Clinical Intelligence

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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Sunovion releases positive data for COPD inhalation solution Brovana

Monday, May 23, 2016

Sunovion Pharmaceuticals has announced the results of a post-hoc analysis of a long-term safety study evaluating Brovana (arformoterol tartrate) Inhalation Solution in people with moderate-to-severe chronic obstructive pulmonary disease (COPD). Results from this analysis reinforce the use of Brovana in COPD, as measured by COPD exacerbation-related hospitalizations compared to those treated with placebo.

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FDA grants Genentech’s cancer immunotherapy Tecentriq (atezolizumab) Accelerated Approval

Friday, May 20, 2016

The FDA granted Accelerated Approval to Genentech’s Tecentriq (atezolizumab) for the treatment of people with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-based chemotherapy, or whose disease has worsened within 12 months of receiving platinum-based chemotherapy before surgery (neoadjuvant) or after surgery (adjuvant). Urothelial carcinoma accounts for 90% of all bladder cancers and can also be found in the renal pelvis, ureter and urethra.

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Pfizer showcases results from two phase III TRUMENBA studies

Monday, May 16, 2016

Pfizer has announced results of two phase III studies demonstrating the immunogenicity of TRUMENBA (Meningococcal Group B Vaccine) against invasive meningococcal B (MnB) strains representative of prevalent strains in the U.S. and Europe. The two studies, one in adolescents and one in young adults, met all primary immunogenicity endpoints. Also, secondary data presented show that TRUMENBA demonstrated similar immune responses against ten additional MnB strains, in both adolescents and young adults.

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