Regulatory Recon: FDA Approves New Lung Cancer Drug, Companion Diagnostic (13 November 2015)

Posted 13 November 2015 By Zachary Brennan

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Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher , @Zachary Brennan and @RAPSorg on Twitter.

In Focus: US

  • FDA approves AstraZeneca pill to treat certain patients with non-small cell lung cancer (FDA) (FierceBiotech) (Reuters)
  • The Case for Quality: Working with Stakeholders to Improve the Safety of Medical Devices for Patients (FDA Voice)
  • FDA to Examine Maternal Vaccines to Protect Infants (MedPage Today)
  • U.S. FDA approves Gilead's hepatitis C drug for expanded use (Reuters)
  • After Merger, Two Competing Drugs and Billion-Dollar Questions (New York Times)
  • U.S. Public Health Preparedness for Seasonal Influenza: Has the Response Improved? (House Energy & Commerce Committee)
  • Firewalls and medical devices are extremely vulnerable to hacking (Bloomberg)

In Focus: International

  • EMA Prepares To Pronounce On Rasi Re-Appointment (SCRIP-$)
  • Russia plans to continue imports of high-priced Western drugs after 2020 (Pharma Letter-$)
  • China's new pharma crackdown may help top companies (FierceBiotech)

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US: Pharmaceuticals and Biotechnology

  • Mylan’s Hostile Bid for Perrigo Fails (Bloomberg) (FirstWord Pharma)
  • Can CRISPR avoid the Monsanto problem? (New Yorker)
  • CRISPR: A path through the thicket (Nature)
  • Merck defeated in antibiotic patent case in US (PMLive)(Law360-$)
  • Greater education efforts needed to aid biosimilars in US, say developers (BioPharma-Reporter)
  • Obviously, FDA Loves Opdivo: Another Quick Nod (SCRIP-$)
  • Roche exits four manufacturing sites with loss of 1,200 jobs (PMLive) (GEN) (Pharmafile)
  • Genetically engineering algae to kill cancer cells (Manufacturing Chemist)
  • Biologicals patent expiries (GaBI)
  • U.S. heart groups to weigh new data for hypertension treatment guidelines (Reuters)
  • Rite Aid offers genetic testing of Rx efficacy (Drug Store News)
  • Biotech Stock Mailbag (TheStreet)

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

  • Panel recommends Merck & Co continue cholesterol drug study (Reuters) (CardioBrief)
  • Bone Therapeutics granted orphan drug designation by FDA and EMA for Allob in brittle bones (Pharma Letter-$)
  • Pfizer, Endo Unit Duck MDL Claims Over Testosterone Drugs (Law360-$)
  • 3rd Circ. Asked To Revive Effexor Pay-For-Delay Claims (Law360-$)
  • Engineered bat virus stirs debate over risky research (Nature News)
  • New Analyses Further Add to the Efficacy and Safety Profile of OFEV® (nintedanib) in Idiopathic Pulmonary Fibrosis (IPF) (Press)
  • Off-label prescribing linked with higher rates of adverse drug events (Pharmaceutical Journal)
  • Quintiles: Innovation and integration drives Apple ResearchKit input (Outsourcing-Pharma)

US: Medical Devices

  • APPROVALS ANALYSIS: Diagnostics, Cardiovascular Devices Lead Big Month (Clinica-$)
  • Patient, Health Care Groups Urge Congress To Ensure FDA Oversight Of LDTs (Inside Health Policy-$)
  • NEMA PUBLISHES NEMA/MITA CSP 1-2015 CYBERSECURITY FOR MEDICAL IMAGING (MITA)
  • J&J Can't Move Pelvic Mesh Cases Out Of Philly (Law360-$)
  • J&J Unit Settles Proposed Bellwether In Vaginal Mesh MDL (Law360-$)

US: Assorted and Government

  • Why the FBI and Pentagon are afraid of this new genetic technology (Stat)
  • FDA Releases Groundbreaking Rules on Produce and Imported Foods to Modernize and Strengthen Food Safety System (FDA)
  • FDA evaluation of residual solvents in generics (GaBI)
  • FDA Fortification Policy – “Now With More Guidance!” (National Law Review)
  • Home-Health Agency Owners and Director of Nursing Indicted in $13 Million Medicare Fraud Conspiracy (Dept of Justice)
  • What is the FDA Form 3674? (IMARC)

Upcoming Meetings and Events

India

  • India’s MHFW will launch the electronic portal of CDSCO on 14.11.2015 at 1030 Hrs (CDSCO)
  • Government caps price of 6 formulations packs (Economic Times)

China

  • China FDA Cracks Down on Quality Issues with Drug Rejections (Pharmaceutical Manufacturing)
  • CFDA Minister Bi Jingquan meets the delegation from Ministry for Environment and Food of the Kingdom of Denmark (CFDA)

General Health and Other Interesting Articles

  • How Do You Measure The Health Of Health Care Markets? (Health Affairs)
  • Uterus Transplants May Soon Help Some Infertile Women in the U.S. Become Pregnant (New York Times)
  • U.S. sees alarming jump in rate of newborns with syphilis (Washington Post)

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? 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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