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May 6, 2011
Novartis' Afinitor approved as advanced pancreatic NET treatment

The Food and Drug Administration has approved a drug made by Novartis as the first treatment for advanced pancreatic neuroendocrine tumors, Novartis said Thursday.

EAST HANOVER, N.J. — The Food and Drug Administration has approved a drug made by Novartis as the first treatment for advanced pancreatic neuroendocrine tumors, Novartis said Thursday.

Novartis announced the approval of Afinitor (everolimus), saying it marked the first approval of a drug for advanced pancreatic NET in nearly 30 years. The drug already is approved for treating cancers of the kidneys and brain.

May 5, 2011
Lilly invests $2.5 million into Grow What Works campaign

Eli Lilly announced its largest-ever education-focused grant.

INDIANAPOLIS — Eli Lilly announced its largest-ever education-focused grant.

The drug maker has teamed up with nonprofit group The Mind Trust to launch the Grow What Works campaign, which seeks to raise and invest $18 million in the highest-impact education organizations working in Indianapolis. Lilly invested $2.5 million for the cause.

Since its founding in 2006, The Mind Trust has been strategically building a network of the nation's best education reform organizations in Indianapolis, Lilly said.

May 5, 2011
Pfizer: Pristiq reduces hot flashes among postmenopausal women

A major depressive disorder treatment made by Pfizer significantly reduced the number and severity of moderate-to-severe hot flashes in postmenopausal women, compared with placebo, according to a new study.

WASHINGTON — A major depressive disorder treatment made by Pfizer significantly reduced the number and severity of moderate-to-severe hot flashes in postmenopausal women, compared with placebo, according to a new study.

May 4, 2011
Report: Novartis to boost biosimilars portfolio

Novartis is making big investments in biosimilars, CEO Joe Jimenez said in an interview with Fortune magazine.

NEW YORK — Novartis is making big investments in biosimilars, CEO Joe Jimenez said in an interview with Fortune magazine.

Jimenez told Fortune that the Swiss drug maker — which markets generics and biosimilars through its Sandoz division — was investing heavily in biosimilars and difficult-to-make generics for such conditions as cancer and respiratory disorders.

May 2, 2011
FDA approves Abbott's AndroGel

The Food and Drug Administration has approved a treatment made by Abbott for low testosterone in men, the drug maker said Friday.

ABBOTT PARK, Ill. — The Food and Drug Administration has approved a treatment made by Abbott for low testosterone in men, the drug maker said Friday.

Abbott announced the approval of AndroGel (testosterone gel) in the 1.62% strength, a clear, odorless topical gel for men with hypogonadism. The company already markets AndroGel in the 1% strength.

The new gel contains 40.5 mg of testosterone in two pump presses, while AndroGel 1% contains 50 mg in four pump presses, but the company said the two were not interchangeable.

May 2, 2011
Teva comes up as front-runner to buy Cephalon

Cephalon has another suitor in the form of the world’s largest generic drug company.

JERUSALEM — Cephalon has another suitor in the form of the world’s largest generic drug company.

Teva Pharmaceutical Industries said Monday that it would buy Frazer, Pa.-based Cephalon for $6.8 billion, undercutting efforts by Valeant Pharmaceuticals International, which had offered $5.7 billion in March.

The boards of both companies have agreed to the acquisition, equal to $81.50 per share. Cephalon previously had turned down Valeant’s offer, prompting the Mississauga, Ontario-based company to take its case directly to Cephalon’s shareholders.

May 2, 2011
Tradjenta approved as Type 2 diabetes treatment

The Food and Drug Administration has approved a new treatment for Type 2 diabetes, the agency said Monday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new treatment for Type 2 diabetes, the agency said Monday.

The FDA announced the approval of Tradjenta (linagliptin), made by Indianapolis-based Eli Lilly and German drug maker Boehringer Ingelheim.

“This approval provides another treatment option for the millions of Americans with Type 2 diabetes,” FDA Division of Metabolism and Endocrinology Products director Mary Parks said. “It is effective when used alone or when added to existing treatment regimens.”

May 2, 2011
Watson announces launch of Generess Fe, patient support program

Watson Pharmaceuticals has launched a low-dose chewable contraceptive, the company said Monday.

PARSIPPANY, N.J. — Watson Pharmaceuticals has launched a low-dose chewable contraceptive, the company said Monday.

Watson announced the U.S. commercial launch of Generess Fe (norethindrone and ethinyl estradiol chewable tablets, and ferrous fumarate chewable tablets) in the 0.8-mg/25-mcg strength.

April 29, 2011
Zytiga OKed as prostate cancer treatment

The Food and Drug Administration has approved a new treatment for prostate cancer made by Johnson & Johnson.

