Content about Pharmaceutical industry

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.

May 22, 2013

Generic drug maker Par Pharmaceutical Cos. has started shipping an authorized generic version of a heart-disease medication made by AstraZeneca.

WOODCLIFF LAKE, N.J. — Generic drug maker Par Pharmaceutical Cos. has started shipping an authorized generic version of a heart-disease medication made by AstraZeneca.

Par said it had entered into an agreement with AstraZeneca to supply authorized generic Atacand (candesartan cilexetil) and had begun shipping the drug in the 4 mg, 8 mg, 16 mg and 32 mg strengths. Atacand has annual sales of about $113 million, according to IMS Health, and is used to treat certain kinds of heart failure and high blood pressure in children and adults.

May 21, 2013

Impax Labs has launched an authorized generic drug for migraine headaches under a partnership with AstraZeneca, Impax said.

HAYWARD, Calif. — Impax Labs has launched an authorized generic drug for migraine headaches under a partnership with AstraZeneca, Impax said.

Impax said its generics division, Global Pharmaceuticals, began shipping authorized generic zolmitriptan tablets and orally disintegrating tablets in the 2.5 mg and 5 mg strengths. The drug is a version of AstraZeneca's Zomig.

Zomig had sales of about $196 million during the 12-month period that ended in April, according to IMS Health.

May 13, 2013

The Generic Pharmaceutical Association has promoted Jason Money to associate VP federal government affairs, the trade group said Monday.

WASHINGTON — The Generic Pharmaceutical Association has promoted Jason Money to associate VP federal government affairs, the trade group said Monday.

Money, who has worked for the GPhA for six years, was previously the organization's senior director for federal affairs. In the new position, he will continue lobbying on behalf of the generic drug industry in Congress.

May 10, 2013

Actavis is looking into the possibility of buying Warner Chilcott, the generic drug maker said.

PARSIPPANY, N.J. — Actavis is looking into the possibility of buying Warner Chilcott, the generic drug maker said Friday.

Actavis, the world's third-largest generic drug maker, said it had entered into early-stage discussions with Warner Chilcott about a potential combination of the two, but that no agreement had been reached, and that it wouldn't issue further comment about the matter.

May 10, 2013

The Food and Drug Administration has approved a biotech drug made by Novartis for treating a form of arthritis that affects children, the Swiss drug maker said Friday.

EAST HANOVER, N.J. — The Food and Drug Administration has approved a biotech drug made by Novartis for treating a form of arthritis that affects children, the Swiss drug maker said Friday.

May 9, 2013

The November 2011 expiration of Pfizer's patent on the cholesterol drug Lipitor and Ranbaxy Labs' release of the generic version received significant play in the media, particularly due to the theretofore status of Lipitor (atorvastatin calcium) as the drug with the highest sales in the country, $7.7 billion in the United States, according to healthcare analytics firm IMS Health.

The November 2011 expiration of Pfizer's patent on the cholesterol drug Lipitor and Ranbaxy Labs' release of the generic version received significant play in the media, particularly due to the theretofore status of Lipitor (atorvastatin calcium) as the drug with the highest sales in the country, $7.7 billion in the United States, according to healthcare analytics firm IMS Health.

May 8, 2013

Drug maker Bristol-Myers Squibb foresees significant effects on its business from the Patient Protection and Affordable Care Act, company executives told attendees of its recent shareholder meeting.

WASHINGTON — Drug maker Bristol-Myers Squibb foresees significant effects on its business from the Patient Protection and Affordable Care Act, company executives told attendees of the its recent shareholder meeting.

May 8, 2013

Drug maker Merck is seeking regulatory approval for an experimental tablet placed under the tongue that could be used to treat ragweed allergies.

WHITEHOUSE STATION, N.J. — Drug maker Merck is seeking regulatory approval for an experimental tablet placed under the tongue that could be used to treat ragweed allergies.

Merck said the Food and Drug Administration accepted a regulatory application for its ragweed pollen sublingual allergy immunotherapy tablet. Ragweed, also known as Ambrosia artemisiifolia, is a major cause of seasonal allergies in the United States. Merck also submitted an application for a similar drug, for Timothy grass pollen allergies, in March.

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.

May 6, 2013

Florida's state legislature approved a bill last week that will allow pharmacists to substitute biosimilars for brand name biotech drugs.

NEW YORK — Florida's state legislature approved a bill last week that will allow pharmacists to substitute biosimilars for brand name biotech drugs.

The bill, which was approved last Tuesday and is scheduled to take effect on July 1, institutes requirements for pharmacists to substitute biosimilars when they are determined to be biosimilar to and interchangeable with the brand name product, while also requiring the state board of pharmacy to maintain a current list of interchangeable products.

