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