Recon: Softbank builds $5B stake in Roche; FDA aiming to approve Pfizer vaccine in early September - NYT

• FDA Aims to Give Final Approval to Pfizer Vaccine by Early Next Month (NYTimes) (Reuters) (Politico)
• Amgen Disputes IRS Claim It Owes $3.6 Billion in Back Taxes (WSJ)
• Amgen, expecting higher demand for its medicines, to build plant in North Carolina (BioPharmaDive) (Endpoints)
• FDA classifies Philips ventilator recall due to low oxygen risk as most serious (Reuters)
• CVS hedges on 2022 earnings growth target as COVID-19 uncertainty persists (Reuters)
• Sarepta adds another gene therapy to its ever-expanding pipeline (BioPharmaDive)
• Pfizer, Moderna and Alnylam flag pharma labor shortage in Massachusetts—and the people bottleneck doesn't stop there (Fierce)

• WHO calls for moratorium on COVID-19 vaccine booster doses (Reuters)
• SoftBank Builds a $5 Billion Stake in Pharma Giant Roche (Bloomberg) (FT)
• EU seals deal with Novavax for up to 200 million COVID-19 vaccines (Reuters)
• MHRA approves Opdivo plus Yervoy for unresectable malignant pleural mesothelioma (PharmaTimes)
• EU Pharma Rejects Proposed Changes To Orphan Medicine Criteria (Pink Sheet)
• India initiates anti-dumping probe against Chinese pharma chemical (Economic Times)

• Analysis: Don’t Want a Vaccine? Be Prepared to Pay More for Insurance. (KHN)
• J&J Covid vaccine recipients can get supplemental Pfizer or Moderna dose in San Francisco (CNBC)

• Alzheimer’s patients are in limbo as hospitals, insurers grapple with whether to offer Aduhelm (STAT)
• We Are Releasing the Full Video of Richard Sackler’s Testimony About Purdue Pharma and the Opioid Crisis (ProPublica)
• Roche's PD-L1 franchise player nabs priority review; One of world's first psychedelics research institutes opens in Australia (Reuters)
• Biogen, Eisai are pushing for another accelerated Alzheimer's OK — this time for BAN2401 (Endpoints)
• Demand for Novo Nordisk's new weight-loss drug Wegovy outstripped early supply, analysts say (Fierce)
• FDA slaps back small-cap's bid to repurpose 50-year-old chemotherapy (Endpoints)
• Amgen Reports Second Quarter 2021 Financial Results (Press)
• Amgen halts a PhI for FLT3 BiTE while resuming dosing on another (Endpoints)
• UK trial to assess Sativex for the treatment of ‘aggressive’ brain tumours (PharmaTimes)
• Takeda Still Hopeful On Dengue Vaccine Candidate (Pink Sheet)
• Synthetic biology outfit Zymergen sees fledgling stock tumble amid CEO departure, product delays (Fierce) (GEN)
• Pfizer puts the pressure on Eli Lilly's JAK inhibitor Olumiant with new data in alopecia areata (Endpoints)
• Ardelyx chops a third of its staff after stock-crushing failure in chronic kidney disease (Endpoints)
• Jeff Bluestone just raised $265M to develop curative cell therapies. We asked him how (Endpoints)
• Samantha Du's Zai Lab inks surprising research collab with Schrödinger for DNA damage drug (Endpoints)

• Rival to Boston Scientific's Sentinel meets skeptics at FDA advisory panel (MedtechInsight)
• Roundup: Medtechs mirror pre-pandemic results in Q2 fueled by procedure volume recovery (MedtechDive)
• Zimmer beats Q2 expectations, pandemic still a drag on large joint procedures (MedtechDive)
• Philips ventilator recall labeled Class I by FDA, second in as many weeks (MedtechDive)

• Georgia Device Sterilizer Sued For Allegedly Causing Cancer, Death (MedtechInsight)
• Abbott Sues To Invalidate Rival's Diabetes Tech Patents (Law360)
• Endo Discovery Fight Overshadows NY Opioid Trial (Law360)
• Fed. Circ. Mulls Generics' Invalidity Argument In Teva IP Row (Law360)
• Glenmark Accuses DOJ Of 'Strong-Arm Tactics' (Law360)
• Hikma Should Face Amarin's Patent Suit, Magistrate Says (Law360)
• FTC Says Illumina Case Too Simple For Extra Experts (Law360)
• Biomet Fails To Escape Mo. Jury's $21M Hip Implant Verdict (Law360)
• Firms Seek Fees For Biogen's 'Egregious' Tactics In Docs Suit (Law360)
• Mallinckrodt Ch. 11 Creditor Blasts Proposed Payout Plan (Law360)
• Medicare Coverage With Evidence Development Mandate Expires After Four Years Under Senate Bill (Pink Sheet)