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Alembic Pharmaceuticals Ltd on Friday said it has received tentative approval from the US health regulator for its generic version of cancer treatment drug Binimetinib tablets. The tentative approval by the US Food & Drug Administration (USFDA) is for the Abbreviated New Drug Application (ANDA) of Binimetinib tablets of strength 45 mg, Alembic Pharmaceuticals said in a regulatory filing. Based on USFDA's paragraph IV certifications list, Alembic is the sole first applicant to have filed its ANDA for Binimetinib Tablets, 45mg and upon final approval of this ANDA by the USFDA, the company may be eligible for 180 days of generic marketing exclusivity in the US, the company said. Alembic had previously received tentative approval for Binimetinib Tablets, 15mg, it added. Binimetinib in combination with encorafenib is used for the treatment of patients with unresectable or metastatic melanoma with resistance to specific targeted therapies in cancer. It is also indicated, in combination
A US-based subsidiary of drugmaker Cipla is recalling over 400 cartons of generic anti-cancer medication due to a manufacturing issue, according to the US Food and Drug Administration (USFDA). Warren (New Jersey)-based Cipla USA, Inc is recalling Nilotinib Capsules in two strengths (150 mg and 200 mg), the US health regulator said in its latest Enforcement Report. The company is recalling the affected lot (271 and 164 cartons) due to "failed tablet/capsule specifications", it stated. Cipla USA, Inc initiated the Class III voluntary recall on February 18 this year. According to the USFDA, a Class III recall is initiated in a "situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences". Nilotinib works by blocking the action of the abnormal protein that signals cancer cells to multiply. This helps to stop or slow the spread of cancer cells. India has the highest number of USFDA-compliant pharmaceutical plants outside of the ...
NATCO Pharma on Tuesday announced the launch of generic Pomalidomide capsules indicated for treatment of adult patients with blood and bone marrow cancer in the US market in partnership with Breckenridge Pharmaceutical, Inc. Pomalidomide capsule is a generic version of Pomalyst by Celgene. The product is available in 1mg, 2mg, 3mg, and 4mg strengths and is distributed primarily through specialty pharmacies and clinics, NATCO Pharma said in a regulatory filing. Commenting on the launch, Vice Chairman and CEO Rajeev Nannapaneni said,"...this further strengthens our oncology and specialty portfolio in the US. The launch highlights our commitment to our mission of making specialty medicines accessible to all the patients worldwide." He further said,"We look forward to bringing more such complex and specialty products to the market in the coming years." Breckenridge Pharmaceutical, Inc President and Chief Commercial Officer, Brian Guy said,"Breckenridge's launch of Pomalidomide capsul
Recent changes to the Goods and Services Tax (GST) framework -- simplified tax structure, removal of tax on drugs and medical equipment and increased taxation on tobacco products -- mark an important policy shift towards making cancer care more affordable and accessible, AIIMS researchers have said. In a commentary published in Frontier, Oncologist Dr Abhishek Shankar and Scientist Dr Vaibhav Sahni from the Department of Radiation Oncology, Dr BR Ambedkar Institute Rotary Cancer Hospital, AIIMS, Delhi, noted that the reforms acknowledge the financial toxicity faced by cancer patients and attempt to address long-standing gaps in treatment affordability. The researchers mentioned that the GST council, in its 56th meeting, recommended the total exemption of 33 lifesaving drugs, including those used in cancer care, from GST altogether (erstwhile 12 per cent to now zero and three critical drugs for rare diseases and cancer from 5 per cent earlier to zero). The council has also recommende
AstraZeneca Pharma India Ltd on Tuesday said it has received permission from India's drug regulator to market Durvalumab solution for infusion used in cancer treatment for an additional indication. The company has received permission from the Central Drugs Standard Control Organisation, Directorate General of Health Services, to import for sale and distribution of Durvalumab solution for infusion of strengths 120 mg/2.4 ml and 500 mg/10 ml (brand name Imfinzi) for an additional indication, AstraZeneca Pharma said in a regulatory filing. Through this approval, Durvalumab in combination with carboplatin and paclitaxel is indicated for the first-line treatment of adults with primary advanced or recurrent endometrial cancer who are candidates for systemic therapy, followed by maintenance treatment with Durvalumab as monotherapy in endometrial cancer which is mismatch repair deficient (dMMR). The receipt of this permission paves way for the marketing of Durvalumab solution for infusion 1
Drug firm Natco Pharma on Tuesday said it has received approval from the US health regulator for a generic cancer medication. The company has received tentative approval for Erdafitinib in strengths of 3 mg, 4mg, and 5 mg, the drug firm said in a regulatory filing. The company's product is a generic version of Janssen Biotech Inc's Balversa. Natco said Erdafitinib is indicated for the treatment of adult patients with locally advanced unresectable or metastatic urothelial carcinoma harbouring susceptible FGFR3 genetic alterations. As per the industry sales data, Erdafitinib tablets had estimated sales of around USD 60 million in the US for 12 months ending September 2025. Shares of Natco Pharma were trading 3.39 per cent up at Rs 851.45 apiece on BSE.