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April 11, 2011

Endo Pharmaceuticals will buy American Medical Systems for $2.9 billion, the drug maker said Monday.

CHADDS FORD, Pa. — Endo Pharmaceuticals will buy American Medical Systems for $2.9 billion, the drug maker said Monday.

Endo said it and AMS had reached an agreement whereby Endo would acquire the maker of devices and therapies for pelvic health for $30 per share. AMS’ business focuses on men’s health, women’s health and benign prostatic hyperplasia.

April 11, 2011

The Food and Drug Administration has approved a drug made by Johnson & Johnson for treating schizophrenia in adolescents.

TITUSVILLE, N.J. — The Food and Drug Administration has approved a drug made by Johnson & Johnson for treating schizophrenia in adolescents.

J&J said Monday that the FDA had approved Invega (paliperidone) extended-release tablets for patients ages 12 to 17 years. The drug is marketed by J&J subsidiary Ortho-McNeil-Janssen Pharmaceuticals. The drug originally was approved in 2006 for treating schizophrenia in adults.

April 11, 2011

A drug originally developed by scientists in the Soviet Union to treat allergies and currently under investigation by Pfizer and Medivation did not yield significant results in a late-stage clinical trial of patients with Huntington disease, a disorder that leads to cognitive decline, the companies said Monday.

NEW YORK — A drug originally developed by scientists in the Soviet Union to treat allergies and currently under investigation by Pfizer and Medivation did not yield significant results in a late-stage clinical trial of patients with Huntington disease, a disorder that leads to cognitive decline, the companies said Monday.

April 11, 2011

Genzyme now officially is a wholly owned subsidiary of Sanofi-Aventis.

PARIS — Genzyme now officially is a wholly owned subsidiary of Sanofi-Aventis.

The Paris-based drug maker said that the closing followed the completion of the exchange offer for drug maker Genzyme last week. As its subsidiary, Genzyme will become a new platform in Sanofi's sustainable growth strategy and expand the company's presence in biotechnology, Sanofi said. Genzyme will continue to operate out of its Cambridge, Mass., headquarters, and will be led by Sanofi CEO Christopher Viehbacher for several months.

April 8, 2011

Danish drug maker Novo Nordisk has received the Corporate Leadership Award from the National Hemophilia Foundation in response to its research and development efforts for the disease, the company said Friday.

PRINCETON, N.J. — Danish drug maker Novo Nordisk has received the Corporate Leadership Award from the National Hemophilia Foundation in response to its research and development efforts for the disease, the company said Friday.

Novo Nordisk president Jurek Gruhn accepted the award at the NHF’s Inaugural Spring Soiree Benefit in New York Thursday. Novo Nordisk makes NovoSeven RT (coagulation factor VIIa [recombinant], room temperature stable), used to treat hemophilia A and B.

April 8, 2011

Regeneron and Bayer HealthCare have initiated 1-of-2 late-stage clinical trials of their aflibercept ophthalmic solution in the treatment of a complication caused by diabetic retinopathy.

TARRYTOWN, N.Y. and BERLIN — Regeneron and Bayer HealthCare have initiated 1-of-2 late-stage clinical trials of their aflibercept ophthalmic solution in the treatment of a complication caused by diabetic retinopathy.

The drug makers said that it would evaluate the efficacy of VEGF Trap-Eye (aflibercept ophthalmic solution) in the treatment of diabetic macular edema, a prevalent cause of vision loss among diabetes patients, after promising results from its previous clinical trial.

April 8, 2011

Watson announced that its subsidiary is seeking approval to market a generic version of a bacterial conjunctivitis treatment.

PARSIPPANY, N.J. — Watson announced that its subsidiary is seeking approval to market a generic version of a bacterial conjunctivitis treatment.

Watson Labs filed an abbreviated new drug application with the Food and Drug Administration for moxifloxacin hydrochloride ophthalmic solution USP in the 0.5% strength. The antibiotic solution is a generic version of Alcon's Vigamox, which had total U.S. sales of about $281 million ended in February, according to IMS Health.

April 7, 2011

The Food and Drug Administration has approved a drug made by AstraZeneca for treating a rare form of thyroid cancer, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration has approved a drug made by AstraZeneca for treating a rare form of thyroid cancer, the agency said.

The FDA announced the approval of the daily pill vandetanib for late-stage medullary thyroid cancer in patients whose disease is growing and causing symptoms but who are ineligible for surgery.

