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  • Iovance Biotherapeutics announces Clinical Data for Lifileucel in Combination with Pembrolizumab in Advanced Cancers

    Iovance Biotherapeutics, Inc a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, today announced clinical data for lifileucel in combination with pembrolizumab in patients with advanced cancers were presented in an oral session at the Society for Immunotherapy of Cancer (SITC) Annual Meeting. A slide presentation is also available on the Iovance website.

  • Pfizer and BioNTech Receive First U.S. FDA Emergency Use Authorization of a COVID-19 Vaccine in Children Ages 5-11 Years

    Pfizer Inc and BioNTech SE announced that the U.S. Food and Drug Administration has authorized for emergency use the Pfizer-BioNTech COVID-19 Vaccine for children 5 through 11 years of age (also referred to as 5 to <12 years). For this age group, the vaccine is to be administered in a two-dose regimen of 10-µg doses given 21 days apart. The 10-µg dose level was carefully selected based on safety, tolerability and immunogenicity data. This is the first COVID-19 vaccine authorized in the U.S. for individuals 5 through 11 years of age.

  • Conatus Pharmaceuticals Inc announced that top-line results from the company’s ENCORE-LF clinical trial of emricasan did not meet its primary endpoint and the company is discontinuing further treatment of patients enrolled in the ENCORE-LF clinical trial.  Also, results from the 24-week extension in the company’s ENCORE-PH clinical trial of emricasan were consistent with results from the initial 24-week treatment period and did not meet predefined objectives. Conatus will continue to work with its partner Novartis on ensuring that all remaining obligations related to the emricasan program are fulfilled.

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  • Bristol - Myers Squibb Company and Celgene Corporation announced that they have entered into a definitive merger agreement under which Bristol-Myers Squibb will acquire Celgene in a cash and stock transaction with an equity value of approximately $74 billion. Under the terms of the agreement, Celgene shareholders will receive 1.0 Bristol-Myers Squibb share and $50.00 in cash for each share of Celgene. Celgene shareholders will also receive one tradeable Contingent Value Right (CVR) for each share of Celgene, which will entitle the holder to receive a payment for the achievement of future regulatory milestones. The Boards of Directors of both companies have approved the combination.

  • Myriad Genetics, Inc a leader in molecular diagnostics and personalized medicine, today announced results from an important study to validate the polygenic component of a forthcoming riskScore™ test for Hispanic women who test negative for a hereditary cancer mutation with the myRisk® Hereditary Cancer test.  The results are being presented at the 2018 San Antonio Breast Cancer Symposium (SABCS) in San Antonio, Texas.

  • Adverum Biotechnologies, Inc a clinical-stage gene therapy company targeting unmet medical needs in serious rare and ocular diseases, today announced its Investigational New Drug (IND) application is active for the planned multi-center, open-label, Phase 1, dose-escalation study of ADVM-022, a novel gene therapy candidate for the treatment of wet age-related macular degeneration (wAMD).

  • Aerie Pharmaceuticals, Inc an ophthalmic pharmaceutical company focused on the discovery, development and commercialization of first-in-class therapies for the treatment of patients with open-angle glaucoma and other diseases of the eye, announced the submission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for RoclatanTM (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005%. RoclatanTM is a once-daily eye drop designed to reduce intraocular pressure (IOP) in patients with glaucoma or ocular hypertension. It is a fixed dose combination of Aerie’s Rhopressa®, which is currently available in the United States, and the widely-prescribed PGA (prostaglandin analog) latanoprost. RoclatanTM successfully achieved its primary efficacy endpoint in two Phase 3 registration trials, named Mercury 1 and Mercury 2, and also achieved successful 12-month safety and efficacy results in Mercury 1, the results of which are included in the NDA submission.

  • Regeneron Pharmaceuticals, Inc. and Sanofi announced they will lower the net price of Praluent® (alirocumab) Injection in exchange for straightforward, more affordable patient access from Express Scripts. Praluent will become the exclusive PCSK9 inhibitor therapy on the Express Scripts national formulary. The agreement significantly simplifies the documentation necessary to secure insurance coverage and may help reduce out-of-pocket costs for eligible patients. Despite having the broadest U.S. formulary coverage of any PCSK9 inhibitor, many patients have been unable to access Praluent because of the complicated utilization management process required by some insurance companies and high patient out-of-pocket costs.

  • Apricus Biosciences, Inc a biopharmaceutical company advancing innovative medicines in urology and rheumatology,  announced the outcome of its end-of-review meeting with the U.S. Food and Drug Administration (FDA) on the New Drug Application (NDA) for Vitaros™ (alprostadil, DDAIP.HCl), a topical cream for the treatment of erectile dysfunction.

  • Zosano Pharma Corp a clinical stage biopharmaceutical company focused on providing rapid systemic administration of therapeutics to subjects using its proprietary Adhesive Dermally-Applied Microarray (“ADAM™”) technology, today announced that the previously announced Notice of Allowance of our patent application titled “Method of Rapidly Achieving Therapeutic Concentrations of Triptans for Treatment of Migraines” has resulted in the issuance of a U.S. patent 9,918,932.  The inventors were Dr. Mahmoud Ameri, Dr. Don Kellerman, Dr. Yi Ao, and Dr. Peter Dadonna, all of whom are current or former employees of Zosano.

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