Regulatory Focus™ > News Articles > 7 > Recon: Sangamo Buys TxCell for $84M; China Probes Vaccine Manufacturer

Recon: Sangamo Buys TxCell for $84M; China Probes Vaccine Manufacturer

Posted 23 July 2018 | By Ana Mulero 

Recon: Sangamo Buys TxCell for $84M; China Probes Vaccine Manufacturer

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

In Focus: US
  • FDA staff raises efficacy doubts on GSK's lung disease treatment (Reuters) (Endpoints)
  • Sanofi Ventures leads $17m round for Click Therapeutics (DDBN) (Fierce)
  • Court Says Allergan Can't Shield Restasis Patents With Tribe (Bloomberg) (STAT-$) (Reuters)
  • Theranos Settles Investor Suit as Funds Run Low (WSJ)
  • Million-person genetic study finds gene patterns linked to how long people stay in school (MIT Tech Review)
  • Analysts Expect Drug Supplier Whiplash To Endure on Rebate Changes (Bloomberg)
  • In lawsuit, Human Longevity alleges that Craig Venter stole trade secrets (STAT)
In Focus: International
  • Sangamo Bags TxCell, and a Next-Gen Cell Therapy Tech, for $84M (Xconomy) (Fierce) (GEN)
  • Chinese authorities to carry out surprise checks on vaccine makers, as Premier Li Keqiang calls for severe punishment (The Straits Times) (Reuters) (The Guardian)
  • China’s pharma scandals sully healthcare cleanup (Reuters)
  • Vaccine Scandal Brings China’s Drugs Stocks Back Down to Earth (Bloomberg-$)
  • Philips says sales growth to improve after China causes Q2 miss (Reuters) (Bloomberg)
  • Commission Staff Working Document on Combatting HIV/AIDS, viral hepatitis and tuberculosis: sustained effort needed to meet 2030 goals (EC)
Pharmaceuticals & Biotechnology
  • Trump battle over drug prices heats up (The Hill) (Politico)
  • Pharmaceutical Companies Seek Stability in Trump Drug Cost Fight (Bloomberg)
  • Health, Drug Lobbying Slows After Big-Spending Start to Year (Bloomberg BNA)
  • Who's Promised What: A Guide To Pharma Drug Pricing Pledges (Scrip-$)
  • Is It Checkmate For Pharma's Epic Gaming Of Patents? (ACSH)
  • Unpacking the bold — and the bluster — in Trump’s plan to bring down drug prices (STAT)
  • FDA’s new ruling on biosimilars could spur Triangle manufacturing (Triangle Business Journal-$)
  • Cambrex to Acquire Halo Pharma, Adding Drug Development and Finished Dosage Capabilities to Global API Manufacturing Network (Press)
  • Bristol-Myers Squibb Announces Departure of Chief Commercial Officer (Press)
  • Isogenica Licenses CIS Display Technology to Aro Biotherapeutics for Centyrin-based Biopharmaceutical Development (Press)
Pharmaceutical and Biotechnology: Study Results, Filings and Designations
  • Top Alzheimer’s researchers hope that near-100 dementia drugs in trials are moving closer to a breakthrough (CNBC)
  • Amneal Announces FDA Approval and Launch of Generic Potassium Chloride Oral Solution (Press)
  • Aerie Pharmaceuticals Announces Early Notification of FDA Acceptance of NDA Submission for Roclatan (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005% with PDUFA Date Set for March 14, 2019 (Press)
  • Acceleron Announces Preliminary Results from Part 1 of the ACE-083 Phase 2 Trial in Patients with Charcot-Marie-Tooth Disease at the 2018 Annual Meeting of the Peripheral Nerve Society (Press)
  • Alnylam Presents New Analyses of Clinical Results from APOLLO Phase 3 Study of Patisiran at 2018 Peripheral Nerve Society Annual Meeting (Press)
  • Aura Biosciences Presents Interim Phase 1b/2 Data at the American Society of Retina Specialists (ASRS) Annual Meeting (Press)
  • Alzheon Presents New Findings in APOE4/4 Homozygous Patients with Mild Alzheimer’s Disease, Further Supporting Precision Medicine Approach and Planned Confirmatory Clinical Trial with ALZ-801 (Press)
Medical Devices
  • House panel to vote today on medical device tax repeal (MassDevice)
  • Repeal of medical device tax would support medical technology innovation (The Hill)
