BioTime's Subsidiary Asterias Biotherapeutics, Inc. Announces a $14.3 Million Strategic Partnership Award from the California Institute for Regenerative Medicine

  • Award Supports Phase 1/2a Dose Escalation Clinical Trial of AST-OPC1 in Cervical Spinal Cord Injury

  • Funding Provides for the Expansion of AST-OPC1 Clinical Trial Originally Initiated by Geron Corporation into Target Population for Pivotal Studies

MENLO PARK, Calif. & ALAMEDA, Calif.-- Asterias Biotherapeutics, Inc. (“Asterias”), a subsidiary of BioTime, Inc. (NYSE MKT: BTX), today announced that it has been awarded a $14.3 million Strategic Partnership III grant entitled “A Phase 1/2a Dose Escalation Study of AST-OPC1 in Patients with Cervical Sensorimotor Complete Cervical Spinal Cord Injury” from the California Institute for Regenerative Medicine (“CIRM”). The award provides funding for Asterias to reinitiate clinical development of AST-OPC1 in subjects with spinal cord injury and to expand clinical testing of escalating doses in the target population intended for future pivotal trials.

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NPS Pharma Introduces Emergency Resources Kit for Patients in Recognition of World Hypoparathyroidism Awareness Day

Free Emergency Resources Kits available at Hypoparathyroidism.com

NPS Pharmaceuticals, Inc. (NPSP), a global biopharmaceutical company pioneering and delivering therapies that transform the lives of patients with rare diseases, today announced its support for World Hypoparathyroidism Awareness Day by introducing a free Emergency Resources Kit designed to support accurate and more rapid diagnosis of Hypoparathyroidism symptoms in emergency care and other medical care settings. The annual global observance encourages the public to increase awareness of the disorder and the need for more education, improved diagnosis, and new treatment options.

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Retrophin Enters into U.S. License Agreement for Thiola® (Tiopronin)

Adds FDA-Approved Product to Kidney and Rare Disease Portfolios -- Increases Financial Guidance

Retrophin, Inc. (RTRX) today announced that it has entered into a license agreement with Mission Pharmacal Company, a private company based in San Antonio, Texas, for U.S. marketing rights to Thiola® (tiopronin). Financial terms of the agreement were not immediately disclosed.

Thiola® is approved by the U.S. Food and Drug Administration for the treatment of cystinuria, a rare genetic cystine transport disorder that causes high cystine levels in the urine and the formation of recurring kidney stones. The resulting long-term damage can cause loss of kidney function in addition to substantial pain and loss of productivity associated with renal colic and stone passage. The worldwide prevalence of the disease is believed to be one in 7,000.

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Nuvo Research® announces U.S. FDA approval of third-party generic of PENNSAID 1.5%

MISSISSAUGA, ON, May 29, 2014 - Nuvo Research Inc. (TSX:NRI.TO ), a specialty pharmaceutical company with a diverse portfolio of topical and immunology products today announced that a third party has received U.S. Food and Drug Administration (FDA) approval to market and sell a topical diclofenac sodium 1.5% solution in the United States.  The product is a generic version of Nuvo's PENNSAID (diclofenac sodium topical solution) 1.5% w/w (PENNSAID 1.5%).

Mallinckrodt Inc. (NYSE:MNK ) is Nuvo's U.S. commercial licensee for the sale of both PENNSAID 1.5% and its follow-on product PENNSAID (diclofenac sodium topical solution) 2% w/w (PENNSAID 2%).  PENNSAID 2% was approved by the FDA on January 16, 2014 and was launched by Mallinckrodt in February 2014.

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Trimel Receives FDA Approval for Natesto™ Nasal Gel to Treat Men with Low Testosterone

Natesto™ is the first nasal testosterone replacement therapy approved by FDA

TORONTO, May 28, 2014 - Trimel Pharmaceuticals Corporation (TSX:TRL.TO - News) announced today that the United States Food and Drug Administration (FDA) has approved Natesto™ (testosterone), formerly CompleoTRT™, the first and only testosterone nasal gel for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. Natesto™ is self-administered via a nasal applicator thereby minimizing the risk of secondary exposure to testosterone of women or children.

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