Content about Pfizer

NEW YORK — The Food and Drug Administration will review a regulatory approval application from Pfizer for a drug to treat an extremely rare and fatal degenerative disease, Pfizer said Wednesday.

Pfizer announced that the FDA had accepted its application for tafamidis meglumine, a treatment for transthyretin familial amyloid polyneuropathy. The disease, also known as TTR-FAP, is a fatal genetic illness that affects about 8,000 people worldwide and causes severe sensory loss, pain, weakness and organ dysfunction.

PHOENIX — Specialty pharmacy provider The Apothecary Shops has inked a deal with Pfizer to distribute a new drug for treating kidney cancer.

The specialty provider announced Wednesday that Pfizer had granted it distribution rights for Inlyta (axitinib), which the Food and Drug Administration approved on Jan. 27 for advanced renal cell carcinoma in patients who have failed one systemic therapy.

PITTSBURGH — The Food and Drug Administration has given tentative approval to a generic cholesterol drug made by Mylan, the drug maker said Thursday.

Mylan announced that it had received tentative approval for a generic version of Pfizer's Lipitor (atorvastatin calcium) in the 10-mg, 20-mg, 40-mg and 80-mg strengths.

SILVER SPRING, Md. — The Food and Drug Administration has approved a drug made by Pfizer for treating advanced kidney cancer, the agency said Friday.

The FDA announced the approval of Inlyta (axitinib) for patients with advanced kidney cancer, also known as renal cell carcinoma, who have not responded to another drug for the disease. The drug, a twice-daily pill, works by blocking certain proteins called kinases that are involved with tumor growth and disease progression.

NEW YORK — The National Advertising Review Board on Tuesday recommended that Novartis Consumer Health discontinue advertising claims that the company’s Excedrin Extra Strength product starts relieving headache pain faster than Advil.

The claims at issue were initially challenged before the National Advertising Division of the Council of Better Business Bureaus by Pfizer Consumer Healthcare, makers of Advil.

WHAT IT MEANS AND WHY IT'S IMPORTANT — One analysis report after another seems to confirm that the generic drug market is in for a huge shift as the number of blockbuster drugs losing patent protection is set to dwindle over the next several years. A recent report by Frost & Sullivan seems to confirm that sentiment.

NEW YORK — A late-stage clinical trial to evaluate a drug in Alzheimer's disease patients came up short, the drug's developers said Tuesday, prompting them to cease its development.

Pfizer and Medivation announced results of the phase-3 "CONCERT" trial of Dimebon (latrepirdine), a trial that had lasted 12 months and enrolled 1,003 patients worldwide. The drug, which the companies have studied since 2009, was originally developed by Soviet Union scientists in the 1980s as an antihistamine.

ADISON, N.J. — Pfizer Consumer Healthcare is giving pain a bad name in marketing its pain-relief brand Advil as the “good” medicine, with Jon Bon Jovi signing on as a company spokesman. The message is part of Pfizer’s “Advil Stories” campaign, which has helped drive growth of the brand in a historically stagnant category — for the 12 weeks ended Nov. 27, Advil sales were up 2.9% to $74.3 million, according to SymphonyIRI Group across food, drug and mass (excluding Walmart). The advertisement aired Dec. 9.

Rather than take off for Christmas, the editors of Drug Store News took a look at the year ahead and the stories, issues and trends that will make headlines in retail pharmacy in 2012.

PHILADELPHIA — Drug makers will focus on patient-specific therapies instead of drugs designed for use by a broad range of people over the next decade, according to a new report released Thursday by Thomson Reuters.

The report, titled "The Changing Role of Chemistry in Drug Discovery" and based on drug industry productivity, patent data and other dynamics and trends, was released in recognition of the International Year of Chemistry 2011.

CAMBRIDGE, Mass. — An orally administered drug made by Genzyme for treating multiple sclerosis did not appear superior to a biotech drug already on the market, according to results of a late-stage clinical trial.

Genzyme, owned by French drug maker Sanofi, compared the once-daily drug teriflunomide with Rebif (interferon beta-1a), made by Pfizer and Merck KGaA, in patients with relapsing MS in the 324-patient "TENERE" trial. Merck KGaA, based in Germany, operates under the name EMD Serono in the United States to avoid confusion with U.S.-based Merck & Co.