Regulatory Recon: OncoMed Lung Cancer Drug Fails in Phase II Study Hanmi Charged for Late Reporting of Fatal Side Effect (17 April 2017)

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

In Focus: US

• New Active Substance Launches Declined Again In 2016 (SCRIP-$)
• Defiant, Generic Drug Maker Continues to Raise Prices (NYTimes)
• Senate, House Draft Reauthorization Bill to Increase Drug, Medical Device User Fees (Focus)
• Congress Doesn't "Dispose" in a Vacuum (Alliance for a Stronger FDA)
• OncoMed's lung cancer drug fails mid-stage study, shares tumble (Reuters) (Endpoints)
• Drug Pricing Pundit Gottlieb Likely To Stay In His Lane At FDA (Pink Sheet-$)
• The Cost of Not Taking Your Medicine (NYTimes)
• America's Got Talent – Regulatory Science Style (FDA Voice)
• Roche's emicizumab hemophilia drug shows positive results with children (Reuters) (Endpoints) (Fierce) (Press)
• Juno recruits Sunil Agarwal as R&D chief, opening a Bay Area facility in research revamp (Endpoints)
• Paul Ryan Could Lose Another Trumpcare Vote Tuesday In Georgia (Forbes)
• Overcoming Opioids: The quest for less addictive drugs (ABC)
• Apple And Google, The Next Big Pharma (Forbes)
• Obamacare lessons from town halls (Politico)
• Obamacare payments could prompt government shutdown fight (Politico)
• Maps Show A Dramatic Rise In Health Insurance Coverage Under ACA (NPR)
• Is Drug Pricing at an Inflection Point? (Real Clear Health)
• Balancing The Use Of Cost-Effectiveness Analysis Across All Types Of Health Care Innovations (Health Affairs Blog)
• How A Budget Squeeze Can Lead To Sloppy Science And Even Cheating (NPR)
• Edible CRISPR Could Replace Antibiotics (MIT Technology Review)
• Zika Found in Common Backyard Asian Tiger Mosquito (NBC)
• How Do You Explain the Large Surge in ANDAs in March? (Lachman Consultants)

In Focus: International

• Hanmi charged with belated reporting of new lung cancer drug's side effect (Korea Herald) (Fierce)
• EMA Addresses Industry's Problems With Periodic Safety Update Reports (Pink Sheet-$)
• EMA Updates Guidance on Clinical Data Publication Policy (Focus)
• Australia demonstrates government, industry can agree on price cuts (BioWorld)
• Drug giant's secret plan to destroy cancer medicine (The Times) (Independent) (Medscape)
• Medtronic's Ishrak sees Chinese health reform as boon to med device business (MassDevice)
• Basaglar challenges Sanofi's insulin drug Lantus (Korea Herald)
• ICH M10 – Bioanalytical Method Validation – Is Harmony Coming to a Lab Near You Soon? (Lachman Consultants)
• With Clinical Research Law Enacted, MHLW Eyes New Panel to Discuss Requirements for "Specified Clinical Research": R&D Division Head (PharmaJapan)

US: Pharmaceuticals & Biotechnology

• The future of biologics (PharmaLetter-$)
• Some vitamins and minerals may carry more risks than benefits (Washington Post)
• Benlysta maker GSK drafts soccer star Boxx to get lupus patients talking (Fierce)
• Payer snubs PTC's Emflaza, signaling pricing trouble ahead of launch (Fierce)
• New Endpoints in NASH (BioCentury)
• Bristol-Myers Squibb and Nordic Bioscience Announce Collaboration for Fibrosis Biomarker Technology (Press)
• All About Dabigatran Reversal in the ED (Medpage)
• Dr. Mark Wainberg, Who Identified a Key AIDS Drug, Dies at 71 (NYTimes)
• Sanofi promotes Sibold to exec VP of Sanofi Genzyme | Personnel Moves – April 13, 2017 (MassDevcie)
• PhRMA Uses Allergan Stage In Campaign To Keep Focus On Industry's Reputation For Innovation (SCRIP-$)
• Puma Biotechnology Announces FDA Advisory Committee to Review Neratinib for the Extended Adjuvant Treatment of HER2-Positive Early Stage Breast Cancer (Press)
• InBrief: Why The DSCSA Will Be Enforced Even Without FDA Guidance (RxTrace)

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

• AmpliPhi Biosciences Announces Positive Feedback from FDA on Phase 2 Development Proposal (Press)

US: Medical Devices

• 510(k) Exemption – What's Actually Exempt? (FDA Law Blog)
• What the new, FDA-approved 23andMe genetic health risk reports can, and can't, tell you (LA Times)
• Cardinal Health wins $47m DoD contract (MassDevice)
• Verily unveils 'Study Watch' for clinical research (Outsourcing-Pharma)

US: Assorted & Government

• Grasping For The Middle Ground On Obamacare (KHN)
• Newly Full SCOTUS Will Have Its Say in Healthcare (Medpage)
• G.O.P. Bill Would Make Medical Malpractice Suits Harder to Win (NYTimes)
• Telehealth and Remote Patient Monitoring Use in Medicare and Selected Federal Programs (GAO)
• PTAB Finds Favor In Court; Novartis Is Latest To Strike Out In Challenge (Pink Sheet-$)
• Vast – Or at Least Half-Vast – Conspiracy Claim Dismissed (Drug & Device Law)
• Baxter Hit With DOJ Subpoena Over Saline Shortages (Law360-$) (Fierce)

Upcoming Meetings & Events

• FDA Advisory Committee Calendar
• Medical Imaging Drugs Advisory Committee; Notice of Meeting – 10 May 2017
• Oncologic Drugs Advisory Committee; Notice of Meeting – 24 May 2017, 25 May 2017

India

• Govt seeks complaints on 'dissolving stents', but has no system to act on it (Economic Times)
• Only a ministry for pharma can save SMEs in this sector: President IDMA (PharmaBiz)
• CDSCO, PvPI to soon come out with guidelines on good pharmacovigilance practices for Indian cos (PharmaBiz)
• Unichem Labs gets USFDA nod for arthritis drug (Economic Times)
• Gujarat FDCA recovers Rs.52 lakh from 20 hospitals for violating NPPA's ceiling price norms on cardiac stents (PharmaBiz)
• Clinical trials are a crucial part of medical treatment for cancer: Dr Vikram Kekatpure (PharmaBiz)
• Govt to roll out PvPI at district level hospitals to get pan India adverse drugs reaction information (PharmaBiz)
• Singh Bros Agree Religare Sale As Daiichi Settlement Case Roils (SCRIP-$)

General Health & Other Interesting Articles

• Unexplained chest pain may signal higher heart risk (Reuters)
• Pedometers tied to less fatigue for rheumatoid arthritis patients (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.

Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @Michael_Mezher or send him an email at [email protected].

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