Recon: FDA uncovers GMP issues at Catalent’s Belgium facility; AstraZeneca’s Fasenra misses goal in late-stage eosinophilic esophagitis trial

ReconRecon | 25 October 2022 |  By 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • FDA inspection at Catalent’s Belgium facility uncovers data, equipment and other QC issues (Endpoints) (FDAnews) (Fierce)
  • Regeneron, Bayer's Eylea nabs six months of pediatric exclusivity as competition waits to enter the market (Endpoints)
  • FDA Says Safety Concerns May Negate Any Oral Dosing Advantage For GSK's Anemia Treatment (Pink Sheet)
  • Medical Organizations Push For Mifeprex Miscarriage Indication, REMS Elimination (Pink Sheet)
  • US FDA Wants To Help Sponsors Generate Evidence CMS Needs, But Won't Be An Intermediary (Pink Sheet)
  • Omicron Outsmarting Immunity; Timing COVID and Flu Shots; Psychedelic Meds (MedPage Today)
  • Omicron mutates again: What we know about 3 new subvariants (The Hill)
In Focus: International
  • EU Takes Focused Approach In Bid To Deliver Decentralized Clinical Trials Guide By Year End (Pink Sheet)
  • AstraZeneca’s Fasenra woes continue as it comes up short in eosinophilic esophagitis (Fierce) (Reuters)
  • Coronavirus Notebook: EMA OKs Moderna’s Second Bivalent Spikevax, New Deal Agreed To Boost Vaccine R&D And Manufacturing (Pink Sheet)
  • Fungal infection list launched by WHO flags global health threat (Reuters)
  • Merck to donate Ebola vaccine candidate for research program in Uganda (Reuters)
  • CEPI teams up with Korean vaccine maker in $140M pact to scale up its nascent mRNA platform (Endpoints)
  • China's exports of COVID protection equipment to N.Korea surge (Reuters)
Pharma & Biotech
  • Astellas Pays $50M for Access to Taysha’s Rett, GAN Programs (Biospace) (Endpoints) (Fierce)
  • Pharma lobbying headed for record-breaking 2022, nonprofit says (Endpoints)
  • Biogen's Q3 revenue declines 10% as focus shifts to new Alzheimer's and ALS drug candidates (Endpoints)
  • Biogen confident in Alzheimer's drug ahead of rivals' data (Reuters)
  • Pfizer to make an almost $1B investment in its Dublin manufacturing facility — report (Endpoints)
  • Novartis tosses more US PD-1 submission plans and another anti-CD40 drug indication (Endpoints)
  • Novartis to uphold generic drug supply despite surging energy costs (Reuters)
  • Normunity launches with $65 million to unleash the immune system on tumors (STAT)
  • What the Alzheimer’s Drug Breakthrough Means for Other Diseases (Bloomberg)
  • On the Horizon, Needle -Free Vaccines could Offer Better Protection and Access (Biospace)
  • Stock Watch: Roche’s Long Shot Over Its Patent Cliff (Scrip)
  • GSK axes Lyell cell therapy, passes programs to Adaptimmune (Fierce)
  • J&J uncorks new Tremfya data in ulcerative colitis as its rival awaits an FDA decision (Endpoints)
  • The 5 Most Affordable Cities for Biopharma Jobs in the US (Biospace)
Medtech
  • MDCG’s Meeting Heralds The Next Chapter In An Increasingly Dramatic EU Medtech Story (MedTech Insight)
  • Pediatric Cardiologists Told To Prepare For Critical Devices Disappearing Due To MDR (MedTech Insight)
  • GOP Lawmakers Want Briefing On $1.3Bn Spent On Chinese COVID-19 Tests (MedTech Insight)
  • Accelerate Diagnostics withdraws BD-partnered device after FDA demands 510(k) clearance (MedTech Dive)
  • FDA Sends Warning Letters To OTC Dermal 'Pen' Firms, While Professional Microneedling Device Gets Award (MedTech Insight)
  • Medtronic's planned spinoff 'doesn't move the needle' in growth strategy: analysts (MedTech Dive)
Government, Regulatory & Legal
  • Ex-Genentech scientist sentenced to six months in prison for stealing trade secrets (Endpoints)
  • In trade secrets case, ex-Genentech staffer and husband get 6-month prison sentence (Fierce)
  • Acadia Sues Three on New Patent for Its Lone Drug, Nuplazid (Bloomberg)
  • Teva Sways Judge to Clarify Lilly Infringement Issues for Jurors (Bloomberg)
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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