Pharma News

Calibre Scientific is pleased to announce the acquisition of Benson Polymeric, a manufacturer of polymer-based HPLC columns and resin. Benson Polymeric further enhances Calibre Scientific’s growing presence in the chromatography sector.

Morepen Laboratories Limited has received USFDA approval for its anti-allergy drug Fexofinadine Hydrochloride that is market in India under the popular brand name Allegra, among others and is the block buster drug of the innovator company Sanofi Aventis, France. Fexofinadine is most widely used, second generation antihistamine drug for the treatment of allergy symptoms and hay fever.

The Union Ministry of Health and Family Welfare has issued answers to Frequently Asked Questions (FAQs) on the new variant of COVID19, classified as Omicron (B.1.1.529) by the WHO on 26th November 2021.

LintonPharm Co., Ltd., a China-based clinical stage biopharmaceutical company focused on the development of T cell engaging bispecific antibodies for cancer immunotherapy, today announced that the first patient has been dosed in the Company’s Phase 1/2 clinical trial program for catumaxomab (clinicaltrials.gov: NCT04799847), a monoclonal bispecific antibody being studied for the treatment of Non-Muscle-Invasive Bladder Cancer (NMIBC) unresponsive to Bacillus Calmette-Guerin (BCG).

Premas Biotech announced that its joint venture Oravax will initiate testing of their oral virus-like particle (VLP) vaccine candidate against Omicron variant of SARS-CoV 2 virus through preclinical, in vitro and challenge studies to assess its efficacy for the new mutant strain. Premas Biotech, Oramed Pharmaceuticals, MyMD Pharmaceuticals, and certain other shareholders formed Oravax Medical to bring an oral COVID-19 vaccine to the market.

FUJIFILM Diosynth Biotechnologies, a world leading contract development and manufacturing organisation (CDMO) for biologics, viral vaccines and viral vectors, has confirmed a £400 million planned investment package at its UK facility in Billingham, Teesside. This investment package more than doubles the site’s existing development and manufacturing footprint, creating the largest multi-modal biopharmaceutical manufacturing site in the United Kingdom and is expected to create up to 350 highly-skilled jobs.

Amgen announced that the U.S. Food and Drug Administration (FDA) has approved the expansion of the KYPROLIS® (carfilzomib) U.S. prescribing information to include its use in combination with DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy. 

The U.S. Food and Drug Administration today approved Cytalux (pafolacianine), an imaging drug intended to assist surgeons in identifying ovarian cancer lesions. The drug is designed to improve the ability to locate additional ovarian cancerous tissue that is normally difficult to detect during surgery.

Cytalux is indicated for use in adult patients with ovarian cancer to help identify cancerous lesions during surgery. The drug is a diagnostic agent that is administered in the form of an intravenous injection prior to surgery.

GlaxoSmithKline plc and Vir Biotechnology, Inc announced an update to bioRxiv, a preprint server, with preclinical data demonstrating that sotrovimab, an investigational monoclonal antibody, retains activity against key mutations1 of the new Omicron SARS-CoV-2 variant (B.1.1.529), including those found in the binding site of sotrovimab. These data were generated through pseudo-virus testing of specific individual mutations found in Omicron.