Regulatory Focus™ > News Articles > Regulatory Recon: China's New Biosimilar Guidance Released (9 March 2015)

Regulatory Recon: China's New Biosimilar Guidance Released (9 March 2015)

Posted 09 March 2015 | By Alexander Gaffney, RAC 

Regulatory Recon: China's New Biosimilar Guidance Released (9 March 2015)

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

In Focus: US

  • FDA nod for Astellas/Basilea antifungals (PharmaTimes) (Press) (BioCentury) (FDA) (MedPage Today) (Reuters) (SCRIP-$)
  • FDA Establishes a Docket for the Public to Comment on any Aspect of Pharmaceutical Compounding (FDA) (FDA Law Blog)
  • Biosimilar Labeling Dissected: Sandoz’s Zarxio Uses Amgen’s Neupogen Text (Pink Sheet-$)
  • Luciana Borio to Take Over From Stephen Ostroff as FDA's Chief Scientist (Pink Sheet-$)
  • Health Affairs Explainer on Right-to-Try Laws (Health Affairs)
  • FDA authorizes use of first device to treat patients with dialysis-related amyloidosis (FDA)
  • Bacterial Outbreaks Triggering Tougher FDA Reprocessing Standards (Gray Sheet-$)
  • Q4 FDA Medical Device Recalls Lowest Since 2012 (MDDI)

In Focus: International

  • China issues guidance on biosimilars (BioCentury) (Ropes & Gray)
  • GSK sacks 110 China staff in wake of drug bribery case (Reuters) (Pharmalot) (PMLive)
  • The EU's Innovative Medicines Initiative Slammed by Newspaper Investigation (De Standaard) (EFPIA Response)
  • $10 Copy of Gilead’s Blockbuster Sovaldi Appears in Bangladesh (Bloomberg)
  • Can you sell your CE-marked device in French overseas territories? (Clinica-$)
  • Pharma companies may have to report drugs’ side effects to Indian regulator (India Times) (PharmaBiz)
  • DCGI issues draft Accreditation Standards for accreditation of ethics committee, investigator & clinical trial site (PharmaBiz)

As the EU Gears up for Major Device Changes, What do Regulatory Pros Need to Know?

  • In Europe, medical devices currently are regulated much the same way they have been since the 1990s. Now, almost 20 years and several major scandals later, EU officials are preparing a massive overhaul of the region's medical device regulatory directives in the hopes of modernizing the system—if only they could agree on what those changes should look like. (Regulatory Focus)
  • Find out what changes are likely to affect medical devices and IVDs next year in this 11 March 2015 webcast featuring expert Erik Vollebregt. (RAPS Webcast)

US: Pharmaceuticals and Biotechnology

  • FDA nod for Astellas/Basilea antifungals (PharmaTimes) (Press) (BioCentury) (FDA) (MedPage Today) (Reuters) (SCRIP-$)
  • FDA Establishes a Docket for the Public to Comment on any Aspect of Pharmaceutical Compounding (FDA) (FDA Law Blog)
  • Biosimilar Labeling Dissected: Sandoz’s Zarxio Uses Amgen’s Neupogen Text (Pink Sheet-$)
  • Luciana Borio to Take Over From Stephen Ostroff as FDA's Chief Scientist (Pink Sheet-$)
  • BIO Calls for FDA to Release Biosimilar Naming Guidance (Press)
  • What's Next for Biosimilars in the US? (DrugWonks)
  • Health Affairs Explainer on Right-to-Try Laws (Health Affairs)
  • Opioid Abuse Deterrence: FDA Development Ideas Are Out Of This World (Pink Sheet-$)
  • FDA Lull In Rx Promotion Citations Continues; Guidances May Be Bigger Priority (Pink Sheet-$)
  • Hamburg’s Departure Hinged On Selection Of FDA Leadership Team (Pink Sheet-$)
  • Pozen's API Supplier Hit With FDA Form 483 (SEC)
  • Citizen Petition for FDA to Add Generic Metadate CD to Orange Book (FDA)
  • Wyoming 'Right to Try' Bill Sent to Governor for Signature (Press)
  • Arkansas 'Right to Try' Bill Sent to Governor for Signature (Press)
  • Nevada bill would allow terminally ill people to try experimental drugs before FDA approval (Daily Reporter)
  • South Dakota Senate Approves ‘Right-to-Try’ Bill (Thompson's)
  • Understanding the Basics of the DSCSA's “Serial Numbers” (RxTrace)
  • FDA Releases New Veterinary ICH Guidance on Drug Withdrawal Periods for Food-Producing Animals (FDA)
  • February 2015 ANDA Approvals (Lachman)
  • Hospira Issues a Voluntary Nationwide Recall of One Lot of Magnesium Sulfate in 5% Dextrose Injection Due to Incorrect Barcode Labeling (FDA)
  • Sun Pharma recalls 5,322 bottles of Ketorolac eye drop in US (India Times)
  • FDA Advisory Committee to Review Sedation in Pediatric Clinical Trials and Drugs Required for Review Under BPCA/PREA/PMDSIA (Tarius)

