Regulatory Recon: Highly-Valued Moderna Hits Safety Problems with Lead Drug; HHS Secretary Calls for Medicare to Negotiate Drug Prices (10 January 2017)

Posted 10 January 2017 By Michael Mezher

placeholder+image

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

In Focus: US

  • Lavishly funded Moderna hits safety problems in bold bid to revolutionize medicine (STAT) (Forbes) (EP Vantage) (Fierce)
  • Sarepta Opens Up About Duchenne Drug Launch, Allays Investors' Worst Fears (The Street)
  • HHS Secretary: Give Medicare Authority To Negotiate Drug Prices (KHN)
  • Sen. McCain Submits Bill to Allow Drug Re-Importation from Canada (Congress.gov)
  • FDA, DOJ Investigate Galena Biopharma's Former Promotions of Fentanyl (Focus)
  • Study: Drug development is no faster now than 20 years ago (STAT)
  • Johnson & Johnson to Report Average Increases in List Prices for US Drugs (WSJ)
  • Regeneron CEO says Amgen not putting patients first in patent dispute (Reuters)
  • Egalet painkiller wins FDA approval but label disappoints (Reuters) (Pharmafile) (Press)
  • Rethinking Pharma Productivity (McKinsey)
  • How to successfully launch a rare disease drug in a patient-centric world (McKinsey)
  • Illumina Promises To Sequence Human Genome For $100 -- But Not Quite Yet (Forbes) (STAT)
  • Illumina Adds IBM Watson To DNA Test For Cancer Patients (Forbes)
  • Potential Breakthrough Option For Parkinson's: LTI Partners With Allergan (LifeSciVC)
  • 'File Over Protest' At US FDA: PTC To Pursue Rarely-Used Pathway For DMD Drug (Pink Sheet-$)
  • ANDA Stress Test: End-Of-Year Submission Bolus Pressures US FDA Review System (Pink Sheet-$)
  • Supreme Court Rejects Merck Bid To Eye On-Sale Bar's Reach (Law360-$)
  • Supreme Court Won't Hear ANDA Venue Case (Law360-$) (Big Molecule Watch)
  • Takeda's Bid for Cancer Drug Maker Looks Expensive (NYTimes) (EP Vantage) (Financial Times)
  • A quiet year for mid-size medtech (EP Vantage)

In Focus: International

  • Innovative access to medicines strategies in lower income countries (PharmaLetter-$)
  • Kite Pharma partners with Japan's Daiichi for cancer therapy (Reuters) (EP Vantage)
  • Kite, Fosun Pharma form JV in China for cancer treatment (Reuters) (Press)
  • International Generic Drug Regulators Outline Plans for Collaboration Through 2020 (Focus)
  • Smoking costs $1 trillion, soon to kill 8 million a year: WHO/NCI study (Reuters)
  • Japanese Regulators to Reduce Some QMS Assessment Fees 30% in 2017 (Emergo)
  • Valeant Agrees to Sell Dendreon to Sanpower for $820 Million (WSJ) (Pharmafile) (Financial Times)
  • Abbott, Alere Offer EU Antitrust Fixes For $5.8B Deal (Law360-$)
  • Interview – German Merck unveils its secret weapon (EP Vantage)
  • EMA Releases Q&A on Exposure Limits and Hazardous Compounds (Focus)

Sponsored: Free ISO 13485:2016 Transition Aid Kit

  • Medical device providers who depend on being ISO 13485 certified to maintain regulatory compliance have only 26 months to transition to the quality management system standard's 2016 revision. BSI, the world's leading notified body, has created an ISO 13485:2016 support package which contains transition briefings, implementation guidances, guidance updates, readiness assessments and more.
  • Get the ISO 13485 transition process right the first time. Download the transition kit here.

