Regulatory Focus™ > News Articles > 2019 > 7 > Recon: Gilead, Galapagos in $5.1B Drug Development Deal

Recon: Gilead, Galapagos in $5.1B Drug Development Deal

Posted 15 July 2019 | By Michael Mezher 

Recon: Gilead, Galapagos in $5.1B Drug Development Deal

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Gilead to raise stake in Belgian biotech in $5.1bn deal (Financial Times) (STAT) (Endpoints) (PMLive) (Press)
  • Lawmakers urge Trump administration to alter trade deal or Americans will pay more for drugs (STAT) (Center for Biosimilars)
  • AstraZeneca's Farxiga fails to get US approval for Type-1 diabetes (Reuters) (Endpoints)
  • Eton's conjunctivitis treatment fails to win FDA nod; shares tumble (Reuters) (Endpoints) (Fierce)
  • There Is No Single, Best Policy for Drug Prices (NYTimes)
  • Advocates frustrated over pace of drug price reform (The Hill)
  • Oklahoma seeks to hold J&J responsible for opioid crisis as trial ends (Reuters)
  • Indivior loses appeal to block generic Suboxone opioid treatments (Reuters)
  • Even When HIV Prevention Drug Is Covered, Other Costs Block Treatment (KHN)
  • J&J Denials of Asbestos in Baby Powder Spur Criminal Probe (Bloomberg) (Reuters)
  • In About-Face, Azar Says Safe Drug Importation Is Possible (IHP)
  • The Promise and Price of Cellular Therapies (The New Yorker)
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In Focus: International
  • Boehringer buys Swiss biotech in its latest M&A deal, going the next-gen cancer vaccine route (Endpoints) (Press)
  • Wu Jinzi: The challenges of taking on big pharma (Financial Times)
  • Novartis offloads lagging endocrine drugs to Recordati for $390M (Fierce) (Press)
  • AbbVie’s Skyrizi gets rapid ‘yes’ from NICE (PMLive)
  • GSK drug helps ovarian cancer patients live longer in late-stage study (Reuters) (Endpoints)
  • GSK to appoint Jonathan Symonds as chairman (Financial Times) (Endpoints)
  • 20 million children miss out on life-saving vaccines, UN warns (Reuters)
  • Fake polio markers highlight risks to Pakistan vaccination drive (Reuters)
  • UN calls for hundreds of millions in more aid to fight Ebola (Reuters)
  • Ebola spread to east Congo's Goma massively raises risk - UN (Reuters)
  • Two Ebola health workers killed in eastern Congo (Reuters)
Pharmaceuticals & Biotechnology
  • Recursion Pharmaceuticals raises $121m to map how disease affects cells (Financial Times) (Endpoints)
  • Bayer's MRI contrast agent gets FDA approval for use in cardiac disease (Reuters)
  • In a small study, a cancer vaccine assist beats immunotherapy drugs alone (STAT)
  • Compounding pharmacies need stricter federal oversight (STAT)
  • Illumina earnings points to worrying signs for consumer genetics industry (STAT)
  • New contraceptive vaginal ring prevents pregnancy for a year, gives women more control (Reuters)
  • When FDA and Advisory Committees Disagree: Study Investigates Gaps (Focus)
  • NIH and partners to launch HIV vaccine efficacy trial in the Americas and Europe (NIH)
  • Why Merck is in infectious disease for the long haul (BioCentury)
  • Broadening role for external control arms in clinical trials (BioCentury)
  • Moving Beyond a Buzzword: How small- to mid-sized biotechs can adopt patient centricity in oncology trials (BioCentury)
  • Peter Kolchinsky and Raj Shah raise a $300M fund devoted to biotech startups (Endpoints)
  • Generex Biotechnology acquires Medisource Partners (Pharmafile)
  • AbbVie beefs up the oncology pipeline, bagging an upstart STING player with its own unique approach (Endpoints) (BioPharmaDive)
  • Microcap Capricor soars on interim PhII DMD data showing functional benefit for older patients (Endpoints)
  • Indoco caught in maelstrom of FDA concerns as plant hit with warning letter (Fierce)
Pharmaceuticals & Biotechnology: Study Results, Filings & Designations
  • Biohaven's Positive Phase 3 Trial of Rimegepant Zydis® Orally Dissolving Tablet for Acute Treatment of Migraine Published in The Lancet (Press)
