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)
- 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)
- 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)
- 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)
- 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)
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