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

  • Spectrum Pharmaceuticals Announces FDA's Acceptance of NDA Filing for Captisol-Enabled (Propylene Glycol-Free) Melphalan (Press)
  • AcelRx Provides Regulatory Update on Zalviso, says FDA Wants Additional Studies (Press)
  • CTI BioPharma blood cancer drug meets main goal in trial (Reuters) (Press) (Fierce) (The Street)
  • Novo Nordisk's Saxenda achieves clinically meaningful body weight reduction in Phase IIIa SCALET trial (Press)

US: Pharmaceuticals and Biotechnology: General

  • Investors Warm to $100,000 Cancer Drugs After $21 Billion Deal (Bloomberg)
  • Proposed Fund for 2012 Meningitis Victims Up to $210M (AP)

US: Medical Devices

  • FDA authorizes use of first device to treat patients with dialysis-related amyloidosis (FDA)
  • Bacterial Outbreaks Triggering Tougher FDA Reprocessing Standards (Gray Sheet-$)
  • Q4 FDA Recalls Lowest Since 2012 (MDDI)
  • As 'superbug' reports increase, Olympus says duodenoscope design modification did not require FDA nod (Fierce)
  • NIH director sees solving data puzzle as key to U.S. precision medicine (Reuters)
  • Complexities in Personalized Medicine: Harmonizing Companion Diagnostics Across a Class of Targeted Therapies (FDA) (FDA)
  • Sunshine Heart Pauses COUNTER HF Trial To Study Patient Deaths (Gray Sheet-$)
  • Phthalates, found in hundreds of household products, may disrupt sex development of male fetus (WaPo)

US: Dietary Supplements

  • 'Tainted' Love: Male 'Enhancement' Pills Draw Alerts, and Laughs (NBC) (BuzzFeed)
  • NPA and UL team up on GMP certification (NI-USA)
  • Amazon Sued Over Teen's Death From Caffeine Overdose (Law 360-$)

US: Assorted And Government

  • Patent trolls are coming for the life sciences industry. What’s next? (MedCityNews)
  • HPV vaccine discoverer to lead NCI after Varmus exit (SCRIP-$)
  • Four Members of FDA Tobacco Panel Leave After Court Ruling (PharmPro)

Upcoming Meetings

Europe

  • The EU's Innovative Medicines Initiative Slammed by Newspaper Investigation (De Standaard) (EFPIA Response)
  • Can you sell your CE-marked device in French overseas territories? (Clinica-$)
  • ANSM to Require Statin Drugmakers to Submit Type IA Variations by 18 April 2015 (ANSM)
  • Irish regulator seeks input on 2016-2020 strategy (SCRIP-$)
  • German court deals another EU patent blow to Lilly's blockbuster Alimta (Fierce)
  • Want your free sale cert out of Ireland? More back-up docs but keep application short (Clinica-$)
  • UK supplement firm flaunts banned claims (NI-USA)

India

  • Pharma companies may have to report drugs’ side effects to Indian regulator (India Times) (PharmaBiz)
  • DCGI issues draft Accreditation Standards for accreditation of ethics committee, investigator & clinical trial site (PharmaBiz)
  • Boehringer Ingelheim’s Patent Revoked By The Indian Patent Office (Two-Four Insight)
  • Hundreds of API suppliers with plants in new Indian state Telangana need to update EDQM (In-Pharma)
  • Regulated medical devices critical to patient safety (India Times)

China

Canada

  • Thalidomide victims to discuss aid with health officials in Ottawa (Globe and Mail)

Other International

Clinical Trials

  • Training on trials: Patients taught the language of drug development (Nature)
  • Evaluation and Treatment of Patients With Lower Extremity Peripheral Artery Disease: Consensus Definitions From Peripheral Academic Research Consortium (PARC) (PubMed)
  • How Can You Bolster Clinical Trial Enrollment? (iMarc)

General Regulatory And Interesting Articles

  • Pregnant Women Are Finding Out They Have Cancer From A Genetic Test Of Their Babies (BuzzFeed)
  • The truth about medicine: we usually overestimate the benefits and underestimate the harms (Vox)
  • Dog sniffs out thyroid cancer (Pharma Times)

Regulatory Reconnaissance #509 – 9 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

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