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Filtering on: "topics regulatory intelligence"

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Regulatory Recon: Trump Showcases Corning Drug Packaging Investment; MHRA To Relocate Near EMA's Current Offices (21 July 2017) By Michael Mezher - Published 21 July 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: NICE Gives Final OKs to Amgen's Kyprolis, Teva's Cinqaero; Ablynx, Sanofi Sign Immunology Deal Worth Up to $2.8B (20 July 2017) By Michael Mezher - Published 20 July 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: Vertex Three Drug Cystic Fibrosis Combos Beat Expectations; FDA Approves Gilead's Vosevi for 2nd Line HCV Treatment (19 July 2017) By Michael Mezher - Published 19 July 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: FDA Approves Puma's Breast Cancer Drug Nerlynx; US Court Upholds Takeda Patent on Velcade (18 July 2017) By Michael Mezher - Published 18 July 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: FDA Accepts Spark's Gene Therapy Application; Amgen Gets CRL for Osteoporosis Candidate Evenity (17 July 2017) Published 17 July 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: J&J Uses Priority Review Voucher to Speed Psoriasis Approval; DoJ Charges 412 in Healthcare, Opioid Schemes (14 July 2017) By Michael Mezher - Published 14 July 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: Amgen's Blincyto Wins Full FDA Approval; NICE Backs Three Drugs for Plaque Psoriasis in Children (13 July 2017) By Michael Mezher - Published 13 July 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

FDA Panel Votes Unanimously in Favor of First CAR-T Cancer Therapy By Zachary Brennan - Published 12 July 2017

The US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee on Wednesday voted unanimously, 10 to 0, in favor of the benefit-risk profile for the first of a new kind of cancer therapy, known as a Chimeric Antigen Receptor T-cell (CAR-T) therapy.

Categories: News, US, FDA, Government affairs, Human cell and tissue, Manufacturing, Quality, Regulatory intelligence, Regulatory strategy

Tags: CAR-T, Novartis, CTL019, gene therapy, cell therapy, ODAC

GAO: FDA Improved Expanded Access but More Clarity Necessary By Zachary Brennan - Published 11 July 2017

With the rise of Right-to-Try legislation across  the US, it might seem like patients with serious or life-threatening ailments and no other comparable medical options might have difficulties in obtaining access to investigational drugs outside of a clinical trial because of the US Food and Drug Administration (FDA).

Categories: News, US, FDA, Drugs, Regulatory intelligence, Regulatory strategy

Tags: expanded access, compassionate use, GAO reports, adverse events

FDA Finalizes List of 1,003 Class II Device Types Exempt From 510(k) Requirements By Zachary Brennan - Published 10 July 2017

The US Food and Drug Administration (FDA) on Monday finalized a list of 1,003 types of class II medical devices that the agency believes do not present risks that require premarket notification review to provide a reasonable assurance of safety and effectiveness.

Categories: News, US, FDA, Government affairs, In vitro diagnostics, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: 510(k), device exemptions, 21st Century Cures, Class II medical devices

FDA Looks to Standardize PQ/CMC Data and Terminologies By Zachary Brennan - Published 10 July 2017

The US Food and Drug Administration (FDA) on Monday said it is drafting and seeking comment on the use of standardized Pharmaceutical Quality/Chemistry Manufacturing and Control (PQ/CMC) data elements for electronic submission.

Categories: News, US, FDA, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: CMC submissions, electronic submissions FDA, PQ/CMC data

FDA Speeding Generic Drug Approvals: Not Just Lip Service By Zachary Brennan - Published 10 July 2017

May and June 2017 have seen the most generic drug approvals since the US Food and Drug Administration (FDA) began tallying its monthly approvals, lending credence to FDA Commissioner Scott Gottlieb's pledge to speed approvals and lower drug costs.

Categories: News, US, FDA, Generic drugs, Regulatory intelligence, Regulatory strategy

Tags: FDA generic drug approvals, GDUFA, ANDA approvals

FDA Approves First New Sickle Cell Drug in Almost 20 Years By Zachary Brennan - Published 07 July 2017

The US Food and Drug Administration (FDA) on Friday granted approval to Emmaus Medical’s Endari (L-glutamine oral powder), the first treatment approved for patients with sickle cell disease in almost 20 years.

