Content about Pharmaceutical industry

November 15, 2010

Generic drug maker Actavis has filed for approval of a generic version of an antidepressant...

LAVAL, Quebec — Generic drug maker Actavis has filed for approval of a generic version of an antidepressant made by Canada’s Labopharm, Labopharm said.

 

The drug maker said it received a notification stating that Actavis had applied to the Food and Drug Administration for approval of a generic version of Oletpro (trazodone hydrochloride) extended-release tablets in the 150-mg and 300-mg strengths.

 

 

November 15, 2010

The Food and Drug Administration has granted orphan drug designation to a drug for treating...

SAN DIEGO — The Food and Drug Administration has granted orphan drug designation to a drug for treating sickle cell disease.

 

November 15, 2010

A social media go-to-market strategy is fast becoming a must-have for companies these days, especially...

CHICAGO — A social media go-to-market strategy is fast becoming a must-have for companies these days, especially those companies operating in the healthcare arena. It’s no longer enough to push patient education out through a branded online page, not with the growing prominence of social media sites. Today, companies need to seed that education across Facebook and Twitter and/or actively engage bloggers and heavy users to successfully get that education out to the masses online.

 

November 14, 2010

William Gibson, the science-fiction author who helped create the cyberpunk genre in the 1980s and...

WALTHAM, Mass. — William Gibson, the science-fiction author who helped create the cyberpunk genre in the 1980s and paved the way for “The Matrix” movie franchise, once said, “The future is already here—it’s just not evenly distributed.”

He was correct. Emerging technologies, ranging from computers to mobile phones, historically have migrated from the theoretical to the inaccessible to the aristocratic to the indispensable and finally to the mundane.

November 14, 2010

The world of generic drugs has a big year ahead of it. Actually, it has...

The world of generic drugs has a big year ahead of it. Actually, it has a few big years ahead of it. But 2011 in particular carries a certain symbolic value as the year in which Pfizer, the world’s biggest drug maker, loses control of its patent for the cholesterol-lowering drug Lipitor (atorvastatin calcium), the world’s top-selling drug.

November 14, 2010

A backlog of more than 2,000 drug entities and devices is awaiting approval. That’s the...

ROCKVILLE, Md. — A backlog of more than 2,000 drug entities and devices is awaiting approval. That’s the situation facing the Food and Drug Administration and the generic pharmaceutical industry—and it’s the chief impetus behind the FDA’s push to impose user fees on generic drug makers seeking the agency’s review and approval for their brand-equivalent medicines.

November 14, 2010

A ghost from 2008 soon could come back to haunt 2010....

NEW YORK — A ghost from 2008 soon could come back to haunt 2010.

According to published reports, the Food and Drug Administration may be considering adopting tougher standards for certain classes of generic drugs if it determines that some are not equivalent to their branded counterparts.

November 14, 2010

In a ruling hailed by retail pharmacy leaders, the Department of Defense now is insisting...

ALEXANDRIA, Va. — In a ruling hailed by retail pharmacy leaders, the Department of Defense now is insisting that drug manufacturers extend the same discounts for prescription drugs sold at community pharmacies that the military gets for medicines dispensed through base dispensaries or mail order.

November 14, 2010

The often wide gap between what consumers will pay out of pocket for a branded...

NEW YORK —The often wide gap between what consumers will pay out of pocket for a branded versus a generic drug is one big factor driving the continually rising demand curve for me-too medicines.

November 14, 2010

Look for a big surge in brand-to-generic drug switches at the pharmacy counter over the...

NEW YORK — Look for a big surge in brand-to-generic drug switches at the pharmacy counter over the next year.

November 14, 2010

K-V Pharmaceutical has created a new marketing subsidiary for generic drugs, the company said. K-V...

November 11, 2010

The president and CEO of Agensys, a subsidiary of Japanese drug maker Astellas, will retire,...

TOKYO The president and CEO of Agensys, a subsidiary of Japanese drug maker Astellas, will retire, Astellas said Tuesday.

 

Donald Rice founded Agensys as UroGenesys in Santa Monica, Calif., in 1996 for the development of biotech drugs for treating cancer. Astellas acquired Agensys in December 2007.

 

Former Allergan SVP, head of global drug development and chief medical officer Sef Kurstjens will replace Rice as president and CEO of Agensys.

November 9, 2010

Watson Pharmaceuticals biotech subsidiary Eden Biodesign has signed a manufacturing agreement with Dutch biotech company...

RESEARCH TRIANGLE PARK, N.C. Watson Pharmaceuticals biotech subsidiary Eden Biodesign has signed a manufacturing agreement with Dutch biotech company Crucell that will give Watson access to Crucell’s cell line technology, the two companies announced Wednesday.

 

Under the agreement, Eden will provide process development and current good manufacturing practice services using Crucell’s PER.C6 technology to licensees using the technology to develop vaccines and gene therapies.

 

 

November 9, 2010

To express it in modern parlance, follow-on biologics will be a hot mess....

NEW YORK To express it in modern parlance, follow-on biologics will be a hot mess.

