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FDA accepts Iroko Pharmaceuticals' ZORVOLEX sNDA for review

Iroko Pharmaceuticals, LLC, a global specialty pharmaceutical company dedicated to advancing the science of analgesia, announced that the U.S. Food and Drug Administration has accepted for review the Supplemental New Drug Application for ZORVOLEX (diclofenac), a lower dose nonsteroidal anti-inflammatory drug, for the proposed indication of treatment of osteoarthritis pain in adults. ZORVOLEX was approved by FDA in October 2013 for the treatment of mild to moderate acute pain in adults.

15 Jan 2014

FAMPYRA now available in Ireland for symptomatic treatment of walking impairment in MS patients

Biogen Idec today announced that FAMPYRA (prolonged-release fampridine tablets) has been made available in Ireland for the symptomatic treatment of walking impairment in adults with Multiple Sclerosis. FAMPYRA is a prescription drug and is licensed for use in all types of the disease, including the progressive forms. FAMPYRA is available by way of retail pharmacy on a private payment basis.

15 Jan 2014

TaiGen, R-Pharm sign exclusive agreement to develop and commercialize nemonoxacin

TaiGen Biotechnology Company, Limited today announced that they have signed an exclusive agreement with R-Pharm, a leading Russian pharmaceutical company, to develop and commercialize nemonoxacin (Taigexyn) in the Russian Federation, Turkey and other members of the Commonwealth Independent States.

15 Jan 2014

Study shows that high-blood pressure medicine may also prevent migraines

Candesartan is just as effective as more the commonly prescribed propranolol when it comes to preventing migraine attacks, according to a new study from St. Olavs Hospital in Trondheim, Norway and the Norwegian University of Science and Technology (NTNU).

13 Jan 2014

Obama administration proposes Medicare drug change

In a move that some fear could compromise care for Medicare recipients, the Obama administration is proposing to remove special protections that guarantee seniors access to a wide selection of three types of drugs.

13 Jan 2014

Coalition publishes new evidence on patient impact of drug shortages in US

According to newly published results from a survey of pharmacy directors, drug shortages remain a serious problem for patient safety. Nearly half of the responding directors reported adverse events at their facilities due to drug shortages, including patient deaths.

13 Jan 2014

FDA approves Farxiga tablets to improve glycemic control in adults with type 2 diabetes mellitus

AstraZeneca and Bristol-Myers Squibb Company announced the U.S. Food and Drug Administration approved Farxiga™ [far-SEE-ga] (dapagliflozin), a once-daily oral treatment indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

13 Jan 2014

Texas researcher receives U.S. patent for new class of compounds that protect against TBI

A researcher in the School of Medicine at The University of Texas Health Science Center at San Antonio received a U.S. patent Dec. 31 for his discovery that a class of compounds is protective against traumatic brain injury.

13 Jan 2014

Aetna is helping to reverse abuse of prescription painkillers

Abuse of prescription painkillers, known as opioids, is a widespread and growing problem in the United States. The epidemic adds billions of dollars to health care, work place and criminal justice costs each year.

10 Jan 2014

Low doses of anticancer drug can prevent development of diabetes mellitus type 1

Very low doses of a drug used to treat certain types of cancer protect the insulin-producing cells in the pancreas and prevent the development of diabetes mellitus type 1 in mice. The medicine works by lowering the level of so-called sterile inflammation. The findings have been made by researchers from the University of Copenhagen, the Technical University of Denmark and the University of Southern Denmark working with researchers in Belgium, Italy, Canada, Netherlands and the USA.

9 Jan 2014

Antipsychotic medication can actively combat cells of difficult-to-treat form of ALL

In a prime example of finding new uses for older drugs, studies in zebrafish show that a 50-year-old antipsychotic medication called perphenazine can actively combat the cells of a difficult-to-treat form of acute lymphoblastic leukemia. The drug works by turning on a cancer-suppressing enzyme called PP2A and causing malignant tumor cells to self-destruct.

9 Jan 2014

Akorn acquires NDA and all rights to Betimol from Santen

Akorn, Inc., a niche generic pharmaceutical company, today announced that it has acquired the NDA and all rights to Betimol (timolol ophthalmic solution) 0.25% & 0.5% from Santen. Akorn plans to begin shipping Betimol in the first quarter of 2014.

