Zydus Cadila gets DCGI gesture for NAFLD drug in India Kumar Jeetendra | December 30, 2020 New Delhi, Dec 30 (PTI) Drug firm Zydus Cadila on Wednesday said it has received approval from the Drug Controller General of India (DCGI) for Saroglitazar Mg, used for the treatment of non-alcoholic fatty liver disease (NAFLD), in the nation. Zydus Cadila explained the prevalence of NAFLD in India is estimated to be nearly 25-30 …
Lupin receives tentative nod from USFDA for its toenail fungus remedy topical solution Kumar Jeetendra | December 25, 2020 NEW DELHI: Drug company Lupin on Thursday said it has received tentative nod in the US health regulator to market generic Efinaconazole topical solution used for treatment of fungal infections of toenails. The business has received tentative approval to market its Efinaconazole topical solution, 10%, by the United States Food and Drug Administration (USFDA), Lupin …
AstraZeneca says its vaccine need to be powerful in opposition to new coronavirus variant Kumar Jeetendra | December 23, 2020 British drugmaker AstraZeneca Plc told Reuters on Tuesday that its COVID-19 vaccine should be effective against the new coronavirus version, including that studies were under way to completely probe the effect of the mutation. “AZD1222 (AstraZeneca’s vaccine candidate) contains the genetic material of this SARS-CoV-2 virus spike protein, as well as the changes to the …
Glenmark Pharma gets provisional gesture from USFDA for blood thinning drug Kumar Jeetendra | December 21, 2020 Pradaxa is used to prevent blood clots from forming due to certain irregular heart rhythm. Glenmark Pharmaceuticals was granted tentative approval by the United States Food and Drug Administration (USFDA) for Dabigatran Etexilate capsules at the advantages of 75 mg, 110 mg, and 150 mg, the company said in a regulatory filing. Quoting IQVIA sales …
Moderna COVID-19 shots leave distribution centers, broadening US vaccination push Kumar Jeetendra | December 20, 2020 Shipments of Moderna Inc’s COVID-19 vaccine started leaving warehouses early on Sunday, heading for healthcare facilities around the USA in a push to disperse the second authorized coronavirus vaccine. The distribution of Moderna’s vaccine to over 3,700 locations in the United States will vastly expand the rollout started a week by Pfizer Inc.. The U.S. …
Strides Pharma gets USFDA gesture for conventional Oxybutynin Chloride tablets Kumar Jeetendra | December 18, 2020 Drug firm Strides Pharma Science on Friday said its Singapore-based arm has received approval from the US health regulator for generic Oxybutynin Chloride tablets used to treat symptoms of overactive bladder and urinary incontinence. Company’s step-down wholly owned subsidiary Strides Pharma Global Pte Ltd, Singapore, has received approval for Oxybutynin Chloride Tablets USP, 5 mg …
Cipla Launches ‘CIPtest’ Rapid Antigen Detection Test for COVID-19 Diagnosis Kumar Jeetendra | December 16, 2020 Mumbai, India; December 16, 2020: Cipla Limited (BSE: 500087; NSE: CIPLA EQ) referred to as “Cipla” today announced its partnership with the Premier Medical Corporation Private Limited for commercialisation of the rapid antigen test kits for COVID-19 in India. The company will commence supply from this week. This is Cipla’s second launch in the diagnostics …
LogiNext Presents World’s First Complete COVID-19 Vaccine Supply Chain Management Platform Kumar Jeetendra | December 15, 2020 Mumbai, INDIA – December 15, 2020 – LogiNext today announced the launch of a COVID -19 vaccine supply chain management and tracking platform. With several parts of the globe in the grips of a second or third wave of the COVID-19 pandemic, vaccine trials are on and a reliable supply chain mechanism for the vaccine …
Alembic Pharmaceuticals gets USFDA endorsement for Asenapine Sublingual Tablets Kumar Jeetendra | December 12, 2020 Alembic Pharmaceuticals announced it has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Asenapine Sublingual Tablets, 5 mg and 10 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Saphris Sublingual Tablets, 5 mg and 10 mg, of Allergan Sales, LLC …
Cipla announces settlement of Revlimid® (Lenalidomide) capsules patent Litigation Kumar Jeetendra | December 11, 2020 Mumbai, India, December 11, 2020: Cipla Limited (BSE: 500087; NSE: CIPLA EQ) (“Cipla”) today announced the settlement of its litigation with Celgene Corporation, and wholly owned subsidiary of Bristol Myers Squibb (NYSE: BMY) relating to patents for REVLIMID® (lenalidomide). As part of the settlement, the Parties will file Consent Judgments with the United States District …
Sanofi and GSK defer COVID-19 antibody, marking setback to worldwide battle Kumar Jeetendra | December 11, 2020 The announcement on Friday, which emphasized the challenges of developing shots at record speed, hinders attempts to develop the multiple options that experts say that the world needs to cancel a disease that has killed over 1.5 million people. The news, which came on the same day as Australia axed a domestic vaccine project, can …
UK cautions individuals with serious allergies to maintain a strategic distance from Pfizer vaccine after two unfavorable responses Kumar Jeetendra | December 10, 2020 Britain’s medication regulator said anyone with a history of anaphylaxis to a medicine or food should not get the Pfizer-BioNTech COVID-19 vaccine, giving more advice on an earlier allergy warning about the shot. Starting with the elderly and frontline workers, Britain began mass vaccinating its population on Tuesday, part of a worldwide drive that poses …