Content about Pharmaceutical industry

June 13, 2013

Drug maker Actavis is working with nonprofit pharmaceutical company Medicines360 to make low-cost intrauterine devices available to women, the two said.

PARSIPPANY, N.J. — Drug maker Actavis is working with nonprofit pharmaceutical company Medicines360 to make low-cost intrauterine devices available to women, the two said.

June 13, 2013

The Food and Drug Administration has approved a drug made by Amgen for treating a rare and usually noncancerous bone tumor, the agency said Thursday.

SILVER SPRING, Md. – The Food and Drug Administration has approved a drug made by Amgen for treating a rare and usually noncancerous bone tumor, the agency said Thursday.

June 12, 2013

More than 200 drugs are under development for cardiovascular disease, according to a drug industry trade group.

WASHINGTON — More than 200 drugs are under development for cardiovascular disease, according to a drug industry trade group.

June 12, 2013

Pfizer will receive more than $2 billion from Teva Pharmaceutical Industries and Sun Pharmaceutical Industries to settle a case concerning a gastroesophageal reflux disease drug.

NEW YORK — Pfizer will receive more than $2 billion from Teva Pharmaceutical Industries and Sun Pharmaceutical Industries to settle a case concerning a gastroesophageal reflux disease drug.

June 10, 2013

Anglo-Swedish drug maker AstraZeneca will pay up to $1.15 billion for a U.S. developer of drugs for respiratory diseases, AstraZeneca said Monday.

LONDON — Anglo-Swedish drug maker AstraZeneca will pay up to $1.15 billion for a U.S. developer of drugs for respiratory diseases, AstraZeneca said Monday.

The company announced that it would buy Redwood City, Calif.-based Pearl Therapeutics, which has an inhaled drug for chronic obstructive pulmonary disease, called PT003 (formoterol fumarate; glycopyrrolate), in late-stage clinical development.

June 10, 2013

A 26-member joint panel comprising the Food and Drug Administration's Endocrinologic and Metabolic Drugs and Drug Safety and Risk Management advisory committees voted to support modifying or removing the risk evaluation and mitigation strategy protocol for GlaxoSmithKline's Type 2 diabetes drug Avandia (rosiglitazone).

Historically, the FDA has followed advisory committee votes when making a decision on the marketing of a drug even though it is not bound by them, but assuming the agency follows the panel's advice, it could mean a lot for the controversial drug and the way it's dispensed. But even if Avandia winds up on retail pharmacy shelves again, it faces a very different landscape from its heyday.

A 26-member joint panel comprising the Food and Drug Administration's Endocrinologic and Metabolic Drugs and Drug Safety and Risk Management advisory committees voted to support modifying or removing the risk evaluation and mitigation strategy protocol for GlaxoSmithKline's Type 2 diabetes drug Avandia (rosiglitazone).

June 7, 2013

Actavis is hoping to become the first to market generic versions of a contraceptive and a sedative, the drug maker said.

PARSIPPANY, N.J. — Actavis is hoping to become the first to market generic versions of a contraceptive and a sedative, the drug maker said.

June 7, 2013

A joint Food and Drug Administration expert panel voted to recommend keeping a controversial GlaxoSmithKline diabetes drug available for certain patients, GSK said.

PHILADELPHIA — A joint Food and Drug Administration expert panel voted to recommend keeping a controversial GlaxoSmithKline diabetes drug available for certain patients, GSK said.

June 5, 2013

South Korean drug maker Hanmi Pharmaceutical Co. and U.S. partner Amneal Pharmaceuticals have made an agreement in federal court concerning a generic heartburn drug.

SEOUL, South Korea — South Korean drug maker Hanmi Pharmaceutical Co. and U.S. partner Amneal Pharmaceuticals have made an agreement in federal court concerning a generic heartburn drug that they said clears a major hurdle to its launch.

