Recon: FDA says extra doses from Pfizer-BioNTech vials can be used; EU seeks 200M doses of Novavax vaccine

• FDA, Pfizer Revising Covid Vaccine Guidelines on Side Effects (Bloomberg)
• Alaska reports adverse reaction from Pfizer vaccine in health worker (Politico) (NYTimes)
• FDA says extra doses from vials of Pfizer's COVID-19 vaccine can be used (Reuters) (STAT) (Politico)
• US could get additional Pfizer vaccine doses by summer (Politico)
• Did the FDA understaff its review of the Pfizer/BioNTech vaccine? (STAT)
• FDA Panel Weighs Moderna's COVID-19 Vaccine (NPR) (Reuters)
• Moderna's COVID-19 vaccine ready to ship pending FDA approval -U.S. health chief (Reuters)
• 'A precedent you might not want to set.' FDA-invited expert blasts Moderna unblinding plan as adcomm gets underway (Endpoints)
• You can’t sue Pfizer or Moderna if you have severe Covid vaccine side effects. The government likely won’t compensate you for damages either (CNBC)
• AbbVie wins 21 months of wrinkle-free competition for Botox thanks to an ITC ruling (STAT)
• Opioid prescribing has dropped dramatically since 2011, but experts say there’s ‘more to go’ (STAT)
• This tiny, one-drug biotech company is the loudest critic of Trump’s new international drug pricing policy (STAT)

• Oxford says vaccine has good immune response with two dose regime (Reuters)
• AstraZeneca makes tough unblinding call, grappling with a vaccine rollout that threatens to impair their embattled PhIII (Endpoints)
• Macron tests positive for COVID-19, forcing leaders to self isolate (Reuters)
• EU to order more Pfizer vaccine after declining earlier offer (Reuters)
• EU concludes preliminary talks to buy up to 200 million doses of Novavax COVID vaccine (Reuters)
• EU states to start COVID-19 vaccinations from Dec. 27 (Reuters)
• Drugmakers should cut COVID-19 vaccine prices for Africa - Africa CDC (Reuters)
• Japan review of Avigan says efficacy for COVID-19 treatment inconclusive -Kyodo (Reuters)
• Pfizer hits snags registering vaccine for emergency use in Brazil -health minister (Reuters)
• Novartis acquires Cadent Therapeutics in potential $770 million deal (Pharmafile)
• Need a ventilator? Polish arms dealer has plenty (Reuters)

• ‘We want them infected’: Trump appointee demanded ‘herd immunity’ strategy, emails reveal (Politico)
• Groups mount lobbying blitz to be next in line for Covid shots (Politico)
• The Vaccines Are Supposed to Be Free. Surprise Bills Could Happen Anyway. (NYTimes)
• WHO says Beijing welcomes COVID-19 investigators trip to China (Reuters)
• EMA working on COVID-19 and Brexit over holiday period (EMA)
• Mexico hopes to ink CanSino COVID-19 vaccine contract by next week (Reuters)
• COVID vaccine is bonanza for digital supply chain tracking industry (Reuters)
• Saudi Arabia begins inoculating people with Pfizer COVID-19 vaccines (Reuters)
• International consortium creates ‘open platform’ for COVID-19 drug discovery (PharmaTimes)

• Big Pharma Passes Its Annual Checkup (WSJ)
• Opinion: Big Pharma Is Fooling Us (NYTimes)
• Big pharma catalysts to ring in the new year (Evaluate)
• Pandemic Will Limit Role Of US FDA Inspections In Driving FY 2021 Drug GMP Sanctions (Pink Sheet)
• MacroGenics wins FDA approval of breast cancer drug (BioPharmaDive)
• Messenger RNA gave us a COVID-19 vaccine. Will it treat diseases, too? (Science)
• Alzheimer’s Inc.: Colleagues Question Scientist’s Pricey Recipe Against Memory Loss (KHN)
• GSK puts up to $815M on the table for Surface Oncology's antibody (Fierce) (Endpoints)
• A booming market propels China CRO to a $100M raise. Is an IPO next? (Endpoints)
• AbbVie's Covid-19 antibody partner wraps $221M Hong Kong IPO (Endpoints)
• The biotech IPO train keeps chugging, as Virios prices $30M public debut (Endpoints)
• Gilead's CAR T therapy Tecartus authorised in EU for MCL (PharmaTimes)
• Samsung Biologics names John Rim as CEO and President (Pharmafile)
• Amgen guns for speedy KRAS cancer approval as it leads race (Fierce)
• Neurogene adds another $115M to the pot for trials for its gene therapies (Fierce)
• IQVIA teams up with French pharma Servier to 'reinvent clinical development' (Fierce)
• US FDA To Screen Rx Drug Launch Promos Prior To Initiating Review (Pink Sheet)
• US Retail Drug Spending Growth Accelerates In 2019, Driven Mostly By Utilization, Not Prices (Pink Sheet)
• Tale Of Two Adcomms: US FDA Handling Of Entresto Data May Have Helped Avoid Aducanumab’s Fate (Pink Sheet)
• Continuing rapid expansion, Thermo Fisher says it will add on plasmid DNA manufacturing site in California (Endpoints)
• GlaxoSmithKline's Benlysta earns first FDA approval for lupus nephritis as competitors wait in the wings (Endpoints) (Press)
• News briefing: British psychedelic investment firm launches; Irish cell therapy company gains exclusive license options (Endpoints)
• Minority investor WaterMill succeeds in activist attack of Ziopharm, winning two board seats and removal of chairman (Endpoints)
• Developing Predictive Indicators of Genome Stability and Cell Maturation as Measures of Cell Therapy Product Safety and Efficacy (FDA)

• FDA Authorizes Marketing of New Implant to Repair a Torn ACL (FDA)
• Stryker, Zimmer shift strategies to capitalize on growing ASC market (MedtechDive)
• Breakthrough designations go to renal denervation devices in latest FDA batch (MedtechDive)
• US FDA May Destroy Counterfeit Devices Under Bill Awaiting President’s Signature (MedtechInsight)

• FDA, USPTO Data Show Earlier Small-Molecule Drug Patenting (Law360)
• Senate OKs Bill To Expand Research On Medical Cannabis (Law360)
• KEI Files Amicus Brief in GlaxoSmithKline vs Teva Induced Infringement Case (KEI)
• Mallinckrodt Says Market Bodes Ill For Ch. 11 Equity Salvage (Law360)
• Bausch Accuses Lupin Of Infringing Plenvu Patents (Law360)
• Eli Lilly Should Face IP Suit Over Migraine App, Judge Says (Law360)
• J&J Elmiron Suits Sent To NJ Federal Court (Law360)