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May 19, 2020
by Michael Mezher

Recon: BARDA awards new firm $350M for domestic drug production; FDA approves Tecentric for first-line therapy for some lung cancers

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Trump says big announcements made and coming on therapeutics, vaccines (Reuters)
  • Trump to Tap New Company to Make Covid-19 Drugs in the US (NYTimes) (Reuters)
  • Politics could dictate who gets a coronavirus vaccine (Politico)
  • Trump says he is taking hydroxychloroquine despite FDA warning (Reuters)
  • CDC plans sweeping COVID-19 antibody study in 25 metropolitan areas (Reuters)
  • Roche's Tecentriq wins FDA approval as first-line therapy for some lung cancer forms (Reuters) (Endpoints) (Press) (FDA)
  • Alexion becomes latest company to face pressure to sell from activist investor (STAT)
In Focus: International
  • US-China Feud Over Coronavirus Erupts at World Health Assembly (Reuters)
  • US backs pandemic resolution at WHO but rejects patent wording (Reuters) (Financial Times)
  • International pandemic cooperation a 'no brainer': EU Commission chief (Reuters)
  • Germany, France Propose $543 Billion EU Coronavirus Recovery Fund (NPR)
  • Russia hopes to start COVID-19 vaccine trials soon - health minister (Reuters)
  • AstraZeneca in talks with other governments to replicate UK vaccine deal (Reuters)
  • UK ventilator consortium says scaling up in case of COVID-19 second spike (Reuters)
  • Novartis wins conditional EU approval for gene therapy Zolgensma (Reuters) (Press)
Coronavirus Pandemic
  • Another Set of Coronavirus Vaccine Candidates (In the Pipeline)
  • Criticism of the Oxford Coronavirus Vaccine (In the Pipeline)
  • Preclinical data suggest Oxford vaccine could reduce COVID-19 symptoms, won’t provide herd immunity (BioCentury)
  • T cells play a role in fighting coronavirus; COVID-19 affects children differently (Reuters)
  • ‘Hard stop’: States could lose National Guard virus workers (Politico)
  • South Africa BCG booster trials seek low-cost weapon against COVID-19 (Reuters)
  • U.S. to send Russia 200 ventilators as Russian coronavirus cases near 300,000 (Reuters)
  • Verily seeks to establish new COVID-19 'Baseline' with coronavirus antibody research project (Fierce)
Pharma & Biotech
  • Moderna carries a big-boy market valuation now, so it shouldn’t act like a biotech penny stock (STAT)
  • Despite skepticism, Gilead’s remdesivir could become a ‘multi-year commercial opportunity’ (STAT)
  • WuXi Biologics clinches deal to build first US facility at Boston area hub (Fierce)
  • Kintor Pharmaceuticals completes $240 million IPO; WuXi Biologics is opening a Boston plant (Endpoints)
  • Two years in, Hong Kong’s biotech experiment has been validated (Endpoints)
  • 'Tis the season for biopharma fundraising, as Cowen closes $493M fund (Endpoints)
  • How a California biotech briefly tripled its value by hyping a Covid-19 ‘cure’ (Endpoints)
  • With bucks from Pfizer added to their new round, Amplyx steers a tricky course through PhII and a global pandemic (Endpoints)
  • Pandemic-related vaccination drop raises concern about US measles outbreak (Reuters) (CDC)
  • Martin Mackay’s rare disease startup gets $145 million as it enters the clinic (Endpoints)
  • Roche’s James Sabry zeroes in on a new pathway for protein degradation — and he’s paying $135M cash for a hot ticket (Endpoints)
  • EMA Strengthens Breast Cancer Risk Info For Menopause HRT Medicines (Pink Sheet)
  • ‘Can You Hear Me?’ US FDA Begins Meeting Virtually (Pink Sheet)
  • Virtual Advisory Committees Pose Technical And Practical Challenges For US FDA, Sponsors (Pink Sheet)
  • Novartis taps Iya Khalil, physicist co-founder of GNS Healthcare, to lead AI Innovation Center (Endpoints)
Medtech
  • Knee replacements nearly halted as hospitals braced for COVID-19, new data show (MedtechDive)
  • Ventilators can save people with serious Covid-19. The people behind them are even more important (STAT)
  • Edwards secures CE mark for Pascal tricuspid valve repair device (MedtechDive)
  • Investors bet diabetes tech immune to full brunt of COVID-19 (MedtechDive)
  • Philips lung ultrasound, Beckman sepsis diagnostic receive BARDA coronavirus backing (MedtechDive)
  • Medtronic's Melody, Harmony transcatheter pulmonary valves show gains in congenital heart disease (Fierce)
  • Zebra Medical Vision wins FDA clearance for AI to predict osteoporosis (MassDevice)
  • Class 1 Device Recall StealthStation DBS Software Nexframe AutoRegistration (FDA)
Government & Regulatory
  • Essential work to combat the COVID-19 pandemic to continue during EMA's closure from 21 to 22 May 2020 (EMA)
  • COVID-19: It’s a Threat. And It’s Material (FDA Law Blog)
  • German Lab Accused Of Illegally Selling Tick Test Kits In US (Law360)
  • USPTO Announces COVID-19 Prioritized Examination Pilot Program (Patent Docs)
  • Dr. Reddy's $9M Deal Gets Nod In Quality Control Suit (Law360)
  • Regulation of stem cell treatments: information for practitioners (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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