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Mylan launches Risedronate Sodium Tablets USP, 150 mg

Mylan Inc. today announced that it has launched Risedronate Sodium Tablets USP, 150 mg, the generic version of Warner Chilcott's Actonel Tablets. Mylan received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for this product, which is indicated for the treatment and prevention of osteoporosis in postmenopausal women.

11 Jun 2014

Auxilium and Prasco introduce authorized generic version of Testim

Auxilium Pharmaceuticals, Inc., a fully integrated specialty biopharmaceutical company, today announced that it has partnered with Prasco, LLC ("Prasco") to introduce an Authorized Generic version of Testim® (testosterone gel).

11 Jun 2014

ClarityMD effective in clearing acne without irritation

Envy Medical, Inc., a leader in professional skincare products and services, is excited to announce the publication of a new study in the June issue of the Journal of Drugs in Dermatology (JDD) proving the superior efficacy of its highly innovative acne system – ClarityMD.

11 Jun 2014

New prescription weight-loss medication combines antidepressant with addiction medication

A new prescription weight-loss medication that combines a popular antidepressant with a medication for addiction will be reviewed by the Federal Drug Administration (FDA) for potential approval.

11 Jun 2014

AbbVie's ALIGN study underscores patients’ attitudes and adherence toward TNF inhibitors

AbbVie today announced results from its multi-country ALIGN study, which shows that across six chronic immune-mediated inflammatory diseases (IMIDs), adherence to treatment was generally higher in patients being treated with TNF inhibitors compared to patients treated with conventional therapy.

11 Jun 2014

Bayer HealthCare seeks EU marketing authorization of EYLEA for macular edema following BRVO

Regeneron Pharmaceuticals, Inc. and Bayer HealthCare today announced that Bayer HealthCare has submitted an application to the European Medicines Agency (EMA) seeking marketing authorization in the European Union (EU) for EYLEA (aflibercept) Injection for the treatment of macular edema following branch retinal vein occlusion (BRVO).

11 Jun 2014

Type 2 diabetes Patients who take metformin plus insulin at higher risk for heart disease, death

Patients with type 2 diabetes who take a combination of metformin plus insulin may be at higher risk for cardiovascular disease and death compared with those who take a combination of metformin plus sulfonylurea, according to a new study funded by the Agency for Healthcare Research and Quality that appears in the June 11 issue of JAMA.

11 Jun 2014

FDA grants orphan drug designation to EffRx Pharmaceuticals' EX404 for treatment of PCOS

EffRx Pharmaceuticals SA, a specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration has granted orphan drug designation to its proprietary metformin-based product candidate, EX404, for the treatment of pediatric polycystic ovary syndrome (PCOS).

11 Jun 2014

InSite and Senju collaborate to develop and market azithromycin ophthalmic solution using DuraSite

InSite Vision Incorporated and Senju Pharmaceutical Co., Ltd. today announced that they have entered into a collaboration and license agreement to develop and market InSite's azithromycin ophthalmic solution using DuraSite® including AzaSite® 1% and AzaSite XtraTM 2% ocular antibiotics in Japan. Senju has agreed to pay InSite an upfront license fee, additional development milestones fees, and a percentage royalty on net sales.

10 Jun 2014

Alkermes initiates FORWARD-3 and FORWARD-4 efficacy studies in pivotal clinical program for ALKS 5461

Alkermes plc today announced the initiation of FORWARD-3 and FORWARD-4, two of the three planned phase 3 core efficacy studies in the pivotal clinical program for ALKS 5461, a once-daily, oral investigational medicine with a novel mechanism of action for the adjunctive treatment of major depressive disorder (MDD).

10 Jun 2014

$arGEN-X partner with LLS to develop ARGX-110 for patients with refractory WM$

arGEN-X partner with LLS to develop ARGX-110 for patients with refractory WM

arGEN-X, a clinical stage biopharmaceutical company focused on creating and developing differentiated therapeutic antibodies for the treatment of cancer and severe autoimmune diseases, today announced it has entered into a partnership with The Leukemia & Lymphoma Society (LLS) in which both parties will contribute to the funding of a Phase 2 clinical study of the Company's lead candidate, ARGX-110, in patients with refractory Waldenström's macroglobulinemia (WM).

