Content about Branded

December 27, 2013

The Food and Drug Administration has approved an HIV pill made by Gilead Sciences for patients who are switching from other therapy regimens, the company said.

FOSTER CITY, Calif. — The Food and Drug Administration has approved an HIV pill made by Gilead Sciences for patients who are switching from other therapy regimens, the company said.

Gilead said the FDA approved its single-pill regimen, Complera (emtricitabine; rilpivirine; tenofovir disoproxil fumarate) for use in adult patients who have suppressed their infections on stable antiretroviral regimens and are replacing their current regimens. The FDA originally approved the drug in 2011.

December 27, 2013

Drug maker Shire is extending the deadline for its offer to buy Exton, Pa.-based ViroPharma for $4.2 billion, Shire said Friday.

DUBLIN — Drug maker Shire is extending the deadline for its offer to buy Exton, Pa.-based ViroPharma for $4.2 billion, Shire said Friday.

The company said it had extended the expiration date of its tender offer for ViroPharma until Jan. 9. The offer had previously been planned to expire on Thursday. Shire announced the $50-per-share offer last month.

December 26, 2013

The Food and Drug Administration declined to approve an experimental contraceptive patch developed by Actavis, the drug maker said Tuesday.

DUBLIN — The Food and Drug Administration declined to approve an experimental contraceptive patch developed by Actavis, the drug maker said Tuesday.

Actavis said the FDA sent it a complete response letter for its progestin-only transdermal contraceptive patch. A complete response letter means that the agency has finished reviewing a drug-approval application, but questions remain that preclude final approval.

December 26, 2013

Earlier this year, the IMS Institute for Healthcare Informatics, the research wing of the healthcare industry analysis firm IMS Health, dropped a bombshell when it showed that U.S. spending on drugs fell in 2012, the first time that had happened in 55 years.

Earlier this year, the IMS Institute for Healthcare Informatics, the research wing of the healthcare industry analysis firm IMS Health, dropped a bombshell when it showed that U.S. spending on drugs fell in 2012, the first time that had happened in 55 years. But according to IMS’ latest figures, it was not the start of a trend.

December 23, 2013

A federal court decision paves the way for Amneal Pharmaceuticals and its South Korean partnering company to market a drug for treating gastroesophageal reflux disease, the companies said Monday.

BRIDGEWATER, N.J. — A federal court decision paves the way for Amneal Pharmaceuticals and its South Korean partnering company to market a drug for treating gastroesophageal reflux disease, the companies said Monday.

December 23, 2013

Two experimental drugs under development by Biogen Idec are effective in reducing bleeding episodes in patients with two forms of hemophilia when administered as a preventive treatment, while also reducing the need for frequent injections, according to late-stage clinical trial data.

NEW YORK — Two experimental drugs under development by Biogen Idec are effective in reducing bleeding episodes in patients with two forms of hemophilia when administered as a preventive treatment, while also reducing the need for frequent injections, according to late-stage clinical trial data.

December 23, 2013

The Food and Drug Administration has approved revisions to the labeling of a leukemia drug made by Ariad Pharmaceuticals that allow the company to resume selling it, the company said.

CAMBRIDGE, Mass. — The Food and Drug Administration has approved revisions to the labeling of a leukemia drug made by Ariad Pharmaceuticals that allow the company to resume selling it, the company said.

December 23, 2013

This year's influenza virus is beginning its prominence in the South, as Alabama, Louisiana, Mississippi and Texas reported high influenza-like illness activity, the Centers for Disease Control and Prevention reported.

ATLANTA — This year's influenza virus is beginning its prominence in the South, as Alabama, Louisiana, Mississippi and Texas reported high influenza-like illness activity, the Centers for Disease Control and Prevention reported Friday. 

Oklahoma reported moderate ILI activity. 

For those who got a flu shot this year, so far they appear to be well protected. 

CDC has antigenically characterized 317 influenza viruses, including 265 2009 H1N1 viruses, 46 influenza A (H3N2) viruses and 6 influenza B viruses since Oct. 1. 

December 23, 2013

The Food and Drug Administration has approved a new treatment made by Danish drug maker Novo Nordiskfor a rare, genetic bleeding disorder, the agency said Monday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new treatment made by Danish drug maker Novo Nordiskfor a rare, genetic bleeding disorder, the agency said Monday.