May 3, 2013

Actavis' had $1.9 billion in sales in first quarter 2013, the drug maker said.

PARSIPPANY, N.J. — Actavis' had $1.9 billion in sales in first quarter 2013, the drug maker said.

The latest figure represented a 24% increase from first quarter 2012's $1.52 billion. "The new Actavis is off to a strong start in 2013, and as a result, we are increasing our 2013 forecast based on the strong performance and execution against our objectives to date," president and CEO Paul Bisaro said.

May 2, 2013

Drug makers Boehringer Ingelheim and Eli Lilly have started a campaign designed to educate healthcare professionals about the role a type of protein plays in maintaining blood-sugar balance.

INDIANAPOLIS — Drug makers Boehringer Ingelheim and Eli Lilly have started a campaign designed to educate healthcare professionals about the role a type of protein plays in maintaining blood-sugar balance.

BI and Lilly created the website sglt.com to inform users about the role of sodium glucose co-transporters. The program also includes a video, Glucose Perspectives, in the form of a sketch animation by the United Kingdom's Royal Society for the Encouragement of Arts, Manufactures and Commerce.

May 2, 2013

Rite Aid's same-store sales decreased 4% in April compared with April 2012 due to an earlier Easter and introductions of new generic drugs, the retail pharmacy chain said.

CAMP HILL, Pa. — Rite Aid's same-store sales decreased 4% in April compared with April 2012 due to an earlier Easter and introductions of new generic drugs, the retail pharmacy chain said Thursday.

The numbers released Thursday included a 3.5% decrease in sales on the front end and a 4.2% decrease in pharmacy sales, but the pharmacy figure included a 4.54% negative effect due to new generics. Same-store prescription count decreased by 0.2%.

Total sales for the month were $1.902 billion, a 4.6% decrease over April 2012's $1.993 billion.

May 1, 2013

Drug maker Actavis has acquired rights to a treatment for an experimental bacterial vaginosis from Valeant Pharmaceuticals International for about $55 million, the drug makers said.

PARSIPPANY, N.J. — Drug maker Actavis has acquired rights to a treatment for an experimental bacterial vaginosis from Valeant Pharmaceuticals International for about $55 million, the drug makers said Wednesday.

Actavis Specialty Brands' acquisition of Valeant's metronidazole vaginal gel is in the 1.3% strength. The deal includes an upfront payment, milestone payments and royalties for the first three years after the drug is commercialized. Actavis hopes to market the drug as early as the middle of next year.

May 1, 2013

Teva Pharmaceutical Industries has launched a generic inhaler used to treat bronchospasm, the company said.

NORTH WALES, Pa. — Teva Pharmaceutical Industries has launched a generic inhaler used to treat bronchospasm, the company said.

Teva announced the introduction of levalbuterol inhalation solution. The product is a generic version of Sunovion's Xopenex and is available in the 0.31 mg, 0.63 mg and 1.25 mg strengths.

Various versions of the drug had sales of $438.8 million in 2012, according to IMS Health.

April 30, 2013

The Food and Drug Administration has approved two generic drugs made by Aurobindo Pharma, the drug maker said.

HYDERABAD — The Food and Drug Administration has approved two generic drugs made by Aurobindo Pharma, the drug maker said.

The company announced Tuesday the approval of quinapril tablets in the 5-mg, 10-mg, 20-mg and 40-mg strengths. The drug is a generic version of Pfizer's Accupril and is used to treat high blood pressure. Various versions of the drug had sales of about $49 million during the 12-month period ending in September, according to IMS Health.

April 26, 2013

Generic drug maker Actavis is settling a patent-infringement suit with Purdue Pharma concerning the opioid painkiller OxyContin, Actavis said, saying it expected to make more than $100 million in the deal between 2014 and 2015.

PARSIPPANY, N.J. — Generic drug maker Actavis is settling a patent-infringement suit with Purdue Pharma concerning the opioid painkiller OxyContin, Actavis said Friday, saying it expected to make more than $100 million in the deal between 2014 and 2015.

April 26, 2013

More than 200 drugs for blood cancers are under development, according to a new report by a drug industry trade group.

WASHINGTON — More than 200 drugs for blood cancers are under development, according to a new report by a drug industry trade group.

The Pharmaceutical Research and Manufacturers of America said 241 medicines were in clinical development or under review by the Food and Drug Administration, including 98 for lymphoma, 97 for leukemia, 52 for multiple myeloma and 24 for malignancies of the bone marrow, blood and lymph nodes.