Content about Merck & Co.

April 11, 2014

Ian Read, chairman and CEO of Pfizer, was elected chairman of the Pharmaceutical Research and Manufacturers of America at the trade association’s annual meeting.

WASHINGTON — Ian Read, chairman and CEO of Pfizer, Inc, was elected chairman of the Pharmaceutical Research and Manufacturers of America Friday at the trade association’s annual meeting. Also elected were Kenneth Frazier, chairman, president and CEO of Merck, as chairman-elect of the PhRMA board of directors, and George Scangos, CEO of Biogen Idec, as board treasurer.

Read succeeds Robert Hugin, chairman and CEO of Celgene Corp., as PhRMA’s chairman.

January 16, 2014

Merck on Wednesday commended the U.S. Food and Drug Administration’s Cardiovascular and Renal Drugs Advisory Committee’s recommendation for approval of vorapaxar.

WHITEHOUSE STATION, N.J. — Merck on Wednesday commended the U.S. Food and Drug Administration’s Cardiovascular and Renal Drugs Advisory Committee’s recommendation for approval of vorapaxar. Vorapaxar is the company’s investigational antiplatelet medicine for the reduction of atherothrombotic events, when added to standard of care, in patients with a history of heart attack and no history of stroke or transient ischemic attack.

January 10, 2014

The Food and Drug Administraiton has approved a liquid formulation of an HIV drug made by Merck, the company said.

WHITEHOUSE STATION, N.J. — The Food and Drug Administraiton has approved a liquid formulation of an HIV drug made by Merck, the company said.

Merck announced the approval of Isentress (raltegravir) for oral suspension, aimed at small children with HIV. The drug may be used by patients as young as four weeks, and the full line of formulations of Isentress now includes the orlal suspension, as well as chewable tablets and film--coated tablets. The company plans to launch the oral suspension in the third quarter of this year.

January 9, 2014

Novartis AG is reportedly in talks with Merck to swap its animal health and vaccines businesses for Merck’s OTC business, which includes the Coppertone sunscreen and Claritin allergy medicine brands, according to a Bloomberg report.

NEW YORK — Novartis AG is reportedly in talks with Merck to swap its animal health and vaccines businesses for Merck’s OTC business, which includes the Coppertone sunscreen and Claritin allergy medicine brands, according to a Bloomberg report.

November 26, 2013

The Food and Drug Administration has approved a new tablet form of an antifungal drug made by Merck, the company said Tuesday.

WHITEHOUSE STATION, N.J. — The Food and Drug Administration has approved a new tablet form of an antifungal drug made by Merck, the company said Tuesday.

Merck announced the FDA approval of Noxafil (posaconazole) 100-mg delayed release tablets. The company also markets a 40-mg-per-milliliter oral suspension form of the drug. The new tablet formulation is designed to be taken in two 300-mg doses on the first day, followed by a 300-mg dose once per day.

October 18, 2013

The Food and Drug Administration has approved a pre-filled injector pen made by EMD Serono for infertile women, the company said Friday.

DARMSTADT, Germany — The Food and Drug Administration has approved a pre-filled injector pen made by EMD Serono for infertile women, the company said Friday.

The drug maker — the U.S. subsidiary of Germany's Merck Serono, so-called to distinguish it from U.S.-based Merck & Co. — announced the approval of Gonal-f RFF Redi-ject (follitropin alfa), a disposable pre-filled injector pen intended for injection under the skin of a liquid formulation of Gonal-f RFF. The pens will be available in the United States in December.

July 1, 2013

The Food and Drug Administration has declined to approve a sleeping pill made by Merck & Co., citing issues with dosage.

WHITEHOUSE STATION, N.J. — The Food and Drug Administration has declined to approve a sleeping pill made by Merck & Co., citing issues with dosage.

The drug maker said Monday that it received a complete response letter from the FDA concerning the drug suvorexant, for which it is seeking regulatory approval. A complete response letter means that the agency has finished reviewing its approval application, but questions remain that preclude final approval.

May 6, 2013

The Food and Drug Administration has approved a new drug made by Merck for treating high cholesterol, the drug maker said.

WHITEHOUSE STATION, N.J. — The Food and Drug Administration has approved a new drug made by Merck for treating high cholesterol, the drug maker said.