10 Jun 2014

Combined MMRV vaccine slightly increases risk of febrile seizures in children

The combined measles-mumps-rubella-varicella (MMRV) vaccine shows a slightly increased risk of febrile seizures in children, compared with the previously separate vaccines for MMR and varicella (chickenpox) (MMR+V), according to an article in CMAJ (Canadian Medical Association Journal).

10 Jun 2014

FDA accepts Pharmacyclics' IMBRUVICA sNDA for review

Pharmacyclics, Inc. today announced that the U.S. Food and Drug Administration has accepted for filing its supplemental New Drug Application (sNDA) to support the review of IMBRUVICA (ibrutinib) in the treatment of patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) who have received at least one prior therapy for a full approval.

9 Jun 2014

Celsus’ expert highlights serious side effects of topical corticosteroids

A 2013 Mayo Clinic study involving more than 140,000 patients revealed that skin disorders are the most common nonacute reason Americans seek health care.

9 Jun 2014

Antiviral therapy may prevent hepatitis B virus from developing into hepatocellular carcinoma

Researchers have found that antiviral therapy may be successful in preventing hepatitis B virus from developing into the most common form of liver cancer, hepatocellular carcinoma (HCC).

9 Jun 2014

NIDA review offers new insights into the negative health effects of marijuana

The current state of science on the adverse health effects of marijuana use links the drug to several significant adverse effects including addiction, a review reports.

9 Jun 2014

BioDelivery Sciences receives approval of NDA for BUNAVAIL from FDA

BioDelivery Sciences International, Inc. received approval of the New Drug Application (NDA) for BUNAVAIL™ (buprenorphine and naloxone) buccal film (CIII) from the U.S. Food and Drug Administration (FDA).

9 Jun 2014

Aradigm’s common shares approved for listing on NASDAQ Capital Market

Aradigm Corporation is pleased to announce that its common shares have been approved for listing on the NASDAQ Capital Market.

9 Jun 2014

Mylan launches generic version of Bristol-Myers Squibb's Paraplatin Injection

Mylan Inc. today announced that it has launched Carboplatin Injection, 50 mg/5 ml, in multi-dose vials, which is the generic version of Bristol-Myers Squibb's Paraplatin® Injection.

9 Jun 2014

Cubist Pharmaceuticals publishes positive results from Phase 3 clinical trial of SIVEXTRO

Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today announced that The Lancet Infectious Diseases published online the positive results from ESTABLISH-2, a pivotal Phase 3 clinical trial of the investigational antibiotic SIVEXTRO™ (tedizolid phosphate), which is being developed for the treatment of acute bacterial skin and skin structure infections (ABSSSI) and complicated skin and soft tissue infections (cSSTI).

9 Jun 2014

Pharmaceutical News

Mylan launches Risedronate Sodium Tablets USP, 150 mg

Auxilium and Prasco introduce authorized generic version of Testim

ClarityMD effective in clearing acne without irritation

New prescription weight-loss medication combines antidepressant with addiction medication

AbbVie's ALIGN study underscores patients’ attitudes and adherence toward TNF inhibitors

Bayer HealthCare seeks EU marketing authorization of EYLEA for macular edema following BRVO

Type 2 diabetes Patients who take metformin plus insulin at higher risk for heart disease, death

FDA grants orphan drug designation to EffRx Pharmaceuticals' EX404 for treatment of PCOS

InSite and Senju collaborate to develop and market azithromycin ophthalmic solution using DuraSite

Alkermes initiates FORWARD-3 and FORWARD-4 efficacy studies in pivotal clinical program for ALKS 5461

arGEN-X partner with LLS to develop ARGX-110 for patients with refractory WM

Combined MMRV vaccine slightly increases risk of febrile seizures in children

FDA accepts Pharmacyclics' IMBRUVICA sNDA for review

Celsus’ expert highlights serious side effects of topical corticosteroids

Antiviral therapy may prevent hepatitis B virus from developing into hepatocellular carcinoma

NIDA review offers new insights into the negative health effects of marijuana

BioDelivery Sciences receives approval of NDA for BUNAVAIL from FDA

Aradigm’s common shares approved for listing on NASDAQ Capital Market

Mylan launches generic version of Bristol-Myers Squibb's Paraplatin Injection

Cubist Pharmaceuticals publishes positive results from Phase 3 clinical trial of SIVEXTRO

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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