Recon: FDA advisors back Amylyx ALS drug after second adcomm; Revance’s Botox rival wins FDA approval

ReconRecon | 08 September 2022 |  By 

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
In Focus: US
  • Amylyx's ALS drug gets U.S. FDA panel's backing in rare turnaround (Reuters) (Endpoints) (STAT)
  • Botox rival from Revance gets U.S. approval (Reuters)
  • U.S. starts enrollments in trial testing smaller dosage of monkeypox vaccine (Reuters            )
  • U.S. to expand monkeypox vaccine, drug distribution through AmerisourceBergen contract (Reuters)
  • Gilead's Trodelvy extends breast cancer survival by 3.2 months -study (Reuters) (STAT)
  • Bayer, Regeneron's eye drug shown to work at higher dose, longer intervals (Reuters)
  • Relay Therapeutics drug shows promise in early trial (STAT)
  • Pandemic Readiness Lobby Draws Biotech, Government Members (Bloomberg)
In Focus: International
  • Oxford malaria vaccine data bodes well for effort to combat deadly disease (Reuters)
  • Paris prosecution office investigates Philips ventilators (Reuters)
  • Canada Launches ‘More Responsive’ Post-Marketing Drug Evaluation Program (Pink Sheet)
  • Illumina’s hold on Grail depends now on separate appeals in US, Europe (BioPharmaDive)
  • Roche to pay $250M for Good Therapeutics and its targeted drug technology (BioPharmaDive)
  • MHRA launches new conflicts of interest code of practice for independent advisors (MHRA)
  • EU secures more doses of Bavarian monkeypox vaccine (Reuters)
  • EU wants screenings for more types of cancer as pandemic slashed check-ups (Reuters)
  • Grifols in 15-year deal with Canada for plasma-based medicines (Reuters)
  • Pfizer donates Paxlovid to group targeting COVID in poorer countries (Reuters)
  • Gambia probes link between child deaths and a paracetamol syrup (Reuters)
Pharma & Biotech
  • Did NICE play fair? J&J wins appeal—in part—to glean rationale behind cost watchdog's Spravato snub (Fierce)
  • On the heels of unprompted EMA review of Covid drug, FDA schedules adcomm for potential EUA (Endpoints)
  • New study reveals the extent to which drugmakers use condition-specific charities to induce spending on costly drugs (Endpoints)
  • Form 483 reveals spore contamination at a South Korean manufacturing site last year (Endpoints)
  • AstraZeneca, Merck's Lynparza rejected by NICE in prostate cancer over pricing—again (Fierce)
  • CDER and CBER accept first submission to ISTAND Pilot Program (FDA)
  • Alnylam details anticipated results from heart disease drug trial (BioPharmaDive)
  • Going beyond protein degradation, a new Broad startup kicks into gear to fix protein functionality (Endpoints)
  • Thanks for Nodus-ing: Basilea hands off preclinical oncology program for $248M in ongoing anti-infectives pivot (Endpoints)
  • Boehringer Ingelheim preps FDA submission with new data in rare pediatric lung disease (Endpoints)
  • How sub can you subset? Erasca shores up case for testing its two lead candidates in combo (Endpoints)
  • #ESMO22: After day filled with investor, GSK appetite, SpringWorks brings out the data for cancer drug nearing FDA (Endpoints)
  • #ESMO22: Trailing Roche’s Tecentriq, immune checkpoint therapies meet untreated liver cancer with mixed results (Endpoints)
  • #ESMO22: Outside liver cancer, Keytruda notches key win in neoadjuvant setting but flops in head and neck tumors (Endpoints)
  • #ESMO22: Bristol Myers spells out kidney cancer flop for Opdivo/Yervoy combo — but can a triplet catch on? (Endpoints)
  • #ESMO22: Mirati vs Amgen: Scrappy KRAS G12C contender outperforms its giant rival in colorectal cancer (Endpoints)
  • Orca Bio looks to increase its cell therapy manufacturing capacity with a new facility in Sacramento (Endpoints)
  • Abbott heart device for newborns shows longer-term benefits in release of three-year data (MedtechDive)
  • How MDR’s Clinical Investigation Rules Could Drive Some Spinal Fusion Products Out Of EU (MedtechInsight)
  • EU MDR Implementation Group Reinforces Historic Clinical Evidence Guidance Document Value (MedtechInsight)
  • Philips recalls 17M sleep apnea masks over magnets that could affect implanted devices (MedtechDive) (FDA)
  • FDA clears Magnus neuromodulation system in major depressive disorder (MedtechDive)
Government, Regulatory & Legal
  • Texas judge deems Obamacare HIV prevention drug mandate unlawful (Reuters)
Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe. Regulatory Recon is published each week on Monday, Tuesday and Thursday.
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.


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