June 4, 2013

The Center for Healthcare Supply Chain Research, HDMA’s nonprofit research foundation, and Genentech on Tuesday honored Robert Belknap, executive director of trade sales and operations for Boehringer Ingelheim Pharmaceuticals, with the 2013 Nexus Award for Lifetime Achievement.

ARLINGTON, Va. — The Center for Healthcare Supply Chain Research, HDMA’s nonprofit research foundation, and Genentech on Tuesday honored Robert Belknap, executive director of trade sales and operations for Boehringer Ingelheim Pharmaceuticals, with the 2013 Nexus Award for Lifetime Achievement.

June 4, 2013

The House of Representatives voted Monday to pass a bill that would establish national standards for the pharmaceutical supply chain.

WASHINGTON — The House of Representatives voted Monday to pass a bill that would establish national standards for the pharmaceutical supply chain.

June 4, 2013

A subsidiary of Aceto Corp. has launched a generic treatment for seasonal and perennial allergies, the company said Tuesday.

PORT WASHINGTON, N.Y. — A subsidiary of Aceto Corp. has launched a generic treatment for seasonal and perennial allergies, the company said Tuesday.

Rising Pharmaceuticals announced the launch of flunisolide nasal solution in the 0.025% strength.

June 3, 2013

Dr. Reddy's Labs and Fujifilm have terminated a deal to market generic drugs in Japan, Dr. Reddy's said.

HYDERABAD, India — Dr. Reddy's Labs and Fujifilm have terminated a deal to market generic drugs in Japan, Dr. Reddy's said Monday.

The two had signed a memorandum of understanding in June 2011 to establish a joint venture for developing and manufacturing generics in Japan. The ending of the deal was the result of Fujifilm changing its long-term strategy for the drug business, but Dr. Reddy's said they would continue looking into opportunities for partnerships and alliances in other drug businesses.

May 31, 2013

India-based Sun Pharmaceutical Industries may buy Sweden-based Meda for $5 billion to $6 billion, according to published reports.

NEW YORK — India-based Sun Pharmaceutical Industries may buy Sweden-based Meda for $5 billion to $6 billion, according to published reports.

Reuters reported that the two companies were in talks for Sun to buy Meda in order to boost its generics business in developed markets.

May 30, 2013

When does the double-edged sword of generic drug price reductions begin to cut the government agency or health system holding the sword?

That's the question many pharmacy leaders in Canada have for the provincial health system policy-makers who have embarked on a crusade to whack pharmacy reimbursement levels for many lower-cost generic medicines sold under the nation's publicly funded health system.

When does the double-edged sword of generic drug price reductions begin to cut the government agency or health system holding the sword?

That's the question many pharmacy leaders in Canada have for the provincial health system policy-makers who have embarked on a crusade to whack pharmacy reimbursement levels for many lower-cost generic medicines sold under the nation's publicly funded health system. The effort has drawn the ire of pharmacy advocates even as proponents in government and health policy circles tout its cost-saving benefits.

May 30, 2013

This summer, the Supreme Court will decide on a case that could determine whether generic drug makers can be held liable when patients suffer harmful side effects from taking their drugs.

This summer, the Supreme Court will decide on a case that could determine whether generic drug makers can be held liable when patients suffer harmful side effects from taking their drugs.

May 30, 2013

The year is only halfway done, but 2013 is already proving to be a year of particular importance for generic drugs as the industry awaits two important decisions from the Supreme Court and continues to wait for federal biosimilar regulations while fending off efforts to limit the scope of their use at the state level.

The year is only halfway done, but 2013 is already proving to be a year of particular importance for generic drugs as the industry awaits two important decisions from the Supreme Court and continues to wait for federal biosimilar regulations while fending off efforts to limit the scope of their use at the state level.

May 30, 2013

While the passage of the Patient Protection and Affordable Care Act of 2010 was a milestone in a number of respects, it also was one of the biggest moments in the history of the generic drug industry since the 1984 passage of the Hatch-Waxman Act, which created an abbreviated regulatory approval pathway for generic pharmaceutical drugs.

