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Regulatory Focus™ > News Articles > 12 > Recon: FDA Approves Roche Combo for First-Line Lung Cancer Use; NICE OKs Yescarta for Adults With Ly

Recon: FDA Approves Roche Combo for First-Line Lung Cancer Use; NICE OKs Yescarta for Adults With Lymphoma

Posted 07 December 2018 | By Michael Mezher 

Recon: FDA Approves Roche Combo for First-Line Lung Cancer Use; NICE OKs Yescarta for Adults With Lymphoma

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Democrats are suddenly eyeing a valuable pharma asset: its patents (STAT-$)
  • Patent abuse is driving up drug prices. Just look at Lantus (STAT-$)
  • Special Report: After a child's dire diagnosis, hope and uncertainty at the frontiers of medicine (Reuters)
  • Special Report: Learning about targeted-therapy options (Reuters)
  • Growth of Health Care Spending Slowed Last Year (NYTimes) (Reuters)
  • Roche's lung cancer combo treatment wins FDA approval (Reuters) (Endpoints) (Press)
  • Moderna Raises $604M and Nails Down Biotech’s Biggest IPO Ever (Xconomy) (Fierce) (Endpoints)
  • With Tesaro off the block, will Clovis be the next PARP maker to get swallowed up? (Fierce)
  • Sandoz prepares early 2019 launch for EpiPen alternative Symjepi at 16% discount (Fierce) (AP)
  • Novartis, aiming to protect blockbuster sales, advances Xolair follow-up to phase 3 (Fierce)
  • Delaware justices uphold Fresenius' Akorn Merger Drop (Law360-$)
  • NIH is pressed to ensure affordable pricing before awarding a license for a CAR-T therapy (STAT)
  • J&J unit to pay $360 million to US to resolve charity kickback probe (Reuters) (NYTimes) (STAT) (Law360-$) (Endpoints) (DoJ)
In Focus: International
  • EU warns of bioterror and disease risk as vaccination rates fall (Financial Times) (EC) (Vaccines for Europe)
  • Nobel laureates: Despite progress, cancer won’t be wiped out (AP)
  • Solving China’s Drugs-Price Problem Is Hurting Drugmakers (WSJ)
  • Big Pharma’s off-patent drugs lose out in China’s new price-cutting scheme (Fierce)
  • NICE give go-ahead to Gilead's Yescarta for adults with lymphoma (Pharmafile)
  • UK’s genomics leadership attracts IQVIA investment, regardless of Brexit (PMLive)
  • AstraZeneca's Imfinzi fails to meet main goals in head and neck cancer study (Reuters) (Pharmafile) (Endpoints)
  • Novartis CEO calls for cultural shift to cater for millennial generation (Pharmafile)
  • Canada’s MDSAP Transition Deadline Fast Approaching (Emergo)
  • Update: Ebola virus disease – Democratic Republic of the Congo (WHO)
Pharmaceuticals & Biotechnology
  • The World Cup of Conferences (LifeSciVC)
  • Synthorx Gets $131M In Upsized IPO For Synthetic Biology Drugs (Xconomy)
  • A nonprofit biotech venture is betting on pig skin to help burn victims with first-ever clinical trial (STAT)
  • Targeted Drug Plus Hormone Therapy Stops Tumor Growth In Patients With Early Breast Cancer (Forbes)
  • Joining hunt for hep B cure, Brii Bio inks maiden deals featuring VBI, Vir, WuXi with a big appetite for more (Endpoints)
  • Scientists Discover A Probable Cause Of 'Chemo Brain' And It May Be Treatable (Forbes)
  • DiaMedica pulls off IPO to fund midphase stroke trial (Fierce)
  • Tris Pharma Issues Voluntary Nationwide Recall of Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, Due to Potential Higher Concentrations of Ibuprofen (FDA)
Pharmaceuticals & Biotechnology: Study Results, Filings & Designations
  • Bio-Thera Solutions Initiates Phase I Clinical Trial for BAT4306F, an ADCC-enhanced CD20 monoclonal antibody (Press)
Medical Devices
  • How Reggie Groves reinvented Medtronic’s atrial fibrillation biz (MassDevice)
  • Renal Denervation: FDA Panel, Industry Mostly on the Same Page (Medpage)
  • SpeeDx Gets CE-IVD Mark for Antibiotic-Resistant Gonorrhea MDx (GenomeWeb)
  • Corindus touts first-in-human coronary telerobotics study with CorPath system (MassDevice)
  • FDA warns Globus subsidiary HBT over ViaCell production facility issues (MassDevice)
  • FCC document suggests Apple may launch new Beddit device (mobihealthnews)
  • Olympus wins FDA nod for Spiration bronchial valve (MassDevice)
  • MiMedx to lay off 24% of workforce in restructuring effort (MassDevice)
  • Illumina Announces a New Genotyping Array and Scientific Contribution to Three Genome Centers to Support the All of Us Research Program (Press)
US: Assorted & Government
  • Why has ACA enrollment plunged? (Politico)
  • Elizabeth Warren Stands by DNA Test. But Around Her, Worries Abound. (NYTimes)
  • Spectrum Dynamics sues GE for trade theft (MassDevice)
  • Children of the nation's drug crisis face long-term health effects (CBS)
  • Fed. Circ. Asks Whether Endo's Opioid Patent Was Obvious (Law360-$)
  • Gov't Presses Judge To Force Insys Founder To Produce Docs (Law360-$)
  • 'Opioid Babies' Denied MDL Separate From Ohio Gov't Suits (Law360-$)
  • Akorn fights to salvage Fresenius deal in appeal to Delaware Supreme Court (Fierce)
  • Online Seller to Pay $60,000 Penalty for Violating the Contact Lens Rule (FTC)
  • The Other Shoe Drops on ev3 (FDALawBlog)
  • “Alter Ego” Allegations Aren’t Enough For Personal Jurisdiction (Drug & Device Law)
Upcoming Meetings & Events Europe
  • The European public-procurement opportunity: Delivering value in medtech (McKinsey)
  • French Gene & Cell Therapy Trials To Get Own Fast-Track Approval Process (Pink Sheet-$)
  • Brexit And Cooperation: Insights From Danish Medicines Agency Head Thomas Senderovitz (Scrip-$)
  • Japan R&D Industry Presents United Front On Policy Reforms (Pink Sheet-$)
  • Chinese Biopharma Stocks Plummet After Centralized Tendering Report (BioCentury)
  • Database of section 19A approvals to import and supply medicines to address medicine shortages (TGA)
General Health & Other Interesting Articles
  • Older Americans Are Flocking to Medical Marijuana (NYTimes)
  • Uterine cancer on the rise, especially for black women (NBC)
  • Scientists urge ban of insecticides tied to brain impairment in kids (Reuters)
  • 'Narrative medicine' may help stem doctor burnout (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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