Recon: China vaccinates 100K for COVID; EUA for Roche COVID-flu combo test
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
Genentech scores sixth FDA approval in lung cancer with Gavreto (Pharmafile )
US FDA Personnel Costs Drop: Is the Next Generation Taking Over? (Pink Sheet )
Gottlieb: Staged Access To Coronavirus Vaccine Possible Through EUA (Pink Sheet )
Why Saving The Economy Or Tackling The Pandemic Is A False Dilemma (Forbes )
Here’s how Trump could bigfoot the FDA and get a vaccine out ahead of the science (WKTV/CNN )
FDA Rejects Oleandrin, Extract Pushed By MyPillow CEO, As A Dietary Supplement (Forbes )
In Focus: International
Chinese drug firm says thousands have been vaccinated for COVID-19 on an emergency use scheme (Pharmafile ) (Pink Sheet )
President of Sanofi France expects COVID-19 vaccine to be priced below ten Euros (Pharmafile )
NICE no for Pierre Fabre's Braftovi (PharmaTimes )
EU expands scope of Imbruvica to include untreated CLL patients (PharmaTimes )
Same Price & Trial Data: Scotland OKs Spravato Funding After England Says No (Pink Sheet )
WHO says India in talks to join 'COVAX' global vaccine scheme (Economic Times )
Australia announces deal for 84 million COVID-19 vaccine doses (BioPharma Reporter )
Coronavirus Pandemic
Senate to vote on scaled-down coronavirus relief package (The Hill )
WHO warns against 'politically motivated' information in coronavirus response (The Hill )
Pfizer CEO says people who don’t get vaccinated will become ‘weak link’ that allows coronavirus to spread (CNBC )
Merck CEO Stresses Need For ‘Fair Return’ On COVID-19 Interventions (Scrip )
Celltrion to begin mass producing antibody treatment before getting approval (Endpoints ) (Reuters )
Trump and Biden accuse each other of politicizing Covid-19 vaccine (Financial Times )
Sinovac’s COVID-19 vaccine appears safe in older adults (PMLive )
Progress on BioNTech and Pfizer’s COVID-19 vaccine candidate BNT162b2 (PharmaLetter )
World must be better prepared for next pandemic, WHO says (CNBC )
India surpasses Brazil, second behind U.S., in total coronavirus cases (NBC ) (NPR )
How Can You Tell If A COVID-19 Vaccine Is Working? (NPR )
Inovio partners with Thermo Fisher to bolster COVID-19 vaccine supply (Reuters )
Pharma & Biotech
Finance Watch: One Small Pain Drug Maker And Three Biotech SPACs Launch IPOs (Scrip )
Takeda to sell another non-core portfolio for $260 million to Cheplapharm (Pharmafile )
Extension study reveals Dupixent's benefit can last up to three years in moderate-to-severe asthma (Pharmafile )
Gilead’s Kite submits FDA approval application for CAR-T in slow-growing lymphomas (MedCity News )
Sanofi's later-stage trials hardest hit by COVID-19: report (Fierce Biotech )
Merck chronic cough drug shows mixed results in late-stage clinical trials, raising questions about its future (STAT ) (Endpoints )
After carefully building up expectations, a small-cap biotech’s big plans come crashing down in PhIII catastrophe (Endpoints )
Ahead of merger with Pfizer's generic unit, Mylan makes $757M+ purchase for European thrombosis portfolio (Endpoints )
Medtech
Daily Coronavirus Testing at Home? Many Experts Are Skeptical (NYT )
‘An unchartered situation for all of us’: From shipping containers to security concerns, a Covid-19 vaccine supply chain takes shape (STAT )
Roche COVID-19, flu combo test gets FDA emergency authorization (MedTech Dive )
FDA flags 428 spinal cord stimulator patient deaths, urges more tests before implant (MedTech Dive )
Boston Scientific, Stryker win CMS new tech add-on pay, BD left out (MedTech Dive )
Roche BK Virus Test Garners FDA Clearance (GenomeWeb )
Government & Regulatory
Major COVID-19 Rule Leads Busy Week (American Action Forum )
HHS Unit Probes Funding For Moderna's Patented Vaccines (Law360 ) (STAT )
Court Halts Boehringer’s COPD Inhaler Comparative Claims Vs. GSK Products (Pink Sheet )
Bold Action Needed to Save Medicare, Says MedPAC Commissioner (MedPage Today )
Evidence of 510(k) Clearance Is Relevant and Admissible, Says E.D. Pa. IVC Filter Judge (Drug & Device Law )
Why did the US justice department let Purdue off the hook for the opioid crisis? (Guardian )
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.
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