Search Results for Zachary Brennan

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EMA Plots Workload Shift Ahead of UK Experts' Departures in 2019 By Zachary Brennan - Published 28 April 2017

With a meeting yesterday between the European Medicines Agency's (EMA) Management Board and heads of the National Competent Authorities (NCAs) of the EU/EEA member states, a discussion was initiated on how to share the work of evaluating and monitoring medicines without the UK's help.

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

Tags: Brexit, EMA headquarters, EMA move

House and Senate Revive Bill Targeting Generic Drug Delays By Zachary Brennan - Published 27 April 2017

Leaders of the Senate and House Judiciary Committees, led by Sen. Patrick Leahy (D-VT), on Thursday re-introduced legislation to combat anticompetitive practices that can block the market entry of lower-cost generic drugs. 

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

Tags: CREATES Act, generic drug delay, REMS, Leahy

FDA Approves First Treatment for a Form of Batten Disease By Zachary Brennan - Published 27 April 2017

The US Food and Drug Administration (FDA) on Thursday approved the first-ever treatment for a form of the rare pediatric Batten disease, bringing Biomarin its second lucrative priority review voucher (PRV).

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

Tags: Batten disease, priority review voucher, PRV, Stivarga, Brineura, Bayer, Biomarin

Senate Committee Advances Gottlieb Nomination as FDA Commissioner By Zachary Brennan - Published 27 April 2017

The Senate Health, Education, Labor & Pensions (HELP) committee on Thursday advanced Dr. Scott Gottlieb’s nomination to lead the US Food and Drug Administration (FDA).

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

Tags: Gottlieb, Senate FDA, FDA commissioner

Supreme Court Weighs Biosimilar Patent Dance By Zachary Brennan - Published 26 April 2017

All nine justices of the US Supreme Court gathered Wednesday to hear oral arguments from the lawyers of Novartis subsidiary Sandoz and Amgen, who took sides on what's known as the biosimilar "patent dance," and whether a notice of licensure 180 days prior to marketing is necessary.

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

Tags: Supreme Court, biosimilars, Novartis, Sandoz

FDA Warns Teva API Plant in China By Zachary Brennan - Published 25 April 2017

The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent 10 April to Teva for deficiencies related to an active pharmaceutical ingredient (API) manufacturing site in Hangzhou, China.

Categories: News, US, FDA, Active pharmaceutical ingredients, Drugs, Postmarket surveillance, Regulatory intelligence, Regulatory strategy

Tags: Teva, warning letter, FDA inspections

Generic Drug Industry Group Seeks FDA Regulation Changes By Zachary Brennan - Published 25 April 2017

The Association of Accessible Medicines (AAM), formerly known as the Generic Pharmaceutical Association, has recommended five major US Food and Drug Administration (FDA) regulation tweaks in a letter to the Department of Commerce.

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

Tags: generic drug policy, AAM and FDA regulations, label changes for generics

Pharma Execs Seek Smooth and Quick Transition of EMA Headquarters Out of London By Zachary Brennan - Published 24 April 2017

With an eye to avoiding public health issues during a transition period, executives from Novartis, Pfizer, Eli Lilly, Amgen and other companies are calling on the European Council to decide on the new headquarters location of the European Medicines Agency (EMA) “as early on as possibly, preferably at its meeting in June.”

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

Tags: Brexit, EMA headquarters

FDA Offers Draft Guidance on Generic Versions of Opioid Overdose Nasal Spray By Zachary Brennan - Published 24 April 2017

As the opioid epidemic continues to spread, the US Food and Drug Administration (FDA) is looking to alleviate some of that pain by offering draft guidance to generic drug companies looking to develop generic versions of the nasal spray that can revive those who have overdosed on opioids.

Categories: News, US, FDA, Combination products, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: Narcan, opioid overdose, Narcan nasal spray, naloxone

FDA to Texas and Arizona: Destroy or Export Detained Shipments of Execution Drugs By Zachary Brennan - Published 24 April 2017

After a lengthy wait, the US Food and Drug Administration (FDA) has officially told Texas and Arizona that their imported execution drugs cannot be used because they were unlawfully obtained.

Categories: News, US, FDA, Crisis management, Drugs, Due Diligence

Tags: sodium thiopental, execution drugs, FDA and state executions, misbranded drugs

MHRA Plans for the Future of Drug, Device Regulation Post-Brexit By Zachary Brennan - Published 21 April 2017

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Friday released a business plan for the upcoming year, noting its primary focus on developing a consensus around a proposed model for the future of the country’s regulation of medicines and medical devices following its departure from the EU.

Categories: News, Europe, EC, EMA, MHRA, NICE, Drugs, Government affairs, Medical Devices

Tags: UK MHRA business plan, UK medical devices, pharmaceutical regulations

Medical Product Communications: Industry Seeks to Reform FDA Draft Guidances By Zachary Brennan - Published 21 April 2017

With a flood of new comments, pharmaceutical, biotech and medical device companies are seeking changes to two draft guidances explaining the US Food and Drug Administration's (FDA) evolving policies on industry communications with payers and claims that adhere to a drug's label.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Government affairs, In vitro diagnostics, Labeling, Medical Devices

Tags: medical product communications, off-label promotion, payer communications

FDA Approves 5th Biosimilar, 2nd for Remicade By Zachary Brennan - Published 21 April 2017

The US Food and Drug Administration (FDA) on Friday announced its fifth biosimilar approval: Samsung Bioepis’ Renflexis (infliximab-abda), an intravenous infusion for multiple indications.

