Recon: Moderna begins pediatric COVID vaccine trial; Eli Lilly bowel disease drug succeeds in Phase 3

ReconRecon
| 16 March 2021 | By Michael Mezher 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • US drug distributors urge govt to boost COVID-19 vaccine supply network (Reuters)
  • Moderna begins study of COVID-19 vaccine in kids (Reuters)
  • AstraZeneca, US agree 500,000 more supplies of COVID-19 antibody cocktail (Reuters)
  • Purdue Pharma to use public trusts, Sackler cash to settle opioid litigation (Reuters) (NYTimes)
  • Eli Lilly bowel disease treatment succeeds in late-stage study (Reuters)
  • Vaccinated Americans have been getting their second doses on time, the CDC says. (NYTimes)
  • AbbVie in talks to sell $5 billion women's drugs portfolio – sources (Reuters)
In Focus: International
  • EMA: Benefits of AstraZeneca vaccine continue to outweigh the risks (Reuters)
  • EU regulator to meet on Thursday to discuss AstraZeneca vaccine (Reuters)
  • WHO urges world not to halt vaccinations as AstraZeneca shot divides Europe (Reuters)
  • WHO vaccine safety panel may issue statement on AstraZeneca on Tuesday – spokesman (Reuters)
  • Dutch regulator says it is not bypassing EMA with AstraZeneca halt (Reuters)
  • Pfizer to delivery 200 million vaccine doses to EU in second quarter (Reuters)
  • Canada's Medicago begins late-stage study of COVID-19 vaccine (Reuters)
  • Lonza gets licence to make ingredients for Moderna vaccine (Reuters)
  • Takeda grants J&J German production capacity for COVID-19 shot (Reuters)
  • Roche launches COVID-19 variant test to help monitor mutations (Reuters)
Coronavirus Pandemic
  • FDA requires Regeneron, Lilly to monitor variants as a condition of mAb EUAs (Endpoints)
  • WHO Points To Wildlife Farms In Southern China As Likely Source Of Pandemic (NPR)
  • World's top vaccine maker India criticised at home for exports as infections rise (Reuters)
  • Ocugen seeks to sell 100 million Indian vaccine doses in US in 2021 (Reuters)
  • India's Gland Pharma to make up to 252 million Sputnik V vaccine doses (Reuters)
  • Mexico focuses vaccine loan request on U.S. stockpile of AstraZeneca doses (Reuters)
  • Kremlin says pressure on countries to reject Russia's Sputnik V vaccine is unprecedented (Reuters)
  • Canada to recommend use of AstraZeneca COVID-19 vaccine for those over 65: CBC News (Reuters)
  • Brazil signs Pfizer deal for 100 million vaccine doses: source (Reuters)
  • Sweden pauses AstraZeneca COVID-19 vaccinations (Reuters)
  • Latvia suspends use of AstraZeneca's COVID-19 vaccine (Reuters)
  • Portugal temporarily suspends AstraZeneca COVID-19 shots (Reuters)
  • Spain joins countries halting AstraZeneca COVID-19 vaccine (Reuters)
  • Cyprus suspends AstraZeneca vaccine pending EU agency review (Reuters)
  • Slovenia temporarily halts AstraZeneca vaccine use (Reuters)
Pharma & Biotech
  • US FDA Mulls Possibility Of Preannouncing Post-COVID Domestic Surveillance Inspections (Pink Sheet)
  • Pharma mergers face fresh scrutiny by a new international antitrust group (STAT)
  • Opinion: The Drugs at the Heart of Our Pricing Crisis (NYTimes)
  • Once again, the viability of the U.S. biosimilar market is thrown into question (STAT)
  • Takeda, Sarepta double down on a biotech partner's platform to engineer better AAV capsids by mapping out their structure (Endpoints)
  • BIO chair slams Trump’s HHS, calls to stop Russian disinformation campaign on vaccines (Endpoints)
  • What’s in a (drug) name? FDA to study how they affect efficacy perceptions (Endpoints)
  • US FDA Exclusivity Battles Continue: Alvogen and Sandoz Challenge Buprenorphine, Aubagio Awards (Pink Sheet)
  • In restarted study, Solid Bio reports no serious toxicity in Duchenne patient given ‘safer’ gene therapy (STAT)
  • With all the buzz in gene therapy, Sanofi offloads two small molecule sickle cell programs from $11.6B buyout to Global Blood Therapeutics (Endpoints)
  • Merck wins priority review for rare carcinoma drug belzutifan, the centerpiece of $1B+ Peloton buyout (Endpoints)
  • GSK, German Merck's $4.2B bintrafusp alfa drug flops again, but companies squint to see glimmers of hope (Fierce)
  • Specialty drugmaker ANI to boost CDMO work, generics portfolio with $210M Novitium buyout (Fierce)
  • Can a CRISPR startup succeed where Pfizer, GlaxoSmithKline, Biogen and Genentech failed and cure chronic pain? (Endpoints)
  • Record funding flowed into cell, gene therapy companies last year: report (BioPharmaDive)
  • No quick redemption for GlaxoSmithKline’s $4B alliance with Merck KGaA as bispecific cancer drug flunks a second trial (Endpoints)
  • A Rubius drug derived from red blood cells produces anti-tumor responses — and more questions (STAT)
  • Johnson & Johnson’s arthritis drug shows promising results in Phase III trial (Pharmafile)
  • Melinta Therapeutics nabs FDA nod for more convenient rework of antibiotic Orbactiv, a former Eli Lilly candidate (Endpoints)
  • Daphne Koller lines up $400M for a global shopping spree to vault forward on AI drug discovery (Endpoints)
  • Taiwan's Acepodia closes Series B with the promise of conjugating antibodies and off-the-shelf NK cells (Endpoints)
  •  
Medtech
  • FDA issues safety alert for plastic breaks in Stryker-made STAR ankle replacements (Fierce) (FDA)
  • All eyes on elective care after a rollercoaster year for medtech (MedtechDive)
  • 1 year after COVID-19 hit: What's next for FDA, electives, testing and robotics (MedtechDive)
  • 5 things medtech can expect from FDA in 2021 (MedtechDive)
  • Australia will develop UDI system for medical devices following new regulatory amendment (Emergo)
  • FDA Activities Related to Essure (FDA)
Government, Regulatory & Legal
  • Insulin makers win a significant round in Minnesota lawsuit accusing them of racketeering (STAT)
  • Spinal Device Co. Wins Ban Against Rival, But Must Pay Bond (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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