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Recon: FDA extends review of BioMarin's hemophilia gene therapy; Abbott's blood test for concussions cleared by FDA

ReconRecon | 07 March 2023 |  By 

Recon: FDA extends review of BioMarin's hemophilia gene therapy; Abbott's blood test for concussions cleared by FDA

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

In Focus: US
  • U.S. FDA extends review of BioMarin's bleeding disorder therapy (Reuters)
  • California to not do business with Walgreens over abortion pills issue, Governor says (Reuters)
  • WeightWatchers Moves Into the Ozempic Market With Telehealth Deal (WSJ) (Reuters)
  • FDA panel to reevaluate the most common over-the-counter decongestant, phenylephrine, criticized as useless (CBS)
  • Biden proposes expanding Medicare drug negotiation program (STAT) (Endpoints)
  • U.S. FDA clears Abbott's blood test for concussions (Reuters)
  • Moderna CEO Defends Pricing Plans for Covid-19 Shot (WSJ)
  • Q&A: Califf on obesity drugs, advisory panels, and how threats hurt recruitment at FDA (STAT)
In Focus: International
  • Pandemic fund vastly oversubscribed, more money needed - World Bank (Reuters)
  • Advisory Group Reform Proposals (MHRA)
  • AdvaMed calls Europe’s MDR extension a ‘strong step forward,’ but warns challenges remain (MedtechDive)
  • UK spring Covid boosters should target elderly and vulnerable, say experts (FT)
  • Brazil To Use Regulatory Reliance For GMP Inspections (Pink Sheet)
  • Top companies and drugs by sales in 2022 (Nature)
Pharma & Biotech
  • Rare disease trials can't find enough patients. It's forcing the FDA to rethink its approach (Endpoints)
  • Could the Next Blockbuster Drug Be Lab-Rat Free? (NYTimes)
  • Large biopharma companies cull about 40 immuno-oncology programs over the last two quarters (Endpoints)
  • Pharma industry lobbies Congress for solution to primate shortage after indictments for alleged smuggling (Endpoints)
  • With CRISPR cures on horizon, sickle cell patients ask hard questions about who can access them (STAT)
  • F-star's sale to Chinese buyer cleared by CFIUS following months of holdup (Endpoints)
  • Despite mid-stage plaque psoriasis win, J&J appears uncertain on partner's IL-23 drug (Endpoints)
  • Lenz Therapeutics eyes better vision than AbbVie, Orasis with $80M+ for three PhIII trials (Endpoints)
  • BridgeBio to raise $150M; FDA accepts Ionis' antisense drug NDA (Endpoints)
  • Alex Denner's firm takes over Amarin, ousts non-Sarissa board members (Endpoints)
  • FDA axes diagnostic requirement for Lilly's Verzenio + endocrine therapy in certain breast cancer patients (Endpoints)
  • Immuneering cuts neuroscience programs to focus on oncology, extend cash runway (Endpoints)
  • Ampersand snags $50M as Flagship focuses therapeutics on desired targets only (Endpoints)
  • Oncology specialist Volastra brings in PhI drug from Amgen, nabs $60M in Series A (Endpoints)
  • Chiesi offers Affibody breath of fresh air in respiratory disease deal worth up to $637M (Fierce) (Endpoints)
  • J&J-backed startup launches with $100M to build better brain drugs (BioPharmaDive) (Endpoints)
Medtech
  • Johnson & Johnson is cutting jobs in its MedTech business (MassDevice)
  • Best Buy-Atrium deal offers glimpse of tech’s future in home health (STAT)
  • ACC23: Medtronic makes strides in pulsed field ablation race against Boston Scientific, J&J (Fierce)
  • Medtronic TAVR data in healthier patients fuels battle with Edwards for heart valve market share (MedtechDive)
  • FDA sounds out de novo clearance for neuromodulation device to treat tinnitus (Fierce)
  • Medtechs plan to centralize regulatory information management in modernization push: survey (MedtechDive)
  • Sooma receives FDA Breakthrough Device designation for depression therapy device (Pharmafile)
Government, Regulatory & Legal
  • Republican states say the FDA doesn’t have the authority to override state abortion pill bans (CNBC)
  • Gilead Prevails In Antiviral IP Claim Fight At Fed. Circ. (Law360)
  • Merck Hit With 3rd-Party Payor Suit Over Vaccine Bundling (Law360)
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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