Regulatory Focus™ > News Articles > 11 > Recon: Genentech to Pay Immunocore $100M to Test MAGE-A4 Drug With Tecentriq

Recon: Genentech to Pay Immunocore $100M to Test MAGE-A4 Drug With Tecentriq

Posted 19 November 2018 | By Michael Mezher 

Recon: Genentech to Pay Immunocore $100M to Test MAGE-A4 Drug With Tecentriq

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Pharma dreads Chuck Grassley as Senate Finance chair (Axios)
  • Company hiked price for opioid overdose treatment 600 percent: Senate report (The Hill) (Politico) (CBS) (Report)
  • Novartis' blood disorder drug gets FDA approval for expanded use (Reuters) (Press)
  • Gottlieb pushes for funding to speed gene therapy reviews (STAT)
  • FDA declines to approve Aquestive's Viagra rival (Reuters) (Press)
  • FDA approves new drug to treat travelers’ diarrhea (FDA)
  • Playing On Fear And Fun, Hospitals Follow Pharma In Direct-To-Consumer Advertising (KHN)
  • Peanut allergy treatment is effective but not always easy to tolerate, new review shows (STAT) (NYTimes) (Fierce)
  • Opioid Industry Fights Efforts to Make It Pay for Crisis (WSJ)
  • Cancer drug company Tesaro shares rise 39% following report that it will explore sale (CNBC) (Endpoints)
  • Protesters at Sanofi in Cambridge decry high price of insulin (Boston Globe)
  • Pfizer to raise US drug prices in January after previously backing down (Reuters) (CNBC)
  • Alphabet unit halts glucose-detecting contact lens project (Reuters) (CNBC) (Press)
  • What you're giving away with those home DNA tests (CNBC)
  • Anti-vaccination stronghold in NC hit with state’s worst chickenpox outbreak in 2 decades (Washington Post)
  • Maryland joins in $625 million settlement with company over adulterated cancer drugs (Baltimore Sun)
In Focus: International
  • WHO director-general: Violence in DRC is allowing Ebola to spread (STAT)
  • Immunocore nabs $100M cash to co-develop preclinical asset with Roche (Endpoints) (Fierce) (PMLive)
  • Pharma leaders warn Brexit deal lacks detail needed for patient safety (Financial Times)
  • Pharma ignores the squabbling and prepares for a hard Brexit (Financial Times)
  • Palantir to offer cancer analytics under JV deal with Germany's Merck (Reuters)
  • Eli Lilly Considers Sale of China Assets to Raise Cash (Bloomberg) (Fierce)
  • Novartis CEO Bets on Cutting-Edge Science to Remake Drug Giant (WSJ)
  • North Korea running low on TB meds, experts fear epidemic (Washington Post)
  • Is AstraZeneca looking for the ideal candidate to replace Pascal Soriot? (Endpoints) (The Times)
  • NHS, Pharma and Biotech industries call on Government to protect patients in future UK-EU relationship (ABPI)
  • A Chinese CAR-T company got the world’s attention with early data. At ASH, it has questions to answer (STAT)
  • Roche withdraws EU Tecentriq combo application in first-line renal cell carcinoma (Pharmafile)
  • NICE green light for Keytruda in melanoma setting (PharmaTimes)
  • Opinion: America’s opioid crisis is a warning to the NHS. Don’t let big pharma loose on policy (The Guardian)
  • The Fight Against Malaria Has Reached a Standstill (NYTimes) (Reuters)
Pharmaceuticals & Biotechnology
  • Pfizer, Merck KGaA's Bavencio flunks another trial, this time in ovarian cancer (Fierce) (Endpoints)
  • Bristol-Myers Squibb laying off 69 employees in Florida in push to 'focus resources' (Fierce)
  • Inflazome raises €40M to get NLRP3 drug into humans (Fierce) (Endpoints)
  • Genfit plans US listing as NASH drugmakers race to the finish line (Endpoints)
