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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

Pfizer, Bristol-Myers Squibb receive FDA CRL for ELIQUIS NDA

Bristol-Myers Squibb Company and Pfizer announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for ELIQUIS (apixaban) for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.

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

GMCSF linked with rapid cognitive recovery in patients with cancer

Growth factors shown to cure Alzheimer's disease in a mouse model and administered to cancer patients as part of their treatment regimen were linked to significant improvements in the patients' cognitive function following stem cell transplantation, a preliminary clinical study reports.

23 Jun 2012

No definitive link between hormonal contraceptives and increased risk of HIV infection among women, CDC says

"There is no clear link between the use of contraceptives such as the birth control pill or Depo-Provera shots and an increased risk that a woman will contract HIV, the U.S. Centers for Disease Control and Prevention said on Thursday," Reuters reports, noting that the WHO came to the same conclusion in February.

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

WCMC researchers devise innovative boxer-like strategy to fight multiple myeloma

Weill Cornell Medical College researchers have devised an innovative boxer-like strategy, based on the serial use of two anti-cancer drugs, to deliver a one-two punch to first weaken the defenses of multiple myeloma and then deliver the final knock-out punch to win the fight.

23 Jun 2012

EMA CHMP adopts positive opinion for Seebri Breezhaler to treat COPD

Sosei Group Corporation confirms the information released today by Novartis that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Seebri Breezhaler (glycopyrronium/NVA237) 44 mcg delivered dose (50 mcg glycopyrronium per capsule), as a once-daily inhaled maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).

23 Jun 2012

FDA issues CRL to Repligen's RG1068 NDA for treatment of pancreatitis

Repligen Corporation today announced that it has received a Complete Response Letter (CRL) from the U.S. Food & Drug Administration (FDA) regarding the Company's New Drug Application (NDA) for RG1068.

23 Jun 2012

WM Holdings, Full Motion Beverage sign LOI for GX Supplements

Full Motion Beverage, Inc. a new age beverage company has signed a letter of intent (LOI) with WM Holdings, LLC, makers of GX Supplements.

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

Researchers uncover why ointment and photodynamic therapy cause pain in skin cancer patients

Apply the ointment, light on, light off - that's how easy it is to cure various forms of non-melanoma skin cancer. However, the majority of patients suffer severe pain during the so-termed photodynamic therapy.

23 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

Abbott challenges copies of its biologic drugs

If the challenge succeeds, less-expensive versions of complex biologic drugs couldn't go on sale in the U.S. for years, and consumers may never have access to facsimiles of existing treatments such as Abbott's rheumatoid arthritis therapy Humira.

22 Jun 2012

No legal recourse because generic drug caused injury

Carrie Scott went in to the hospital for abnormal bleeding. Days later she returned home without her hand and forearm. The generic form of Phenergan was given improperly, apparently from an inadequate warning label. Scott has no legal recourse because a generic drug caused her injury, rather than its brand-name equivalent.

22 Jun 2012

Patients taking common blood pressure drug show symptoms of celiac disease

Mayo Clinic researchers have discovered an association between a commonly prescribed blood pressure drug, Olmesartan, and severe gastrointestinal issues such as nausea, vomiting, diarrhea, weight loss and electrolyte abnormalities -- symptoms common among those who have celiac disease. The findings are published online today in the medical journal Mayo Clinic Proceedings.

22 Jun 2012

Janssen receives FDA complete response letter for XARELTO sNDA

Janssen Research & Development, LLC (Janssen R&D) announced today the U.S. Food and Drug Administration (FDA) issued a complete response letter regarding a supplemental New Drug Application (sNDA) for XARELTO (rivaroxaban) for the reduction of the risk of secondary cardiovascular events in patients with acute coronary syndrome (ACS).

22 Jun 2012

Fructose may not be as bad for us as previously thought

A new study by researchers at St. Michael's Hospital suggests that fructose may not be as bad for us as previously thought and that it may even provide some benefit.

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