Facing €200M phase 3 bill, Abivax sells stock at knockdown price to keep lights on into next year Beyond headlines and amyloid, the Alzheimer's pipeline chugs along Targeting Novo Nordisk in China's obesity market with a unique proposition, LeaderMed eyes US IPO Precision rejigs leadership team, tasking CSO with managing partnerships in wake of Novartis pact Boehringer Ingelheim finally has skin in the game, scoring its first dermatology FDA nod Trinity Health wraps up purchase of CommonSpirit Health's 50% stake in MercyOne Health System 'The Top Line': Depth in the Alzheimer's pipeline, the staying power of 2012's Fierce 15 honorees and more As EU challenge intensifies, Illumina clocks a stateside win in FTC antitrust case over Grail buy Targeting $500M opportunity, Amneal files for FDA approval of extended-release Parkinson's prospect MA plans to CMS: Controversial audit rule could wreck popular program if finalized Use of Lilly, Regeneron COVID-19 antibodies 'widespread' after FDA ban, potentially costing US more than $70M: study Chutes & Ladders—Novartis R&D chief Jay Bradner leaves after 7 years Fierce Pharma Asia—Biocon's biosimilar production faults; Fosun unit's PD-1 plan; Takeda-Finch IBD severance Featured Story | By Nick Paul Taylor Abivax has bitten the bullet and issued new shares despite the deterioration of its stock price. The action has raised €49.2 million ($49.2 million), enabling the French biotech to keep going into the first quarter of next year but leaving it needing an additional €154 million to fund its phase 3 ulcerative colitis trial. read more |
| |
|---|
|
Top Stories By Annalee Armstrong There's more to the Alzheimer's disease pipeline than the three leading therapies: Eisai and Biogen’s lecanemab, Genentech’s gantenerumab and Eli Lilly’s donanemab. The Alzheimer’s Association scraped data from the ClinicalTrials.gov database and found that there are 143 drugs in the pipeline—not just three—spread across 172 clinical trials. read more By Angus Liu Many companies have adopted an in-licensing business model to bring drugs by Western biotechs to China. But Sanofi veteran Joanne Jiang, Ph.D., believes her new company, LeaderMed, has a unique business proposition to tackle China’s metabolic disease market and could attract U.S. investors in a New York IPO. read more By Nick Paul Taylor Precision BioSciences is rejigging its senior leadership team, putting Jeff Smith, Ph.D., in charge of its research programs and asking Chief Scientific Officer Derek Jantz, Ph.D., to focus on “formulating company strategy and managing relationships with external stakeholders.” read more By Kevin Dunleavy Boehringer Ingelheim gained an FDA approval to treat generalized pustular psoriasis, a rare and life-threatening skin condition that causes eruptions of painful blisters. Spevigo is an IL-36 receptor inhibitor, and marks the first dermatology go-ahead for the German firm. read more By Dave Muoio The Catholic health giants had jointly owned and operated the 16-hospital regional health system since 1998. Terms were not disclosed. read more By Querida Anderson This week on "The Top Line," we discuss just how deep—and broad—the Alzheimer’s pipeline is despite major players dominating the headlines. We also chat about our research into the 2012 class of Fierce 15 and where those biotechs are now. read more By Andrea Park An administrative law judge ruled in Illumina’s favor on Thursday in the U.S. Federal Trade Commission’s challenge to the DNA sequencing giant’s acquisition of blood test maker Grail. read more By Nick Paul Taylor Amneal Pharmaceuticals has filed for FDA approval of an extended-release Parkinson’s disease prospect that is tipped to deliver peak U.S. sales of up to $500 million. With Amneal hitting its third quarter filing goal, the company is on track to bring the therapy to market around the middle of next year. read more By Robert King Insurer groups are clamoring that CMS scrap a controversial proposed rule that could leave plans on the hook for greater overpayments to Medicare. read more By Fraiser Kansteiner The FDA trimmed its authorizations for Lilly and Regeneron’s antibodies early in the year on data that suggested they weren’t effective against the omicron variant. Despite the FDA ban, however, hospitals and health systems administered more than 158,000 deauthorized monoclonal antibody doses in early 2022, a new JAMA study contends. read more By Max Bayer,Gabrielle Masson After leading Novartis' R&D unit for seven years, Bradner set to depart. Pfizer fills inaugural chief marketing officer