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Regulatory Focus™ > News Articles > 9 > Recon: Alexion to Buy Biotech Syntimmune for $1.2B

Recon: Alexion to Buy Biotech Syntimmune for $1.2B

Posted 26 September 2018 | By Michael Mezher 

Recon: Alexion to Buy Biotech Syntimmune for $1.2B

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Alexion to buy biotech firm Syntimmune for up to $1.2 billion (Reuters) (Endpoints) (Fierce)
  • Pharmacists May Soon Be Able to Tell You the Cheapest Way to Get Prescriptions (Bloomberg)
  • With PBMs firmly in Washington’s crosshairs, their top lobbyist steps down with no regrets (STAT)
  • Merck board waves off a forced retirement for CEO Ken Frazier, happy to extend his reign (Endpoints)
  • GAO Makes Appointments to PCORI Governing Board (GAO)
  • Shingles Vaccine Shortages Result From High Demand (NYTimes)
  • With CDC backing reinstated, AstraZeneca ships FluMist for the coming flu season (Fierce)
  • Health data breaches on the rise (Reuters) (JAMA)
  • Cancer Center Switches Focus on Fund-Raising as Problems Mount (NYTimes)
  • Sham Petition Suits Are Piercing Big Pharma's Antitrust Shield (Law360-$)
  • Chinese Drug Maker Clarifies Development Strategy For Bringing Cancer Drug To The US Market (Forbes)
  • Big Pharma Boosts Drug Prices As Supplies Run Low, Study Reveals (Forbes)
  • Tax Reform No Shot In Arm For Pharma Deals (Forbes)
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In Focus: International
  • GSK vaccine success a milestone in TB, but room for improvement (Reuters) (Endpoints) (NBC)
  • Canada Balks at US Demand for 10 Years of Biologics Exclusivity (BioCentury)
  • Takeda's dream of a first-line ALK inhibitor supported by late-stage data (BioPharmaDive) (Pharmafile) (PharmaTimes)
  • Daiichi-Sankyo takes rival to Roche’s Kadcyla into phase 3 (PMLive)
  • Ray Chambers appointed WHO Ambassador for Global Strategy (WHO)
  • India Rolls Out Modicare - Can It Redefine Healthcare Access, Market Potential? (Pink Sheet-$)
  • First cancer drug from Amgen/Astellas JV approved in Japan (PharmaLetter-$)
  • Sudan reports outbreak of mosquito-borne Chikungunya disease in eastern state (Reuters)
  • UK healthcare worker contracts rare monkeypox virus in third case (Reuters)
Pharmaceuticals & Biotechnology
  • Breakthrough In Nanotechnology Brings Nanomotors Closer To Reality For Drug Delivery (Forbes)
  • US FDA’s Opaque Galafold Review: A Rare Misstep In The Trump Era (Pink Sheet-$)
  • Safe and effective prescribing: A new and important initiative from the PhRMA Foundation (PhRMA)
  • PhRMA comments in response to request for information on competitive bidding program in Medicare Part B (PhRMA)
  • Appendicitis? Antibiotics May Be All You Need (NYTimes)
  • Adapt tests ads urging opioid users' loved ones to stock Narcan at home (Fierce)
  • Trump's Chinese Import Tariff Hike Could Take Toll On Consumer Health Sector (Pink Sheet-$)
  • API Makers Must Control Dangerous Impurities Better, FDA Compliance Official Says (Pink Sheet-$)
  • One top oncologist failed to disclose payments from big pharma. That hurts all cancer patients (The Guardian)
  • Roche-backed Minoryx raises €21M to expand CNS R&D (Fierce)
  • NIH-funded genome centers to accelerate precision medicine discoveries (NIH)
  • NIH releases strategic plan to address tuberculosis research (NIH)
  • CDER Publishes MAPP on Prioritizing CGMP Surveillance Inspections (FDA Law Blog)
  • Curis moves up COO as CEO Fattaey leaves company (Fierce)
  • Everest Adds Another Antibiotic To Pipeline Through Venatorx Deal (BioCentury)
  • Guest column: The 3 big waves reshaping investment strategies in early-stage biotech (Endpoints)