  • Seeking an edge in the global I/O race, Alphamab Oncology loads up $100M-plus from marquee backers (Endpoints)
  • OTC drugmakers face an uphill battle on Amazon. But they should still be there, expert says (Fierce)
  • Alnylam's Onpattro sales look 'disappointing' in early days of RNAi launch: analyst (Fierce)
  • Why Is The Opioid Epidemic Still Happening? (NPR)
  • Novartis Joins Call Asking FDA To Stop Biosimilar Trash-Talkers (BioCentury)
  • Mundipharma name GSK veteran as new Senior Vice President & CFO (Pharmafile)
  • Scientists Discover A Way To Get Drugs To The Brain Faster And More Efficiently (Forbes)
Pharmaceuticals & Biotechnology: Study Results, Filings & Designations
  • ArQule to Present Clinical Data for its BTK Inhibitor, ARQ 531, at the 2018 American Society of Hematology (ASH) Annual Meeting (Press)
  • CStone initiates a bridging Phase I clinical trial for PD-1 antibody CS1003 with first patient dosed in China (Press)
  • Tenax Therapeutics Activates First Clinical Research Site for Phase 2 Pulmonary Hypertension Clinical Trial (Press)
  • DURECT Announces Amendment to Accelerate Ongoing Phase 2a Trial of DUR-928 in Alcoholic Hepatitis (AH) by Allowing Dosing of Severe AH Patients in Parallel to Moderate AH Patients (Press)
  • Blue Earth Diagnostics Announces Results of Investigational Phase 3 Blinded Image Evaluation Study of 18F-Fluciclovine PET Imaging in Glioma (Press)
  • GlycoMimetics Enrolls First Patient in Global Phase 3 Clinical Trial of Uproleselan in Relapsed/Refractory Acute Myeloid Leukemia (Press)
Medical Devices
  • Roche Diagnostics to Replace CoaguChek® XS PT Test Strips (FDA)
  • Is Progress on MDR and IVDR Happening Fast Enough? (MDDI)
  • FDA clears Thermi in “vaginal rejuvenation” product inquiry (MassDevice)
  • Intracranial Hemorrhage Detection Software Receives FDA Clearance (MDDI)
  • Edwards' Sapien 3 Ultra Valve Wins CE Mark (MDDI)
  • Nico raises $13m Series B for neurosurgery devices (MassDevice)
US: Assorted & Government
  • Florida sues drug store chains for allegedly aiding opioid crisis (The Hill)
  • The SUPPORT for Patients and Communities Act (P.L. 115-271): Food and Drug Administration and Controlled Substance Provisions (CRS)
  • Texas Man Convicted In $36M Drug Resale Scheme (Law360-$)
  • Medtronic’s HeartWare to settle investor suit for $55m (MassDevice)
  • Sunset for Cy Pres, or Standing in Cyber-Privacy Litigation – Take Your Pick (Drug & Device Law)
Upcoming Meetings & Events Europe
  • Innovative skin cancer drug available on Cancer Drugs Fund (NICE)
  • Reclassification of therapeutic products in dispensing category C: Evaluation concluded (Swissmedic)
  • NICE publishes draft scope for new guideline on cannabis-based products for medicinal use (Pharmaceutical Journal)
Asia
  • Fuji Pharma to sell Alvotech biosimilars in Japan (PharmaLetter-$)
  • Innovent Biologics applies for adalimumab biosimilar in China (Biosimilar News)
India
  • Aurobindo Pharma to launch oncology, respiratory products in US by 2021 (Economic Times)
  • Superbugs kill more in India than globally, mortality rate is 13% (Times of India)
  • Pharma cos to make big ticket investments as Gujarat FDCA approves layout designs of 185 drug units post GST (PharmaBiz)
  • Karnataka sharply increases fees for non-statutory services for 11 certificates like GMP, CoPP & WHO-GMP (PharmaBiz)
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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