Thermo Fisher Scientific has completed the acquisition of Groupe Novasep’s acquisition of viral vector manufacturing business in Belgium – Henogen for nearly €725 million in cash. The divested viral vector manufacturing business of Novasep offers contract manufacturing services for vaccines and therapies to biotech firms and large biopharma customers. Through its two locations in Seneffe […]
Dr. Reddy’s Laboratories has secured the go-ahead from the Drugs Control General of India (DCGI) to begin phase 3 clinical trial for the Russian Covid-19 vaccine Sputnik V in India. The Indian pharma company plans to hold the phase 3 study on 1500 volunteers as part of the randomized, double-blind, parallel-group, placebo-controlled study. G V […]
DARZALEX FASPRO FDA approval for AL amyloidosis : Janssen Pharmaceutical, a subsidiary of Johnson & Johnson, has secured approval from the US Food and Drug Administration (FDA) for DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) in combination with bortezomib, cyclophosphamide, and dexamethasone (D-VCd) for the treatment of light chain (AL) amyloidosis, which has been newly diagnosed in […]
Indian pharma company Dr. Reddy’s Laboratories announced that Sputnik V, a registered Covid-19 vaccine in Russia, has succeeded in a phase 2 trial in India by meeting the primary endpoint of safety. An independent data and safety monitoring board (DSMB) has recommended the Sputnik V Covid-19 vaccine to be advanced to a phase 3 trial […]
Sanofi acquisition of Kymab : French pharma giant Sanofi has signed a deal worth up to $1.45 billion to acquire Kymab, a UK-based clinical-stage biopharma company focused on developing fully human monoclonal antibodies, particularly for immune-mediated diseases, and immuno-oncology therapeutics. The consideration includes an upfront payment of around $1.1 billion and up to $350 million […]
OncoSec Medical has dosed the first patient in the OMS-104 phase 2 clinical trial, which is evaluating TAVO (tavokinogene telseplasmid) in combination with OPDIVO (nivolumab) as a neoadjuvant therapy for melanoma. TAVO is OncoSec Medical’s intratumoral DNA plasmid-based interleukin-12 (IL-12) therapy, which is intended to be administered using its gene delivery platform (gene electrotransfer). On […]
The Drugs Controller General of India (DCGI) has granted emergency approvals to Serum Institute of India’s Covishield and Bharat Biotech’s Covaxin vaccines for the prevention of Covid-19. COVISHIELD has been developed at the Serum Institute of India’s laboratory in Pune with a master seed from Oxford University and pharma giant AstraZeneca. According to DCGI VG […]
The Drugs Controller General of India (DCGI) has granted emergency approvals to Serum Institute of India’s Covishield and Bharat Biotech’s Covaxin vaccines for the prevention of Covid-19. COVISHIELD has been developed at the Serum Institute of India’s laboratory in Pune with a master seed from Oxford University and pharma giant AstraZeneca. According to DCGI VG […]
Biocon, an Indian biopharma company, has expanded its generic formulations portfolio with the US launch of generic Tacrolimus capsules. Tacrolimus is a calcineurin inhibitor and an immunosuppressant, which was approved last month by the US Food and Drug Administration (FDA) for its use in the treatment of organ transplant patients. In organ transplant patients, the […]
Swissmedic, the Swiss Agency for Therapeutic Products, has authorized the use of the BNT162b2 Covid-19 vaccine from US pharma giant Pfizer and German biotech company BioNTech. The Swiss pharma regulator said that as per the data it has assessed, the level of protection afforded seven days following the second dose of the mRNA vaccine is […]