Home / Specialty Pharmacy

Specialty Pharmacy

Bone Therapeutics’ Allogeneic Cell Therapy Product Meets Primary Endpoints in Phase 2a Study in Patients Undergoing Lumbar Spinal Fusion

Gosselies, Belgium, 13 June 2019, 7 am CEST – BONE THERAPEUTICS (Euronext Brussels and Paris: BOTHE), the leading biotech company focused on the development of innovative cell and biological therapeutics to address high unmet medical needs in orthopaedics and bone diseases, today announces that its allogeneic cell therapy product, ALLOB, successfully completed …

Read More »

CymaBay’s Seladelpar Fails to the Meet Primary Endpoint in an Ongoing Phase 2b Trial in Patients with NASH

NEWARK, Calif., June 11, 2019 (GLOBE NEWSWIRE) — CymaBay Therapeutics, Inc. (NASDAQ: CBAY) today announced 12-week topline results from an ongoing 52-week Phase 2b dose-ranging, paired liver biopsy study of seladelpar for the treatment of nonalcoholic steatohepatitis (NASH). Seladelpar is a potent and selective peroxisome proliferator-activated receptor delta (PPARδ) agonist …

Read More »

La Jolla Pharmaceutical Announces Positive Interim Results from Phase 2 Study of LJPC-401 in Patients with Hereditary Hemochromatosis

SAN DIEGO, June 06, 2019 (GLOBE NEWSWIRE) — La Jolla Pharmaceutical Company (Nasdaq: LJPC), a leader in the discovery, development and commercialization of innovative therapies intended to significantly improve outcomes in patients suffering from life-threatening diseases, today announced positive results from the pre-specified interim analysis of its Phase 2 study of LJPC-401 …

Read More »

Pfizer’s Lyrica Fails to Meet its Primary Endpoint in its Phase 3 Study in Epilepsy Patients with Primary Generalized Tonic-Clonic Seizures

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE: PFE) announced today that a Phase 3 study to assess the use of LYRICA®(pregabalin) as adjunctive therapy for epilepsy patients 5 to 65 years of age with primary generalized tonic-clonic (PGTC) seizures did not meet its primary endpoint. Treatment with LYRICA did not result in …

Read More »

Genfit Announces the Launch of a Combination Therapy Clinical Program in NASH

Lille (France), Cambridge (Massachusetts, United States), May 23, 2019 – GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to the discovery and development of innovative therapeutic and diagnostic solutions in metabolic and liver related diseases, today announced the launch of a combination program to identify new treatment options for …

Read More »

Inventiva Announces FDA Lifts Target Class Clinical Hold on which Allows Long-Term Clinical Studies with Lanifibranor in NASH

Daix (France), May 23, 2019 – Inventiva (Euronext: IVA), a clinical-stage biopharmaceutical company developing oral small molecule therapies for the treatment of diseases in the areas of fibrosis, lysosomal storage disorders and oncology, today announced that the U.S. Food and Drug Administration (FDA) has lifted for lanifibranor the clinical hold in …

Read More »

FDA Approves UCB’s Nayzilam Nasal Spray to Treat Intermittent, Stereotypic Episodes of Frequent Seizure Activity in Patients with Epilepsy

BRUSSELS and ATLANTA, May 20, 2019 /PRNewswire/ — UCB announced today that the U.S. Food and Drug Administration (FDA) has approved a New Drug Application for the company’s newest anti-epileptic drug (AED) NAYZILAM® (midazolam) nasal spray CIV, a benzodiazepine indicated for the acute treatment of intermittent, stereotypic episodes of  frequent …

Read More »

FDA Approves Pfizer’s Fragmin, as the First Anticoagulant for Pediatric Patients to Treat Potentially Life-Threatening Blood Clots

The U.S. Food and Drug Administration today approved Fragmin (dalteparin sodium) injection, for subcutaneous use, to reduce the recurrence of symptomatic venous thromboembolism (VTE) in pediatric patients one month of age and older. VTE can include deep vein thrombosis (blood clot in the deep veins of the leg) and pulmonary …

Read More »

Mayo Clinic and Premise Health Collaborate to Increase Access to Quality Care and Lower Health Costs

BRENTWOOD, Tenn., May 15, 2019 /PRNewswire/ — Mayo Clinic and Premise Health, a direct health care company that provides primary care, occupational health, pharmacy and other services to large employers, have announced that they will collaborate to enhance health care delivery for Premise members and their families. The two organizations …

Read More »

Pfizer Announces Positive Top-Line Results from Phase 3 Study of Abrocitinib in Patients Aged 12 and Older with Moderate to Severe Atopic Dermatitis

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE: PFE) announced today positive top-line results from a Phase 3 pivotal study (B7451012) evaluating the efficacy and safety of its investigational oral Janus kinase 1 (JAK1) inhibitor, abrocitinib (PF-04965842), in patients aged 12 and older with moderate to severe atopic dermatitis (AD). B7451012 was a …

Read More »