Drug

India's TB programme: Low cost generics of J&J's MDR-TB drug on the anvil

Indian Patent Office's decision on J&J's bedaquiline came on the eve of World Tuberculosis Day, marked on March 24 every year, to raise public awareness & to boost efforts to end the TB epidemic

Motivate youth for drug-free state, says Himachal Pradesh Governor

During a courtesy call on the Governor at Raj Bhavan here, the Governor asked him to actively contribute in the campaign for a drug-free Himachal Pradesh

Drug firm Glenmark gets USFDA nod for generic diabetes drug to market in US

Drug firm Glenmark said it has received approval from the US health regulator to market a generic medication to treat diabetes in the American market. Glenmark Pharmaceuticals Inc, USA, a unit of the company, has received tentative approval from the US Food & Drug Administration (US FDA) for Saxagliptin Tablets in strengths of 2.5 mg and 5 mg, the Mumbai-based drug maker said in a statement. The company's product is the generic version of AstraZeneca AB's Onglyza tablets (2.5 mg and 5 mg), it added. According to IQVIA sales data for the 12-month period ending December 2022, the Onglyza tablets (2.5 mg and 5 mg) achieved annual sales of around USD 122.3 million. Glenmark said its current portfolio consists of 179 products authorised for distribution in the US marketplace. The drug firm has 46 abbreviated new drug applications (ANDAs) pending approval with the USFDA, it added. In addition to these internal filings, Glenmark continues to identify and explore external development ...

Lupin Pharma's US-based arm recalls blood pressure tablets in US market

Pharmaceuticals firm Lupin Ltd on Thursday said its US-based arm is recalling four lots of Quinapril tablets used to treat high blood pressure due to the presence of a nitrosamine impurity. Lupin Pharmaceuticals Inc, the company's wholly-owned arm, is recalling the said tablets due to the presence of a nitrosamine impurity, N-Nitroso-Quinapril, observed in recent testing above the acceptable daily intake (ADI) level, Lupin Ltd said in a regulatory filing. "To date, Lupin has received no reports of illness that appear to relate to this issue," it said, adding it discontinued marketing of Quinapril tablets in September 2022. Quinapril tablets of strengths 20mg and 40mg packaged in separate 90 count bottles were distributed nationwide in the US to wholesalers, drug chains, mail order pharmacies and supermarkets, it added. The filing further said Lupin Pharmaceuticals Inc is notifying its wholesalers, distributors, drug chains, mail order pharmacies and supermarkets by phone and throug

Seizure of high-value drugs rises manifold to 310 kg in FY22: DRI report

High-value drugs like cocaine, methamphetamine and heroin have witnessed record seizures by revenue intelligence officers in the last fiscal, according to a report by the Directorate Revenue Intelligence. Signalling a disturbing trend, the figures revealed that the seizure of highly addictive party drug cocaine has shot up 36-fold to 310 kg in 2021-22 from 8.7 kg in 2020-21 and just 1.1 kg in 2019-20. Another high-value party drug methamphetamine saw a 14-fold increase in seizures by DRI officers at 884.69 kg in 2021-22, up from 64.39 kg in 2020-21. Besides, 3,410.71 kg of heroin, a highly addictive opioid drug, was seized in 2021-22, up 17-fold from the previous fiscal. Of this, 2,988 kg was seized at Mundra port in 2021-22. In 2020-21 and 2019-20, 202 kg and 143 kg of heroin were seized by the DRI officers across the country. According to the DRI report, two key trends have been observed in drug smuggling in recent times. These are the trafficking of heroin via trade routes, ...

