Search Results for Merck

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EMA, Drugmakers Weigh FDA Draft Guidance on Physiologically Based PK Analyses By Zachary Brennan - Published 13 February 2017

With an eye toward more harmonization, the European Medicines Agency (EMA) earlier this month weighed in on the US Food and Drug Administration’s (FDA) draft guidance on physiologically based pharmacokinetic (PK) analyses, alongside pharmaceutical companies including Novartis, Merck and Bayer.

Categories: News, Europe, US, EMA, FDA, Clinical, Drugs, Regulatory intelligence, Regulatory strategy

Tags: PBPK modeling and simulation, EMA and FDA harmonization, Bayer, Merck, Novartis

New House E&C Chairman to Consider Value-Based Drug Price Negotiations By Zachary Brennan - Published 02 February 2017

The newly minted chairman of the influential House Energy & Commerce Committee is looking to tackle pharmaceutical price gouging with a new bill and comments on how there need to be more negotiations to bring down prices.

Categories: News, US, Drugs, Reimbursement

Tags: Walden, House E&C, Schrader, Merck, CMS drug negotiations

Asia Regulatory Roundup: CFDA Offers Guidance on Device Quality Control (10 January 2017) By Nick Paul Taylor - Published 10 January 2017

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

Categories: News, Asia, CDSCO, CFDA, PMDA, Biologics and biotechnology, Drugs, Medical Devices

Tags: AstraZeneca, Bristol-Myers Squibb, Merck, CDSCO, codeine

FDA Adds Boxed Warning to Hepatitis C Drugs, Warns of Hepatitis B Reactivation Risk By Zachary Brennan - Published 04 October 2016

The US Food and Drug Administration (FDA) on Tuesday warned of serious risks for some patients who have been infected with the hepatitis B virus (HBV) and are being treated with certain direct-acting antiviral (DAA) medicines for hepatitis C virus (HCV).

Categories: News, Asia, Europe, US, EMA, FDA, PMDA, Drugs

Tags: Sovaldi, Gilead, Harvoni, Merck, antivirals

EMA Adds Four New Drugs to PRIME Scheme By Michael Mezher - Published 27 July 2016

The European Medicines Agency (EMA) has granted four new drugs eligibility to its PRIority MEdicines (PRIME) scheme, bringing the total number of drugs accepted to the program to eight.

Categories: News, Europe, EMA, Biologics and biotechnology, Clinical, Drugs, Preclinical, Regulatory strategy, Research and development, Submission and registration

Tags: PRIME scheme, PRIority MEdicines, Novartis, Merck, Adaptimmune, DNATrix, CTL019, Ebola Vaccine, NY-ESO-1c259T, DNX-2401

How a Fax Caused the Federal Circuit to Invalidate a Patent for Two Bayer Oral Contraceptives By Zachary Brennan - Published 16 May 2016

The US Court of Appeals for the Federal Circuit on Friday ruled that a Merck KGaA patent - linked to two of Bayer’s oral contraceptives, Safyral and Beyaz - is invalid because ingredients in the drug were offered for sale before the filing of the patent.

Categories: News, US, FDA, Drugs

Tags: Merck KGaA, Bayer, Beyaz, contraceptives, fax machine, drug patents

Asia Regulatory Roundup: China Fast Tracks Hepatitis C, Cancer Drug Approvals (26 April 2016) By Nick Paul Taylor - Published 26 April 2016

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

Categories: News, Asia, CFDA, Drugs, Government affairs, Medical writing, Product withdrawl and retirement, Quality

Tags: Harvoni, Sovaldi, CFDA inspections, Merck Serono, Sandoz

Industry to FDA: Why Publicize Unsubstantiated Device Safety Signals? By Zachary Brennan - Published 01 April 2016

Industry groups are raising some serious questions with the US Food and Drug Administration’s (FDA) proposal to release emerging safety signals to the public even before those signals have been substantiated.

Categories: News, US, FDA, Clinical, Medical Devices, Postmarket surveillance

Tags: emerging device safety signals, AdvaMed, MDMA, GE, Merck, Novo Nordisk

FDA Warns Chinese API Manufacturer for Serious Data Manipulation By Zachary Brennan - Published 12 January 2016

The US Food and Drug Administration (FDA) has warned China-based Zhejiang Hisun Pharmaceutical, which established a joint venture with Pfizer in 2012, for data integrity violations more than three months after banning the company’s products from entering the US.