Medullary thyroid cancer involves specific cells found in the thyroid gland and can occur spontaneously or be part of a genetic disease. There currently are no FDA-approved treatments for this cancer.

April 7, 2011

The Food and Drug Administration has approved a drug made by GlaxoSmithKline and Xenoport for treating restless legs syndrome, the agency said Thursday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a drug made by GlaxoSmithKline and Xenoport for treating restless legs syndrome, the agency said Thursday.

The FDA approved Horizant (gabapentin enacarbil) as a once-daily treatment for moderate-to-severe RLS.

“People with restless legs syndrome can experience considerable distress from their symptoms,” FDA Division of Neurology Products director Russell Katz said. “Horizant provides significant help in treating these symptoms.”

April 7, 2011

Pfizer is partnering with San Diego biotech company Zacharon Pharmaceuticals to develop treatments for rare genetic disorders Zacharon said Thursday.

SAN DIEGO — Pfizer is partnering with San Diego biotech company Zacharon Pharmaceuticals to develop treatments for rare genetic disorders Zacharon said Thursday.

Under the collaboration, which could garner Zacharon up to $210 million, the companies will discover and develop pharmaceutical drugs for treating lysosomal storage disorders, a class of illnesses that includes Fabry disease, Gaucher disease, Pompe disease and Tay-Sachs disease.

April 6, 2011

Generex Biotechnology has revamped its corporate website to underscore the company's focus on the development and approval of its diabetes and immunotherapeutic vaccine products pipeline.

WORCESTER, Mass. — Generex Biotechnology has revamped its corporate website to underscore the company's focus on the development and approval of its diabetes and immunotherapeutic vaccine products pipeline.

The company said that the site will provide improved descriptions of products, technologies, scientific research in progress, trial results and new corporate relationships as they unfold. Generex also will boost its social media presence through Twitter and Facebook.

April 6, 2011

British drug maker Shire has filed suit against Watson Pharmaceuticals and subsidiaries, alleging patent infringement in a case concerning a drug used to treat attention deficit hyperactivity disorder.

DUBLIN — British drug maker Shire has filed suit against Watson Pharmaceuticals and subsidiaries, alleging patent infringement in a case concerning a drug used to treat attention deficit hyperactivity disorder.

Shire announced Wednesday that it had filed the suit in the U.S. District Court for the Southern District of New York against Watson and several subsidiaries over their attempt to market a generic version of Adderall XR (amphetamine, dextroamphetamine mixed salts) and breach of contract.

April 5, 2011

Drug maker Merck is looking to boost its eye care portfolio by acquiring a company focused on developing and commercializing ophthalmic products. The deal carries a cash value of about $430 million.

WHITEHOUSE STATION, N.J. — Drug maker Merck is looking to boost its eye care portfolio by acquiring a company focused on developing and commercializing ophthalmic products. The deal carries a cash value of about $430 million.

April 5, 2011

The Food and Drug Administration has approved Boehringer Ingelheim Pharmaceuticals' single-pill antiretroviral for HIV-1 patients, BI said Tuesday.

RIDGEFIELD, Conn. — The Food and Drug Administration has approved Boehringer Ingelheim Pharmaceuticals' single-pill antiretroviral for HIV-1 patients, BI said Tuesday.

The FDA approved Viramune XR (nevirapine), a single-pill, once-daily, extended-release formulation of nevirapine for use in combination with other antiretroviral drugs.

April 4, 2011

Daiichi Sankyo's SVP commercial operations has taken on a new role at the company.

PARSIPPANY, N.J. — Daiichi Sankyo's SVP commercial operations has taken on a new role at the company.

The drug maker said that John Gargiulo would become president and CEO, effective Monday, following the retirement of current leader Joseph Pieroni.

Gargiulo has been with Daiichi Sankyo since its inception in 1996. In addition to his role at the company, he currently serves on the board of directors of the Pharmaceutical Research and Manufacturers Association, as well as the National Pharmaceutical Council.

April 4, 2011

A topical medication for treating low testosterone in men now is available, drug maker Eli Lilly said.

INDIANAPOLIS — A topical medication for treating low testosterone in men now is available, drug maker Eli Lilly said.

Lilly announced the availability of Axiron (testosterone), a topical solution designed for application under the arm.

The Food and Drug Administration approved Axiron in November, making it the only testosterone replacement therapy applied to the underarm.

April 4, 2011

Pfizer will sell its Capsugel business to Kohlberg Kravis Roberts & Co. for nearly $2.4 billion, the drug maker said Monday.

