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November 6, 2023
by Jason Scott

Recon: Drugmakers to increase Adderall output to combat U.S. shortage; EU’s proposed legislation may hurt pharma innovation

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

In Focus: US
  • Adderall makers agree to increase production: DEA (The Hill)
  • Lawmakers ask FDA for information on US drug shortages (CIDRAP)
  • Generics Review Data From US FDA Reveals Positives, Negatives For Industry (Pink Sheet)
  • Watching The Clock Stop: US/EU Regulatory Review Time Parity In Sight, Study Suggests (Pink Sheet)
  • Pharmacist Prescribing for BP Control Makes Economic Sense (Medpage Today)
  • Medicare moves ahead with more price transparency requirements for hospitals (STAT)
  • US CDC to expand surveillance of travelers for respiratory viruses (Reuters)
  • ‘Resilient’ Trials: US FDA Wants To Apply COVID Lessons In Trial Design (MedTech Insight)
In Focus: International
  • EU proposal may accelerate pharma innovation decline, industry group says (Reuters)
  • European Parliament Explains ‘Vanishing’ Study On Balancing Access & Innovation In EU (Pink Sheet)
  • EU Decision Time For GSK’s Rare Cancer Drug Momelotinib & Others (Pink Sheet)
  • Novo Nordisk warns EU that new rules will push it to expand faster in US (The Financial Times)
  • Vertex may face another battle in the U.K. over the value of its cystic fibrosis medicines (STAT)
  • England's young cystic fibrosis patients face new treatment worry (Reuters)
  • BioNTech cuts 2023 revenue target on reduced prospects for vaccine (Reuters)
Pharma & Biotech
  • Astellas shows enough data for eye treatment to support expanded use, but still lags competitor (STAT)
  • XBI biotech index rises, giving investors a shred of hope (STAT)
  • Bristol Myers buys Orum's blood cancer therapy for up to $180 mln (Reuters)
  • The Endpoints Slack interview: Roivant CEO Matt Gline on playing moneyball in pharma, Vivek and politics, and the $7B Roche deal (Endpoints)
  • CARGO Therapeutics eyes one of 2023's largest IPOs in a dull year for listings (Endpoints)
  • MoonLake’s stock falls more than 20% despite mid-stage success in psoriatic arthritis (Endpoints)
  • Zentalis shakes up PhIII plans in ovarian cancer; Halozyme's deal with Acumen; Korro's $117M private placement (Endpoints)
  • Cellares to produce Cabaletta’s autoimmune CAR-T candidate (Endpoints)
  • BioNTech grabs PD-L1/VEGF bispecific with $55M upfront, expanding pipeline while lowering Covid guidance (Endpoints)
  • RAPT Therapeutics bolsters partner search with PhII data on small molecule-Keytruda combo (Endpoints)
  • AstraZeneca, Eledon and Alpine spell out kidney program successes: ASN roundup (Endpoints)
  • Starton Therapeutics scraps SPAC deal that would have taken it public, brought in $50M (Endpoints)
Medtech
  • Notified Body Designations Under The MDR Hit The 40 Mark With New Turkish Designation (MedTech Insight)
  • Twists And Turns Ahead For Medtech In Europe As AI Dominates October Regulatory Debates (MedTech Insight)
  • In experiment, electrical stimulation of the spinal cord helps a patient with Parkinson’s to walk (STAT)
  • 5 companies to watch as medtech earnings wind down (MedTech Dive)
  • Siemens Healthineers to lay off 300 workers, move some manufacturing to Ireland (MedTech Dive)
  • J&J links radiofrequency catheter to improved quality of life in atrial fibrillation study (MedTech Dive)
  • Stryker in ‘sprint back to 2019’ as procedures grow and supply chain, staffing pressures improve (MedTech Dive)
  • Inari Medical to buy limb-saving device maker LimFlow for up to $415M (MedTech Dive)
  • Penumbra touts benefits of vacuum thrombectomy for PE in late-breaking data (MedTech Dive)
Government, Regulatory & Legal
  • California Low-Cost Insulin Faces Delays After Price-Cap Veto (Bloomberg Law)
  • Gilead Wants Ex-Executive to Repay Millions for Insider Probe (Bloomberg Law)
  • Latest data shows millions of eligible Americans have been disenrolled from Medicaid (STAT)
  • Exclusive: Cigna explores shedding Medicare Advantage business -sources (Reuters)
  • News We’re Watching: AGs Push For Pulse Ox Warnings. VP Harris Announces AI Initiatives; FDA Looks At Digital Health And Diabetes (MedTech Insight)
 
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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