US: Pharmaceuticals & Biotechnology

  • In Search Of A Vaccine To Vanquish The Plague (KHN)
  • Novartis' Jimenez gives biosimilar update (BioCentury)
  • FDA Offers Draft Q&A on Reporting Requirements for Wholesalers, Third-Party Logistics (Focus)
  • PCSK9 Drug Could Be in Legal Limbo into 2018 (Medpage)
  • Biden outlines steps to pursue post-Obama 'cancer moonshot' (CNBC)
  • GAO: FDA's White Oak Campus Poses Security Risk (Focus)
  • The 20-year journey yielding a new weapon against cancer (PhRMA)
  • FDA Encourages More Participation, Diversity in Clinical Trials (FDA)
  • How Google Ventures Is Thinking About Biotech (The Information)
  • Pharma Strategizes On Drug Pricing On Day One Of J.P. Morgan (SCRIP-$)
  • J.P. Morgan Notebook Day 1: PCSK9 Face-Off, Teva's Slowed Growth, Merck's Keytruda Wins, Lilly's CDK4/6 Hopes And More (SCRIP-$)
  • Vertex Pharma Will Use Deals to Diversify Beyond Cystic Fibrosis (The Street)
  • Research finds cancer cells spread even before tumour development (Pharmafile)
  • Public Variant Databases: Data Share with Care (Harvard Bill of Health)
  • Drug discovery collaboration could lead to a long-term clinical development effort (Outsourcing Pharma)
  • Cumberland and Clinigen enter Totect US commercialization pact (PharmaLetter-$)
  • Mast Therapeutics, Savara ink merger deal (Drug Delivery)
  • Can CRISPR Technology Help Us Meet the Goals of "One Health"? (BIO)
  • Targeting SAMHD1 with the Vpx protein to improve cytarabine therapy for hematological malignancies (Nature)
  • BioMarin eyeing pivotal hemophilia gene therapy trial (BioCentury)
  • Arrowhead Nets $9.6M Investment From U.K.-Based Silence Therapeutics (Xconomy)
  • FDA's Rx Promo Citations Rise Slightly In 2016; Investigational Drug Promos Scrutinized (Pink Sheet-$)
  • Easing The Process For Requesting Experimental Drugs (Law360-$)
  • Comparing Significant Risk Vs. Non-Significant Risk Studies (imarc)
  • Recommendations for Assessment of Blood Donor Eligibility, Donor Deferral and Blood Product Management in Response to Ebola Virus; Guidance for Industry; Availability (FDA)

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

  • ViraCyte Granted U.S. FDA Fast Track Designation for Viralym-C (Press)
  • NeuroGenetic Pharmaceuticals Completes Phase 1 Clinical Trials for NGP 555 to Treat and Prevent Alzheimer's Disease; Shown as Safe and Well-Tolerated in Healthy Volunteers (Press)

US: Medical Devices

  • An Interview with Biotronik's Marlou Janssen (MDDI)
  • FDA approves Roche's assay to assess ovarian reserve (EPR)
  • One In Three Women With Breast Cancer Treated Unnecessarily, Study Concludes (KHN) (NPR) (Reuters)
  • FDA Finalizes its Guidance Regarding Medical Device Accessories (FDA Law Blog)
  • Orthofix wins FDA nod, CE Mark for bone growth stimulators (MassDevice)
  • Medicrea submits 510(k) app for 3D-printed spinal interbody device (MassDevice)
  • Arterys Receives FDA Clearance For The First Zero-Footprint Medical Imaging Analytics Cloud Software With Deep Learning For Cardiac MRI (Press)

US: Assorted & Government

  • Donald Trump Pressures Republicans to Repeal, Replace Health Law at Same Time (WSJ)
  • Why key Senate Republicans want to slow down on Obamacare repeal (Politico)
  • Muted Response From Health Lobby as Affordable Care Act Faces Repeal (NYTimes)
  • Phigenix, Inc. v. ImmunoGen, Inc. (Fed. Cir. 2016) (Patent Docs)
  • "Regulatory Causation" Roundup (Drug & Device Law)
  • Specialty Pharmacies Say Benefit Managers Are Squeezing Them Out (NYTimes)
  • Meningitis Outbreak Was Murder, Feds Tell Jury (Law360-$)
  • Top 5 Drug And Device Developments Of 2016 (Law360-$)
  • $337M Has GSK Research Complex Trading Hands (Law360-$)
  • UnitedHealth's Optum to Acquire Surgical Care Affiliates for $2.3 Billion (WSJ)
  • Size matters: Study shows big difference in office visit reimbursements (Reuters)

Upcoming Meetings & Events

Europe

  • Parallel Traders Slam Czech Plan For List Of Non-Exportable Drugs (Pink Sheet-$)
  • Recycling drugs: Roivant's subsidiary model powers on (MedCityNews)
  • NeuroVive pipeline rebuild continues with Karolinska pact (Fierce)
  • OptiScan wins CE Mark for OptiScanner ICU CGM, lactate monitor (MassDevice)

Asia

  • AbbVie reports positive results from Phase III HCV drug trial in Japan (PharmaLetter-$)
  • Astellas Terminates Agreement with UMN Pharma for Cell Culture Based Influenza Vaccine Programs (Press)

India

  • Gujarat FDCA raids 50 chemist shops selling spurious antibiotics in Ahmedabad (PharmaBiz)
  • Aurobindo Takes Pole Position In Less Genericized Portuguese Market (SCRIP-$)
  • All you need to know about stent prices (Economic Times)
  • ICMR issues guidelines on diagnosis & management of celiac disease (PharmaBiz)

Australia

  • Australia approves drug that can 'melt away' cancer cells (BioSpectrum)

General Health & Other Interesting Articles

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.

Share this article:

Categories: Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence, News

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

Regulatory Exchange: Latest Updates From the Community