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FDA approves Actavis Mixed Amphetamine Salts ER Capsules

Actavis Group, an international generic pharmaceuticals company, today announced that it has received approval from the US Food & Drug Administration to market Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate Extended-Release Capsules CII, (hereafter referred to as Mixed Amphetamine Salts ER Capsules), in all available strengths: 5mg, 10mg, 15mg, 20mg, 25mg, and 30mg.

25 Jun 2012

MAP Pharmaceuticals completes End-of-Review meeting with FDA for LEVADEX NDA

MAP Pharmaceuticals, Inc. today announced that the Company completed an End-of-Review meeting with the United States Food and Drug Administration (FDA) for its New Drug Application (NDA) for LEVADEX (dihydroergotamine) inhalation aerosol.

25 Jun 2012

Watson enters new $1.8B senior secured term loan facility

Watson Pharmaceuticals, Inc. today announced that it has entered into a new senior secured term loan facility in an aggregate principal amount of $1.8 billion. Borrowings under the new term loan facility bear interest, at a rate equal to LIBOR plus an expected margin of 1.50%, which is subject to a ratings based margin grid. The new five year term loan is fully prepayable.

25 Jun 2012

Researchers create endothelial cells with blood-brain barrier qualities

The blood-brain barrier -- the filter that governs what can and cannot come into contact with the mammalian brain -- is a marvel of nature. It effectively separates circulating blood from the fluid that bathes the brain, and it keeps out bacteria, viruses and other agents that could damage it.

25 Jun 2012

Positive results from Lexicon’s LX4211 Phase 2b trial on type 2 diabetes

Lexicon Pharmaceuticals, Inc., announced today that LX4211, an investigational, oral, dual inhibitor of sodium glucose transporters 1 and 2 (SGLT1 and SGLT2), showed substantial, dose-dependent, statistically-significant reductions in hemoglobin A1c (HbA1c) in a Phase 2b trial in patients diagnosed with poorly-controlled type 2 diabetes who were concurrently treated with metformin, an established diabetes therapy.

25 Jun 2012

BV treatment: full enrolment for phase 2 and first phase 3 trial

Starpharma Holdings Ltd (ASX:SPL; OTCQX: SPHRY) is pleased to report that recruitment is now 100% complete for its Phase 2 clinical trial to investigate the ability of VivaGel® to prevent the recurrence of BV, and also for the first of two pivotal Phase 3 studies of VivaGel® for the treatment of BV.

25 Jun 2012

U.S. District Court rules in favor of Teva in COPAXONE patent infringement case

Teva Pharmaceutical Industries Ltd. announced today the U.S. District Court for the Southern District of New York has found in favor of Teva in the Company's patent infringement lawsuit against Momenta Pharmaceuticals, Inc./Sandoz Inc. and Mylan Laboratories Inc./Natco Pharmaceuticals regarding Teva's relapsing-remitting multiple sclerosis (RRMS) product, COPAXONE.

23 Jun 2012

Growing number of countries adopting flexible IP regulations after India issues country's first compulsory license

"A growing number of countries are adopting India's intellectual property regulations, which give enough flexibility to local companies to produce generic versions of popular drugs to safeguard public health," India's Economic Times reports, noting, "In March, India issued the country's first compulsory license, allowing Natco Pharma to legally manufacture and sell a low-cost version of German drugmaker Bayer AG's patented cancer drug, Nexavar, at 3 percent of the original medicine's price on the grounds that Bayer's drug was not meeting public health requirement."

23 Jun 2012

AIO first in the Pittsburgh area to offer laser surgery for cataract removal

Associates in Ophthalmology (AIO), an eye care and surgery practice with seven locations in the Tri-State Area, has become the region's first medical group to offer bladeless, computer-controlled laser surgery for cataract removal.

23 Jun 2012

EC grants marketing authorization for AMAG's ferumoxytol to treat IDA

AMAG Pharmaceuticals, Inc. today announced that the European Commission has granted marketing authorization for ferumoxytol, an intravenous (IV) iron therapy to treat iron deficiency anemia (IDA) in adult patients with chronic kidney disease (CKD).

23 Jun 2012

Alexza resubmits ADASUVE NDA to U.S. FDA

Alexza Pharmaceuticals, Inc. announced today that it has resubmitted its ADASUVE New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in response to a Complete Response Letter (CRL) received in May 2012.

22 Jun 2012

European CHMP adopts positive opinion for teduglutide to treat short bowel syndrome

Takeda Pharmaceutical Company Limited and NPS Pharmaceuticals, Inc., jointly announced today that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product teduglutide (Revestive) as a once-daily treatment for adult patients with short bowel syndrome (SBS).

22 Jun 2012

UC3M joins European research project on tuberculosis treatments

Scientists at the Carlos III University in Madrid (UC3M) are participating in a European research project designed to study tuberculosis treatments. The objective of the study is to improve diagnostic imaging technology in order to help develop new drugs to treat the disease.

22 Jun 2012

Indica Labs' image analysis algorithm portfolio integrated into Leica Microsystems' digital pathology solution

Leica Microsystems, world-leading provider of Total Digital Pathology solutions, and Indica Labs, developing excellence in image analysis for Digital Pathology, today announce the integration of Indica Labs' advanced image analysis algorithm portfolio into Leica Microsystems digital pathology solution.

22 Jun 2012

Ambulatory monitoring will become more and more part of patients' everyday lives

In the future, patients will become even more involved in the observation and monitoring of their own health or illnesses. For example, blood pressure can be checked 24 hours a day using a blood pressure cuff at home.

22 Jun 2012

Parents must be considered during expansion of genetic screening programs for newborns

Parents must be considered when states decide to expand genetic screening programs for newborns, according to a new study that looked at mandatory testing panels and political pressure by advocacy groups.

22 Jun 2012

New melatonin analogues more efficient in inhibiting NOS activity in Parkinson's disease

University of Granada researchers have tested melatonin analogues in rats as it inhibits the enzyme nitric oxide synthase (NOS), which is involved in the development of conditions as inflammatory bowel disease, septic shock or rheumatoid arthritis, as well as in neurodegenerative conditions as Huntington's disease, Alzheimer's disease, Parkinson's disease and amyotrophic lateral sclerosis.

22 Jun 2012

Shanghai Institutes of Preventative Medicine, Gentris sign MOU to advance personalized medicine

Gentris Corporation, a global leader in the application of genomic biomarkers to clinical studies, announced today that it has signed a Memorandum of Understanding with the Shanghai Institutes of Preventative Medicine to advance global personalized medicine.

22 Jun 2012

Depomed acquires all rights to Zipsor from Xanodyne

Depomed, Inc. today announced that it has acquired all rights to Zipsor (diclofenac potassium) Liquid Filled Capsules from Xanodyne Pharmaceuticals, Inc. Zipsor is a non-steroidal anti-inflammatory drug (NSAID) indicated for relief of mild to moderate acute pain in adults.

22 Jun 2012

Iroko announces results from diclofenac Phase 3 study on post-surgical pain

Iroko Pharmaceuticals, LLC today announced Phase 3 study results that showed patients treated with the company's novel, submicron particle, lower-dose diclofenac (18mg and 35mg), a non-steroidal anti-inflammatory drug (NSAID), experienced significant pain relief post surgery compared with placebo>0.01 and P<0.001 respectively).

22 Jun 2012