Search Results for Merck

Showing 1 – 25  of 27

Merck: Cyberattack Caused $135M in Lost Sales By Michael Mezher - Published 27 October 2017

In its third quarter earnings report, US pharmaceutical company Merck said that manufacturing disruptions tied to a cyberattack last June led to $135 million in lost sales and caused the company to borrow from a US Centers for Disease Control's (CDC) strategic stockpile to meet demand for one of its vaccines.

Categories: News, US, Biologics and biotechnology, Manufacturing

Tags: Cybersecurity, Merck, Cyberattack, Petya, Gardasil 9

Congress Sets Sights on Pharma Cybersecurity After Attack By Michael Mezher - Published 22 September 2017

Leadership from the House Energy and Commerce (E&C) committee on Wednesday called on Merck CEO Ken Frazier and Department of Health and Human Services Secretary (HHS) Tom Price to brief Congress on the impact of a recent cyberattack on the healthcare sector.

Categories: News, US, Biologics and biotechnology, Drugs

Tags: Cybersecurity, NotPetya, Petya, Energy & Commerce, Merck

The 505(b)(2) Pathway and Why Some Follow-on Insulins Aren’t Yet Biosimilars in the US By Zachary Brennan - Published 05 September 2017

Why has the European Medicines Agency (EMA) approved follow-on insulin products as biosimilars while the US Food and Drug Administration (FDA) has not? A look at several recent examples shows what is happening and what will change in the US over the next several years.

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

Tags: insulin, Merck, Lilly, Sanofi, Admelog, 505(b)(2), biosimilars

FDA Alerts on Risks From Merck’s Keytruda in Multiple Myeloma Following Halted Trials By Zachary Brennan - Published 31 August 2017

The US Food and Drug Administration (FDA) on Thursday released an alert and summary of findings from two halted Merck clinical trials evaluating the use of Keytruda (pembrolizumab) combined with other treatments in patients with multiple myeloma.

Categories: News, US, CDER, Biologics and biotechnology, Clinical, Crisis management, Drugs

Tags: Keytruda, Merck, multiple myeloma, FDA alert

FDA Considers Label Changes for Keytruda, Opdivo and Yervoy By Zachary Brennan - Published 12 July 2017

The US Food and Drug Administration (FDA) told Focus on Wednesday that the agency is considering labeling changes to include additional ocular inflammatory conditions for three immune checkpoint inhibitors.

Categories: News, US, FDA, Drugs, Postmarket surveillance

Tags: Opdivo, Keytruda, Yervoy, B-MS, Merck, uveitis

A First for FDA: Cancer Treatment Approved for Any Solid Tumor with a Specific Biomarker By Zachary Brennan - Published 23 May 2017

The US Food and Drug Administration (FDA) on Tuesday granted accelerated approval to Merck’s Keytruda (pembrolizumab) for patients whose cancers have a specific biomarker.

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

Tags: Keytruda, Merck, biomarkers, oncology approvals

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