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Pfizer seeks FDA and EMA approval for expanded use of Prevnar 13 for pneumococcal disease

Pfizer Inc today announced that it has submitted supplemental applications to both the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to expand the use of Prevnar 13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) to adults 50 years of age and older for the prevention of pneumococcal disease caused by the 13 serotypes contained in the vaccine.

23 Dec 2010

Merck announces FDA approval for GARDASIL against HPV-related anal cancer

Merck, known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has approved GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant] for the prevention of anal cancer caused by human papillomavirus (HPV) types 16 and 18 and for the prevention of anal intraepithelial neoplasia (AIN) grades 1, 2 and 3 (anal dysplasias and precancerous lesions) caused by HPV types 6, 11, 16 and 18, in males and females 9 through 26 years of age.

23 Dec 2010

Certain drugs may block tumor host interactions but do not destroy cancer cells

A class of drugs thought to kill cancer cells may in fact block "cross talk" between the cancer cell and normal immune cells, resulting in reduced cancer growth and spread-a discovery that could significantly alter the way cancer drugs are evaluated in the future.

23 Dec 2010

Amylin, Lilly submit BYETTA sNDA for type 2 diabetes

Amylin Pharmaceuticals, Inc. and Eli Lilly and Company today announced that a supplemental New Drug Application (sNDA) has been submitted to the U.S. Food and Drug Administration (FDA) for the expanded use of BYETTA® (exenatide) injection as an add-on therapy to basal insulin, with or without metformin and/or a thiazolidinedione (TZD) in conjunction with diet and exercise for adults with type 2 diabetes who are not achieving adequate glycemic control.

23 Dec 2010

FDA approves Gardasil for prevention of anal cancer

The U.S. Food and Drug Administration today approved the vaccine Gardasil for the prevention of anal cancer and associated precancerous lesions due to human papillomavirus (HPV) types 6, 11, 16, and 18 in people ages 9 through 26 years.

23 Dec 2010

FDA approves Novartis' Amturnide for treatment of high blood pressure

Today Novartis announced that the US Food and Drug Administration (FDA) approved Amturnide (aliskiren, amlodipine and hydrochlorothiazide) tablets for the treatment of high blood pressure. Amturnide combines the only approved direct renin inhibitor worldwide, Tekturna (aliskiren), with the widely used calcium channel blocker amlodipine and the diuretic hydrochlorothiazide (HCTZ).

23 Dec 2010

FDA approves Watson's novel oral contraceptive

Watson Pharmaceuticals today announced the U.S. Food and Drug Administration (FDA) approval of a novel oral contraceptive product – the first and only low dose oral contraceptive to combine 0.8 mg norethindrone and 0.025 mg ethinyl estradiol in chewable form, with four 75 mg ferrous fumarate (iron) placebo tablets. Taken orally, once daily, the product is proven effective in lowering the risk of pregnancy.

22 Dec 2010

New era for anticoagulant therapy

In a Guest Editorial published in the new publication Clinical Investigation, Dr Jeffrey Weitz and Dr John Eikelboom of McMaster University in Hamilton, Canada highlight the importance of the approval in October by the FDA of dabigatran etexilate (Pradaxa®; Boehringer Ingelheim). This new oral thrombin inhibitor provides an alternative to warfarin for long-term stroke prevention in patients with non-valvular atrial fibrillation.

22 Dec 2010

New cough suppressant from cocoa

People suffering from persistent cough may soon have a remedy that is derived from cocoa. At present researchers are carrying out the final stages of clinical trials of a drug that contains theobromine, an ingredient found in chocolate and cocoa. The drug could be in the market in another two years.

22 Dec 2010

Arena, Eisai complete lorcaserin NDA end-of-review meeting with FDA

Arena Pharmaceuticals, Inc. and Eisai Inc. announced today the completion of an end-of-review meeting with the US Food and Drug Administration (FDA) for the lorcaserin New Drug Application (NDA).

