Regulatory Focus™ > News Articles > 6 > Recon: Roche Buys the Rest of Foundation Medicine for $2.4B

Recon: Roche Buys the Rest of Foundation Medicine for $2.4B

Posted 19 June 2018 | By Michael Mezher 

Recon: Roche Buys the Rest of Foundation Medicine for $2.4B

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

In Focus: US

  • Roche pays $2.4 billion for rest of cancer expert Foundation Medicine (Reuters) (Endpoints) (Financial Times) (Press)
  • Sarepta shares soar as gene therapy study shows promise (Reuters) (Forbes)
  • Biogen plunges after rival drug for spinal muscular atrophy shows promise (CNBC)
  • Bipartisan group of senators asks FDA to examine drug shortages (The Hill)
  • Opioid addiction drugs severely underutilized, study finds (CNN) (KHN) (NIH)
  • With FDA input, compassionate use programs appear to work well: study (Reuters) (JAMA)
  • Trump's association health plan rule is imminent (Politico) (NYTimes)
  • Some parents of epileptic kids wary of pot-based medication (AP)
  • CVS introduces prescription drug delivery as it braces for Amazon's possible disruption (CNBC)

In Focus: International

  • These are the most — and least — reputable drug companies in the world (Business Insider)            
  • Nearly Eradicated in Humans, the Guinea Worm Finds New Victims: Dogs (NYTimes)
  • Scotland to house world-first manufacturing innovation centre (PharmaTimes)
  • Vertex Gets Reimbursement Deal For Orkambi In Sweden (BioCentury)
  • Roche To Work With UK's NICE Following Blow For Perjeta (Pink Sheet-$)
  • Sanofi recruits veteran French auto executive to replace outgoing CFO Contamine (Fierce)

Pharmaceuticals & Biotechnology

  • 4 Takeaways From The FDA's Info-Sharing Guidance (Law360-$)
  • Vertex doubles size of cystic fibrosis drug discovery site (Fierce)
  • MAT Tied to Fewer Deaths a Year after Opioid Overdose (Medpage)
  • Building up its rare obesity pipeline, Rhythm Pharma to raise $150M (Endpoints)
  • A Third of Children Use Alternative Medicines (NYTimes)
  • No pharma Grand Prix—again—at Cannes Lions Health, but record number of awards for drugmakers (Fierce)
  • Corporate responsibility investor group touts support of first-year resolutions over executive pay, drug pricing (Fierce)
  • What's next for embattled Allergan? Depends on pipeline performance, analysts say (Fierce)
  • Pediatric Cancer Studies: US FDA's Molecular Target Lists Face Panel Vetting (Pink Sheet-$)
  • Antibiotic Development Question: Should A Phage Library Equal One Application? (Pink Sheet-$)
  • Payers, Drugmakers Face Off Over CAR T Medicare Coverage (BioCentury)
  • USFDA approves first product from Glenmark's US plant (Economic Times)
  • Medivir delays pivotal HDAC trial as FDA discussions stall (Fierce)

Pharmaceuticals & Biotechnology: Study Results, Filings & Designations

  • Alexion Submits Application for Priority Review and Approval of ALXN1210 as a Treatment for Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) in the U.S. (Press)
  • Bristol-Myers, AbbVie eye new use for myeloma drug Empliciti after phase 2 combo win (Fierce)
  • Janssen Phase 3 Study Programme of Esketamine Nasal Spray in Patients with Treatment-Resistant Depression Presented for the First Time in Europe (Press)
  • ImmunoGen Announces FDA Fast Track Designation for Mirvetuximab Soravtansine in Patients with Platinum-Resistant Ovarian Cancer (Press)
  • Novus Therapeutics Receives FDA Guidance at Type C Meeting for OP-02 in the Treatment and Prevention of Otitis Media (Press)
  • Can-Fite Updates on Status of Phase II Advanced Liver Cancer Trial (Press)

Medical Devices

  • Abbott's choice: acquire more businesses now or pay later (Modern Healthcare)
  • Myriad Genetics Submits Supplementary PMA for BRACAnalysis CDx (GenomeWeb)
  • What You Need to Know about FDA's Draft Guidance on Writing Test Reports (MDDI)
  • Haemonetics closes $700m debt refi (MassDevice)
  • DreaMed Diabetes wins FDA authorization to market insulin therapy management platform (DrugDelivery)
  • Neural Analytics lands CE Mark for NeuralBot ultrasound guidance device (MassDevice)
  • Elekta wins CE Mark for Unity high-field MR-linac (MassDevice)
  • Bay Labs' EchoMD AutoEF Software Receives FDA Clearance for Fully Automated AI Echocardiogram Analysis (Press)

US: Assorted & Government

  • Bristol-Myers Squibb: 1 Year Later (Law360-$)
  • Boston Scientific Wins Jury Verdict in Pelvic Mesh Trial (MDDI)
  • New York Judge's Ruling Could Be Painful For Opioid-Makers Sued Over Addiction Crisis (Forbes)
  • Bayer Dodges Yaz, Yasmin Suit After Improper Expert Report (Law360-$)
  • PTAB Rejects Samsung Challenge To Herceptin Patent (Law360-$)
  • How The Opioid Crisis Is Depressing America's Labor Force (NPR)

Europe

  • Bayer issues new bonds with a volume of 15 billion U.S. dollars (Press)
  • Ready or Not, Changes Are Coming to Legacy Device Requirements in the EU (MDDI)
  • NHS could save £7bn with greater diagnostics use (PMLive)
  • Novo Nordisk links with Kallyope to tackle obesity, diabetes (PharmaLetter-$)
  • Syncona powers gene therapy startup Freeline to £88M B round (Fierce)
  • Denying it has lost war on drugs, UK rules out legalizing cannabis (Reuters)
  • UK signals changes on medicinal cannabis use after epileptic boy's case (Reuters)
  • After law change, Greek medicinal users hope to enter cannabis business (Reuters)

India

  • CDSCO identifies 300 top brands for 'trace and track' mechanism, to meet firms on June 25 to discuss implementation (PharmaBiz)
  • Gujarat FDCA prosecutes spurious drug manufacturer for supplying fake medicine to US market (PharmaBiz)
  • Trade associations seek demarcation of generics to comply with DCGI direction on separate shelf for generics (PharmaBiz)

Canada

  • Health Canada Approves Hologic Panther Fusion System; Flu, Respiratory Assays (GenomeWeb)

General Health & Other Interesting Articles

  • 'Cutting Edge' Program For Children With Autism And ADHD Rests On Razor-Thin Evidence (NPR)
  • It Was Supposed to Be an Unbiased Study of Drinking. They Wanted to Call It 'Cheers.' (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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