While the passage of the Patient Protection and Affordable Care Act of 2010 was a milestone in a number of respects, it also was one of the biggest moments in the history of the generic drug industry since the 1984 passage of the Hatch-Waxman Act, which created an abbreviated regulatory approval pathway for generic pharmaceutical drugs.

May 29, 2013

Texas has become the latest state to defeat a bill that critics say would limit the reach of knock-off versions of biotech drugs.

WASHINGTON — Texas has become the latest state to defeat a bill that critics say would limit the reach of knock-off versions of biotech drugs.

May 29, 2013

The Food and Drug Administration has approved a generic drug for incontinence made by Perrigo Co., the drug maker said.

ALLEGAN, Mich. — The Food and Drug Administration has approved a generic drug for incontinence made by Perrigo Co., the drug maker said Wednesday.

Perrigo announced the approval of trospium chloride extended-release capsules in the 60 mg strength, a once-daily treatment for overactive bladder with symptoms of urge urinary incontinence, urgency and urinary frequency. The drug is a generic version of Allergan's Sanctura XR, which has annual sales of $54 million, according to Symphony Health Solutions.

May 29, 2013

British drug maker GlaxoSmithKline has acquired Swiss vaccine development company Okairos for $325 million, GSK said Wednesday.

LONDON — British drug maker GlaxoSmithKline has acquired Swiss vaccine development company Okairos for $325 million, GSK said Wednesday.

Privately owned Okairos develops technologies used to create vaccines, and GSK said it would use them in the development of the "next generation" of vaccines for preventing infections and for treatment of infections and diseases, saying it would allow the development of the "next generation.

May 28, 2013

Anglo-Swedish drug maker AstraZeneca will buy Omthera Pharmaceuticals for $323 million, the two companies said.

PRINCETON, N.J. — Anglo-Swedish drug maker AstraZeneca will buy Omthera Pharmaceuticals for $323 million, the two companies said Tuesday.

Omthera, based in Princeton, N.J., develops drugs for dyslipidemia, conditions that result in abnormal levels of lipids in the blood. Its lead products include Epanova, an experimental drug for patients with high triglycerides that's based on omega-3 fatty acids; Omthera has finished late-stage clinical trials of the drug and plans to file for Food and Drug Administration approval in mid-2013.

May 28, 2013

A federal court has blocked Actavis from distributing its generic version of a drug for treating asthma, the company said.

PARSIPPANY, N.J. — A federal court has blocked Actavis from distributing its generic version of a drug for treating asthma, the company said.

Actavis said the U.S. Court of Appeals for the Federal Circuit had issued an injunction against Actavis' distribution of budesonide inhalation suspension at the request of AstraZeneca, which sells the drug under the trade name Pulmicort Respules.

May 23, 2013

Johnson & Johnson expects to file for Food and Drug Administration approval of more than 10 new drugs over the next four years, the drug maker said Thursday.

NEW BRUNSWICK, N.J. — Johnson & Johnson expects to file for Food and Drug Administration approval of more than 10 new drugs over the next four years, the drug maker said Thursday.

J&J's Janssen Pharmaceutical Cos. highlighted its more than 11 new product launches since 2009 and said it hoped to file with the FDA for more than two-dozen "significant" extensions to its branded drug lines by 2017.

May 22, 2013

The Food and Drug Administration has approved a generic heart disease drug made by Sandoz, the company said.

PRINCETON, N.J. — The Food and Drug Administration has approved a generic heart-disease drug made by Sandoz, the company said Wednesday.

Sandoz, the generics division of Swiss drug maker Novartis, announced the approval of candesartan cilexetil tablets, a generic version of AstraZeneca's Atacand.

The drug is used to treat some types of heart failure in adults with left ventricular systolic dysfunction, as well as high blood pressure in adults and children as young as 1.

Atacand had sales of $120.3 million in 2012, according to IMS Health.