Pharmaceuticals News and Research

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FDA approves Lupin’s Norgestimate and Ethinyl Estradiol Tablets

Pharma major, Lupin Ltd., announced today that its subsidiary, Lupin Pharmaceuticals Inc. has received approval for its Norgestimate and Ethinyl Estradiol Tablets, 0.18 mg/0.025 mg, 0.215 mg/0.025 mg, and 0.25 mg/0.025 mg from the United States Food and Drugs Administration (FDA).

4 Jul 2012

Treating Sickle Cell Disease with L-Glutamine

By focusing on how best to help patients, researchers can sometimes find solutions that are much simpler than anticipated. That has been the guiding approach to our efforts to develop a treatment for sickle cell disease.

3 Jul 2012

Research highlights three factors that could determine outbreak of pandemic flu

A major collaboration between US research centers has highlighted three factors that could ultimately determine whether an outbreak of influenza becomes a serious epidemic that threatens national health. The research suggests that the numbers in current response plans could be out by a factor of two or more depending on the characteristics of the particular pandemic influenza.

3 Jul 2012

IRIN examines antibiotic resistance, efforts to discover new drugs

IRIN examines a global increase in resistance to antibiotics, writing, "Almost one in every five deaths worldwide occurs as a result of infection, but many bacterial illnesses will become incurable as the efficacy of current antibiotic drugs wanes, according to the World Health Organization (WHO)."

3 Jul 2012

First Edition: July 3, 2012

Today's headlines include reports that continue to delve into the policy-oriented and political repercussions of last week's high court decision on the health law.

3 Jul 2012

GHB binds to GABAA-receptor in the brain under physiologically relevant conditions

Researchers are closer to understanding the biology behind GHB, a transmitter substance in the brain, best known in its synthetic form as the illegal drug fantasy. These findings have just been published in the scientific journal PNAS.

3 Jul 2012

FDA accepts BLA filing and grants Priority Review to ThromboGenics' ocriplasmin

ThromboGenics NV, a biopharmaceutical company focused on developing innovative ophthalmic medicines, today announced that the U.S. Food and Drug Administration (FDA) has informed the Company that it has officially accepted the filing of the Biologics License Application for ocriplasmin intravitreal injection, 2.5 mg/ml and granted it Priority Review.

3 Jul 2012

Pernix to acquire Great Southern

Pernix Therapeutics Holdings, Inc., a specialty pharmaceutical company, today announced that it has entered into a definitive agreement to acquire Great Southern Laboratories, a privately-held pharmaceutical contract manufacturing company located in Houston, Texas.

3 Jul 2012

NYSE-Amex accepts CorMedix's plan to regain compliance with continued listing standards

CorMedix Inc., a pharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of Cardiorenal disease, announces the receipt of notice on June 27, 2012 from the NYSE Amex LLC, that the NYSE-Amex has accepted the CorMedix's plan to regain compliance with continued listing standards of the NYSE-Amex.

3 Jul 2012

Muhammad Ali Parkinson Center receives $3M donation from Celebrity Fight Night

The Muhammad Ali Parkinson Center at St. Joseph's Hospital and Medical Center in Phoenix has received a $3 million donation from Celebrity Fight Night that will be used to help dramatically expand the renowned facility and its programs.

3 Jul 2012

Savient's KRYSTEXXA improves HRQOL and physical function in patients with RCG

Savient Pharmaceuticals, Inc. announced a new publication showing that adult patients with refractory chronic gout (RCG) treated bi-weekly with KRYSTEXXA- (pegloticase) experienced statistically significant and clinically meaningful improvements in health-related quality of life (HRQOL), pain and physical function.

3 Jul 2012

USPTO issues notice of allowance to Avanir for NUEDEXTA

Avanir Pharmaceuticals, Inc. announced today that the United States Patent and Trademark Office (USPTO) has allowed a new patent that covers Avanir's product NUEDEXTA, further expanding the intellectual property portfolio for the company's lead commercial asset.

2 Jul 2012

'Adaptive' clinical trials now being planned at U-M, other sites

A new approach to testing medical treatment options could ensure that more patients get the most beneficial treatment for them - but still yield valuable research results that stand up to scientific scrutiny.

2 Jul 2012

Onyx commences ENDEAVOR Kyprolis Phase 3 trial for relapsed multiple myeloma

Onyx Pharmaceuticals, Inc. announced today that the company has begun enrollment in the ENDEAVOR trial, a Phase 3 trial evaluating Kyprolis in combination with dexamethasone, versus bortezomib with dexamethasone in patients with relapsed multiple myeloma.

2 Jul 2012

Rexahn submits RX-5902 IND to FDA for treatment of advanced or metastatic solid tumors

Rexahn Pharmaceuticals, Inc., a clinical stage pharmaceutical company developing and commercializing potential best in class oncology and CNS therapeutics, today announced that it has submitted an investigational new drug application (IND) to the Food and Drug Administration for a first-in-human study of RX-5902 to treat advanced or metastatic solid tumors.

2 Jul 2012

Sosei completes SO-1105 Phase I trial for oropharyngeal candidiasis in Japan

Sosei Group Corporation, the biopharmaceutical company, today announces that its wholly owned Japanese subsidiary, Sosei Co., Ltd., has successfully completed a Japanese Phase I trial for SO-1105 for the treatment of oropharyngeal candidiasis.

2 Jul 2012

Janssen seeks accelerated FDA approval for bedaquiline to treat MDR-TB

Janssen Research & Development, LLC today announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking accelerated approval for the use of the investigational drug bedaquiline (TMC207) as an oral treatment, to be used as part of combination therapy for pulmonary, multi-drug resistant tuberculosis (MDR-TB) in adults.

2 Jul 2012

CytRx granted European patent for tumor-targeting linker platform technology

CytRx Corporation, a biopharmaceutical company specializing in oncology, today announced that the European Patent Office (EPO) has issued a patent covering the Company's tumor-targeting linker platform technology and pharmaceutical compositions.

2 Jul 2012

Bristol-Myers Squibb to acquire Amylin

Bristol-Myers Squibb Company and Amylin Pharmaceuticals, Inc. announced today that Bristol-Myers Squibb will acquire Amylin for $31.00 per share in cash, pursuant to a cash tender offer and second step merger, or an aggregate purchase price of approximately $5.3 billion.

2 Jul 2012

Clinical results for Teva's biologic oncology candidates presented at MASCC/ISOO 2012

Teva Pharmaceutical Industries Ltd. announced today the presentation of clinical results for its biologic oncology candidates, lipegfilgrastim and balugrastim, at the Multinational Association of Supportive Care in Cancer (MASCC)/International Society of Oral Oncology (ISOO) 2012 International Symposium on Supportive Care in Cancer being held in New York June 28-30.

2 Jul 2012