  • A tax on medical devices makes no sense. It’s time to eliminate it for good (STAT)
  • MITA urges Congress to permanently repeal the medical device tax (MITA)
  • MIT, Harvard Face New Challenge to Gene-Editing Patent (Bloomberg-$)
  • Medical Devices Are Going Mobile, but Makers Face Barriers (Bloomberg-$)
  • NIH Clinical Center releases dataset of 32,000 CT images (NIH)
  • Statement from FDA Commissioner Scott Gottlieb, M.D., on manufacturer announcement to halt Essure sales in the U.S.; agency’s continued commitment to postmarket review of Essure and keeping women informed (FDA)
  • MEDICALgorithmics, Medi-Lynx Receive FDA 510(K) Clearance for PocketECG CRS Mobile Cardiac Rehabilitation System (Press)
US: Assorted & Government
  • A move to undermine women’s reproductive health (The Hill)
  • Senate set to confirm Wilkie for Veterans Affairs secretary (AP News)
  • Sniffles? Cancer? Under Medicare Plan, Payments for Office Visits Would Be Same for Both (NYT)
  • 70 Democrats Sign On to New ‘Medicare for All’ House Caucus (The Daily Beast)
  • FDA’s Product Jurisdiction Proposal: More Changes are Needed (FDA Law Blog)
  • Pharmacy Compounding Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments (FDA)
  • Regulatory Perspectives on Otic and Vestibular Toxicity: Challenges in Translating Animal Studies to Human Risk Assessment; Public Workshop (FDA)
Upcoming Meetings & Events Europe
  • Abbott to add 500 new jobs at Donegal healthcare plant (The Irish Times)
  • Roche wins CE Mark for Accu-Chek Solo insulin micropump (DDBN)
  • First generation JOURNEY BCS Knee System– Higher than expected risk of revision (MDA/2018/026) (MHRA)
  • Updated: Suspended and revoked licences and registrations for manufacturers and wholesalers of medicines and ingredients (MHRA)
  • Updated: Field safety notices - 16 to 20 July 2018 (MHRA)
  • Out-of-stock - Tepadina, powder for solution for infusion (swissmedic)
  • Committee for medicinal products for human use (CHMP): Draft agenda for the meeting on 23-26 July 2018 (EMA)
  • Accounting Officer’s certificate on the annual accounts for the financial year 2017 (EMA)
  • Omeros Corporation Initiates Sales of OMIDRIA in Europe (Press)
  • Owen Mumford Launches New HIV Rapid Testing to European Markets (Press)
Asia
  • Singapore Hack Is a Speed Bump for $9 Trillion Industry (Bloomberg)
  • 3D Printer of PEKK Implants Expanding in Asia (MD+DI)
  • Expert forum: Revising the law for the system of medical device listing permit holder (China Association for Medical Devices Industry)
  • SanBio: Joint Research Agreement for SB623 Targeting Dementia (Press)
India
  • CDSCO concludes 15 inspections in Maharashtra, MP, Chattisgarh, Gujarat and Goa towards implementing new MD Rules (Pharmabiz)
Australia
  • Johnson & Johnson’s DePuy to incorporate wearable tech into total knee replacements in Australia and New Zealand (Fierce)
Canada
  • Eye on Drug Charities • Clinical Trials in Canada (Bloomberg-$)
Brazil
  • Regulation: Portal allows monitoring issues for 2018 (Anvisa)
  • Burden of disease in Brazil, 1990–2016: a systematic subnational analysis for the Global Burden of Disease Study 2016 (The Lancet)
  • Zika epidemic sheds light on Brazil's 'invisible children' (The Guardian)
General Health & Other Interesting Articles
  • A big overlooked flaw with health tech: Patients hate going to the doctor (CNBC)
  • LifePoint Health Agrees to Apollo Buyout (WSJ)
  • Anthem In Telehealth Deal With Samsung And American Well (Forbes)
  • One Man’s $50 Billion Vendetta Against Opioids (Bloomberg)
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.
Need to contact the editor of Regulatory Reconnaissance? Email us at news@raps.org.
A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.
 

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