Industry News

Roche voluntarily withdraws the U.S. indication of Tecentriq (atezolizumab) for the treatment of adults with locally advanced or metastatic urothelial carcinoma, a bladder cancer.

An estimated 81,000 cases of bladder cancer will be diagnosed in the United States in 2022. Urothelial carcinoma, which develops in the cells of the bladder lining, is the most common type of bladder cancer, accounting for about 90% of all cases. In total, 30% of cases are considered advanced based on muscle-invasive or metastatic disease.

Bharat Biotech International Limited a global leader in vaccine innovation and developer of vaccines for infectious diseases, today announced that iNCOVACC® (BBV154), has received approval from the Central Drugs Standard Control Organisation (CDSCO) under Rcstrictcd Use in Emcrgcncy Situation for ages 18 and above, in India, for heterologous booster doses.

AstraZeneca Pharma India has received an import and market permission in Form CT-20 (subsequent new drug approval) from the Central Drugs Standard Control Organisation for Dapagliflozin tablets of 10 mg.

Through this approval, the Company is permitted to deal in Dapagliflozin (Forxiga®) tablets of 10 mg in additional/expanded indication to reduce the risk of sustained eGFR and kidney disease, cardiovascular death and hospitalization for heart failure in adult with chronic kidney disease at risk of progression with condition.

Eli Lilly India has announced the launch of the additional indication for Ramiven (abemaciclib), following approval from The Drug Controller General of India (DCGI) in combination with endocrine therapy for adjuvant treatment in adult patients with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative, node-positive early breast cancer (EBC) at high risk of recurrence.

Antitrust case filed against Dr Reddys Labs in the US over maintaining a shared monopoly in the sale of brand and generic Revlimid through their respective settlements of patent litigation with other pharmaceutical companies.

Dr Reddys Lab along with Celgene, Bristol Myers Squibb and several generic pharmaceutical companies, were named as defendants in a complaint filed on November 18, 2022, in the District of New Jersey, USA.

Amneal Pharmaceuticals, Inc announced the commercial launch of RELEUKO® (filgrastim-ayow), a biosimilar referencing Neupogen®. RELEUKO® is used to treat neutropenia which is commonly experienced by patients undergoing chemotherapy. This product was developed in collaboration with Kashiv Biosciences, LLC located in Chicago, Illinois.

Glenmark Pharmaceuticals Inc., USA (Glenmark) and Glenmark Pharmaceuticals Limited have reached a settlement agreement with Pfizer Inc., PF Prism C.V., and PF Prism IMB B.V. (Pfizer) for Axitinib Tablets, 1 mg and 5 mg, the generic version of their Inlyta®1 Tablets, 1 mg and 5 mg.

Glenmark had previously announced it received tentative approval by the United States Food & Drug Administration (U.S. FDA) for their generic Axitinib Tablets, 1 mg and 5 mg on November 30, 2020.

USFDA has issued Form 483 with 10 observations for the Gundlamachnoor facility of Aurobindo Pharma.

The United States Food and Drug Administration (US FDA) inspected the Company Unit - IX, an intermediate facility situated at Gundlamachnoor Village, Sangareddy District, Telangana, from November 10 to November 18, 2022.

The U.S. Food and Drug Administration approved Tzield (teplizumab-mzwv) injection to delay the onset of stage 3 type 1 diabetes in adults and pediatric patients 8 years and older who currently have stage 2 type 1 diabetes.