Categories: News, US, FDA, Biologics and biotechnology

Tags: biosimilar, FDA approval

Regulatory Recon: Biotech M&A Falls Off; E&C Presses HHS on Pandemic Flu Plan (21 April 2017) By Zachary Brennan - Published 21 April 2017

Welcome to Regulatory Recon, a daily regulatory news and intelligence briefing.

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

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

Regulatory Recon: Uniqure to Abandon Gene Therapy in EU; Pfizer Subpoenaed Over Saline Shortages (20 April 2017) By Zachary Brennan - Published 20 April 2017

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @RAPSorg on Twitter.

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

US Supreme Court to Consider Biosimilar Patent Process Next Week By Zachary Brennan - Published 20 April 2017

The highest court in the US next Wednesday will take up a fight over the so-called biosimilar "patent dance" and whether biosimilar companies have to notify reference product sponsors of the impending marketing of a new product, likely leading to a decision with ramifications for all subsequent biosimilars approved by the US Food and Drug Administration (FDA).

Categories: News, US, FDA, Biologics and biotechnology, Compliance, Ethics, Government affairs

Tags: biosimilars, Amgen, Sandoz, patents

FDA Requires Label Changes to Better Protect Children From Pain and Cough Medicines By Zachary Brennan - Published 20 April 2017

The US Food and Drug Administration (FDA) on Thursday announced label changes to two opioids, codeine and tramadol (found in various prescription pain and cough medicines and some over-the-counter cough medicines), to better protect children from serious risks.

Categories: News, US, FDA, Crisis management, Government affairs, Labeling

Tags: codeine, tramadol, label changes

EMA-FDA QbD Pilot Program Led to Further Harmonization By Zachary Brennan - Published 19 April 2017

The European Medicines Agency (EMA) and US Food and Drug Administration (FDA) have wrapped up a joint pilot program assessing applications containing Quality by Design (QbD) elements that led to further hamornization of concepts introduced through the International Council for Harmonisation (ICH).

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

Tags: QbD pilot, EMA-FDA joint program, quality by design

FDA Hedges: A Proposal to Better Share R&D Risks By Zachary Brennan - Published 19 April 2017

The probability that an investigational drug will succeed in all three phases of clinical trials and win US Food and Drug Administration (FDA) approval is very low. So low, in fact, that a group of economists have written a new paper calling for a system whereby developers could hedge their research and development (R&D) risks by buying options that would pay companies a pre-specified amount in the event that a treatment fails a given phase of the FDA approval process.

Categories: News, US, FDA, Biologics and biotechnology, Business and Leadership, Drugs, Ethics

Tags: R&D risk, pharmaceutical risks, FDA hedges

Theranos Agrees to Two Year Ban, Refunds Every Arizonan Who Purchased a Blood Test By Zachary Brennan - Published 18 April 2017

As part of an agreement reached with Arizona attorney general Mark Brnovich, the medical device startup Theranos on Tuesday agreed to pay $4.65 million for about 1.5 million blood tests sold to more than 175,000 Arizonans.

Categories: News, US, Compliance, Crisis management, In vitro diagnostics, Medical Devices

Tags: Theranos, blood test, Arizona, CMS

FDA Warns LA-Based Medical Food Company for Clinical Trial Without an IND By Zachary Brennan - Published 18 April 2017

The US Food and Drug Administration (FDA) warning letter released Tuesday says that Los Angeles-based Targeted Medical Pharma ran a clinical investigation of a medical food without first submitting an investigational new drug (IND) application to the agency.

Categories: News, US, FDA, Clinical, Compliance, Crisis management, Nutritional and dietary supplements, Research and development

Tags: warning letter, LA medical foods, medical food clinical trial

MHRA Investigates GMP Deficiency Trends From 2016 By Zachary Brennan - Published 18 April 2017

The UK’s Medicines & Healthcare products Regulatory Agency (MHRA) on Tuesday released a new report on the trends seen from inspecting pharmaceutical manufacturing plants and evaluating their good manufacturing practices (GMPs).

Categories: News, Europe, MHRA, Government affairs, Manufacturing, Regulatory intelligence, Regulatory strategy

Tags: GMP deficiencies, pharmaceutical inspections, GMP deficiency trends

Drug and Device Companies Offer Recommendations for FDA’s Combo Product Policy Council By Zachary Brennan - Published 17 April 2017

Johnson & Johnson (J&J), Allergan, Pfizer and industry group BIO’s suggestions to the US Food and Drug Administration’s (FDA) new Combination Product Policy Council released Monday build on efforts included in the 21st Century Cures Act and the new user fee agreements.

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

Tags: J&J, Pfizer, Allergan, combination products and FDA

BIO, AdvaMed Seek to Tweak FDA’s New Pre-Request Draft Guidance for Combo Products By Zachary Brennan - Published 17 April 2017

Industry groups BIO and AdvaMed are seeking some changes to the US Food and Drug Administration’s (FDA) guidance on requesting informal input on combination product designations.

Categories: News, US, CBER, CDER, CDRH, Biologics and biotechnology, Combination products, Drugs, In vitro diagnostics, Medical Devices, Quality, Regulatory intelligence, Regulatory strategy

Tags: BIO, AdvaMed, combination product guidance, pre-RFD program

Senate, House Draft Reauthorization Bill to Increase Drug, Medical Device User Fees By Zachary Brennan - Published 14 April 2017

With an aim to avoid thousands of US Food and Drug Administration (FDA) employee layoffs, House and Senate committees on Friday released a draft bill to reauthorize the user fee programs for pharmaceuticals, generic drugs, medical devices and biosimilars from 2018 to 2022.

Categories: News, US, FDA, Active pharmaceutical ingredients, Biologics and biotechnology, Combination products, Drugs, Due Diligence, Government affairs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: user fee reauthorization, FDA user fees, drug review fees