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Filtering on: "topics biologics and biotechnology"

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Regulatory Recon: Teva Said to Reveal Restructuring Plan Thursday; Sanofi Looks to Pipeline to Offset Recent Setbacks (13 December 2017) By Michael Mezher - Published 13 December 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

Resolving Gene Editing Technology's Ethical and Regulatory Challenges By Vidya Narayanaswami, PhD, Dr. Stephen F. Amato - Published 13 December 2017

This article provides an overview of biomedical applications of gene editing technology, addresses ethical and regulatory challenges associated with its implementation for therapeutic development, and proposes approaches for overcoming these challenges.

Categories: Features, FDA, Biologics and biotechnology, Ethics

Tags: Gene Editing, Gene Therapy, CRISPR, Cas9

Regulatory Recon: FDA Approves First Drug for Eosinophilic Granulomatosis with Polyangiitis; Allergan Acquires Ailing Repros (12 December 2017) By Michael Mezher - Published 12 December 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

When Can FDA 'Refuse to File' NDAs and BLAs? New Draft Guidance Explains By Zachary Brennan - Published 12 December 2017

When a new drug application (NDA) or biologics license application (BLA) is deemed incomplete by the US Food and Drug Administration (FDA), the agency can decide not to review the application. So when can this occur? On Tuesday, the agency released draft guidance on what incompleteness means and when it can lead to a "refusal to file" decision.

Categories: News, US, FDA, Biologics and biotechnology, Compliance, Drugs, Due Diligence, Government affairs, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: refuse to file, NDA, BLA, FDA draft guidance

French Regulators Set Up Dedicated Unit for Overseeing Early Stage Clinical Trials By Michael Mezher - Published 11 December 2017

France's Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) last week announced that it is setting up a new unit dedicated to overseeing first-in-human and other early stage clinical trials.

Categories: News, Europe, EMA, Biologics and biotechnology, Clinical, Drugs

Tags: First-in-Human, Clinical Trials, ANSM, Bial

Regulatory Recon: News From ASH 2017; Drugmakers Sue to Block Calif. Price Law (11 December 2017) Published 11 December 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

Have PRVs Incentivized New Rare or Neglected Disease Research? Experts Discuss By Zachary Brennan - Published 08 December 2017

The priority review voucher (PRV) programs, created by Congress with an eye to incentivizing the development of new rare pediatric and neglected tropical disease drugs, have so far rewarded a wide range of small and large biopharma companies and projects, though whether PRVs have actually spurred new research remains a question.

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

Tags: priority review voucher, neglected tropical disease, rare pediatric disease

IPRF and IGRP Merge to Become the International Pharmaceutical Regulators Programme  By Zachary Brennan - Published 08 December 2017

With an aim toward better exchanging information and avoiding duplication, the International Pharmaceutical Regulators Forum (IPRF) and International Generic Drug Regulators Programme (IGDRP) initiatives will merge as of the first of next year and be known as the International Pharmaceutical Regulators Programme (IPRP), according to notes from the IPRF's management committee meeting in Geneva on 12-13 November.

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

Tags: IGDRP, IPRF,

Regulatory Recon: Trump Signs Short-Term Funding Bill Averting Shutdown; Philippines Seeks $59M Refund for Sanofi Dengue Vaccine (8 December 2017) By Michael Mezher - Published 08 December 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

Regulatory Recon: Sage Rises as Depression Drug Succeeds in Phase II; Edwards to Buy Harpoon for $250M (7 December 2017) By Michael Mezher - Published 07 December 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

Tracking Post-Approval Study Completion: Majority On-Schedule but Not Submitted By Zachary Brennan - Published 07 December 2017

The US Food and Drug Administration (FDA) on Thursday released its most recent report tracking the progress that new drug and biologic applicants are making on post-approval studies.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy, Research and development

Tags: post-approval studies, research requirements, post-marketing research

European Regulatory Roundup: EU Stands Firm on Demand for UK to Pay for EMA’s Exit (7 December 2017) By Nick Paul Taylor - Published 07 December 2017

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

Categories: News, Europe, EC, EMA, Biologics and biotechnology, Drugs, Government affairs

Tags: Brexit, PRAC, orphan drugs

FDA Puts Opioids, Compounding, Stem Cells at Forefront of Enforcement Efforts By Zachary Brennan - Published 06 December 2017

The US opioid epidemic, drug compounding and the proliferation of stem cell clinics selling unproven treatments were highlighted as some of the focal points for US Food and Drug Administration (FDA) enforcement efforts last year and next year, officials said Wednesday at the Food and Drug Law Institute’s litigation and compliance conference in Washington, D.C.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Government affairs

Tags: opioids, FDA enforcement, FDA compliance, FDLI, stem cells

FDA's Frey Reflects on Final Year of PDUFA V By Michael Mezher - Published 06 December 2017

As the year comes to a close, Patrick Frey, senior advisor to the director of the Office of New Drugs (OND) at the Center for Drug Evaluation and Research (CDER), looked back at FDA's performance over the final year of the fifth iteration of the Prescription Drug User Fee Act (PDUFA V) and what's to come in PDUFA VI.

