Regulatory Recon: Juno Abandons Lead CAR-T Candidate After Patient Deaths; Trump to Meet With Cummings on Drug Pricing (2 March 2017)

Posted 02 March 2017 By Michael Mezher

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

In Focus: US

  • Would Trump's FDA Deregulation Create An Age Of Miracles? Don't Bet On It (Forbes)
  • Pompe drug lauded by Trump costs $300,000 a year (Reuters)
  • Aurinia's lupus drug shows no new safety concerns (Reuters)
  • Trump To Discuss Drug Prices With Cummings (BioCentury)
  • Resisting the Suppression of Science (NEJM)
  • Science could suffer if Obamacare protections are weakened (Politico)
  • Employment Effects of the Medical Device Tax (American Action Forum)
  • A Citizen's Pathway Gone Astray — Delaying Competition from Generic Drugs (NEJM)
  • Big Pharma Is Losing a Fortune Trying to Cure Alzheimer's (Bloomberg)
  • Amyloid-Busting Drugs for Alzheimer's Keep Failing, but So Does Everything Else (MIT Technology Review)
  • Juno ends development of high-profile leukemia drug after deaths (Reuters) (Endpoints) (Fierce)
  • PTC says to abandon cystic fibrosis drug after trial failure (Reuters) (Fierce)
  • Bracing for the biosimilar wave (Nature)
  • FDA's Commitment to Women's Heart Health Research (FDA Voice)
  • Making Multiple Drugs In One Factory Risks Scary Side Effect Of Shortages (KHN)
  • Patient Advocacy Groups Rake In Donations From Pharma (KHN) (Reuters) (NYTimes)
  • FDA approves Odactra for house dust mite allergies (FDA) (Medpage)
  • Drug Companies Block Shareholder Votes on Price Transparency Proposals (WSJ)
  • Trump Picks a Side: How Tax Credits Would Work in a GOP Health Plan (NYTimes)
  • Republican Unity on Health Care Is Elusive, Despite Trump's Support (NYTimes)
  • FDA Warns of Complications With Neurovascular Catheters (Focus)
  • FDA Warns China API Manufacturer for Data Integrity Violations (Focus)

In Focus: International

  • US & EU Forge Landmark Agreement to Mutually Recognize Drug Manufacturing Inspections (Focus) (FDA)
  • Roche trial finds new drug cocktail cuts breast cancer deaths (Reuters) (Bloomberg) (Xconomy) (Press)
  • South Korea fines Novartis over kickbacks, suspends sales of some drugs (Reuters) (Pharmafile) (Fierce)
  • Novo rejigs US team as passed-over CEO candidate heads for the door (Fierce)
  • Pharma Firms In Russia Must Adhere To New Good Distribution Practices (Pink Sheet-$)
  • International Generic Drug Regulators Unveil New Biowaiver Assessment Template (Focus)
  • MDSAP Update: Lukewarm Interest among Australian Medical Device Companies (Emergo)
  • First Approvals Under EMA's Adaptive Pathways May Be Just A Few Years Away (Pink Sheet-$)
  • NICE approves first biliary cholangitis drug in 20 years (Pharmafile)
  • EMA adds Alnylam RNAi drug to PRIME fast-track scheme (Fierce) (Press)
  • Jazz: 24/7 production shifts could help stem Erwinaze shortage (BioPharmaReporter)
  • Are we prepared for the 'real world'? (Pharmafile)
  • Asian clinical trial boom attributed to low costs, concentrated patient pools and infrastructure (PharmaLetter-$)

