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FDA approves Rapaflo for treatment of symptoms due to benign prostatic hyperplasia

The U.S. Food and Drug Administration today approved Rapaflo (silodosin) capsules for the treatment of symptoms due to benign prostatic hyperplasia (BPH), a condition also known as an enlarged prostate.

12 Oct 2008

FDA licenses for marketing Cinryze for hereditary angioedema

The U.S. Food and Drug Administration today licensed for marketing the first product in the United States intended to protect people with hereditary angioedema (HAE), a rare and potentially life-threatening genetic disease. HAE affects about 6,000 to 10,000 individuals in the United States.

12 Oct 2008

Cheap 'Polypill' deals with heart disease and stroke

The 'Polypill' is a single pill which combines a range of drugs that protect against heart disease and stroke and was first considered a number of years ago as a cost effective way to significantly reduce the death toll from cardiovascular disease. But progress has been hampered by the reluctance of pharmaceutical companies to embark on a project involving inexpensive drugs which offered little financial incentive.

7 Oct 2008

Lilly to acquire ImClone Systems for $6.5 billion

Eli Lilly and Company and ImClone Systems Inc. today announced that the boards of directors of both companies have approved a definitive merger agreement under which Lilly will acquire ImClone through an all cash tender offer of $70.00 per share, or approximately $6.5 billion.

6 Oct 2008

FDA accepts ATryn biologics license application

The US Food and Drug Administration, or FDA, has accepted for review GTC Biotherapeutics, Inc.'s Biologics License Application, or BLA, for ATryn.

6 Oct 2008

University of Minnesota task force seeks greater transparency in faculty conflicts of interest with pharmaceutical companies

A task force that examined conflicts of interest at the University of Minnesota Medical School has recommended that the university expand its disclosure policy regarding relationships between the school's faculty and the drug industry, the AP/Fargo Forum reports.

5 Oct 2008

Advanced Life Sciences submits NDA for cethromycin in mild-to-moderate community acquired pneumonia

Advanced Life Sciences Holdings, Inc. has announced the submission of a new drug application (NDA) for cethromycin in mild-to-moderate community acquired pneumonia (CAP). Advanced Life Sciences also entered into debt and equity financing agreements to strengthen its balance sheet and help fund commitments associated with the NDA submission and pre-commercialization activities.

2 Oct 2008

Bayer's new oral anticoagulant Xarelto (Rivaroxaban) gets European licence

A new drug launched today could help in the fight against what experts and campaigners are calling a 'major patient safety issue' - the prevention of hospital-acquired DVT (deep vein thrombosis).

2 Oct 2008

Merck ditches taranabant for obesity

Merck & Co., Inc. will not seek regulatory approval for taranabant, an investigational medicine, to treat obesity and is discontinuing its Phase III clinical development program for taranabant for obesity.

2 Oct 2008

Exelixis files investigational new drug application for anticancer compound

Exelixis, Inc. announced today that it has submitted an investigational new drug (IND) application to the U.S. Food and Drug Administration for XL888, a novel anticancer compound. XL888 is an orally available small molecule inhibitor of HSP90, which is a chaperone protein that promotes the activity and stability of a range of key regulatory proteins, including kinases.

2 Oct 2008

A control dashboard for the pharmaceuticals industry

Research scientists at SINTEF have developed a control dashboard for the pharmaceuticals industry. This enables all pharmacies, wholesalers and manufacturers to check where products are in the supply chain, availability, what stocks the neighbouring pharmacy has and the future prognoses.

29 Sep 2008

Arana files U.S. IND for lead anti-Inflammatory

Biotechnology company Arana Therapeutics Limited today announced it has submitted an Investigational New Drug application (IND) to the FDA (U.S. Food and Drug Administration) for the anti-inflammatory product ART621 in a rheumatoid arthritis (RA) indication.

29 Sep 2008

Senate passes bill to aid low-income seniors pay Medicare premiums

The Senate on Thursday passed a bill (S 3560) that would authorize an additional $45 million to assist low-income seniors with Medicare premiums and increase incentives for certain drug manufactures to produce antibiotics, CQ Today reports.

29 Sep 2008

Average monthly premium for stand-alone Medicare prescription drug coverage will increase by 24% in 2009 to $37, according to report

The average monthly premium for stand-alone Medicare prescription drug coverage will increase by 24% to $37 next year, according to an analysis of the plans by Avalere Health, the Wall Street Journal reports.

29 Sep 2008

PEPFAR suspends funding for three Ranbaxy AIDS drugs banned by FDA

The President's Emergency Plan for AIDS Relief program has suspended funding for three antiretroviral drugs manufactured by Indian generic drugmaker Ranbaxy that were included in an importation ban imposed by FDA on Sept. 16, Bloomberg reports.

29 Sep 2008

CytRx to present new data on molecular chaperone drug discovery technology

CytRx Corporation today announced that Bin Zhang, Ph.D., Associate Director of Biochemistry and Screening, will present at the monthly meeting of the San Diego "LEADS" discussion group, the premium San Diego consortium of screening researchers, to be held on October 1, 2008.

25 Sep 2008

House members send letter to Condoleezza Rice requesting information on antiretrovirals supplied to PEPFAR by Ranbaxy

Rep. John Dingell (D-Mich.) and members of the House Committee on Energy and Commerce on Friday sent a letter to Secretary of State Condoleezza Rice requesting information about alleged safety problems with antiretrovirals manufactured by the Indian generic pharmaceutical company Ranbaxy and distributed through the President's Emergency Plan for AIDS Relief, the AP/International Herald Tribune reports (AP/International Herald Tribune, 9/19).

22 Sep 2008

Pharmacy benefits managers promote low-cost generics, adherence to drug plans

Pharmacy benefits managers have begun offering tools to help consumers find low-cost generic drugs, adhere to drug regimens and increase consumer choice, all of which can help increase profit margins, the Wall Street Journal reports.

22 Sep 2008

Utah preferred prescription drug list savings less than projected

Utah's Medicaid preferred prescription drug list in its first year has reduced spending by nearly $546,000, but the savings fell about $2.75 million short of original estimates by the Utah Department of Health, according to Michael Hales, the director of the state Division of Health Care Financing, the Salt Lake Tribune reports.

22 Sep 2008

Supreme Court prepares to hear pre-emption case that could give pharmaceutical companies protection against liability

The case of a Vermont women who won a $6 million award from Wyeth for failure to adequately warn her of the risk of one of its products is the "latest in a brisk parade of similar ones" in which the U.S. Supreme Court will examine the principle of pre-emption, which states that FDA approval of drugs or medical devices pre-empts the ability for individuals to sue manufacturers for liability in state courts, the New York Times reports.

22 Sep 2008