Content about Pharmaceutical industry

November 13, 2013

Johnson & Johnson and Pharmacyclics have added a New York-based specialty pharmacy company focused on cancer to their limited-distribution network for a drug recently approved for a rare form of blood cancer.

NEW YORK — Johnson & Johnson and Pharmacyclics have added a New York-based specialty pharmacy company focused on cancer to their limited-distribution network for a drug recently approved for a rare form of blood cancer.

Onco360 said Wednesday that it had become part of the network for distributing Imbruvica (ibrutinib) capsules. The announcement came the same day that the Food and Drug Adminsitration announced the approval of Imbruvica (ibrutinib) for mantle cell lymphoma, or MCL.

November 12, 2013

As patients face higher out-of-pocket costs for drugs and more complex treatment plans, they expect greater focus on their needs, like they would get from retail, which creates new opportunities for drug manufacturers, according to a new report from PwC.

NEW YORK — As patients face higher out-of-pocket costs for drugs and more complex treatment plans, they expect greater focus on their needs, like they would get from retail, which creates new opportunities for drug manufacturers, according to a new report from PwC.

November 11, 2013

Swiss drug maker Novartis is selling its blood transfusion diagnostics business to a Spanish manufacturer for $1.7 billion, Novartis said Monday.

BASEL, Switzerland — Swiss drug maker Novartis is selling its blood transfusion diagnostics business to a Spanish manufacturer for $1.675 billion, Novartis said Monday.

The drug maker said it expected the sale, to Grifols, to be completed in 2014. Novartis bought the Emeryville, Calif.-based unit in 2006 as part of its acquisition of Chiron. Its sales in 2012 were about $565 million. Grifols is headquartered in Barcelona.

November 8, 2013

When the maker of a branded drug updates the safety information on its product labeling, makers of generic versions of that drug must wait until the Food and Drug Administration approves the new labeling before they can update theirs, but that could soon change under a rule proposed by the FDA.

SILVER SPRING, Md. — When the maker of a branded drug updates the safety information on its product labeling, makers of generic versions of that drug must wait until the Food and Drug Administration approves the new labeling before they can update theirs, but that could soon change under a rule proposed by the FDA.

November 8, 2013

Boehringer Ingelheim SVP managed markets Jeff Huth has been elected by the National Pharmaceutical Council as chairman of the board for 2013-2014, the organization said Friday.

WASHINGTON — Boehringer Ingelheim SVP managed markets Jeff Huth has been elected by the National Pharmaceutical Council as chairman of the board for 2013-2014, the organization said Friday.

Huth has served as a member of the NPC's board since 2009 and has previously had the positions of vice chairman and treasurer. The NPC, founded in 1953, describes itself as a health policy research organization focused on the advancement of science and medical innovation.

November 8, 2013

The United States is leading in its preference for generic drugs. According to a new report by Rhinebeck, N.Y.-based Phoenix Marketing International, 37% of American consumers expressed a preference for generic drugs when they were available, compared with 22% of the French, 21% of Canadians and 12% of Britons. The study was based on 810 consumers in the four countries.

The United States is leading in its preference for generic drugs. According to a new report by Rhinebeck, N.Y.-based Phoenix Marketing International, 37% of American consumers expressed a preference for generic drugs when they were available, compared with 22% of the French, 21% of Canadians and 12% of Britons. The study was based on 810 consumers in the four countries.

November 5, 2013

The Food and Drug Administration has approved a generic drug made by Mylan for treating overactive bladder, according to agency records.

SILVER SPRING, Md. — The Food and Drug Administration has approved a generic drug made by Mylan for treating overactive bladder, according to agency records.

The FDA approved Mylan's tolterodine tartrate extended-release capsules in the 2-mg and 4-mg strengths.

The drug is a generic version of Pfizer's Detrol LA. Detrol LA has annual sales of about $700 million, according to published reports.

 

November 4, 2013

Silvergate Pharmaceuticals has launched a new drug for treating high blood pressure in children, the company said Monday.

DENVER — Silvergate Pharmaceuticals has launched a new drug for treating high blood pressure in children, the company said Monday.

