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 […]
Continue reading …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 […]
Continue reading …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 […]
Continue reading …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 […]
Continue reading …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 […]
Continue reading …AstraZeneca has secured extended approval from the US Food and Drug Administration for using Tagrisso (osimertinib) as an adjuvant treatment of non-small cell lung cancer (NSCLC) in patients whose tumors have a certain type of genetic mutation. According to the FDA, nearly 20% of patients with non-small cell lung cancer will have epidermal growth factor […]
Continue reading …Eli Lilly and Company (Lilly) has revealed plans to launch a new pragmatic study of bamlanivimab (LY-CoV555) in high-risk patients with Covid-19, in partnership with major local institutions in New Mexico. The US pharma giant said that carrying out the study in New Mexico will help in the collection of data on the effectiveness and […]
Continue reading …Moderna Covid-19 vaccine : The US Food and Drug Administration (FDA) has given emergency use authorization (EUA) for mRNA-1273, the messenger RNA (mRNA) Covid-19 vaccine candidate of Moderna. The FDA authorization is for the use of mRNA-1273 in individuals aged 18 years and more for the prevention of Covid-19 caused by severe acute respiratory syndrome […]
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