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FDA approves Endo's FORTESTA Gel for low testosterone

Endo Pharmaceuticals today announced that the U.S. Food and Drug Administration (FDA) has approved FORTESTA Gel for the treatment of low testosterone, or 'Low T,' also known as hypogonadism. Symptoms associated with Low T include erectile dysfunction and decreased sexual desire, fatigue and loss of energy, mood depression, regression of secondary sexual characteristics and osteoporosis.

29 Dec 2010

FDA stops pain drug trial over safety concerns

Johnson & Johnson revealed Tuesday this week that a clinical trial of its experimental pain drug, fulranumab, has been stopped after the Food and Drug Administration expressed concerns that patients taking the drug could suffer increased joint damage.

29 Dec 2010

Santarus, Pharming submit RHUCIN BLA to FDA for treatment of HAE attacks

Specialty biopharmaceutical company Santarus, Inc. and biotech company Pharming Group NV today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) to obtain marketing approval for RHUCIN® (recombinant human C1 inhibitor) for the treatment of acute angioedema attacks in patients with Hereditary Angioedema (HAE).

29 Dec 2010

Patients unresponsive to anti-anemia drug have higher risk of cardiovascular disease, death

Patients with diabetes, kidney disease and anemia who don't respond to treatment with an anti-anemia drug have a higher risk of cardiovascular disease or death, researchers at UT Southwestern Medical Center have found.

28 Dec 2010

Cephalon receives second FDA Complete Response Letter for NUVIGIL sNDA

Cephalon, Inc. today announced that the company received a second Complete Response Letter from the U.S. Food and Drug Administration (FDA) for the supplemental new drug application (sNDA) for NUVIGIL(R) (armodafinil) Tablets [C-IV] for the treatment of patients with excessive sleepiness associated with jet lag disorder resulting from eastbound travel. In its letter to the company, the FDA reiterated its previously stated concerns regarding the NUVIGIL sNDA.

28 Dec 2010

King Pharmaceuticals resubmits NDA for REMOXY

King Pharmaceuticals®, Inc. and Pain Therapeutics®, Inc. today announced that King has resubmitted a New Drug Application for REMOXY® to the U.S. Food and Drug Administration in response to a Complete Response letter received by Pain Therapeutics in December 2008.

28 Dec 2010

NDA resubmitted for DURECT's ORADUR technology based REMOXY

DURECT Corporation today reported that King Pharmaceuticals, Inc. and Pain Therapeutics, Inc. have announced that King has resubmitted a New Drug Application (NDA) for REMOXY® to the U.S. Food and Drug Administration (FDA) in response to a Complete Response Letter received by Pain Therapeutics in December 2008. This is a Class 2 resubmission with a six month review cycle.

28 Dec 2010

Study sheds light on how bacteria developed resistance to antibiotics

Studying how bacteria incorporate foreign DNA from invading viruses into their own regulatory processes, Thomas Wood, professor in the Artie McFerrin Department of Chemical Engineering at Texas A&M University, is uncovering the secrets of one of nature's most primitive immune systems.

27 Dec 2010

Transition, Elan to modify collaboration agreement for development, commercialization of ELND005

Transition Therapeutics Inc. today announced that the Company and Elan Corporation, plc have mutually agreed to modify their collaboration agreement for the development and commercialization of ELND005.

27 Dec 2010

60% of type 2 diabetics who use insulin would switch to a less expensive biosimilar insulin if available

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that 60 percent of surveyed type 2 diabetes patients in the U.S. who currently use insulin indicate they would request that their doctor switch them to a less expensive biosimilar insulin if such an agent became available.

24 Dec 2010

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

Pharmaceutical News

FDA approves Endo's FORTESTA Gel for low testosterone

FDA stops pain drug trial over safety concerns

Santarus, Pharming submit RHUCIN BLA to FDA for treatment of HAE attacks

Patients unresponsive to anti-anemia drug have higher risk of cardiovascular disease, death

Cephalon receives second FDA Complete Response Letter for NUVIGIL sNDA

King Pharmaceuticals resubmits NDA for REMOXY

NDA resubmitted for DURECT's ORADUR technology based REMOXY

Study sheds light on how bacteria developed resistance to antibiotics

Transition, Elan to modify collaboration agreement for development, commercialization of ELND005

60% of type 2 diabetics who use insulin would switch to a less expensive biosimilar insulin if available

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

Real-time Raman monitoring for pharmaceutical hot melt extrusion

Synthetic Psychedelics: A Growing Public Health Concern

How the Vutara VXL simplifies single-molecule imaging

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