Regulatory Focus™ > News Articles > Regulatory Recon: FDA on Pace to Match Drug Approval Records (24 March 2015)

Regulatory Recon: FDA on Pace to Match Drug Approval Records (24 March 2015)

Posted 24 March 2015 | By Alexander Gaffney, RAC

Regulatory Recon: FDA on Pace to Match Drug Approval Records (24 March 2015)

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

In Focus: US

  • FDA 'In a Boom Period,' on Pace to Match Approval Records (Bloomberg)
  • Woodcock: FDA Making Strides on Adopting Personalized Medicine (FDA)
  • FDA recommends no changes to Lilly's schizophrenia injection use (Reuters) (FDA) (FamilyPracticeNews)
  • Zogenix’s Battle with the Commonwealth of Massachusetts Continues (Drug and Device Law)
  • A Review of 2014 Cancer Drug Approvals, With a Look at 2015 and Beyond (P&T-PDF)
  • Drug Safety Advocates Want Bioequivalence Data To Be Made Public (IHP-$)
  • FDA approves Abiomed's blood pump device (Reuters) (FDA) (Forbes)
  • AdvaMed Rearranges FDA’s Priority List (MDDI) (Gray Sheet-$)

In Focus: International

  • What the UK's pharmaceutical industry wants from the next government (Guardian)
  • EMA elects new vice-chair (Pharmafile)
  • IQWiG amends findings on Provenge in Dendreon's favor (SCRIP-$) (PMLive)
  • CDSCO, US FDA to work closely as FDA plans to expand its presence in India (PharmaBiz)
  • WHO calls for proactive strategies to combat falsified, substandard medicines (In-Pharma)

Learn About--and Help Shape--FDA's Draft Combo Products GMP Guidance

  • When it comes to combination products, more regulations can mean more difficulties for regulatory professionals. That's why we've teamed up with the Combination Products Coalition (CPC) to offer a full day interactive program focused on FDA's newest draft guidance on Good Manufacturing Practices (GMPs) for combination products. Learn from FDA experts and industry veterans in this unique experience that will help agency regulators to shape and clarify the final guidance document. Register for the 1 April 2015 program here.

US: Pharmaceuticals and Biotechnology

  • FDA 'In a Boom Period,' on Pace to Match Approval Records (Bloomberg)
  • Woodcock: FDA Making Strides on Adopting Personalized Medicine (FDA)
  • FDA recommends no changes to Lilly's schizophrenia injection use (Reuters) (FDA) (FamilyPracticeNews)
  • Zogenix’s Battle with the Commonwealth of Massachusetts Continues (Drug and Device Law)
  • A Review of 2014 Cancer Drug Approvals, With a Look at 2015 and Beyond (P&T-PDF)
  • FDA Outlines “Expedited” Review For Breakthrough Therapies; “Hyper-Fast” Reviews, Beyond Oncology (RPM Report-$)
  • Drug Safety Advocates Want Bioequivalence Data To Be Made Public (IHP-$)
  • Gov. Pence To Sign "Right To Try" Bill (WBIW)
  • Import Alert for Two of Aarti Drug's Manufacturing Facilities (FDA) (India Times)
  • FDA Seeks Regulatory Science ‘Bridge’ To Find Pharmacogenomics Biomarkers (Pink Sheet-$)
  • Reality Check For Real World Data: FDA’s Sentinel Network Enters “Production” Stage (RPM Report-$)
  • Purdue Abuse Study May Create Ongoing Challenge For Generic Entry (Pink Sheet-$) (MM&M)
  • Is Bigger Safer? OPDP Enforcement Patterns and Company Size (EyeonFDA)
  • New ASBM survey provides physicians’ views on biosimilar labeling (Biosimilar News)
  • More on the 505(b)(2)/ANDA Proposed Rule (Lachman)
  • Pliva Urges Justices To Overturn Iowa Court Generics Ruling (Law 360-$)
  • Gilead's Hepatitis Drugs Tripped By Old Heart Drug (Forbes) (Reuters)

