Recon: Abernethy to leave FDA next month; AstraZeneca’s ‘outdated’ vaccine data

| 23 March 2021 | By Michael Mezher 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Amy Abernethy, deputy commissioner who aimed to amp up FDA’s tech knowhow, to leave post (STAT) (Endpoints)
  • AstraZeneca to issue trial update after US criticism over data (Reuters 1, 2) (WSJ) (Endpoints) (STAT) (Politico 1, 2) (NYTimes) (FT)
  • Back and forth over Astrazeneca's COVID-19 statement an 'unforced error' – Fauci (Reuters)
  • Biden administration frets J&J may miss vaccine goal (Politico)
  • McKinsey settles with holdout Nevada for $45 million over role in opioid crisis (Reuters)
  • Pfizer Goes It Alone to Expand Vaccine Business Beyond Covid-19 Pandemic (WSJ) (Reuters)
  • Pfizer begins early stage clinical trial testing oral antiviral drug for Covid (CNBC)
  • FDA won't review Novo diabetes drug in latest case of regulatory pushback (BioPharmaDive) (Endpoints)
  • In a first, Merck's Keytruda snags FDA nod for esophageal cancer as stomach cancer label hangs in the balance (Fierce) (Endpoints) (FDA)
  • Drugmakers prepare for the unusual: A defeat in Washington (Politico)
  • Democrats Eye Medicare Negotiations to Lower Drug Prices (KHN)
In Focus: International
  • AstraZeneca to provide EU with US trial data - EMA's Cooke (Reuters)
  • EU vaccine boss says will use all tools available over AstraZeneca shortfalls (Reuters)
  • EU to widen criteria for possible Covid vaccine export bans (The Guardian)
  • Regeneron and Roche's antibody cocktail shown helping in COVID-19 cases (Reuters) (Endpoints)
  • Swiss approve Johnson & Johnson COVID-19 vaccine, haven't bought any (Reuters)
  • African countries keen on AstraZeneca COVID-19 vaccine: WHO (Reuters)
  • Vaccine makers should license technology to overcome 'grotesque' inequity: WHO (Reuters)
  • CanSinoBIO gets China nod for inhaled COVID-19 vaccine trial (Reuters)
  • Sinovac COVID-19 vaccine appears safe, triggers antibodies in trial in children: researcher (Reuters)
  • Israel, NZ give interim approval for sale of virus nasal spray, company says (Reuters)
  • Novartis radioligand therapy improves prostate cancer survival (Reuters) (Endpoints)
Coronavirus Pandemic
  • Some Nations Could Wait Years for Covid Shots. That’s Bad for Everyone. (NYTimes)
  • COVAX to set aside 5% of vaccine doses for emergency stockpile (Reuters)
  • COVAX on track to deliver 300 million COVID-19 vaccine doses by end of second quarter: WHO (Reuters)
  • Russia tests one-dose 'light' version of Sputnik V shot in UAE, Ghana – RDIF (Reuters)
  • Vietnam says approves Russia's Sputnik V vaccine for use (Reuters)
Pharma & Biotech
  • Roche stops giving Huntington's disease drug in closely watched study (BioPharmaDive)
  • PDUFA VII Negotiations Completed, Commitment Letter Ratification Ongoing (Pink Sheet)
  • 'Part of recovery is awareness': Pandemic casts harsh spotlight on industry-wide lack of diversity in clinical trials (Endpoints)
  • Zealand’s Zegalogue treatment for hypoglycemia approved by FDA (Pharmafile)
  • EU GMP Annex I Is A Top Priority For EMA While Industry Has Lingering Concerns (Pink Sheet)
  • What Will It Take To Get Real-World Evidence To An Inflection Point? (Pink Sheet)
  • Regulators Decide On EU Marketing For “Game-Changing” Contraceptive (Pink Sheet)
  • MHLW Panel Hails Use of Clinical Research Data for Regulatory Submissions, but Wants Requirements to Ensure Safety (PharmaJapan)
  • Takeda’s OTC Unit to Be Renamed Alinamin with New Chief from Blackstone (PharmaJapan)
  • Asher Biotherapeutics joins search for a better IL-2 sans the toxicities (Endpoints)
  • Trans-Pacific bispecific player caps 'very challenging' pandemic year with $120M to gain a foothold among the giants (Endpoints)
  • Jeff Aronin's Emalex raises $35M Series C; British protein degradation biotech emerges from stealth (Endpoints)
  • Recursion will take its AI platform public in latest IPO filing, while rare heart mutation biotech jumps on SPAC train (Endpoints)
  • 3 Biotech Firms Join Packed Calendar Of At Least 19 IPOs (Law360)
  • Two M&A deals and $9B later, Lonnie Moulder is ramping up his latest biotech startup. And this one comes with global vision built in (Endpoints)
  • Exclusive: Maze unveils their $191M pipeline, taking on Vertex and two long-sought conditions (Endpoints)
  • Microsoft, Sam Altman back a new AI biotech upstart (Endpoints)
  • Insulet's upcoming artificial pancreas system shows gains at all ages in Type 1 diabetes (Fierce)
  • Baxter, digital health startups lead pushback against 510(k) exemptions (MedtechDive)
  • EU Expert Panels On The Starting Line But Waiting For Commission Whistle (MedtechInsight)
  • Adverse Event Codes From IMDRF Now Used By FDA’s eMDR System (MedtechInsight)
  • Medtronic-Sponsored Trial Shows Expanded Benefits Of CRT For Heart Failure Patients (MedtechInsight)
  • DaVita, Fresenius team up to bring dialysis care out of their clinics and into the home (Fierce)
  • Cancer screenings bounced back after steep pandemic declines, Rand report shows (MedtechDive)
Government, Regulatory & Legal
  • High Court Won't Hear Generic MS Drug Patent Challenge (Law360)
  • FDA Cracks Down On CBD 'Pain Relief' Products (Law360) (FDA)
  • AbbVie Says Rival Used Stolen Trade Secrets To Copy Drug (Law360)
  • Boston Scientific Can't Duck Implant Wrongful Death Suit (Law360)
  • White FDA Scientist's Race-Bias Suit Comes Up Short (Law360)
  • Mallinckrodt To Pay $267M Over Maine Mercury Contamination (Law360)
  • Medicare Part B Shift To Discourage Prescribing Of Costly New 340 Drugs Weighed By MedPAC (Pink Sheet)
  • Pitfalls of the Notification Pathway – “I’m Sciencing as Fast as I Can” (FDA Law Blog)
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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