Cytiva and Longitude (a Financial Times company) reveal five major challenges for the industry in new Global Biopharma Resilience Index Kumar Jeetendra | March 8, 2021 Global life sciences leader Cytiva, along with the Financial Times’ research arm Longitude, have compiled a global index, ranking the ability of the biopharma industry to respond to five major challenges; in supply chain, talent, research and development, manufacturing, and government policy and regulation. Respondents answered questions on a scale of 1 to 10 in …
Natco Pharma rises after USFDA gesture for cancer treatment drug Kumar Jeetendra | March 8, 2021 Natco Pharma jumped 6.2% to Rs 884.35 after the company received final approval for everolimus tablets in the US market. Natco Pharma announced that its marketing partner, Breckenridge Pharmaceutical Inc. (BPI), has received final approval for its abbreviated new drug application (ANDA) for everolimus tablets (a generic version of Afinitor) from the US Food and …
Oxford study demonstrates AstraZeneca powerful against Brazil variant, source says Kumar Jeetendra | March 6, 2021 Preliminary data from a study conducted at the University of Oxford suggests that the COVID-19 vaccine developed by AstraZeneca PLC is successful against the P1, or Brazilian, version, a source with knowledge of the study told Reuters on Friday. The data suggests that the vaccine won’t need to be modified so as to safeguard against …
Alembic Pharma JV packs USFDA gesture on testosterone gel Kumar Jeetendra | March 4, 2021 Alembic Pharmaceuticals announced that its joint venture (JV), Aleor Dermaceuticals has obtained the final approval from the US drug regulator for its Abbreviated New Drug Application (ANDA) for testosterone gel, 1.62%. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), AndroGel 1.62%, of AbbVie Inc. (AbbVie). Testosterone gel, 1.62% (20.25 mg/1.25 …
Unichem Laboratories Ltd gets ANDA endorsement for Guanfacine Tablets Kumar Jeetendra | March 4, 2021 Unichem Laboratories Limited has obtained ANDA approval for its Guanfacine Tablets, USP 1 mg and 2 mg in the United States Food and Drug Administration (USFDA) to market a generic version of TENEX® (Guanfacine) Tablets 1 mg and 2 mg of Promius Pharma LLC. Guanfacine Tablets are indicated in the management of hypertension. The product …
J&J CEO Alex Gorsky sees COVID-19 shots in American arms in 1-2 days as transportation begins Kumar Jeetendra | March 2, 2021 Johnson & Johnson’s newly authorized COVID-19 vaccine has begun shipping and its top executive said on Monday that Americans should have the ability to get the single-dose shot over the next 24 to 48 hours, including a third vaccine in america. The drugmaker intends to deliver 4 million vaccine doses this week, 20 million by …
Cipla receives final approval for generic version of GlaxoSmithKline’s IMITREX® (Sumatriptan Nasal Spray, 20 mg) Kumar Jeetendra | March 2, 2021 Mumbai, India, March 02, 2021: Cipla Limited (BSE: 500087; NSE: CIPLA EQ hereinafter referred to as “Cipla”) today announced that it has received final approval for its Abbreviated New Drug Application (ANDA) for Sumatriptan Nasal Spray, 20 mg from the United States Food and Drug Administration (U.S. FDA). Cipla’s Sumatriptan Nasal Spray USP, 20 mg …
Pfizer COVID-19 antibody diminishes transmission after one dose: UK study Kumar Jeetendra | February 26, 2021 A single dose of Pfizer and BioNtech’s COVID-19 vaccine cuts the amount of asymptomatic infections and might significantly lower the risk of transmission of this virus, results of a UK study discovered on Friday. Researchers analysed results from tens of thousands of COVID-19 tests completed each week as part of hospital screenings of healthcare staff …
USFDA rules against Sun Pharma Advanced Research Co’s’ allure with respect to cancer drug application Kumar Jeetendra | February 23, 2021 The Office of New Drugs (OND) of the US Food and Drug Administration (FDA) has denied the company”s appeal of the Comprehensive Response Letter (CRL) in relation to the New Drug Application (NDA) for Taclantis, Sun Pharma Advanced Research Company (SPARC) stated in a regulatory filing. In its letter, the OND asked the conduct of …
ICRA upgrades rating and outlook of Lincoln Pharmaceuticals Ltd Kumar Jeetendra | February 22, 2021 22 February 2021:- The rating agency ICRA Ltd has upgraded ratings and outlook of Lincoln Pharmaceuticals Ltd. ICRA has upgraded rating of company’s long-term bank loan facilities to ICRA A with stable outlook from ICRA A- and positive outlook. Short term bank loan facilities of the company were upgraded to ICRA A1 from ICRA A2+ …
GSK, Sanofi start new COVID-19 immunization preliminary trial after setback last year Kumar Jeetendra | February 22, 2021 Britain’s GlaxoSmithKline and France’s Sanofi on Monday said they had started a new clinical trial of their protein-based COVID-19 vaccine candidate and aim to get to the final testing phase in the second quarter. If the results are conclusive, both drugmakers hope to find the vaccine approved by the fourth quarter after having originally targeted …
Aurobindo Pharma gets USFDA gesture for conventional Droxidopa capsules Kumar Jeetendra | February 20, 2021 New Delhi: Drug major Aurobindo Pharma on Friday said it has received final approval from the US health regulator to manufacture and market Droxidopa capsules, used to treat dizziness and lightheadedness. The approved product is a generic version of Lundbeck NA Ltd’s Northera capsules. The business has received final approval from the US Food and …
