Regulatory Focus™ > News Articles > 2020 > 4 > Recon: Gilead disputes report remdesivir flopped in first trial; WHO launches COVID-19 development i

Recon: Gilead disputes report remdesivir flopped in first trial; WHO launches COVID-19 development initiative

Posted 24 April 2020 | By Michael Mezher 

Recon: Gilead disputes report remdesivir flopped in first trial; WHO launches COVID-19 development initiative

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Gilead antiviral drug remdesivir flops in first trial (Financial Times) (STAT) (Endpoints)
  • Gilead disputes report that its drug flopped in leaked coronavirus trial (Reuters) (CNBC)
  • Congress’ coronavirus money train is slowing (Politico)
  • Trump team wanted 'nationwide' access to malaria drugs, ousted vaccine chief claims (Politico) (CNBC) (STAT)
  • House to Examine Ouster of Health Official Who Doubted Drugs Trump Pushed (NYTimes)
  • J&J strikes deal with Emergent BioSolutions on coronavirus vaccine manufacturing (Reuters)
  • Lilly to Start Testing Experimental Drug in Coronavirus Patients Soon (WSJ)
  • Thousands Fighting Coronavirus Take Antimalaria Drugs Amid Uncertainty They Help (WSJ)
  • Drugmaker tripled the price of a pill as it pursued coronavirus use (Axios)
  • Fragments of data about a coronavirus drug don't tell us much (Axios)
  • US approves Sanofi's meningococcal vaccine (PharmaTimes) (Press)
  • Abbott’s Fast COVID Test Poses Safety Issues, Lab Workers Say (KHN)
In Focus: International
  • World leaders launch WHO COVID-19 plan, but US not involved (Reuters 1, 2, 3) (WHO)
  • EU Leaders Fail To Agree On Coronavirus Economic Recovery Program (NPR)
  • France first - Paris ignores EU calls to lift export bans on COVID-19 drugs (Reuters)
  • Sanofi warns Europe on Covid-19 vaccine (Financial Times)
  • Canada gets Biomerieux formula for free to produce virus testing chemicals (Reuters)
  • Siemens Healthineers joins race to supply coronavirus antibody tests (Reuters)
  • AstraZeneca's Lynparza shows further promise in prostate cancer study (Reuters)
  • Japan Moving to Thwart Foreign Takeover of Drug, Medical Devices Makers (PharmaJapan)
  • Takeda auctions off a $670M portfolio of drugs and manufacturing ops, getting closer to its $10B goal (Endpoints) (Press)
  • NICE rejects NHS funding for Portola's Ondexxya (PharmaTimes)
  • UK Home secretary faces calls to relax palliative drug rules (Financial Times)
Coronavirus Pandemic
  • Coronavirus shakes the conceit of ‘American exceptionalism’ (AP)
  • The race to make vaccines faster (Axios)
  • A Close Look at the Frontrunning Coronavirus Vaccines As of April 23 (In the Pipeline)
  • Trump's disinfectant idea shocking and dangerous, doctors say (Reuters)
  • Lysol maker urges people not to inject disinfectants after Trump remarks (Reuters)
  • Trump Asks if Sunlight Can Kill Viruses. ‘Not as a Treatment,’ Birx Says. (NYTimes)
  • Nearly All Patients Hospitalized With Covid-19 Had Chronic Health Issues, Study Finds (NYTimes)
  • New York survey suggests nearly 14% in state may have coronavirus antibodies (Reuters)
  • Coronavirus: First patients injected in UK vaccine trial (BBC) (MHRA)
  • COVID-19 vaccine protects monkeys from new coronavirus, Chinese biotech reports (Science Mag)
  • “I Take That as a Threat”: Big Pharma Is Meddling in the Race for a COVID-19 Treatment (Vanity Fair)
  • The FDA just approved Columbia’s Covid-19 plasma therapy study, backed by Amazon (CNBC)
  • Maker of drug touted as coronavirus cure accuses China of gouging (Financial Times)
