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ISO: Identification of Medicinal Products Standards Revised By Zachary Brennan - Published 23 October 2017

The International Organization for Standardization (ISO) is revising a series of standards known as Identification of Medicinal Products (IDMP) standards as part of an effort to simplify the exchange of medicinal product information.

Categories: News, Canada, Europe, US, ISO, Compliance, Drugs, Government affairs

Tags: IDMP standards

Regulatory Recon: FDA Approves New Shingles Vaccine; NICE Oks Gene Therapy for Rare Condition (23 October 2017) By Zachary Brennan - Published 23 October 2017

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

Categories: News, Asia, Europe, US, EC, EMA, FDA, NICE, WHO, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

UK Strategy for Pharmacopeial Quality Standards for Biologics: MHRA Discusses Comments By Zachary Brennan - Published 23 October 2017

Trade associations, manufacturers, academia and researchers have offered their opinions on the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) draft strategy for crafting pharmacopoeial standards for biologics, according to a report issued Monday.

Categories: News, Europe, MHRA, Biologics and biotechnology, Government affairs

Tags: quality standards for biological medicines, pharmacopeial standards

FDA Warns Lead-Testing Diagnostics Company By Zachary Brennan - Published 23 October 2017

The US Food and Drug Administration (FDA) on Monday sent a warning letter to Massachusetts-based Magellan Diagnostics, a subsidiary of Meridian Bioscience, finding the company made significant changes to its lead-testing devices without notifying the agency, among other violations.

Categories: News, US, CDRH, Due Diligence, Medical Devices, Quality

Tags: lead tests, Magellan Diagnostics, Meridian Bioscience

Will FDA Add Suffixes to Approved Biologics' Names? By Zachary Brennan - Published 20 October 2017

Back in January, the US Food and Drug Administration (FDA) finalized guidance on how biosimilars and their biologic reference products' names should include a four-letter, FDA-designated meaningless suffix attached at the end of the nonproprietary name.

Categories: News, US, FDA, Biologics and biotechnology

Tags: biosimilars, biosimilar naming

EMA, European Commission Look to Foster Development of Advanced Therapies By Zachary Brennan - Published 20 October 2017

The European Medicines Agency (EMA) and European Commission on Friday published a joint action plan to further the development of new cell and gene therapies, as well as other advanced therapy medicinal products (ATMPs).

Categories: News, Europe, EC, EMA, Biologics and biotechnology, Government affairs, Human cell and tissue

Tags: ATMPs, gene therapy EU

Regulatory Recon: Celgene Abandons Late-Stage Trial in Crohn’s Disease (20 October 2017) By Zachary Brennan - Published 20 October 2017

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

Categories: News, Europe, US, EMA, FDA, NICE

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

First Implementing Act Under EU MDR, IVDR Open for Consultation By Zachary Brennan - Published 20 October 2017

The first implementing act for the EU’s new Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) is open for comments until next Wednesday.

Categories: News, Europe, EC, In vitro diagnostics, Medical Devices

Tags: MDR, IVDR, medical device regulations Europe

FTC Seeks Comments on Competition in Prescription Drug Markets By Zachary Brennan - Published 19 October 2017

Ahead of a November workshop in which FDA Commissioner Scott Gottlieb will give a keynote address, the Federal Trade Commission (FTC) is seeking comments on a variety of questions related to competition issues in the US prescription drug market.

Categories: News, US, FTC, Business and Leadership, Crisis management, Distribution, Drugs, Regulatory intelligence, Regulatory strategy

Tags: FTC on drug prices

Updated: FDA Releases Flurry of New, Revised Drug-Specific Guidance Documents By Zachary Brennan - Published 19 October 2017

The US Food and Drug Administration (FDA) on Thursday released new draft guidances for 32 drugs, including for those companies looking to develop generic versions of Mylan’s EpiPen (epinephrine) alternative Adrenaclick, Novartis’ cancer treatment Afinitor (everolimus) and AstraZeneca’s cancer treatment Lynparza (olaparib).

Categories: News, US, CDER, Drugs, Regulatory intelligence, Regulatory strategy, Research and development

Tags: FDA guidance, product-specific guidance, generic drug guidance

European Regulatory Roundup: MHRA Chief Floats Faster Reviews, Closer Ties to NICE (19 October 2017) By Nick Paul Taylor - Published 19 October 2017

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EMA, MHRA, Drugs, Regulatory intelligence, Regulatory strategy

Tags: Brexit, HPV vaccine, CHMP

WHO Will Hold Off on Using Biological Qualifiers for Biosimilars By Zachary Brennan - Published 19 October 2017

No consensus has been reached on whether the World Health Organization (WHO) should continue with its biological qualifier proposal in assigning international nonproprietary names for biosimilars, and WHO says it "will not be proceeding with this at present," according to an October report.

Categories: News, Asia, Europe, US, WHO, Biologics and biotechnology, Labeling, Postmarket surveillance

Tags: biological qualifier, biosimilar naming

European Commission Consults on Recalibrating Aspects of Drug Patents, SPCs By Zachary Brennan - Published 19 October 2017

The European Commission last week released for consultation a proposal to re-work certain elements of the EU pharmaceutical patent system and industry group Medicines for Europe is calling for the introduction of a Supplementary Protection Certificate (SPC) manufacturing waiver and for a wider definition of the research exemption.

