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Cannabis drug for MS - don't hold your breath!!

Medicine regulators have been accused of dragging their feet over a cannabis drug for people with multiple sclerosis.

23 Jul 2007

Wyeth wins case of Lisa Dean v. Wyeth

Wyeth has announced that the jury in the case of Lisa Dean v. Wyeth in U.S. District Court found in favor of Wyeth.

23 Jul 2007

IDM Pharma plans to amend NDA for Mifamurtide (L-MTP-PE) for the treatment of osteosarcoma

IDM Pharma, Inc. has announced that it has recently met with the U.S. Food and Drug Administration (FDA) and informed the FDA that the Company intends to take immediate action to supplement the data in its current New Drug Application (NDA) for mifamurtide (L-MTP-PE), formerly known as Junovan, which is being reviewed for the treatment of children and adolescents with non-metastatic osteosarcoma.

23 Jul 2007

European watchdog warns about dangers of Acomplia

The European Medicines Agency has warned consumers that the weight loss drug Acomplia heightens the risk of suicide among those taking anti-depressants.

21 Jul 2007

Schering-Plough announces licensing of Acadesine

Schering-Plough Corporation has announced the worldwide licensing of acadesine, an investigational, potentially first-in-class adenosine regulating agent (ARA), from PeriCor Therapeutics, Inc., a privately held, specialty biopharmaceutical company.

20 Jul 2007

Tibotec Pharmaceuticals submits NDA for investigational HIV treatment

Tibotec Pharmaceuticals Ltd. has announced the submission of a New Drug Application to the U.S. Food and Drug Administration (FDA) for TMC125 (etravirine), an investigational non- nucleoside reverse transcriptase inhibitor (NNRTI), being studied for use with other antiretroviral (ARV) agents as a treatment for people infected with HIV- 1.

19 Jul 2007

GSK's Cervarix receives positive opinion in Europe

GlaxoSmithKline has announced that its cervical cancer candidate vaccine received a positive opinion from the European Committee for Human Medicinal Products (CHMP) for the prevention of precancerous lesions (high grade cervical intraepithelial neoplasia - CIN grades 2 and 3) and cervical cancer causally related to human papillomavirus types 16 and 18.

19 Jul 2007

Lupin receives approval for Amlodipine tablets

Lupin Pharmaceuticals, Inc. has announced that the U.S. Food and Drug Administration (FDA) has granted final approval for the Company's Abbreviated New Drug Application (ANDA) for Amlodipine Besylate Tablets, 2.5 mg (base), 5 mg (base) and 10 mg (base).

18 Jul 2007

FDA approves Extina for seborrheic dermatitis

Stiefel Laboratories, Inc. has announced that the U.S. Food and Drug Administration (FDA) has approved its new drug application for Extina (ketoconazole) Foam, 2% for the treatment of seborrheic dermatitis.

18 Jul 2007

Analysis of diabetes drugs

Most oral medications prescribed for type 2 diabetes are similarly effective for reducing blood glucose, but the drug metformin is less likely to cause weight gain and may be more likely than other treatments to decrease so-called bad cholesterol, according to a report funded by HHS Agency for Healthcare Research and Quality.

17 Jul 2007

Tackling counterfeit Chinese pharmaceuticals

Agencies worldwide are cracking down on counterfeit pharmaceuticals, and much of the focus has been on China, where an official was recently executed for approving fake medicines.

17 Jul 2007

NDA for Lubiprostone to treat irritable bowel syndrome with constipation

Sucampo Pharmaceuticals, Inc., has announced that it has submitted a supplemental New Drug Application to the U.S. Food and Drug Administration to seek market approval of a lower strength of lubiprostone (8 mcg) to treat irritable bowel syndrome with constipation (IBS-C).

13 Jul 2007

Roche statement on offer for Ventana Medical Systems

Roche released the following statement in response to the announcement by Ventana Medical Systems, Inc. ("Ventana").

12 Jul 2007

Caraco Pharmaceutical Labs announces FDA approval to market generic Tenormin

Caraco Pharmaceutical Laboratories has announced that the US Food and Drug Administration (FDA) has granted final approval for the Company's Abbreviated New Drug Application (ANDA) for Atenolol Tablets USP (atenolol).

12 Jul 2007

Baxter receives FDA approval for new dosage of Advate for hemophilia A

Baxter Healthcare Corporation announced that the U.S. Food and Drug Administration (FDA) has approved a new 3000 IU (5mL) dosage strength of ADVATE [Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method].

12 Jul 2007

Ajinomoto to market Capsiate Natura in the U.S.

Ajinomoto has announced plans to introduce Capsiate Natura, a capsinoid dietary supplement, into the United States market.

12 Jul 2007

Ranbaxy receives approval to manufacture and market Amlodipine Besylate tablets

Ranbaxy Pharmaceuticals Inc. (RPI), a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), has announced that RLL has received final approval from the U.S. Food and Drug Administration to manufacture and market Amlodipine Besylate Tablets, 2.5 mg (base), 5 mg (base) and 10 mg (base).

11 Jul 2007

CMS issues final rule for Medicaid prescription drug reimbursements

CMS on Friday released a final rule that will change the Medicaid prescription drug reimbursement formula for pharmacies from being based on the average wholesale price to being based on the average manufacturer price, CongressDaily reports (Edney, CongressDaily, 7/10).

11 Jul 2007

Abiogen licenses RFB4 antibody from Cancer Research Technology

Cancer Research Technology Limited (CRT), the oncology-focused development and commercialisation company, today announces it has agreed an exclusive worldwide licence with Abiogen Pharma S.p.A. (Italy).

11 Jul 2007

Roxane Laboratories announces launch of Amlodipine Besylate tablets

Roxane Laboratories, Inc. has announced the approval of its Abbreviated New Drug Application (ANDA) for Amlodipine Besylate Tablets, 2.5mg, 5mg, and 10mg by the U.S. Food and Drug Administration.

10 Jul 2007