  • Vaping, Opioid Addiction Accelerate Coronavirus Risks, Says NIDA Director (KHN)
  • NICE publishes new COVID-19 guidelines (PharmaTimes)
  • Britain's self-referral testing website closes after 'significant demand' (Reuters)
  • Mortality rates drop sharply in parts of India, bucking coronavirus trend (Reuters)
  • 'Toughest over': Spain's daily coronavirus deaths lowest in a month (Reuters)
  • Italy's coronavirus epidemic began in January, study shows (Reuters)
  • Coronavirus (COVID-19) Update: Daily Roundup April 23, 2020 (FDA)
  • Baxter Obtains U.S. FDA Emergency Use Authorization for Oxiris Blood Purification Filter for COVID-19 Treatment (Press)
Pharma & Biotech
  • Big Pharma Will Turn to Mergers After Crisis, Says RBC (Barron’s)
  • Pandemic Underscores U.S. Dependence On Overseas Factories For Medicines (NPR)
  • Takeda licenses ProThera plasma drug for use in inflammatory conditions (Fierce)
  • Biotech stock soars on debut as coronavirus fuels investor boom (Financial Times)
  • Novartis announces flexible return to office and on-site field activities, starting May 11, 2020 (Press)
  • UK Explains Dos and Don’ts Of Adaptive Clinical Trials (Pink Sheet)
  • Gene Therapy May Pack US FDA’s Calendar This Fall; CBER Staffs Up (Pink Sheet)
  • Former FDA Commissioner Donald Kennedy: Lessons From A Different Era (Pink Sheet) (FDA)
  • Review on the safety of low dose cannabidiol (TGA)
  • Laura Shawver on why she came back after an $88M windfall; MorphoSys taps Amgen vet as CCO (Endpoints)
  • Eli Lilly execs have been thinking about the longterm effects of the pandemic and damage control. Here’s what they believe (Endpoints)
  • GSK flashes positive data for Tesaro drug that could become 7th approved PD-(L)1 (Endpoints)
  • How Life Sciences Cos. Can Adapt To Remote Compliance (Law360)
  • COVID-19 Could Offer Some DSCSA Enforcement Relief For Manufacturers (Pink Sheet)
  • Xbrane Biopharma Plans to Continue Phase III Trial of its Xlucane® (Ranibizumab) Biosimilar Product (Big Molecule Watch)
  • Tech entrepreneurs' newest ally: The FDA (Politico)
  • FDA OKs updated instructions for Abbott POC coronavirus test amid accuracy concerns (MedtechDive)
  • FDA lifts injunction on manufacture and distribution of Philips’ defibrillators in the US (Press)
  • FDA grants breakthrough status to heart failure, stent graft tech (MedtechDive)
Government & Regulatory
  • FDA Warns Companies Illegally Selling CBD Products to Treat Medical Conditions, Opioid Addiction (FDA)
  • Just a Decade Later, DEA Reopens Comment Period for Electronic Prescriptions for Controlled Substances (FDA Law Blog)
  • USPTO Board Denies Illumina Request to Review BGI Patent (GenomeWeb)
  • Fed. Circ. Says Drugmaker Can't Appeal Novartis PTAB Win (Law360)
  • Georgia Man Claims Zantac Caused His Stage 3 Colon Cancer (Law360)
  • Drugmaker Drops Antitrust Suit Against 'Pharma Bro' Shkreli (Law360)
  • PTAB Won't Review DNA Patent Challenged By Illumina (Law360)
  • Judge Says Drug IP Bench Trial A Go 'Even During Pandemic’ (Law360)
  • Insys Prosecutors To Appeal Part Of Landmark Guilty Verdict (Law360)
  • Serious Shortage Medicine Substitution Notices (TGA)
  • TGA to permit conditional substitution to ease serious shortages (TGA)
  • Consultation: Proposed amendments to the Poisons Standard - Joint ACMS/ACCS meetings, June 2020 (TGA)
  • Domestic Good Manufacturing Practice (GMP) inspections during the COVID-19 pandemic (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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