US: Pharmaceuticals & Biotechnology

  • Osteoporosis drugs potentially causing long-term bone weakness (Pharmafile)
  • Sanofi R&D Chief Zerhouni: How I'm Doing More With Less (Scrip-$)
  • New COO for Celgene (Pharmafile)
  • Who Needs Another Cancer? (NYTimes)
  • The Changing Face Of Informed Consent (NEJM)
  • US Patient Medical Information Rule: Will It Be Delayed Again? (Pink Sheet-$)
  • Maryland governor declares state of emergency for opioid crisis (Washington Post)
  • Lilly Announces Changes in Senior Management (Press)
  • Rational Vaccines: A case study in pharma deregulation (MedCityNews)
  • A pharmacological approach in newly established retinal vein occlusion model (Nature)
  • Mylan Plans Summer Launch For Advair Generic, Now Called Wixala Inhub (Scrip-$)
  • Mylan posts Street-beating Q4 earnings (Drug Delivery)
  • Protocol Posted for Public Comment through March 15, 2017: Implementation of a Randomized Controlled Trial to Improve Treatment with Oral Anticoagulants in Patients with Atrial Fibrillation (IMPACT-AFib) Protocol (Sentinel)

US: Pharmaceuticals and Biotechnology: Clinical Study Results, Filings & Designations

  • Aerie resubmits NDA for Rhopressa eye drops (Drug Delivery)
  • Blinatumomab versus Chemotherapy for Advanced Acute Lymphoblastic Leukemia (NEJM)
  • Anti–Interleukin-31 Receptor A Antibody for Atopic Dermatitis (NEJM)
  • EnGeneIC Receives FDA Orphan Drug Designation for Targeted EDV™ Nanocells to Treat Glioblastoma Multiforme (Press)
  • 22nd Century Granted FDA Guidance Meeting for X-22 Smoking Cessation Aid (Press)
  • Chugai's Anti-IL-31 Receptor A Humanized Monoclonal Antibody "nemolizumab (CIM331)" Global Phase II Study Data Published in The New England Journal of Medicine Online (Press)

US: Medical Devices

  • FDA Oversight Of Lab-Developed Tests Is Likely To Lessen (Law360-$)
  • FDA releases January 2017 510(k) clearances (MassDevice)
  • The War over Government Affairs Life Sciences Talent (MDDI)
  • Abbott wins FDA nod for FlexAbility sensor-enabled ablation cath (MassDevice)
  • Penumbra shares rise on whopping Q4, FY2016 earnings beat (MassDevice)
  • Neocis Inc. Announces FDA Clearance for First Robotic System for Dental Implant Procedures (Press)
  • What The Intuitive Ruling Means For Medical Device Makers (Law360-$)

US: Assorted & Government

  • Biosimilar Talks Needed To Trigger Litigation Clock: Judge (Law360-$)
  • Theranos Says Investors Can't Sue Over Blood Tests (Law360-$)
  • Bloomberg and AIPLA Conduct Survey on Attitudes about PTAB (Patent Docs)
  • Regulate cannabis potency to reduce psychosis risk, experts say (Reuters)
  • Maybe It Was Worth a Try . . . . Kentucky Defendant, Charged with Illegally Selling "Herbal Supplements," Loses Motion to Dismiss (FDA Law Blog)
  • Southern District of Indiana Excludes Plaintiffs' Experts in Hernia Mesh Case (Drug & Device Law)

Upcoming Meetings & Events

Europe

  • LivaNova slips despite Q4, 2016 earnings beats (MassDevice)
  • EMA website briefly unavailable on 3 March (EMA)
  • Traditional herbal medicinal products and simplified registrations for homeopathic medicinal products: pharmacovigilance requirements and EudraVigilance access (EMA)
  • Sobi Receives Approval From the European Medicines Agency for Higher capacity Drug Substance Manufacturing for Elocta (Press)

India

  • Spooked by Donald Trump, Indian pharma cos seeks government help to woo Capitol Hill (Economic Times)
  • Lupin launches generic drug to treat depression in US (Economic Times)

Australia

  • TGA presentation: ARCS webinar, 17 February 2017 (TGA)

General Health & Other Interesting Articles

  • Informed Patient? Don't Bet On It (NYTimes)
  • US scientists find way to safely thaw cryopreserved tissues (Reuters)
  • Cool Videos: Flashes of Neuronal Brilliance (NIH)
  • Obesity strongly linked to 11 types of cancer (Reuters)
  • No benefit in treating mildly low thyroid function in pregnancy, NIH network study finds (NIH)

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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