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Regulatory Focus™ > News Articles > 2021 > 1 > Recon: WHO says three COVID vaccines in final review for EUL; Hahn’s exit interviews

Recon: WHO says three COVID vaccines in final review for EUL; Hahn’s exit interviews

Posted 20 January 2021 | By Michael Mezher 

Recon: WHO says three COVID vaccines in final review for EUL; Hahn’s exit interviews

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Outgoing FDA chief: The agency fought 'substantial' pressure under Trump (Politico)
  • Trump FDA Chief Was 'Disgusted' by Riots, Stayed to Guide Agency: Q&A (Bloomberg)
  • “A Tsunami of Randoms”: How Trump’s COVID Chaos Drowned the FDA in Junk Science (Vanity Fair)
  • Janet Woodcock to Lead FDA on Interim Basis (WSJ)
  • Biden to hit reset on nation's fight against COVID-19 after taking office (Reuters) (Politico)
  • The 9 biggest challenges Biden will face on Covid-19, from today on (STAT)
  • Moderna on Track to Make 100 Million Vaccine Doses by End of March, CEO Says (WSJ)
  • Moderna says possible allergic reactions to COVID-19 vaccine under investigation (Reuters)
  • After Moderna’s medical miracle, some investors step back (STAT)
  • 4,400 Moderna Vaccine Doses Not Kept Cold Enough May Be Unusable (NPR)
  • Elderly begin to drop out of Novavax vaccine trial to get Pfizer and Moderna shots (Washington Post)
  • Abbott's COVID-19 antigen test may help with faster detection, isolation – CDC (Reuters)
  • Biden will bring US into COVAX vaccine initiative, Blinken says (Axios)
In Focus: International
  • WHO: Three COVID-19 vaccines under final review for emergency use (Reuters 1, 2)
  • COVID-19 shots to cost $3 to $10 under African Union vaccine plan (Reuters)
  • EU and BioNTech/Pfizer clash over reduced vaccine deliveries (FT) (Reuters)
  • Italy considers legal action over Pfizer vaccine delivery delays (Reuters)
  • Russia files Sputnik V vaccine registration in Europe (Reuters)
  • Chinese media criticise Pfizer COVID-19 vaccine, tout local shots (Reuters)
  • India, 'pharmacy of the world', starts COVID vaccine shipments to neighbors (Reuters)
  • Pfizer vaccine appears effective against UK coronavirus variant (Reuters) (STAT) (FT)
  • Merck KGaA, GSK suffer lung cancer drug setback (Reuters) (Endpoints)
  • China's COVID-19 vaccine makers apply to join COVAX scheme (Reuters)
  • Backers of IP waiver for COVID-19 drugs make fresh push at WTO (Reuters)
  • TGA grants additional provisional determination for a COVID-19 vaccine (TGA)
Coronavirus Pandemic
  • Lower-income countries fall behind in race for vaccines (FT)
  • Cheap antiparasitic could cut chance of Covid-19 deaths by up to 75% (FT)
  • Senate Democrats call on Biden to immediately invoke Defense Production Act (The Hill)
  • New California Variant May Be Driving Virus Surge There, Study Suggests (NYTimes)
  • Pandemic could be WHO's Chernobyl moment for reform -review panel (Reuters)
  • WHO chief welcomes EU proposal for pandemic preparedness treaty (Reuters)
  • Could a Smell Test Screen People for Covid? (NYTimes)
  • Japan's vaccine programme chief denies reports of May roll-out (Reuters)
  • South Korea in talks to secure 40 million doses of Novavax's COVID-19 vaccine (Reuters)
  • Cash-strapped Venezuela cannot join COVAX vaccine program, PAHO says (Reuters)
  • Mexico to ramp up distribution of Sputnik V vaccine through March (Reuters)
  • Brazil battles Chinese red tape to get active vaccine ingredients (Reuters)
  • Brazil does not expect to finish AstraZeneca vaccines locally until March – Fiocruz (Reuters)
  • Peru says Sinopharm, Pfizer seek approval for their COVID-19 vaccines (Reuters)
  • China steps up COVID-19 vaccine drive ahead of Lunar New Year (Reuters)
  • S.African experts urge government to lay out COVID-19 vaccine plan (Reuters)
  • Chile regulator greenlights Sinovac COVID-19 vaccine for emergency use (Reuters)
Pharma & Biotech
