| Publisher’s Note: Last chance to submit nominations for the Fierce Biotech Innovation Awards. Nominations close Thursday, September 22nd. Enter today. | This whitepaper provides insight into the basic principles of longitudinal qualitative research, which can guide development efforts and inform communication strategies for a patient centric approach in any therapy area. Learn More.
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Today's Big News Sep 19, 2022 Genfit revs up liver failure strategy with $41M biotech buyout, bagging phase 2-ready candidate Fortress falls: Virios flunks fibromyalgia study but claims drug may work in the omicron era Everest appoints Gilead, COVID therapy vet as CEO to bring variety of therapies to market in China After scoring hit in US study, Pfizer racks up EU infant win for 20-valent pneumococcal vaccine BioNTech's COVID vaccine sales are poised to slip, but the shot will remain a 'cash cow' in the long term: analysts Immunotherapies targeting 2 peptides blast fibrosis in mice Epic launches program for clinical trial matchmaking in effort to expand access to marginalized participants A $3M gene therapy: Bluebird bio breaks its own pricing record with FDA approval of Skysona Heron scores FDA go-ahead for Aponvie, an IV alternative to pills for postoperative nausea Johnson & Johnson pours €100M into contact lens plant in Ireland Featured | | By Nick Paul Taylor Genfit’s pivot to acute-on-chronic liver failure has led it to the deal table. Having granted Ipsen global rights to its lead candidate late last year, the French biotech is using some of the proceeds to buy Versantis for 40 million Swiss francs ($41 million) upfront to bag a phase 2-ready ACLF drug candidate. |
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Top Stories By Nick Paul Taylor Virios Therapeutics’ antiviral fibromyalgia drug candidate IMC-1 has flunked a midphase clinical trial. But, while the prospect failed to improve pain more than placebo in the overall population, Virios is making the case that it was effective after the emergence of the omicron variant of COVID-19. By James Waldron Less than a month after Everest revealed that CEO Kerry Blanchard had resigned, the Chinese drug developer unveiled his replacement as pharma veteran Rogers Yongqing Luo. By Nick Paul Taylor Pfizer has followed up the recent success of a U.S. clinical trial of its 20-valent pneumococcal conjugate vaccine in infants with a win in the EU, keeping it on track to advance toward approvals in the population on both sides of the Atlantic. By Fraiser Kansteiner Reports of dwindling COVID-19 vaccine demand have been circulating for months. Now, the slump threatens to cut into BioNTech's revenue hauls in 2022 and beyond, according to one group of analysts. By Helen Floersh A research team led by scientists from Switzerland’s University of Zurich reported that immunotherapies separately targeting two peptides expressed only on fibrotic fibroblasts with cytotoxic T cells reduced liver and lung fibrosis in mouse models without damaging healthy tissue or processes. By Anastassia Gliadkovskaya Epic's life sciences program will work with providers, pharmaceutical companies and medical device manufacturers to recruit participants for research, expand trial access to underrepresented communities and speed up the development of new therapies. By Angus Liu The title of the world’s most expensive treatment has changed hands within one company in a single month. On the heels of $2.8 million price tag for gene therapy Zynteglo, bluebird bio will charge $3 million for freshly FDA-approved Skysona, and it won't have an outcomes-based payment structure. By Kevin Dunleavy On Friday, the FDA approved Aponvie, which becomes the first intravenous P/neurokinin-1 (NK) receptor antagonist available for postoperative nausea and vomiting (PONV) in adults. Delivered in a single 30-second IV injection, Aponvie is the same drug as Merck’s Emend, which is now widely available as a generic. The difference is its IV formulation as opposed to Emend, which is taken in pill form. By Kevin Dunleavy Johnson & Johnson revealed a 100 million euro ($100 million) expansion of its National Technology Park facility in Limerick which will add up to 80 new jobs in operations, engineering and quality control. The contact lens plant currently employs about 1,600. Fierce podcasts Don't miss an episode | | This week on "The Top Line," we chat about this year’s European Society for Medical Oncology meeting, where Merck presented a series of trial flops for Keytruda. We also discuss the lessons learned from the COVID-19 pandemic and how they are being applied to the monkeypox test EUA. |
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