Categories: News, Europe, EC, Biologics and biotechnology, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: Supplementary Protection Certificate, Bolar exemption, research exemption, pharmaceutical patents

Regulatory Recon: FDA Approves CAR-T Therapy from Gilead’s Kite (19 October 2017) By Zachary Brennan - Published 19 October 2017

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

Categories: News, Asia, Europe, US, EC, EMA, FDA, Biologics and biotechnology, Drugs, Medical Devices

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

FDA Analyst Counters Critiques of Orphan Drug Act By Michael Mezher - Published 18 October 2017

While recent reports have claimed that drugmakers are manipulating the incentives provided by the Orphan Drug Act, Mike Lanthier, an operations research analyst at the US Food and Drug Administration (FDA), says that in most cases, the act is working as intended.

Categories: News, FDA, Biologics and biotechnology, Drugs, Orphan products

Tags: Orphan Drugs, Orphan Drug Act

How Price Caps in India are Forcing US Device Companies to Sell Stents and Implants at a Loss By Zachary Brennan - Published 18 October 2017

Hypothetical talk circulating on Capitol Hill this week around the idea of price ceilings for certain pharmaceuticals set off alarm bells for industry. But on the medical device side, companies are already seeing what happens when a government, in this case India, sets price caps for certain devices and mandates that companies remain in the market and take a loss on sales.

Categories: News, India, US, MHLW, Government affairs, In vitro diagnostics, Medical Devices, Reimbursement

Tags: stents, knee implants, India price ceilings, medical devices in india

Updated FDA Manual Offers Inside Look at Inspection Protocols By Zachary Brennan - Published 18 October 2017

The US Food and Drug Administration (FDA) earlier this week published its 2017 version of a chapter of its investigations operations manual on establishment inspections, offering an inside look at how inspections are conducted and what companies should expect.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Government affairs, Manufacturing, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: FDA inspections, contamination, sterile environments

Regulatory Recon: Former Lilly Exec Said to be Front Runner for HHS Secretary; Alnylam Partners With Vir on RNAi Hep B Treatment (18 October 2017) By Michael Mezher - Published 18 October 2017

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

Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

ICH Transparency: New Info on Funding, Expert Working Groups By Zachary Brennan - Published 17 October 2017

The International Council for Harmonisation (ICH) on Monday began a push toward more transparency, with the release of which members make up its expert working groups and new data on how ICH is funded.

Categories: News, Asia, Canada, Europe, US, ICH, Biologics and biotechnology, Drugs, Regulatory intelligence, Regulatory strategy

Tags: ICH funding, E9, E11, S5

FDA Officials Offer Advice on Efficient Orphan Drug Development By Michael Mezher - Published 17 October 2017

A group of top US Food and Drug Administration (FDA) officials shared insights on how drugmakers can be more efficient when developing treatments for rare diseases, according to comments on Tuesday at the National Organization for Rare Disorders' (NORD) Summit in Washington, DC.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Drugs, Orphan products

Many Questions, Few Answers in Senate Hearing on Opaque US Drug Pricing System By Zachary Brennan - Published 17 October 2017

The Senate Health, Education, Labor & Pensions (HELP) committee on Tuesday discussed with representatives of the pharmaceutical supply chain how the drug delivery system affects what patients pay.

Categories: News, US, Drugs, Reimbursement

Tags: pharmaceutical pricing, Senate HELP committee, PhRMA

Asia Regulatory Roundup: India Tightens Stem Cell Guidelines (17 September 2017) By Nick Paul Taylor - Published 17 October 2017

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

Categories: News, Asia, CDSCO, CFDA, TGA, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: Asia Regulatory Roundup, stem cells, black triangle

Regulatory Recon: J&J Halts Two Drugs in Development; Novartis to Close Colorado Manufacturing Site (17 October 2017) By Zachary Brennan - Published 17 October 2017

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

Categories: News, Asia, Europe, US, EMA, FDA, Biologics and biotechnology, Drugs, Medical Devices

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

Biopharma Firms Seek Clarity on FDA Draft Guidance on CMC Annual Reports By Zachary Brennan - Published 16 October 2017

Industry groups and biopharma companies are seeking additional clarity from the US Food and Drug Administration (FDA) regarding draft guidance released in August on chemistry, manufacturing and controls (CMC) postapproval changes to be documented in annual reports.

Categories: News, US, FDA, Biologics and biotechnology, Manufacturing, Regulatory intelligence, Regulatory strategy

Tags: CMC changes, BIO, Sanofi, Pfizer, GSK, AAM

Court Finds Restasis Patents Invalid, Raises Concerns About Allergan, Mohawk Tribe Agreement By Zachary Brennan - Published 16 October 2017

In a setback for Allergan, four of the company’s patents covering its blockbuster eye drug Restasis were ruled invalid on Monday by the US District Court for the Eastern District of Texas. Allergan has said it will appeal the decision, but what might have a wider ripple effect was another order that raised questions about Allergan’s decision to pay to transfer the patents to a Native American tribe and prolong the launch of Restasis generics.

Categories: News, US, Biologics and biotechnology, Drugs, Due Diligence, Government affairs

Tags: Restasis, Allergan, Saint Regis Mohawk Tribe