Regulatory Focus™ > News Articles > Regulatory Recon: J&J Says China's Drug Approval Process Getting Harder (23 January 2015)

Regulatory Recon: J&J Says China's Drug Approval Process Getting Harder (23 January 2015)

Posted 23 January 2015 | By Alexander Gaffney, RAC

Regulatory Recon: J&J Says China's Drug Approval Process Getting Harder (23 January 2015)

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

In Focus: US

  • FDA panel backs Astellas drug for invasive fungal infections (Reuters) (Tarius) (Fierce) (Press) (BioCentury) (PMLive) (Pink Sheet-$) (SCRIP-$)
  • Searching social networks to detect adverse reactions (PharmJournal)
  • Compassionate Use: The CEO Who Saved a Life and Lost His Job (Bloomberg)
  • FDA Voucher for Leishmaniasis Treatment: Can Both Patients and Companies Win? (PLos)
  • Why Pharma's Sunshine Act Payments to Doctors Were So Hard to Parse (ProPublica)
  • CDRH Touts Progress On Clinical Study Reviews (Gray Sheet-$) (FDA)
  • FDA Releases New Strategic Priorities for CDRH (FDA)
  • After Nearly 5 Years, GMP Compliance Still A Challenge for Many Supplement Makers (NPI)

In Focus: International

  • Drugs’ Path to China Slows as Regulatory Delays Add Up, J&J Says (Bloomberg)
  • Ebola Vaccine Trials May Be Limited by Waning Epidemic (Bloomberg)
  • EMA recommends suspending medicines over flawed studies by GVK Biosciences (EMA) (MHRA)
  • EMA's CHMP Recommends Approval for Seven New Medicines (EMA) (Reuters)
  • Novo's liraglutide gets CHMP nod for obesity (BioCentury) (PharmaTimes) (EMA)
  • India: Government may negotiate price of patented drugs before market entry (India Times)

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US: Pharmaceuticals and Biotechnology

  • FDA panel backs Astellas drug for invasive fungal infections (Reuters) (Tarius) (Fierce) (Press) (BioCentury) (PMLive) (Pink Sheet-$) (SCRIP-$)
  • Searching social networks to detect adverse reactions (PharmJournal)
  • Compassionate Use: The CEO Who Saved a Life and Lost His Job (Bloomberg)
  • FDA Voucher for Leishmaniasis Treatment: Can Both Patients and Companies Win? (PLos)
  • Biotech Stock Valuations and Public Policy: Will “Buy” Ratings Make “21st Century Cures” A Tough Sell? (RPM Report-$)
  • DEA Removes Naloxegol from Schedule II Control (DEA)
  • KYTHERA Biopharmaceuticals Announces Date of FDA Advisory Committee Review of ATX-101 for the Treatment of Submental Fullness  (Press) (FDA)
  • The BPCIA “Patent Dance” – Waiting for the Music to Begin (PCM)

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

  • CytRx touts survival data after aldoxorubicin hold lifted (SCRIP-$)
  • New Xtandi data bolster case for pre-chemo use (SCRIP-$)

US: Pharmaceuticals and Biotechnology: General

  • Why Pharma's Sunshine Act Payments to Doctors Were So Hard to Parse (ProPublica)
  • High Rates of Opioid Prescriptions Among Women Raise Birth Defect Fears (NYTimes) (Reuters) (CDC)

US: Medical Devices

  • CDRH Touts Progress On Clinical Study Reviews (Gray Sheet-$) (FDA)
  • FDA Releases New Strategic Priorities for CDRH (FDA)
  • Groundhog Day: FDA and Proposed Oversight of LDTs (Genomics Law Report)
  • October 2014 PMA Approvals (FDA)
  • FTC Stays Tough On Health Software, Even As FDA Eases Up (Law 360-$)
  • FDA Approves MED-EL’s SYNCHRONY Cochlear Implant (Press)
  • Nevro Receives Approvable Letter from U.S. Food and Drug Administration for Senza Spinal Cord Stimulation System (Press)
  • Failed Calibration of Anesthesia Machine Due to Look-Alike Oxygen Sensors (PubMed)
  • Public Citizen Urges FTC to Investigate Life Line Screening’s Ads for Cardiovascular Disease and Osteoporosis Screening Package (Public Citizen)
  • New Device to Lower Resistant High Blood Pressure Shows Early Promise (Forbes)

US: Dietary Supplements

  • After Nearly 5 Years, GMP Compliance Still A Challenge for Many Supplement Makers (NPI)
  • FDA Clamps Down on Another Contract Manufacturer for cGMP Violations (NPI)
  • The Importance of Preparing for GMP Certification (NPI)

US: Assorted And Government

  • Sen. Paul and Rep. Young Introduce REINS Act, Targeting Regulation (Press)

Upcoming Meetings

Ebola Outbreak

Europe

  • EMA recommends suspending medicines over flawed studies by GVK Biosciences (EMA) (MHRA)
  • EMA's CHMP Recommends Approval for Seven New Medicines (EMA) (Reuters)
  • Novo's liraglutide gets CHMP nod for obesity (BioCentury) (PharmaTimes) (EMA)
  • The Medicines Company Receives CHMP Positive Opinions for Three Hospital Acute Care Products: KENGREXAL (cangrelor), ORBACTIV (oritavancin) and RAPLIXA (sealant powder) (Press) (Fierce)
  • Novartis' Jakavi drug wins EU green light for wider use (Reuters)
  • Celgene Receives Positive CHMP Opinion for ABRAXANE for First-Line Treatment of Patients with Non-Small Cell Lung Cancer (Press)
  • Prevenar 13 Receives CHMP Positive Opinion For Prevention Of Vaccine-Type Pneumococcal Pneumonia in Adults (Press)
  • Notified body credibility gets a bad jolt from journalist lampooning (Clinica-$)
  • Saatchi Bill not needed and adds no value: Royal Colleges (PharmaTimes)
  • mHealth: AliveCor wins CE Mark for new afib algorithm (Mass Device)
  • Patients Blame Cost for Coverage Delay in England of Gilead Drug (Pharmalot)
  • German Federal Joint Committee confirms 'considerable' benefit of Eisai's Halaven in breast cancer (PharmaLetter-$)

India

  • Government may negotiate price of patented drugs before market entry (India Times)
  • Over-pricing of drugs: Delhi High Court directs Pharma firm to seek review (India Times)
  • Need to sensitise physicians on ADRs to strengthen pharmacovigilance in India: Dr G N Singh (PharmaBiz)
  • India Looks to Increase Pharmacovigilance Capacity (PharmaBiz)
  • Ahead of Obama visit, MSF cautions India of US pressure against India’s patent law (PharmaBiz)

China

  • Drugs’ Path to China Slows as Regulatory Delays Add Up, J&J Says (Bloomberg)

Australia

  • New TGA Guidance on "Release for Supply" (TGA)

Clinical Trials

General Regulatory And Interesting Articles

  • Antibiotics "a terrible business model" for Pharmas expert tells Davos (In-Pharma)

Regulatory Reconnaissance #478 – 23 January 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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