Alembic Pharmaceuticals on Monday said it has received the final approval from the US health regulator for its generic Doxorubicin Hydrochloride Liposome injection in different types of cancer. The approval by the US Food & Drug Administration (USFDA) for the abbreviated new drug application (ANDA) is for Doxorubicin Hydrochloride Liposome injection of strengths 20 mg/10 mL (2 mg/mL) and 50 mg/25 mL (2 mg/mL) single-dose vials, Alembic Pharmaceuticals said in a statement. The approved ANDA is therapeutically equivalent to the reference-listed drug product (RLD), Doxil Liposome Injection, 20 mg/10 mL (2 mg/mL) and 50 mg/25 mL (2 mg/mL), of Baxter Healthcare Corporation, it added. Doxorubicin Hydrochloride Liposome Injection is indicated for the treatment of ovarian Cancer, AIDS-Related Kaposi's sarcoma, and multiple myeloma, the company said. Citing IQVIA data, Alembic said Doxorubicin Hydrochloride Liposome injection, 20 mg/10 mL (2 mg/mL) and 50 mg/25 mL (2mg/mL) single-dose ...
Experts believe that the drug still holds potential for future market entry, and the current development should be viewed as a temporary setback
Studies show that widespread HPV vaccination can reduce infection rates by up to 90% and could nearly eliminate cervical cancer in the coming decades
The company is searching for its next blockbuster candidate as its major revenue driver, Keytruda, is expected to lose patent protection by the end of the decade
Glenmark will introduce Brukinsa, a BTK inhibitor developed by BeOne Medicines, in India after DCGI approval to treat five B-cell blood cancers with proven safety and efficacy
In the dose-escalation stage of the trial, 35 patients were treated, most of whom had received a median of six prior therapies
Fact-check Friday: Doctors debunk persistent cancer myths-from sugar and deodorants to breast surgery and mobile phones-that often mislead patients, delay diagnosis, and derail treatment decisions
New research suggests GLP-1 drugs like Ozempic, Wegovy, Mounjaro may lower the risk of several obesity-related cancers, even matching surgery in preventive benefits
Despite NDMA-related cancer concerns and global withdrawals, Indian drug regulators have opted not to suspend Ranitidine, pending further safety review and investigation by a larger expert committee
On an adjusted basis, the company earned $2.77 per share in the quarter, 2.2 per cent higher than the previous year and above analysts' estimates of $2.59 per share
AstraZeneca Pharma India Ltd on Tuesday said it has surrendered the marketing authorisation of prostate cancer treatment drug Olaparib (Lynparza) 100mg and 150mg in India citing commercial reasons. The company had received marketing authorisation for Olaparib film-coated tablets 100mg and 150mg (Lynparza) on November 17, 2023, AstraZeneca Pharma India said in a regulatory filing. It has now surrendered the marketing authorisation of the indication of Olaparib (Lynparza) 100mg and 150mg, the filing added. "...since the date of receipt of marketing authorisation for the said indications i.e. November 17, 2023, till date, we have never marketed the said indication in India," the company said, adding, "the discontinuation decision is only on the basis of commercial reasons and is not due to efficacy or safety reasons." The drug is indicated in combination with Abiraterone and Prednisone or Prednisolone for the treatment of adult patients with metastatic castration-resistant prostate ..
Drug major Cipla on Friday said it has received approval from the US health regulator to market a generic cancer treatment drug. The company has received the final approval from the US Food and Drug Administration (USFDA) for the Abbreviated New Drug Application (ANDA) submitted for paclitaxel protein-bound particles for injectable suspension (albumin-bound), 100 mg/vial, single-dose vial, Cipla said in a regulatory filing. Cipla's protein-bound paclitaxel is a generic therapeutic equivalent version of Bristol Myers Squibb's Abraxane for injectable suspension 100 mg/vial. Protein-bound paclitaxel is indicated for the treatment of metastatic breast cancer, locally advanced or metastatic non-small cell lung cancer and metastatic adenocarcinoma of the pancreas. The product is expected to be launched in the first half of the current fiscal year in the US, the Mumbai-based drugmaker said. Shares of the company were trading 2.73 per cent up at Rs 1,454.90 apiece on the BSE.
Denosumab works by specifically targeting the RANK ligand (RANKL), a critical protein in the lifecycle of osteoclasts, the cells that break down bone
Jobevne works by blocking a protein called VEGF, which helps tumours grow new blood vessels
The drug, vepdegestrant, failed to meaningfully delay cancer progression for all patients enrolled in the study but met its goals for a subset who have a specific genetic mutation
Apollo Hospitals on Tuesday said it has tied up with Ion Beam Applications to introduce proton beam therapy solutions for cancer treatment. The healthcare major has tied up with Ion Beam Applications to introduce the Proteus One system in India. "The addition of Proteus One to our Apollo Proton Cancer Centres further solidifies our position as a global leader in Proton Therapy. This next-generation technology will allow us to achieve superior clinical outcomes and significantly improve the quality of life for cancer patients in India and beyond," Apollo Hospitals Enterprise Founder-Chairman Prathap C Reddy said in a statement. As per the study published in The Lancet Regional Health, worldwide in terms of absolute incidence number, following China and the US, India ranks third, contributing 7.5 per cent of all new cancer incidences and is expected to grow to 1.5 million this year. Ion Beam Applications CEO Olivier Legrain said: "These contracts expand upon the close relationship we
The WHO predicts a global surge in breast cancer cases and deaths. There are several reasons for this concerning tendency. The journal Nature Medicine published the results The WHO predicts a global s
Three in every five people in India succumb to cancer following diagnosis with women bearing a "disproportionate burden" compared to men, an analysis of global cancer data has estimated. The incidence to mortality ratio in the US was found to be about one in four, while in China it was one in two, according to the results published in 'The Lancet Regional Health Southeast Asia' journal. The Indian Council of Medical Research (ICMR) study found that India ranked third highest in cancer incidence, after China and the US, and accounted for over 10 per cent of the world's cancer-related deaths, ranking second after China. Researchers also projected that in the coming two decades, India will face a formidable challenge in managing deaths related to cancer incidence, with a yearly increase of two per cent in cases as the population ages. The team examined trends in 36 types of cancer across age groups and genders in India over the past 20 years, using the Global Cancer Observatory ...
Five of top 20 drug introductions target cancer, reflecting its rising incidence in India
In response to a parliamentary query, the ministry said that the Department of Pharmaceuticals, through the National Pharmaceutical Pricing Authority (NPPA)