Pharma News

Glenmark Pharmaceuticals Limited (Glenmark) has received final approval by the United States Food & Drug Administration (U.S. FDA) for Amphetamine Sulfate Tablets USP, 5 mg and 10 mg, the generic version of Evekeo®1 Tablets, 5 mg and 10 mg, of Arbor Pharmaceuticals, LLC.

According to IQVIATM sales data for the 12 month period ending November 2020, the Evekeo® Tablets, 5 mg and 10 mg market2 achieved annual sales of approximately $21.5 million*.

BioArctic AB announced that the European Patent Office (EPO) has issued a decision to grant European patent EP 2 448 968 B1 for novel antibodies that could be developed into a treatment for Alzheimer’s disease. The antibodies target a shorter (truncated) form of amyloid beta (pE3-Aβ) and are linked to the company’s project AD1503. The patent enters into force on 27 January 2021 and expires in 2030.

WHO recommended that the dapivirine vaginal ring (DPV-VR) may be offered as an additional prevention choice for women at substantial risk[1] of HIV infection as part of combination prevention approaches.

United States Food and Drug Administration (USFDA) has granted ‘Orphan Drug Designation’ (ODD) to Saroglitazar for the treatment of patients with Primary Biliary Cholangitis (PBC). Orphan drug designation provides eligibility for certain development incentives, including tax credits for qualified clinical testing, prescription drug user fee exemptions and seven-year marketing exclusivity upon FDA approval. This follows the grant of ‘Fast Track Designation’ by the USFDA to Saroglitazar Mg for PBC in December 2020.

Mundipharma and Cidara Therapeutics announced that the European Commission (EC) has now adopted the European Medicines Agency’s (EMA) Committee for Orphan Medicinal Products (COMP) recommendation to grant Orphan Drug Designation (ODD) to rezafungin, a novel, once-weekly echinocandin, for the treatment of invasive candidiasis (IC).

A new in vitro study done collaboratively by Utah State University and Northwestern University finds Xlear components (grapefruit seed extract and xylitol) significantly eliminates SARS-CoV-2, the virus that causes COVID-19. The imaging research study component was performed at the BioCryo facility of Northwestern University’s NUANCE Center.

MSD outside the United States and Canada announced that the company is discontinuing development of its SARS-CoV-2/COVID-19 vaccine candidates, V590 and V591, and plans to focus its SARS-CoV-2/COVID-19 research strategy and production capabilities on advancing two therapeutic candidates, MK-4482 and MK-7110. This decision follows Merck’s review of findings from Phase 1 clinical studies for the vaccines.

Human papillomavirus (HPV) is the most common sexually transmitted infection, with an estimated 79 million Americans currently infected with the virus, according to the Centers for Disease Control and Prevention. If a high-risk HPV infection does not go away, it can lead to the development of a variety of cancers, including 91% of all cervical cancers, 70% of oropharyngeal cancers and cancers of the vulva, vagina, penis and anus.

Head and neck cancer is the sixth most common cancer worldwide, and while effective treatments exist, sadly, the cancer often returns.

Researchers at the University of Cincinnati have tested a new combination therapy in animal models to see if they could find a way to make an already effective treatment even better.

Since they're using a Food and Drug Administration-approved drug to do it, this could help humans sooner than later.