Recon: Globus to acquire NuVasive in $3B deal; AstraZeneca seeks growth with new drugs amid falling COVID sales

ReconRecon | 09 February 2023 |  By 

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

In Focus: US
  • Pfizer, Novartis, Merck Executives Say They Are Hunting for Deals Again (WSJ)
  • Why the Odds Are Stacked Against a Promising New Covid Drug (NYTimes)
  • Medtronic hit with $106.5M US verdict in heart-valve patent case (Reuters)
  • Globus Medical to buy NuVasive in deal valued at about $3 billion (Reuters) (MedtechDive)
  • Elon Musk's Neuralink may have illegally transported pathogens, animal advocates say (Reuters)
  • Study suggests DNA sequencing could reduce infant deaths, often caused by genetic disease (STAT)
  • The high cost of diabetes drugs has led to a flourishing black market (NBC)
In Focus: International
  • Germany's Fresenius may give up control of FMC dialysis business (Reuters)
  • German union opposes Bayer split after CEO departure - taz newspaper (Reuters)
  • Bayer, facing investor ire, appoints an outsider CEO (STAT)
  • AstraZeneca goes for growth with new drugs as COVID sales wane (Reuters)
  • AstraZeneca CEO says UK business climate deters investment (Reuters)
  • AstraZeneca moves forward with a $360M API plant in Ireland (Endpoints)
  • Why Europe's drug shortages may get worse (Reuters)
  • World should 'calm down' about China COVID variants, Chinese scientist says (Reuters)
  • Japan's 1st plant for mRNA COVID vaccine to be built by Daiichi Sankyo (Nikkei Asia)
  • ABPI President Steps Down Amid Novo Nordisk Code Of Practice Breach (ABPI)
Pharma & Biotech
  • Drug sales to reach $1.9 trillion within 5 years? (Nature Reviews)
  • Lonza breaks ground on $500M+ Swiss manufacturing facility (Endpoints)
  • UK microcap faces partial clinical hold in mid-stage IPF trial (Endpoints)
  • Ozempic and Wegovy add new layers to the understanding of obesity as a chronic health condition (NBC)
  • PhIII implosion forces Galapagos to scrap a filing plan for filgotinib (Endpoints)
  • Ovid brings two Big Pharma vets on board as new CMO, head of epilepsy research (Endpoints)
  • Regeneron wins another FDA nod for powerhouse Eylea despite trial flops (Fierce)
  • Aligos cuts another 10% of its workforce in reprioritization for NASH and Covid pipelines (Endpoints)
  • Magenta CEO exits, 84% of staff let go as shuttering looms (Endpoints)
  • New Teva CEO Richard Francis reprioritizes to 'get back to growth' (Endpoints)
  • Engineered virus shows promise against aggressive form of breast cancer (STAT)
  • What The FDA Looks For When Inspecting Sites Soon After Approving Drugs (Pink Sheet)
  • FDA offers former biotech unicorn Intarcia a chance for a panel review (BioPharmaDive)
  • FDA grants RMAT designation for Mesoblast’s chronic low back pain treatment (Pharmafile)
  • Medtech CDMO sector poised for M&A rebound in 2023 amid ‘attractive’ targets: report (MedtechDive)
  • Baxter profit forecast falls short, to lay off up to 5% workforce (Reuters)
  • Abbott to pay $890M to acquire CSI, gaining atherectomy device (MedtechDive)
  • Thermo Fisher shrinks headcount in San Diego area, axing over 200 positions (Endpoints)
  • How the CPAP crisis has paved the way for Philips’ biggest rivals to rake in profits (STAT)
  • 3M rolls out skin-sticking adhesive allowing wearable monitors to last up to 4 weeks (Fierce)
  • Former Oracle Exec Joins FDA As Director Of Digital Health Center Of Excellence (MedtechInsight)
Government, Regulatory & Legal
  • Fed. Circ. Mulls Amgen-Sandoz Psoriasis Drug Dispute (Law360)
  • Merck Seeks Dismissal Of NC Gardasil Vax Claims (Law360)
  • Medtronic Unit Hit With $106.5M Heart Valve Patent Trial Loss (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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