Regulatory Focus™ > News Articles > Regulatory Recon: Chinese Regulatory Approvals Delayed by Years for Foreign Companies (8 December 2

Regulatory Recon: Chinese Regulatory Approvals Delayed by Years for Foreign Companies (8 December 2014)

Posted 08 December 2014 | By Alexander Gaffney, RAC

Regulatory Recon: Chinese Regulatory Approvals Delayed by Years for Foreign Companies  (8 December 2014)

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

In Focus: US

  • Deal to delay generic Nexium didn't violate antitrust laws, jury rules (ModernHealthcare) (Law 360-$)
  • FDA Sets Up Database For Wholesalers, 3PLs, As Companies Mull Guidance (IHP-$)
  • Sandoz loses bid to shield psoriasis drug (Reuters) (Pink Sheet-$)
  • Mixed recommendation for Actavis' ceftazidime/avibactam (BioCentury) (Tarius) (MedPage Today) (Reuters) (Press) (Pink Sheet-$) (SCRIP-$)
  • Federal Circuit Affirms Dismissal of First BPCIA “Patent Dance” Challenge, But Remains Mum on BPCIA Interpretation . . . At Least for Now (FDA Law Blog) (Court)
  • Orrin Hatch: MEDTECH Act vital to protecting healthcare innovation (Fierce) (HDM) (HITS)
  • As recalls increase, hospitals should embrace medical device tracking (MedCityNews)
  • Do Anti-Theft Systems Impact Medical Devices? (MedDeviceOnline)
  • The Importance of Quality Control Agreements  (NPI)

In Focus: International

  • Foreign Drug Companies in China See Approval Delays (Bloomberg)
  • EMA: Rasi can apply to get his job back (SCRIP-$)
  • Flu vaccine underwent 35 QA/QC tests in Italy death probe, says Novartis (BioPharmaReporter)
  • Fluad's Italian Problem Could Reduce Confidence In Vaccines Across Europe (Pink Sheet-$)
  • Clinical Trial regulation in India: Science or social justice? (Financial Express)
  • Expectation and Challenge for Japan's New Regulatory Framework of Regenerative Medicines (Thompson Reuters)

US: Pharmaceuticals and Biotechnology

  • Deal to delay generic Nexium didn't violate antitrust laws, jury rules (ModernHealthcare) (Law 360-$)
  • FDA Sets Up Database For Wholesalers, 3PLs, As Companies Mull Guidance (IHP-$)
  • FDA’s Office of Pharmaceutical Quality Revs Up Process to Accelerate ANDA Reviews (FDAnews-$)
  • Sandoz loses bid to shield psoriasis drug (Reuters) (Pink Sheet-$)
  • Mixed recommendation for Actavis' ceftazidime/avibactam (BioCentury) (Tarius) (MedPage Today) (Reuters) (Press) (Pink Sheet-$) (SCRIP-$)
  • Federal Circuit Affirms Dismissal of First BPCIA “Patent Dance” Challenge, But Remains Mum on BPCIA Interpretation . . . At Least for Now (FDA Law Blog) (Court)
  • Assessment of benefits and risks in development of targeted therapies for cancer - The view of regulatory authorities (PubMed)
  • ‘First Generic’ Definition Is Two-Sentence Tug Of War For FDA, Industry (Pink Sheet-$)
  • FDA Updates its Class-Wide Opioid REMS (FDA)
  • REMS for Amgen's Blincyto (FDA)
  • SPF Ratings: When More Is Neither Better Nor a Lawsuit (D&D Law)
  • Wraser Receives FDA Approval on Trezix Capsules, CIII for Moderate to Moderately Severe Pain (Press)
  • US FDA approves the labeling update of Abilify Maintena (aripiprazole) for extended-release injectable suspension to describe new clinical data for the treatment of acutely relapsed adults with schizophrenia (Press)
  • Cadila recalls 15,144 bottles of hypertension drug in US (Business Standard)
  • The potential role of advanced technologies for virus detection in development and regulation of vaccines (PubMed)
  • FDA Approves Amgen's XGEVA (Denosumab) For The Treatment Of Hypercalcemia Of Malignancy Refractory To Bisphosphonate Therapy (Press)
  • Paging FDA: Blatantly Violative Advertising Alert (Press) (FDA Stance)
  • Costly, Unproven Stem Cell Therapy for Neurological Disorders Questioned (NBC)

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

  • Merck immunotherapy drug shows promise against lymphoma: study (Reuters)
  • High rate of lymphoma patients respond to Bristol-Myers drug: study (Reuters)
  • ASH – A way in for anti-PD-1 therapy in haematology (EP Vantage) (Fierce) (NYTimes) (SCRIP-$) (WSJ-$) (Pink Sheet-$)
  • Novartis copy of Amgen biotech drug shows similar efficacy-study (Reuters)
  • ASH 2014: Takeda's oral ixazomib succeeds as myeloma maintenance therapy (SCRIP-$)
  • Sunovion Pharmaceuticals Inc. Submits Supplemental New Drug Application Seeking Approval for the Use of Aptiom (eslicarbazepine acetate) as Monotherapy Treatment for Partial-Onset Seizures (Press)
  • Addition of Amgen drug boosts benefits in relapsed myeloma: study (Reuters) (PharmaTimes) (PMLive)
  • Seattle Genetics and Takeda Report Phase 3 AETHERA Clinical Trial Data from ADCETRIS (Brentuximab Vedotin) in Post-Transplant Hodgkin Lymphoma Patients at Risk of Relapse at ASH Annual Meeting (Press)
  • Pharmacyclics/J&J's Imbruvica shows promise in MM (PharmaTimes)
  • PaxVax Announces Primary Endpoints Met in Phase 3 Cholera Vaccine Trial (Press)
  • Eisai Presents Results From Phase III Trial Of Antiepileptic Drug Fycompa As Adjunctive Therapy For Primary Generalized Tonic-Clonic Seizures At 68th American Epilepsy Society Annual Meeting (Press)
  • Orexo presents new Ph III data for Zubsolv (PharmaLetter-$)
  • Positive new Ph III data for Novo Nordisk’s NovoEight in hemophilia A (Pharma Letter-$)
  • Cellceutix Antibiotic Brilacidin Receives QIDP Designation From FDA (Press)
  • ERYTECH reports additional positive Phase III results from clinical study with ERY-ASP/GRASPA® in Acute Lymphoblastic Leukemia (Press)