HORSHAM, Pa. — The Food and Drug Administration has approved a new treatment for prostate cancer made by Johnson & Johnson.

Centocor Ortho Biotech, J&J’s biotech subsidiary, announced Thursday the approval of Zytiga (abiraterone acetate), a daily pill for use in combination with the corticosteroid prednisone for treating castration-resistant prostate cancer that has spread to other parts of the body in men who have received prior chemotherapy with Sanofi-Aventis’ Taxotere (docetaxel).

April 28, 2011
Bayer extends sponsorship agreement with World Federation of Hemophilia

Bayer HealthCare Pharmaceuticals and the World Federation of Hemophilia announced Thursday a three-year extension of Bayer’s sponsorship agreement with the WFH.

MONTVILLE, N.J. — Bayer HealthCare Pharmaceuticals and the World Federation of Hemophilia announced Thursday a three-year extension of Bayer’s sponsorship agreement with the WFH.

The agreement calls for Bayer to serve as the sole sponsor of the WFH’s International Hemophilia Training Centre program and provide support for other activities of the organiztion, such as its website and Congress. The program trains healthcare professionals in developing countries in diagnosis and management of hemophilia and related bleeding disorders.

April 28, 2011
Court upholds Lilly's patent for Cymbalta

Drug maker Eli Lilly will get at least two more years of patent exclusivity on a drug used to treat depression, anxiety and pain resulting from diabetic neuropathy and fibromyalgia, thanks to a court order issued Wednesday.

INDIANAPOLIS — Drug maker Eli Lilly will get at least two more years of patent exclusivity on a drug used to treat depression, anxiety and pain resulting from diabetic neuropathy and fibromyalgia, thanks to a court order issued Wednesday.

The U.S. District Court for the Southern District of Indiana ruled to forbid Wockhardt and other generic drug companies from selling generic versions of Cymbalta (duloxetine hydrochloride) until patent protection expires, which is expected to occur in June 2013.

April 28, 2011
Merck closer to acquiring Inspire

Merck has cleared a hurdle in its effort to buy eye care company Inspire Pharmaceuticals for $430 million, the company said Thursday.

WHITEHOUSE STATION, N.J. — Merck has cleared a hurdle in its effort to buy eye care company Inspire Pharmaceuticals for $430 million, the company said Thursday.

The expiration of the waiting period mandated by the Hart-Scott-Rodino Antitrust Improvements Act of 1976 brings Merck one step closer to acquiring Inspire.

Merck announced its intention to buy Raleigh, N.C.-based Inspire for $5 per share on April 15.

April 27, 2011
AstraZeneca adds 'click-to-chat' feature to Crestor, Nexium websites

AstraZeneca has launched a new technology on two of its products' websites to give consumers an option to contact a live AstraZeneca customer service representative with just a click of a button.

WILMINGTON, Del. — AstraZeneca has launched a new technology on two of its products' websites to give consumers an option to contact a live AstraZeneca customer service representative with just a click of a button.

April 27, 2011
Columbia Labs, Watson submit NDA for Prochieve

A drug designed to reduce the risk of premature birth among pregnant women has been submitted to the Food and Drug Administration for approval.

LIVINGSTON and PARSIPPANY, N.J. — A drug designed to reduce the risk of premature birth among pregnant women has been submitted to the Food and Drug Administration for approval.

April 27, 2011
Investigational drug, in combo with chemo, shown to help colorectal cancer patients survive longer

An investigational drug helped patients survive longer when combined with chemotherapy as a second-line treatment for colorectal cancer that had spread to other parts of the body, according to results of a late-stage clinical trial announced by French drug maker Sanofi-Aventis and U.S.-based Regeneron Pharmaceuticals.

PARIS — An investigational drug helped patients survive longer when combined with chemotherapy as a second-line treatment for colorectal cancer that had spread to other parts of the body, according to results of a late-stage clinical trial announced by French drug maker Sanofi-Aventis and U.S.-based Regeneron Pharmaceuticals.

The phase-3 trial combined the drug Zaltrap (aflibercept) with a combination of the chemotherapy drugs folinic acid (leucovorin), 5-fluorouracil and irinotecan, also known as the FOLFIRI regimen.

April 26, 2011
FDA OKs storage option for Kogenate FS

The Food and Drug Administration has approved a new storage option for a hemophilia A treatment made by Bayer HealthCare Pharmaceuticals, the drug maker said.

WAYNE, N.J. — The Food and Drug Administration has approved a new storage option for a hemophilia A treatment made by Bayer HealthCare Pharmaceuticals, the drug maker said.

