Recon: EU threatens to curb COVID vaccine exports; Pfizer to halt biosimilar manufacturing in China

Regulatory NewsRegulatory News
| 17 March 2021 | By Michael Mezher 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • FDA extends review period for expanded use of Abbvie's arthritis drug (Reuters)
  • Democrats treading lightly on Biden’s next big health care promise (Politico)
  • Pharma wins a round in a battle with HHS over a drug discount program for hospitals (STAT) (Law360) (Endpoints)
  • Washington may become the second state to distribute its own generic drugs (STAT)
  • Pfizer execs say there's a 'significant opportunity' to hike prices of its COVID vaccine (Insider)
  • US could start vaccinating young kids in early 2022, Dr. Fauci says (CNBC)
  • US talking to several countries about extra COVID-19 vaccine: Biden (Reuters)
In Focus: International
  • EU 'should probably help Russia' with Sputnik V vaccine, Commissioner says (Reuters)
  • Facing 'crisis of century', EU threatens ban on COVID vaccine exports to UK (Reuters 1, 2) (Endpoints)
  • Political role under fire in European AstraZeneca vaccine suspensions (Reuters)
  • WHO statement on AstraZeneca COVID-19 vaccine safety signals (WHO)
  • Six EU countries raise concerns over COVID jabs distribution: official (Reuters)
  • India backs AstraZeneca shot as COVID-19 cases hit three-month high (Reuters)
  • Pfizer to halt biosimilar output in China, sell assets to WuXi Biologics (Reuters)
  • COVAX vaccine-sharing scheme to send out 'hundreds of millions' of J&J shots (Reuters)
  • Catalent to ramp up J&J vaccine production at Italian plant (Reuters)
Coronavirus Pandemic
  • Vietnam says homegrown COVID-19 vaccine to be available by fourth quarter (Reuters)
  • Further MHRA response to the precautionary suspensions of COVID-19 Vaccine AstraZeneca (MHRA)
  • AstraZeneca and Catalent defend Covid vaccine manufacturing process (FT)
  • Efficacy of the ChAdOx1 nCoV-19 Covid-19 Vaccine against the B.1.351 Variant (NEJM)
  • Interim recommendations for the use of the Janssen Ad26.COV2.S (‎COVID-19)‎ vaccine: interim guidance, 17 March 2021 (WHO)
  • EMA In The Clear Over Transparency In COVID-19 Product Assessments (Pink Sheet)
  • Inside Africa's world-leading coronavirus supply chain (The Hill)
  • Australian regulator says AstraZeneca vaccine rollout to continue (Reuters)
  • Kazakhstan suspends talks on buying AstraZeneca vaccine (Reuters)
Pharma & Biotech
  • Pharma is riding a vaccine high, but reputational risks loom (FT)
  • Top companies and drugs by sales in 2020 (Nature)
  • US FDA's On-Time Review Decision Rates Slips During The Pandemic, Especially For Biosimilars (Pink Sheet)
  • Biotech start-up behind AstraZeneca jab raises $168m (FT)
  • Observational Study Hurdles: From Data Blinding To Data Sharing (Pink Sheet)
  • Advanced Cancers Are Emerging, Doctors Warn, Citing Pandemic Drop in Screenings (NYTimes)
  • Do Two Recent Drug GMP Warning Letters Signal A Shift In FDA Enforcement Focus? (Validant)
  • UK’s NICE Namuscla Decision A ‘Red Flag’ For Repurposed Medicines (Pink Sheet)
  • Global Blood takes on more sickle cell drugs through Sanofi deal (BioPharmaDive)
  • MHLW to Continue Looking into Cause of Generic Scandals: Minister (PharmaJapan)
  • CureApp Hypertension Therapeutic App Hits PIII Goal, 2021 Submission Eyed (PharmaJapan)
  • Bluebird's top doctor to depart as company grapples with safety review (BioPharmaDive)
  • Montreal AI startup with a touted advisor licenses its 'few-shot' platform to Repare for synthetic lethality molecules (Endpoints)
  • Dean Li invites another under-the-radar biotech to Merck's dealmaking table as Amathus signs neurodegeneration pact (Endpoints)
  • Eli Lilly, Novartis back a biotech startup boasting 'best of both worlds' protein degraders (Endpoints)
  • Fresh out of the bluebird bio oncology split, Joanne Smith-Farrell flies the coop to Be Bio and its B cell platform (Endpoints)
  • After a roller coaster ride, Sage COO strikes out on his own to chart a new biotech path (Endpoints)
Medtech
  • FDA touts real-world evidence use by Abbott, Medtronic in analysis of regulatory decisions (MedtechDive)
  • Bayer posts second analysis of Essure adverse events taken from social media (MedtechDive)
  • CMS puts the brakes on breakthrough device coverage rule (MedtechDive)
  • Device Firms In Non-EU Markets Using The CE Mark Should Expect Some MDR Disruption After May (MedtechInsight)
  • Abbott halts trial enrollment for HeartMate PHP catheter blood pump (MedtechDive)
  • GE Healthcare announces its first wireless portable ultrasound device (mobihealthnews)
  • NovaSight eyes FDA clearance with upcoming clinical trial (mobihealthnews)
  • Singapore HSA will require government accreditation for certification bodies issuing ISO 13485 certificates (Emergo)
Government, Regulatory & Legal
  • When Is Skinny Not Skinny Enough? (FDA Law Blog)
  • Senate Passes Bill on Advancing Education on Biosimilars (Big Molecule Watch)
  • Generics Call Alcon Glaucoma Drug Obvious As Trial Begins (Law360)
  • AstraZeneca Resets FTC Review Clock For $39B Alexion Deal (Law360)
  • PhRMA Can't Get Minn. Insulin Pricing Law Overturned (Law360)
  • McKinsey Opioid Deal With NY AG Approved Amid Objections (Law360)
  • AbbVie Denies Judge-Shopping In Humira Kickback Cases (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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