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Financial Times examines how Brazil's state-run drug sector is engaging in partnerships at home, abroad

"Dilma Rousseff had barely been confirmed as Brazil's new president in November when she made her first foreign visit, to Mozambique," which "included a symbolic stop-off at a pharmaceutical factory that is under construction in preparation for opening in 2014. … The plant will produce a range of medicines for one of its leading lusophone - Portuguese-speaking - African partners, marking the resurgent power and growing reach of its sponsor, Brazil's own state-led drug sector," the Financial Times writes in an article that examines the partnerships Brazil is establishing at home and abroad.

24 Dec 2010

Teva receives FDA complete response letter for glatiramer acetate 0.5mL injection sNDA

Teva Pharmaceutical Industries Ltd. announced today that it has received a complete response letter from the U.S. Food and Drug Administration (FDA) for its supplemental New Drug Application (sNDA) for a lower-volume (0.5mL) injection of glatiramer acetate. Copaxone® containing 20mg of glatiramer acetate in 1ml is the global market leader in the treatment of relapsing-remitting multiple sclerosis (RRMS).

24 Dec 2010

American Regent initiates voluntary recall of Sodium Bicarbonate Injection, USP 7.5% and 8.4%

American Regent is conducting a nationwide voluntary recall to the consumer and user level of ALL unexpired lots of the following products: Sodium Bicarbonate Injection, USP, 7.5%, 44.6 mEq/50 mL, Single Dose Vial

24 Dec 2010

Alimera receives FDA CRL for ILUVIEN NDA

pSivida Corp., a leader in developing sustained release, drug delivery products for treatment of back-of-the-eye diseases, including the investigational drug ILUVIEN® for the treatment of Diabetic Macular Edema (DME), today announced that Alimera Sciences, Inc, pSivida's collaborative partner, received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for ILUVIEN. The FDA issued the CRL to communicate its decision that the NDA cannot be approved in its present form.

24 Dec 2010

MigreLief releases safe, proven effective supplement for children with migraines

MigreLief, the first name in migraine prevention, releases a safe and proven effective supplement for children of all ages: Children's MigreLief.

24 Dec 2010

AVMA offers DEA guidance on new controls for propofol

The American Veterinary Medical Association (AVMA) has offered input to help smooth implementation of proposed new federal guidelines on a useful and effective induction agent, propofol.

23 Dec 2010

Janssen files abiraterone acetate NDS with Health Canada for metastatic, advanced prostate cancer

Janssen Inc. has filed a New Drug Submission (NDS) to Health Canada for the investigational drug abiraterone acetate administered with prednisone for the treatment of metastatic, advanced prostate cancer in patients who have received prior chemotherapy containing a taxane. Submissions for abiraterone acetate have also been filed with health authorities in the United States and Europe.

23 Dec 2010

Meda gains exclusive marketing and distribution rights for EpiPen Auto-Injector in Europe

Meda has signed a long-term license agreement with the specialty division of Mylan Inc., Dey Pharma, L.P., for exclusive marketing and distribution rights of EpiPen® (epinephrine) Auto-Injector in Europe. EpiPen is used for emergency treatment of severe allergic reactions (anaphylaxis). Anaphylaxis can occur quickly (often within a couple of minutes) and may be life-threatening.

23 Dec 2010

$Herbal pain medication gets fractured runner back running again$

Herbal pain medication gets fractured runner back running again

Debilitating injuries can impact quality of life long after the injury has occurred and healed, producing long-term pain and limited mobility. Individuals recuperating from a surgery or other procedure may want explore different options to getting back on their feet after an injury.

23 Dec 2010

Immunization with VLP vaccine results in functional, protective immune responses against RSV

Novavax, and scientists at the University of Massachusetts Medical School, led by Dr. Trudy Morrison, published in the January 2011 issue of The Journal of Virology, a report indicating that a novel virus-like particle vaccine candidate against respiratory syncytial virus (RSV) protects mice from a live virus challenge.

23 Dec 2010

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

Pharmaceutical News

Financial Times examines how Brazil's state-run drug sector is engaging in partnerships at home, abroad

Teva receives FDA complete response letter for glatiramer acetate 0.5mL injection sNDA

American Regent initiates voluntary recall of Sodium Bicarbonate Injection, USP 7.5% and 8.4%

Alimera receives FDA CRL for ILUVIEN NDA

MigreLief releases safe, proven effective supplement for children with migraines

AVMA offers DEA guidance on new controls for propofol

Janssen files abiraterone acetate NDS with Health Canada for metastatic, advanced prostate cancer

Meda gains exclusive marketing and distribution rights for EpiPen Auto-Injector in Europe

Herbal pain medication gets fractured runner back running again

Immunization with VLP vaccine results in functional, protective immune responses against RSV

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

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

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

Amylin, Lilly submit BYETTA sNDA for type 2 diabetes

FDA approves Gardasil for prevention of anal cancer

FDA approves Novartis' Amturnide for treatment of high blood pressure

FDA approves Watson's novel oral contraceptive

New era for anticoagulant therapy

New cough suppressant from cocoa

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

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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