Bayer announced that Kogenate FS (antihemophilic factor [recombinant]) now can be stored at room temperature, up to 77 degrees, for up to one year. Previously, it could be stored at room temperature for three months, and most Factor VIII products must be stored in a refrigerator.

April 26, 2011
Lamictal XR receives FDA approval as monotherapy

The Food and Drug Administration has approved a new indication for an epilepsy drug made by GlaxoSmithKline, the drug maker said Monday.

RESEARCH TRIANGLE PARK, N.C. — The Food and Drug Administration has approved a new indication for an epilepsy drug made by GlaxoSmithKline, the drug maker said Monday.

April 26, 2011
Watson joins Walgreens on New Life Agency's Fertility Pharmacy Care Card

The New Life Agency has added a prescription progesterone supplement and RESOLVE: the National Fertility Association to the Fertility Pharmacy Care Card.

RANCHO MIRAGE, Calif. — The New Life Agency has added a prescription progesterone supplement and RESOLVE: the National Fertility Association to the Fertility Pharmacy Care Card.

April 25, 2011
AP Pharma announces financing, appoints new executives

Drug maker AP Pharma has appointed two new executives and may receive financing of up to $4.5 million, the company said Monday.

REDWOOD CITY, Calif. — Drug maker AP Pharma has appointed two new executives and may receive financing of up to $4.5 million, the company said Monday.

AP announced the appointment of John Whelan as president, CEO and director, and Michael Adam as SVP and COO.

April 25, 2011
AstraZeneca's thyroid cancer drug launches

Anglo-Swedish drug maker AstraZeneca has made the drug vandetanib available to certain thyroid cancer patients.

WILMINGTON, Del. — Anglo-Swedish drug maker AstraZeneca has made the drug vandetanib available to certain thyroid cancer patients.

The drug maker announced Monday that the drug would be available to patients with medullary thyroid cancer that could not be removed surgically or that had spread to other parts of the body. The Food and Drug Administration approved the drug on April 6, and it is available exclusively through the pharmacy business unit of Biologics Inc., an integrated cancer management company.

April 25, 2011
Menactra approved for use in infants, toddlers

The Food and Drug Administration has approved the first vaccine for preventing meningococcal disease in children as young as 9 months old, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration has approved the first vaccine for preventing meningococcal disease in children as young as 9 months old, the agency said.

The FDA announced the approval of Menactra, made by Sanofi Pasteur, the vaccines arm of French drug maker Sanofi-Aventis. Meningococcal disease is a life-threatening illness caused by Neisseria meningitidis bacteria that infect the bloodstream and the lining surrounding the brain and spinal cord.

April 25, 2011
Pozen, AstraZeneca file suit against Dr. Reddy's over generic Vimovo

A generic drug maker is being sued for patent infringement for its version of a fixed-dose combination drug co-created by Pozen and AstraZeneca.

CHAPEL HILL, N.C. — A generic drug maker is being sued for patent infringement for its version of a fixed-dose combination drug co-created by Pozen and AstraZeneca.

April 22, 2011
Valeant issues letter to Cephalon stockholders

Valeant Pharmaceuticals International is taking its case directly to Cephalon’s shareholders in its effort to acquire the Frazer, Pa.-based drug maker.

MISSISSAUGA, Ontario — Valeant Pharmaceuticals International is taking its case directly to Cephalon’s shareholders in its effort to acquire the Frazer, Pa.-based drug maker.

In a letter to the shareholders Thursday, Valeant said its $73-per-share offer, totaling $5.7 billion, was a 29% premium over the 30-day stock price of Cephalon, noting that the price had declined over the last five years and that the average stock price in the month before the offer was $57, which Wall Street analysts didn’t expect to rise above $60.

April 21, 2011
GSK applauds agreement to support global preparedness against pandemic influenza

Companies that make vaccines, drugs and diagnostic tests for influenza will become key stakeholders in the World Health Organization’s Global Influenza Surveillance Network under an agreement reached at the Open Ended Working Group that WHO coordinated to support global preparedness for a future influenza pandemic.

LONDON — Companies that make vaccines, drugs and diagnostic tests for influenza will become key stakeholders in the World Health Organization’s Global Influenza Surveillance Network under an agreement reached at the Open Ended Working Group that WHO coordinated to support global preparedness for a future influenza pandemic.

April 21, 2011
GSK, Valeant respond to CRL for ezogabine

GlaxoSmithKline and Valeant last week responded to the Food and Drug Administration's complete response letter for the companies' investigational anti-epileptic drug.

LONDON — GlaxoSmithKline and Valeant last week responded to the Food and Drug Administration's complete response letter for the companies' investigational anti-epileptic drug.