News about Biotechnology

Zydus Cadila gets US FDA tentative marketing nod for epilepsy drug, brivaracetam

Zydus Cadila has received tentative approval from the US FDA to market brivaracetam tablets, in the strengths of 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg. Brivaracetam is used to treat partial-onset of seizures (epilepsy).

Biotechnology | 14/06/2021 | By Darshana |  221

Roche gets CE mark for SARS-CoV-2 Antigen Self Test Nasal for at-home testing

Roche announced it has received CE mark for its SARS-CoV-2 Antigen Self Test Nasal for at-home testing. The test will be available in countries accepting the CE mark through pharmacies and other locations, in packs of five tests

Biotechnology | 09/06/2021 | By Darshana |  196

Lupin receives US FDA approval for generic Truvada tablets

Global pharma major Lupin Limited has received approval for its emtricitabine and tenofovir disoproxil fumarate tablets, 200 mg/300 mg, from the United States Food and Drug Administration (FDA), to market a generic equivalent of Truvada tablets, 200 mg/300 mg, of Gilead Sciences, Inc.

Biotechnology | 07/06/2021 | By Darshana |  197

Moderna inks agreement with Government of the Republic of Botswana for supply of Covid-19 vaccine

Moderna announced a supply agreement with the Government of the Republic of Botswana for Moderna's vaccine against Covid-19, to support the government's ongoing efforts to secure access to Covid-19 vaccines for the people of Botswana. The Company also announced that the Botswana Medicines Regulatory Authority (BMRA)

Biotechnology | 06/06/2021 | By Darshana |  198

Glenmark Pharma receives US FDA approval for theophylline ER tablets

Glenmark Pharmaceuticals Limited (Glenmark) has received final approval from the United States Food & Drug Administration (FDA) for theophylline extended release tablets, 300 mg and 450 mg, bioequivalent and therapeutically equivalent to the reference listed drug, theophylline extended release tablets, 300 mg and 450 mg, of Alembic Pharmaceuticals Lmt

Biotechnology | 04/06/2021 | By Darshana |  211

Glenmark Pharma launches generic Banzel tablets

Glenmark Pharmaceuticals has launched rufinamide tablets USP, 200 mg and 400 mg, a therapeutic equivalent of Banzel tablets, 200 mg and 400 mg of Eisai. Glenmark was one of the first ANDA applicants to submit a substantially complete ANDA for rufinamide tablets USP, 200 mg and 400 mg, with a paragraph IV certification and received final approval

Biotechnology | 01/06/2021 | By Darshana |  206

Dyadic enters collaboration with Syngene to develop Covid-19 vaccine

Dyadic International, Inc. (Dyadic), a global biotechnology company, has entered into a collaboration with Syngene International Limited (Syngene), an integrated research, development, and manufacturing services company, to develop a Covid-19 vaccine candidate that can protect against the emerging variants of concern

Biotechnology | 27/05/2021 | By Darshana |  243

Lupin announces achievement of key milestones for its clinical stage MEK inhibitor compound

Global pharma major Lupin Limited announced the achievement of key milestones for Lupin's MEK inhibitor compound (LNP3794) that is planned for development by Boehringer Ingelheim in combination as potential targeted therapy for patients with difficult-to-treat cancers

Biotechnology | 27/05/2021 | By Darshana |  398

Glenmark Pharma receives US FDA approval for generic Firazyr injection

Glenmark Pharmaceuticals Limited has received final approval by the United States Food & Drug Administration (FDA) for icatibant injection, 30 mg/3 mL (10 mg/mL) single-dose prefilled syringe, the generic version of Firazyr injection, 30 mg/3 mL (10 mg/mL) single-dose prefilled syringe, of Shire Human Genetic Therapies, Inc

Biotechnology | 24/05/2021 | By Darshana |  252

MSN Labs launches posaconazole to treat black fungus

MSN Laboratories has launched posaconazole in India under the brand name PosaOne as 100 mg delayed release tablets & 300 mg injections respectively. Posaconazole is a triazole antifungal agent indicated for treating mucormycosis patients

Biotechnology | 21/05/2021 | By Darshana |  231