9 Jan 2014

Mylan announces launch of Mycophenolic Acid Delayed-release Tablets

Mylan Inc. today announced that its U.S.-based subsidiary Mylan Pharmaceuticals Inc. has launched Mycophenolic Acid Delayed-release Tablets, 180 mg and 360 mg. This product is the generic version of Novartis' Myfortic Delayed-release Tablets.

9 Jan 2014

Zymeworks, ImClone Systems partner to develop novel bi-specific antibody oncology therapeutics

Zymeworks Inc. today announced that it has entered into a licensing and collaboration agreement with ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company, to develop an undisclosed number of novel bi-specific antibody oncology therapeutics using Zymeworks' proprietary Azymetric platform. Bi-specific antibodies have the potential to provide improved outcomes for patients by simultaneously targeting two tumor associated antigens to induce a synergistic therapeutic response.

9 Jan 2014

GSK receives FDA approval for combination of Mekinist with Tafinlar for treatment of melanoma

GlaxoSmithKline plc announced today that the U.S. Food and Drug Administration (FDA) has approved Mekinist® (trametinib) for use in combination with Tafinlar® (dabrafenib) for the treatment of patients with unresectable melanoma (melanoma that cannot be removed by surgery) or metastatic melanoma (melanoma which has spread to other parts of the body) with BRAF V600E or V600K mutations.

9 Jan 2014

Daily antibiotic use is effective for preventing recurrent urinary tract infections in women

While daily antibiotic use is the most effective method for preventing recurrent urinary tract infections in women, daily cranberry pills, daily estrogen therapy and monthly acupuncture treatments also have benefits that may be preferable for some patients, according to a new study by researchers at the Los Angeles Biomedical Research Institute.

9 Jan 2014

Merck announces FDA approval of ISENTRESS for oral suspension

Merck, known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration recently approved ISENTRESS for oral suspension, a new pediatric formulation of Merck's integrase inhibitor. With this approval, ISENTRESS is now indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in patients four weeks of age and older.

9 Jan 2014

Proteon's PRT-201 gets orphan drug designation for prevention of arteriovenous access dysfunction

Proteon Therapeutics, Inc., a privately held biopharmaceutical company developing novel, first-in-class pharmaceuticals to address the critical medical needs of patients with kidney and vascular diseases, today announced that its lead product, PRT-201, has received orphan drug designation in the European Union for the prevention of arteriovenous access dysfunction in hemodialysis patients.

9 Jan 2014

FDA approves Actavis' ANDA for Telmisartan Immediate-Release Tablets

Actavis plc today announced that it has received approval from the U.S. Food and Drug Administration on its Abbreviated New Drug Application for Telmisartan Immediate-Release Tablets, 20 mg, 40 mg and 80 mg, a generic equivalent to Boehringer Ingelheim's Micardis. Actavis intends to launch the product immediately.

9 Jan 2014

Study shows that anticoagulant medicine appears to protect patients against stroke

Heart palpitations. Shortness of breath. Tiredness. More and more people can recognise the symptoms of atrial fibrillation, which is one of the most common types of heart disease.

9 Jan 2014

Pharmaceutical News

FDA accepts Iroko Pharmaceuticals' ZORVOLEX sNDA for review

FAMPYRA now available in Ireland for symptomatic treatment of walking impairment in MS patients

TaiGen, R-Pharm sign exclusive agreement to develop and commercialize nemonoxacin

Study shows that high-blood pressure medicine may also prevent migraines

Obama administration proposes Medicare drug change

Coalition publishes new evidence on patient impact of drug shortages in US

FDA approves Farxiga tablets to improve glycemic control in adults with type 2 diabetes mellitus

Texas researcher receives U.S. patent for new class of compounds that protect against TBI

Aetna is helping to reverse abuse of prescription painkillers

Low doses of anticancer drug can prevent development of diabetes mellitus type 1

Antipsychotic medication can actively combat cells of difficult-to-treat form of ALL

Akorn acquires NDA and all rights to Betimol from Santen

Mylan announces launch of Mycophenolic Acid Delayed-release Tablets

Zymeworks, ImClone Systems partner to develop novel bi-specific antibody oncology therapeutics

GSK receives FDA approval for combination of Mekinist with Tafinlar for treatment of melanoma

Daily antibiotic use is effective for preventing recurrent urinary tract infections in women

Merck announces FDA approval of ISENTRESS for oral suspension

Proteon's PRT-201 gets orphan drug designation for prevention of arteriovenous access dysfunction

FDA approves Actavis' ANDA for Telmisartan Immediate-Release Tablets

Study shows that anticoagulant medicine appears to protect patients against stroke

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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