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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

Withdrawal of Pergolide products

The U.S. Food and Drug Administration (FDA) today announced that manufacturers of pergolide drug products, which are used to treat Parkinson's disease, will voluntarily remove these drugs from the market because of the risk of serious damage to patients' heart valves.

29 Mar 2007

Curecumin - potential treatment for lung cancer

Bioponic Phytoceuticals has announced that its Curecumin (a Bioresonant Phytotherapeutic form of Turmeric containing curcumin in a liquid nasal delivery system) may be an important treatment for Lung Cancer.

28 Mar 2007

Thailand, pharmaceutical companies to continue talks on compulsory drug licenses

Thai public health officials plan to continue discussions with international pharmaceutical companies following recent debates over compulsory licenses issued by the country for some medications, U.S. Chamber of Commerce Senior Vice President Daniel Christman said on Tuesday, Reuters UK reports

22 Mar 2007

Massachusetts health insurance connector board votes to require prescription drug coverage as part of draft minimum coverage requirements

The Massachusetts Commonwealth Health Insurance Connector Authority on Tuesday approved minimum coverage requirements for health insurance plans to comply with the state's universal coverage law, including requiring prescription drug coverage, the New York Times reports.

22 Mar 2007

Prescription drug safety legislation introduced in House

Democratic Reps. Henry Waxman (Calif.) and Edward Markey (Mass.) have introduced legislation (HR 1561) that they say would make greater strides toward ensuring the safety of prescription drugs than Senate legislation (S 484) introduced by Sens. Edward Kennedy (D-Mass.) and Mike Enzi (R-Wyo.), CQ HealthBeat reports.

22 Mar 2007

FDA proposes rules to prevent conflicts of interest among agency advisory committee members

FDA on Wednesday announced proposed rules under which medical experts with more than a $50,000 financial interest in pharmaceutical companies could not serve on agency advisory committees that review their products or the products of their competitors, the Washington Post reports.

22 Mar 2007

Promising new pain-killing drug

A potential new pain-killing drug developed by medical scientists at the University of Leicester and Ferrara in Italy is to be discussed at a public lecture on 20th March.

19 Mar 2007

FDA approves Soliris (eculizumab), first treatment for paroxysmal nocturnal hemoglobinuria

The U.S. Food and Drug Administration (FDA) has approved Soliris (eculizumab), the first product for the treatment of paroxysmal nocturnal hemoglobinuria (PNH), a rare type of blood disorder that can lead to disability and premature death.

19 Mar 2007

CDC releases safety data on rotavirus vaccine RotaTeq

The Centers for Disease Control and Prevention (CDC) released today new safety data on a recently licensed rotavirus vaccine given to infants that indicate the vaccine does not pose an elevated risk for intussusception, the most common cause of bowel obstruction in infants.

15 Mar 2007