Clinical Intelligence

FDA grants Accelerated Approval to Ocaliva for primary biliary cirrhosis

Wednesday, June 1, 2016

Intercept Pharmaceuticals, a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat non-viral, progressive liver diseases, has announced that the FDA has granted accelerated approval to Ocaliva (obeticholic acid) for the treatment of primary biliary cholangitis, previously known as primary biliary cirrhosis (PBC), in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA. Ocaliva is an agonist of the farnesoid X receptor (FXR), a nuclear receptor expressed in the liver and intestine and a key regulator of bile acid, inflammatory, fibrotic and metabolic pathways. 

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Minerva’s MIN-101 trial met primary endpoint in schizophrenia

Wednesday, June 1, 2016

Minerva Neurosciences has announced positive top line results from a prospective phase IIb, 12-week, randomized, double-blind, placebo-controlled parallel clinical trial evaluating the efficacy, safety and tolerability of MIN-101 in patients with negative symptoms of schizophrenia. These negative symptoms, for which no approved treatment is currently available, affect the majority of schizophrenic patients and can persist over their lifetimes.

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FDA approves CSL Behring’s AFSTYLA for hemophilia A

Tuesday, May 31, 2016

CSL Behring has announced that the FDA has approved AFSTYLA [Antihemophilic Factor (Recombinant), Single Chain], its novel long-lasting recombinant factor VIII single-chain therapy for adults and children with hemophilia A. AFSTYLA is the first and only single-chain product for hemophilia A that is specifically designed for long-lasting protection from bleeds with two to three times weekly dosing.

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FDA approves first buprenorphine implant for opioid dependence

Friday, May 27, 2016

The FDA has approved Probuphine, the first buprenorphine implant for the maintenance treatment of opioid dependence. Probuphine is designed to provide a constant, low-level dose of buprenorphine for six months in patients who are already stable on low-to-moderate doses of other forms of buprenorphine, as part of a complete treatment program.

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Merrimack, Baxalta initiate phase I study of MM-151 for colorectal cancer

Tuesday, May 24, 2016

Merrimack Pharmaceuticals and Baxalta are initiating a phase I clinical study of Merrimack’s oligoclonal EGFR (epidermal growth factor receptor) inhibitor, MM-151, in combination with ONIVYDE (irinotecan liposome injection) plus fluorouracil (5-FU) and leucovorin in patients with RAS wild-type metastatic colorectal cancer. Data from a prior phase I study of MM-151 supports further clinical evaluation of the investigational therapy in patients with metastatic colorectal cancer.

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Acorda to discontinues PLUMIAZ for epilepsy

Tuesday, May 24, 2016

Acorda Therapeutics will discontinue development of PLUMIAZ (diazepam) Nasal Spray, an investigational therapy being studied for the treatment of seizure clusters in people with epilepsy. Data from the ongoing clinical trials do not demonstrate its bioequivalence to Diastat rectal gel, needed to re-file the New Drug Application (NDA) under section 505(b)(2). Specifically, the data demonstrated unexpectedly lower nasal mucosa absorption of diazepam in persons with epilepsy compared to studies in healthy volunteers.

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Sunovion releases long-term data of biopolar depression treatment Latuda

Monday, May 23, 2016

Sunovion Pharmaceuticals has published results in the journal Depression and Anxiety from a six-month, open-label extension study that evaluated the long-term safety, tolerability and effectiveness of Latuda (lurasidone HCI) when used either as monotherapy or as adjunctive therapy in combination with lithium or valproate in adults with major depressive episodes associated with bipolar I disorder (bipolar depression).

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