Industry News

Janssen Pharmaceuticals, Inc. (Janssen) announced results from the Phase 2b Topaz Trial which demonstrated that treatment with pimodivir (JNJ-63623872) significantly decreased viral load over seven days versus placebo, in adult patients with acute, uncomplicated seasonal influenza A. Patients treated with pimodivir and oseltamivir (OST) also demonstrated a significantly lower viral load compared with those who received pimodivir alone at the same dose. 

Aurobindo Pharma Limited is pleased to announce that the company has received final approval from the US Food & Drug Administration (USFDA) to manufacture Sevelamer Carbonate oral suspension, 0.8 gm and 2.4 gm. Sevelamer Carbonate oral suspension, a therapeutic equivalent generic version of Genzyme's Renvela® oral suspension. The product is being launched immediately.

Dr. Reddy’s Laboratories Ltd.announced that it has launched Bivalirudin for
Injection, 250 mg/vial, a therapeutic equivalent generic version of Angiomax® (Bivalirudin) for Injection, approved by the U.S. Food and Drug Administration (USFDA).

Nesher Pharmaceuticals, a subsidiary of Zydus Pharmaceuticals USA has received final approval from the USFDA to market Nystatin Topical Powder USP, 100,000 units per gram.

Fibrocell Science, Inc. a gene therapy company focused on transformational autologous cell-based therapies for skin and connective tissue diseases, announced that the remaining two patients in the NC1+ cohort have been dosed in the Phase 1 portion of the Phase 1/2 clinical trial of FCX-007 for the treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB), a devastating genetic skin disease with a high mortality rate. The cohort consists of three patients.

Cell Design Labs, Inc. announced the issuance of U.S. Patent No. 9,670,281, entitled “Binding-triggered transcriptional switches and the methods of use thereof.” This patent, issued to UC San Francisco (UCSF) and exclusively licensed to Cell Design Labs, broadly covers composition of matter for proprietary synNotch™ constructs, cells genetically modified with synNotch receptors and methods for treating diseases.

Zydus Cadila has informed that the USFDA has given final approval to market Mesalamine Delayed- Release Tablets USP, 1.2 g in the US market. Zydus Cadila was the first to file an Abbreviated New Drug Application (ANDA) for a generic version of Lialda® (mesalamine).

Alkermes plc announced the initiation of ENLIGHTEN-Early, a supportive study in the ENLIGHTEN clinical development program for ALKS 3831, an investigational, novel, once-daily, oral atypical antipsychotic drug candidate designed to be a broad-spectrum treatment for schizophrenia.

Tonix Pharmaceuticals Holding Corp. (Nasdaq:TNXP) (Tonix), a company that is developing innovative pharmaceutical products to address public health challenges, presented entitled “Phase 2 Multisite Double-Blind Placebo-Controlled Trial of TNX-102 SL in Military-Related Posttraumatic Stress Disorder: Mediators and Moderators of Treatment Response” (Poster No. 3001130) at the 72nd Annual Scientific Convention of the Society of Biological Psychiatry in San Diego. The poster can be found on the Scientific Presentations page on Tonix’s website. A moderator is a characteristic of study participants that is associated with a treatment response.

Alembic Pharmaceuticals Limited announced that the Company has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Fenofibric Acid Delayed-Release Capsules, 45 mg and 135 mg.