Search Results for Michael Mezher

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Regulatory Recon: Roche Surges on Positive Lung Cancer, Hemophilia A Results; Bayer Signs Development Deal with Japan's PeptiDream (20 November 2017) By Michael Mezher - Published 20 November 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

Study Uses Real World Evidence to Replicate Pivotal Trial Results By Michael Mezher - Published 20 November 2017

A study published in JAMA Internal Medicine on Monday was able to replicate the results of a large randomized controlled clinical trial for the blood pressure drug telmisartan using real world evidence gathered from insurance claims data.

Categories: News, US, FDA, Drugs

Tags: Real World Evidence

Regulatory Recon: FDA Panel Votes No on Bayer's Inhaled Cipro; Takeda CEO Eyes Deals Outside Japan (17 November 2017) By Michael Mezher - Published 17 November 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, EMA and PMDA Plot Harmonized Path for Antibiotics By Michael Mezher - Published 17 November 2017

Regulators from the US Food and Drug Administration (FDA), European Medicines Agency (EMA) and Japan's Pharmaceuticals and Medical Devices Agency (PMDA), met in Tokyo last month to plot out an approach that would allow drugmakers to conduct a single development plan for new antibiotics.

Categories: News, EMA, FDA, PMDA, Clinical, Drugs, Preclinical

Tags: Antimicrobial Resistance, AMR, Antibiotics, Harmonization

Devices Referencing Drugs: Questions Raised Over Potential Regulatory Pathways By Michael Mezher - Published 16 November 2017

The US Food and Drug Administration (FDA) on Thursday held a public hearing to look into the scientific, regulatory and legal challenges posed by devices referencing drugs (DRDs) and the agency's proposed approach to regulating such products.

Categories: News, US, FDA, Combination products, Drugs, Medical Devices, Postmarket surveillance, Submission and registration

Tags: Devices Referencing Drugs, DRD, Combination Products

Regulatory Recon: FDA Approves Roche Hemophilia A Drug Hemlibra; Ultragenyx Gets Priority Review Voucher With Enzyme Replacement Therapy Approval (16 November 2017) By Michael Mezher - Published 16 November 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 Announces Third-Party Review Pathway for Tumor Profiling Tests By Michael Mezher - Published 15 November 2017

The US Food and Drug Administration (FDA) on Wednesday announced it has cleared a next-generation sequencing (NGS) test developed by Memorial Sloan Kettering Cancer Center (MSK) that can detect 468 unique gene mutations and other molecular biomarkers in a patient's tumor.

Categories: News, US, FDA, In vitro diagnostics, Submission and registration

Tags: Next-Generation Sequencing, NGS, Tumor Profiling Tests, MSK-IMPACT, New York State Department of Health, NYSDOH

Regulatory Recon: AstraZeneca Bags Approvals for Fasenra, Faslodex; Shanghai Pharma to Buy Cardinal's China Business for $557M (15 November 2017) By Michael Mezher - Published 15 November 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

Lupin Warned by FDA for Deficiencies at Two Facilities By Michael Mezher - Published 15 November 2017

The US Food and Drug Administration (FDA) earlier this month warned Indian drugmaker Lupin Limited for good manufacturing practice (GMP) deficiencies at its facilities in Goa and Indore, India.

Categories: News, India, US, FDA, APIs, Drugs, Manufacturing

Tags: Warning Letter, GMP, Lupin, Goa, Indore

Experts Tell Senate Committee Current Gene Editing Regulations are Appropriate By Michael Mezher - Published 14 November 2017

At a Senate Health, Education, Labor and Pensions (HELP) hearing in Washington, D.C. on Tuesday, experts explained that the current regulatory framework for gene editing in the US is appropriate and cautioned that an overly strict approach could drive research to other countries.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Ethics

Tags: Gene Editing, Gene Therapy, CRISPR, CRISPR-Cas9, Editas

Regulatory Recon: FDA Approves Otsuka, Proteus' Digital Pill; Janssen Drops Suit Against Samsung Bioepis' Remicade Biosimilar (14 November 2017) By Michael Mezher - Published 14 November 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 Sets Monthly ANDA Records in October By Michael Mezher - Published 14 November 2017

The US Food and Drug Administration (FDA) in October issued complete responses to 325 abbreviated new drug applications (ANDAs) and approved or tentatively approved 101 ANDAs, the highest numbers in a single month since the enactment of Generic Drug User Fee Amendments (GDUFA).

