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OncoGenex achieves key regulatory milestone for lead product candidate

OncoGenex Pharmaceuticals Inc. today announced that it concluded a meeting with the U.S. Food and Drug Administration (FDA) on October 7, 2008, and that the FDA agreed that "durable pain palliation is an acceptable and desirable study endpoint" to support a product marketing approval for OGX-011 as a treatment for hormone refractory prostate cancer (HRPC).

13 Oct 2008

New maturation inhibitor drugs may help solve HIV treatment conundrum

Since AIDS was first recognized in 1981, significant advances have been made in developing an effective arsenal of drugs to manage the disease and extend patients' lives.

13 Oct 2008

Drug companies plan to invest in HIV/AIDS drug development, improve access, U.N. Secretary-General says

United Nations Secretary-General Ban Ki-moon on Thursday said that many large pharmaceutical companies -- including Abbott Labs, Boehringer Ingelheim, GlaxoSmithKline and Pfizer -- plan to increase their efforts to develop HIV/AIDS drugs and diagnostics for impoverished regions, Reuters reports.

13 Oct 2008

Kinaxo partners with Boehringer Ingelheim

Kinaxo Biotechnologies GmbH announced today that it has entered into a two-year collaboration with Boehringer Ingelheim. Under the agreement Kinaxo will apply its new platform technologies to studies on drug mode of action and target identification. Financial details of the agreement were not disclosed.

13 Oct 2008

FDA continues review of Takeda's NDA for Alogliptin

Takeda Pharmaceutical Company Limited has announced that Takeda Global Research and Development Center, Inc., a wholly owned United States (U.S.) subsidiary, received notification that the U.S. Food and Drug Administration (FDA) will not be able to complete its review of the alogliptin New Drug Application (NDA) by the Prescription Drug User Fee Act (PDUFA) date of October 27, 2008.

12 Oct 2008

FDA licenses Kogenate FS to prevent joint damage in children with hemophilia A

The U.S. Food and Drug Administration has approved a new use for the blood product Kogenate FS to reduce the frequency of bleeding episodes and prevent joint damage in children with the most severe form of hemophilia.

12 Oct 2008

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