Recon: Alexion to Buy Biotech Syntimmune for $1.2B

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• FDA Advisory Committee Calendar

• 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)

• Cases of newborns with syphilis doubles in four years – CDC (Reuters)