Sarepta Therapeutics Announces Plans to Submit Rolling NDA for Eteplirsen following Today’s Pre-NDA Meeting with the FDA

- Held pre-NDA meeting and agreed on rolling submission with the Agency -
- Will submit first two components of the NDA this week -
- Plans to complete the submission by mid-year -

CAMBRIDGE, Mass.--- Sarepta Therapeutics, Inc. (SRPT), a developer of innovative RNA-targeted therapeutics, today announced that the Company held a pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA) regarding its lead product candidate, eteplirsen, for the treatment of Duchenne muscular dystrophy (DMD). Sarepta has agreed with the Agency to initiate a rolling NDA submission and will submit the non-clinical and CMC components of the NDA by the end of this week. As previously announced, Sarepta plans to submit the final component of the NDA by mid-year 2015.

Published: 20 May 2015
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CVac Shows Clear Trend for Overall Survival Benefit in Second Remission Ovarian Cancer in Phase II Study

SYDNEY, AUSTRALIA--(May 19, 2015) - Prima BioMed Ltd (ASX: PRR) (NASDAQ: PBMD)

  • Final Data from the CAN-003 Phase II trial after 5 years of data collection
  • Final Overall Survival data provided at least 16 months benefit for second remission ovarian cancer patients ("second remission patients") using CVac™  
  • Follows Progression Free Survival data showing 8 month benefit for second remission patients

Prima BioMed Ltd (ASX: PRR) (NASDAQ: PBMD) ("Prima" or the "Company") is pleased to announce that the final CVac data from the Phase II CAN-003 ovarian cancer clinical trial has shown a trend for a clinically meaningful improvement in Overall Survival ("OS") over standard of care ("SOC") in second remission patients.

Published: 20 May 2015
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ProMetic Enters Into Strategic Long-Term Manufacturing Agreement With Emergent BioSolutions

- Provides ProMetic with additional cGMP, FDA-licensed manufacturing capacity of up to 250,000 liters of plasma processing per annum - Enables the acceleration of additional IND filings - Technology transfer commencing in July 2015 - Manufacturing scale-up to follow in 2015

LAVAL, QUEBEC--(May 19, 2015) - ProMetic Life Sciences Inc. (PLI.TO) (PFSCF) ("ProMetic" or the "Corporation") announced today that it has entered into a strategic manufacturing agreement with Emergent BioSolutions ("Emergent"). The long-term manufacturing agreement provides ProMetic with access to additional cGMP capacity in an FDA-licensed facility, located in Winnipeg, Canada. ProMetic will use this capacity for the development and manufacture of plasma-derived biopharmaceuticals using ProMetic's proprietary plasma purification platform, known as Plasma Protein Purification System ("PPPS™"). The additional product manufacturing capacity will provide the ability to process up to 250,000 liters of plasma annually with the potential for further expansion should the parties agree.

Published: 19 May 2015
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NantWorks Acquires Cynviloq(TM) For Up To $1.3+ Billion

--$90 million+ up-front payment and $1.2 billion+ milestone payments
--Sorrento retains option for co-development and/or co-marketing of Cynviloq™

SAN DIEGO, May 15, 2015 - Sorrento Therapeutics, Inc. (NASDAQ: SRNE; Sorrento), announced today that NantPharma, founded by Dr. Patrick Soon-Shiong and a member of the NantWorks ecosystem of companies, agreed to acquire the rights to Cynviloq through the acquisition of Igdrasol, Inc., a wholly-owned subsidiary of Sorrento, which has been developing Cynviloq (paclitaxel nanoparticle polymeric micelle) in a bio-equivalence trial. Dr. Soon-Shiong was the founder of Abraxis BioScience and inventor and developer of the blockbuster drug Abraxane® (albumin-bound paclitaxel), currently approved for the treatment of breast, lung, and pancreatic cancers.

Published: 15 May 2015
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Theralase Discovers Anti-Cancer Drug Fluoresces in Tissue

TORONTO, ON / May 14, 2015 / Theralase Technologies Inc. ("Theralase" or the "Company") (TSX Venture: TLT) (TLTFF), a leading biotechnology manufacturer focused on commercializing medical technologies to eliminate pain and destroy cancer, has discovered that its lead anti-cancer drug, TLD-1433, emits a fluorescent signature when light activated in a Non-Muscle Invasive Bladder Cancer ("NMIBC") animal model.

The advantages of this discovery are three fold:

1) It can be used as a diagnostic tool for the oncologist to detect the presence of cancer cells and micro-metastases too small to be seen by the human eye.
2) It can be used to determine sufficient uptake of TLD-1433 into the cancer cells
3) After light activation, it can determine if the cancer cells that have absorbed the drug have been destroyed.

Published: 14 May 2015
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