US: Pharmaceuticals and Biotechnology: General

  • Paid to Promote Eye Drug, and Prescribing It Widely (NYTimes)
  • Merck to Buy Cubist Pharmaceuticals for $8.4 Billion (WSJ-$) (Bloomberg)
  • BioCenturyTV Episode on the High Price to Obtain Regulatory Approval (BCTV)
  • Sky-High Genetic Cholesterol Targeted for Blockbuster Drug. Now to Find the Patients (Bloomberg)

US: Medical Devices

  • Orrin Hatch: MEDTECH Act vital to protecting healthcare innovation (Fierce) (HDM) (HITS)
  • As recalls increase, hospitals should embrace medical device tracking (MedCityNews)
  • Do Anti-Theft Systems Impact Medical Devices? (MedDeviceOnline)
  • FDA Hiring Lead Reviewer for its OIVD (Posting)
  • FDA approves J&J spinal device for rare pediatric syndrome (Mass Device)
  • New Device Gives Panoramic View of the Colon (Medscape)

US: Dietary Supplements

  • The Importance of Quality Control Agreements  (NPI)
  • New FDA Observations Data For Fy 2014 Released (The Supplement)
  • ‘Impacting industry in a meaningful way’: NPA and UL announce education alliance for GMPs, claims and more (NPI)
  • US: Assorted And Government
  • Why Unfunded Mandates Can Be a Real Problem for FDA (StrengthenFDA)
  • FDA Regulatory Legend Frances Kelsey Returns to Live in Canada (Globe and Mail)
  • Enforcement Report - Week of December 2, 2014 (FDA)

Upcoming Meetings

Ebola Outbreak

  • If You Had Ebola, Would You Want A Placebo? (Forbes)
  • Ebola Czar Ron Klain to Return to Private Sector (NBC) (The Hill) (SCRIP-$)
  • Fauci: Ebola must be a 'shake the cage moment' (SCRIP-$)

Europe

  • EMA: Rasi can apply to get his job back (SCRIP-$)
  • Flu vaccine underwent 35 QA/QC tests in Italy death probe, says Novartis (BioPharmaReporter)
  • Fluad's Italian Problem Could Reduce Confidence In Vaccines Across Europe (Pink Sheet-$)
  • Industry bodies clash over need for specific biosimilar label (SCRIP-$)
  • HTA Agencies, Manufacturers, and the Debate Over Drug Pricing (Context Matters)
  • Galderma removed from list of companies compliant to UK Code (PMLive)
  • Scottish patients get access to Roche's CLL drug on NHS (PharmaTimes)
  • Experts warn of dangers of veterinary pharmaceuticals to wildlife (PhysOrg)
  • EFPIA Weighs in on "Pay-to-Delay" Cases (EFPIA)

India

  • Clinical Trial regulation in India: Science or social justice? (Financial Express)
  • Novartis blasts 'unfounded' Onbrez patent challenge in India (SCRIP-$)
  • NPPA issues notices to medical devices cos on exorbitant prices and huge price variations (PharmaBiz)
  • Insight On India – Highlights For The Week Of Nov 30-Dec 6, 2014 (Two-Four Insight)

China

  • Foreign Drug Companies in China See Approval Delays (Bloomberg)

Japan

  • Expectation and Challenge for New Regulatory Framework of Regenerative Medicines (Thompson Reuters)

Australia

  • TGA presentation given at the Australasian Ethics Network Conference workshop, 3 December 2014 (TGA)
  • TGA Issues Warning About Janssen-Cilag's Alzheimer's Drug Reminyl (TGA)

Other International

  • IPEC Seeks to Narrow Excipient Maker/User Communication Gap on Visible Particles (IPQ-$)

Clinical Trials

  • Why it's about to get a lot harder to hide the results of medical studies (Vox)
  • Who Is Responsible For Clinical Trial Informed Consent? (Law 360-$)
  • Pfizer CTI Research Network Expands With NIH Collaboration (Pink Sheet-$)
  • Proceedings From FDA/A.S.P.E.N. Public Workshop: Clinical Trial Design for Intravenous Fat Emulsion Products, October 29, 2013 (PubMed)
  • Reporting of sample size calculations in analgesic clinical trials: ACTTION systematic review (PubMed)

General Regulatory And Interesting Articles

  • ​Cure Hunters: How do scientists beat devastating diseases? By living with chronic failure (National Journal)
  • Baby's Necklace Could End Up Being A Life Saver (NPR)
  • Exact calculation of power and sample size in bioequivalence studies using two one-sided tests. (PubMed)
  • Old And Overmedicated: The Real Drug Problem In Nursing Homes (NPR)

Regulatory Reconnaissance #454 – 8 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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