Page 12 - Pharmaceutical Firms

Pharma major Glenmark gets USFDA nod for generic ophthalmic solution

Glenmark Pharmaceuticals Ltd on Friday said it has received final approval from the US health regulator for its generic brimonidine tartrate and timolol maleate ophthalmic solution indicated in the treatment increased pressure in the eye caused by glaucoma or other conditions. The final approval by the US Food & Drug Administration (USFDA) is for brimonidine tartrate and timolol maleate ophthalmic solution of strength 0.2 per cent/0.5 per cent, Glenmark said in a statement. The company's brimonidine tartrate and timolol maleate ophthalmic solution, 0.2 per cent/0.5 per cent has been determined by the USFDA to be bioequivalent and therapeutically equivalent to Combigan ophthalmic solution, 0.2 per cent/0.5 per cent of AbbVie, Inc, it added. The solution will be distributed in the US by Glenmark Pharmaceuticals Inc, USA, it added. Combigan ophthalmic solution, 0.2 per cent/0.5 per cent achieved annual sales of approximately USD 290 million, the company said citing IQVIATM sales data

GSK's Shingrix vaccine can prevent shingles for over a decade: Study

Shingles is a painful rash caused by the reactivation of the varicella-zoster virus, the same virus that causes chickenpox. Up to one in three people will develop shingles in their lifetime

Cipla promoters sell 2.53% stake worth Rs 2,637 cr to fund philanthropy

ICICI Prudential MF, Aditya Birla Sun Life MF among top buyers

Granules India Q4 results: Revenue declines 1.6% on weak paracetamol sales

The company's consolidated revenue fell year-on-year to 1,176 crore rupees (nearly $141 million) for the three months to March 31

Zydus Wellness Q4: Net profit up 3.44% to Rs 150 cr, revenue at 782 cr

Zydus Wellness Ltd on Tuesday reported a 3.44 per cent rise in consolidated net profit at Rs 150.3 crore in the fourth quarter ended March 31, 2024. The company had posted a consolidated net profit of Rs 145.3 crore in the same quarter of the previous fiscal, Zydus Wellness said in a regulatory filing. Consolidated total revenue from operations in the quarter under review stood at Rs 782.6 crore, as against Rs 713 crore in the corresponding period a year ago, it said. Total expenses were higher at Rs 632.2 crore in the fourth quarter of financial year 2023-24, as compared to Rs 580.2 crore in the year-ago period. For the fiscal ended March 31, 2024 consolidated net profit was at Rs 266.9 crore, as against Rs 310.4 crore in the previous fiscal, the company said. In FY24, consolidated total revenue from operations stood at Rs 2,327.8 crore, as compared to Rs 2,254.8 crore in FY23. The board of directors at their meeting held on May 14, 2024 recommended a final dividend Rs 5 per equ

Pfizer reaches settlement in over 10,000 cancer lawsuits related to Zantac

Financial terms of the settlements were not immediately disclosed for the discontinued over-the-counter drug that was used to treat heartburn

AstraZeneca to withdraw Covid-19 vaccine Vaxzevria globally on weak demand

AstraZeneca will start the withdrawal of marketing authorisation for the vaccine in Europe

Lupin appoints Jeffrey Kindler, Alfonso 'Chito' Zulueta as independent dirs

Pharma major Lupin Ltd on Thursday announced appointments of ex-Pfizer Chairman and CEO, Jeffrey Kindler and Alfonso 'Chito' Zulueta as independent directors on its board. Kindler is currently the CEO of Centrexion Therapeutics, a privately-held biotechnology company, Senior Advisor to Blackstone, Operating Partner at ARTIS Ventures and Global Chair of GLG Institute, Lupin said in a regulatory filing. He brings over four decades of business experience holding leadership positions at some of the world's most recognised companies, including Pfizer, where he served as Chairman & Chief Executive Officer, as well as McDonald's Corporation and General Electric Company, the company added. Before that, he was a partner at law firm Williams & Connolly. Zulueta currently serves as Non-Executive Chairman of the board of directors of Interpharma Investments Ltd, the holding company of Zuellig Pharma, one of the largest healthcare services groups in Asia, Lupin said. He is also President ..

