Recon: BioNTech buys production site, T-cell platform from Gilead; China approves AstraZeneca’s Imfinzi for aggressive form of lung cancer

• BioNTech strengthens cancer therapy expertise with US acquisition (Reuters) (Endpoints)
• FDA investigating how a known carcinogen wound up in J&J sunscreen (Reuters)
• US to allow temporary rise in impurities in anti-smoking drug (Reuters) (FDA)
• Kadmon wins approval for drug to treat chronic graft-versus-host disease (STAT) (FDA)
• FDA Approves New Use of Transplant Drug Based on Real-World Evidence (FDA)

• EU evaluates Sobi arthritis drug to treat COVID-19 with pneumonia (Reuters) (EMA)
• China approves Astra drug Imfinzi for aggressive form of lung cancer (Reuters)
• Mexico says will soon authorize Moderna's COVID vaccine (Reuters)
• Britain backs slew of 'long COVID' research studies (Reuters) (FT)
• CARMAT announces the first commercial implant of its Aeson artificial heart (Reuters)
• Taiwan approves Medigen's COVID-19 vaccine candidate (Reuters)

• The one vaccine strategy the Biden administration isn’t considering (Politico)
• Novavax’s Effort to Vaccinate the World, From Zero to Not Quite Warp Speed (KHN)
• Booster shot debate takes centre stage as global Covid cases rise (FT)
• Bharat Biotech dossier under review for Covaxin emergency use listing: WHO (Economic Times)
• China Zhifei's COVID shot largely retains effect against Delta variant-lab study (Reuters)
• Adagio seeks IPO to bring COVID-19 antibody to market in 2022 (Fierce)

• FDA’s domestic biopharma inspections return to normal as agency faces backlog of 8,000+ (Endpoints)
• Cytokinetics drug improves blood flow in patients with inherited form of heart disease (STAT)
• Biden’s July Executive Order Includes Drug Pricing Provisions. But Will They Do Enough? (KHN)
• Biogen wasted no time in rolling out a ‘disease awareness’ campaign for Alzheimer's as an R&D marathon turns into a sprint. A top analyst awards gold, silver and bronze (Endpoints)
• Opinion: Too close for comfort: FDA shouldn’t loosen conflict rules for its expert panels (STAT)
• US FDA’s Regulatory Affairs Office Building Case For More User Fee Funding (Pink Sheet)
• MHRA’s new Chief Safety Officer, Dr Alison Cave, starts vital vigilance work today (MHRA)
• Tillman Gerngross is betting well over $500M that the pandemic will never really end. Here’s the IPO pitch (Endpoints)
• Merck KGaA fortifies its ‘site of the future’ with $319M research, staff training centers (Endpoints)
• IPOs continue to bustle as three more biotechs prepare to make the Nasdaq leap (Endpoints)
• AstraZeneca earns another approval in jam-packed Chinese PD-(L)1 market, this time in late-stage lung cancer (Endpoints)
• PureTech-backed Gelesis wins biotech's latest SPAC deal, planning to bring weight loss product to up to 150M Americans (Endpoints)
• Months after Amgen's landmark KRAS approval, Chris Varma bags a crossover round for next-gen KRAS candidate (Endpoints)
• Cytokinetics is getting its shot at a major PhIII showdown with Bristol Myers after posting positive data for a rare cardio disease. Shares rocket up (Endpoints)
• Merck crosses the finish line with its next-gen pneumococcal vaccine. Does it stand a chance against Pfizer's 20-valent shot? (Endpoints)
• Product-Specific Guidance for Cilastatin Sodium; Imipenem; Relebactam; Draft Guidance for Industry (FDA)
• Guilty Rulings for 3 Wholesalers, Employees Now Final and Binding: Bid-Rigging Trial (PharmaJapan)

• Abbott, Intuitive and J&J kick off medtech earnings as COVID-19 bellwethers (MedtechDive)
• Dexcom gets FDA go-ahead to pair diabetes data with Garmin, Livongo and more through third-party APIs (Fierce)
• Foundation Medicine Obtains FDA Approval For Non Small Cell Lung Cancer Companion Diagnostic (MedtechInsight)
• FDA Cautions EUA-Holders They Have Same MDR Reporting Responsibilities As Other Manufacturers (MedtechInsight)
• Gelesis to take its stomach-filling weight loss capsule public in $1.3B SPAC merger (Fierce)

• Amid Purdue bankruptcy talks, Connecticut attorney general accuses some Sacklers of intimidation (STAT)
• Apotex Pays Texas $26M To End Medicaid Fraud Probe (Law360)
• McKinsey Says Cherokee Opioid Suit Destined For MDL (Law360)
• Novartis' Expert Denies Rival Atty's Plagiarism Claim In IP Trial (Law360)