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Watson confirms new drug application for generic Sanctura XR

Watson Pharmaceuticals, Inc. has confirmed that its subsidiary, Watson Laboratories, Inc.-Florida, has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration seeking approval to market its trospium chloride extended-release 60 mg capsules prior to the expiration of a patent owned by Supernus Pharmaceuticals, Inc.

15 Jul 2009

New drug blocks common cancer pathway

Scientists have developed a new drug which can reduce the growth of tumours in mice by up to 98 per cent, according to a study published in Molecular Cancer Therapeutics ** this week.

15 Jul 2009

HELP Committee approves protection for high tech drug companies from generics

"Senators agreed Monday to give high-tech biologic drugs 12 years of market protection before generic versions can compete," according to The Associated Press.

15 Jul 2009

WHO recommends vaccine makers move forward in mass production of H1N1 vaccine

"Saying the new H1N1 [swine flu] virus is 'unstoppable', the WHO gave drug makers a full go-ahead to manufacture vaccines against the pandemic influenza strain on Monday and said healthcare workers should be the first to get one," Reuters reports (Fox, 7/14).

15 Jul 2009

Survey: Illinois seniors delay buying prescription drugs

Some seniors in Illinois are delaying buying prescription drugs because of the cost, according to the AARP. United Press International reports: "Twenty-one percent of AARP members surveyed in Illinois report not filling or delaying filling prescriptions due to cost, a survey indicated.

14 Jul 2009

FDA issues draft guidance on drug anticounterfeiting

The U.S. Food and Drug Administration has issued a draft guidance on the use of inks, pigments, flavors, and other physical-chemical identifiers (PCIDs) by manufacturers to make drug products more difficult to duplicate by counterfeiters, and to make it easier to identify the genuine version of the drug.

13 Jul 2009

Too many Australians abusing prescription drugs

The demise of yet another pop icon from the use and abuse of pharmaceutical drugs has again put the spotlight on an increasing addiction to prescription medication among the general public.

13 Jul 2009

Two drug-related legislative plans pose problems for stakeholders

"The Senate dealt a blow to the drug lobby Thursday by voting to permit people in the United States to order lower-cost drugs from Canada over the Internet," the Associated Press/Arizona Republic reports.

12 Jul 2009

WHO approves second HPV vaccine

The WHO announced Thursday it had approved a second cervical cancer vaccine, opening "U.N. agencies and partners [to] now officially buy millions of doses of the vaccine for poor countries worldwide," where an estimated 80 percent of the 280,000 annual deaths from cervical cancer occur each year, the AP/Google.com reports (7/9).

12 Jul 2009

Largest-ever study looks at safety of Non-Steroidal Anti-Inflammatory drugs (NSAIDS)

They are a group of drugs which millions of people rely on to keep pain at bay but they can have unwanted side-effects which are sometimes more serious than the original health problem. Now scientists at The University of Nottingham are taking part in the largest-ever study on the safety of Non-Steroidal Anti-Inflammatory Drugs (NSAIDS) that has ever been performed.

12 Jul 2009

FDA approves Effient (prasugrel) for heart attack in angioplasty patients

The U.S. Food and Drug Administration has approved the blood-thinning drug Effient tablets (prasugrel) to reduce the risk of blood clots from forming in patients who undergo angioplasty, a common procedure to unblock a clogged coronary artery.

12 Jul 2009

White House reassures drug CEOs: reimportation could be 'unnecessary'

The Wall Street Journal reports: "Industry representatives met at the White House Tuesday with officials to consider specifics of a cost-saving agreement the industry reached last month with health-care negotiators and to discuss other concerns that the pharmaceutical industry has with the larger health-care overhaul being considered by Congress.

8 Jul 2009

Multaq approved for atrial fibrillation by FDA

Sanofi-aventis announced today that the U.S. Food and Drug Administration (FDA) has approved Multaq (dronedarone) 400 mg Tablets. Patients with atrial fibrillation (AF) or atrial flutter (AFL) soon will have a new treatment option to help improve current management of their disease. Multaq is the first drug approved in the United States that has shown a clinical benefit to reduce cardiovascular hospitalization in patients with AF/AFL.

7 Jul 2009

NDA for Exenatide once weekly accepted for FDA review

Amylin Pharmaceuticals, Inc., Eli Lilly and Company and Alkermes, Inc. today announced that the New Drug Application (NDA) for exenatide once weekly has been accepted for review by the U.S. Food and Drug Administration (FDA).

7 Jul 2009

WSJ examines pharmaceutical companies expansion into developing countries

The Wall Street Journal examines the "strategic shift in the $770 billion pharmaceutical industry to target the working poor in the developing world" through the eyes of a Pfizer pharmaceutical representative working in the slums overlooking Caracas, Venezuela.

7 Jul 2009

Shire files treatment protocol for Velaglucerase Alfa for Gaucher’s disease

Shire plc has announced that, at the request of the FDA, in view of a potential restriction on the availability of the current approved and marketed treatment for Gaucher’s disease patients, it has filed a treatment protocol for velaglucerase alfa, its enzyme replacement therapy in development for the treatment of Gaucher’s disease.

7 Jul 2009

FDA approves Alimta (pemetrexed) for advanced lung cancer

The U.S. Food and Drug Administration has approved Alimta (pemetrexed), the first drug available for maintenance therapy of advanced or metastatic lung cancer.

6 Jul 2009

Warnings about ‘over-use’ of paracetamol

A panel of experts in the United States has raised new concerns about the popular painkiller paracetamol and are calling for the Food and Drug Administration (FDA) to reduce the maximum dose of paracetamol allowed because they say 'over-use' can cause serious liver damage.

5 Jul 2009

Question marks on credibility of some published clinical trials

Randomised Controlled Trials (RCTs) are considered the 'gold standard' research method for assessing new medical treatments. But research published in BioMed Central's open access journal Trials shows that the design of a remarkable 93 percent of 2235 so-called RCTs published in some Chinese medical journals during 1994 to 2005 was flawed, casting doubt on the reliability of research that is likely to influence medical decision-makers.

2 Jul 2009

FDA approves Multaq tablets (dronedarone) to treat atrial fibrillation

The U.S. Food and Drug Administration has approved Multaq tablets (dronedarone) to help maintain normal heart rhythms in patients with a history of atrial fibrillation or atrial flutter (heart rhythm disorders). The drug is approved to be used in patients whose hearts have returned to normal rhythm or who will undergo drug or electric-shock treatment to restore a normal heart beat.

2 Jul 2009