Regulatory Focus™ > News Articles > Regulatory Recon: Biosimilar Manufacturer Join Together, Form New Group (6 May 2015)

Regulatory Recon: Biosimilar Manufacturer Join Together, Form New Group (6 May 2015)

Posted 06 May 2015 | By Alexander Gaffney, RAC

Regulatory Recon: Biosimilar Manufacturer Join Together, Form New Group (6 May 2015)

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

In Focus: US

  • Industry partners launch Biosimilars Forum (BioCentury) (Press)
  • FDA AdComm to Review Sprout's Female Dysfunction Drug, Flibanserin (FDA)
  • Help-Seeking Communications Guidance Withdrawn (RegulatoryRx)
  • FDA investigates U of M drug researcher amid department criticism (Fox9)
  • FDA to Fund Investigation of Generic Drugs and Their Role in Adverse Events (FDA)
  • Working out the Bugs: Congress Wants to Clarify FDA Software Regulation (MDDI)
  • FDA Transparency at Heart of Device Risk and Recall Discussion (MDS)
  • FDA to probe experts on duodenoscope cleaning procedure at upcoming meeting (Fierce)
  • Lab Group Eyes Suit Over FDA's LDT Plan (IHP-$)
  • Supplement Company suing Harvard researchers for $200 million (NPI)

In Focus: International

  • EMA tightens rules on 'revolving door' for committee members and experts (EMA) (EMA) (EMA) (Reuters)
  • EU court's dismissal of Spanish actions clears way for new patent system (SCRIP-$)
  • U.K. regulators find issues with Indian-owned API distributor Relonchem (Fierce)
  • India’s Troubled Drug Regulatory System (24 Insight)
  • Analysis of the revisions in China's Drug Administration Law (ChinaLawInsight)
  • Finishing line in sight for ICH reforms (SCRIP RA-$)

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US: Pharmaceuticals and Biotechnology

  • Industry partners launch Biosimilars Forum (BioCentury)
  • FDA AdComm to Review Sprout's Female Dysfunction Drug, Flibanserin (FDA)
  • Help-Seeking Communications Guidance Withdrawn (RegulatoryRx)
  • Generics substitution, bioequivalence standards, and oversight of international pharmacies: Complex issues facing the FDA (AEI)
  • FDA investigates U of M drug researcher amid department criticism (Fox9)
  • FDA to Fund Investigation of Generic Drugs and Their Role in Adverse Events (FDA)
  • New Guidance Available Pertaining to FDA Review of New Animal Drug Applications (FDA)
  • ‘Right-to-Try’ Bill Introduced in Pennsylvania House (Thompson's)
  • Amgen Wins Temporary Injunction Against Sandoz in Landmark Biosimilars Case (OrangeBookBlog)
  • Drug Serialization Trends and Developments (PCM)
  • Recall for Teva's Adrucil Due to Particulate Matter (FDA)

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

  • AbbVie Snags Breakthrough Product Designation for Venetoclax, Plans FDA, EMA Filings (Press)
  • Digoxin Linked To Increased Risk Of Death (Forbes)
  • AstraZeneca partner Ardelyx dives (again) as lead drug flunks PhII (Fierce) (PharmaTimes)
  • Roche presses pause on PTC's SMA drug over a safety scare (Fierce) (BioCentury)
  • Indivior PLC Announces Positive Top-line Results From Pivotal Phase 3 Trial of RBP-7000 in Schizophrenia (Press)
  • AbbVie Announces Pivotal Phase 3 Data Evaluating Efficacy and Safety of HUMIRA (adalimumab) in Patients with Non-Infectious Intermediate, Posterior, or Panuveitis (Press)
  • Retrophin Receives FDA Orphan Drug Designation for RE-024 for the Treatment of Pantothenate Kinase-Associated Neurodegeneration (Press)

US: Pharmaceuticals and Biotechnology: General

  • Diabetes Drugs Compete With Prices That Rise in Lockstep (Bloomberg)

US: Medical Devices

  • Working out the Bugs: Congress Wants to Clarify FDA Software Regulation (MDDI)
  • FDA Transparency at Heart of Device Risk and Recall Discussion (MDS)
  • FDA to probe experts on duodenoscope cleaning procedure at upcoming meeting (Fierce)
  • Lab Group Eyes Suit Over FDA's LDT Plan; Upton Asks FDA To Help Craft Diagnostic Reg Alternative (IHP-$)
  • Aetna curtails coverage of power morcellators, citing cancer risk (AP) (Fierce)
  • Medtronic Announces FDA Clearance and U.S. Launch of the Euphora Semicompliant Coronary Balloon (Press)
  • Boston Scientific Didn't Test Pelvic Mesh, Jury Told (Law 360-$)

US: Dietary Supplements

  • Hi-Tech Pharmaceuticals suing Harvard researchers for $200 million (NPI)

US: Assorted And Government

  • Senator: Failing Electronic Health Records Program May Stand in Way of Precision Medicine (Senate)
  • NIH chief: Don't let moment pass for precision medicine (SCRIP-$)
  • IBM's Watson to guide cancer therapies at 14 centers (Reuters)
  • #SubHealth Reviews Bipartisan Legislation to Protect Waters from Microbeads in Cosmetic Products (E&C)
  • Exploring adverse drug events at the class level (PubMed)

Upcoming Meetings and Events

Europe

  • EMA tightens rules on 'revolving door' for committee members and experts (EMA) (EMA) (EMA) (Reuters)
  • EU court's dismissal of Spanish actions clears way for new patent system (SCRIP-$)
  • U.K. regulators find issues with Indian-owned API distributor Relonchem (Fierce)
  • EU watchdog disagrees with negative view on UniQure gene therapy (Reuters)
  • Sweden Bans Sale Of Paracetamol In Supermarkets (ESM Mag)

India

  • India’s Troubled Drug Regulatory System (24 Insight)
  • Online pharmacies can be allowed with strict norms under D&C Rules: Dr Jagashetty (PharmaBiz)

China

  • China plans first-ever rules on animal testing in medical research by year end (Fierce)
  • Analysis of the revisions in the Drug Administration Law (ChinaLawInsight)

Canada

Other International

  • Finishing line in sight for ICH reforms, new body set to begin operating early next year (SCRIP RA-$)
  • Marijuana advocates turn to UN to fight global drug laws (The Hill)

General Regulatory And Interesting Articles

  • Transparency Is Still A Problem As Big Pharma Struggles With Its Image (Forbes)
  • Spore Wars Help Fend Off Life-Threatening Bacterial Infections (NPR)
  • Whooping Cough Vaccine's Protection Fades Quickly (NPR)

Regulatory Reconnaissance #551 – 6 May 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

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