The drug maker announced the availability of Epaned (enalapril maleate) powder for oral suspension, for treating hypertension in patients older than 1 month. Enalapril is one of the most commonly prescribed medicines in the United States for high blood pressure. Epaned was approved in August 2013 as a flavored liquid solution to appeal to children and others who have difficulty swallowing enalapril tablets.

November 1, 2013

Indian drug maker Dr. Reddy's Labs had sales of $536 million in second quarter 2014 and profits of $110 million, the company said.

HYDERABAD, India — Indian drug maker Dr. Reddy's Labs had sales of $536 million in second-quarter 2014 and profits of $110 million, the company said.

Those figures represented sales growth of 17% and a 76% growth in profits over second quarter 2013. Seventy-nine percent of the company's sales came from generic drugs, including 50% from sales in North America; sales of generics grew by 32% over last year.

November 1, 2013

Mylan expects to be the first to market with a generic version of a drug for treating patients with gout, the company said Friday, though its filing has triggered a lawsuit from the makers of the branded version.

PITTSBURGH — Mylan expects to be the first to market with a generic version of a drug for treating patients with gout, the company said Friday, though its filing has triggered a lawsuit from the makers of the branded version.

November 1, 2013

Teva Pharmaceutical Industries had $5.1 billion in sales and $711 million in profits in third-quarter 2013, the Israeli drug maker said.

JERUSALEM — Teva Pharmaceutical Industries had $5.1 billion in sales and $711 million in profits in third-quarter 2013, the Israeli drug maker said.

October 31, 2013

Actavis is seeking Food and Drug Administration approval for a generic drug used to treat acne, triggering a lawsuit in a federal court from the maker of the branded version, the company said Thursday.

DUBLIN — Actavis is seeking Food and Drug Administration approval for a generic drug used to treat acne, triggering a lawsuit in a federal court from the maker of the branded version, the company said Thursday.

The drug maker said it had filed with the FDA for approval of isotretinoin capsules in the 10-mg, 20-mg, 30-mg and 40-mg strengths. The drug is a generic version of Ranbaxy's Absorica, a retinoid used to treat severe, recalcitrant nodular acne in patients 12 and older.

October 30, 2013

Crossmark has named former GlaxoSmithKline executive Janet Carter-Smith as VP business development.

PLANO, Texas — Crossmark has named former GlaxoSmithKline executive Janet Carter-Smith as VP business development.

In her role, Carter-Smith will be focused on working with new client opportunities across Crossmark’s portfolio of services.

October 29, 2013

In what is emerging as the latest battle over follow-on biologics, a new argument has emerged about what to call them, and supporters of biotechnology companies are the latest to take a shot.

NEW YORK — In what is emerging as the latest battle over follow-on biologics, a new argument has emerged about what to call them, and supporters of biotechnology companies are the latest to take a shot.

October 29, 2013

Ranbaxy Labs had global sales of $447.6 million in third quarter 2013, compared with $434.6 million in third quarter 2012, the Indian drug maker said Tuesday.

GURGAON, India — Ranbaxy Labs had global sales of $447.6 million in third quarter 2013, compared with $434.6 million in third quarter 2012, the Indian drug maker said Tuesday.

Sales from generics were $208.4 million, while branded and OTC drugs had sales of $239.3 million North American sales were $143.24 million including $128.6 million in the United States, lower than in Q3 2012 due to a large contribution last year from new generic drugs.

October 29, 2013

Generic drug maker Amneal Pharmaceuticals is seeking Food and Drug Administration approval for a gout drug, prompting a lawsuit from the maker of the branded version, according to published reports.

NEW YORK — Generic drug maker Amneal Pharmaceuticals is seeking Food and Drug Administration approval for a gout drug, prompting a lawsuit from the maker of the branded version, according to published reports.

Law360 reported that Takeda Pharmaceuticals USA had sued Amneal in the U.S. District Court for the District of Delaware over the drug Colcrys (colchicine), used to treat gout and familial Mediterranean fever.

October 28, 2013

The last six drug take-back days sponsored by the Drug Enforcement Agency have collected nearly 2.8 million pounds of prescription drugs at more than 5,800 sites across the country, drawing praise from a drug industry trade organization.

