Regulatory Focus™ > News Articles > 2019 > 1 > Recon: BMS to Acquire Celgene in $74B Deal

Recon: BMS to Acquire Celgene in $74B Deal

Posted 03 January 2019 | By Michael Mezher 

Recon: BMS to Acquire Celgene in $74B Deal

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Bristol-Myers Squibb will acquire Celgene in blockbuster $74B deal (STAT) (NYTimes) (Endpoints) (The Hill) (CNBC) (Press)
  • Trump says he expects to see lower drug prices (Reuters)
  • Supreme Court to examine a common legal strategy drug makers use to sidestep patient lawsuits (STAT)
  • With Senate votes, Trump gets a permanent drug czar — and his first science adviser (STAT) (Politico)
  • California reports show changes in drug spending as two companies sue over disclosure (STAT)
  • For head of Massachusetts biotech trade group, drug progress is personal (STAT)
  • After blueprinting R&D hub, AbbVie dishes out $105M for CD39 pact with Tizona’s new CEO from Roche (Endpoints)
  • Merck goes all-in on a late-stage NASH drug from NGM as development race heats up (Endpoints)
  • Google is quietly infiltrating medicine — but what rules will it play by? (STAT)
In Focus: International
  • Gilead tussles with the Malaysian government over licensing for its hepatitis C treatment (STAT)
  • Takeda builds arsenal for immuno-oncology research, creates cell therapy group (Endpoints)
  • NZ Plans Major Regulatory Overhaul, New Independent Agency (Pink Sheet-$)
  • MHRA releases response to consultation on EU exit no-deal legislative proposals (MHRA)
  • Further guidance note on the regulation of medicines, medical devices and clinical trials if there’s no Brexit deal (MHRA)
  • Merck's Keytruda wins 5 new approvals in Japan (MarketWatch) (Press)
Pharmaceuticals & Biotechnology
  • Why did Liz Barrett turn her back on a top job at Novartis in exchange for the helm of a biotech you never heard of? (Endpoints)
  • J&J takes stake in Locus’ CRISPR-based ‘Pac-Man’ antimicrobials (Fierce)
  • Another ADHD failure cements Aevi’s penny stock status (Endpoints)
  • AbbVie's Humira holds on to TV ad crown in Dec. despite Pfizer's year-end Xeljanz push (Fierce)
  • It's not just pharma kicking back at Trump's international drug-price index. Docs and hospitals hate it, too (Fierce)
  • Gene silencing company NeuBase Therapeutics to reverse merge its way onto Nasdaq via troubled microcap Ohr (Endpoints)
  • With early-stage studies underway, Connect Biopharmaceuticals closes $55M round to advance immune modulators (Endpoints)
  • US FDA Guidance On Interference With Inspections Needs More Detail, Attorneys Say (Pink Sheet-$)
Pharmaceuticals & Biotechnology: Study Results, Filings & Designations
  • Bristol-Myers Squibb’s Sprycel® (dasatinib) Tablets Now Approved in Combination with Chemotherapy in Certain Pediatric Patients with Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Press)
  • Catabasis Pharmaceuticals Phase 3 PolarisDMD Clinical Trial for Edasalonexent in Duchenne Muscular Dystrophy Progress Update and Additional Trial Sites Open for Enrollment (Press)
  • Pfizer Initiates Phase 2b/3 Clinical Trial for PF-06651600, an Oral JAK3 Inhibitor, for the Treatment of Patients with Moderate to Severe Alopecia Areata (Press)
  • Urovant Sciences Initiates Patient Enrollment in Phase 2a Clinical Trial for Vibegron in Patients with Abdominal Pain Due to Irritable Bowel Syndrome (Press)
  • Sesen Bio Announces Positive Preliminary 12-Month Data from Registration Phase 3 VISTA Trial of Vicinium for Non-Muscle Invasive Bladder Cancer (Press)
  • Aadi Bioscience Receives Breakthrough Therapy Designation for TARZIFYX™ (ABI-009) in PEComa Indication (Press)
  • Synthetic Biologics Announces First Two Patients Enrolled in Phase 2b Investigator-Sponsored (Press)
  • Seres Therapeutics Announces Initiation of SER-287 Phase 2B ECO-RESET Clinical Study for Ulcerative Colitis (Press)
  • Deciphera Pharmaceuticals Initiates a Phase 1b/2 Clinical Trial of Rebastinib in Combination with Carboplatin in Patients with Advanced or Metastatic Solid Tumors (Press)
Medical Devices
  • Out of joint: When knee replacements bring pain and regret (NBC)
  • US FDA Scaling Back 30-Day Grace Period for GUDID Medical Device Data Corrections (Emergo)
  • Titan Medical eyes 2019 for U.S., EU Sport robot submissions (MassDevice)
  • Cook Medical buys ex-cigarette plant in N.C. (MassDevice)
  • Axonics submits interim data to FDA for sacral neuromod device (MassDevice)
  • Medtronic, IBM Watson debut hypoglycemia prediction feature for diabetes app (MassDevice) (Press)
  • Veracyte partners with J&J on development of lung cancer test (MedCity)
  • BrainScope's FDA clearance expands, Kansas judge nixes tele-abortion ban, and more digital health news briefs (mobihealthnews)
US: Assorted & Government
  • On “Buckmanizing” the Controlled Substances Act (Drug & Device Law)
  • Avalanche or Roadblock: FDA Publishes Flurries of Biologic and Biosimilar Materials (FDA Law Blog)
  • The SUPPORT for Patients and Communities Act — What Will It Mean for the Opioid-Overdose Crisis? (NEJM)
  • Amid Opioid Crisis, The Joint Commission Revises Pain Standards For Health Facilities (Forbes)
  • RiteAid to Pay $300K for Over-Dispensing of Controlled Substances (FDANews-$)
Upcoming Meetings & Events Europe
  • New EU regulatory changes are coming: Here’s what you need to know (Medical Design & Outsourcing)
  • New Clinical Trial Aims To Detect Cancer With A Quick Breathalyzer Test (Forbes)
  • Irbesartan blood pressure and heart medication recalled from pharmacies (MHRA)
Australia
  • Submissions received and high level summary: Transition to eCTD only for prescription medicines (TGA)
General Health & Other Interesting Articles
  • The Dangerous Rise of the IUD as Poverty Cure (NYTimes)
Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory news stories from around the globe. Each weekday morning, we aim to bring you the latest highlights of new approvals, meetings, legal and political developments, regulations and guidance, and the latest trends with the potential to impact regulatory affairs professionals and the industry in which they work.
 
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