices, at home and in the community. It recently debuted a series of three activity books from its “Risk to Reasons” initiative, which addresses sex and health issues for oneself, with partners and with healthcare providers. Available in both digital and hard copy versions, the ViiV team, along with partners and advocates, is distributing the purposefully thought-provoking books at the community level and in areas with greater need. Keep reading Endpoints with a free subscription Unlock this story instantly and join 163,000+ biopharma pros reading Endpoints daily — and it's free. SIGN UP Beth Snyder Bulik Senior Editor Novo Nordisk was slapped with a two-year suspension from the UK pharma industry group, the Association of the British Pharmaceutical Industry (ABPI), on Thursday for crossing the line on its code of conduct. The suspension stems from an investigation by the Prescription Medicines Code of Practice Authority (PMCPA), which oversees the complaints procedure of the ABPI Code, over a LinkedIn post promoting a “free weight management course” by a third-party provider that was supported by Novo Nordisk. Keep reading Endpoints with a free subscription Unlock this story instantly and join 163,000+ biopharma pros reading Endpoints daily — and it's free. SIGN UP LOG IN