role. I-Mab sneaks a duo of executive changes into its latest earnings report. read more By Angus Liu Biocon's biosimilar manufacturing sites was hit with FDA Forms 483. Fosun Pharma's Henlius is looking for a U.S. partner for its PD-1 inhibitor. Takeda returned two microbiome-based inflammatory bowel disease projects to Finch Therapeutics. And more. read more Resources Sponsored by: Genpact Learn how a private health insurance company uses analytics to deliver exceptional service to its employees and members Sponsored by: Cognizant How a new app brings the power of CRM to a leading lab instruments provider’s field service engineers Sponsored by: ZS ZS helps life sciences companies shape the future of medicine by turning healthcare data into transformative insights. Discover the power of R&D innovation Sponsored by: DocuSign, Inc Today’s healthcare systems are adapting to an ever changing landscape with declining margins, M&A pressures, and the need for staff flexibility due to shortages. Read our whitepaper and dive into the way healthcare providers can digitally transform day-to-day work by streamlining costs and increasing agility by removing manual paper burdens. Sponsored by: Blue Matter Consulting This paper explores how Medical Affairs is increasingly playing a key leadership role in evidence planning and generation (part 3 in a series). Sponsored by: ReachBio | The Cell Biology Experts™ How can we predict the ability of a preclinical drug to inadvertently cause or intentionally inhibit cytokine secretion and T cell activation Sponsored by: Unlearn TwinRCTs require fewer patients and shorten trial timelines for rare neurodegenerative diseases. Sponsored by: Ferma.AI, a Product of ZoomRx Improve your congress competitive intelligence and cut down costs by 50% Sponsored by: JLL Read through this library of resources to find out how you can strengthen innovation and efficiency, improve safety and quality, and prioritize resources to support your long-term goals. Sponsored by: Catalent Learn more about how the transition from early to late phase of a small molecule program plays a pivotal role in a program’s ultimate success. Sponsored by: Bio-Techne Advanced research requires advanced tools. Our next-generation ELISA takes a fraction of the time to run eight analytes simultaneously while saving your sample volume. Simply load, scan, and insert your cartridge and come back to fully analyzed results in 75 minutes. Rethink your ELISA, with Ella. Sponsored by: Thermo Fisher Scientific Set a solid foundation for successful scale-up of buffer preparation. The total immersion, transformative training will take place at the Harvard Club in Boston. VIRTUAL in real time is also available. Contingencies for COVID19 will apply. Register NOW for a large early bird discount www.drugstomarket.com/drugbootcamp. Sponsored by: Thermo Fisher Scientific See how integration of innovative genetic analysis techniques into drug development is driving biopharma & biotech companies ahead. Sponsored by: Catalent What is the most suitable dosage form technology for the Oral Delivery of Lipid-Based Formulations? Sponsored by: Catalent Learn how formulation development for a PFS affects manufacturing to drive the industry toward optimizing delivery of injectable products and, ultimately, improving patient care. Sponsored by: Catalent Did you know Catalent has newly expanded in-house capabilities spanning clinical and commercial scale manufacturing for DPIs, unit-dose, bi-dose and preserved multi-dose nasal sprays? Sponsored by: Catalent What are key considerations for intranasal delivery in the treatment of acute and chronic conditions? Sponsored by: Catalent Learn more about how the versatility of Softgel Technology helped a customer with a volatile compound. Sponsored by: Catalent How can Lipid-Based Drug Delivery System help bring poorly soluble drugs to market? Sponsored by: Catalent Carla Vozone discusses the significant trends in the OINDP segment including large molecules and novel indications, changes within CDMOs and various challenges facing the industry. Sponsored by: Catalent Ypsomed and Catalent Biologics experts discuss strategies for integrated PFS manufacturing and auto-injector assembly to accelerate timelines and more in this webinar. Events European Healthcare Compliance Certificate Program Septemeber 19-23, 2022 Fierce Biotech Cell & Gene Therapy Forum October 19, 2022 | Free Virtual Event Fierce Pharma Meeting Professionals Summit November 2-3, 2022 | Atlantic City, NJ Drug Development Boot Camp® 2022 November 16-17, 2022 |
