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July 6, 2020
by Michael Mezher

Recon: GSK, Sanofi in talks for £500M UK coronavirus vaccine deal; Regeneron begins Phase 2/3 trial for COVID-19 antibody cocktail

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • White House teases executive orders on China, immigration and prescription drugs (Politico)
  • Regeneron starts COVID-19 antibody cocktail late-stage trials, shares rise (Reuters) (Press)
  • 2021 Health Plans Granted Leeway To Limit Consumers’ Benefit From Drug Coupons (KHN)
  • FDA Commissioner Stephen Hahn won’t confirm Trump’s promises on vaccine timing (ABC)
  • Trial of Moderna Covid-19 vaccine delayed, investigators say, but July start still possible (STAT)
  • FDA lifts partial hold on ADC, clearing way for a 2021 readout and two potential near-term approvals (Endpoints)
  • ViiV gets FDA nod for Rukobia drug for older HIV patients (PharmaPhorum) (Press)
  • Which drug developers offer Trump a quick, game-changing ‘solution’ as the pandemic roars back? Eli Lilly and AbCellera look to break out of the pack (Endpoints)
  • Pharma industry seizes on pandemic as a shot at redemption (Financial Times)
  • House spending bill counters Trump threat to cut WHO funding (The Hill)
  • Federal Circuit Denies Genentech’s Appeal to Block Sales of Amgen’s MVASI (Big Molecule Watch)
In Focus: International
  • UK in talks to join EU coronavirus vaccine plan (Financial Times)
  • Glaxo Smith Kline nears £500m UK coronavirus vaccine deal (The Times) (Bloomberg)
  • Australia’s CSL warns drugmakers not to rush Covid-19 vaccine (Financial Times)
  • Mylan to launch generic remdesivir version in India at $64 per 100 mg vial (Reuters)
  • India scientists alarmed over 'unrealistic' Covid vaccine deadline (BBC)
  • Gilead's COVID-19 antiviral remdesivir gets conditional EU clearance (Reuters)
  • WHO halts hydroxychloroquine, HIV drugs in COVID trials after failure to reduce death (Reuters) (WHO)
  • Tesla to make molecule printers for German COVID-19 vaccine developer CureVac (Reuters)
  • Repurpose.AI partnered with LEO Pharma to accelerate drug discovery (Business Insider)
  • WHO: access to HIV medicines severely impacted by COVID-19 as AIDS response stalls (WHO)
Coronavirus Pandemic
  • 239 Experts With One Big Claim: The Coronavirus Is Airborne (NYTimes)
  • Why the US still hasn't solved its testing crisis (Politico)
  • US Should Build Up Antibody Therapy Supply, Ex-FDA Chief Says (Bloomberg)
  • CDC gets FDA nod for coronavirus-flu combination diagnostic (MedtechDive)
  • BD launches coronavirus antigen test, 2nd to get FDA emergency use authorization (MedtechDive)
  • US Coronavirus Cases Are Rising Sharply, but Deaths Are Still Down (NYTimes)
  • The Pandemic’s Big Mystery: How Deadly Is the Coronavirus? (NYTimes)
  • Phoenix Mayor Says FEMA Refused to Help With Testing (NYTimes)
  • DNA Linked to Covid-19 Was Inherited From Neanderthals, Study Finds (NYTimes)
  • UK study to research long-term health impact of COVID-19 (PharmaTimes)
  • Data show panic and disorganization dominate the study of Covid-19 drugs (STAT)
  • How a Covid-19 Vaccine Could Cost Americans Dearly (NYTimes)
  • How Much Would Coronavirus Vaccine Cost? (NPR)
Pharma & Biotech
  • Immunomedics’ breast cancer drug delays tumor growth, prolongs survival in clinical trial (STAT)
  • Bellus Health suffers setback with clinical trial failure of chronic cough drug (STAT) (Endpoints)
  • Stacked User Fee Calendar Puts Another Record-Setting Year For US FDA Novel Approvals Within Reach (Pink Sheet)
  • Pfizer re-ups on Mission Therapeutics collaboration, leading a $15M round and grabbing first dibs on DUBs (Endpoints)
  • A little biotech slaps back at a 'criminal' short attack, vowing to pursue a prosecution of their case (Endpoints)
  • Poseida tees $150M IPO; Gilead sends HBV program back to Precision; New HIV data from Merck, Gilead (Endpoints)
  • A booming Dragonfly is taking its TriNKETs to Copenhagen as the latest Bristol Myers pact spurs expansion plans — outside the US (Endpoints)
  • IPO bound? Actually, Annexon was already prepped and primed to toss its S-1 to Wall Street as investors rallied (Endpoints)
  • Immunomedics spells out PFS benefit of Trodelvy in mTNBC, hunting a full OK just weeks after accelerated approval (Endpoints)
  • ObsEva’s second uterine fibroids PhIII comes through, sending some investors to the hills (Endpoints)
  • Japan Govt Likely to Stick to 2020 Off-Year Drug Re-Pricing Plan in Honebuto Paper(PharmaJapan)
Medtech
  • Endologix files for Ch. 11 bankruptcy, plans to go private (MedtechDive)
  • Commission Notified Body Survey For COVID-19 Products Falls Short On Detail (MedtechInsight)
  • How a device shelved for health reasons in France remained in use in US (Miami Herald) (MassDevice)
  • Abbott Trifecta / Trifecta GT bioprosthetic aortic heart valves: cases of structural valve deterioration (SVD) (MDA/2020/019) (MHRA)
Government & Regulatory 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.
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