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October 24, 2011

The Food and Drug Administration has approved a new drug for treating a severe form of epilepsy, the agency said Monday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug for treating a severe form of epilepsy, the agency said Monday.

The FDA announced the approval of Onfi (clobazam) tablets, made by Catalent Pharma Solutions and Lundbeck, as an add-on treatment for seizures associated with Lennox-Gastaut syndrome in patients ages 2 years and older. The agency gave the drug orphan drug designation because the disease affects fewer than 200,000 people in the United States.

October 24, 2011

More than three-quarters of patients with multiple sclerosis using a drug made by Sanofi subsidiary Genzyme did not experience disease relapse for two years, according to results of a late-stage clinical trial revealed over the weekend.

CAMBRIDGE, Mass. — More than three-quarters of patients with multiple sclerosis using a drug made by Sanofi subsidiary Genzyme did not experience disease relapse for two years, according to results of a late-stage clinical trial revealed over the weekend.

The drug maker announced Saturday results of the "CARE-MS I" trial, the first of two phase-3 clinical trials comparing the investigational drug Lemtrada (alemtuzumab) with Pfizer's and EMD Serono's Rebif (interferon beta-1a) in patients with relapsing-remitting MS.

October 21, 2011

More than 1-in-10 Americans ages 12 years and older take antidepressants, and the rate of antidepressant use in the United States among all ages increased 400% between 1988 and 2008, according to a new report by the Centers for Disease Control and Prevention's National Center for Health Statistics.

ATLANTA — More than 1-in-10 Americans ages 12 years and older take antidepressants, and the rate of antidepressant use in the United States among all ages increased 400% between 1988 and 2008, according to a new report by the Centers for Disease Control and Prevention's National Center for Health Statistics.

October 21, 2011

The Food and Drug Administration has approved a new formulation of a testosterone therapy made by Watson Pharmaceuticals, the drug maker said Friday.

PARSIPPANY, N.J. — The Food and Drug Administration has approved a new formulation of a testosterone therapy made by Watson Pharmaceuticals, the drug maker said Friday.

Watson announced the approval of its Androderm (testosterone) transdermal system in the 2-mg and 4-mg formulation. The company said the new smaller size and lower-dose patch would provide "highly effective" testosterone administration with a 20% reduction in the active ingredient from the original strength. Watson plans to launch the new patch next month.

October 21, 2011

Two senators are trying to get the Joint Select Committee on Deficit Reduction to take up a bill that would ban so-called "pay-for-delay" patent settlements between brand and generic drug companies, according to published reports.

WASHINGTON — Two senators are trying to get the Joint Select Committee on Deficit Reduction to take up a bill that would ban so-called "pay-for-delay" patent settlements between brand and generic drug companies, according to published reports.

The Pharma Letter reported that Sens. Herb Kohl, D-Wis., and Chuck Grassley, R-Iowa, had urged the "super committee" to support a bill that would ban settlements that include any form of payment in exchange for holding off launch of a generic drug.

October 21, 2011

Sanofi Pasteur, the vaccines division of Sanofi, released data from a new study examining the ability of its Fluzone High-Dose vaccine to provoke an immune response in elderly and younger adults, compared with a standard dose of Fluzone vaccine.

SWIFTWATER, Pa. — Sanofi Pasteur, the vaccines division of Sanofi, released data from a new study examining the ability of its Fluzone High-Dose vaccine to provoke an immune response in elderly and younger adults, compared with a standard dose of Fluzone vaccine.

"The results further support the immunogenicity advantages of Fluzone High-Dose vaccine as compared to Fluzone vaccine, the standard dose comparator, in seniors 65 years of age and older," stated Peter Tsang, director clinical development, Sanofi Pasteur.

October 21, 2011

Walgreens and Novo Nordisk are working with Sharps Compliance to offer Sharps' Complete Needle Collection & Disposal System for customers who use injectable drugs.

HOUSTON — Walgreens and Novo Nordisk are working with Sharps Compliance to offer Sharps' Complete Needle Collection & Disposal System for customers who use injectable drugs.

October 20, 2011

Former Bristol-Myers Squibb executive Anthony Hooper has joined Amgen as EVP global commercial operations.

THOUSAND OAKS, Calif. — Former Bristol-Myers Squibb executive Anthony Hooper has joined Amgen as EVP global commercial operations.