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

  • Study of Merck melanoma drug halted after survival prolonged (Reuters) (Press)
  • How Nektar plans to make case for etirinotecan pegol in metastatic breast cancer (BioCentury-$)
  • FDA grants orphan drug status to Treeway's ALS treatment (PMLive)
  • US orphan status for AB Science's muscle-wasting drug (PharmaTimes)
  • Silence golden on pancreatic cancer data (BioCentury)

US: Pharmaceuticals and Biotechnology: General

  • It’s true: drug companies are bombarding your TV with more ads than ever (WonkBlog)
  • How Medicines Co. develops drugs to show both health and economic benefits (BioCentury-$)

US: Medical Devices

  • FDA approves Abiomed's blood pump device (Reuters) (FDA) (Forbes)
  • FDA Classified Limited Output Transcutaneous Piezoelectric Stimulator for Skin Reactions Associated With Insect Bites (FDA)
  • AdvaMed Rearranges FDA’s Priority List (MDDI) (Gray Sheet-$)
  • What You Can Learn From Other Manufacturers' Unique Device Identification Mistakes (Silver Sheet-$)
  • Regulators, industry, doctors dig deep to clean dirty devices following deadly outbreak (Fierce)
  • Registry data to be shared at meeting of orthopedic surgeons (Fierce)
  • DOJ cracks down on devicemakers in 2014 with $100M+ in fines (Fierce)
  • Wireless Security: A Work in Progress (MDDI)
  • Lawmaker says it's 'unfair' for Olympus to profit from superbug outbreaks (LATimes)
  • Clinical Laboratory Improvement Advisory Committee Meeting (CDC)
  • Ross Medical Technology Receives FDA 510(K) Clearance for ECG Monitoring Platform to Help Replace Traditional Hospital Admissions (Press)

US: Assorted And Government

  • NIH selects awardees to help speed development of health technologies (NIH)
  • U.S. developing bird flu vaccine, no distribution plans yet (Reuters)
  • U.S. funding research of better anthrax vaccine: health officials (Reuters)

Upcoming Meetings and Events

Europe

  • What the UK's pharmaceutical industry wants from the next government (Guardian)
  • EMA elects new vice-chair (Pharmafile)
  • IQWiG amends findings on Provenge in Dendreon's favor (SCRIP-$) (PMLive)
  • EC approves Novo's Saxenda (BioCentury) (Pharmafile)
  • The Joint Assessment on "Ramucirumab (Cyramza) in combination with Paclitaxel as second-line treatment for adult patients with advanced gastric or gastro-oesophageal junction adenocarcinoma" available (EU HTA Net)
  • Volcano wins CE Mark for new FFR software (Mass Device)
  • New versions of electronic Application forms released (Exalon)

India

  • India Lapses Test Relationship But Let’s Listen And Learn: U.S. FDA (PharmAsia-$)
  • CDSCO, US FDA to work closely as FDA plans to expand its presence in India (PharmaBiz)

China

  • China FDA approves first proton carbon ion therapy for Siemens device (Fierce)

Canada

  • Canadian Provinces to Provide Public Funding for Harvoni (Press)

Other International

  • WHO calls for proactive strategies to combat falsified, substandard medicines (In-Pharma)
  • ARIAD and Medison Pharma Announce Approval of Iclusig (Ponatinib) in Israel (Press)

Clinical Trials

  • Sharing Clinical Trial Data to Increase Innovation and Improve Patient Care (Piper Report)
  • A University’s Handling of Clinical Trial Practices Raises ‘Serious Ethical Issues’ (Pharmalot)

General Regulatory And Interesting Articles

  • Opossum Peptides Could Provide Promising Antivenom (C&EN)
  • New Study Shows How The Potency Of Pot Has Changed Over Time (Forbes)
  • If You're Going To Die Soon, Do You Really Need Statins? (NPR)
  • Why The War On Cancer Hasn't Been Won (NPR)
  • 10% of Patients Modify Their Drug Dosage (MPR)
  • Antidepressants have sexual side effects in teens, too (Reuters)

Regulatory Reconnaissance #520 – 24 March 2015

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 @AlecGaffney 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.


Categories: Recon, Regulatory News

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe