Recon: Pfizer, BioNTech request vaccine EUA for children 5-11; Moderna plans African vaccine manufacturing site

• Pfizer vaccine for children may be ready by Thanksgiving -White House adviser (Reuters)
• Pfizer, BioNTech seek U.S. COVID-19 vaccine clearance for children 5-11 (Reuters) (WSJ) (Politico)
• Tensions grow between Moderna, White House over vaccine production (Politico)
• Moderna Wants Fed. Cir. Help to Avoid Covid Vaccine Patent Suits (Bloomberg)
• Biden closes in on pick to lead Food and Drug Administration (Politico) (Endpoints)
• Amgen to invest $100 million in SoftBank-backed Neumora (Reuters) (STAT)
• Becton Dickinson expands syringe making to support vaccination in U.S. (Reuters)
• Disappointing tumor responses, more side effects, seen with latest Amgen KRAS combination studies (STAT)

• Moderna plans African vaccine plant as drugmakers urged to help poorest (Reuters)
• U.N. chief appeals for $8 bln to equitably vaccinate 40% of world in 2021 (Reuters)
• Sanofi says good results from flu vaccine with mRNA booster study (Reuters)
• African Union to start talks with WHO on malaria vaccine rollout (Reuters)
• Countries in the Asia-Pacific region rush to buy Merck’s Covid-19 pills. (NYTimes)
• Additional manufacturing site for COVID-19 Vaccine Janssen (EMA)

• Finland joins Sweden and Denmark in limiting Moderna COVID-19 vaccine (Reuters)
• Brazil regulator to probe hospital chain over use of hydroxychloroquine (Reuters)
• Malaysia buys 150,000 courses of Merck's COVID-19 pill (Reuters)
• Uzbekistan starts producing Russian Sputnik V vaccine (Reuters)

• RA Capital kicks off third VC fund as Peter Kolchinsky and Rajeev Shah bank $880M (Endpoints)
• Tiny player picks up $30M to go after CAR-T's biggest challenges (Endpoints)
• With a fresh $75M, Michael Ehlers' latest take on non-viral gene therapy is ready for takeoff (Endpoints)
• Bayer drops $460M into contraceptive manufacturing sites with the United Nations' backing (Endpoints)
• Science 37 takes the SPAC shortcut to Nasdaq, landing a $235M windfall for its push on decentralized trials (Endpoints)
• Alnylam becomes new partner in the Medicines Manufacturing Innovation Centre (PharmaTimes)
• Ginkgo Bioworks 'a hoax for the ages,' says activist short seller firm (Fierce)
• AbbVie touts more Rinvoq data in inflammatory spinal arthritis as it awaits key FDA decisions (Fierce)
• FDA-EMA Pilot Could Further Push Global Generic Harmonization, But Will Sponsors Use It? (Pink Sheet)
• Remote Methods Drove Most US FDA Enforcement Actions In FY 2021 (Pink Sheet)
• England’s NICE Starts Work To Develop RWE Standards (Pink Sheet)
• As More Products Get Priority Review, User Fee Cost Gap From Standard Review Is Narrowing (Pink Sheet)
• US FDA’s Confidentiality Policies Seen As Big EUA Shortcoming (Pink Sheet)
• Emboldened by a positive PhIII, Novartis steers a late-stage BTK inhibitor into a pivotal MS trial (Endpoints)
• Bristol Myers' TYK2 drug bombs ulcerative colitis test, but hopes are still high with psoriasis filing on deck (Endpoints)
• Catalent opens newest clinical supply site in Japan, expanding its footprint in the Pacific Rim (Endpoints)
• OrbiMed's TKI play makes its Nasdaq debut as Theseus prices IPO (Endpoints)

• What's under the hood of a medical device? Software bill of materials hits inflection point (MedtechDive)
• Medtechs opened 2021 with a flurry of M&A and have not stopped spending since (MedtechDive)
• In digital health, Series A has become the new Series B (STAT)
• Medicare To Cover At-Home Test To Detect Organ Rejection After Kidney Transplant Surgery (MedtechInsight)
• Hologic Makes Good On Mobidiag Acquisition With Expanded Launch Of Diagnostics Platform (MedtechInsight)

• Former Safeway CEO says Theranos delays raised red flags as emotional juror is dismissed from case (CNBC)
• Court Sides With Rival In AbbVie's Trade Secrets Suit (Law360)
• Mallinckrodt Facing $93M Drug Royalty Claim In Ch. 11 (Law360)