Pharma News

BioXcel, a privately held biopharmaceutical company based in Connecticut, announced that the U. S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to BXCL101 for the treatment of Neurofibromatosis Type 2 (NF2), an orphan disease with significant unmet medical need. BXCL101 is the first and only systemic therapy being developed to eliminate existing lesions and prevent the formation of new lesions by targeting the molecular mechanism of NF2 pathophysiology.

Akari Therapeutics announced that the U.S. Food and Drug Administration (FDA) has granted to Akari an Orphan Drug Designation for recombinant protein inhibitor of complement factor 5 for the treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH). Coversin, Akari’s lead clinical product, which falls within the Orphan Drug Designation, is a second-generation complement inhibitor that acts on complement component-C5, preventing release of C5a and formation of C5b-9 (also known as the membrane attack complex or MAC).

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 A new study from scientists at The Scripps Research Institute (TSRI) shows that "holes" in HIV's defensive sugar shield could be important in designing an HIV vaccine.

Dr. Reddy’s Laboratories Ltd has launched Bupropion HCl extended-release tablets, USP (SR) in 100 mg, 150 mg and 200 mg, a therapeutic equivalent generic version of Wellbutrin® SR (bupropion HCl) Sustained-Release Tablets in the United States market approved by the U.S. Food & Drug Administration (USFDA).

Sanofi  and Verily Life Sciences LLC, (formerly Google Life Sciences), an Alphabet company, today announced the launch of Onduo, a joint venture created through Sanofi and Verily’s diabetes-focused collaboration. The joint venture is based in Kendall Square in Cambridge.  Onduo’s mission is to help people with diabetes live full, healthy lives by developing comprehensive solutions that combine devices, software, medicine, and professional care to enable simple and intelligent disease management.

Boehringer Ingelheim announced that the European Commission (EC) and U.S. Food and Drug Administration (FDA) have granted Orphan Drug Designation to nintedanib for the treatment of systemic sclerosis (SSc, also known as scleroderma), including the associated interstitial lung disease (SSc-ILD).

Novartis introduces a novel in office point of care diagnostic tool - the Niji System and Total IgE Test. This first test delivers quantitative total IgE (Immunoglobulin E) levels in about 12 minutes using only one to two droplets of finger stick blood, allowing for quick in-office diagnosis of IgE-mediated allergic disorders in conjunction with other clinical findings.

Results from a new post-hoc analysis of two large phase III trials (LUX-Lung 3 and LUX-Lung 6) assessing the impact of dose adjustments for Giotrif (afatinib) in patients with advanced non-small cell lung cancer (NSCLC) were published in Annals of Oncology. The analysis suggests specific dose reductions, as described in SmPC / prescribing information, led to decreases in the incidence and severity of treatment-related adverse events (AEs) in afatinib-treated patients without any apparent compromise in efficacy.