Recon: Moderna vaccine trial struggling to enroll enough minorities; Russia fast-tracks second COVID-19 vaccine

• White House Blocks New Coronavirus Vaccine Guidelines (NYTimes) (Politico) (Reuters)
• ‘Don’t Be Afraid of Covid,’ Trump Says, Undermining Public Health Messages (NYTimes)
• Moderna vaccine trial contractors fail to enroll enough minorities, prompting slowdown (Reuters)
• FDA hands Y-mAbs refusal to file letter in one of its pediatric neuroblastoma programs (Endpoints)
• New forecast says biosimilars will cut U.S. drug spending by $100 billion in five years (STAT) (Drug Channels)
• Supreme Court to review state law governing pharmacy benefit managers (STAT) (Law360)
• J&J to Pay More Than $100 Million to End Over 1,000 Talc Suits (Bloomberg) (Reuters)
• Biogen, gene-editing startup Scribe to develop therapies for Lou Gehrig's disease (Reuters)

• COVID-19 vaccine may be ready by year-end - WHO's Tedros (Reuters)
• EU reviewing Pfizer-BioNTech COVID-19 vaccine in real time (Reuters) (FT) (EMA)
• Russia Fast-Tracks Second Coronavirus Vaccine (WSJ)
• China in talks with WHO over assessing its COVID-19 vaccines for global use (Reuters)
• European countries face shortages of COVID-19 drug remdesivir (Reuters)
• UK to follow clinical advice in deploying COVID-19 vaccine, Hancock says (Reuters)
• Ministers to be questioned over UK coronavirus vaccination target (FT)
• Santhera halts trial of DMD drug Puldysa, launches revamp (Reuters) (Endpoints)

• CDC says coronavirus is airborne, but weakens language from earlier warning (Politico) (NYTimes)
• Nearly One-Third of Covid-19 Patients in Study Had Altered Mental State (NYTimes)
• Easier-to-Use Coronavirus Saliva Tests Start to Catch On (KHN)
• Regeneron Pushes Legal, Ethical Boundaries With Offer Of COVID-19 Antibody To Biden Campaign (Pink Sheet)
• GSK to widen COVID-19 antibody treatment trial after safety clearance (Reuters) (Endpoints)
• HIV treatment has no benefit for hospitalised COVID-19 patients – study (Reuters)
• FDA issues rare emergency authorization for an algorithm used to inform Covid-19 care (STAT)
• Quidel antigen test to detect COVID-19 and flu gets FDA nod (MedtechDive)
• Britain buys 1 million COVID-19 antibody tests (Reuters)
• Oxford Biomedica earns U.K. nod for 4th manufacturing suite to boost COVID-19 production (Fierce)
• Pfizer, Regeneron Hit With Patent Suits Over COVID-19 Tech (Law360)

• EU Pharma Strategy To Balance Innovation Incentives & Competition (Pink Sheet)
• Marksans expands metformin recall as carcinogen contamination worries continue to grow (Fierce) (FDA)
• Mylan, Hikma versions of injectable diuretic recommended for recall by Kentucky researchers (Fierce)
• With a sweetened offer, BridgeBio plans to reel in a subsidiary (BioPharmaDive)
• Walden Biosciences launches with $51M and a 2-pronged approach to 'completely transform' kidney disease (Fierce)
• Novartis offloads 2 Spanish finished-dose facilities to Swiss contract manufacturer (Fierce)
• Nvidia to build the U.K.'s fastest supercomputer for AI drug-hunters at GSK, AstraZeneca and more (Fierce)
• MHLW Lays Out Compliance Guidelines for Manufacturers; Introduction Planned in August 2021 under Amended PMD Law (PharmaJapan)
• Amgen posts upbeat assessment of PhII KRAS data on AMG510 — but there's no clear picture of what researchers saw (Endpoints)
• The latest Jennifer Doudna startup launches with a Biogen partnership and eyes on big targets few CRISPR companies have chased (Endpoints)
• Talaris Therapeutics bags another $115M to curb immunosuppression in organ transplant patients (Endpoints)
• Axovant reports improved motor function in small Parkinson's trial; Bain life sciences SPAC files for $125M IPO (Endpoints)
• Iovance shares hammered on TIL therapy filing delay — although analysts aren't as bothered (Endpoints)

• CMS officials elaborate on proposed breakthrough device coverage pathway (MedtechDive)
• FDA Approves Medtronic’s Resolute Onyx DES With Short-Term Dual-Antiplatelet Therapy (MedtechInsight)
• M&A on horizon as deep-pocketed medtechs eye distressed assets: EY (MedtechDive)
• Guidance on the vigilance system for CE-marked medical devices – Insulin infusion pumps and integrated meter systems (EC)

• Drug Distributors Fear 'Super-Spreader' Trial In Opioid MDL (Law360)
• Key Highlights As House Dems Drop Hammer On Drugmakers (Law360)
• Justices Skip Opioid Treatment Case Disputing PTAB's Power (Law360)
• GSK Can't Get High Court Review In Avandia Marketing Fight (Law360)
• Chancery Orders Walmart To Turn Over Opioid Oversight Docs (Law360)
• Justices Won't Hear Widow's Appeal Over Heart Drug Warning (Law360)
• Fed. Circ. Mulls New Trial In Vectura's $107M Inhaler IP Win (Law360)
• Highlights of Management Board: October 2020 meeting (EMA)