Content about Pharmaceutical industry

September 29, 2010

Teva Pharmaceutical Industries and OncoGenex Pharmaceuticals have started a late-stage clinical trial of an investigative...

BOTHELL, Wash. Teva Pharmaceutical Industries and OncoGenex Pharmaceuticals have started a late-stage clinical trial of an investigative treatment for advanced prostate cancer, the two companies said Thursday.

 

Teva and OncoGenex, a company based in the Seattle suburb of Bothell, Wash., that develops cancer therapies, announced the start of “SYNERGY,” a phase-3 trial of OGX-011/TV-1011 (custirsen), a first-line therapy for treating castrate-resistant prostate cancer.

 

 

September 29, 2010

Walgreens announced Thursday that Jeffrey Berkowitz, a former SVP at drug maker Merck, has joined...

DEERFIELD, Ill. Walgreens announced Thursday that Jeffrey Berkowitz, a former SVP at drug maker Merck, has joined the company.

Berkowitz will serve as Walgreens' SVP pharmaceutical development and market access, responsible for the overall pharmacy contracting strategy for the company, both on the pharmaceutical manufacturing side and on the retail payer side, the drug store chain said. He will report to Walgreens' pharmacy services president Kermit Crawford.

September 28, 2010

Sun Pharmaceutical Industries' subsequent offering period by one of its subsidiaries for all outstanding ordinary...

MUMBAI, India Sun Pharmaceutical Industries' subsequent offering period by one of its subsidiaries for all outstanding ordinary shares for drug maker Taro has expired, Sun Pharma said Wednesday.

Sun subsidiary Alkaloida Chemical Company Exclusive Group was informed that 29,382 ordinary shares of Taro had been tendered as of Tuesday. During the pendency of the subsequent offering period, no additional shares have been tendered. All tendered ordinary shares were accepted for payment.

September 27, 2010

Endo Pharmaceuticals will acquire generic drug maker Qualitest Pharmaceuticals for $1.2 billion, Endo said Tuesday....

CHADDS FORD, Pa. Endo Pharmaceuticals will acquire generic drug maker Qualitest Pharmaceuticals for $1.2 billion, Endo said Tuesday.

Endo said the purchase of privately owned Qualitest would expand its offering of branded drugs, generics, devices and services in areas such as pain and urology. Qualitest is the sixth largest generic drug company in the United States, as measured by prescriptions filled.

September 27, 2010

The Food and Drug Administration has approved a generic version of a drug for a...

MUMBAI, India The Food and Drug Administration has approved a generic version of a drug for a devastating muscular disorder.

 

Sun Pharmaceutical Industries announced Tuesday the approval of riluzole hydrochloride in the 50-mg strength. The tablets are used to treat amyotrophic lateral sclerosis or ALS, also known as Lou Gehrig’s disease.

 

 

The drug is a generic version of Sanofi-Aventis’ Rilutek, which has sales of around $50 million, according to Sun.

 

September 27, 2010

The Hart-Scott-Rodino waiting period for Bristol-Myers Squibb’s acquisition of Seattle-based biotech company ZymoGenetics has expired,...

NEW YORK The Hart-Scott-Rodino waiting period for Bristol-Myers Squibb’s acquisition of Seattle-based biotech company ZymoGenetics has expired, enabling Bristol’s acquisition to go through, the drug maker said Tuesday.

 

The drug maker announced the deal to acquire ZymoGenetics for $885 million, or $9.75 per share, earlier this month.

 

 

September 26, 2010

Biosimilars, biogenerics, follow-on biologics—whatever the designation one prefers for knockoffs of biotech drugs—they will soon...

September 26, 2010

More than a dozen top Food and Drug Administration officials will meet with generic drug...

September 26, 2010

Federal efforts to simplify and standardize the information that patients receive with their prescription medications...

September 26, 2010

Winc Design is launching its Charlie Banana brand of environmentally friendly cloth diapers and baby...

Like a freighter in the Atlantic Ocean during hurricane season, anyone with a stake in the generic drug industry will encounter smooth and bumpy sailing alike over the next few years, according to a recent presentation by an industry expert.

September 26, 2010

The generics subsidiary of Pfizer is launching a new business focused on authorized generics. Greenstone...

PEAPACK, N.J. —The generics subsidiary of Pfizer is launching a new business focused on authorized generics. Greenstone announced the launch of the Authorized Generics Alliance, which it said would combine its business model and 17 years of experience in the generics market with the expertise of other drug makers to market authorized generics in the United States under the Greenstone label.

September 26, 2010

Many generic drug companies have long marketed branded drugs on the side, but lately, some...

Many generic drug companies have long marketed branded drugs on the side, but lately, some branded drug companies have sought to enter the generics business as well. One of those companies is Meda Pharmaceuticals, the U.S. subsidiary of Swedish drug maker Meda AB. Drug Store News recently interviewed John White, Meda’s senior director of marketing.

