ACORDA THERAPEUTICS, INC.: Announces FDA Acceptance of New Drug Application for INBRIJA™ (levodopa inhalation powder)

Acorda Therapeutics, Inc. (Nasdaq:ACOR) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing its New Drug Application (NDA) for INBRIJA. INBRIJA is an investigational inhaled levodopa treatment for symptoms of OFF periods in people with Parkinson’s disease taking a carbidopa/levodopa regimen Read More »

PHIZER: Receives Breakthrough Therapy Designation from FDA for PF-04965842, an oral JAK1 Inhibitor, for the Treatment of Patients with Moderate-to-Severe Atopic Dermatitis

Pfizer Inc. announced its once-daily oral Janus kinase 1 (JAK1) inhibitor PF-04965842 received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for the treatment of patients with moderate-to-severe atopic dermatitis (AD). The Phase 3 program for PF-04965842 initiated in December and is the first trial in the JAK1 Atopic Dermatitis Efficacy and Safety (JADE) global development program. Read More »

APPLIED GENETIC TECHNOLOGIES CORPORATION: AGTC Announces Sue Washer, CEO, Elected to Biotechnology Innovation Organization's Board of Directors

Applied Genetic Technologies Corporation (NASDAQ:AGTC), a biotechnology company conducting human clinical trials of adeno-associated virus (AAV)-based gene therapies for the treatment of rare diseases, today announced the election of Sue Washer, President and Chief Executive Officer, to the Biotechnology Innovation Organization (BIO)'s Board of Directors. Read More »

GSK VACCINES: GSK receives European approval for expanded indication for Fluarix Tetra (Influenza Vaccine) for ages six months and older

GSK announced the expanded indication for Fluarix Tetra (Quadrivalent Influenza Vaccine) has been approved in Europe to include adults and now children from six months of age for the prevention of influenza disease caused by the two influenza A virus subtypes and the two influenza B virus types contained in the vaccine. Read More »

TROVAGENE, INC.: Trovagene Presents Data Showing Synergy of PCM-075 in Combination with Zytiga® in Castration-Resistant Prostate Cancer Model at 2018 Genitourinary Cancers Symposium

Trovagene, Inc. (NASDAQ: TROV), a precision medicine biotechnology company, developing targeted cancer therapeutics, today announced that preclinical data demonstrating the synergy of PCM-075, its highly-selective Polo-like kinase 1 (PLK1) Inhibitor, in combination with abiraterone acetate (Zytiga® – Johnson & Johnson) Read More »

SALIX PHARMACEUTICALS, INC.: Salix Provides Update on FDA Submission for PLENVU®

Salix Pharmaceuticals, Ltd., one of the largest specialty pharmaceutical companies in the world committed to the prevention and treatment of gastrointestinal diseases and a wholly owned subsidiary of Valeant Pharmaceuticals International, Inc. have received notice that the U.S. Food and Drug Administration has extended the PDUFA action date for its review of the New Drug Application for PLENVU®* (NER1006) by three months to May 13, 2018. Read More »

JAZZ PHARMACEUTICALS PLC: National Comprehensive Cancer Network® adds Jazz Pharmaceuticals' Vyxeos™ (daunorubicin and cytarabine) Liposome for Injection to Clinical Practice Guidelines in Oncology

Jazz Pharmaceuticals plc announced that the National Comprehensive Cancer Network® (NCCN®) added Vyxeos™ (daunorubicin and cytarabine) liposome for injection to the Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Acute Myeloid Leukemia (AML). Read More »