Pharma News

CASI Pharmaceuticals, Inc. (CASI), a biopharmaceutical company dedicated to the acquisition, development and commercialization of innovative therapeutics addressing cancer and other unmet medical needs for the global market with a commercial focus on China, announced that China’s Food and Drug Administration (CFDA) has accepted for review its import drug registration application for MARQIBO® (vinCRIStine sulfate LIPOSOME injection).

Immunovaccine Inc, a clinical stage vaccine and immunotherapy company, announced U.S. Food and Drug Administration (FDA) and Health Canada clearance to initiate a clinical study of DPX-Survivac in combination with low-dose cyclophosphamide and epacadostat. Resulting from a recently announced collaboration between Immunovaccine and Incyte Corporation (“Incyte”), the Phase 1b clinical trial will assess the safety and effectiveness of Immunovaccine’s novel T cell activating therapy, DPX-Survivac, along with Incyte’s investigational oral indoleamine 2,3-dioxygenase 1 (IDO1) inhibitor, epacadostat (INCB24360), and low-dose cyclophosphamide in patients with recurrent ovarian cancer who have measurable disease. Immunovaccine anticipates starting the trial, which Incyte will co-fund under the terms of the agreement between the two companies, by Q2 2016.

Enanta Pharmaceuticals, Inc., a research and development-focused biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, announced that the U.S. Food and Drug Administration (FDA) has accepted AbbVie’s supplemental New Drug Application (sNDA) and granted priority review for VIEKIRA PAK® (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) without ribavirin (RBV) in patients with genotype 1b (GT1b) chronic hepatitis C virus (HCV) and compensated cirrhosis (Child-Pugh A). The current dosing recommendation for patients with GT1b and compensated cirrhosis is to administer RBV with VIEKIRA PAK for 12 weeks.

Aquinox Pharmaceutical Inc., a clinical-stage pharmaceutical company discovering and developing targeted therapeutics in disease areas of inflammation and immuno-oncology,  announced receipt of official minutes from its December 8, 2015 meeting with the Division of Bone, Reproductive and Urologic Products (DBRUP) of the United States Food and Drug Administration (FDA) and provided an update on its plans for development of AQX-1125 for the treatment of patients with bladder pain syndrome/interstitial cystitis (BPS/IC). Discussed at the meeting were guidance and recommendations regarding proposed pivotal trial designs with AQX-1125 for BPS/IC, as well as additional supportive clinical, preclinical and manufacturing activities that could potentially be required for registration.

Anacor Pharmaceuticals, Inc. (NASDAQ:ANAC) announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval of crisaborole topical ointment, 2%, a novel non-steroidal topical anti-inflammatory phosphodiesterase-4 (PDE-4) inhibitor in development for the potential treatment of mild-to-moderate atopic dermatitis in children and adults.

Immune Design, a clinical-stage immunotherapy company focused on oncology, announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for LV305 and G305 for the treatment of soft tissue sarcoma.  LV305 and G305 are the complementary agents that comprise CMB305, Immune Design's "prime boost" cancer immunotherapy product candidate.

Merck, known as MSD outside the United States and Canada, announced that it has acquired IOmet, a privately-held UK-based drug discovery company focused on the development of innovative medicines for the treatment of cancer, with a particular emphasis on the fields of cancer immunotherapy and cancer metabolism. Under terms of the agreement, Merck, through a subsidiary, will acquire IOmet, including its comprehensive pre-clinical pipeline of IDO (indoleamine-2,3-dioxygenase 1), TDO (tryptophan-2,3-dioxygenase), and dual-acting IDO/TDO inhibitors. Based on the transaction, IOmet will become a wholly owned subsidiary of Merck.

MST–Medical Surgery Technologies Ltd., a leader in the field of advanced image-based robotic technology, announced that the U.S. Food and Drug Administration (FDA) has cleared the Follow Me™ software designed for minimally invasive robotic surgery. Follow Me™ is an advanced function of MST’s AutoLap®, an image-guided laparoscope positioning system. Powered by MST’s image-based intelligence technology, AutoLap® enables full and natural control of the surgical procedure with minimal user interaction.

Stealth BioTherapeutics (Stealth), a biopharmaceutical company developing drug candidates for treating mitochondrial dysfunction, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for MTP-131 (also known as Bendavia) for the treatment of primary mitochondrial myopathy, characterized by muscle weakness in patients with genetic mitochondrial diseases. MTP-131 is currently being studied for the treatment of primary mitochondrial myopathy in its MMPOWER trial, with results expected midyear.

Researchers have discovered a previously unknown cellular defect in patients with Parkinson's disease, and identified a sequence of pathological events that can trigger or accelerate premature death of certain neurons in the brain seen in this disease.

[adsense:336x280:8701650588]