Content about Pharmaceutical industry

DEERFIELD, Ill. — Drug maker Takeda Pharmaceutical has resubmitted regulatory approval applications for two drugs designed to treat diabetes, the company said.

Takeda announced the resubmission to the Food and Drug Administration of applications for alogliptin and a drug that combines alogliptin with pioglitazone, the active ingredient in the Takeda drug Actos.

NEW YORK — A district court ruled in favor of Pfizer and Northwestern University in a patent infringement case relating to Lyrica (pregabalin).

HAWTHORNE, N.Y. — Israeli drug maker Taro Pharmaceutical Industries has rejected India-based Sun Pharmaceutical Industries' takeover bid, Taro said Thursday.

Taro said its board of directors unanimously voted to reject a $24.50-per-share offer Sun made on Oct. 18, 2011. Taro began listing its shares on the New York Stock Exchange in March.

Sun has sought to buy Taro since 2007.

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SILVER SPRING, Md. — The Food and Drug Administration has approved a new weight-loss drug made by Vivus, the agency said.

The FDA announced the approval of Qsymia (phentermine and topiramate) extended-release, designed for use by overweight and obese adults alongside a reduced-calorie diet and exercise for chronic weight management. The drug's original brand name was Qnexa.

Another prescription drug-related crime is drug counterfeiting, which got significant attention in March 2011 when CBS News’ “60 Minutes” reported on the problem, including a tour of a drug counterfeiting operation.


In March, the Senate passed S. 1886, the Counterfeit Drug Penalty Enhancement Act, which toughens punishments for criminals who produce and traffic counterfeit medications, drawing praise from the National Association of Chain Drug Stores.


WOODCLIFF LAKE, N.J. — A subsidiary of Par Pharmaceutical Cos. acquired earlier this year has received its first Food and Drug Administration approval.

Par said Par Formulations received approval from the FDA for labetalol hydrochloride tablets in the 100-mg, 200-mg and 300-mg strengths. The drug, a generic version of Prometheus Labs' Trandate, is used to treat hypertension.

Par acquired Par Formulations, formerly the Chennai, India-based drug maker Edict Pharmaceuticals, in February 2012.

SILVER SPRING, Md. — The main office of the Food and Drug Administration in charge of regulating generic drugs has appointed a new director, the agency said Friday.

The FDA announced the appointment of Gregory Geba as director of the Office of Generic Drugs, replacing acting director Keith Webber, effective Sunday.

Geba has served in various senior-level clinical and managerial positions in the drug industry for the past 15 years, most recently as deputy chief medical officer for Sanofi US, a subsidiary of French drug maker Sanofi.

WASHINGTON — Nearly 200 drugs for mental illnesses are under clinical development or under review by the Food and Drug Administration, the largest trade group for the drug industry said Thursday.

The Pharmaceutical Research and Manufacturers of America released a report listing 187 drugs, including 52 for depression, 37 for schizophrenia and 26 for anxiety disorders.

INDIANAPOLIS — A clinical trial of a drug for schizophrenia did not yield the desired results, the drug's developer said.

Eli Lilly announced results of the H8Y-MC-HBBM study of pomaglumetad methionil, for patients with acute exacerbation of schizophrenia. The company said results did not show the drug produced a significantly different effect from the placebo.

WASHINGTON — President Barack Obama signed into law Monday what some called a "historic" reauthorization of the Prescription Drug User Fee Act.

NEW YORK — The Food and Drug Administration has approved a drug made by Eli Lilly and Bristol-Myers Squibb for treating a form of colorectal cancer, the two companies said.

Lilly and Bristol announced the approval of Erbitux (cetuximab) for treating colorectal cancer that is KRAS mutation-negative, expresses the epidermal growth factor receptor and has spread to other parts of the body, also known as metastasis. The drug is approved for use alongside a chemotherapy combination containing irinotecan, 5-fluorouracil and leucovorin, also known as FOLFIRI.

WAYNE, N.J., and SOUTH SAN FRANCISCO, Calif. — The Food and Drug Administration has granted priority review for an investigational cancer treatment created by Bayer and Onyx Pharmaceuticals.

The companies said Bayer's new drug application for oral multikinase inhibitor regorafenib initially was filed in April for the treatment of patients with metastatic colorectal cancer, whose disease has progressed after approved standard therapies. The FDA grants priority review to medicines that provide a treatment where little or no adequate therapy exists.