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Mylan sued in connection with ANDA filing for generic version of Zytiga

Mylan N.V. today confirmed that the company has been sued by BTG International Ltd., Janssen Biotech, Inc., Janssen Oncology, Inc., and Janssen Research & Development, LLC in connection with the filing of an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration for Abiraterone Acetate Tablets, 250 mg.

18 Aug 2015

Hi-Tech acquires LG Sciences brand of Sports Nutrition and Bodybuilding products

Hi-Tech Pharmaceuticals, a leading global provider of Sports Nutrition, Weight loss products, and Contract Manufacturing services, and LG Sciences, one of the premier Sports Nutrition and Bodybuilding brands in the United States, today announced that Hi-Tech has acquired LG Sciences brand of Sports Nutrition products and Bodybuilding products.

18 Aug 2015

Researchers examine how GABA supplementation enhances planning, controls different actions

People show an enhanced ability of prioritizing planned actions after the ingestion of the food supplement GABA. Psychologists Laura Steenbergen and Lorenza Colzato, with their colleagues at the Leiden Institute of Brain and Cognition and fellow researchers from the Technical University of Dresden, published their findings in Scientific Reports.

18 Aug 2015

New prescription smoking-cessation drug not helping smokers quit

The introduction of a new prescription smoking-cessation aid, varenicline, in 2006 has had no significant impact on the rate at which Americans age 18 and older successfully quit smoking, according to a study led by researchers at University of California, San Diego School of Medicine.

18 Aug 2015

Vitamin D supplements may help reduce risk of falls in homebound elderly

Every year falls affect approximately one in three older adults living at home, with approximately one in 10 falls resulting in serious injury. Even if an injury does not occur, the fear of falling can lead to reduced activity and a loss of independence.

18 Aug 2015

New OTEMTO phase three results show potential improvement to quality of life for COPD patients

Boehringer Ingelheim announced the publication of new data from the Phase IIIb OTEMTO® 1&2 trials (NCT01964352/NCT02006732), which show Spiolto® Respimat® (tiotropium/olodaterol) provides consistent, clinically meaningful improvements in quality of life versus placebo in patients with COPD

17 Aug 2015

Omeros plans to file patent infringement lawsuit against Par

Omeros Corporation today, in response to investor questions, announced that it plans to file a patent infringement lawsuit against Par Pharmaceutical, Inc. and its subsidiary, Par Sterile Products, LLC in response to the Abbreviated New Drug Application (ANDA) filed by Par seeking FDA approval to market a generic version of Omeros' commercial drug Omidria (phenylephrine and ketorolac injection) 1%/0.3%.

17 Aug 2015

NanoViricides speeds up HerpeCide drug development program

NanoViricides, Inc., a nanomedicine company developing anti-viral drugs, reports that it is accelerating its HerpeCide drug development program.

17 Aug 2015

FDA accepts Chiasma's NDA filing for octreotide capsules for treatment of adult patients with acromegaly

Chiasma, Inc., a U.S. late-stage biopharmaceutical company, today announced that the U.S. Food and Drug Administration has accepted for filing the Company's New Drug Application (NDA) for the marketing and sale of octreotide capsules, an oral drug proposed for the maintenance therapy of adult patients with acromegaly.

17 Aug 2015

Unituxin (dinutuximab) granted EC Marketing Authorisation for treatment of childhood neuroblastoma

United Therapeutics Corporation announced today that the European Commission (EC) has granted Marketing Authorisation for Unituxin (dinutuximab) for the treatment of high-risk neuroblastoma in patients aged 12 months to 17 years, who have previously received induction chemotherapy and achieved at least a partial response, followed by myeloablative therapy and autologous stem cell transplantation (ASCT).

17 Aug 2015

Envarsus XR granted FDA orphan drug designation for prophylaxis of organ rejection in kidney transplant patients

Veloxis Pharmaceuticals A/S, today announced that Envarsus XR was granted Orphan Drug status by the U.S. Food and Drug Administration for prophylaxis of organ rejection in patients who convert from immediate-release tacrolimus. Envarsus XR received marketing authorization from the FDA on July 10, 2015.

