Company News

Niramai, the deep-tech healthcare company offering an innovative AI-based, radiation-free breast cancer screening test has now received the CE mark approval, ISO 13485 and MDSAP (Medical Device Single Audit Programme) international certifications. The CE mark approval indicates that the product may be sold freely in any part of the European Economic Area (EEA) as well as applicable to many Asian, African and Middle East countries.

Germany and Canada have restricted the use of the AstraZeneca vaccine to people over 60 and 55 respectively, due to fear that it can lead to deadly blood clots.

Health Minister of Germany, Jens Spahn and state officials agreed unanimously on Tuesday to only give the vaccine to people aged 60 or older unless they belong to a high-risk category for serious illness from COVID-19 and have agreed with their doctor to take the vaccine despite the small risk of a serious side-effect.

Max Healthcare Institute Ltd (MHC), India’s second largest private hospital chain operator by revenue in Fiscal 2020 announced the successful completion of its Qualified Institutions Placement (QIP). MHC raised INR 1,200 Cr (approx. USD 165 Mn) through its QIP, which saw participation from highly reputable global and domestic investors. MHC has accordingly issued 6,14,12,482 fresh equity shares of face value of INR 10 per equity share at a price of INR 195.40 per equity share.

The US District Court for the Northern District of West Virginia has decided in favour of AstraZeneca in litigation against Mylan Pharmaceuticals Inc. (Mylan) and Kindeva Drug Delivery L.P. (Kindeva), determining that asserted claims in three of AstraZeneca’s patents protecting Symbicort (budesonide/formoterol) in the US are not invalid.

Olympus made its initial investment in Medi-Tate in November 2018, under an agreement that included the rights to distribute Medi-Tate products and gave Olympus an option to acquire 100% of the Israeli company at a later date. Medi-Tate is a medical device manufacturer engaged in the research and development, production, and sale of devices for the minimally invasive treatment of benign prostatic hyperplasia (“BPH”). The company’s flagship product “iTind” has received a European CE mark and is FDA cleared for use in the U.S.

AstraZeneca announced the voluntary withdrawal of the Imfinzi (durvalumab) indication in the US for previously treated adult patients with locally advanced or metastatic bladder cancer. This decision was made in consultation with the Food and Drug Administration (FDA).

Sun Pharmaceutical settled for a case pertaining to alleged violation of listing obligation and disclosure requirements norms with regulator Securities and Exchange Board of India (SEBI). The aggregate settlement charges were paid around Rs 2.9 crores.

The show cause notices issued by SEBI on May 19, 2020 to Sun Pharmaceutical Industries Limited, and the Whole-time Directors and certain officers at the relevant time.

The U.S. Food and Drug Administration (FDA) has approved the PD-1 inhibitor Libtayo® (cemiplimab-rwlc) as the first immunotherapy indicated for patients with advanced basal cell carcinoma (BCC) previously treated with a hedgehog pathway inhibitor (HHI) or for whom an HHI is not appropriate. Full approval was granted for patients with locally advanced BCC and accelerated approval was granted for patients with metastatic BCC.

ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline plc with Pfizer Inc.