Recon: FDA review documents hint at favorable aducanumab review; EMA won’t set minimum efficacy threshold for COVID vaccines

• Biogen Alzheimer's drug gets FDA staff backing, shares jump 40% (Reuters) (Endpoints) (STAT)
• The Endpoints poll: A large majority of biopharma execs turn thumbs down on Biogen's controversial pitch for aducanumab (Endpoints)
• An election night bereft of answers quells biopharma's 'worst-case' fears — analysts (Endpoints)
• Alphabet’s X falls short on goal to find a single biomarker for depression (STAT)
• Will a small, long-shot US company end up producing the best coronavirus vaccine? (Science)
• FTC OKs Stryker's $4B Wright Medical Deal, With Divestitures (Law360)

• EU drug watchdog won't set minimum efficacy levels for potential COVID-19 vaccines (Reuters)
• Different regulatory timelines for COVID vaccine no issue, Oxford trial chief says (Reuters)
• Brexit deal remains elusive, EU's Barnier tells Brussels envoys (Reuters)
• Britain prepares for COVID-19 vaccine as Oxford forecasts result this year (Reuters) (FT)
• UK vaccine chief hopes for positive Oxford and Pfizer data in early December (Reuters)
• Novavax to supply 40 million doses of COVID-19 vaccine to Australia (Reuters)
• China's Fosun to seek approval for BioNTech's COVID-19 second vaccine, ends trials on first (Reuters)

• Lung damage found in COVID dead may shed light on 'long COVID' – study (Reuters)
• US FDA Is Developing Guidance For Interactive Video GMP Evaluations During COVID-19 (Pink Sheet)
• Denmark to cull entire mink population after coronavirus mutation spreads to humans (Reuters)
• UK PM Johnson says will roll out COVID tests on scale never seen before (Reuters)
• Pfizer sidelines US government in COVID-19 vaccine distribution strategy (Fierce)
• Germany readies exhibition halls, mobile teams for COVID-19 vaccination (Reuters)
• UK in talks with Palantir over COVID-19 test-and-trace program: FT (Reuters)
• UK Vaccine Taskforce Leader Under Scrutiny After Investor Meeting (Scrip)

• Doctors are accepting as much money from industry as they were when OpenPayments launched (STAT)
• Perrigo fails to get €1.64bn tax assessment quashed by High Court (RTE)
• Critics say new NIH policy on scientific data sharing falls short (STAT)
• Novartis’ Aimovig tops topiramate in migraine face-off (Pharmaphorum)
• Withdrawing Approval of Makena — A Proposal from the FDA Center for Drug Evaluation and Research (NEJM)
• Preterm Birth and 17OHP — Why the FDA Should Not Withdraw Approval (NEJM)
• UK Early Access For BioCryst’s Hereditary Angioedema Drug (Pink Sheet)
• New Social Media Guidance From US FDA May Be On The Horizon (Pink Sheet)
• Closing The Books On Purdue – And US FDA’s Policies To Control Opioids (Pink Sheet)
• Lack Of Readiness In Responding To DSCSA Verification Requests Major Concern (Pink Sheet)
• Working Group Agrees to Designate 10-20 “Stable Supply Medicines” as Top Priority Drugs (PharmaJapan)
• A year after stunning China OK, Shanghai Alzheimer's drugmaker set to enroll first US patient — and the stakes are huge (Endpoints)
• GW Pharma begins recruitment for US-based Sativex trial (PharmaTimes)
• Vertex, looking to right their R&D ship, flashes data suggesting their sickle cell CRISPR therapy is working (Reuters)
• JW Therapeutics hauls in $300M IPO just as liso-cel-inspired CAR-T nears the finish line in China (Endpoints)
• An ‘innocent bystander’ in the booming biotech investor world is writing a blank check for $100M. Who’s going to cash it? (Endpoints)

• Docs paid by ICD makers more likely to favor manufacturer: JAMA study (MedtechDive)
• Medtronic Recalls Rashkind Balloon Septostomy Catheters for Quality Issues (FDA)
• Key Changes In Commission’s Latest Draft EU Standards Request To CEN/Cenelec (MedtechInsight)
• Salvia BioElectronics Receives FDA Breakthrough Designation For Neurostimulator To Treat Chronic Migraine (MedtechInsight)
• Devicemakers, MedPAC oppose CMS’ proposed coverage determination changes (Modern Healthcare)

• HHS proposes rule to review and eliminate old regulations (Modern Healthcare)
• Generics Cos. Attack 'Serial' Complaints In Price-Fixing Row (Law360)
• Gov't Entities Seek Probe Of $1B Mallinckrodt Debt Swap (Law360)
• Johnson & Johnson fails to overturn $2.12 billion baby powder verdict, plans Supreme Court appeal (Reuters)
• Gilead Says Homeless Recruited To Scam HIV Drug Charity (Law360)
• 3rd Circ. Tosses Defect Claims Over Abbott Artery Device (Law360)
• Red States Back FDA Limits On Abortion Pills At 4th Circ. (Law360)