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Specialty Pharmacy

Genmab Acquires Targeted Antibodies from iDD Biotech, While Opting out of its Co-Development Option with ADC Therapeutics

Genmab A/s is altering its pipeline, announcing that the company has agreed to acquire three pre-clinical stage targeted antibodies from iDD Biotech and the company’s decision to drop the option to co-develop HuMax-TAC-ADC with ADC Therapeutics Sarl. Genmab said that it has entered into an agreement to purchase antibodies and …

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Celgene’s Investigational Crohn’s Disease Drug Demonstrates Promising Mid-Stage Results

Celgene announced that its investigational Crohn’s disease drug was successful in its mid-stage trial, meeting the primary endpoint of clinical remission. The company said that results from the Phase II trial of three doses of GED-0301 (mongersen) in patients with active Crohn’s disease were published in The New England Journal …

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Ignyta Advances its Precision Oncology Vision with its Acquisition of Four Targeted Cancer Programs from Teva

Precision oncology biotech Ignyta has acquired worldwide rights and assets relating to four targeted oncology development programs from Teva Pharmaceutical Industries. The companies announced that Ignyta will acquire four oncology assets from Teva in exchange for 1.5 million shares, or six percent of Ignyta’s common stock. Concurrently, Ignyta has entered …

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With FDA’s Approval of Cholbam, Retrophin Gains Rare Disease Drug and Voucher

Orphan drug biotech Retrophin saw its shares go up nearly 30 percent today, after news hit that not only was the company’s rare disease drug approved, but that it also received a priority review voucher from US health regulators. Today, the US Food and Drug Administration (FDA) approved Cholbam (cholic …

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FDA Approves Expanded Age Range for Vertex’s Kalydeco

Vertex Pharmaceuticals’ cystic fibrosis (CF) drug is now approved in the US for an expanded group of patients. The company announced that the US Food and Drug Administration (FDA) has approved Kalydeco (ivacaftor) for use in children ages 2-5 with CF who have one of 10 mutations in the cystic …

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Nektar’s Breast Cancer Drug Fails its Late-Stage Trial

Nektar Therapeutics’ experimental breast cancer drug, and key to the company’s future growth, failed a late-stage study. The company said that its NKTR-102 failed to meet its primary endpoint in the Phase III BEACON study. The drug is considered key to the Nektar’s future growth. The company’s CEO Howard Robin …

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FDA Grants Orphan Drug Designation to Selten Pharma’s Pulmonary Arterial Hypertension Candidate

Today, privately-held, rare disease focused Selten Pharma, Inc. announced that US health regulators granted its investigational pulmonary arterial hypertension (PAH) drug orphan drug designation. The company said that its lead compound tacrolimus (SPI-026) has been granted orphan drug designation (ODD) by the US Food and Drug Administration (FDA) for the …

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Galapagos and Janssen End Inflammation Alliance

Galapagos NV and Janssen Pharmaceutica NV of Johnson & Johnson have ended their eight-year alliance to develop anti-inflammatory drugs. The companies originally entered into a worldwide multi-target alliance in October 2007, to discover and develop novel small-molecule therapeutics for the treatment of rheumatoid arthritis (RA), a deal which provided Galapagos …

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CSL Behring’s Kcentra Shows Superiority to Plasma in Late-Stage Study

Results from CSL Behring’s late-stage study showing Kcentra’s superiority to plasma for the urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist therapy (VKA, warfarin) therapy in adult patients needing an urgent surgery or invasive procedure were published in The Lancet. CSL’s Kcentra is the first and …

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