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June 2, 2020
by Michael Mezher

Recon: Pfizer to buy $500M of stock in smaller drugmakers; India approves remdesivir for emergency use

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Internal FDA Documents Show How Little Evidence The Agency Had Before Allowing Malaria Drugs To Be Used To Treat COVID-19 (BuzzFeed)
  • Only 891 in Free HIV-Prevention Drug Program Meant for 200,000 (Bloomberg)
  • Pfizer to invest up to $500 million in public drug developers (Reuters) (STAT) (Endpoints)
  • White House Coronavirus Testing Czar To Stand Down (NPR)
  • Gilead's next step on coronavirus: inhaled remdesivir, other easier-to-use versions (Reuters)
  • Operation Warp Speed selects billionaire scientist’s COVID-19 vaccine for monkey tests (Science)
  • Bristol Myers' treatment succeeds in late-stage bowel disease study (Reuters) (Endpoints)
  • New US approval for AZ' Brilinta (PharmaTimes)
  • Amneal recalls metformin due to NDMA impurity (FDA)
  • ASCO 2020 takeaways: AstraZeneca does a star turn, KRAS fizzles, and cell therapy shows progress (STAT)
In Focus: International
  • WHO and other experts say no evidence of coronavirus losing potency (Reuters)
  • India approves emergency use of remdesivir to treat COVID-19 patients (Reuters)
  • CDSCO faces CIC ire over ‘misplaced’ 2013 report on ‘irregular’ approval to drugs (Indian Express)
  • First results from UK's Recovery COVID-19 drug trial expected in early July (Reuters)
  • The 20 executives — and companies — to know in Chinese biotech (STAT)
  • Japan allows saliva-based tests to boost coronavirus detection (Reuters)
  • Novacyt shares drop as France refuses to refund virus test (Reuters)
  • South Korea expects human trials of Celltrion's potential COVID-19 treatment in Europe (Reuters)
  • EU Health Program To Help Boost Post-Coronavirus Recovery (Pink Sheet)
Coronavirus Pandemic
  • US and Chinese Scientists Trace Evolution of Coronaviruses in Bats (NYTimes)
  • Nearly 26,000 Nursing Home Residents Have Died From COVID-19, Federal Data Show (NPR)
  • Why Merck waited, and what they now bring to the Covid-19 fight (Endpoints)
  • Medical Workers Should Use Respirator Masks, Not Surgical Masks (NYTimes)
  • No new COVID sufferers, 300 asymptomatic, after Wuhan-wide tests (Reuters)
  • Coronavirus (COVID-19) Update: Daily Roundup June 1, 2020 (FDA)
Pharma & Biotech
  • Life After Woodcock: US FDA Drug Center’s Leadership Transition (Pink Sheet)
  • Pfizer’s Zoloft Falls Into Shortage as Virus Strains Supplies (Bloomberg)
  • For COVID, Consensus On Value Of Platform Trials, But A Confusion Of Consortia (Pink Sheet)
  • ASCO: Momentum gathers behind next wave of CAR-T therapies (PMLive)
  • Gilead woos filgotinib clinical investigator from Stanford to lead the charge on NASH, inflammatory diseases (Endpoints)
  • 15 Drug Makers See 3.6% Negative Growth in Japan in FY2020 as Re-Pricing, Generic Entries Weigh: Jiho Tally (PharmaJapan)
  • Spark touts animal data for a solution to AAV gene therapy's antibody problem (Endpoints)
  • AbbVie files Rinvoq for psoriatic arthritis (PharmaTimes)
  • Regeneron expands Intellia gene editing deal as its post-Sanofi future emerges (BioPharmaDive)
  • Opinion: It’s time to bring generic drug manufacturing back to the US (STAT)
  • Opinion: Covid-19 has exposed cracks in the global medicines supply chain. We need to fix them (STAT)
  • Novartis chips in $10M for IPO-bound partner Pliant; Tenax shares soar on heart drug data (Endpoints)
  • Once a high flyer, a staggering Aduro is auctioning off most of the pipeline as CEO Stephen Isaacs hands off the shell to new owners (Endpoints)
  • Hillhouse recasts spotlight on China's biotech scene with $160M round for Shanghai-based antibody maker (Endpoints)
  • Novus Therapeutics plunges deep into penny stock territory after failed ear trial (Endpoints)
Medtech
  • Many heart device trials 'small and fragile,' come with misleading spin: JAMA study (MedtechDive)
  • Tests to detect cancer, guide treatment heat up with barrage of data at ASCO (MedtechDive)
  • The FDA Requests Allergan Voluntarily Recall Natrelle BIOCELL Textured Breast Implants and Tissue Expanders from the Market to Protect Patients: FDA Safety Communication (FDA)
  • FDA alerts patients and health care professionals of Amneal and Impax Laboratories epinephrine auto-injector device malfunctions (FDA)
Government & Regulatory
  • Debate over hydroxychloroquine spills over from the White House to congressional campaigns (STAT)
  • EPA Finalizes Ethylene Oxide Reduction To Lower Cancer Risk (Law360)
  • Immunomedics Must Face Suit Over Drug Presentation Claims (Law360)
  • Further changes to reduce opioid harm (TGA)
  • Submissions received: Proposed clarification of the regulatory requirements for medical device systems or procedure packs (TGA)
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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