Merck announced the approval of Liptruzet (ezetimibe and atorvastatin). The drug combines two preexisting cholesterol drugs: ezetimibe, which Merck markets under the brand name Zetia, and atorvastatin, which Pfizer markets under the name Lipitor. Both drugs are available as generics, but because Liptruzet is a novel combination of them, it required FDA approval as a new drug.

January 4, 2013

The Food and Drug Administration has approved a new means of administration for a multiple sclerosis drug, the manufacturers said.

NEW YORK — The Food and Drug Administration has approved a new means of administration for a multiple sclerosis drug, the manufacturers said.

Pfizer and EMD Serono announced the approval of Rebif Rebidose (interferon beta-1a), a single-use auto-injector for self-administering Rebif, used to treat relapsing forms of MS. EMD Serono is the U.S. division of German drug maker Merck KGaA, so-named to avoid confusion with U.S.-based Merck & Co.

June 13, 2012

Merck on Wednesday released new data from two pivotal Phase III efficacy trials for suvorexant, the investigational medicine Merck is developing for the treatment of insomnia.

BOSTON — Merck on Wednesday released new data from two pivotal Phase III efficacy trials for suvorexant, the investigational medicine Merck is developing for the treatment of insomnia.

Merck expects to file a new drug application to the Food and Drug Administration in 2012. If approved, suvorexant would be the first medicine approved in a new class of medicines, called orexin receptor antagonists, for use in patients with difficulty falling or staying asleep. Merck anticipates that suvorexant will be evaluated by the Controlled Substance Staff of the FDA.

April 9, 2012

The Food and Drug Administration has approved a change to the label of a Novo Nordisk drug stating that it offers superior blood-sugar control to a competing drug made by Merck, based on results of two clinical studies, Novo Nordisk said Monday.

PRINCETON, N.J. — The Food and Drug Administration has approved a change to the label of a Novo Nordisk drug stating that it offers superior blood-sugar control to a competing drug made by Merck, based on results of two clinical studies, Novo Nordisk said Monday.

March 6, 2012

The Food and Drug Administration is asking for additional data before it approves a new cholesterol drug made by Merck, the drug maker said.

WHITEHOUSE STATION, N.J. — The Food and Drug Administration is asking for additional data before it approves a new cholesterol drug made by Merck, the drug maker said.

Merck said the agency issued a complete response letter for its regulatory approval application for a drug that would combine the cholesterol drug Zetia (ezetimibe) with atorvastatin, the active ingredient in Pfizer's Lipitor. A complete response letter means that the FDA cannot approve a drug application in its current form.

February 7, 2012

A drug under development by Merck "significantly" reduced the risk of heart attack, stroke and cardiovascular death in patients, according to clinical trial results announced Tuesday.

WHITEHOUSE STATION, N.J. — A drug under development by Merck "significantly" reduced the risk of heart attack, stroke and cardiovascular death in patients, according to clinical trial results announced Tuesday.

February 2, 2012

The Food and Drug Administration has approved a drug made by Merck for Type 2 diabetes, the drug maker said Thursday.

WHITEHOUSE STATION, N.J. — The Food and Drug Administration has approved a drug made by Merck for Type 2 diabetes, the drug maker said Thursday.

Merck announced the approval of Janumet XR (sitagliptin and metformin hydrochloride) extended-release tablets as a once-daily treatment for the disease.

November 23, 2011

Facebook wars happen all the time, but it's not often that drug manufacturers duke it out online.

NEW YORK — Facebook wars happen all the time, but it's not often that drug manufacturers duke it out online.

October 7, 2011

The Food and Drug Administration has approved a drug that it called the first single-pill combination treatment for Type 2 diabetes and high cholesterol.

SILVER SPRING, Md. — The Food and Drug Administration has approved a drug that it called the first single-pill combination treatment for Type 2 diabetes and high cholesterol.

The FDA approved Merck's Juvisync (sitagliptin and simvastatin), manufactured by Merck subsidiary MSD International GmbH Clonmel Co., based in Tipperary, Ireland. Merck operates under the name MSD outside the United States and Canada in order to avoid confusion with Germany-based Merck KGaA.

