Regulatory Focus™ > News Articles > Regulatory Recon: Bayer Loses Major Battle Over Cancer Drug (15 December 2014)

Regulatory Recon: Bayer Loses Major Battle Over Cancer Drug (15 December 2014)

Posted 15 December 2014 | By Alexander Gaffney, RAC 

Regulatory Recon: Bayer Loses Major Battle Over Cancer Drug (15 December 2014)

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

In Focus: US

  • Is the Veterinary Drug Trifexis Safe? And is FDA's Regulatory Pathway Fit for Purpose? (IndyStar)
  • Lilly's Cyramza OK'd for US lung cancer patients (SCRIP-$) (PharmaTimes) (RTT) (BioCentury) (FDA)
  • Pfizer Says FDA Biosimilars Draft Guidance Is Just Fine; Congress Should Be Patient (Pink Sheet-$)
  • Sunscreen TEAs Could Illuminate How Deadlines Influence FDA’s Process (Tan Sheet-$)
  • Public Citizen: FDA Rule Change on Generic Labeling is Needed (Pharmalot)
  • FDA's Maisel: PMA Study could downgrade some high-risk devices (Mass Device)
  • CDRH Initiatives Underway: Submission Withdrawals, Early Interaction, Refuse-To-Accept (Gray Sheet-$)
  • Massive Recall for Stryker Devices (FDA)
  • FDA Budget Set in Funding Bill (THOMAS) (Tan Sheet-$) (SCRIP-$)

In Focus: International

  • Bayer Loses Battle to Block Generic Version of a Cancer Drug in India (Pharmalot) (BioCentury) (India Times) (Reuters)
  • EC: Search for Rasi's replacement could take six months (PMLive)
  • German drugmakers appeal drug suspensions linked to Indian data (Reuters)
  • Diclofenac use in animals poses a risk to European vultures (EMA) (Fierce)
  • Clinical Trials in India: 370 Killed Since Feb 2013, Only 21 Paid Compensation (IBTimes) (Business Standard)
  • PhRMA on India, China: Faster Growth Through Stronger Regulation (Project-Syndicate)
  • WHO's Draft global action plan on antimicrobial resistance (WHO)

US: Pharmaceuticals and Biotechnology

  • Is the Veterinary Drug Trifexis Safe? And is FDA's Regulatory Pathway Fit for Purpose? (IndyStar)
  • Lilly's Cyramza OK'd for US lung cancer patients (SCRIP-$) (PharmaTimes) (RTT) (BioCentury) (FDA)
  • Pfizer Says FDA Biosimilars Draft Guidance Is Just Fine; Congress Should Be Patient (Pink Sheet-$)
  • Sunscreen TEAs Could Illuminate How Deadlines Influence FDA’s Process (Tan Sheet-$)
  • Public Citizen: FDA Rule Change on Generic Labeling is Needed (Pharmalot)
  • Narrow-Spectrum Antibiotics Face Clinical Trial Design Hurdles, Panel Says (Pink Sheet-$)
  • Antibiotic Limited Use Claims Present Challenge Of Actually Limiting Use (Pink Sheet-$)
  • FDA Generics Office Sets Aspirational Goal To Clear Unmeasured ANDAs (Pink Sheet-$)
  • Drug firms face ANDA blues (Financial Express)
  • FDA’s DSCSA Guidance in 2014 (RxTrace)
  • Biosimilar Substitution Legislation Emphasizes Electronic Health Records (Pink Sheet-$)
  • FDA Panel Won’t Meet To Reconsider Ban On Gay Men Donating Blood (BuzzFeed)
  • FDA: Agency's Tools Not Strong Enough To Stop Brands' Misuse Of REMS (IHP-$)
  • Post-marketing Data Confirm Link between Uveitis and Avelox (moxifloxacin) (AdverseEvents-PDF)
  • Drug Development Wish List: Antibiotic Data Cravings Seen At Actavis Committee Review (Pink Sheet-$)
  • FDA: Study Demonstrates Potential for Faster Drug Development (Press)
  • Congress Keeps Tabs on “Three-person Embryos” (Roll Call)
  • FDA Withdaws Approval of ANDA for Oxytetracycline Soluble Powder (FDA)
  • Vial Size of Injectable Drugs Affecting Patient Safety and Medication Shortages (IDSE)
  • From our perspective: Statisticians at CDER (FDA)
  • Availability of Draft Toxicological Profiles (ATSDR)

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

  • Roche biotech unit submits skin cancer drug application to U.S. regulator (Reuters) (RTT) (Press) (PharmaTimes)
  • Relypsa Announces FDA Acceptance of New Drug Application for Patiromer for Oral Suspension to Treat Hyperkalemia (Press)
  • Jazz heads to the FDA with its $1B rare disease drug (Fierce) (PBR)
  • U.S. FDA Accepts for Review Supplemental New Drug Application for Deltoid Administration of Abilify Maintena (aripiprazole) Extended-Release Injectable Suspension (Press)