PEAPACK, N.J. — Pfizer will sell its Capsugel business to Kohlberg Kravis Roberts & Co. for nearly $2.4 billion, the drug maker said Monday.

Capsugel, which develops hard capsules and drug-delivery systems, generated about $750 million in sales last year. The company will maintain its New Jersey headquarters after the sale is complete.

April 4, 2011

A drug used to treat pain in cancer patients now is available in the United States.

BEDMINSTER, N.J. — A drug used to treat pain in cancer patients now is available in the United States.

ProStrakan Group announced Monday the launch of Abstral (fentanyl) sublingual tablets. The tablets, which disintegrate rapidly and are placed under the tongue, treat breakthrough pain, common in one-half to two-thirds of people with cancer-related pain.

The drug, an opioid and controlled substance, only is available through a Food and Drug Administration-mandated REMS program. The FDA approved the drug in January.

April 4, 2011

French drug maker Sanofi-Aventis may get a name change soon, according to a published report.

NEW YORK — French drug maker Sanofi-Aventis may get a name change soon, according to a published report.

Bloomberg reported that the drug maker had scheduled a vote at its May 6 stockholders meeting to shorten the name to “Sanofi.” The article paraphrased a spokesman as saying that the current name is difficult for people in some countries to pronounce.

The Sanofi-Aventis name came into being following the 2004 acquisition of Aventis by Sanofi-Synthelabo.

April 4, 2011

Sanofi-Aventis said it completed its exchange offer for drug maker Genzyme, which expired just before midnight April 1.

PARIS — Sanofi-Aventis said it completed its exchange offer for drug maker Genzyme, which expired just before midnight April 1.

All 224,528,469 shares of Genzyme common stock were validly tendered, which is represented by 84.6% of common stock and 77% of shares on a diluted basis.

Last month, the board of directors of Genzyme unanimously recommended that shareholders accept French drug maker Sanofi-Aventis’ $74-per-share buyout offer.

March 31, 2011

Usually, when the Food and Drug Administration approves a commercial version of a drug, it prohibits compounding pharmacies from producing it, but it’s making an exception in the case of a drug used to prevent premature births.

SILVER SPRING, Md. — Usually, when the Food and Drug Administration approves a commercial version of a drug, it prohibits compounding pharmacies from producing it, but it’s making an exception in the case of a drug used to prevent premature births.

March 31, 2011

A drug used to treat diabetes also may prevent it, according to a new study published in the journal Experimental Biology and Medicine.

CLEVELAND — A drug used to treat diabetes also may prevent it, according to a new study published in the journal Experimental Biology and Medicine.

Researchers at Case Western Reserve University took specially bred obese, prediabetic rats and gave them either Merck’s Januvia (sitagliptin), placebo or glyburide, an older diabetes drug. Both of the diabetes drugs lowered blood-glucose levels after the rats had eaten, but only Junuvia raised the total output of insulin by the pancreas while lowering levels of glucagon.

March 30, 2011

A biopharmaceutical company that specializes in diabetes treatments has appointed a new board chairman.

DANBURY, Conn. — A biopharmaceutical company that specializes in diabetes treatments has appointed a new board chairman.

Biodel said that effective immediately, Brian Pereira, who has served on the drug maker's board since 2007, will become chairman. Current chairman Charles Sanders, who served as chairman since March 2010 after joining the board in August 2006, will continue to serve as a board member, Biodel said.

March 30, 2011

Dr. Reddy’s Labs will assume ownership of a penicillin manufacturing site in Bristol, Tenn., from GlaxoSmithKline.

HYDERABAD, India — Dr. Reddy’s Labs will assume ownership of a penicillin manufacturing site in Bristol, Tenn., from GlaxoSmithKline.

The generic drug maker said it completed the acquisition of the facility and related product portfolio, including Augmentin and Amoxil brands. GSK will retain the existing rights for the aforementioned brands outside the United States.

Further financial terms and conditions of the transaction are not being disclosed.

March 30, 2011

Canadian drug maker Valeant Pharmaceuticals has proposed to buy Cephalon for $5.7 billion, Valeant said Tuesday.

MISSISSAUGA, Ontario — Canadian drug maker Valeant Pharmaceuticals has proposed to buy Cephalon for $5.7 billion, Valeant said Tuesday.

The buyout offer, equal to $73 per share, includes a 29% premium over Cephalon’s stock price. Valeant noted it had made previous offers, but was “disappointed by Cephalon’s unwillingness to engage in discussions in a timely manner.”