December 23, 2013

The Food and Drug Administration has approved a new drug made by United Therapeutics for treating pulmonary arterial hypertension, the company said Monday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug made by United Therapeutics for treating pulmonary arterial hypertension, the company said Monday.

The FDA approved Orenitram (treprostinil) extended-release tablets for treating certain PAH patients to improve exercise capacity. PAH is a disease in which abnormally high blood pressure in the arteries of the lungs causes the right side of the heart to work harder than normal, according to the National Library of Medicine.

December 19, 2013

Bristol-Myers Squibb is selling its diabetes business to AstraZeneca for up to $4.3 billion as part of an effort to focus more on specialty drugs, the company said Thursday.

NEW YORK — Bristol-Myers Squibb is selling its diabetes business to AstraZeneca for up to $4.3 billion as part of an effort to focus more on specialty drugs, the company said Thursday.

BMS said AstraZeneca would pay $2.7 billion upfront, as well as up to $1.4 billion in milestone payments and up to $225 million on the condition of certain assets being sold. The companies have had a diabetes drug-development partnership since 2007.

December 19, 2013

Diplomat has become a distributor of a new cancer drug made by Genentech, Diplomat said Thursday.

FLINT, Mich. — Diplomat has become a distributor of a new cancer drug made by Genentech, Diplomat said Thursday.

The specialty pharmacy company said it had received a distribution contract for Gazyva (obinutuzumab) for chronic lymphocytic leukemia, which received Food and Drug Administration approval on Nov. 1. CLL is a slowly advancing blood and bone marrow disease that, according to the National Cancer Institute, part of the National Institutes of Health, will be diagnosed in 15,680 Americans this year and cause 4,580 deaths.

December 19, 2013

Endo announced Thursday that regulatory waiting periods in the United States and Canada related to its plans to acquire a Montreal-based drug maker have been terminated.

MALVERN, Pa. — Endo announced Thursday that regulatory waiting periods in the United States and Canada related to its plans to acquire a Montreal-based drug maker have been terminated.

December 18, 2013

Actelion has launched a topical gel used to treat a kind of skin cancer, the company said.

SOUTH SAN FRANCISCO, Calif. – Actelion has launched a topical gel used to treat a kind of skin cancer, the company said.

Actelion announced the launch of Valchlor (mechlorethamine), which the Food and Drug Administration approved in August for treating stage 1A and 1B mycosis fungoides-type cutaneous T-cell lymphoma in patient who have received skin-directed therapy before. Actelion acquired rights to the drug when it merged with Ceptaris Therapeutics. Accredo Specialty Pharmacy distributes the drug in the United States.

December 18, 2013

The Food and Drug Administration has approved a new drug made by GlaxoSmithKline and Theravance for treating chronic obstructive pulmonary disease, the agency said Wednesday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug made by GlaxoSmithKline and Theravance for treating chronic obstructive pulmonary disease, the agency said Wednesday.

The FDA announced the approval of Anoro Ellipta (umeclidinium; vilanterol inhalation powder) as a once-per-day maintenance treatment for airflow obstruction in patients with COPD, a term that encompasses chronic bronchitis and emphysema; smoking is the leading cause of COPD in the United States.

December 18, 2013

A new study has found a significant increase in the number of high school students who report having abused a common prescription drug for attention deficit hyperactivity disorder, even as abuse of other prescription drugs has decreased or remained low.

NEW YORK — A new study has found a significant increase in the number of high school students who report having abused a common prescription drug for attention deficit hyperactivity disorder, even as abuse of other prescription drugs has decreased or remained low.

December 18, 2013

Mylan has acquired rights to an experimental respiratory drug made by Pfizer, Mylan said.

PITTSBURGH — Mylan has acquired rights to an experimental respiratory drug made by Pfizer, Mylan said Wednesday.

The drug maker said it had bought exclusive worldwide development, manufacturing and commercialization rights to the drug, which was not named, but was described as a long-acting muscarinic antagonist about to enter phase-2b, or mid-stage, clinical trials. Mylan said it would develop the drug into combination therapies and that they would use a multidose dry powder inhaler technology, also licensed from Pfizer.

