USFDA

MonoSol Rx, a specialty pharmaceutical company leveraging its PharmFilm® drug delivery technology to improve patient outcomes and to address unmet needs, announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to Diazepam Buccal Soluble Film (Diazepam BSF) for the treatment of Acute Repetitive Seizures (ARS). The Company plans to initiate a pivotal study of Diazepam BSF in adults in early 2017. 

Biostage, Inc. a biotechnology company developing bioengineered organ implants to treat cancers and other life-threatening conditions of the esophagus, bronchus and trachea, announced that its Cellspan™ Esophageal Implant was granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) to restore the structure and function of the esophagus subsequent to esophageal damage due to cancer, injury or congenital abnormalities.

AbbVie , a global biopharmaceutical company,  announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to risankizumab (ABBV-066; formerly BI 655066) for the investigational treatment of Crohn's disease in pediatric patients. Risankizumab is being evaluated in immunological disorders, including Crohn's disease, psoriasis, psoriatic arthritis and asthma.

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Merck  known as MSD outside the United States and Canada, announced that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for KEYTRUDA® (pembrolizumab), the company’s anti-PD-1 therapy, for the treatment of patients with refractory classical Hodgkin lymphoma (cHL) or for patients who have relapsed after three or more prior lines of therapy.

Quidel Corporation , a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced  that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) to market its Solana® HSV-1+2/VZV Assay for the qualitative detection and differentiation of herpes simplex virus type 1, herpes simplex virus type 2, and varicella-zoster virus DNA isolated and purified from cutaneous or mucocutaneous lesion samples obtained from symptomatic patients suspected of active herpes simplex virus 1, herpes simplex virus 2 and/or varicella-zoster infection.

PharmaCyte Biotech, Inc. a clinical stage biotechnology company focused on developing targeted treatments for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box®, announced that a Pre-Investigational New Drug (Pre-IND) meeting with the Center for Biologics Evaluation and Research (CBER) of the U.S. Food and Drug Administration (FDA) has been granted by the FDA. During the meeting with representatives from CBER, they will respond to PharmaCyte’s previously submitted questions to the FDA as part of a Pre-IND information package related to PharmaCyte’s clinical trial in locally advanced, inoperable pancreatic cancer (LAPC).

Pharma Major Lupin Limited (Lupin) announced  that its US subsidiary Lupin Pharmaceuticals, Inc. (LPI) has received final approval for its Armodafinil Tablets 50 mg, 150 mg, 200 mg and 250 mg from the United States Food and Drug Administration (FDA) to market a generic version of Cephalon, Inc’s Nuvigil® Tablets 50 mg, 150 mg, 200 mg and 250 mg. LPI shall commence promoting the product in the US shortly.

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PhaseRx, Inc., a biopharmaceutical company developing mRNA treatments for life-threatening inherited liver diseases in children, announced that its lead candidate, PRX-OTC, which is being developed for the treatment of ornithine transcarbamylase deficiency (OTCD), has received orphan drug designation by the US Food and Drug Administration (FDA).

EMD Serono Inc., the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, in the US and Canada, and Pfizer Inc. announced that the US Food and Drug Administration (FDA) has accepted for Priority Review EMD Serono's Biologics License Application (BLA) for avelumab. This review relates to avelumab's proposed use in patients with metastatic Merkel cell carcinoma (MCC), based on tumor response results from the JAVELIN Merkel 200 trial. Avelumab is an investigational fully human anti-PD-L1 IgG1 monoclonal antibody and could be the first treatment indicated for metastatic MCC in the US, if approved. MCC is a rare and aggressive skin cancer, which impacts approximately 2,500 Americans a year.