Filed under: Pharmaceuticals

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Lundbeck seeks FDA approval of epilepsy drug

Lundbeck Inc. said the U.S. Food and Drug Administration will review its experimental drug for a rare epilepsy disorder.

Deerfield-based Lundbeck, the U.S. subsidiary of Denmark’s H. Lundbeck SA, said the drug, clobazam, is a therapy used to treat “seizures associated with Lennox-Gastaut syndrome in patients two years and older.” Known as “LGS,” the disease is typically diagnosed in childhood, the company said. Lundbeck hopes to eventually market the drug here under the trade name Onfi. Get the full story »

BioSante shares up after cancer drug meets goals

BioSante Pharmaceuticals Inc. said Thursday its potential pancreatic cancer treatment met key goals in a midstage study.

The company’s stock surged 32 cents, or 16 percent, to $2.35 in premarket trading.

The company said a newly published study showed the vaccine increased the median survival rate of patients by more than 25 percent to 24.8 months. The results were published in the February issue of the Annals of Surgery and involved 60 patients undergoing treatment at the Johns Hopkins Sidney Kimmel Comprehensive Cancer Center in Baltimore. Get the full story »

Walgreen sales get boost from Duane Reade

Deerfield-based pharmacy giant Walgreen Co. said last month’s sales were up nearly 8 percent, boosted by its acquisition of the large Duane Reade pharmacy chain in New York. Get the full story »

FDA cracks down on untested cold medicines

By Julie Deardorff | The Food and Drug Administration plans to remove some unapproved prescription cough, cold and allergy medicines now sitting on store shelves, the agency announced Wednesday.

Walgreens compounds Tamiflu amid shortage

With seasonal influenza widespread in more than 40 states, Walgreen Co. said it has begun “compounding” Tamiflu to keep with the antiviral drug in adequate supply.

In rare instances, pharmacists will “compound” or mix ingredients in order to fill a prescription. In this case, pharmacists take the Tamiflu capsules, break them down and mix them with a cherry syrup, said Walgreens spokesman Jim Cohn. A spike in demand for the liquid form, largely prescribed to children, has triggered a shortage. Get the full story »

Glaxo: Abbott has illegal monopoly in AIDS drugs

From Bloomberg News | GlaxoSmithKline Plc lawyers, in a trial seeking at least $1.5 billion in damages, told jurors that Abbott Laboratories had an illegal monopoly over HIV drugs. Get the full story>>

FDA approves Takeda blood pressure drug

Takeda Pharmaceuticals North America Inc.  in April will begin selling a new pill to treat high blood pressure after the  Food and Drug Administration approved the Deerfield-based company’s Edarbi tablets, the agency said.

Edarbi, which will cost about $75 for a month’s supply, enters a crowded field of blood pressure medications, including several cheaper generics that employers and consumer groups say work well and can cost pennies a day. Get the full story »

Beset by recalls, J&J cuts CEO’s bonus 45%

Johnson & Johnson cut the 2010 performance bonus of its chief executive, William Weldon, by 45 percent, from 2009 levels to $1.98 million, according to a regulatory filing.

The CEO’s diminished bonus comes after a year in which the company faced repeated recalls of consumer health products, medical devices and other products that hit its bottom line. Get the full story »

Pols want answers on Heparin contamination

Lawmakers scolded the FDA for still not knowing what or who was behind the contamination of the Baxter International’s blood-thinning drug Heparin, nearly three years after launching its investigation.

“It has been almost three years since the the FDA linked deaths and serious allergic reactions of patients to supplies of Heparin that came from China,“ Rep. Fred Upton (R-Mich.), wrote in a letter to FDA Commissioner Margaret Hamburg Wednesday. Upton said the House Energy and Commerce committee, which he chairs, will conduct its own probe into the matter. Get the full story »

Abbott wins appeal of Humira patent enfringement

Abbott's Humira drug. (Handout)

Turning back a threat to sales of Abbott Laboratories’ most lucrative drug, a federal appeals court Wednesday overturned a lower court ruling that claimed the North Chicago drug giant used Johnson & Johnson’s technology to make  a blockbuster rheumatoid arthritis drug.

Humira is Abbott’s largest-selling product and one of the world’s top-selling drugs, generating more than $5 billion in annual sales as a treatment for rheumatoid arthritis, Crohn’s disease and psoriasis among other autoimmune disorders.

The ruling in the U.S. Court of Appeals for the Eastern District of Texas overturned a $1.67 billion verdict against Abbott from Marshall County. At the time of the lower court ruling last year, observers said it was known for being friendly to plaintiffs. Get the full story »

FDA questions Sanofi reporting of side effects

U.S. health regulators have warned Sanofi-Aventis SA’s U.S. unit for failing to submit reports of possible serious drug side effects in a timely manner.

In a Jan. 28 letter made public Tuesday, the Food and Drug Administration said an early response from the drugmaker and its “promised corrective actions are inadequate to address the deficiencies.” Get the full story »

J&J recalls ‘pens’ that deliver Simponi doses

Johnson & Johnson has recalled at least 395 injection devices containing rheumatoid-arthritis drug Simponi in the U.S. and Germany, due to a potential defect that could result in an insufficient dose of the drug.

European health authorities warned Friday that the manufacturing snafu could cause a temporary shortage of the Simponi devices. As an alternative, patients are being advised to use prefilled syringes of Simponi. Get the full story »

Sanofi buys Genzyme for $20.1B

French drugmaker Sanofi-Aventis SA has agreed to buy Genzyme Corp. with a sweetened $20.1 billion cash offer, plus payments tied to the success of the U.S. biotech group’s drugs, the companies said on Wednesday.

The acquisition, which comes nine months after Sanofi CEO Chris Viehbacher first put the idea to Genzyme’s Henri Termeer, is expected to boost Sanofi’s earnings from the first year after completion by giving it a new platform in rare diseases. Get the full story »

Sanofi, Genzyme reportedly reach a deal

Sanofi-Aventis SA and Genzyme Corp. have reached an agreement in principle under which Sanofi will acquire Genzyme for $74 a share in cash plus a right to future payments based on the performance of Genzyme’s experimental multiple sclerosis drug, according to a source with knowledge of the discussions.

The deal is expected to be announced by Wednesday morning, the source said.

Baxter declares 31-cent dividend

Drug and medical device maker Baxter International Inc. said Tuesday that its board declared a quarterly dividend of 31 cents per share.

The Deerfield-based company said the dividend is payable April 1 to shareholders of record as of the close of business March 10. Get the full story »