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December 13, 2021
by Michael Mezher

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)
In Focus: International
  • 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)
Pharma & Biotech
  • 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)
Medtech
  • 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)
Government, Regulatory & Legal
  • 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)
Regulatory Recon is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe.
 
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.
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