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Posted 24 May 2022 | By Michael Mezher 

Recon: Pfizer’s ulcerative colitis drug hits endpoints in Phase 3 trials; India’s Serum Institute plans new Africa plant

2885 Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • U.S. health officials releasing some Jynneos vaccine doses for monkeypox -CDC (Reuters)
  • Pfizer ulcerative colitis drug leads to remission in a third of patients -study (Reuters)
  • Lilly's mirikizumab, once a contender for psoriasis, bolsters case for UC indication in maintenance trial data readout (Endpoints)
  • Moderna testing potential monkeypox vaccines (Reuters)
  • As reports of ‘Paxlovid rebound’ increase, Covid researchers scramble for answers (STAT)
  • The FDA says it’s in the dark about thousands of dietary supplement ingredients (STAT)
  • Covid-19 Vaccine and Drug Sales, Once Booming, Plateau (WSJ)
In Focus: International
  • Drugmaker Hikma's CEO Olafsson to step down (Reuters)
  • Indian vaccine giant Serum plans African plant in global expansion (Reuters)
  • Tedros re-elected as head of World Health Organization (Reuters)
  • Monkeypox Outbreak Stokes Global Demand for Smallpox Vaccine (WSJ)
  • WHO says no urgent need for mass monkeypox vaccinations (Reuters)
  •  
  • WHO says monkeypox outbreak 'containable', confirms 131 cases outside Africa (Reuters)
  • Davos booster for $18 billion fund to fight AIDS, tuberculosis and malaria (Reuters)
Pharma & Biotech
  • A new era of treatment: How biomarkers are changing the way we think about cancer (Endpoints)
  • FDA calls for noninferiority trials for antibacterials, thanks to new drugs for resistant infections (Endpoints)
  • Springworks shares fall despite drug trial’s success (BioPharmaDive)
  • Manufacturing concerns spur clinical hold on small biotech's Alzheimer's trial — shares plunge (Endpoints)
  • Philippines Considers Regulatory Reliance To Speed Up Evaluating Trial Applications (Pink Sheet)
  • CSL Behring gene therapy makes comeback after hold for FDA priority review (Fierce)
  • Kala buys time by selling eye disease drugs to Alcon for $60M (Fierce)
  • Planning ahead for crowded ulcerative colitis market, Pfizer spells out PhIII data on $6.7B Arena drug (Endpoints)
  • Genocea reaches end of road, delisting from Nasdaq and letting go of remaining staff (Endpoints)
  • They sold their last biotech to Merck. Now they're back with a PARP outfit named after a London street (Endpoints)
  • After private and state investment, AmplifyBio plans to expand to another Columbus, OH location (Endpoints)
  • Blaming Covid disruption, supply shortages, microcap biotech hits the brakes on cell therapy trial (Endpoints)
  • With topical approval, Dermavant looks to bring new standard-of-care to plaque psoriasis patients (Endpoints)
Medtech
  • Philips, Hamilton Medical To FDA: QMSR Shouldn’t Subject Devices To ISO Traceability Requirements (MedtechInsight)
  • Medtech companies keep supply, staffing challenges in check even as recession risks loom: analysts (MedtechDive)
  • Dexcom, Insulet in talks to merge into a diabetes device behemoth: report (Fierce)
  • Illumina obtains European companion diagnostic test approval for Bayer rare cancer drug Vitrakvi (Fierce)
  • Senate seeks to reform diagnostic oversight via user-fee bill, sparking mixed response (MedtechDive)
  • BD inks deal to work with syringe material at the sweet spot between glass and plastic (Fierce)
Government, Regulatory & Legal
  • Vanda Fights FDA's Refusal To Fast-Track Gastro Drug Review (Law360)
  • Ethicon Loses Fed. Circ. Bid To Revive Surgical Tool Patent (Law360)
  • Novartis Owes Royalties, Bristol-Myers Squibb Says (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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