Content about Pharmaceutical industry

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.

October 22, 2013

Teva Pharmaceutical Industries is investing more than $100 million in its Croatian division for a plant that will make pills mostly for the international market.

ZAGREB, Croatia — Teva Pharmaceutical Industries is investing more than $100 million in its Croatian division for a plant that will make pills mostly for the international market.

Teva subsidiary Pliva said the new plant, in the capital of Zagreb, would considerably increase its production capacities for tablets and capsules. The company said the new plant would increase the annual manufacturing capacity by more than 25%.

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.

October 17, 2013

As knock-off versions of biotech drugs get closer to reality in the United States, one issue that has emerged has centered on what to call them.

NEW YORK — As knock-off versions of biotech drugs get closer to reality in the United States, one issue that has emerged has centered on what to call them.

October 17, 2013

Prasco Labs will distribute an authorized generic for reducing serum phosphate in patients with end-stage renal disease under a contract with Shire, Prasco said Thursday.

CINCINNATI — Prasco Labs will distribute an authorized generic for reducing serum phosphate in patients with end-stage renal disease under a contract with Shire, Prasco said Thursday.

The company, which focuses on authorized generic drugs, announced the deal for lanthanum carbonate chewable tablets in the 500-mg, 750-mg and 1,000-mg strengths. The drug is a version of Shire's Fosrenol. Authorized generics are branded drugs marketed under their generic names at a discounted price, usually through a third-party company under contract with the branded drug's manufacturer.

October 17, 2013

Nearly two dozen women with heart disease will educate their communities about heart disease in women.

WASHINGTON — Nearly two dozen women with heart disease will educate their communities about heart disease in women.

October 15, 2013

AstraZeneca has acquired a British developer of biotech drugs for treating cancer, AstraZeneca said Tuesday.

LONDON — AstraZeneca has acquired a British developer of biotech drugs for treating cancer, AstraZeneca said Tuesday.

The company said its MedImmune subsidiary had acquired privately held Spirogen and also entered into a collaboration with ADC Therapeutics to develop two of ADC's antibody-drug conjugate programs, currently in pre-clinical development. MedImmune will make an equity investment in ADC, which has an existing licensing agreement with Spirogen.

October 15, 2013

The Food and Drug Administration has approved a new generic drug from Teva Pharmaceutical Industries for treating eye infections, the company said.

JERUSALEM — The Food and Drug Administration has approved a new generic drug from Teva Pharmaceutical Industries for treating eye infections, the company said.

The Israeli drug maker announced the approval of the antibiotic drug tobramycin inhalation solution, a generic version of Novartis' Tobi.

Tobi has sales of about $350 million during the 12-month period that ended in June, according to IMS Health.

 

October 11, 2013

A new law in Maine will allow the importation of drugs from abroad through mail-order from some pharmacies, formalizing a practice that has existed in many parts of the country for several years, and marking the first time a state government has, by law, gone against Food and Drug Administration regulations that bar importation of drugs.

Bloomberg columnist Megan McArdle said Maine was "going rogue" on drug importation, and that pretty much sums it up. The state, which has long had a close relationship with Canada — its governor, Paul LePage, is of French-Canadian descent and spoke Quebecois French as his first language — is openly defying federal law. And because federal law ultimately trumps state law, it's likely the federal government will crack down at some point.

A new law in Maine will allow the importation of drugs from abroad through mail-order from some pharmacies, formalizing a practice that has existed in many parts of the country for several years, and marking the first time a state government has, by law, gone against Food and Drug Administration regulations that bar importation of drugs.

October 10, 2013

One of the Food and Drug Administration's top regulators is not retiring, contrary to rumors reported in news media Thursday.

SILVER SPRING, Md. – One of the Food and Drug Administration's top regulators is not retiring, contrary to rumors reported in news media Thursday.

In a memo sent out to staff, Center for Drug Evaluation and Research director Janet Woodcock wrote that she would not retire, but was becoming "more deeply involved" in such activities as proposed reorganizations of the Office of Pharmaceutical Quality and the Office of Generic Drugs.

October 10, 2013

For the Food and Drug Administration’s Office of Generic Drugs, one of the biggest stumbling blocks has been its significant backlog of generic drug approval applications. But it’s steadily making progress in addressing the problem.

For the Food and Drug Administration’s Office of Generic Drugs, one of the biggest stumbling blocks has been its significant backlog of generic drug approval applications. But it’s steadily making progress in addressing the problem.

When Congress approved a reauthorization of the Prescription Drug User Fee Act that included the Generic Drug User Fee Amendments last year, that backlog included about 2,500 applications. But thanks to GDUFA, the agency has managed to clear muchof it.

October 10, 2013

A subsidiary of Johnson & Johnson has acquired rights to an experimental drug for hepatitis C from GlaxoSmithKline.

TITUSVILLE, N.J. — A subsidiary of Johnson & Johnson has acquired rights to an experimental drug for hepatitis C from GlaxoSmithKline.

Janssen Pharmaceuticals announced that it had bought, for an undisclosed among, the drug GSK2336805 from GSK. The drug, which belongs to a class known as NS5a replication complex inhibitors, is currently in mid-stage development.

