Regulatory Focus™ > News Articles > 2019 > 11 > Recon: Novartis to Buy Medicines Company for $9.7B; Blackstone, Ferring Announce $570M Gene Therapy

Recon: Novartis to Buy Medicines Company for $9.7B; Blackstone, Ferring Announce $570M Gene Therapy Venture

Posted 25 November 2019 | By Michael Mezher 

Recon: Novartis to Buy Medicines Company for $9.7B; Blackstone, Ferring Announce $570M Gene Therapy Venture

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Novartis to Buy the Medicines Company for $9.7 Billion (AP) (Financial Times) (WSJ) (STAT) (Reuters)
  • The big drug hunters: Novartis’ $28B-plus deal spree makes Vas Narasimhan one of the top dealmakers of our time (Endpoints)
  • Adamis shares slump as FDA declines to approve opioid overdose treatment  (Reuters) (Press)
  • FDA approves Aquestive's ALS treatment (Reuters) (Endpoints)
  • Teva, Drugmakers in Talks With U.S. to End Generics Probes (Bloomberg)
  • Generic trade group sues California for an ‘unconstitutional’ law banning pay-to-delay deals (STAT)
  • Roche eyes quick FDA approval in SMA race with Biogen, Novartis (Reuters) (Endpoints) (Press)
  • Blackstone to invest $400 million in gene therapy venture with Ferring (Reuters) (Fierce) (Endpoints)
In Focus: International
  • Longer-term data fail to clear concern over Takeda's dengue vaccine (Reuters) (STAT) (WSJ) (Press)
  • Takeda says cancer drug Alunbrig shows longer benefit vs. crizotinib (Reuters) (Endpoints)
  • Roche says Tecentriq cocktail helps liver cancer patients live longer (Reuters) (Endpoints) (Press)
  • Tories promise new £500m fund to boost access to cutting-edge drugs (Financial Times) (ABPI) (Manifesto)
  • WHO sounds alarm on Ebola due to Congo insecurity (Reuters)
  • Teva partners with Israeli institutes for early-stage drug research (Reuters)
Pharmaceuticals & Biotechnology
  • Facing bottlenecks in manufacturing cell therapies, Boston leaders plan to build their own (STAT) (Endpoints)
  • CymaBay Therapeutics scraps liver disease studies; shares plunge (Reuters) (Endpoints) (Press)
  • Watch: The state of biotech at time of innovation — and high prices (STAT)
  • Ex-Purdue CEO stands to earn a huge windfall in Novartis' buyout of the Medicines Co (Endpoints)
  • Excess Weight Can Weaken The Flu Shot (NPR)
  • More than 1,000 patients may have been exposed to HIV and other viruses after error in sanitizing procedure (CNN)
  • BIO Comments on FDA docket Standards for Future Opioid Analgesic Approvals and Incentives for New Therapeutics to Treat Pain and Addiction (BIO)
  • Promises and Perils of Prescription Drug Monitoring Programs: Workshop Report (Harvard Bill of Health)
Pharmaceutical & Biotechnology: Study Results, Filings & Designations
  • FDA fast-tracks psilocybin treatment for major depressive disorder (Pharmafile) (Press)
  • Revance Submits Biologics License Application (BLA) to the FDA for DAXI to Treat Glabellar (Frown) Lines (Press)
  • EpicentRx Announces Positive Results From Phase 1 Trial of RRx-001 as First-line Treatment in Newly Diagnosed Glioblastoma (Press)
  • TFF Pharmaceuticals Announces Initiation of Phase 1 Clinical Trial of Voriconazole Inhalation Powder, to Treat Invasive Pulmonary Aspergillosis (IPA) (Press)
  • ArQule to Present Clinical Data for its Reversible BTK Inhibitor, ARQ 531, at the American Society of Hematology 2019 Annual Meeting (Press)
  • Verastem Oncology Announces Submission of a Marketing Authorization Application to the European Medicines Agency for COPIKTRA® (duvelisib) (Press)
  • INHIBITOR Therapeutics Submits Investigational New Drug Application for Treatment of Patients with Late-Stage Prostate Cancer (Press)
  • DNAtrix Presents Positive Results from the Phase 2 CAPTIVE/KEYNOTE-192 Study of DNX-2401 in Combination with Pembrolizumab for Glioblastoma at the 2019 SNO Annual Meeting (Press)
  • Dosing of first patient in phase 3 pivotal study of sovateltide (PMZ-1620), a first-in-class investigational product, for acute cerebral ischemic stroke (Press)
  • Medicenna Reports Promising Efficacy in Phase 2b MDNA55 Clinical Trial at the Society for Neuro-Oncology Annual Meeting (Press)
  • Toca 5 Phase 3 Trial Results Presented at the Society for Neuro-Oncology Annual Meeting (Press)
  • SOLIRIS® (eculizumab) Receives Approval in Japan for the Prevention of Relapse in Patients with Neuromyelitis Optica Spectrum Disorder (NMOSD) (Press)
  • Seattle Genetics Announces Health Canada Approval of ADCETRIS® (Brentuximab Vedotin) in Combination with Chemotherapy in Frontline CD30-Expressing Peripheral T-Cell Lymphoma (Press)
Medical Devices
  • Nation’s Business Groups Call for Full Repeal of Medical Device Tax (AdvaMed)
  • AdvaMed lobbied EPA chief Wheeler on cancer report amid delay in ethylene oxide regs (MedtechDive)
  • Medtronic's recovering DCB segment scores FDA approval of IN.PACT AV (MedtechDive)
  • Merit Medical stent graft system gains breakthrough status (MedtechDive)
  • PGx test developers pursue dialogue as FDA maintains its enforcement stance (Gen)
  • Renovia Announces FDA 510(k) Clearance of Next-Generation leva® Pelvic Digital Therapeutic (Press)
  • ANVISA: Nearly half of all Brazil GMP certificates now issued under Medical Device Single Audit Program (Emergo)
US: Assorted & Government
  • Trump says he will allow states to import prescription drugs to lower costs (Reuters) (CRS Report)
  • Trump draws ire after retreat on drug prices pledge (The Hill)
  • Harris County sues insulin manufacturers, alleging price-gouging scheme (Houston Chronicle)
  • A closer look at 'Medicare for All' (Politico)
  • ‘Public Option’ Draws Voters Unsure About ‘Medicare for All’ (NYTimes)
  • In The Fight For Money For The Opioid Crisis, Will The Youngest Victims Be Left Out? (NPR)
  • Too Much, Too Soon: OPDP Issues Untitled Letter for Pre-approval Promotion (FDA Law Blog)
  • CRISPR Motions Day at the PTAB: Broad Files Its Substantive Motion No. 4 (Patent Docs)
  • Size Matters (Drug & Device Law)
Upcoming Meetings & Events Europe
  • New Package Leaflets Needed For EU Drugs With Ethanol Excipient (Pink Sheet-$)
Asia
  • Centralized drug procurement, use to be promoted (China State Council)
  • MHLW to Propose “Special Rule” for Indication Change Re-Pricing (PharmaJapan)
India
  • USFDA finds several violations in Aurobindo sterile injections unit (Economic Times)
  • Aurobindo Pharma aims to become debt free in 3 years sans Sandoz deal (Economic Times)
Other International
  • Samoa measles outbreak kills 20, mostly children (Reuters)
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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