Recon: Pfizer to buy Arena for $6.7B; Novartis sees strong interest in Sandoz unit
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.In Focus: US
- Pfizer bets on Arena's promising bowel disease treatment in $6.7 bln deal (Reuters)
- A year after first U.S. shots, pandemic hallmarks re-emerge (Reuters)
- Out of Control: America’s losing battle against diabetes (Reuters)
- Drugmakers aim big price hikes at U.S. patients, congressional report finds (Reuters) (STAT) (Politico)
- Moderna's flu data offer a clear lesson: mRNA isn't magic (Endpoints)
- CVS takes a swing at Bristol Myers and Pfizer, excluding coverage of their megablockbuster Eliquis in 2022 (Endpoints)
- Generic drug makers win a court round as judge temporarily blocks California pay-to-delay law (STAT)
- Generic drugs and biosimilars get last-minute reprieve from rebates with Senate tweaks to Build Back Better Act (Endpoints)
- Covid-19 Vaccine Makers Are Unsure if Fine-Tuning Shots for Omicron Is Worthwhile (WSJ)
- Merck’s Covid Pill Might Pose Risks for Pregnant Women (NYTimes)
- Novartis sees strong interest in Sandoz generics unit - Finanz und Wirtschaft (Reuters)
- Two-dose vaccines induce lower antibodies against Omicron, study finds (Reuters)
- Israeli study finds Pfizer COVID-19 booster protects against Omicron (Reuters)
- Omicron poses 'very high' risk but data on severity limited (Reuters)
- China's Brii says its COVID-19 antibody cocktail retains activity against Omicron (Reuters)
- Antibody response from China Zhifei's COVID shot weaker against Omicron (Reuters)
- Moderna agrees up to 150 mln extra vaccine doses for COVAX (Reuters)
- Lilly deepens research ties in China with biotech deal (BioPharmaDive)
- International regulators recommend use of remote inspections as complementary tool beyond pandemic (EMA/ICMRA)
- Biotech short seller lands on feds' watch list amid sweeping probe — report (Endpoints)
- Eshoo: More federal incentives needed for 'orphan' drug makers (The Hill)
- Bristol Myers Squibb, after massive Celgene takeover, plots $15B buyback plan (Fierce)
- Novo Nordisk, underway with key launches, reveals $2.58B manufacturing investment (Fierce)
- Patients with rare blood disorder benefit from Bluebird gene therapy while denied access in Europe (STAT)
- In a do-over study, Bellus Health cough treatment shows positive results (STAT) (Endpoints)
- J&J’s new CAR-T therapy shows long-term success, data show (STAT)
- ASH: Bristol Myers' Breyanzi, Gilead's Yescarta lock horns in race to move CAR-T therapy to earlier lymphoma (Fierce) (STAT)
- European Commission approves Pfizer’s atopic dermatitis treatment (PharmaTimes)
- Genentech's tocilizumab shortage due to Covid-19 now hits CAR-T recipients, with FDA offering alternatives to help (Endpoints)
- Roche two-armed antibody posts strong tumor responses in lymphoma study, rivaling CAR-T therapy (STAT)
- More potent version of Global Blood sickle-cell drug improves hemoglobin response in small study (STAT)
- ASH: Servier unveils full dataset for Tibsovo in specific AML mutations, and the FDA appears a stone's throw away (Endpoints)
- ASH: Another 'off-the-shelf' cell therapy leader shows durability issues, raising renewed concerns about emerging field (Endpoints)
- ASH: Gilead's Kite unveils more data on Yescarta's win in second-line lymphoma patients, setting up battle for SOC (Endpoints)
- ASH: A cell therapy startup with roots in Irv Weissman's lab nearly wipes out a chronic side effect in early trials (Endpoints)
- ASH: Tessa Therapeutics' next-gen cell therapy clears four patients' tumors in early study (Endpoints)
- Eli Lilly's Van Naarden hands $380M cash to Flagship-backed upstart in major new oncology deal (Endpoints)
- Qiming-backed CANbridge gets its Hong Kong IPO as Nasdaq slowdown prompts renewed market analysis (Endpoints)
- Junshi and Coherus plan to hustle the latest PD-1 to the FDA after an upbeat PhIII assessment (Endpoints)
- As year-end deals start to sizzle, CSL moves a biotech buyout to the front burner with deal expected Tuesday — report (Endpoints)
- Medtronic's Covidien faces another Class I recall of beleaguered Puritan Bennett ventilators (Fierce)
- Abbott elects CEO Ford chairman of the board as predecessor White retires after 40 years (Fierce)
- Neurostimulator to treat stroke fails to gain FDA advisory panel support (MedtechDive)
- U.S. Supreme Court snubs J&J's bid to avoid Mississippi talc lawsuit (Reuters)
- Bayer says encouraged by U.S. Supreme Court decision (Reuters)
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