  • AMAG expands maternal health pipeline, bags late-stage orphan drug for $12.5M (Endpoints)
  • A player in the bustling microbiome R&D arena promotes its CSO to the top post — just ahead of a PhII NASH study (Endpoints)
  • AstraZeneca-backed Entasis Therapeutics joins the IPO class of 2018 with a weak debut price (Endpoints)
  • Lyra pockets $29.5M to push ear, nose, throat applications of implant tech from Langer, Whitesides (Endpoints) (MedCity)
  • Dilip Patel; Denial of Hearing; Final Debarment Order (Federal Register)
Pharmaceuticals & Biotechnology: Study Results, Filings & Designations
  • Aldeyra shares soar on positive PhII dry eye data — but lose some steam on second look (Endpoints)
  • Aronora's New Blood Clot Treatment Receives FDA Fast Track Designation (Press)
  • Allergan Announces FDA Acceptance of Supplemental New Drug Application For VRAYLAR® (cariprazine) (Press)
  • Ra Pharma Announces Positive Results from Phase 1b Pharmacokinetic Study of Zilucoplan (RA101495 SC) in Patients with Renal Impairment (Press)
  • Marius Pharmaceuticals Completes Efficacy Portion of its Re-Tune Phase 3 Study Evaluating Their Innovative Oral Testosterone Formulation in Hypogonadal Men (Press)
  • Evolve Biologics™ Provides Update on Progress in Phase III Trial for PlasmaCap™ IG (Intravenous Immunoglobulin) (Press)
  • Aurinia Completes Enrollment of AURORA, its Phase 3 Clinical Trial for the Treatment of Lupus Nephritis (Press)
Medical Devices
  • Bridging the Gap Between Electronics and Biology (IEEE)
  • Medtech should think more deeply about the problems it’s trying to solve (Medical Design & Outsourcing)
  • University of Minnesota is launching a medical industry innovation conference (Medical Design & Outsourcing)
  • Astellas Oncology's crowdsourced C3 Prize shortlists pediatric wearable, microscope and more (Fierce)
  • Medtech Needs to Get Serious About Investing in Digital Health (MDDI)
  • 11 pediatric cardiovascular devices you need to know about (MassDevice)
  • Tandem lifts full-year sales guidance (Drug Delivery)
  • Comment Period Re-opened: Coronary Drug-Eluting Stents--Nonclinical and Clinical Studies and Companion Guidance (Federal Register)
  • Premier Biotech's OralTox® Testing Device Granted the First-Ever FDA Clearance for the Detection of Oxycodone in Oral Fluid; 8 Drug Panel Now 510(k) Cleared (Press)
  • Baxter Announces U.S. FDA Clearance of ALTAPORE Bioactive Bone Graft in Posterolateral Spine Surgery (Press)
  • INSIGHTEC Receives FDA Approval for Exablate Neuro Compatibility With Siemens Healthineers MRI Scanners (Press)
  • Renovis Surgical Receives FDA Clearance for Tesera Trabecular Technology 3D-Printed Lateral Interbody Fusion System (Press)
US: Assorted & Government
  • What Is Driving Biopharma Execs Into Politics? (BioSPace)
  • Opko Faces Wave Of Suits After SEC Pump-And-Dump Claims (Law360-$)
  • Statement from FDA Commissioner Scott Gottlieb, M.D., on new FDA commitment to disclose retailer information for certain food recalls to improve consumer safety (FDA)
  • C.D. Cal. Dismisses Lexapro Suicide Case (Drug & Device Law)
Upcoming Meetings & Events Asia
  • Japanese drugmakers join forces on ophthalmic disease targets (PharmaLetter-$)
  • Valeritas kicks off device registration process in China (Drug Delivery)
  • CDSCO to come out with guidance document for effective recall of faulty medical devices (PharmaBiz)
  • Medical Devices Safety Update, Volume 6, Number 5, September 2018 (TGA)
General Health & Other Interesting Articles
  • Cases of newborns with syphilis doubles in four years – CDC (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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