Recon: Pfizer to sell its stake in GSK consumer business after London listing; Sage postpartum depression drug hits goals in Phase III

ReconRecon | 01 June 2022 |  By 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Sage-Biogen drug improves symptoms in postpartum depression study (Reuters)
  • FDA withdraws approval for TG Therapeutics cancer treatment (Reuters)
  • FDA approves Opdivo in combination with chemotherapy and Opdivo in combination with Yervoy for first-line esophageal squamous cell carcinoma indications (FDA)
  • FDA approves tisagenlecleucel for relapsed or refractory follicular lymphoma (FDA)
  • The Doctor Prescribed an Obesity Drug. Her Insurer Called It ‘Vanity.’ (NYTimes)
  • Vaccine injury compensation programs overwhelmed as congressional reform languishes (Politico)
  • Health Care — Tensions rise over drug pricing (The Hill)
  • Documents show problems at Novartis facility where cancer drug production was halted (STAT)
  • Biden, baby formula cos to meet on efforts to ease shortage (Reuters)
In Focus: International
  • Pfizer to exit GSK's consumer health arm after London listing (Reuters)
  • Canada authorizes Pfizer COVID-19 booster for 16 and 17-year-olds (Reuters)
  • NICE recommends UCB’s Fintepla for Dravet syndrome (PharmaTimes)
  • EMA appoints Chief Medical Officer (EMA)
  • Press Release: ICH Assembly Hybrid Meeting in Athens, May 2022 (ICH)
  • Chinese mRNA COVID booster stronger against Omicron than Sinovac shot -trial data (Reuters)
  • Vietnam develops 'world's first' African swine fever vaccine for commercial use (Reuters)
  • Novartis' Sandoz founds new initiative to expand biosimilar use more globally (Endpoints)
  • Research revamp: UK calls on clinical trial sponsors to shut down trials that aren't viable (Endpoints)
Pharma & Biotech
  • Who needs Humira? AbbVie projected to be the top pharma company by sales in 2028: analysts (Fierce)
  • 'Vaccines alone are insufficient': Merck, Aligos work with academic experts to find Covid antivirals as part of $65M NIH grant (Endpoints)
  • Regeneron's cholesterol drug war heats up with lawsuit over Amgen's 'illegal' bundling scheme (Fierce)
  • BioMarin's hemophilia A gene therapy further delayed amid new FDA questions (Fierce)
  • Sanofi’s Hemlibra rival gets step closer to approval with FDA breakthrough tag (Fierce)
  • Bristol Myers Squibb, with new positive lupus data in hand, readies TYK2 inhibitor for final test (Fierce)
  • Amgen's heart drug reduces cardiovascular disease risk factor in phase 2 trial (Fierce)
  • Another 14 generics threaten Eli Lilly's blockbuster chemotherapy Alimta (Endpoints)
  • Once a GSK hopeful for heart disease, an inhibitor class makes a comeback in Alzheimer's deal (Endpoints)
  • University Lab Crammed Too Late To Avoid US FDA Warning Letter (Pink Sheet)
  • Four years after Roche deal, little glyco-focused biotech lands new discovery deal with Astellas (Endpoints)
  • Passage Bio CEO departs after March layoffs as biotech goes with legal chops for interim replacement (Endpoints)
  • FDA’s Center for Devices and Radiological Health’s Continued Efforts to Return to Normal: Reopening for All Pre-Submissions (FDA)
  • BD to patch cybersecurity risks found in drug dispensing, lab management tech (Fierce) (MedtechDive)
  • Abbott's slimmed-down FreeStyle Libre glucose sensor notches FDA nod (Fierce)
  • Recalled devices surge in first quarter, driven by BD connectors (MedtehcDive)
  • MedTech Forum 2022: Bernasconi Mulls HTA Proposal, Defends New Device And Diagnostic Regs (MedtechInsight)
  • A ‘dark horse’ emerges in the DNA sequencing race, boasting a $100 genome (STAT)
Government, Regulatory & Legal
  • SF Opioid Judge Irked At Allergan Argument Against Expert (Law360)
  • Skinny Labels' Future May Hinge On Teva Petitioning Justices (Law360)
  • SEC reaches $628K settlement with SCWorx over 'false and misleading' COVID test scheme (Fierce)
  • J&J takes Aurobindo to court over potential Erleada generic (Endpoints)
  • Pharma mergers: FTC and DOJ to explore new ways of enforcing antitrust laws (Endpoints)
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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