Recon: Amgen to acquire Horizon in $27.8B deal; Roche pharma CEO to step down

ReconRecon | 12 December 2022 |  By 

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

In Focus: US
  • Amgen dives deeper into rare disease drugs with $27.8 bln Horizon deal (Reuters) (STAT) (WSJ)
  • Cancer drugmaker Clovis files for bankruptcy, hit by falling sales (Reuters)
  • Patient selection for AstraZeneca, Daiichi breast cancer drug needs improvement, experts say (Reuters)
  • FDA staff reviewers flag safety concerns over Cytokinetics' heart drug (Reuters)
  • Pfizer sees $10 bln-$15 bln in annual mRNA vaccine revenue by 2030 (Reuters)
  • Can Drugs Treat Addiction? Prisons Offer an Answer (WSJ)
  • U.S. opioid crackdown hampers some patients' access to psychiatric drugs (Reuters)
In Focus: International
  • Queues form at fever clinics as China wrestles with COVID surge (Reuters)
  • Too soon to call end to COVID-19 emergency, GAVI chief says (Reuters)
  • Roche pharmaceuticals CEO Bill Anderson to step down after four-year tenure (STAT)
  • Ebola trial candidate vaccines arrive in Uganda in record 79 days after outbreak declared (WHO)
  • South Africa's Aspen gets $30 mln grant to make vaccines (Reuters)
  • Some bloodstream infection bacteria grew resistant to last-resort drugs in 2020 – WHO (Reuters)
  • Cambodia halts exports of non-human primates, threatening drug discovery efforts (STAT)
Pharma & Biotech
  • Novartis develops CAR-T therapy that can be made in a fraction of the standard time (STAT)
  • Argenx antibody drug benefits patients with platelet-destroying autoimmune disorder (STAT)
  • Emerging class of genetically targeted drugs induce remissions in leukemia patients (STAT)
  • Affimed’s natural killer cell therapy has murky path forward despite encouraging results (STAT)
  • Why a tone-deaf Regeneron executive deserved to be booed over Alzheimer’s drug remarks (STAT)
  • Black Diamond spins out antibody work into new biotech with $30M from Versant, NEA (Endpoints)
  • Vertex, Moderna prepare to take their inhaled mRNA cystic fibrosis drug into the clinic (Endpoints)
  • GSK chief Emma Walmsley picks out a trim new global HQ in downsizing move (Endpoints)
  • ‘We’ve got a new target’: Bispecific antibody for multiple myeloma succeeds in mid-stage trial (STAT)
  • ImmunityBio looks to pull in $157M from founder Patrick Soon-Shiong and another investor (Endpoints)
  • Smiths Medical warns infusion set issues could cause false alarms, underdelivery (Fierce)
  • Boston Scientific angles for majority stake with $523M for Chinese devicemaker Acotec (Fierce) (MedtechDive)
  • Federal agencies release updated privacy guide for health app developers (Mobihealthnews)
Government, Regulatory & Legal
  • Wyden Makes Final Request to Amgen for Voluntary Compliance in Pharma Tax Investigation (Wyden)
  • Theranos Cases Show How DoJ Looks Beyond The FDCA In Prosecuting Drug, Device Companies (MedtechInsight)
  • J&J Unit Hit With $12M Verdict In Spinal Implant IP Suit (Law360)
  • Philips Wants Latest CPAP Foam MDL Complaint Tossed (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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