Drug Store News: What gave Meda the idea of pursuing generics?

September 26, 2010

Greenstone announced the launch of an authorized generic version of the Alzheimer’s disease drug Aricept...

September 26, 2010

For all its successes, the generic drug industry has had a lot to worry about...

September 23, 2010

Perrigo has filed for regulatory approval of a generic version of an over-the-counter medication for...

ALLEGAN, Mich. Perrigo has filed for regulatory approval of a generic version of an over-the-counter medication for frequent heartburn, prompting a lawsuit from the branded version’s manufacturer.

The company announced Friday that it had filed for approval for omeprazole and sodium bicarbonate in the 20 mg/1,100 mg strength. The medication is a generic version of Zegerid OTC, made by Schering-Plough HealthCare, a subsidiary of Merck.

 

September 23, 2010

Drug maker Warner Chilcott will buy the U.S. rights to a treatment for overactive bladder...

ARDEE, Ireland Drug maker Warner Chilcott will buy the U.S. rights to a treatment for overactive bladder for $400 million, the company said Friday.

 

The drug maker announced that it would terminate its co-promotion agreement with Novartis concerning the drug Enablex (darifenacin) and purchase the rights to sell it in the United States. It may be required to make additional milestone payments of up to $20 million to Novartis.

 

 

September 22, 2010

The Food and Drug Administration has approved a manufacturing plan for a drug to treat...

EMERYVILLE, Calif. The Food and Drug Administration has approved a manufacturing plan for a drug to treat hot flashes in menopausal women.

 

Bionovo said Thursday that the FDA had accepted its chemistry, manufacturing and controls plan for the drug Menerba. The decisions and agreements are considered binding on the company and the FDA.

 

 

September 22, 2010

The Food and Drug Administration has moved to significantly restrict access to a controversial diabetes...

SILVER SPRING, Md. The Food and Drug Administration has moved to significantly restrict access to a controversial diabetes drug made by GlaxoSmithKline.

The agency said Thursday that it would restrict access to the Type 2 diabetes medication Avandia (rosiglitazone) in response to clinical study data suggesting that its use can increase the risk of heart attacks and strokes.

September 21, 2010

Abbott on Wednesday initiated a proactive, voluntary recall of certain Similac powder infant formulas in...

ABBOTT PARK, Ill. Abbott on Wednesday initiated a proactive, voluntary recall of certain Similac powder infant formulas in the United States, Puerto Rico, Guam and some countries in the Caribbean following an internal quality review, which detected the remote possibility of the presence of a small common beetle in the product, produced in one production area in a single manufacturing facility.

September 21, 2010

A U.S. District Court has blocked Canadian generic drug maker Apotex from selling generic versions...

PITTSBURGH A U.S. District Court has blocked Canadian generic drug maker Apotex from selling generic versions of an antidepressant drug.

 

Generic drug maker Mylan said Tuesday that it had obtained a temporary restraining order from the U.S. District Court for the District of New Jersey prohibiting Apotex from selling generic versions of the drug Paxil CR (paroxetine hydrochloride), an extended-release formulation of GlaxoSmithKline’s Paxil.

 

 

September 21, 2010

Merck is expanding its patient assistance program, the drug maker said Wednesday....

WHITEHOUSE STATION, N.J. Merck is expanding its patient assistance program, the drug maker said Wednesday.

September 20, 2010

The Food and Drug Administration has approved a generic treatment for organ transplant patients....

PITTSBURGH The Food and Drug Administration has approved a generic treatment for organ transplant patients.

 

Mylan announced Tuesday the approval of tacrolimus capsules in the 0.5-mg, 1-mg and 5-mg strengths, and said it plans to launch the drug immediately. The drug is used to prevent rejection of transplanted organs.

 

 

September 19, 2010

Biotech company Genentech has amended its application to the Food and Drug Administration seeking an...

SOUTH SAN FRANCISCO, Calif. Biotech company Genentech has amended its application to the Food and Drug Administration seeking an additional approval for one of its drugs, which the FDA has deemed a “major amendment,” Genentech said Monday.

 

September 16, 2010

The Food and Drug Administration has accepted for review a regulatory approval application for a...

WOODCLIFF LAKE, N.J. The Food and Drug Administration has accepted for review a regulatory approval application for a patch made by Eisai to treat Alzheimer’s disease, the drug maker said Friday.

 

The agency will review a patch formulation of Aricept (donepezil hydrochloride), a weekly patch for treating mild, moderate and severe stages of the disease. The drug already is available in tablet form.

 

 

September 16, 2010

An advisory committee of the Food and Drug Administration has given a thumbs-down to a...

SAN DIEGO An advisory committee of the Food and Drug Administration has given a thumbs-down to a drug for treating obesity.

 

Eisai and Arena Pharmaceuticals said Thursday that the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted 9-5 to recommend against approval of the drug lorcaserin, saying clinical trial data did not adequately show that its benefits would outweigh its risks.