Recon: FDA approves Keytruda as adjuvant for NSCLC; Philips to cut 6,000 more jobs after Q4 losses

ReconRecon | 30 January 2023 |  By 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • FDA approves another indication for Keytruda, this time in the adjuvant NSCLC setting (Endpoints) (FDA) (MedPage Today)
  • Lilly Gets U.S. FDA Approval of Jaypirca to Treat MCL (Bloomberg) (BioSpace) (Endpoints)
  • FDA approves Italy-based pharma's oral SERD for some breast cancer patients (Endpoints) (Fierce)
  • Drugmakers prevail in dispute over U.S. discount drug program (Reuters)
  • Four years in, Sana gets first FDA go-ahead to bring cancer treatment into the clinic (Endpoints)
  • FDA Urged To Collaborate With USPTO On Orange Book Listings, Eliminate Patent Use Codes (Pink Sheet)
  • Warren keeps pressure on pharma, this time targeting Amgen and Indivior buyouts  (Fierce) (Endpoints)
  • Lawmakers Push Swift FDA Action on Baby Food Safety After Probe (Bloomberg)
  • Immune Patients Cautioned on Covid After Evusheld Pulled in US (Bloomberg)
  • Federal panel approves plans to safeguard lab-made virus research (STAT)
  • Fight Against Parasitic Worms, Sleeping Sickness Gets Funds (Bloomberg)
  • As it turns 40, the Orphan Drug Act for rare diseases needs a refresh (STAT)
  • Eric Lander to return to Broad Institute, one year after White House exit over bullying allegations (Endpoints)
In Focus: International
  • Sanofi and Regeneron’s Dupixent wins new European Commission approval (Reuters) (PharmaLive)
  • EMA Says Yes To BMS’ Sotyktu But Turns Down Ipsen’s Sohonos (Pink Sheet)
  • Post-hoc analysis: EMA's CHMP rejects Ipsen's potential drug for rare genetic disease (Endpoints)
  • Ophthalmic Bevacizumab & CRISPR-Based Gene Therapy Among Latest EU Filings (Pink Sheet)
  • Japan gives priority review status to Alzheimer’s drug developed by Eisai, Biogen (Reuters)
  • Under-funded WHO seeks ‘reinforced’ role in global health at key meeting (Reuters)
  • WHO extends public health emergency over Covid but signals end could come soon (STAT) (Reuters)
  • All countries ‘dangerously unprepared’ for future pandemics, says IFRC (Reuters)
  • Japan’s chip equipment makers in the dark about new China export restrictions  (Reuters)
Pharma & Biotech
  • Amgen, navigating ‘industry headwinds,’ puts 300 commercial jobs on chopping block (Fierce) (Endpoints) (BioSpace)
  • Exclusive: Sanofi to let go of staff at vaccine plants in India as part of review (Reuters)
  • After ‘half-baked’ data drop, CureVac releases results on mRNA flu, COVID-19 vaccines in older adults (Fierce) (BioSpace)
  • Rezafungin Review Highlights US FDA’s ‘Flexible Development' Approach For Antimicrobials (Pink Sheet)
  • Samsung Biologics spells out expansion plans in South Korea and US (Endpoints)
  • Goldfinch Bio falls from the sky after failing to find a path forward for kidney treatments (Fierce) (Endpoints)
  • Biotech pipeline hosts 163 potential meds for mental illness, with depression dominating: PhRMA (Fierce)
  • Time to shine, biosims: Amgen’s Amjevita readies long-awaited assault on AbbVie’s Humira (Fierce)
  • Over $100B in savings? Why the incoming Humira biosimilars will take time to catch on (Endpoints)
  • Size matters: Mechanism behind growing and shrinking cancer cells could be new treatment target (Fierce)
  • Pharma reputation scores drop to pre-COVID levels as Haleon tops most respected, but it’s a huge fall from grace for Pfizer and Moderna (Fierce)
  • Philips will cut 6,000 more jobs to reduce costs after company swung to net loss in Q4 (MedTech Dive) (Reuters) (WSJ)
  • Philips Implements Plan To Address FDA Concerns Following Harsh Inspection Report (MedTech Insight)
  • EMA Expert Advice Pilot Could Be ‘Vital Source Of Guidance’ For SMEs (MedTech Insight)
  • Product Liability Missteps Top List Of Worst Legal Verdicts Of 2022 (MedTech Insight)
  • As Resmed tops $1B revenues in Q2, CEO says Philips’ return to the CPAP market is ‘not a big perturbation’ to long-term strategy (Fierce) (MedTech Dive)
  • Medtronic wearable partner files for bankruptcy but plans to continue ‘without interruption’ (MedTech Dive)
  • Researchers predict Alzheimer’s progression 3.5 years early with unique blood test (Fierce)
Government, Regulatory and Legal
  • ‘A classic case’: A legal expert explains why lawsuits challenging abortion pill restrictions may succeed (STAT)
  • NY State Court Zantac Cases Combined in Single Proceeding (Bloomberg)
  • Texas High Court to Consider Governor Abbott’s Mask Mandate Ban (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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