Industry News

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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Vtesse, Inc., a company committed to developing medicines to benefit patients with ultra rare, life-threatening diseases, announced that the US Food and Drug Administration (FDA) granted Rare Pediatric Disease designation to VTS-270, the company’s investigational drug for children with Niemann-Pick Type C1 disease (NPC). NPC is a progressive, irreversible, chronically debilitating – and ultimately lethal – genetic disease.

SomaGenics, an RNA-focused biotechnology company, announced expansion of its intellectual property portfolio with issue of two new patents for its RNA analysis technologies (miR-ID and RealSeq) and European patent protection for its therapeutic short synthetic hairpin RNA (sshRNA) agents.

MonoSol Rx, a specialty pharmaceutical company leveraging its PharmFilm® drug delivery technology to improve patient outcomes and to address unmet needs, announced that it has filed a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for Tadalafil PharmFilm for the treatment of erectile dysfunction.

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.

Indegene, a global healthcare solutions provider, announced the acquisition of The Encima Group - a pioneer in life science omnichannel marketing automation and analytics and partner to some of the world's largest pharmaceutical organizations. The Delaware Corporation was featured for the 4th consecutive year in the prestigious Inc. 5000 list of fastest-growing private companies in the United States.

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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