Categories: News, US, FDA, Generic drugs, Submission and registration

Tags: ANDAs, GDUFA II, Complete Responses

Regulatory Recon: Gates Makes $100M Investment in Alzheimer's R&D; J&J, Zymeworks Enter Potential $1B Discovery Pact (13 November 2017) By Michael Mezher - Published 13 November 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

EMA, EUnetHTA Sign Off on Three-Year Work Plan By Michael Mezher - Published 13 November 2017

The European Medicines Agency (EMA) and the European Network for Health Technology Assessment (EUnetHTA) on Monday detailed their priorities for the next three years in a joint work plan.

Categories: News, Europe, EMA, Biologics and biotechnology, Drugs, Reimbursement, Submission and registration

Tags: EUnetHTA, HTA, Health Technology Assessment, Parallel Advice

EMA Backs Six Drugs, One Biosimilar for EU Approval By Michael Mezher - Published 10 November 2017

The European Medicines Agency (EMA) on Friday said that its Committee for Medicinal Products for Human Use (CHMP) is recommending six new drugs, a biosimilar and three generic medicines for EU approval.

Categories: News, Europe, EMA, Biologics and biotechnology, Drugs, Submission and registration

Tags: Marketing Authorization Applications, CHMP, Accelerated Assessment, Orphan Designation, Biosimilar, Jorveza, Prevymis, Ocrevus, Adynovi, Fasenra, Intrarosa, Mvasi

Nearly Half of Recent EU Approvals Based on a Single Pivotal Study By Michael Mezher - Published 10 November 2017

A recent study found that 45% of marketing authorizations granted in the EU from 2012 to 2016 were based on evidence from a single pivotal trial.

Categories: News, Europe, US, EMA, FDA, Biologics and biotechnology, Clinical, Drugs, Regulatory strategy

Tags: Pivotal Trials, Single Pivotal Study

Regulatory Recon: FDA Approves Dynavax's Hep B Vaccine; BMS' Sprycel Approved for Pediatric Ph+ CML (10 November 2017) By Michael Mezher - Published 10 November 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

Reproductive Toxicity: FDA Consults on Revised ICH Guideline By Michael Mezher - Published 09 November 2017

The US Food and Drug Administration (FDA) on Thursday released a draft guidance for consultation on a revision to the International Council for Harmonization (ICH) guideline on reproductive toxicity testing.

Categories: News, US, FDA, ICH, Biologics and biotechnology, Clinical, Drugs, Preclinical

Tags: Reproductive Toxicity, ICH, S5(R3), Draft Guideline

Regulatory Recon: Sage Shares Soar After Postpartum Depression Drug Meets Phase III Goals; FDA Approves Merck Drug to Prevent Post-Stem Cell Transplant Infections (9 November 2017) By Michael Mezher - Published 09 November 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

TGA Weighs Changes to Regulations for Personalized, 3D Printed Devices By Michael Mezher - Published 09 November 2017

Australia's Therapeutic Goods Administration (TGA) on Thursday launched a consultation on proposed changes to the country's medical device regulations for personalized and 3D printed medical devices.

Categories: News, Oceania, TGA, Manufacturing, Medical Devices, Submission and registration

Tags: 3D-Printing, Custom Medical Devices

Drugged Driving: FDA Finalizes Study Guidance By Michael Mezher - Published 08 November 2017

The US Food and Drug Administration (FDA) on Tuesday finalized guidance on how drugmakers should study the effects of their drugs on driving ability.

Categories: News, US, FDA, Clinical, Drugs, Preclinical

Tags: Driving, Driving Studies, Final Guidance

Regulatory Recon: Ohio Drug Pricing Ballot Initiative Fails; NICE Rejects Bayer's Stivarga for Liver Cancer (8 November 2017) By Michael Mezher - Published 08 November 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 Seeks Input on Analysis Data Reviewer's Guide for Drug Submissions By Michael Mezher - Published 07 November 2017

The US Food and Drug Administration (FDA) on Tuesday opened for public consultation a proposed analysis data reviewer's guide (ADRG) template developed as part of a collaboration with the Pharmaceutical Users Software Exchange (PhUSE).

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

Tags: ADRG, Analysis Data Reviewer's Guide, PhUSE

Regulatory Recon: FDA Approves Roche Drugs for Rare Blood and Lung Cancers; Sen. Harris Questions Alkermes' Vivitrol Promotion Tactics (7 November 2017) By Michael Mezher - Published 07 November 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 Finalizes Guidance on Antiviral Drugs for Cold Sores By Michael Mezher - Published 07 November 2017

The US Food and Drug Administration (FDA) on Tuesday finalized guidance on developing antiviral drugs for recurrent herpes labialis (RHL), commonly referred to as cold sores, which affects between 20% and 40% of adults in the US.

Categories: News, US, FDA, Clinical, Drugs, Preclinical

Tags: Antiviral, Recurrent Herpes Labialis, RHL, Cold Sores