Biogen (BIIB) and Ionis Pharmaceuticals (IONS) today announced that nusinersen, their investigational treatment for spinal muscular atrophy (SMA), met the primary endpoint pre-specified for the interim analysis of ENDEAR, the Phase 3 trial evaluating nusinersen in infantile-onset (consistent with Type 1) SMA. The analysis found that infants receiving nusinersen experienced a statistically significant improvement in the achievement of motor milestones compared to those who did not receive treatment. Nusinersen demonstrated an acceptable safety profile in the trial. As a result of these findings, Biogen has exercised its option to develop and commercialize nusinersen globally and paid Ionis a $75 million license fee. Biogen will initiate regulatory filings globally in the coming months.

Key Patent Covers Renewable Pluripotent Cell Source for Development of Off-the-Shelf NK- and T-Cell Immunotherapies

 

SAN DIEGO, July 26, 2016 -- Fate Therapeutics, Inc. (FATE), a biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, announced today that the U.S. Patent and Trademark Office issued U.S. Patent No. 9,382,515 covering preparations of human induced pluripotent cells. This newly-issued patent adds to the significant intellectual property portfolio of over 60 issued patents and 90 pending applications, which are owned or exclusively licensed by Fate Therapeutics, covering compositions and methods critical for deriving, engineering, maintaining and differentiating induced pluripotent cells.

 

The compositions protected by the patent cover induced pluripotent cells that do not contain a polynucleotide encoding c-MYC. The MYC family of transcription factors are proto-oncogenes implicated in tumor growth. The expression of c-MYC was previously considered to be indispensable for the generation of human induced pluripotent cells.

– Acquisition Strengthens Galenica’s Business Unit, Vifor Pharma –

 

Galenica will commence a tender offer to acquire all issued and outstanding Relypsa common stock for a cash consideration of $32 per share

Implied fully-diluted equity value of the offer amounts to approximately $1.53 billion

Acquisition affirms commitment of Galenica Board of Directors to separate the Galenica Group into two independent listed companies, partly financed by equity proceeds to be raised in conjunction with the envisaged division of the Galenica Group in 2017

Transaction brings Vifor Pharma a dedicated U.S. commercial organization and global rights to Veltassa®, a potassium binder for the treatment of hyperkalemia

The Boards of Directors of both Relypsa and Galenica have approved the terms of the merger agreement, and the Board of Directors of Relypsa has resolved to recommend that shareholders accept the offer

LAVAL, Quebec and TARRYTOWN, N.Y., July 19, 2016 -- Valeant Pharmaceuticals International, Inc. (NYSE & TSX: VRX) and Progenics Pharmaceuticals, Inc. (Nasdaq:PGNX - News) today announced that the U.S. Food and Drug Administration has approved RELISTOR® (methylnaltrexone bromide) Tablets for the treatment of opioid-induced constipation (OIC) in adults with chronic non-cancer pain. Valeant expects to commence sales of RELISTOR Tablets in the U.S. in the third quarter of 2016.

 

"Opioid-induced constipation represents a long-lasting and potentially debilitating side effect of opioid therapy for millions of patients suffering from chronic pain," commented Joseph C. Papa, Chief Executive Officer of Valeant. "We believe Oral RELISTOR represents a new alternative treatment for OIC, and we look forward to introducing the more convenient oral formulation as soon as practicable."