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February 11, 2021
by Michael Mezher

Recon: Novo’s semaglutide shows promise for weight loss in Phase III trial; EU nears deal with Novavax

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Merck in talks with governments, other drugmakers to produce COVID-19 shots (Reuters)
  • How Merck, a Vaccine Titan, Lost the Covid Race (NYTimes)
  • Can’t Find an N95 Mask? This Company Has 30 Million That It Can’t Sell. (NYTimes)
  • OWS: Accelerated COVID-19 Vaccine Development Status and Efforts to Address Manufacturing Challenges (GAO)
  • Biden admin asks SCOTUS to uphold Obamacare, reversing Trump support for lawsuit (Politico)
  • US still falling short on basic tools to fight the virus (Politico)
  • Fauci: Vaccines for Kids as Young as First Graders Could Be Authorized by September (ProPublica)
  • Drug Prices by Committee: One Way Biden Could Lower Costs (NYTimes)
In Focus: International
  • EU close to vaccine supply deal with Novavax (Reuters)
  • AstraZeneca aims to accelerate adaptation of vaccine for new Covid variants (FT)
  • AstraZeneca expects COVID-19 vaccine capacity of 200 million a month by April (Reuters)
  • Belgian plant says it complies with AstraZeneca contract amid vaccine supply cuts (Reuters)
  • Germany's IDT to help make AstraZeneca's COVID-19 vaccine (Reuters) (FT)
  • Not perfect, but saves lives, AstraZeneca says as Africa backs COVID-19 shot (Reuters)
  • AstraZeneca sales rise 10% in 2020, drugmaker sees revenue growth ahead (CNBC)
  • Democratic Republic of Congo confirms two Ebola cases in resurgence of major outbreak (Reuters)
  • Mexico approves China's CanSino and Sinovac COVID-19 vaccines (Reuters)
  • Semaglutide Brings Significant Weight Loss in Obese Patients (NYTimes) (Endpoints) (NEJM)
  • Roche's tocilizumab cuts deaths in hospitalised COVID-19 patients (Reuters) (STAT)
  • UK in talks with UAE to back life sciences fund (FT)
  • NICE turns down bluebird bio’s gene therapy Zynteglo (PMLive)
Coronavirus Pandemic
  • Vaccinated people need not quarantine post COVID-19 exposure, CDC says (Reuters)
  • Health Workers and Hospitals Grapple With Millions of Counterfeit N95 Masks (KHN)
  • Short On Special Syringes, Japan May Waste Millions Of Pfizer Vaccine Doses (NPR)
  • South Africa may sell AstraZeneca shots as it switches to J&J vaccine to fight variant (Reuters)
  • Kenya says it will move ahead with AstraZeneca COVID-19 vaccine (Reuters)
  • Zimbabwe purchases 600,000 Sinopharm COVID-19 vaccinations -information minister (Reuters)
  • Pfizer to apply for COVID-19 vaccine registration in Ukraine (Reuters)
  • Bolivia signs deal with China´s Sinopharm for coronavirus vaccine (Reuters)
  • Morocco receives 4 million doses of AstraZeneca vaccine from India (Reuters)
  • FDA greenlights Visby Medical's single-use, portable PCR test for COVID-19 (Fierce)
Pharma & Biotech
  • Sana gets a competitor as Takeda, 5AM pour $170M into a Fred Hutch pioneer's quest to unseat CAR-T, ex-vivo gene therapy (Endpoints) (BioPharmaDive)
  • Bristol Myers takes next big gamble on I/O frontier, pledging nearly $1.4B on Texas firm's tumor toxins (Endpoints)
  • Novartis' Sandoz splurges on a trio of GSK antibiotics, doubling down with a $500M bet on a field struggling to combat resistant microbes (Endpoints)
  • Gilead combines shared services into one North Carolina hub, aiming for 'cost and time zone advantages' (Fierce)
  • US Prescribers Embrace Oncology Biosimilars; How Will Humira Follow-Ons Fare? (Scrip)
  • Teva's Slow Recovery Proceeds With Flat Revenue Forecast In 2021 (Scrip)
  • Pfizer Secures Early Patient Access In UK For Eczema Drug Abrocitinib (Pink Sheetd)
  • Rentschler Biopharma to build cell and gene therapy manufacturing capabilities in the UK (PharmaTimes)
  • NICE recommends treatments for pregnancy sickness in new draft guidance (Pharmafile)
  • All in on ide-cel, Bristol Myers Squibb writes off $470M as second BCMA CAR-T is ejected from the pipeline (Endpoints)
  • AC Immune has 'remarkable' Alzheimer's vaccine data. Just don't ask to see them (Endpoints)
  • Dyno sketches tens of thousands of viable next-gen AAV capsids with the help of ML (Endpoints) (STAT)
  • Versant spinout lands $80M to go 'much broader' than the old Roche partnership that birthed it (Endpoints)
  • India's TCG launches new CDMO arm stateside to meet the call for 'American-made' pandemic drugs (Endpoints)
  • SR One recruits an IPO vet and seasoned ops chief for the venture team. And they have some practical advice for you (Endpoints)
Medtech
  • GOP Senator Wants Time Frame And Other Details On FDA’s AI/ML Action Plan (MedtechInsight)
  • Opinion: It’s time to fast track innovation in medical devices for children (STAT)
  • LabCorp warns COVID-19 testing sales could plummet as crisis abates (MedtechDive)
  • UK regulators publish new details on streamlined medical device clinical study review program (Emergo)
  • SetPoint Launches IDE Trial Of Vagus Nerve Stimulation To Treat Arthritis (MedtechInsight)
  • Class I Recall For Smiths Medical’s Medfusion Syringe Pumps (MedtechInsight)
Government, Regulatory & Legal
  • Generic ‘Skinny Labels’ Get Reprieve As Court Agrees To Rehear Teva/GSK Case (Pink Sheet)
  • J&J Seeks To Block Alcon's Eye Surgery Laser Product (Law360)
  • Medtronic Skirted Spine Device FDA Review, 9th Circ. Told (Law360)
  • Teva 'Not Optimistic' About Sealing $23B Opioid Deal Soon (Law360)
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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