Lundbeck A/S and Takeda Announce the FDA has Accepted a Supplemental New Drug Application

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Valby, Denmark and Osaka, Japan, 11 August 2015 – H. Lundbeck A/S (Lundbeck) and Takeda Pharmaceutical Company Limited (Takeda) announced today the US Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for review to add clinical data regarding the effect of Brintellix (vortioxetine) on certain aspects of cognitive dysfunction in adults with Major Depressive Disorder (MDD) to the current product label. Brintellix is currently approved and available in the US for the treatment of MDD in adults. The FDA is expected to take action on this filing by 28 March 2016.

Depression includes a range of symptoms including cognitive ones[i]. The cognitive symptoms of depression may go unrecognized by both healthcare providers and patients.i,[ii] Common cognitive complaints include difficulty concentrating, indecisiveness, trouble thinking and forgetfulness.i These symptoms are common and many of them often persist between major depressive episodes.i,ii According to a three-year prospective study of people treated for depression, cognitive symptoms (defined as diminished ability to think or concentrate and/or indecisiveness) were reported 94% of the time during major depressive episodes and 44% of the time between major depressive episodes (or during periods of partial remission).ii 

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BioClin Therapeutics Initiates Phase 2 Clinical Trial Evaluating B-701 for Treatment of Urothelial Cell Carcinoma  

SAN RAMON, Calif., Aug. 10, 2015 /PRNewswire/ — BioClin Therapeutics, Inc. announced today that it has initiated a Phase 2 clinical study of B-701, an anti-FGFR3 antibody being investigated for the treatment of locally advanced or metastatic urothelial cell carcinoma, also known as bladder cancer. read more

Sorrento Therapeutics And Its Wholly-Owned Subsidiary, TNK Therapeutics, To Exclusively License CytoLumina’s NanoVelcro Circulating Tumor Cell Profiling Assay

SAN DIEGO, Aug. 11, 2015 /PRNewswire/ — Sorrento Therapeutics, Inc. (NASDAQ: SRNE; Sorrento) announced today that it as well as its wholly-owned subsidiary TNK Therapeutics, Inc. have entered into a binding term sheet to exclusively license the NanoVelcro Circulating Tumor Cell (CTC) profiling assay technology from CytoLumina Technologies Corp. and FetoLumina Technologies Corp., two privately-held sister biotechnology companies in Los Angeles, California. The exclusive licenses will cover the applications of the NanoVelcro CTC assay and its portfolio technologies for precision medicine diagnostics in conjunction with all cellular therapies and Sorrento antibody therapeutics. read more

Alvogen First to Bulgarian Market with Generic Version of Velcade tm

PINEBROOK, N.J.–(BUSINESS WIRE)–Alvogen today announced it has launched the first generic version of the cancer drug VelcadeTM (Bortezomib) in Bulgaria. The drug will be marketed under the brand name VortemyelTM. Following the launch in Bulgaria, VortemyelTM will also be rolled-out across several other Central and Eastern European markets.

Bortezomib is the first therapeutic proteasome inhibitor anticancer drug, used for a targeted treatment of multiple myeloma and mantle cell lymphoma. VelcadeTM is Millennium Pharmaceuticals/Janssen Cilag’s reference product, which recorded sales of over US$200 million in 2014 in Central and Eastern European. read more

Asterand Bioscience Acquires AdeptBio LLC

DETROIT–(EON: Enhanced Online News)–Asterand Bioscience, Inc. is pleased to announce the acquisition of AdeptBio LLC, a Memphis-based biobank organization, which specializes in procurement of human tissue specimens.

“The development of new targeted therapies and companion diagnostics rely on availability of tissues, and increasingly biofluids, linked to deep clinical data. Joining AdeptBio’s network with Asterand Bioscience’s network will strengthen their ability to partner and serve the pharmaceutical and diagnostic community.”

“We are delighted to have AdeptBio join our organization,” says Peter Ferrigno, CCO of Asterand Bioscience. “Together, we will strengthen our partnership with the pharmaceutical and diagnostic community; providing unparalleled quality samples, highly regulated collection and tailored specifications, for their research needs.” read more


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