Categories: News, US, FDA, Drugs, Regulatory intelligence, Submission and registration

Tags: sickle cell, new FDA drug, Endari

Regulatory Recon: FDA Halts Three Keytruda Studies After Patient Deaths; Euro Biotech Firms Raised $2.3B in First Half of 2017 (6 July 2017) By Michael Mezher - Published 06 July 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

European Regulatory Roundup: New Gateway for Parallel Consultations on Marketing Authorizations, HTAs (6 July 2017) By Nick Paul Taylor - Published 06 July 2017

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

Categories: News, Europe, EC, EMA, MHRA, Biologics and biotechnology, Drugs, Due Diligence, Regulatory intelligence, Regulatory strategy

Tags: EUnetHTA, type II variations, ATMPs

10 Years in, EU Pediatric-Use Marketing Authorization Called a 'Disappointment' By Zachary Brennan - Published 06 July 2017

Biopharmaceutical companies and regulators across Europe have said that in the 10 years since the Pediatric Regulation took effect, some pediatric therapeutic areas have seen progress, though the pediatric-use marketing authorization (PUMA) has not lived up to expectations.

Categories: News, Europe, EC, EMA, MHRA, Biologics and biotechnology, Drugs, Orphan products, Regulatory intelligence, Regulatory strategy

Tags: pediatric-use marketing authorisation, EMA and PUMA, pediatric drugs

Regulatory Recon: NICE Expands Access to Strensiq; Stada Execs Step Down as Bain, Cinven Prepare New Bid (5 July 2017) By Michael Mezher - Published 05 July 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

Pediatric Legislation, Quality Certificates, Global Regulatory Oversight, Biosimilars and a Preview of July By Gloria Hall - Published 05 July 2017

Feature articles over the past several weeks have highlighted global pediatric activities, certificates for small molecule drug products, the New Drug Application (NDA) process in Egypt and the global debate over naming biological products and biosimilars.

Categories: Features, Africa, Asia, Canada, Europe, Oceania, US, EMA, FDA, Health Canada, MHLW, TGA, WHO, Biologics and biotechnology, Clinical, Drugs, Medical Devices, Regulatory intelligence, Submission and registration

Tags: Regulatory Focus, Feature Articles

Researchers Find Most Expert Speakers at FDA ODAC Meetings Receive Sizable Industry Payments By Zachary Brennan - Published 05 July 2017

Experts speaking on behalf of a pharmaceutical company at US Food and Drug Administration (FDA) Oncology Drug Advisory Committee (ODAC) meetings often receive sizable sums, raising questions about the relationships between the companies and the experts ahead of three ODAC meetings next week.

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

Tags: ODAC, Oncology Drug Advisory Committee, FDA advisory committees

Regulatory Recon: Canada Supreme Court Hands Patent Victory to Pharma; GSK Signs $43m AI Drug Discovery Deal (3 July 2017) By Michael Mezher - Published 03 July 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

British Ministers Call for Post-Brexit Cooperation With EMA By Zachary Brennan - Published 03 July 2017

UK health minister Jeremy Hunt and business minister Greg Clark on Monday wrote a letter to the Financial Times calling for the UK to continue working with the European Medicines Agency after Brexit.

Categories: News, Europe, EC, EMA, MHRA, Biologics and biotechnology, Crisis management, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: Brexit, Jeremy Hunt, EMA post-Brexit

EMA and FDA Look to Facilitate Development of Gaucher Disease Treatments By Zachary Brennan - Published 03 July 2017

The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) on Monday released a new strategy document to aid in the development of new treatments for Gaucher disease, a rare lysosomal storage disorder.

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

Tags: EMA and FDA, Gaucher disease, rare pediatric disease

ICER to Work With VA on Drug Price Negotiations By Zachary Brennan - Published 03 July 2017

In a first for the Institute for Clinical and Economic Review (ICER), which estimates the cost-effectiveness of drugs, the Department of Veterans Affairs (VA) Pharmacy Benefits Management Services office (PBM) has agreed to use ICER drug assessment reports in drug coverage and price negotiations with the pharmaceutical industry.

Categories: News, US, Drugs, Government affairs, Regulatory intelligence

Tags: ICER, VA, drug prices

Regulatory Recon: Pfizer's Besponsa Gets EU Approval; Roche Buys Diabetes App Firm (30 June 2017) By Michael Mezher - Published 30 June 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: World Bank Launches Pandemic Bond; Final NICE OK for Sanofi Gaucher Drug (29 June 2017) By Michael Mezher - Published 29 June 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