Regulatory Focus™ > News Articles > 5 > Recon: Celsius Snags $65M for Precision Medicines, Gilead to Build EU CART-T Facility

Recon: Celsius Snags $65M for Precision Medicines, Gilead to Build EU CART-T Facility

Posted 15 May 2018 | By Ana Mulero 

Recon: Celsius Snags $65M for Precision Medicines, Gilead to Build EU CART-T Facility

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In Focus: US [Paid Advertisement]
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In Focus: International
  • Gilead finds new home in Europe for CAR-T manufacturing (BioPharma Dive) (Fierce) (The Pharma Letter) (Endpoints)
  • Novartis CEO scrambles 5,000 managers for damage control as Swiss prosecutors and U.S. lawmakers circle (Fierce) (Bloomberg)
  • Cambridge spinout CellCentric gets $26M for single-asset epigenetics approach to prostate cancer (Endpoints) (Business Weekly) (Scrip-$)
  • Daiichi Sankyo Triples Down on Immuno-Oncology Collaboration with Zymeworks (GEN) (Fierce)
  • Federal, provincial governments pen agreement to up Sask. health care money by $158M over 5 years (CBC News) (National Post)
  • BioArctic, Uppsala University extend research collaboration on new antibody technology (Pharmabiz) (The Pharma Letter)
  • Elsevier/Bayer study findings could cut animal testing (PharmaTimes) (pharmaphorum)
  • FDA Commissioner Gottlieb: US could see lower drug prices if Europe pays more of its fair share (CNBC)
  • As Ebola flares once again, a rapid global response invites cautious hope (STAT)
  • AAM expresses concerns on USTR’s proposed China tariffs (The Pharma Letter)
  • US medtech companies lobby against proposed Chinese tariffs (MassDevice)
Pharmaceuticals & Biotechnology
  • In the ‘diabetes belt,’ a small town grapples with growth of the world’s largest insulin maker (STAT)
  • AbbVie and J&J reverse course on a price hike in face of criticism (STAT-$)
  • Defending the ‘middlemen’ in the battle on drug prices (The Hill)
  • Leading biotech investor Dr. Beth Seidenberg will step down from her role at Kleiner Perkins (Recode)
  • The top 15 pharma companies by 2017 revenue (Fierce)
  • Pfizer vet Travis Wager takes R&D reins at Aquinnah (Fierce) (Press)
  • Azar threatens drugmakers with Trump's temper if they hike prices for no reason (Fierce)
  • Novartis completes tender offer for all outstanding shares of AveXis (Pharmabiz) (Press)
  • Trump's pharma plan highlights drug coupons (Axios)
  • McKesson High Volume Solutions and Discount Drug Mart Partner to Build a Central Fill Pharmacy (Press)
Pharmaceutical and Biotechnology: Study Results, Filings and Designations
  • Azithromycin: A Generic Antibiotic That Continues To Provide Surprising Life-Saving Benefits (Forbes)
  • Medicxi, RA Capital join $30M round for Dutch biotech’s late-stage transplantation med (Endpoints)
  • Polyphor parlays a pathogen-specific antibiotic and I/O work into a $165M IPO for its PhIII program (Endpoints)
  • Memory transferred between snails, challenging standard theory of how the brain remembers (STAT)
  • Merck cements its novel drug approval dominance (EP Vantage)
  • FDA Approves Subcutaneous Formulation Of Actemra (Genentech)
  • Precise Control of Bulk, Multi-Component Nanostructures (Newswise)
  • NIH funds three national cryo-EM service centers and training for new microscopists (NIH)
  • Novartis ARROW trial to assess mechanistic superiority of direct IL-17A inhibition (Cosentyx) over IL-23 inhibition (Tremfya) (Press)
  • Saama Technologies and ICON Commercialization and Outcomes Partner to Unlock the Value of Real World Evidence (RWE) (Press)
  • Illumina Acquires Edico Genome to Accelerate Genomic Data Analysis (Press)
Medical Devices
  • The worries of medical equipment suppliers (Axios)
  • PolarityTE aims to ‘wage war on skin grafts’ with regenerative tech (Drug Delivery Business News)
  • Recreational ancestry DNA testing may reveal more than consumers bargained for (The Conversation)
  • DHS warns of security flaws in GE, Philips, Silex medical devices (Healthcare IT News)
