Recon: Obamacare architect floated for FDA commissioner; Takeover battle for inhaler specialist Vectura may head to auction

• Obamacare architect floated for top FDA job (Politico) (The Hill)
• As White House mulls FDA commissioner job, a sign of industry backing for Woodcock surfaces (STAT)
• Pediatricians plead with FDA to move quickly on Covid vaccine for kids (NBC)
• FDA Aiming to Speed Extra Vaccine Doses for Immunocompromised Patients (NYTimes)
• Purdue’s bankruptcy deal shields Sackler family owners from future opioid liability (FT)
• BioNTech says vaccine repeats beat devising new one for now (Reuters)
• BioNTech profits soar as Covid vaccine demand surges (FT)
• FDA to allow export of certain lots of AZ COVID vaccine made at Baltimore plant (Reuters)
• Letter from FDA outlining deficiencies for lead drug causes Axsome stock to crater. (Endpoints)
• CMS Scraps ‘Most Favored Nation’ Rule To Lower Medicare Part B Drug Costs (Law360) (Endpoints)

• India approves J&J vaccine; no delivery timeline yet (Reuters)
• No link found so far between menstrual disorders and COVID-19 vaccines, EU says (Reuters)
• S.Korea apologises as Moderna halves August COVID-19 vaccine shipments (Reuters)
• Moderna COVID-19 vaccine gets Swiss approval for 12- to 17-year-olds (Reuters)
• TGA provisionally approves Moderna’s COVID-19 vaccine (TGA)
• Israeli survey finds 3rd Pfizer vaccine dose has similar side effects to 2^nd (Reuters)
• Philip Morris and Carlyle face auction in battle for inhaler group (FT) (Reuters)
• Philip Morris' biopharma addiction ramps up, as heart attack biotech OtiTopic joins cigarette maker on 'Beyond Nicotine' journey (Fierce)

• U.S. administers over 350 mln doses of COVID-19 vaccines -CDC (Reuters)
• Vaccine reduces risk of infection even in people who have already had Covid, the C.D.C. says. (NYTimes)
• Egypt receives first batch of J&J COVID-19 vaccines (Reuters)

• AZ’s Forxiga gains EC, MHRA approvals for chronic kidney disease (PharmaTimes)
• Adagio raises $300 million in IPO, looks to advance Covid-19 antibody therapy (STAT)
• AbbVie hands back headline drug in $63B Allergan buyout to Molecular Partners after FDA rejection. What's next? (Endpoints)
• AstraZeneca and Daiichi Sankyo continue to flesh out Enhertu plans, claiming win in earlier breast cancer line (Endpoints)
• Bluebird forced to halt trials after a cancer-like case, pulls gene therapies from Europe following pricing backlash — shares slammed (Endpoints)
• ADC experts at Seagen find a $2.6B HER2 gem in China that they think can go where Enhertu, Kadcyla can't (Endpoints)
• BioLife Solutions sets up shop in Indianapolis, adding a slate of new cell and gene therapy tools to its belt (Endpoints)
• Sanofi wins approval for Lumizyme successor, although uptake remains a mystery (Endpoints)
• On a quest to treat newly diagnosed lymphoma patients, Roche teases positive pivotal data (Endpoints)
• Robert Bazemore inks one last deal for Epizyme — adding China to Tazverik's global blueprint — before heading out from CEO office (Endpoints)
• AbbVie, on a Mission, picks Alzheimer's, Parkinson's targets, as partner nabs $20M (Fierce)
• MHRA recalls contaminated Irbesartan- batches as precautionary measure (MHRA)

• Safety Mode Troubles Lead To Class I Recall For Boston Scientific’s Ingenio Pacemakers (MedtechInsight)
• Altoida's Alzheimer's-predicting smartphone app snags FDA breakthrough status (Fierce)
• SpinTech’s brain imaging software nabs FDA clearance to speed diagnosis of Parkinson’s, MS and more (Fierce)
• Graphene-Based Devices Face Regulation Hurdles In Europe (MedtechInsight)
• Diabetes tech companies set sights on Type 2 patients as user numbers climb (MedtechDive)
• ResMed pegs Philips recall to add up to $350M in sales as it struggles to meet surging demand (MedtechDive)
• As HIMSS approaches, plans for health tech’s biggest gathering are clashing with Covid-19 concerns (STAT)
• 5 must-watch panels at an unprecedented HIMSS21 (MedtechDive)

• Valeant To Pay $23M To End 'Secret' Pharmacy RICO Claims (Law360)