  • Biotech’s presence on new social media app Clubhouse is growing (STAT)
  • Merck, Bayer win FDA approval for heart failure drug (BioPharmaDive)
  • 2020 biotech IPOs shatter all the records (Nature)
  • Trump and DeSantis want Florida to import prescription drugs. Does Biden? (TampaBayTimes)
  • The IPO flood keeps rising with 4 more biotechs and a SPAC on their way to Nasdaq (Endpoints)
  • Focus on Covid-19 does not distract the FDA (Evaluate)
  • Enhertu bags EU approval for HER2-positive breast cancer (PharmaTimes)
  • Beam, Verve stockpile cash as investors bank on gene editing progress (BioPharmaDive)
  • Failure to launch? Half of drugs rolled out since 2004 didn't live up to sales forecasts: report (Fierce)
  • ANDA Submissions Drop To Start FY 2021, Perhaps Forced Down By COVID-19 (Pink Sheet)
  • Keep Makena Under Accelerated Approval Pending More Studies, AMAG Tells US FDA (Pink Sheet)
  • Covid-19 claims another PDUFA victim as GlaxoSmithKline pushes back planned PD-1 rollout (Endpoints) (Evaluate)
  • Beyond 2021: Cell Therapy Manufacturing Trends (GEN)
  • Biopharma Manufacturers Shouldn’t Rush When “Going Digital” (GEN)
  • Adagene plans $125M IPO to go after cancer niches targeted by BMS and Pfizer (Fierce)
  • Fresenius Kabi pulls anti-inflammation drug Ketorolac over particulate fears—again (Fierce)
  • Turnstone buys Myst to add tumor-infiltrating lymphocyte assets (Fierce)
  • Amryt’s Myalepta scores NICE backing for rare lipid disorder (PharmaTimes)
  • Lonza to sell 2 plants to NextPharma as it plows ahead with $93M capsule expansion (Fierce)
  • Pieris finally vaults FDA hold on next-gen solid tumor hunter, clearing the path for mid-stage trial (Endpoints)
  • FDA hits the brakes on Histogen's knee cartilage therapy, asking for more info on manufacturing process (Endpoints)
  • News briefing: Verastem CMO exits two weeks after joining company; Thermo Fisher inks $550M M&A deal (Endpoints)
  • BioMed Realty snaps up innovation campus site within earshot of pricey and bustling Boston biotech hub (Endpoints)
  • Paul Hudson faces down French unions in fight to restructure Sanofi (Endpoints)
  • FDA Grants Priority Review to 2 sBLAs for Nivolumab in the Treatment of Cancers of the Gastrointestinal Tract (Cancer Network)
Medtech
  • Thermo Fisher nets hand-held COVID-19 test maker Mesa Biotech with $550M deal (Fierce)
  • Philips to buy medical device integrator Capsule Technologies for $635M (Fierce)
  • Forging trust in AI, sustaining the virtual care boom and other CES takeaways (MedtechDive)
  • Hillrom makes cardiac monitoring play with $375M Bardy Dx buy (MedtechDive)
  • CMS rejects 1st colorectal cancer blood test, tweaks path for Exact, Guardant and others (MedtechDive)
  • Patient Safety Advocate Raises Alarm Over HHS/FDA Push That Could Exempt 80+ Devices From Regulation (MedtechInsight)
  • Chinese regulators announce classification adjustments and UDI submission guidelines (Emergo)
Government, Regulatory & Legal
  • Latest CMS Data Reveal the Truth About U.S. Drug Spending (Drug Channels)
  • Exit Interview: C.D.C. Head Redfield Reflects on His Time on the Job (NYTimes)
  • Opinion: Azar’s ‘Sunset Rule’ will bring a dangerous new dawn for health regulation (STAT)
  • Surgeon general to step down as Biden requested (Politico)
  • Longtime Becerra aide and two health policy experts to be tapped for key posts (STAT)
  • ALS Patients To Gain Quicker Access To Disability Benefits And Medicare (NPR)
  • Bayer Must Face Bulk Of Takeda's Hemophilia Drug IP Suit (Law360)
  • PTAB Denies Bid To Review Eye Shot Patent, Citing ITC Case (Law360)
  • Mallinckrodt OK'd To Pay Fees In Ch. 11 Despite Outcry (Law360)
  • BPCIA Info Exchange Is Failing To Streamline Patent Litigation (Law360)
  • FCC Exempts Certain Pharma Calls From TCPA Rules (Law360)
  • Mylan Can't Escape EpiPen Distributors' Antitrust Claims (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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