Orchid Pharma antibiotic product for treating UTI coming to India: MD

Company says it's returning to profit after takeover by Dhanuka Laboratories under insolvency resolution

World's most expensive drug approved to treat hemophilia at $3.5 mn a dose

CSL Behring's Hemgenix, administered just once, cut the number of bleeding events expected over the course of a year by 54%, a key study of the therapy found

Drug reactions can be life-threatening; not to be neglected: KGMU doctors

Rashes that do not itch, swollen eyes, burning sensation in lips and sore throat could be symptoms of severe adverse drug reaction (ADR)

Largest Ibuprofen API maker eyes double revenue in next four years

As part of de-risking their business, they have started reducing the share of ibuprofen in their overall turnover, and add more popular products to the portfolio

FDA panel backs much-debated experimental ALS drug in rare second review

A panel of federal health advisers have voted to recommend approval for an experimental drug to treat Lou Gehrig's disease, a remarkable turnaround for the much-debated medication that was previously rejected by the same group earlier this year. The Food and Drug Administration advisers voted 7-2 that data from Amylyx Pharma warranted approval, despite hours of debate about the strength and reliability of the company's lone study. The FDA is not required to follow the group's advice, but its positive recommendation suggests an approval is likely later this month. The FDA has approved only two therapies for the disease, amyotrophic lateral sclerosis, or ALS, which destroys nerve cells needed for basic functions like walking, talking and swallowing. ALS patients and their families have rallied behind Amylyx's drug, launching an aggressive lobbying campaign and enlisting members of Congress to push the FDA to grant approval. Despite a negative review published by FDA's internal ...

Specialty drugs may push Sun Pharma's US biz beyond $2 bn by 2025

The share of specialty medicines in overall pharmaceutical spending has been consistently increasing over the past decade, from 22 per cent in 2011 to 39 per cent in 2021

Sun Pharma Q1 net up 43% to Rs 2,061 crore on specialty sales, India biz

Gross sales up 10.1% YoY to Rs 10,644 cr; EBITDA at Rs 2,884.4 cr, with a margin of 26.8%

CBI arrests Jt Drug Controller, Biocon Biologics execs over fishy approvals

All five apprehended will be presented in court on Tuesday afternoon, agency to seek police custody

Glenmark Pharma launches first FDC drug Indamet for asthma patients

Glenmark Pharmaceuticals on Thursday said it has launched a novel fixed-dose combination (FDC) drug in the country for patients with uncontrolled asthma. The Mumbai-based drug major has launched - Indacaterol + Mometasone FDC under the brand name Indamet. The drug will be available in three strengths with a fixed dose of Indacaterol 150 mcg and variable doses of Mometasone 80 mcg, 160 mcg and 320 mcg to be taken once daily. "Respiratory is a key focus area for Glenmark, and the company leads from the front in providing access to the latest treatment options to patients. "We are proud to introduce this novel fixed-dose combination Indamet, which is the first of its kind in India, offering an affordable treatment option to both adults and adolescents 12 years of age and older suffering from uncontrolled asthma," Glenmark Pharmaceuticals Group Vice President & Head (India Formulations) Alok Malik said in a statement. The drug maker is the first company in India to market the FDC of .

Pfizer to offer all its drugs not-for-profit to 45 lower-income countries

Pfizer has announced it is to supply all its current and future patent-protected medicines and vaccines on a not-for-profit basis to 45 lower-income countries and is talking to other big drugmakers

Telangana police to set up special cell to check drug menace

The Chief Minister held a review meeting in this regard with Chief Secretary

US drug overdose deaths over 1 million over past 20 years: Report

Deaths due to drug overdose have topped a million over past 20 years, U.S. broadcaster NPR reported on Thursday, citing statistics from the Centers for Disease Control and Prevention (CDC)

Centre forms 8-member panel for new Drugs, Cosmetics, Medical Devices Act

Committee will frame draft Bill and submit it by November 30

Oral drug to treat 'black fungus' ready for tech transfer: IIT Hyderabad

: Researchers at Indian Institute of Technology, Hyderabad, have developed an oral solution to treat Black Fungus (Mucormycosis) and other fungus and are ready to transfer the technology to take it forward, the premier institute said.

Delhi HC directs Google to remove verdict acquitting man in drug case

The Delhi High Court has directed online search engine Google to remove links to a judgement acquitting an Indian origin American citizen of drug charges