In his new role, Hooper will be responsible for the drug maker's global commercial operations and will report to Amgen president and COO Robert Bradway.

"As we continue to grow, Tony's track record of delivering results and his passion for serving patients across the globe make him an outstanding addition to Amgen's leadership team," Bradway said.

October 20, 2011

Bristol-Myers Squibb announced changes to its senior management team, including the appointment of its U.S. pharmaceuticals president.

NEW YORK — Bristol-Myers Squibb announced changes to its senior management team, including the appointment of its U.S. pharmaceuticals president.

October 20, 2011

A diabetes drug made by Eli Lilly and Amylin Pharmaceuticals has received approval from the Food and Drug Administration for use with an insulin product made by Sanofi.

INDIANAPOLIS — A diabetes drug made by Eli Lilly and Amylin Pharmaceuticals has received approval from the Food and Drug Administration for use with an insulin product made by Sanofi.

Lilly and Amylin said Byetta (eventide) won approval from the FDA as an add-on therapy for patients with Type 2 diabetes taking Sanofi's Lantus (insulin glargine [rDNA origin]) who have not achieved adequate blood sugar control on Lantus alone.

October 20, 2011

On average, 20,000 children under the age of 5 years are hospitalized due to flu symptoms each year, the Loyola University Health System announced Thursday in a press release encouraging parents to have their children inoculated.

MAYWOOD, Ill. — On average, 20,000 children under the age of 5 years are hospitalized due to flu symptoms each year, the Loyola University Health System announced Thursday in a press release encouraging parents to have their children inoculated.

October 20, 2011

The Senate voted 55-45 Thursday to scrap an appropriations bill amendment that would have allowed personal importation of prescription drugs.

WASHINGTON — The Senate voted 55-45 Thursday to scrap an appropriations bill amendment that would have allowed personal importation of prescription drugs.

The amendment had been proposed for the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Bill. The Senate's vote drew applause from an organization representing retail pharmacy chains.

October 20, 2011

Vertex Pharmaceuticals has filed for Food and Drug Administration approval of a drug for cystic fibrosis, the company said.

CAMBRIDGE, Mass. — Vertex Pharmaceuticals has filed for Food and Drug Administration approval of a drug for cystic fibrosis, the company said.

Vertex announced the submission to the FDA of an application for approval and priority review of Kalydeco (ivacaftor), which it said was potentially the first medicine to target the underlying cause of cystic fibrosis, namely mutations in the CFTR gene that causes defective or missing CFTR proteins that inhibit the flow of salt and water across cell membranes and lead to mucus buildup.

October 19, 2011

Abbott on Wednesday morning announced plans to separate into two publicly traded companies, one in diversified medical products and the other in research-based pharmaceuticals.

ABBOTT PARK, Ill. — Abbott on Wednesday morning announced plans to separate into two publicly traded companies, one in diversified medical products and the other in research-based pharmaceuticals.

"Today's news is a significant event for Abbott, and reflects another dynamic change in our company's 123-year history, strengthening our outlook for strong and sustainable growth and shareholder returns," Abbott chairman and CEO Miles White said.

October 19, 2011

ParaPRO on Saturday presented data showing the effectiveness of Natroba (spinosad) topical suspension, 0.9% against head lice and nits following one treatment without nit combing.

BOSTON — ParaPRO on Saturday presented data showing the effectiveness of Natroba (spinosad) topical suspension, 0.9% against head lice and nits following one treatment without nit combing. Those data about the pediculicide, derived from a naturally occurring soil bacterium, were presented in a poster session at the American Academy of Pediatrics National Conference and Exhibition here.

October 19, 2011

Takeda Pharmaceuticals has started a late-stage clinical trial program for a drug to treat Type 2 diabetes, the drug maker said.

OSAKA, Japan — Takeda Pharmaceuticals has started a late-stage clinical trial program for a drug to treat Type 2 diabetes, the drug maker said.

October 18, 2011

The Healthcare Distribution Management Association on Tuesday named six new members to its board of directors.

ARLINGTON, Va. — The Healthcare Distribution Management Association on Tuesday named six new members to its board of directors — Maria Burns, Burlington Drug Co. VP and corporate secretart; Gregory Drew, Value Drug Co. president; Terrance Haas, Harvard Drug Group CEO; David Neu, AmerisourceBergen president; Dale Smith, H. D. Smith chairman and CEO; and Albert Thomas, senior director and general manager of VaxServe, a Sanofi Pasteur company.

