Pharma News

Teva Pharmaceutical Industries Ltd. announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for SD-809 (deutetrabenazine) tablets for the treatment of chorea associated Huntington disease (HD). This is the first deuterated product to be reviewed by the FDA. The FDA has asked Teva to examine blood levels of certain metabolites. These metabolites are not novel, and are the same seen in subjects who take tetrabenazine or deutetrabenazine. No new clinical trials have been requested.

Indivior Inc., a subsidiary of Indivior PLC announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for RBP-6000 buprenorphine monthly depot, an investigational new drug for the treatment of opioid use disorder as part of a complete treatment plan to include counseling and psychosocial support.

Roche announced that it has launched the CoaguChek® INRange system in countries. The CoaguChek INRange system is the first Bluetooth enabled PT/INR home health device that helps patients and their healthcare providers (HCPs) have greater control over their coagulation status and the ability to monitor Vitamin K Antagonist (VKA) therapy.

Takeda Pharmaceutical Company Limited, a global, R&D-driven pharmaceutical company, announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the extension of the current conditional approval of Adcetris (brentuximab vedotin) and recommended its approval for the treatment of adult patients with CD30+ Hodgkin lymphoma at increased risk of relapse or progression following autologous stem cell transplantation (ASCT).

CordenPharma International would like to notify customers about a warning letter received from the USFDA on May 24, 2016 in its CordenPharma Latina facility in Sermoneta, Italy. This action follows an earlier inspection of the site by the agency in May 2015.

One of India’s largest sterile Injectables company, Claris Lifesciences Limited (Claris/Company), announced today that it has received the Establishment Inspection Report (EIR) for its manufacturing facility located near Ahmedabad, wherein the US FDA has concluded that the inspection stands closed and the facility was found to be acceptable.

Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a positive opinion, recommending the approval of saxa/dapa (saxagliptin and dapagliflozin) tablets for the treatment of adults with type-2 diabetes. The fixed-dose combination of saxagliptin and dapagliflozin has the potential to be the first DPP-4i/SGLT-2i combination product approved in Europe.

Caladrius Biosciences, Inc., a cell therapy company combining an industry-leading development and manufacturing services provider (PCT) with a select therapeutic development pipeline, has licensed to AiVita Biomedical, Inc., the exclusive global rights to its tumour cell/dendritic cell technology for the treatment of ovarian cancer. In return, Caladrius will receive certain development milestone payments as well as royalties on sales of any commercial product. This transaction supports the Caladrius' strategy to monetize non-core assets. Under the license agreement AiVita will assume responsibility for all costs to develop a product using the licensed intellectual property, including the maintenance costs of the associated intellectual property.

Intercept Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (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.

Palatin Technologies, Inc. announced that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for U.S. Patent Application Serial Number 14/514,472 (the '472 application).  The allowed composition of matter claims are to a broad family of melanocortin receptor-1 (MC1r) peptides with potential application in inflammatory disease-related and autoimmune indications.

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