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May 28, 2024
by Jason Scott

Recon: J&J buys experimental eczema drug from Numab for $1.25B; Asahi Kasei to acquire Calliditas in $1.1B deal

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

In Focus: US
  • In light of H5N1 outbreak, U.S. in talks with mRNA vaccine makers on bird flu (STAT)
  • J&J makes another I&I acquisition with $1.25B deal for Numab's Yellow Jersey (Endpoints) (Reuters)
  • The top 20 drugs by worldwide sales in 2023 (Fierce Pharma)
  • FDA follows Form 483 to Indian drugmaker Laurus Synthesis with a 2nd rebuke (Fierce Pharma)
  • More than a third of healthcare organizations aren’t prepared for cyberattacks: report (MedTech Dive)
  • Musk's Neuralink seeks to enroll three patients in brain implant study (Reuters)
  • Sen. Paul Leads Effort To Halt FDA’s LDT Final Rule (MedTech Insight)
In Focus: International
  • Japanese conglomerate to buy Calliditas Therapeutics, maker of a kidney disease drug (STAT)
  • Western states push for deal on pandemic response rules at WHO meeting (Reuters)
  • The world needs the new pandemic treaty (STAT)
  • EU’s Future Regulatory Priorities Will Soon Be Solidified So Medtech Must Engage Now (MedTech Insight)
  • France Consults On Best Practice Guidelines For Decentralized Trials (MedTech Insight)
  • Industry Applauds AUD18.8m Funding For Australia’s ‘One Stop Shop’ For Clinical Trials (MedTech Insight)
Pharma & Biotech
  • Weight-loss drug forecasts jump to $150 billion as supply grows (Reuters)
  • Airway disease drug from Insmed succeeds in one of the year’s most anticipated trials (STAT)
  • Duchenne muscular dystrophy drug from Nippon Shinyaku fails in rare confirmatory trial (STAT)
  • Gene therapies for deafness dredge up an old question: Do deaf people want a ‘cure’? (STAT)
  • Merus drug, with immunotherapy, boosts tumor response in patients with head and neck cancer (STAT)
  • NewAmsterdam says former Amgen cardio drug reduces heart disease risk factor (Endpoints)
  • Joe Panetta to step down as Biocom California CEO (Endpoints)
  • After 14 years calling partnering shots at Genentech/Roche, James Sabry is headed back into the biotech fray (Endpoints)
  • Second engineered B cell therapy enters the clinic, promising to do in hemophilia B what gene therapies can't (Endpoints)
  • Agios sells rights to glioma drug to Royalty Pharma; Cargo’s $110M placement (Endpoints)
  • Takeda to lay off 640 workers in Massachusetts as part of multiyear overhaul (Endpoints)
  • Duchenne muscular dystrophy drug flunks Phase 3 confirmatory trial (Endpoints)
  • Corrected: AstraZeneca, Daiichi Sankyo’s TROP2 ADC boosts survival in Phase 3 lung cancer subgroup (Endpoints)
  • Novartis rides IgAN trioka to 2 trial wins in rare kidney diseases (Fierce Pharma)
Medtech
  • Achieving telehealth equity for people with hearing loss (STAT)
  • JPA Health continues expansion with acquisition of medical comms agency BioCentric (Fierce Pharma)
  • J&J’s Nisha Johnson on Ethizia wound-sealing patch, biosurgery market (MedTech Dive)
  • New products take center stage in medtech’s latest earnings season (MedTech Dive)
Government, Regulatory & Legal
  • Dark money group runs ads on China biotech bill (STAT)
  • At Las Vegas conference, methadone clinics blast idea of doctors prescribing directly (STAT)
  • Explainer: What does Louisiana's new abortion pill law mean for patients? (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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