Recon: Regeneron to stop enrolling sickest patients in COVID antibody trials; AZ sells rights to two drugs for $400M

• Regeneron to stop enrolling very sick COVID-19 patients in antibody trials (Reuters) (Endpoints)
• Inside Operation Warp Speed’s $18 Billion Sprint for a Vaccine (Bloomberg)
• Biden’s policies could spell trouble for biotech — but industry CEOs are backing him anyway (STAT)
• AbbVie Reports Third-Quarter 2020 Financial Results (Press)
• Medtronic to Pay Over $9.2 Million To Settle Allegations of Improper Payments to South Dakota Neurosurgeon (DOJ)
• Reauthorization of the Biosimilar User Fee Act; Public Meeting (FDA)

• EU will wait for late-stage data before approving COVID vaccine: Spahn (Reuters)
• EU Commission says talking to four companies on COVID vaccine (Reuters)
• BioNTech CEO expects data from late-stage study soon (Reuters)
• AstraZeneca sells commercial rights to two drugs in $400 million deal (Reuters) (Endpoints)
• Moscow plans vaccinations as Russia's COVID-19 cases hit record amid doctor shortage (Reuters)
• EU urges quick WHO reform, asks for more transparency in pandemics (Reuters)
• Lonza to make COVID-19 antibody combination for AstraZeneca (Reuters)
• Zejula (Pre
• Novartis sickle cell medicine Adakveo® approved in Europe to prevent recurrent vaso-occlusive crises (Press)

• Will the Hardest-Hit Communities Get the Coronavirus Vaccine? (NYTimes)
• Trump administration to require insurers cover coronavirus vaccines (BioPharmaDive)
• AstraZeneca Gets $287M Vaccine Contract From Army (Law360)
• Trump administration vetted political views of 274 celebrities for botched $265 million Covid ad campaign, House lawmakers say (CNBC)
• China's Clover applies for Philippines COVID-19 vaccine trial (Reuters)

• Two more biotechs price IPOs, bringing total raise to record heights (Endpoints)
• Atea, riding interest in COVID-19 drugs, pulls off one of 2020's top biotech IPOs (BioPharmaDive)
• A $200 Debit Card Won’t Do Much for Seniors’ Drug Costs (KHN)
• Crispr Gene Editing Can Lead to Big Mistakes in Human Embryos (WSJ)
• Novartis fills manufacturing gap for CAR-T therapy Kymriah with first Asian production facility (Fierce)
• Regulatory update - EMA encourages companies to submit type I variations for 2020 by end of November (EMA)
• Incoming EMA Chief Throws Weight Behind Antimicrobial Resistance Fight (Pink Sheet)
• US FDA’s Help May Get Charleston’s Hydexor Through Second Advisory Committee (Pink Sheet)
• Bellicum slashes 79% of staffers after early data quash hope around next-gen CAR-T (Endpoints)
• Novo Nordisk quietly nabs a rare 'breakthrough' status in NASH for its cash cow (Endpoints)
• Novo Nordisk scraps Type 1 diabetes drug after phase 2 trial (Fierce)
• NICE recommends Novo's liraglutide for management of obesity and non-diabetic hyperglycaemia (Pharmafile)
• Takeda Done with Majority of Non-Core Asset Divestitures with US$10 Billion Target Achieved: CEO (PharmaJapan)
• Watch out, Merck: FDA grants Regeneron, Sanofi's Libtayo priority review for coveted first-line use in lung cancer (Fierce)
• OxyContin Gets Delayed Approval in Japan with Special Distribution Scheme Now in Place (PharmaJapan)
• Sanofi, Regeneron win EU patent case against Amgen over PCSK9 antibodies (FirstWorldPharma)
• Axovant faces months of delay on lead Parkinson's gene therapy; Chinese CAR-T biotech nabs $100M (Endpoints)
• In early blow to Kenji Yasukawa's R&D revamp, Astellas drops out of the TIGIT race, citing PhI failure (Endpoints)
• Troubled Unum rebrands as Cogent Biosciences, replaces CEO Chuck Wilson with Andrew Robbins; Jennifer Fox appointed as CFO at David Hung-led Nuvation Bio (Endpoints)
• George Golumbeski and Faheem Hasnain team up with Vertex Ventures HC in managing $320M of biotech cash (Endpoints)

• Medtronic expands head, neck portfolio with new acquisition and FDA clearance (Fierce)
• C2N debuts Alzheimer's blood test for predicting amyloid plaque deposits in the brain (Fierce)
• Smith & Nephew lays path to 10% growth for acquired Integra assets (MedtechDive)
• How TÜV SÜD Issues First Certificate Under EU’s IVD Regulation And Says Technical Documentation Is Key (MedtechInsight)
• Latest European Commission Document Focuses On New Rapid Antigen Tests for COVID-19 (MedtechInsight)
• Baxter Issues Urgent Device Correction to Reinforce Important Safety Information Regarding Cleaning Practices of all Sigma Spectrum Infusion Pumps (V6, V8 and IQ) (Press)

• The Potential Life Sciences Implications of the Election (FDA Law Blog)
• H.R. 5668, Making Objective Drug Evidence Revisions for New Labeling Act of 2020 (CBO)
• Drugmaker In IP Fight With Mylan Calls EPO Ruling 'Irrelevant' (Law360)
• CMS competitive bidding process fails to drive expected savings, sparking rethink (MedtechDive)
• Court Tosses Manufacturer’s Bid For Medicare Coverage (MedtechInsight)