Categories: News, China, US, FDA, Active pharmaceutical ingredients, Drugs, Manufacturing, Postmarket surveillance, Quality, Regulatory intelligence

Tags: FDA warning letters, Hisun, Pfizer, Merck

HHS Pharmaceutical Pricing Forum: Lots of Questions, Few Definitive Answers By Zachary Brennan - Published 20 November 2015

The Department of Health and Human Services’ (HHS) invite-only Pharmaceutical Forum on Friday turned out to be more of a listening session for a range of stakeholders to explain concerns and discuss a number of potential ways to lower drug prices, some of which involve US Food and Drug Administration (FDA) reforms.

Categories: News, US, FDA, Active pharmaceutical ingredients, Biologics and biotechnology, Drugs, Ethics, Government affairs, Regulatory strategy, Reimbursement, Research and development, Submission and registration

Tags: drug pricing, HHS pharmaceutical forum, Merck, Express Scripts, GPhA, IMS Health

Indian Court Sides with Merck in Patent Dispute By Michael Mezher - Published 23 March 2015

A prominent court in India has issued an interim injunction, overturning a previous ruling, in favor of US drug maker Merck in a patent dispute with Glenmark Pharmaceuticals over an active ingredient used in two of Merck's diabetes medicines, Januvia and Janumet.  

Categories: News, India, Active pharmaceutical ingredients, Drugs, Regulatory strategy

Tags: Intellectual Property, Patents, Delhi High Court, Merck, Glenmark, Januvia

Merck's Insomnia Drug Belsomra Clears Final DEA Hurdle By Alexander Gaffney, RAC - Published 27 August 2014

The US Drug Enforcement Administration (DEA) has given a final and long-awaited approval to Merck to market its new insomnia drug Belsomra (suvorexant) as a Schedule IV drug.

Categories: News, US, Prescription drugs, Submission and registration

Tags: Merck, Suvorecant, Belsomra, DEA, Schedule IV, CSA, Controlled Substances Act

Will Merck's Suvorexant Avoid DEA's Regulatory 'Black Hole' That Snared Arena's Belviq? By Alexander Gaffney, RAC - Published 14 February 2014

Categories: US, FDA

Tags: Merck, DEA

FDA Debars Two for Falsifying Clinical Trial Data By Alexander Gaffney - Published 12 September 2012

Categories: FDA

Tags: Schering-Plough, Debar, Debarment, Merck, Court, Latest News, clinical trials

Blockbuster Asthma Drug Singulair Receives Generic Competition By Alexander Gaffney - Published 06 August 2012

Categories: FDA

Tags: Asthma, Blockbuster, Singulair, Patent Cliff, Approved, Merck, Generic, Latest News

FDA's 'Bad Ad' Program Marks Second Year of Operation By Alexander Gaffney - Published 19 July 2012

Categories: FDA

Tags: Bad Ad Program, OPDP, Pfizer, Merck, Latest News, marketing, advertising

Group to FTC: Merck's Marketing Tie-ins Violate Advertising Regulations By Alexander Gaffney - Published 21 June 2012

Tags: Candy, Claratin, Children, Merck, Pediatric, Latest News, marketing, advertising

House Goes After Pharmaceutical Companies, Seeking Info on PPACA Negotiations By Alexander Gaffney - Published 08 May 2012

Tags: Negotiating, Amgen, Abbott, AstraZeneca, Pfizer, Merck, E&C, Energy and Commerce Committee, PhRMA, House, negotiation, Latest News, Obama, PPACA, information

Merck Settles Vioxx Criminal Charges With US for $322 Million By Alexander Gaffney - Published 20 April 2012

Categories: FDA

Tags: Charges, Illegal, $322 Million, Department of Justice, Arthritis, Criminal, Vioxx, Merck, Rheumatoid Arthritis, Latest News

FDA Guidance on Veterinary Antibiotic Use Prompts Compliance, Criticism By Alexander Gaffney - Published 12 April 2012

Categories: FDA

Tags: NRDC, Taylor, Eli Lilly, antibiotics, Pfizer, Merck, Veterinary, CVM, Latest News, draft guidance, guidance

Merck Gets Warning Letter After Failing to Complete Postmarketing Safety Study By Alexander Gaffney - Published 29 February 2012

Categories: FDA

Tags: Januvia, Janumet, Merck Sharp and Dohme Corp, Merck, Nonclinical, warning letter, Postmarketing, Misbranded, Letter, Latest News, Warning, study