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August 28, 2023
by Michael Mezher

Recon: Danaher to buy Abcam for $5.7B; Novocure device flops in late-stage ovarian cancer study

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
 
In Focus: US
  • Novocure device fails in late-stage ovarian cancer trial, shares slump (Reuters) (Endpoints)
  • Life sciences firm Danaher to buy Abcam in $5.7 bln deal (Reuters) (Endpoints)
  • Drugmaker Mallinckrodt files for second bankruptcy in the US (Reuters)
  • Weight loss drug Wegovy improves function in people with common type of heart failure (STAT)
  • U.S. health officials lay out plans to cope with respiratory virus season (STAT) (Endpoints)
  • FTC pauses challenge of Amgen's $28B Horizon takeover to consider settlement (Endpoints)
  • FDA publishes Oncopeptides’ withdrawal appeal for Swedish biotech’s cancer drug Pepaxto (Endpoints) (Pink Sheet)
  • How Fast Is ‘Expedited’? Pepaxto To Show Speed Of New Withdrawal Process For Accelerated Approval Drugs (Pink Sheet)
In Focus: International
  • Bayer says Parkinson's stem cell therapy improves symptoms in initial trial (Reuters)
  • Europe to face shortage of Lilly's diabetes drug through September (Reuters)
  • How Ozempic and Weight Loss Drugs Are Reshaping This Country’s Economy (NYTimes)
  • Wegovy reimbursement would cost Denmark up to $4 bln each year -ministry (Reuters)
  • China to drop COVID antigen test requirement for inbound travelers (Reuters)
Pharma & Biotech
  • Verastem Oncology secures collaboration with GenFleet Therapeutics, potentially worth up to $600M+ (Endpoints)
  • The ADHD drug market is already stretched thin. Now it’s facing a back-to-school supply strain (CNBC)
  • Orphan drugs: small markets, large rewards (Financial Times)
  • Novartis’ Leqvio cuts LDL levels by 50% over three years: #ESC23 (Endpoints)
  • US FDA’s New Generics Chief: We Need More Flexibility For Complex Products (Pink Sheet)
  • Intarcia Gets Its Hearing: FDA Panel To Weigh Nonapproval Of Diabetes Drug/Device Combo In September (Pink Sheet)
  • BridgeBio's ATTR-CM drug bests placebo in detailed PhIII data, bolstering plans for NDA (Endpoints)
  • Baxter CDMO BioPharma Solutions names Franco Negron as CEO ahead of proposed sale (Endpoints)
  • Pharma enters ‘age of uncertainty’ amid challenges from IRA, FTC and patent cliffs (Endpoints)
  • Merck and Eisai to stop Keytruda plus Lenvima trial in head and neck cancer after disappointing interim results (Endpoints)
Medtech
  • Withings' Smart Scale Passes US FDA Test; Clearance For Detecting Atrial Fibrillation (MedtechInsight)
  • GE HealthCare to bring cardiovascular-focused handheld ultrasound probe to U.S. (Fierce)
  • One More IVDR Notified Body In The Wings As Designation Progress Continues To Advance (MedtechInsight)
Government, Regulatory & Legal
  • AstraZeneca sues US over Medicare drug price negotiation plans (Reuters) (STAT)
  • Drug retailer Rite Aid prepares to file for bankruptcy, Wall Street Journal reports (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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