Regulatory Recon: Teva Hires Lundbeck's Schultz as CEO; Updates from ESMO (11 September 2017)

Posted 11 September 2017 By Michael Mezher

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

In Focus: US

  • Allergan pays Mohawk Tribe to protect patents from challenges (Reuters) (NYTimes) (Harvard Bill of Health) (Endpoints) (STAT)
  • ESMO: AstraZeneca wows with Imfinzi's 11-month survival edge in lung cancer (Fierce) (Press)
  • ESMO: AstraZeneca's Tagrisso bests rivals at holding off EGFR lung cancer growth (Fierce)
  • AstraZeneca rebuilds cancer drug hopes with new lung data (Reuters) (Financial Times)
  • J&J unit ends hepatitis C drug development in crowded market (Reuters) (Endpoints)
  • Bristol's drug cocktail cuts kidney cancer death risk 37 percent (Reuters) (Endpoints) (Press)
  • After melanoma surgery, Bristol's Opdivo offers new care standard (Reuters) (Washington Post) (NEJM) (Press)
  • Lilly's Cyramza posts modest survival win in hard-to-treat bladder cancer group (Fierce) (Press)
  • Lilly takes on Pfizer, Novartis with new breast cancer drug data (Reuters) (Endpoints) (Fierce)
  • Merck to co-lead Big Data alliance (PharmaTimes)
  • Ohio's Opioid Suit Should Be Thrown Out, Purdue Pharma Argues (Bloomberg)
  • Expedited Approval Pathways Associated With Increased Safety-Related Label Changes, Study Finds (Focus)
  • Galena Biopharma Settles Opioid Kickback Allegations (Focus)

In Focus: International

Pharmaceuticals & Biotechnology

  • Patent watch: The evolving intellectual property landscape for pruritus therapies (Nature)
  • This Alphabet-backed startup wants to turn injectable drugs into pills (CNBC)
  • Patient Death Won't Slow Research on "Off-the-Shelf" Immune Cells to Treat Cancer (MIT Technology Review)
  • Drug quality from a patient's perspective (BioWorld)
  • A Helpful Tool to Combat the Opioid Crisis (NYTimes)
  • Why Do People Stop Taking Their Meds? Cost Is Just One Reason (NPR)
  • Too few women with breast cancer get genetic testing (Reuters)
  • The FMD Product Code (RxTrace)
  • Blocking two proteins could improve stem cell transplants for blood cancers (Fierce)
  • AbbVie preps JAK atopic dermatitis candidate for phase 3 (Fierce)
  • Boosting a mitochondria-targeting protein could postpone aging (Fierce)
  • Oncolytics player Replimune bags $55M to hit clinical POC (Fierce)

Pharmaceuticals and Biotechnology: Study Results, Filings and Designations

  • Issuance of Priority Review Voucher – Kymriah (FDA)
  • Teva Showcases Data Demonstrating Potential of Fremanezumab to Address Significant Unmet Need in Patients with Chronic and Episodic Migraine (Press)
  • Ipsen receives validation from European Medicines Agency for the application of a new indication for Cabometyx® (cabozantinib) for first-line treatment of advanced renal cell carcinoma in adults (Press)
  • Merck's KEYTRUDA® (pembrolizumab) Plus Pemetrexed and Carboplatin (pem/carbo) Demonstrated Continued Benefit in Overall Response Rates and Progression-Free Survival Compared to Pem/Carbo Alone in Patients with First-Line Nonsquamous NSCLC (Press)
  • Seattle Genetics Highlights Promising Data with Tisotumab Vedotin in Cervical Cancer at ESMO 2017 Congress (Press)
  • Astellas Submits Supplemental New Drug Application for Approval of Additional Indication of "Linaclotide" for Patients with Chronic Constipation in Japan (Press)
  • Pfizer Presents Positive Pivotal Data for PF-05280014, an Investigational Biosimilar to Herceptin® (trastuzumab), at the European Society for Medical Oncology (ESMO) 2017 Congress (Press)
  • Celltrion Healthcare: Biosimilar Trastuzumab Candidate, CT-P6, Shown to Be Similar in Efficacy and Safety to Reference Trastuzumab in Breast Cancer Patients as Neoadjuvant and Adjuvant Treatment (Press)
  • Pfizer Presents Positive Pivotal Data for PF-05280014, an Investigational Biosimilar to Herceptin® (trastuzumab), at the European Society for Medical Oncology (ESMO) 2017 Congress (Press)
  • Progression-Free Survival Data from ECHO-202 Trial of Incyte's Epacadostat in Combination with KEYTRUDA® (pembrolizumab) Underscore Durability of Response in Patients with Advanced Melanoma (Press)
  • Merck's KEYTRUDA® (pembrolizumab) Continues to Show Overall Survival Benefit Over Chemotherapy with Nearly Two Years Follow-Up in Previously Treated Patients with Advanced Urothelial Carcinoma, Post-Platinum Failure (Press)
  • Ipsen and Exelixis Announce Results from Phase 2 CABOSUN Trial of Cabozantinib versus Sunitinib in Previously Untreated Advanced Renal Cell Carcinoma at ESMO 2017 (Press)
  • amcure Presents Phase I/Ib Study Design for Lead Compound AMC303 at ESMO 2017 Congress (Press)

Medical Devices

  • The growth imperative for medical-device companies (McKinsey)
  • DHS Warns of 8 Cybersecurity Vulnerabilities in Smiths Medical Wireless Infusion Pumps (Focus)
  • Medtronic recalls insulin infusion sets (MassDevice)

US: Assorted & Government

Upcoming Meetings & Events

Europe

  • Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 5–7 September 2017 (EMA)

India

  • CDSCO sets up team of drug control officials to conduct random inspections on drug testing labs (PharmaBiz)
  • CDSCO streamlines ICEGATE system for online tracking of drugs at ports (PharmaBiz)
  • Karnataka DC dept seizes 20 not-of-standards quality drugs during inspection drive (PharmaBiz)
  • Glenmark gets USFDA approval for Rythmol SR generic (Economic Times)

Australia

  • GMP clearance process - compliance verification (TGA)

Other International

  • Over 500 dead as Congo cholera epidemic spreads: WHO (Reuters)

General Health & Other Interesting Articles

  • A Rare Dementia Gene Runs In The Family, But He's Fine — So Far (KHN)

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? Find him on Twitter at @Michael_Mezher or send him an email at news@raps.org.

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.

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