22 Dec 2010

Delcath completes NDA submission for chemosaturation system

Delcath Systems, Inc. today announced that the Company has submitted the remaining modules of its 505(b)(2) New Drug Application (NDA) for its proprietary chemosaturation system to the U.S. Food & Drug Administration (FDA). The Company had previously submitted Module 4, consisting of literature based non-clinical data, to the FDA in late April 2010. The Company is seeking an indication for the percutaneous intra-arterial administration of melphalan hydrochloride for use in the treatment of patients with metastatic melanoma in the liver.

22 Dec 2010

FDA issues CRL to Cumberland's Acetadote sNDA for non-acetaminophen acute liver failure

Cumberland Pharmaceuticals Inc. announced today that it has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) regarding its supplemental new drug application (sNDA) for Acetadote® (acetylcysteine) Injection to treat patients with non-acetaminophen induced acute liver failure.

22 Dec 2010

Intellipharmaceutics announces delay of patent approvement to market Protonix drug

Intellipharmaceutics International, today announced that it has notified the U.S. Food and Drug Administration that it has not received notification, as provided for under the Hatch-Waxman Act, of any patent infringement proceedings by the brand owner, Wyeth Pharmaceuticals, a wholly-owned subsidiary of Pfizer, for its application to market a generic of Wyeth's Protonix® tablets.

22 Dec 2010

LFB receives positive review feedback for closing of Willfact 1000 IU Mutual Recognition Procedure

LFB received from the German regulatory authority (Paul-Ehrlich-Institute) a positive review feedback for the closing of the Mutual Recognition Procedure (MRP) of Willfact® 1000 IU with Germany as the reference member state.

22 Dec 2010

Maternal prenatal supplements boost child's intellectual and motor function

In an area where iron deficiency is prevalent, children of mothers in rural Nepal who received prenatal iron, folic acid and vitamin A supplementation performed better on measures of intellectual and motor functioning compared to offspring of mothers who received vitamin A alone, according to a study in the December 22/29 issue of JAMA.

22 Dec 2010

Biogen Idec, Elan propose updated product labeling for TYSABRI to FDA and EMA

Biogen Idec and Elan Corporation, plc announced that the companies have submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) and a Type II Variation to the European Medicines Agency (EMA) to request review and approval to update the respective TYSABRI Prescribing Information and Summary of Product Characteristics.

22 Dec 2010

Poison centers raise concern over dangerous substance marketed as bath salts

Doctors and clinicians at U.S. poison centers are increasingly concerned about products marketed as bath salts that are causing increased blood pressure, increased heart rate, agitation, hallucinations, extreme paranoia and delusions.

22 Dec 2010

Takeda completes settlements in patent litigation over generic ACTOS, ACTOplus met, and duetact ANDAs

Takeda Pharmaceutical Company Limited ("Takeda") today announced that Takeda and its wholly-owned subsidiary, Takeda Pharmaceuticals North America, Inc. ("TPNA"), have completed settlements with all defendants in patent litigation brought against the companies in response to their Abbreviated New Drug Applications ("ANDAs") for generic ACTOS® (pioglitazone HCl), ACTOplus met® (pioglitazone HCl and metformin HCl), and duetact® (pioglitazone HCl and glimepiride).

22 Dec 2010

Spinal Botox injection reduces pain

Botulinum neurotoxin type A (BoNT/A)—better known as Botox—reduces responses to an inflammation-related pain stimulus when injected into the spinal canal in mice, reports a study in the January issue of Anesthesia & Analgesia, official journal of the International Anesthesia Research Society (IARS).

22 Dec 2010

Prenatal iron-folic acid supplementation increases intellectual, motor function in children

In developing countries where iron deficiency is prevalent, prenatal iron-folic acid supplementation increased offspring intellectual and motor functioning during school age, according to researchers from the Johns Hopkins Bloomberg School of Public Health.

22 Dec 2010