December 18, 2013

Four school districts have won a competition sponsored by Mylan to raise awareness about dangerous allergic reactions, the company said.

PITTSBURGH — Four school districts have won a competition sponsored by Mylan to raise awareness about dangerous allergic reactions, the company said Wednesday.

Mylan, whose Mylan Specialty division makes the EpiPen injector pen for severe allergic reactions, known as anaphylaxis, announced the winners of the Raise Your Hand for Anaphylaxis Awareness competition, for which it hired actress Julie Bowen as a celebrity spokeswoman.

December 18, 2013

Perrigo has finalized its acquisition of Elan Corp., Perrigo said Wednesday.

DUBLIN — Perrigo has finalized its acquisition of Elan Corp., Perrigo said Wednesday.

The Michigan-based maker of branded and generic prescription and OTC drugs announced last week that the Irish High Court had approved its $8.6 billion deal to buy Ireland-based Elan, the last regulatory hurdle it had to clear before finalizing the deal, which it announced in July.

December 17, 2013

Amneal Pharmaceuticals has launched a new treatment for gastroesophageal reflux disease under a partnership with a South Korean drug maker.

BRIDGEWATER, N.J. — Amneal Pharmaceuticals has launched a new treatment for gastroesophageal reflux disease under a partnership with a South Korean drug maker.

Amneal announced Tuesday the launch of esomeprazole strontium delayed-release capsules in the 49.3-mg strength, which it is marketing in the United States under a contract with Hanmi Pharmaceutical Co. The drug is expected to begin shipping Wednesday in 30-count bottles.

December 17, 2013

Three organizations will receive part of $1.3 million in funding that German drug maker Merck KGaA and the National Multiple Sclerosis Society are distributing for MS research.

NEW YORK — Three organizations will receive part of $1.3 million in funding that German drug maker Merck KGaA and the National Multiple Sclerosis Society are distributing for MS research.

EMD Serono, the name the Merck KGaA uses in the United States to avoid confusion with U.S.-based Merck & Co., and the National MS Society said the money will help encourage early-stage drug discovery for the autoimmune disease.

December 16, 2013

A redesigned version of an injector pen used to treat infertility is available for distribution in the United States, the manufacturer said.

ROCKLAND, Mass. — A redesigned version of an injector pen used to treat infertility is available for distribution in the United States, the manufacturer said Monday.

EMD Serono, a subsidiary of German drug maker Merck KGaA, said that Gonal-f RFF Redi-ject, a disposable, pre-filled pen used for the drug Gonal-f RFF (follitropin alfa), had become available. The Food and Drug Administration approved the redesigned pen in October. Merck KGaA operates in the United States under the name EMD in order to avoid confusion with U.S.-based Merck & Co.

December 16, 2013

Endo Health Solutions will acquire the maker of a patch used to treat migraines that received Food and Drug Administration approval at the beginning of this year.

MALVERN, Pa. – Endo Health Solutions will acquire the maker of a patch used to treat migraines that received Food and Drug Administration approval at the beginning of this year.

Endo said Monday that it would buy NuPathe for $105 million. In January, the FDA approved NuPathe's patch, Zecuity, a disposable, single-use, battery-powered transdermal patch that delivers the drug sumatriptan, the most widely prescribed migraine medication.

December 16, 2013

Everett Labs has acquired Quinnova Pharmaceuticals from Amneal Enterprises, Everett said Monday.

CHATHAM, N.J. — Everett Labs has acquired Quinnova Pharmaceuticals from Amneal Enterprises, Everett said Monday.

Everett Labs, a subsidiary of Spain-based Exeltis, said the purchase would help it expand into the U.S. dermatology and women's health markets. Financial terms of the deal were not disclosed.

December 16, 2013

A drug made by Novartis extends the lives of patients with a life-threatening blood cancer to a greater extent than conventional therapy or placebo, according to results of a late-stage clinical trial.

BASEL, Switzerland — A drug marketed by Novartis and Incyte Corp. extends the lives of patients with a life-threatening blood cancer to a greater extent than conventional therapy or placebo, according to results of a late-stage clinical trial.

Novartis announced the results of two phase-3 studies of Jakavi (ruxolitinib) in patients with myelofibrosis, presenting them at the American Society of Hematology's annual meeting and exposition in New Orleans.