Recon: Brazil’s Anvisa allows J&J to resume COVID-19 vaccine trial; BMS reports positive Phase III for novel psoriasis drug

• Experts to review Biogen drug that could be first new Alzheimer's treatment in decades (Reuters)
• FDA bars critic from review panel of Biogen's controversial Alzheimer's drug (Reuters) (Endpoints)
• The Endpoints News poll: Should the FDA panel back an approval for aducanumab, or should they send Biogen packing? (Endpoints)
• Gilead faces pressure to relinquish valuable FDA voucher awarded with remdesivir approval (STAT)
• Takeda price hikes for a GI drug may give some patients another kind of stomachache (STAT)
• McKesson says states seek $21 billion from drug distributors in opioid settlement (Reuters)
• Health agencies resist Trump civil service executive order (Politico)
• Bristol Myers psoriasis drug succeeds in late-stage study (Reuters) (STAT) (Endpoints)

• Germany requests 5% of EU supply of remdesivir (Reuters)
• Germany says remdesivir useful for some COVID-19 patients (Reuters)
• Brazil's Anvisa gives nod for resumption of trial with Janssen COVID-19 vaccine (Reuters)
• CanSino Biologics delivers COVID-19 vaccine to Mexico for late-stage trial (Reuters)
• CEPI to fund development of COVID-19 vaccine candidate by China's Clover (Reuters)
• Novo Nordisk’s Saxenda bags NICE recommendation (PharmaTimes)

• The pandemic surge in charts (Politico)
• Pregnant Women Face Increased Risks From Covid-19 (NYTimes)
• India Expert panel rejects Dr Reddy’s proposal for full approval of remdesivir (LiveMint)
• Zydus Cadila files investigational new drug application for COVID-19 treatment (Economic Times)

• GDUFA III: First-Cycle Approval, Priority Assessment Improvements Are Early Priorities (Pink Sheet)
• AstraZeneca partners with Fusion to test radiopharmaceuticals in cancer (BioPharmaDive)
• Novavax expands in Maryland as it gears up for late-stage COVID vaccine trial in the US (Fierce)
• Lilly, Incyte tout new baricitinib data in eczema (PharmaTimes)
• Discomfort With REMS Highlighted At Negative Hydexor Advisory Committee (Pink Sheet)
• Pfizer announces €300m investment in Irish manufacturing sites (Pharmafile)
• Nostrum Issues Voluntary Nationwide Recall of Metformin HCl Extended Release Tablets Due NDMA (FDA)
• Jounce shares take a beating as their lead drug spurs only a weak response in PhII — trial halted (Endpoints)
• Eyeing commercialization, a Shanghai-based CAR-T startup nabs a $186M megaround (Endpoints)
• Sana Therapeutics snags Oscine, adding cell therapy leader Steve Goldman to its star-studded staff (Endpoints)
• Can a darkhorse synthetic biology Covid-19 vaccine one-up the frontunners? The Gates Foundation, Amgen bet 'yes' (Endpoints)
• Gilead submits filgotinib to European regulators for UC; GW Pharmaceuticals launches PhIII trial for MS candidate made with cannabis extracts (Endpoints)
• Prevail and Alector both claim victory in arbitration over scientist-CEO, telling divergent tales of confidential hearings (Endpoints)
• Small cap immunotherapy player Ziopharm faces an activist attack, rebukes call for board seats (Endpoints)
• An ‘innocent bystander’ in the booming biotech investor world is writing a blank check for $100M. Who’s going to cash it? (Endpoints)
• A little biotech's second crack at dry eye disease comes up short. And this time there will be no extra shot at success (Endpoints)

• FDA approves Boston Scientific paclitaxel-coated balloon as sector revives after scrutiny (MedtechDive)
• MedPAC pans CMS idea to lean on commercial payers for Medicare coverage decisions (MedtechDive)
• EU Regulatory Roundup, October 2020: Commission Holds Steadfast On MDR/IVDR Dates Despite (MedtechInsight)
• Deadlines Needed For Urgent EU MDR Vigilance And Postmarket Surveillance Guidance Documents (MedtechInsight)
• Brexit and the UK’s medical device usability requirements (Emergo)

• Florida Resident Pleads Guilty to Conspiracy to Falsify Clinical Trial Data (DOJ)
• No Longer “Waiting for Godot,” Godot has arrived. DEA Finally Issues a Proposed Rule on Suspicious Orders (FDA Law Blog)
• Feds Approve Fractious Georgia Plan to Change ACA Marketplace (KHN)
• Boehringer Accused Of Withholding Royalties As Trial Starts (Law360)
• AbbVie Wants Hypertension Drug Antitrust Row Sent To NJ (Law360)
• Abbott accuses former executive of taking test secrets to competitor (Modern Healthcare)