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

• 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)

• 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)

• 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)

• 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)

• 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)