October 6, 2011

Merck chairman Richard Clark is retiring, the company said Thursday.

WHITEHOUSE STATION, N.J. — Merck chairman Richard Clark is retiring, the company said Thursday.

Merck announced that Clark, who remained chairman of the company after stepping down as president and CEO in 2010, would retire from the company and its board of directors as of Dec. 1. Kenneth Frazier took over as president and CEO in January 2011, and the board has elected him to serve as chairman following Clark's departure.

October 5, 2011

The Food and Drug Administration has accepted a regulatory approval application from Merck and Ariad Pharmaceuticals for a new drug to treat soft-tissue and bone cancers, the drug makers said Wednesday.

WHITEHOUSE STATION, N.J. — The Food and Drug Administration has accepted a regulatory approval application from Merck and Ariad Pharmaceuticals for a new drug to treat soft-tissue and bone cancers, the drug makers said Wednesday.

The FDA is expected to complete its review of ridaforolimus for soft-tissue and bone sarcomas in patients who have shown a favorable response to chemotherapy by second quarter 2012.

Sarcomas are cancers of the body's connective tissues, and treatment options remain limited, the companies said.

September 19, 2011

A drug made by Merck for treating HIV infection was effective and tolerated in patients regardless of their gender or race, according to results of a late-stage clinical trial announced Monday.

CHICAGO — A drug made by Merck for treating HIV infection was effective and tolerated in patients regardless of their gender or race, according to results of a late-stage clinical trial announced Monday.

September 14, 2011

Attacks on a human papillomavirus vaccine made amid an increasingly caustic Republican presidential primary battle have drawn a response from the manufacturer.

NEW YORK — Attacks on a human papillomavirus vaccine made amid an increasingly caustic Republican presidential primary battle have drawn a response from the manufacturer.

July 14, 2011

A team comprised of scientists from drug maker Merck and several U.S. universities will look for ways to eradicate HIV, Merck said.

WHITEHOUSE STATION, N.J. — A team comprised of scientists from drug maker Merck and several U.S. universities will look for ways to eradicate HIV, Merck said.

June 13, 2011

The Food and Drug Administration has approved changes to the labels of several drugs made by Merck, the agency said Friday.

SILVER SPRING, Md. — The Food and Drug Administration has approved changes to the labels of several drugs made by Merck, the agency said Friday.

Merck’s Label Standardization Project includes the revision of 34 container labels for 16 drugs, all orally administered pills. These include the cardiovascular drugs Cozaar (losartan) and Hyzaar (losartan and hydrochlorothiazide), the diabetes drugs Januvia (sitagliptin) and Janumet (sitagliptin and metformin), the allergy and asthma drug Singulair (montelukast), the HIV drug Isentress (raltegravir) and others.

May 9, 2011

Drug maker Merck announced that it has kicked off an initiative that includes a wide range of public education and patient support programs, as well as research efforts to help improve care for people living with chronic hepatitis C virus infections.

WHITEHOUSE STATION, N.J. — Drug maker Merck announced that it has kicked off an initiative that includes a wide range of public education and patient support programs, as well as research efforts to help improve care for people living with chronic hepatitis C virus infections.

Merck's Hope Against Hepatitis C initiative includes a variety of public-private partnerships, educational programs and collaborative research efforts aimed at supporting the hepatitis C community.

March 9, 2011

The Food and Drug Administration has accepted an approval application from Merck for a drug to treat eye diseases, Merck said Wednesday.

WHITEHOUSE STATION, N.J. — The Food and Drug Administration has accepted an approval application from Merck for a drug to treat eye diseases, Merck said Wednesday.

Merck is seeking approval for Saflutan (tafluprost) ophthalmic solution, an investigational drug for relieving eye pressure in patients with glaucoma and ocular hypertension.

November 30, 2010

The president of drug maker Merck now will fill an additional position at the company: CEO.

WHITEHOUSE STATION, N.J. — The president of drug maker Merck now will fill an additional position at the company: CEO.

Merck's board of directors elected president and board member Kenneth Frazier as the company's next leader, effective Jan. 1. Frazier will succeed Richard Clark, who has served as Merck's CEO since 2005. Clark will continue as chairman of the board, the drug maker said.