14 Aug 2015

Risk for endophthalmitis no higher with Avastin, finds study

Eye injections of the drug Avastin, used to treat retinal diseases, bring no greater risk of endophthalmitis, a potentially blinding eye infection, than injections with the much more expensive drug Lucentis made by the same company, according to new research from the Perelman School of Medicine at the University of Pennsylvania. Their findings are published today in JAMA Ophthalmology.

14 Aug 2015

Centenary Institute researchers take lead on promising new class of drugs for melanoma treatment

Researchers at Sydney’s Centenary Institute have taken the lead on a promising new class of drugs that may prove to be highly effective for the treatment of certain cases of melanoma.

14 Aug 2015

Opioids produced by yeast; revealing the potential for cheaper pain relief

Researchers at Stanford University have genetically engineered yeast so it produces hydrocodone, a semi-synthetic opioid analgesic used in the United States for relief of moderate to severe pain.

14 Aug 2015

New study focuses on dental screenings for drug misuse

A visit to the dentist has the potential to be more than a checkup of our teeth as patients are increasingly screened for medical conditions like heart disease and diabetes.

14 Aug 2015

PHIV children may lack immunity against measles, mumps, and rubella despite vaccination

Between one-third and one-half of individuals in the United States who were infected with HIV around the time of birth may not have sufficient immunity to ward off measles, mumps, and rubella--even though they may have been vaccinated against these diseases.

14 Aug 2015

CPhI reports positive outlook on the Chinese pharmaceutical market

CPhI – a division of UBM EMEA – alongside UBM Sinexpo, announces the findings of the Pharma Insights China 2015 report.

13 Aug 2015

RealTime Dynamix: New monthly service launched for pharmaceutical markets

Spherix Global Insights announces the launch of RealTime Dynamix, its new monthly service developed to keep clients on the pulse in highly dynamic specialty markets.

13 Aug 2015

Combination of chemotherapy and immune-blocking drug could prevent cancer recurrence

Giving patients a drug that blocks part of the immune system from going into overdrive might help prevent cancer coming back in some people, according to research published today in Cancer Research.

13 Aug 2015

BDSI announces FDA approval of sNDA for new formulation of ONSOLIS (fentanyl buccal soluble film) CII

BioDelivery Sciences International, Inc. announced the approval by the U.S. Food and Drug Administration of a Supplemental New Drug Application (sNDA) for a new formulation of ONSOLIS (fentanyl buccal soluble film) CII for the management of breakthrough pain in patients with cancer who are opioid tolerant.

13 Aug 2015

Pharmaceutical News

Mylan sued in connection with ANDA filing for generic version of Zytiga

Hi-Tech acquires LG Sciences brand of Sports Nutrition and Bodybuilding products

Researchers examine how GABA supplementation enhances planning, controls different actions

New prescription smoking-cessation drug not helping smokers quit

Vitamin D supplements may help reduce risk of falls in homebound elderly

New OTEMTO phase three results show potential improvement to quality of life for COPD patients

Omeros plans to file patent infringement lawsuit against Par

NanoViricides speeds up HerpeCide drug development program

FDA accepts Chiasma's NDA filing for octreotide capsules for treatment of adult patients with acromegaly

Unituxin (dinutuximab) granted EC Marketing Authorisation for treatment of childhood neuroblastoma

Envarsus XR granted FDA orphan drug designation for prophylaxis of organ rejection in kidney transplant patients

Risk for endophthalmitis no higher with Avastin, finds study

Centenary Institute researchers take lead on promising new class of drugs for melanoma treatment

Opioids produced by yeast; revealing the potential for cheaper pain relief

New study focuses on dental screenings for drug misuse

PHIV children may lack immunity against measles, mumps, and rubella despite vaccination

CPhI reports positive outlook on the Chinese pharmaceutical market

RealTime Dynamix: New monthly service launched for pharmaceutical markets

Combination of chemotherapy and immune-blocking drug could prevent cancer recurrence

BDSI announces FDA approval of sNDA for new formulation of ONSOLIS (fentanyl buccal soluble film) CII

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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