Industry News

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.

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.

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.

Pfizer Inc and BioNTech announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion on the administration of the companies’ COVID-19 vaccine COMIRNATY® in children 5 to under 12 years of age. The European Commission (EC) will review the CHMP recommendation and is expected to make a final decision on a variation to the Conditional Marketing Authorization in the near future.

 Labcorp a leading global life sciences company, today announced that it has entered into a definitive agreement to acquire Toxikon , a contract research organization delivering best-in-class nonclinical testing services. Once completed, the transaction will create a strategic footprint for Labcorp to partner with pharmaceutical and biotechnology clients in the Boston, Mass., area and bolster its strong nonclinical development portfolio.

Roche announced the launch of the cobas® 5800 System, a new molecular laboratory instrument, in countries accepting the CE mark. Testing is one of the first lines of defense to protect a patient’s general well-being and is vitally important in quickly guiding their treatment. The cobas 5800 System helps address challenges that laboratories are facing from an increase in patient testing, reimbursement complexities and the need for a more diverse testing menu while providing meaningful and timely results.