Recon: Boston Scientific settles surgical mesh claims for $189M; EU tightens COVID vaccine export rules

• J&J plant authorization clears way for big boost in US COVID-19 shots (Reuters)
• Boston Scientific in $189 million settlement with US states over surgical mesh devices (Reuters)
• Kaleido Biosciences says oral drug cuts COVID-19 recovery time, hospitalizations (Reuters)
• ‘A mess across the board’: Senate committee kicks off talks on drug pricing reforms (Endpoints)
• A ‘conditional’ EUA for a CytoDyn Covid treatment? FDA says no such thing exists (STAT)
• Pelosi: Drug pricing measure under discussion for infrastructure package (The Hill)

• GSK fires former US vaccine head Slaoui over harassment allegation (Reuters) (STAT) (Politico) (GSK)
• EU sharpens COVID vaccine export rules as third wave of infections rises (Reuters) (NYTimes)
• AstraZeneca vaccine doses found in Italy, export block on table (Reuters) (NYTimes) (FT)
• Hong Kong halts BioNTech COVID-19 vaccines, investigates packaging (Reuters)
• Canada recommends AstraZeneca vaccine despite US criticism of trial data (Reuters)
• CureVac sets up Swiss business ahead of seeking COVID-19 shot approval (Reuters)
• Doubts overshadow China’s pledge to vaccinate developing countries (FT)

• World gets 'failing' grade for COVID-19 preparedness, OECD says (Reuters)
• Boris Johnson under fire for putting UK vaccine success down to ‘greed’ (FT)
• China triples output of COVID-19 vaccines from early February: Xinhua (Reuters)
• India delays big exports of AstraZeneca shot as infections surge, say sources (Economic Times)
• India detects 'double mutant' coronavirus variant in western state (Reuters)
• Brazil could approve Russian coronavirus vaccine in days, says pharmaceutical firm (Reuters)
• Vietnam seeks to diversify COVID-19 vaccine sources amid supply issues (Reuters)
• Shionogi Partner BioAge Begins US PII Study for COVID-19 Drug (PharmaJapan)
• Roche bets COVID-19 vaccination drive to favor PCR over antigen testing (MedtechDive)

• Tougher regulatory environment for biopharma? Debate ensues (Endpoints)
• Britain to launch new health security agency to battle pandemics (Reuters)
• In a first for upstart synthetic biology field, Zymergen files for $100M IPO (Endpoints)
• Program Participants Urge The FDA To Adopt Some Pharmaceutical Quality Metrics And Avoid Others (Pink Sheet)
• After leading a corporate turnaround, a swashbuckling CEO flies AstraZeneca into turbulence (STAT)
• Merck's big C-suite shuffle continues as Caroline Litchfield is tapped as new CFO (Endpoints)
• After spurning Sanofi for diabetes disappointment, Zealand nets FDA approval in severe hypoglycemia (Endpoints)
• Novo Nordisk obesity treatment successful in clinical trials (Pharmafile)
• An industry consortium wants to standardize cell tracking for regenerative meds. Could that avert a disaster? (Endpoints)
• One of the masterminds behind remdesivir, Gilead's Diana Brainard jumps ship to antiviral T cell player AlloVir (Endpoints)
• Myovant adds relugolix data in uterine fibroids ahead of June PDUFA; Mubadala teams up with UK for $1B+ fund (Endpoints)
• BridgeBio's Calcilytix Sees POC For Encaleret And Options To Discuss With FDA (Scrip)
• Hearing loss specialists at Frequency pin the blame for PhIIa flop on trial design — but they couldn't stem a freefall in share price (Endpoints)
• Step Pharma closes $41M round to take enzyme targeting lead program into early-stage trial for T cell malignancies (Endpoints)
• With Amazon and Ro on its heels, Uber expands its prescription delivery business (STAT)
• Generics Coverage In Medicare Part D Plans Worsens In 2021 (Pink Sheet)
• Japan Approves Incyte’s Pemazyre, Bayer’s Vitrakvi, Novartis’ Kesimpta, and More (PharmaJapan)
• Bendamustine (Levact): increased risk of non-melanoma skin cancer and progressive multifocal encephalopathy (PML) (MHRA)

• FDA Introduces Biocompatibility Assessment Resource Center (FDA Law Blog)
• J&J's allergy-fighting contact lens nets first approval in Japan, allowing wearers to skip eye drops (Fierce)

• Vivek Murthy confirmed by Senate as surgeon general, will focus on Covid, opioids (NBC)
• 11th Circ. Rips FDA's 'Invisible Ink' Interpretation Of Drug Act (Law360)
• J&J Seeks High Court Holy Grail: A Cap On Punitive Damages (Law360)
• Generics MDL Special Master Says Calif. AG Merits Sanctions (Law360)
• Feds Don't Want Hospital Groups In Pharma Discount Fight (Law360)
• Sacklers Say No Ch. 11 Deal Without Injunction Extension (Law360)
• Fla. Woman Asks 11th Circ. To Revive Pelvic Mesh Claims (Law360)
• 3 Arthrex-Adjacent High Court Cases Could Affect PTAB's Fate (Law360)
• Senate reaches deal to extend Medicare pay bump for health care providers through 2021 (STAT)
• Universities launch opioid litigation archive to ‘ensure history doesn’t repeat itself’ (STAT)
• AbbVie accuses rival of stealing blockbuster ‘trade secrets’ as clock ticks down on biosimilar assault (Endpoints)
• 14 Defendants Sentenced to 74+ Years in Forest Park Healthcare Fraud (FDA)
• Medical Doctor and Study Coordinator Sentenced to Prison in Scheme to Falsify Clinical Trial Data (FDA)