October 10, 2013

“The best of a chain combined with the best of an independent pharmacy.”

That’s how Health Mart president Steve Courtman describes Health Mart’s “unique value proposition in the marketplace.” That value, he added, is defined every day in thousands of communities across the United States by the pharmacy owner-operators who serve as the most accessible and most-utilized patient care providers in their local healthcare networks.

“The best of a chain combined with the best of an independent pharmacy.”

That’s how Health Mart president Steve Courtman describes Health Mart’s “unique value proposition in the marketplace.” That value, he added, is defined every day in thousands of communities across the United States by the pharmacy owner-operators who serve as the most accessible and most-utilized patient care providers in their local healthcare networks.

October 10, 2013

A coalition of organizations that includes major retail pharmacy and drug manufacturing groups is warning consumers against purchasing drug from foreign, online outlets.

NEW YORK — A coalition of organizations that includes major retail pharmacy and drug manufacturing groups is warning consumers against purchasing drugs from foreign, online outlets.

October 10, 2013

While the boom in generic drugs now looks set to wane, another segment of the pharmaceutical industry is rapidly rising and presenting new growth opportunities for pharmacy retailers: specialty drugs.

While the boom in generic drugs now looks set to wane, another segment of the pharmaceutical industry is rapidly rising and presenting new growth opportunities for pharmacy retailers: specialty drugs.

October 9, 2013

A new law in Maine will allow consumers to purchase drugs by mail order from some pharmacies overseas, according to published reports.

NEW YORK — A new law in Maine will allow consumers to purchase drugs by mail order from some pharmacies overseas, according to published reports.

The Wall Street Journal reported Wednesday that the law, a first, had sparked lawsuits from drug companies, who say the law will threaten patient safety by opening the U.S. supply chain to counterfeit and adulterated medications. Supporters of the law, including Republican Gov. Paul LePage, say drug makers are more concerned about losing money from the law.

October 8, 2013

Consumers in the United States are more likely than those in three other countries to say they prefer to receive generic drugs over branded drugs, according to a new study.

RHINEBECK, N.Y. — Consumers in the United States are more likely than those in three other countries to say they prefer to receive generic drugs over branded drugs, according to a new study.

The study, by Phoenix Marketing International, included 810 consumers from the United States, Canada, the United Kingdom and France. Among respondents, 37% of American consumers expressed a preference for generics when they were available, compared with 22% of those in France, 12% in the United Kingdom and 21% in Canada.

October 7, 2013

Late-stage clinical data support the efficacy of an experimental drug under development by Teva Pharmaceutical Industries and Active Biotech for multiple sclerosis, the two companies said.

JERUSALEM — Late-stage clinical data support the efficacy of an experimental drug under development by Teva Pharmaceutical Industries and Active Biotech for multiple sclerosis, the two companies said.

October 7, 2013

An analysis by the New York Times published over the weekend makes the case for generic drugs.

NEW YORK — An analysis by the New York Times published over the weekend makes the case for generic drugs.

Times reporter Katie Thomas opened the analysis Saturday by recalling an episode of the Netflix series "Orange Is the New Black," in which the prison saves money by switching inmates to generic drugs, much to their dismay. But that bit of artistic license on the part of the show's writers is evidence of the negative perceptions of generic drugs among the public.

October 4, 2013

AmerisourceBergen on Friday announced the company will hold its annual manufacturer summit, ThinkLive 2013, Oct. 7 to 8 at the Fairmont Hotel in Dallas.

VALLEY FORGE, Pa. — AmerisourceBergen on Friday announced the company will hold its annual manufacturer summit, ThinkLive 2013, Oct. 7 to 8 at the Fairmont Hotel in Dallas. The trade show is expected to draw a diverse group of manufacturer executives from the pharmaceutical industry, including those responsible for pharmaceutical brand management, trade relations, supply chain, market access, reimbursement strategy, global pharmaceuticals, medical devices, over-the-counter products and global pharmaceuticals. 

October 4, 2013

A new mobile game app designed by CyberDoctor showed improvements in medication adherence, diet and exercise in diabetes patients, according to a study.

SANTA CLARA, Calif. — A new mobile game app designed by CyberDoctor showed improvements in medication adherence, diet and exercise in diabetes patients, according to a study.

The company said that breakthrough clinical trial results for the game, called PatientPartner," documented for the first time the effectiveness of a story-driven game in changing health behavior and biomarkers. The study was conducted among 100 nonadherence patients at Hershey, Pa.-based Pinnacle Health Systems and presented at the Health2.0 Conference Wednesday in Santa Clara, Calif.

October 1, 2013

Generic drug maker Teva Pharmaceutical Industries has launched a version of a drug used to treat a parathyroid disorder related to kidney disease.

JERUSALEM — Generic drug maker Teva Pharmaceutical Industries has launched a version of a drug used to treat a parathyroid disorder related to kidney disease.

Teva announced Tuesday the launch of paricalcitol, a generic version of AbbVie's Zemplar. As the first company to win Food and Drug Administration approval for the drug, Teva has 180 days in which to compete directly with the branded version.