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.

The first long-acting option to protect women from HIV, proven to reduce women’s HIV risk, has been recommended for use by the World Health Organization (WHO).

Alembic Pharmaceuticals Limited announced that it has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Dabigatran Etexilate Capsules, 150 mg. The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) PRADAXA® Dabigatran Etexilate Mesylate Capsules, Eq to 150 mg base, Boehringer Ingelheim.

Sanofi announced today it entered into an agreement to acquire Origimm Biotechnology GmbH, an Austrian privately owned biotechnology company specializing in the discovery of virulent skin microbiome components and antigens from bacteria causing skin disease, such as acne. With this acquisition, Sanofi continues executing its global Play to Win strategy, pursuing growth opportunities and building an industry-leading vaccines pipeline.

A Kerala-based medical technology start-up has been adjudged the winner of Startup India Grand Challenge 2021 in the medical device category of the Government of India.

SARS-CoV-2 has affected more than 200 million people causing more than 5 million deaths worldwide as per the WHO statistics. The rise in mutant variants of SARS-CoV-2 virus has led to concerns regarding vaccine effectiveness. Delta (B.1.617.2) variant is the predominant strain in India. The vaccination programme in India is driven largely by the Covishield vaccine (ChAdOx1 nCoV-19).

Amazon Web Services, Inc an Amazon.com, Inc. company announced that Gilead Sciences, Inc.  a biopharmaceutical company advancing innovative medicines to prevent and treat life-threatening diseases, has selected AWS as its preferred cloud provider. Innovating on AWS and with the help of AWS experts and partners in healthcare and life sciences, Gilead provides its data scientists with the latest advances in machine learning and analytics.

The PLI Scheme for Pharmaceuticals is based on the strategy of Atmanirbhar Bharat- Strategies for enhancing Indias manufacturing capabilities and enhancing exports in ten sectors”, which had been approved by the Union Cabinet on 24.02.2021.  The Operational Guidelines for the scheme inviting applications from the pharmaceutical industry were issued on 01.06.2021 by the Department of Pharmaceuticals after intensive consultation with industry and related departments   and NITI Aayog.