US: Pharmaceuticals and Biotechnology: General

  • Does drug pricing reflect innovation? (MedCityNews)
  • Drugs Not ‘On Radar’ For Medicare Coverage Review, Official Says (Pink Sheet-$)
  • Ex-FDA/CMS chief: Delivery efficiencies could balance drug costs (SCRIP-$)
  • Judge: Texas Must Reveal Execution Drug Maker (AP)
  • Pricey 'breakthrough' drugs confound Medicaid rate-setting (ModernHealthcare)
  • Drug companiess to lose $65 billion on patents (Boston Herald)
  • US Capitol Capsule: NIH I-Corps takes startups on focused path to commercialization (SCRIP-$)

US: Medical Devices

  • FDA's Maisel: PMA Study could downgrade some high-risk devices (Mass Device)
  • CDRH Initiatives Underway: Submission Withdrawals, Early Interaction, Refuse-To-Accept (Gray Sheet-$)
  • Massive Recall for Stryker Devices (FDA)
  • Unusual experiment raises concerns about prenatal testing labs (NECIR)
  • Prenatal Tests Have High Failure Rate, Triggering Abortions  (NBC)
  • Senate Advances Budget Bill, CDRH Funding Remains Flat (FDAnews-$)
  • How to Clean Reusable Orthopedic Instruments (MDDI)
  • Vertiflex Superion Spacer Panel Reset To Give FDA More Review Time (Gray Sheet-$) (Press)

US: Dietary Supplements

  • FTC continues cracking down on weight loss scams (MoneyWatch) (Tan Sheet-$)
  • Supplement usage holding steady, CRN survey finds (NI-USA)
  • Scilabs Nutraceuticals Responds to FDA Consent Decree (Press)

US: Assorted And Government

  • President Signs Funding Bill (THOMAS)
  • FDA Gets Senate Funding, House Scolding In Fiscal 2015 Appropriation (Tan Sheet-$) (SCRIP-$)
  • Murray Announces Intent to Succeed Harkin as Ranking Democrat on the HELP Committee (RollCall) (The Hill)
  • Sen. Orrin Hatch Introduces the Searching for and Cutting Regulations That Are Unnecessarily Burdensome (SCRUB) Act of 2014 (Hatch)

Upcoming Meetings

Ebola Outbreak

  • Ebola vaccine halt 'a precaution' say researchers (PMLive)

Europe

  • EC: Search for Rasi's replacement could take six months (PMLive)
  • German drugmakers appeal drug suspensions linked to Indian data (Reuters)
  • Diclofenac use in animals poses a risk to European vultures (EMA) (Fierce)
  • Europe's response "disproportionate" says GVK Biosciences  (Outsourcing Pharma)
  • ‘Quack’s charter’ warning over bill on untested medicines (Guardian)
  • Outcomes From EMA's CVMP Meeting (EMA)
  • NICE says ‘yes’ to Remicade, Humira and Simponi for ulcerative colitis (PharmaLetter-$) (PharmaTimes)
  • EU Commission Misses Chance To Lead On Drug Patent Settlements (Pink Sheet-$)
  • CVRx's Barostim neo gets CE Mark for use with MRIs (Mass Device)
  • Cancer Drugs Fund 'costly mistake' as re-evaluation begins (PharmaTimes)
  • MorphoSys's MOR208 Program Receives Positive Opinion for Orphan Medicinal Product Designation from EMA for DLBCL (Press)

India

  • Bayer Loses Battle to Block Generic Version of a Cancer Drug in India (Pharmalot) (BioCentury) (India Times) (Reuters)
  • Clinical Trials in India: 370 Killed Since Feb 2013, Only 21 Paid Compensation (IBTimes) (Business Standard)
  • PhRMA on India, China: Faster Growth Through Stronger Regulation (Project-Syndicate)
  • After price control, several key drugs in short supply (India Times)
  • Government might cap maximum retail price of critical medical devices like stents (India Times)
  • Pharma companies should be ready to adapt to changing norms: Israel Makov, chairman of Sun Pharmaceutical (India Times)
  • Government may not act on Cipla’s patent plea (India Times)
  • Indian firms, checkers need to do more' (Business Standard)
  • Form regulatory body to clear ads of medicines: HC to govt (India Times)
  • United States And India Hit Restart (Two-Four Insight)
  • Insight On India – Highlights From The Week Of Dec 7-13, 2014 (Two-Four Insight)

China

Canada

Australia

  • Updates to the prescribing medicines in pregnancy database (TGA)

Other International

  • WHO's Draft global action plan on antimicrobial resistance (WHO)
  • IPEC-Americas aims to make drug excipient users TUPP aware (In-Pharma)
  • Parallel Trade Dogs Turkey’s Pharma Import Efforts (PharmAsia-$)
  • UNODC draws fire over fraudulent medicines plans (Securing Industry)

General Regulatory And Interesting Articles

  • Family Receives 38-Piece AstraZeneca Assorted Pill Sampler (The Onion-Satire)

Regulatory Reconnaissance #459 – 15 December 2014

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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