Recon: Pfizer expected to seek broader authorization for COVID booster; Regeneron says antibody reduces risk of contracting COVID for up to 8 months

• Pfizer says its antiviral pill slashes risk of severe COVID-19 by 89% (Reuters) (STAT)
• Pfizer-BioNTech expected to seek authorization for coronavirus booster for people 18 and older (Washington Post) (Reuters)
• Regeneron's COVID antibody drug shows protection for up to 8 months (Reuters)
• Dems' $100B deal reduced further: Medicare drug price negotiations pushed to 13 years for biologics (Endpoints) (NYTimes)
• House Oversight Committee digs in on McKinsey's conflicting ties with FDA, opioids, and blocking Humira competitors (Endpoints)
• Takeda launches value-based pricing program for lung cancer med Alunbrig, promises more deals to come (Fierce)

• Pfizer CEO in talks with 90 countries for COVID-19 pill (Reuters)
• Merck ahead of Pfizer in EU talks on COVID-19 pills -EU source (Reuters)
• EU to advise on Merck's COVID-19 pill in "shortest possible" time (Reuters)
• J&J fails in final bid to appeal Australian pelvic mesh class action ruling (Reuters)
• GSK says anaemia drug shows positive safety profile (Reuters) (Endpoints)
• US and China urged to collaborate on cancer drugs through new initiative (FT)
• Breaking: Majority of African Countries Have Now Signed African Medicines Agency Treaty, Enabling Better Access to Newer, Safer Medicines (Health Policy Watch)

• Indonesia reviewing Merck COVID-19 pill, up to 1 mln doses targeted (Reuters)
• EU says face masks don't pose health risks after report raises concerns (Reuters)
• India to buy 10 mln doses of Zydus Cadila's COVID-19 shot at about $4 each (Reuters)
• Samsung Pharmaceutical’s manufacturing suspended for 3 months (Korea Biomed) (Endpoints)
• Ocugen, Inc. Announces Submission of Emergency Use Authorization Request to the US FDA for Investigational COVID-19 Vaccine COVAXIN™ (BBV152) for Children Ages 2-18 Years (Press)
• US Food and Drug Administration Declines Emergency Use Authorization for ZYESAMI® (aviptadil) for Patients with Critical COVID-19 with Respiratory Failure (Press)

• Pandemic puts Oxford Nanopore ‘on the map’ (FT)
• Amgen breaks ground on New Albany, OH manufacturing plant of the future — report (Endpoints)
• Clinical trial sites face challenges in diversifying personnel and participants, study finds (STAT)
• Moderna millionaires and the double-edged sword of stock market riches (STAT)
• Infected blood scandal: firm claimed products were safe despite using untested donors (The Guardian)
• India DoP proposes Bayh-Dole like policy to encourage academic discoveries move into commercial landscape (PharmaBiz)
• Fresh off corporate split, bluebird bio plots new hybrid headquarters at Somerville's Assembly Row (Endpoints) (PMLive)
• Provention Bio, hit by AdComm rejection for lead drug, hires early research exec from Gossamer (Fierce)
• Thanks for the boost, biotech. Pharma industry reputation now close to biotech industry esteem: Harris Poll (Endpoints)
• Blackstone doubles down on cell therapy, pouring life (and a lot of cash) into a once hot biotech (Endpoints)
• They had promising gene therapies for their daughter's ultra-rare disease. But how to tell if one worked? (Endpoints)
• A pair of European biotechs hit below their mark as close of 2021 biotech IPO market chugs a little bit slower (Endpoints)
• Cell therapy startup bit.bio adds $100M+ to its coffers and some impressive names to its board of directors (Endpoints)
• A Bloomberg-backed cancer drug summit aims to thaw US-China relations (Endpoints)
• Bristol Myers adds to neoadjuvant win for Opdivo in lung cancer, escalating early cancer showdown with Merck (Endpoints)
• 'We were wrong': After ushering Merck KGaA into PD-(L)1 frenzy, oncology chief jumps on mission to 'turbocharge' T cells (Endpoints)
• Seagen and Daiichi are duking it out over the linkers used in some blockbuster drug plays. Could that affect a high-dollar AstraZeneca collaboration? (Endpoints)
• Abbott plots new paths to clinical trial diversity, joining biopharma push for broader inclusion (Endpoints)
• Deciphera's TKI drug flops key test in earlier-line GI tumors, sending stock into a tailspin (Endpoints)

• Will FDA Release Its Draft Quality System Reg This Year? All Signs Point To No (MedtechInsight)
• EU MDCG Meetings In The Pipeline: November 2021 To February 2022 (MedtechInsight)
• Alcon scopes out $475M acquisition of glaucoma stent maker Ivantis (Fierce)
• Philips augments cardiac AI diagnostic programs with Cardiologs acquisition (Fierce)
• Latest Abbott, Boston Scientific LAAC devices yield mixed results in first clinical comparison (MedtechDive)
• Edwards, Medtronic bolster economic, clinical case for using TAVR over surgery (MedtechDive)
• Stryker, Zimmer, Smith & Nephew warn orthopaedic headwinds to last into Q4 (MedtechDive)
• ReWalk lands FDA breakthrough label for home exoskeleton device to restore ankle function after stroke (Fierce)

• Mixed court decisions for Novartis in DC and Sanofi, Novo Nordisk in NJ further complicate whose interpretation of 340B is correct (Endpoints) (STAT)
• 2 Sun Pharma US Units To Pay $85M In Generic Drugs MDL (Law360)
• What Red Flags? Elizabeth Holmes Trial Exposes Investors’ Carelessness (NYTimes)