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

Posted 03 November 2020 | By Michael Mezher 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US

  • 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)

In Focus: International

  • 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)

Coronavirus Pandemic

  • 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)

Pharma Biotech

  • 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)

Government, Regulatory Legal

  • 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)

Regulatory Recon is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe.
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.