Categories: News, US, CDER, Biologics and biotechnology, Communication, Drugs, Orphan products, Submission and registration

Tags: PDUFA, NDA, BLA, Orphan Drugs, Approvals

Regulatory Recon: FDA Approves Novo Nordisk's Diabetes Drug Ozempic; Australian Competition Watchdog Sues GSK, Novartis Over Pain Relief Marketing (6 December 2017) By Michael Mezher - Published 06 December 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

Regulatory Recon: Galectin Plummets After NASH Candidate Fails in Phase IIb Trial; Montana Sues Purdue Over Opioid Epidemic (5 December 2017) By Michael Mezher - Published 05 December 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

Woodcock: CDER Informatics System is Top Priority for 2018 By Michael Mezher - Published 05 December 2017

Going into 2018, Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration (FDA), said that her top priority will be to implement a center-wide informatics system.

Categories: News, US, CDER, Biologics and biotechnology, Compliance, Generic drugs, Over the counter drugs, Prescription drugs, Submission and registration

Tags: 21st Century Cures, Informatics, CDER

Asia Regulatory Roundup: Australia Bans Transvaginal Mesh Products (5 December 2017) By Nick Paul Taylor - Published 05 December 2017

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

Categories: News, China, Oceania, CFDA, TGA, Biologics and biotechnology, Drugs, Medical Devices

Tags: transvaginal mesh, confidential information, medicine naming

Regulatory Recon: CVS to Buy Aetna for $69B; FDA Approves Heart Protection Claims for Amgen's Repatha (4 December 2017) By Michael Mezher - Published 04 December 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

Evaluating Analytical Similarity: Stakeholders Raise Questions With FDA Draft Guidance By Zachary Brennan - Published 04 December 2017

Biopharma companies and industry groups, including Pfizer, Genentech, Boehringer Ingelheim and the Biosimilars Council, have raised detailed questions in recently released comments on the US Food and Drug Administration’s (FDA) draft guidance on statistical approaches to evaluate analytical similarities for biosimilars.

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

Tags: biosimilar guidance, analytical similarity

Merck and PhRMA to FDA: Wait for ICH Before Finalizing Guidance on Toxicity Testing for Cancer Drugs By Zachary Brennan - Published 04 December 2017

Drugmakers and industry groups are calling on the US Food and Drug Administration (FDA) to hold off on finalizing a draft guidance until the International Council on Harmonisation (ICH) finalizes its own guidance on the topic of reproductive toxicity testing for oncology drugs.

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

Tags: cancer drugs, toxicity

March 2019: EMA Updates Guidance on Brexit By Zachary Brennan - Published 01 December 2017

The European Medicines Agency (EMA) and the European Commission on Friday updated guidance for pharmaceutical companies on the UK’s departure from the EU, much of which hinges on March 2019 deadlines.

Categories: News, Europe, EC, EMA, Biologics and biotechnology, Drugs

Tags: Brexit

FDA Approves Eighth Biosimilar, First for Cancer Drug Herceptin By Zachary Brennan - Published 01 December 2017

The US Food and Drug Administration (FDA) on Friday approved the first biosimilar to Roche’s breast and stomach cancer drug Herceptin (trastuzumab). Mylan and Biocon’s biosimilar is called Ogivri (trastuzumab-dkst) and follows a back and forth of delays with regulators over manufacturing issues at a plant in India.

Categories: News, Canada, Europe, US, FDA, Biologics and biotechnology

Tags: Herceptin, biosimilar, FDA approval

Regulatory Recon: Astellas Acquires MitoBridge in $450M Deal; National Academy of Sciences Report Lays Out Steps to Cut Drug Prices (1 December 2017) By Michael Mezher - Published 01 December 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

Cures Act Implementation: Gottlieb Says Faster Cancer Drug Approvals Coming for Secondary Indications By Zachary Brennan - Published 30 November 2017

US Food and Drug Administration (FDA) Commissioner Scott Gottlieb and NIH Director Francis Collins testified on Thursday before the House Energy & Commerce Committee on how their agencies have worked to implement provisions from the 21st Century Cures Act passed and signed by President Barack Obama a month before he left office.

Categories: News, FDA, Biologics and biotechnology, Drugs, Regulatory intelligence, Regulatory strategy

Tags: 21st Century Cures, Scott Gottlieb, FDASIA