  • St. Louis biotech firm receives FDA clearance for UTI detection device (St. Louis Business Journal-$) (Press)
  • Caliber Imaging & Diagnostics, Inc. Announces FDA 510(k) Clearance for its VIVASCOPE System (Press)
  • New Analysis Shows Medtronic Cardiac Resynchronization Therapy Feature Associated with Improved Patient Survival (Press)
US: Assorted & Government
  • Amid Opioid Crisis, Chicago Drug Sales Rep License Gains National Momentum (Forbes)
  • Democrats run on GOP health care 'sabotage' (Politico)
  • As Trump railed against the ‘drug lobby,’ lawmakers funded by pharma watched from Rose Garden (STAT)
  • Groups sue to stop Iowa's 'fetal heartbeat' abortion ban (Reuters)
  • DoD responds to report calling Cerner EHR 'not operationally suitable' (Healthcare IT News)
  • Apple Health Records: Where early adopters see the biggest impact so far (MobiHealthNews)
  • Tom Price: Everyone should have health care coverage (CNN)
  • Brand-Name Drug Cos. Not Liable For Generics' Tags In W.Va. (Law360-$)
  • Trump Admin Poised To Give Rural Whites A Carve-Out On Medicaid Work Rules (TPM)
  • 8,000 Volunteers in Week One of NIH Precision Medicine Study (Bloomberg-$)
  • CMS renews Maryland's all-payer system (Modern Healthcare)
  • Special Report: Philip Morris device knows a lot about your smoking habit (Reuters)
  • Drug Discount Program: Status of Agency Efforts to Improve 340B Program Oversight (GAO)
Upcoming Meetings & Events Europe
  • New mental health approach cuts hospital admissions 75 percent (PharmaTimes)
  • Groups hails potential of organ on a chip tech for UK (PharmaTimes)
  • NHS Confederation launches petition on NHS funding plan (PharmaTimes)
Asia
  • Two surgeons in China developing a method to transplant a human head (CNBC)
  • Kitov Pharma inks deal with China's Changshan Pharma (BioSpectrum)
  • S. Windsor manufacturer announces Asia expansion (Hartford Business)
  • Pharmacopoeial Discussion Group holds first videoconference meeting (PMDA)
  • Promethera Biosciences Establishes Branch Office in Tokyo (Press)
India
  • For Indian pharma, US FDA's CI checks account for 50% of regulatory audit (Pharmabiz)
  • Discrimination kills 230,000 girls under five in India each year, study shows (The Guardian)
  • Why IT and pharma mutual funds may be a good bet now (Economic Times)
Australia
  • Apotex and Strides to merge their Australia businesses to become the country's largest generics player (Fierce)
  • CStone Pharma begins phase I trial in Australia for anti-PD-1 antibody CS1003 to treat advanced solid tumors (Pharmabiz)
  • Australia releases framework for My Health Record to deliver better outcomes for patients (OpenGov)
  • All cancer patients should be prescribed exercise, Australian guidelines say (CBC News)
  • Medicine labels: Guidance on TGO 91 and TGO 92 (TGA)
  • Claims about hemp and CBD oils misleading consumers (TGA)
Canada
  • How to solve Canada’s wait time problem (The Conversation)
  • Cipher Pharmaceuticals Completes Acquisition of Canadian Business Portfolio of Cardiome Pharma (Press)
  • Correvio Pharma Corp Completes Strategic Transaction with Cipher Pharmaceuticals (Press)
Brazil
  • Open CP on prescription-only medicines (ANVISA)
  • Certificates will be sent electronically (ANVISA)
General Health & Other Interesting Articles
  • Which Poor People Shouldn’t Have to Work for Aid? (NYT)
  • In the midst of a massive opioid crisis, hospitals are experiencing an opioid shortage (Marketplace)
  • More female leaders will help drive innovation in the medtech and biotech industries (STAT)
  • Americans are paying more but getting less from health care (Axios)
  • The Doctors Who Hate Insurance So Much They Go Without It (Bloomberg)
  • Report finds cases of STDs reach all-time high in California (AP News)
  • How to improve patient outcomes with digital health (pharmaphorum)
Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top 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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