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Filtering on: "topics biologics and biotechnology"

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Regulatory Recon: Novo Diabetes Drug Succeeds in Key Trial; Generic Drugmakers Feel Pinch as Prices Crumble (17 August 2017) By Zachary Brennan - Published 17 August 2017

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

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

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

European Regulatory Roundup: Ireland Starts Consultation on Biosimilar Policy (17 August 2017) By Nick Paul Taylor - Published 17 August 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

Tags: European regulatory roundup, Ireland biosimilars, CROs

Regulatory Recon: BMS Sees Mixed Results for Opdivo, Yervoy Combo in Kidney Cancer; South Carolina Sues Purdue Over Opioid Marketing (16 August 2017) By Michael Mezher - Published 16 August 2017

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

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

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

PhRMA Criticizes FDA's 'Unnecessary' Research on Drug Advertising and Promotion By Zachary Brennan - Published 16 August 2017

The pharmaceutical industry lobbying group known as the Pharmaceutical Research and Manufacturers of America (PhRMA) is harshly criticizing the US Food and Drug Administration's (FDA) research focused on prescription drug advertising and promotion and calling for a clearer vision on how this research protects public health.

Categories: News, US, FDA, Advertising and Promotion, Biologics and biotechnology, Drugs, Government affairs, Quality, Regulatory strategy

Tags: PhRMA, drug advertising and promotion, FDA research

How the Government Will Pay Companies to Develop Biodefense Products and Win Lucrative PRVs By Zachary Brennan - Published 15 August 2017

As the nearly 1,000-page 21st Century Cures Act is implemented in phases, the full impact of the law is just beginning to be realized, and for one provision, the law has created a new program that rewards companies for developing products that the government purchases and often pays to develop.

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

Tags: priority review vouchers, biodefense, medical countermeasures

Regulatory Recon: Early Looks at Trial Results Giving Investors Whiplash; Biosimilars Still Hard to Sell Against Rivals (15 August 2017) By Michael Mezher - Published 15 August 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

Asia Regulatory Roundup: No Manufacturers Have Complied With India's GMP Request (15 August 2017) By Nick Paul Taylor - Published 15 August 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

Tags: Asia Regulatory Roundup, DCGI, GMP/GLP

Regulatory Recon: FDA Restricts Foreign Scientist Hirings; Trump Blasts Merck CEO for Quitting Council (14 August 2017) By Michael Mezher - Published 14 August 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

Is Increasing Antibiotic Resistance Driving Bacteriophage Therapy Closer to Being a Reality? By Max Sherman - Published 14 August 2017

This article reviews the history of bacteriophage discovery, biology, and potential medical uses, and discusses therapeutic pros and cons compared to and potentially replacing antibiotics due to increasing antibiotic resistance. The article also highlights the future of phage therapy and the need for more scientific investigation and clinical trials prior to approval for human use and the possible patenting and regulatory issues impacting bacteriophage development. The US Food and Drug Administration (FDA) recently covered issues related to bacteriophage development during a workshop in July 2017.

Categories: Features, FDA, Biologics and biotechnology

Tags: Bacteriophage, Phage, Antimicrobial Resistance

Regulatory Recon: Trump Labels Opioid Crisis a National Emergency; FDA Warns of Deaths With Intragastric Balloons (11 August 2017) By Michael Mezher - Published 11 August 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: Grail Sees Hope for Liquid Biopsy; Study Finds Heart Drug Prescribing Slashed After Price Hikes (10 August 2017) By Michael Mezher - Published 10 August 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

Federal Circuit Dismisses Amgen Appeal on Pfizer's Epogen Biosimilar By Zachary Brennan - Published 10 August 2017

The US Court of Appeals for the Federal Circuit on Thursday dismissed Amgen’s appeal related to a lawsuit over Pfizer’s Epogen (epoetin alfa) biosimilar.

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

Tags: Epogen, epoetin alfa, complete response letter, Pfizer, Amgen

Do Drugs Approved Via Expedited Pathways Offer Greater Benefits? Study and Doctors Debate By Michael Mezher - Published 09 August 2017

A recent study in Health Affairs suggests that drugs given an expedited review by the US Food and Drug Administration (FDA) offer greater health gains than drugs that receiving a conventional review. But experts caution that the study might only show incremental benefits.