WASHINGTON — The last six drug take-back days sponsored by the Drug Enforcement Agency have collected nearly 2.8 million pounds of prescription drugs at more than 5,800 sites across the country, drawing praise from a drug industry trade organization.

The Generic Pharmaceutical Association said it "strongly supports" the DEA's efforts, including the seventh annual National Prescription Drug Take-Back Day, which took place Saturday.

October 28, 2013

The Food and Drug Administration has launched an online learning course aimed at healthcare professionals to educate them about potentially untruthful or misleading drug ads and promotional materials.

SILVER SPRING, Md. — The Food and Drug Administration has launched an online learning course aimed at healthcare professionals to educate them about potentially untruthful or misleading drug ads and promotional materials.

October 22, 2013

Biotech drug maker Amgen has acquired from Roche the rights to drugs used to boost the immune systems of cancer patients on chemotherapy in 100 markets.

THOUSAND OAKS, Calif. — Biotech drug maker Amgen has acquired from Roche the rights to drugs used to boost the immune systems of cancer patients on chemotherapy in 100 markets.

October 22, 2013

A top executive of generic drug maker Hospira spoke in favor of giving biosimilar drugs the same generic names as the branded biologics they're based on.

LAKE FOREST, Ill. — A top executive of generic drug maker Hospira spoke in favor of giving biosimilar drugs the same generic names as the branded biologics they're based on.

October 22, 2013

The Food and Drug Administration has approved a generic contraceptive drug made by Famy Care, agency records show.

SILVER SPRING, Md. — The Food and Drug Administration has approved a generic contraceptive drug made by Famy Care, agency records show.

The agency approved Famy's levonorgestrel and ethinyl estradiol tablets in the 0.02-mg/0.1-mg strengths.

The drug is a generic version of Aviane-28, made by Teva Women's Health, a division of Israeli drug maker Teva Pharmaceutical Industries that previously went under the name Duramed.

 

October 22, 2013

The Food and Drug Administration has approved drugs for depression and smoking cessation made by Jubilant Life Sciences, the company said.

NOIDA, India — The Food and Drug Administration has approved drugs for depression and smoking cessation made by Jubilant Life Sciences, the company said.

Jubilant, based in India, announced the approval of generic bupropion hydrochloride extended-release tablets in the 100-mg, 150-mg and 200-mg strengths, and another bupropion hydrochloride extended-release tablet product in the 150-mg strength.

The first product is a generic version of GlaxoSmithKline's antidepressant Wellbutrin SR, while the second is a version of GSK's anti-smoking drug Zyban.

October 22, 2013

The Food and Drug Administration has approved a new generic drug for treating bacterial and protozoan infections, according to the agency.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new generic drug for treating bacterial and protozoan infections, according to the agency.

The FDA approved a generic version of Mission Pharmacal's Tindamax (tinidazole) made by Unique Pharmaceuticals. The drug is a tablet in the 250-mg and 500-mg strengths.

Tindamax is used to treat bacterial vaginosis, trichomoniasis and giardiasis. The drug has annual sales of about $16.2 million, according to IMS Health.

 

October 22, 2013

The Food and Drug Administration, in a complaint filed by the U.S. Department of Justice, on Monday sought a permanent injunction against the dietary supplement manufacturer James G. Cole; its president, James Cole; and its general manager, Julie Graves, following the company’s repeated distribution of unapproved drugs and adulterated dietary supplements in violation of the Federal Food, Drug and Cosmetic Act.

SILVER SPRING, Md. — The Food and Drug Administration, in a complaint filed by the U.S. Department of Justice, on Monday sought a permanent injunction against the dietary supplement manufacturer James G. Cole; its president, James Cole; and its general manager, Julie Graves, following the company’s repeated distribution of unapproved drugs and adulterated dietary supplements in violation of the Federal Food, Drug and Cosmetic Act.

October 22, 2013

Keeping counterfeit and diverted drugs out of the U.S. drug supply chain will require closing vulnerable regulatory gaps that risk letting them in, according to a new report by the National Association of Boards of Pharmacy.

NEW YORK — Keeping counterfeit and diverted drugs out of the U.S. drug supply chain will require closing vulnerable regulatory gaps that risk letting them in, according to a new report by the National Association of Boards of Pharmacy.