AQUESTIVE THERAPEUTICS: Granted Temporary Restraining Order (TRO) Against Alvogen

Aquestive Therapeutics, Inc. (Nasdaq: AQST), a specialty pharmaceutical company, focused on developing and commercializing differentiated products to solve therapeutic problems, announced that the U.S. District Court for the District of New Jersey has granted a temporary restraining order (TRO) that enjoins Alvogen from initiating any launch activities related to its generic buprenorphine/naloxone sublingual film. Read More »

SUNOVION PHARMACEUTICALS INC: Receives Complete Response Letter from FDA for Apomorphine Sublingual Film (APL-130277)

Sunovion Pharmaceuticals Inc. (Sunovion) announced today that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for the New Drug Application (NDA) for apomorphine sublingual film (APL-130277) to treat OFF episodes (the re-emergence or worsening of Parkinson’s symptoms otherwise controlled by medications) experienced by people living with Parkinson’s disease (PD). Read More »

MYLAN INC: Announces FDA Approval of Wixela™ Inhub™ (fluticasone propionate and salmeterol inhalation powder, USP), First Generic of ADVAIR DISKUS® (fluticasone propionate and salmeterol inhalation powder)

Wixela™ Inhub™ is the first FDA-approved therapeutically equivalent generic of ADVAIR DISKUS® (fluticasone propionate and salmeterol inhalation powder) for certain patients with asthma or chronic obstructive pulmonary disease (COPD) Read More »

CANNABICS PHARMACEUTICALS INC.: Cannabics Pharmaceuticals and Wize Pharma to Form Joint Venture to Develop Cannabinoid Based Ophthalmic Therapeutics

Cannabics Pharmaceuticals Inc. (OTCQB: CNBX) a world leader in personalized cannabinoid medicine focused on cancer and its side effects, today announced that it has entered into agreement with Wize Pharma, Inc. (OTCQB: WIZP), a clinical-stage biopharmaceutical company focused on the treatment of ophthalmic disorders, and that has distribution rights of known medical formulae related to eye diseases. Read More »

DIAGNOSTIC SOLUTIONS LABORATORY: Revolutionizes Precision Medicine with GenomicInsight™ Genomic Health Profile Powered by Opus23 Explorer™

Diagnostic Solutions Laboratory (DSL) continues its innovative vision to transform and improve personalized medicine by introducing its first DNA SNP test, GenomicInsight™ Genomic Health Profile powered by Opus23 Explorer™, a proprietary version of DataPunk's Opus23 informatics software, conceived, developed, and coded by Dr. Peter D'Adamo, Distinguished Professor of Clinical Sciences, University of Bridgeport. Read More »

DAIICHI SANKYO INC.: Daiichi Sankyo Europe and Esperion Announce Validation of the Marketing Authorisation Application (MAA) for Bempedoic Acid and the Bempedoic Acid / Ezetimibe Fixed Dose Combination Tablet

Daiichi Sankyo Europe (hereafter, Daiichi Sankyo) and Esperion Therapeutics Inc. (hereafter, Esperion) announced today the validation of the Marketing Authorisation Application (MAA) for bempedoic acid and the bempedoic acid / ezetimibe fixed dose combination tablet by the European Medicines Agency (EMA) Read More »

ARENA PHARMACEUTICALS, INC.: Presented New Phase 2 Data for Etrasimod and Olorinab at the 14th Congress of European Crohn's and Colitis Organisation

Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) presented new Phase 2 data from its investigative drug candidates etrasimod, a next-generation, oral, selective sphingosine 1 phosphate (S1P) receptor modulator in development for the treatment of moderate to severely active ulcerative colitis (UC), and olorinab, a peripherally restricted, highly selective, full agonist of the cannabinoid receptor type 2 (CB2) in development for the treatment of visceral pain associated with gastrointestinal (GI) diseases, at the 14th Congress of European Crohn's and Colitis Organisation (ECCO). Read More »