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

Tags: Priority Review, Accelerated Approval, Fast Track, Breakthrough Therapy

Regulatory Recon: SoftBank Bets $1.1B on US Biotech Roivant; Mylan Delays Product Launches Over Uncertainty (9 August 2017) By Michael Mezher - Published 09 August 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

Asia Regulatory Roundup: CFDA Seeks Feedback on Guidance for Medical Device Clinical Trial Sites (8 August 2017) By Nick Paul Taylor - Published 08 August 2017

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

Categories: News, Asia, CFDA, TGA, Biologics and biotechnology, Drugs, Medical Devices, Regulatory strategy, Submission and registration

Tags: Asia Regulatory Roundup, China guidance

EMA Reports Rise in Pharmacovigilance Inspections in 2016 By Michael Mezher - Published 08 August 2017

In a report released on Tuesday, the European Medicines Agency (EMA) said the number of pharmacovigilance inspections for centrally authorized products rose in 2016, mainly driven by an increase in routine inspections carried out under national inspection programs.

Categories: News, Europe, EMA, Biologics and biotechnology, Compliance, Drugs, Postmarket surveillance

Tags: Pharmacovigilance, Pharmacovigilance Inspections

Regulatory Recon: Kite CAR-T Drug Gets a Pass on Advisory Committee Review; FDA Again Rejects Valeant Glaucoma Drug Over Manufacturing Issues at Florida Site (8 August 2017) By Michael Mezher - Published 08 August 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

Proposed and Final FDA Rules: What’s Left in 2017 By Zachary Brennan - Published 08 August 2017

The US Food and Drug Administration (FDA) is planning to release seven proposed rules and six final rules to close out 2017, according to an updated list of Department of Health and Human Services rulemakings.

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

Tags: FDA rulemakings, biologics manufacturing inspections, de novo, medical device rulemakings

FDA Drafts Guidance on Postapproval Manufacturing Changes for Biologics By Zachary Brennan - Published 08 August 2017

As the number of chemistry, manufacturing and controls (CMC) postapproval manufacturing supplements continues to increase, the US Food and Drug Administration (FDA) on Tuesday released draft guidance offering recommendations for holders of biologics license applications (BLAs) on the types of minor changes to be documented in an annual report.

Categories: News, US, FDA, Biologics and biotechnology, Manufacturing, Postmarket surveillance

Tags: BLA, CMC changes, postapproval manufacturing changes, FDA draft guidance

WHO Drafts New Prequalification Timeline, KPIs By Zachary Brennan - Published 07 August 2017

As part of efforts to better monitor and improve the performance of its prequalification program, the World Health Organization (WHO) has proposed a new algorithm to calculate the prequalification timeline and drafted new key performance indicators (KPIs) to track. 

Categories: News, Asia, Europe, US, WHO, Biologics and biotechnology, Drugs, In vitro diagnostics, Regulatory intelligence, Regulatory strategy

Tags: WHO prequalification

Nature Editorial: FDA Needs Help Assessing Cutting-Edge Tech Published 07 August 2017

The US Food and Drug Administration (FDA) is increasingly being tasked with evaluating cutting-edge therapies and technology that its in-house expertise may not be able to address, according to a Nature editorial, which recommends academic scientists help the agency.

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

Tags: CAR-T, academic scientists, Scott Gottlieb

BIO Highlights IP Challenges Around the Globe By Zachary Brennan - Published 07 August 2017

As part of an effort to help the US Trade Representative understand and preserve strong intellectual property (IP) protections for US companies, the Biotechnology Innovation Organization (BIO) recently put together a report highlighting challenges worldwide and noting that IP reforms outside the US could improve conditions for exporting biotech products.

Categories: News, Africa, Asia, Middle East, Anvisa, CFDA, Biologics and biotechnology, Drugs, Government affairs

Tags: intellectual property BIO, biopharmaceutical patents, ANVISA, IP protections

Regulatory Recon: MyoKardia Plots Course After Phase II Success; How PBMs Maintain EpiPen Market Share Despite Generic Alternatives (7 August 2017) By Michael Mezher - Published 07 August 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

Former CDC Director: Medicine Should Look Beyond Randomized Controlled Trials By Michael Mezher - Published 04 August 2017

In an article in the New England Journal of Medicine on Thursday, former director of the US Centers for Disease Control and Prevention Thomas Frieden calls for greater use of alternative data sources, other than randomized controlled trials (RCTs), for health care decision making.

Categories: News, Biologics and biotechnology, Clinical, Drugs

Tags: Randomized Controlled Trials, RCTs, Observational Studies

Regulatory Recon: BMS to Acquire IFM Therapeutics in $2.3B Deal; FDA Approves AbbVie's 8-Week Pan-Genotypic Hep C Drug (4 August 2017) Published 04 August 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