Recon: FDA delays decision on BMS’ liso-cel therapy; Amazon launches online pharmacy service

• FDA delays decision on Bristol Myers cancer therapy due to COVID-19 travel curbs (Reuters) (Endpoints) (Press)
• FDA rejects Alkermes schizophrenia drug, citing manufacturing concerns (BioPharmaDive) (Endpoints)
• Amazon launches online pharmacy in new contest with drug retail (Reuters) (STAT)
• US hospitals to restrict Lilly COVID-19 antibody treatment due to limited supply (Reuters)
• Pfizer to start pilot delivery program for its COVID-19 vaccine in four US states (Reuters)
• The man in charge of evaluating coronavirus vaccines for the FDA lays out why it will take weeks to vet a COVID-19 shot (BI)

• EU states agonize over rules on rapid COVID tests, document says, in new blow to airlines (Reuters)
• Nobody has looked at AstraZeneca vaccine data yet - UK health official (Reuters)
• Samsung BioLogics says mass producing Eli Lilly's COVID-19 treatment (Reuters)
• Moderna says UK deal will supply COVID-19 vaccine from March (Reuters)
• Spain in negotiations to buy Moderna vaccine, Government spokeswoman says (Reuters)
• CureVac hiking capacity to 300 million COVID-19 doses in 2021 (Reuters)
• India pins hopes on locally-tested COVID-19 vaccines given Pfizer constraints (Reuters)
• WHO takes aim at cervical cancer to reduce cases, deaths (Reuters) (WHO)
• Vaccine Unproven? No Problem in China, Where People Scramble for Shots (NYTimes)

• Inside the Chaotic, Cutthroat Gray Market for N95 Masks (NYTimes)
• How two companies sprinted ahead in extraordinary race for a COVID vaccine (Reuters)
• U.S. government to send out over 7 million Abbott BinaxNOW tests this week (Reuters)
• Israel in talks with Russia for Sputnik V COVID-19 vaccine (Reuters)
• Bharat Biotech begins Phase-III trials for COVID-19 vaccine, Covaxin, with 26,000 volunteers (Economic Times)

• Breakthrough COVID vaccine tech could help defeat other diseases (Reuters)
• Lead Pharma and Roche enter €260m collaboration agreement (PharmaTimes) (Endpoints)
• Gilead and Novo Nordisk’s NASH trial meets primary endpoint (PharmaTimes)
• Patients Struggle to Find Prescription Opioids After NY Tax Drives Out Suppliers (KHN)
• Opinion: Does Remdesivir Actually Work Against Covid-19? (NYTimes)
• Consortium Grows As Drugmakers Share Excipient Metal Impurities Data To Ease ICH Q3D Testing Burden (Pink Sheet)
• Apellis' Soliris rival gets a date at the FDA for a rare blood disorder, with potentially $400M worth of implications (Endpoints)
• Vaccine maker Seqirus plots $800M investment into major Australian shot manufacturing center (Fierce)
• The primary failed. The key secondary failed. But this biotech still believes it can win an FDA OK in ALS (Endpoints)
• Penny stock player Adamis gets another CRL for high-dose naloxone as shares crater (Endpoints)
• BioMarin taps AI upstart Deep Genomics for discovery pact; Praxis says it has a path to lifting clinical hold (Endpoints)
• BeiGene beefs up PD-1 data with positive PhIII results for tislelizumab, this time in metastatic NSCLC (Endpoints)
• Drug Makers Disclosing as Much Cost Info as Possible in Price Negotiations, JPMA Chief Rebuts Concerns Aired in Project Review (PharmaJapan)

• Long-Awaited EU IVD Classification Guidance Just Published: Initial Reactions (MedtechInsight)
• Boston Scientific to discontinue Lotus Edge TAVR program (MedtechDive)
• Study: Medtronic touts cryoablation results as better than medication (MassDevice)
• Medtronic buys French AI-enabled spinal surgery company Medicrea (mobihealthnews)
• Medica 2020 Opens Its Virtual Doors As German Medtechs Demand More Support (MedtechInsight)

• Rebate Rule May Be Finalized Soon, But Skepticism Lingers That Trump Can Make Lasting Changes On Rx Pricing (Pink Sheet)
• Trump officials preparing to move forward with major step to lower Medicare drug prices (The Hill)
• Feds Say $225M Sackler Fine To Go To Medicare, Medicaid (Law360)
• Missing Inventor Doomed Broad's CRISPR Patent At EPO (Law360)
• Pfizer moves US court against Aurobindo Pharma, Dr Reddy's on cancer drug (Economic Times)
• 'We Are Shipping To The U.S.': Inside China's Online Synthetic Drug Networks (NPR)