  • Exelixis Updates Phase 1b COSMIC-021 Trial of Cabozantinib in Combination With Atezolizumab in Patients With Advanced Solid Tumors (Press)
  • Synlogic Reports Positive Top-line Data from Phase 1/2a Study of SYNB1618 in Patients with Phenylketonuria and Guides to Next Phase of Development (Press)
  • Ascentage Pharma announces first patient dosed in Phase I clinical trial of APG-2575 in China as the first China-made Bcl-2 Inhibitor (Press)
  • Could Karyopharm's newly approved multiple myeloma drug also work in glioblastoma? (Fierce)
  • Dicerna Receives Breakthrough Therapy Designation for DCR-PHXC for Treatment of Primary Hyperoxaluria Type 1 (PH1) (Press)
  • Teva Announces FDA Approval of AirDuo® Digihaler™ (fluticasone propionate 113 mcg and salmeterol 14 mcg) Inhalation Powder (Press)
  • I-Mab Announces IND Approval for Its Proprietary TJC4, A Potentially Differentiated CD47 Antibody, to Initiate Clinical Trials in China (Press)
  • New Immune Data from Ongoing ADXS-NEO Phase 1 Study Support Clinical Potential for Neoantigen-Directed Immunotherapies (Press)
Medical Devices
  • GE Healthcare recall involves tens of thousands of infant warmers (MassDevice)
  • Hamilton Medical recalls ventilators over software glitch (MassDevice)
  • Consort Medical warns profits will be hit by explosion at plant (Financial Times)
  • LivaNova Receives U.S. FDA 510(k) Clearance for LifeSPARC Advanced Circulatory Support System (Press)
  • AirXpanders® Receives FDA 510(k) Clearance for a Smooth Shell Version of the AeroForm® Tissue Expander System (Press)
US: Assorted & Government
  • Biden healthcare plan would curb drug prices, raise taxes on rich (Reuters) (STAT)
  • Biden Cancer Initiative to suspend operations as 2020 campaign heats up (STAT)
  • US federal judge orders FDA to implement 10-month deadline for e-cig applications (Reuters)
  • US appeals court blocks Trump administration birth control exemptions (Reuters)
  • Will Agency Deference Ruling Affect Preemption? (Drug & Device Law)
  • Athena Diagnostics v. Mayo Collaborative Services -- The Concurrences (Patent Docs)
  • After Dozens of Fentanyl Killings, Hospital C.E.O. and 23 Employees Are Forced Out (NYTimes)
Upcoming Meetings & Events
  • FDA Advisory Committee Calendar
  • Regulatory Education for Industry (REdI) and CERSI Workshop: Current State and Future Expectations of Translational Modeling Strategies to Support Drug Product Development, Manufacturing Changes and Controls – Sep. 23-25, 2019
Europe
  • EMA Reviews Meningioma Risk With Cyproterone Medicines (Pink Sheet-$)
  • Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 July  (EMA)
  • Early access to medicines scheme (EAMS) scientific opinion: avelumab in combination with axitinib for first-line treatment of advanced renal cancer (MHRA)
  • Medicinal products with orphan drug status (Swissmedic)
India
  • Bayer’s move to block Natco’s colorectal cancer brand dismissed by Delhi HC (Economic Times)
  • Lupin aims to launch new products across geographies this fiscal (Economic Times)
  • CDSCO declares 26 samples as NSQ and 817 samples as SQ in random sampling for June (Pharmabiz)
  • USFDA found birds flying in warehouse, lack of toilet paper at United Breweries plant (Economic Times)
Canada
  • Regulators in Canada order dozens of stem cell clinics to stop (IPSCell)
  • Summary Safety Review - Propofol-containing products – (Health Canada)
Australia
  • TGA presentation: Digital Devices Webinar 3, 20 June 2019 (TGA)
  • State and territory governments continue to regulate fluoridated drinking water in Australia (TGA)
General Health & Other Interesting Articles
  • Urinary Tract Infections Affect Millions. The Cures Are Faltering. (NYTimes)
  • In Hawaii, Rat Lungworm Disease Infects People but Eludes Researchers (NYTimes)
  • U.S. recorded 14 new cases of measles (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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