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

• 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)

• 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)

• 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)

• 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)

• 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)