October 18, 2011

Johnson & Johnson Tuesday morning pledged significant support behind the relaunch of several McNeil Consumer products into the marketplace in 2012, and feels confident impacted brands — Tylenol and Motrin, among others — will be able to recapture market share, despite significant private-label erosion.

NEW BRUNSWICK, N.J. — Johnson & Johnson Tuesday morning pledged significant support behind the relaunch of several McNeil Consumer products into the marketplace in 2012, and feels confident impacted brands — Tylenol and Motrin, among others — will be able to recapture market share, despite significant private-label erosion.

October 18, 2011

Teva Pharmaceutical Industries has completed its acquisition of another drug maker, following clearance from the Federal Trade Commission.

JERUSALEM — Teva Pharmaceutical Industries has completed its acquisition of another drug maker, following clearance from the Federal Trade Commission.

Teva said its acquisition of Frazier, Pa.-based Cephalon, valued at $6.8 billion, will help the company build out its branded and specialty pharmaceuticals business. The combined company is expected to generate about $20 billion in revenues (on a pro-forma basis) for the 12 months ended in June.

In relation to the deal, Teva sold three generic drugs to Par Pharmaceutical Cos.

October 17, 2011

Archimedes Pharma has launched a new drug for breakthrough cancer pain, the drug maker said Monday.

BEDMINSTER, N.J. — Archimedes Pharma has launched a new drug for breakthrough cancer pain, the drug maker said Monday.

Archimedes announced the launch of Lazanda (fentanyl) nasal spray for adult patients who have developed a tolerance to opioid therapy for persistent, underlying cancer pain. The drug uses Archimedes' patented PecSys delivery system, which allows the drug to be absorbed across the nasal membrane and directly into the bloodstream. The Food and Drug Administration approved the drug on June 30.

October 17, 2011

Vivus has reapplied to the Food and Drug Administration for approval of a drug to treat obesity, the company said Monday.

MOUNTAIN VIEW, Calif. — Vivus has reapplied to the Food and Drug Administration for approval of a drug to treat obesity, the company said Monday.

Vivus said it sent in its regulatory approval application for Qnexa (phentermine and topiramate), a drug designed to treat obese and overweight patients by inducing and maintaining weight loss.

The company originally sought approval for the drug in October 2010, though the FDA declined to approve it.

October 14, 2011

Two classes of drugs for treating Type 2 diabetes will experience the biggest growth in market share of all classes of drugs for the condition, according to a new study by Decision Resources.

BURLINGTON, Mass. — Two classes of drugs for treating Type 2 diabetes will experience the biggest growth in market share of all classes of drugs for the condition, according to a new study by Decision Resources.

The study found that DPP-IV inhibitors and GLP-1 analogues would experience the biggest growth in market share among all drug classes, with a combined market share that will increase from 20% in 2010 to 47% in 2020 in the United States, France, Germany, Italy, Spain, the United Kingdom and Japan.

October 14, 2011

The Food and Drug Adminsitration has approved a drug made by ApoPharma for a complication resulting from treatments for a genetic condition that causes anemia, the agency said Friday.

SILVER SPRING, Md. — The Food and Drug Adminsitration has approved a drug made by ApoPharma for a complication resulting from treatments for a genetic condition that causes anemia, the agency said Friday.

The FDA announced the approval of Ferriprox (deferiprone), used to treat patients with iron overload due to blood transfusions for thalassemia, a blood disorder. Patients with the disease have excess iron in their bodies because of the frequent blood transfusions they must receive that can lead to iron overload, a condition that can be fatal.

October 14, 2011

ECRM recently was recognized for its involvement with the nonprofit organization Operation Shoebox, a charity that delivers personal care items, food and stationery to soldiers stationed all around the world.

CLEVELAND — ECRM recently was recognized for its involvement with the nonprofit organization Operation Shoebox, a charity that delivers personal care items, food and stationery to soldiers stationed all around the world.

October 13, 2011

More than half of parents in Massachusetts said their children have access to prescription drugs that could be abused, according to a new survey.

BOSTON — More than half of parents in Massachusetts said their children have access to prescription drugs that could be abused, according to a new survey.