 

While speaking at the Reuters Health Summit, according to Reuters, Food and Drug Administration commissioner Margaret Hamburg didn’t put it quite that colorfully, but she had said the science will evolve, meaning a regulatory approval pathway never will be a truly done deal.

 

 

November 8, 2010

Loss of patent protection for branded drugs and subsequent competition from generics could save the...

NEW YORK Loss of patent protection for branded drugs and subsequent competition from generics could save the U.S. healthcare system $70 billion or more over the next four years, according to published reports.

 

Reuters reported IMS Health SVP Murray Aitken as saying at the Reuters Health Summit that generics also would increase their dominance in terms of prescriptions dispensed, increasing from 77% during the first half of this year to perhaps 85% by 2014.

 

 

November 8, 2010

Government officials said problems have arisen with the Food and Drug Administration’s approval of a...

NEW YORK Government officials said problems have arisen with the Food and Drug Administration’s approval of a generic blood-thinning drug due to its previous relationship with the generic drug’s manufacturer, according to published reports.

 

November 4, 2010

Biotech company Amgen took home a top award for one of its drugs at an...

THOUSAND OAKS, Calif. Biotech company Amgen took home a top award for one of its drugs at an annual event for drug makers, the company said Friday.

 

Amgen won the Best New Drug award for the osteoporosis treatment Prolia (denosumab) at the 2010 Scrip Awards in London Thursday.

 

The drug works by targeting the cells that break down bone, called osteoclasts, and was named one of the top 10 medical breakthroughs of 2009 in Time magazine.

November 3, 2010

Swiss drug maker Biogen Idec and U.S. drug maker Cardiokine have terminated an agreement to...

WESTON, Mass. Swiss drug maker Biogen Idec and U.S. drug maker Cardiokine have terminated an agreement to develop a treatment for abnormally low sodium levels in the blood, the two companies said Wednesday.

 

The agreement will give Cardiokine all rights to lixivaptan, a treatment for the condition, known as hyponatremia. The collaboration began in 2007, and the drug is in late-stage clinical studies.

 

 

November 3, 2010

Nearly 100 drugs are in development for treating Alzheimer’s disease, according to a new report...

WASHINGTON Nearly 100 drugs are in development for treating Alzheimer’s disease, according to a new report by the main lobby for the pharmaceutical industry.

 

The Pharmaceutical Research and Manufacturers of America said 98 medicines for dementia, mostly Alzheimer’s, were in clinical trials or under review by the Food and Drug Administration.

 

 

November 3, 2010

Sales for generic drug maker Watson Pharmaceuticals grew 33%, to $882.4 million, in third quarter...

MORRISTOWN, N.J. Sales for generic drug maker Watson Pharmaceuticals grew 33%, to $882.4 million, in third quarter 2010, according to an earnings report released Thursday.

 

The sales figure for the current quarter compared with $662.1 million in third quarter 2009. Profits were $105.9 million, compared with $90 million in third quarter 2009.

 

 

“Watson delivered another quarter of strong financial results and continued progress against our strategic objectives,” Watson president and CEO Paul Bisaro said.

November 2, 2010

The main lobbies for the biotechnology and generic drug industries, and a leading manufacturer of...

SILVER SPRING, Md. The main lobbies for the biotechnology and generic drug industries, and a leading manufacturer of generic drugs, testified Wednesday at a hearing sponsored by the Food and Drug Administration to collect public and industry input on the implementation of the regulatory approval pathway for follow-on biologics included in the healthcare-reform bill.

 

November 2, 2010

The Food and Drug Administration has approved a generic treatment made by Lupin Pharmaceuticals for...

SILVER SPRING, Md. The Food and Drug Administration has approved a generic treatment made by Lupin Pharmaceuticals for allergies, according to FDA records.

 

The drug is a generic version of Schering-Plough’s Clarinex.

 

 

Clarinex has annual sales of around $229 million, according to IMS Health data reported by several media in India, where Lupin is based.

 

November 1, 2010

Strong generic sales helped Endo edge analyst expectations for the third quarter, the company noted....

CHADDS FORD, Pa. Strong generic sales helped Endo edge analyst expectations for the third quarter, the company noted.

Net income reached $54.2 million, compared with $49.4 million during the period ended Sept. 30. Net sales jumped 23% to $444.1 million, versus $361 million during the same period a year ago. Analysts had estimated sales of $443.36 million for the quarter.

November 1, 2010

Hyland’s plans to have a reformulated Teething Tablets product back on the market in early...

LOS ANGELES Hyland’s plans to have a reformulated Teething Tablets product back on the market in early 2011, the company stated, following the initiation of its voluntary recall of the product last week.

 

November 1, 2010

The National Association of Chain Drug Stores is urging federal health officials to adopt a...

ALEXANDRIA, Va. The National Association of Chain Drug Stores is urging federal health officials to adopt a simpler means of communicating drug safety and efficacy information to patients, and to clear the way for an approval pathway for generic versions of biologically engineered drugs.

 

NACDS made its priorities known in a letter Monday to Margaret Hamburg, commissioner of the Food and Drug Administration. The letter came from Kevin Nicholson, the group’s VP government affairs and public policy.