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Roche to acquire BioVeris

BioVeris Corporation has announced that the Company has reached a definitive agreement under which Roche will acquire BioVeris for $21.50 per share in cash, or a total of approximately $600 million.

From Roche Sequencing and Life Science 5 Apr 2007

Pharmacyclics undergoes 'file over protest' for Xcytrin NDA

Pharmacyclics, Inc. has announced its request to the U.S. Food and Drug Administration (FDA) that its New Drug Application (NDA) for Xcytrin (motexafin gadolinium) Injection be filed over protest.

5 Apr 2007

PhRMA statement on the Medicare prescription drug program

Pharmaceutical Research and Manufacturers of America Senior Vice President Ken Johnson issued the following statement on the AARP's campaign to modify the Medicare prescription drug program.

5 Apr 2007

Market study into the distribution of medicines in the UK

The OFT has launched a market study into the distribution of medicines in the UK. This decision follows recent and proposed distribution changes by leading UK medicine suppliers.

5 Apr 2007

Bayer Healthcare Pharmaceuticals launches in the U.S.

Bayer HealthCare Pharmaceuticals Inc. today announced its official U.S. launch. The new company incorporates the former Berlex Inc.into Bayer HealthCare Pharmaceuticals, as part of Bayer's acquisition of Schering AG, Germany, Berlex's former parent company.

5 Apr 2007

AARP asks U.S. Senator Coleman to stand up to big pharma

AARP State President Skip Humphrey stood with a group of red-shirted AARP members and representatives of the Minnesota Senior Federation and the Elder Care Rights Alliance to urge U.S. Senator Norm Coleman to support legislation to give Medicare the authority to negotiate with drug companies for lower prescription drug prices.

5 Apr 2007

FDA approves Twinrix

GlaxoSmithKline has announced that the U.S. Food and Drug Administration (FDA) has approved Twinrix [Hepatitis A Vaccine (Inactivated) and Hepatitis B (Recombinant) Vaccine], for an accelerated dosing schedule that consists of three doses given within three weeks followed by a booster dose at 12 months.

4 Apr 2007

Effects of changing Paracetamol pack size regulations in UK

Fatal poisonings involving paracetamol (acetaminophen) fell after a law introduced in the UK restricted the number of tablets that could be sold across the counter.

4 Apr 2007

Eli Lilly acquires Hypnion

Eli Lilly and Company has announced that it has completed its acquisition of Hypnion, Inc., a privately held neuroscience drug discovery company focused on sleep disorder research.

3 Apr 2007

CSL Biotherapies submits Biologics License Application to FDA

Pending approval of that application, CSL Biotherapies will introduce its influenza vaccine to the U.S. marketplace. The company's BLA requests that the vaccine be approved to immunize people 18 years of age and older.

3 Apr 2007

Debate continues over access to experimental medications for terminally ill

USA Today on Monday examined the debate over whether patients with terminal illnesses should have expanded access to experimental medications -- an issue currently under consideration in a lawsuit before the U.S. Court of Appeals for the District of Columbia.

3 Apr 2007

Supermarket surgeries - back door way of privatising the NHS

Last week, the government announced plans to let supermarkets and retail pharmacies provide GP services, particularly in under doctored areas.

3 Apr 2007

Takeda acquires rights for drug to treat cervical dysplasia, HPV

Japanese pharmaceutical company Takeda on Friday announced that it has acquired from 3M the rights for a drug, called R-851, to treat cervical dysplasia and "high-risk" human papillomavirus infection, Reuters reports.

2 Apr 2007

FDA discourages consumers from purchasing Accutane online

FDA last week launched a Web page aimed at discouraging consumers from purchasing the acne drug isotretinoin, sold by Roche under the brand name Accutane, on the Internet, Dow Jones/Marketwatch reports.

2 Apr 2007

Cephalon provides update on Nuvigil NDA

Cephalon has announced that it has received an approvable letter, together with draft labeling, from the U.S. Food and Drug Administration (FDA) for its new drug application (NDA) for NUVIGIL (armodafinil) Tablets [C-IV] for the treatment of excessive sleepiness associated with narcolepsy, obstructive sleep apnea/hypopnea syndrome (OSAHS) and shift work sleep disorder (SWSD).

2 Apr 2007

AARP says, "give Medicare the power to negotiate for lower prescription drug prices"

With the support of its 2.6 million members in New York, AARP is calling on the U.S. Senate to stand with the overwhelming majority of Americans and vote to give Medicare the power to negotiate for lower prescription drug prices.

2 Apr 2007

GlaxoSmithKline submits Biologics License Application (BLA) for CERVARIX

If licensed, the vaccine will be indicated for the prevention of cervical cancer and precancerous lesions associated with the most common cancer-causing human papillomavirus types.

1 Apr 2007

GlaxoSmithKline files European meningococcal conjugate vaccine

GlaxoSmithKline has announced the submission of a regulatory file to European Medicines Agency (EMEA) under Article 58 for the combination vaccine candidate Globorix (diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b, Neisseria meningitides serogroups A and C).

1 Apr 2007

FDA approves Ceprotin to treat severe congenital protein C deficiency

The U.S. Food and Drug Administration (FDA) today licensed Ceprotin, the first biologic treatment for patients with a rare genetic defect that can cause a potentially life-threatening clotting disorder.

30 Mar 2007

FDA announces marketing halt for GI drug, Zelnorm

The Food and Drug Administration (FDA) has requested that Novartis Pharmaceuticals Corporation of East Hanover, New Jersey, voluntarily discontinue marketing of Zelnorm (tegaserod) based on the recently identified finding of an increased risk of serious cardiovascular adverse events (heart problems) associated with use of the drug. Novartis has agreed to voluntarily suspend marketing of the drug in the United States.

30 Mar 2007