India raises issue of pharma pricing control in Australia on generic drugs

India has raised the issue of pharmaceutical pricing control in Australia, particularly on generic medicines, during a recent bilateral meeting between the officials of the two countries. The two sides have decided to work closely on timely resolution of market access issues, deepen people-to-people contacts, and create an institutional mechanism for sharing of preferential import data, the commerce ministry said on Saturday. The bilateral trade between the countries declined 7.7 per cent to USD 24 billion in 2023-24 as against USD 26 billion in 2022-23. These issues among others were discussed during the first Joint Committee Meeting (JCM) in Canberra under India-Australia Economic Co-operation and Trade Agreement (Ind-Aus ECTA). "Both the sides while acknowledging the smooth implementation of the ECTA, briefly elaborated on ECTA implementation issues including MRAs (mutual recognition agreements) on organic products, market access issues related to products like okra, pomegranate

AstraZeneca vaccine: From its origin to side effects, all you need to know

Manufactured first in 2021, the AstraZeneca vaccine, known in India as Covishield, has been facing scrutiny over the years, with many countries banning it back in 2021 itself

Uttarakhand suspends licences of 14 products of Ramdev's pharma firms

SC had recently criticised Ramdev for not complying with its directives in an ongoing lawsuit to stop misleading advertisements of some of his traditional ayurvedic medicines

Glenmark Pharma receives USFDA nod for generic anti-inflammatory drug

Glenmark Pharmaceuticals on Monday said it has received approval from the US health regulator to sell a generic version of anti-inflammatory drug in the American market. The company has received approval from the US Food and Drug Administration (USFDA) for Acetaminophen and Ibuprofen tablets (250 mg/125 mg), the Mumbai-based drug maker said in a statement. The company's product is the generic version of Haleon US Holdings, LLC's Advil 2 Dual Action with Acetaminophen Tablets, 250 mg/125 mg (OTC), it added. Glenmark Therapeutics Inc, USA will distribute the drug in the US market, the drug maker said. According to Nielsen syndicated data for the latest 52 weeks period ending March 23, 2024, the Advil Dual Action with Acetaminophen Tablets, 250 mg/125 mg achieved annual sales of around USD 84.1 million. Glenmark said its current portfolio consists of 195 products authorised for distribution in the US marketplace and 52 abbreviated new drug applications (ANDAs) pending approval with

Glenmark Life Sciences Q4 results: Profit dips 33.62% to Rs 97.93 crore

For the fiscal year 2023-2024, Glenmark Life Sciences reported revenue from operations of Rs 2,283.2 crore, marking a growth of 5.6 per cent year-over-year (Y-o-Y)

Glenmark Life Sciences Q4 results: Profit down 33% at Rs 97.9 crore

Revenue from its API business, its biggest, fell 8.6% in the fourth quarter, leading to a nearly 14% fall in its total revenue

Lupin rises over 3% after US FDA approves Mirabegron tablets

The surge came after the United States Food and Drug Administration (US FDA) on April 20, approved the launch of Lupin's Mirabegron extended-release (ER) tablets, 25 mg, in the United States

Biocon partners Biomm SA to commercialise it's diabetes drug in Brazil

Biotechnology firm Biocon on Wednesday said it has tied up with Brazil-based Biomm SA for the commercialisation of its diabetes drug in the Latin American nation. Under the terms of the agreement, Biocon will undertake the development, manufacturing and supply of Semaglutide (gOzempic), and Biomm will be responsible for obtaining regulatory approval and commercialization in the Brazilian market. Biomm focuses on developing, manufacturing and commercialising complex biotech and biosimilar drug products at its production facility in Nova Lima. "Our partnership with Biomm marks another important step forward in our strategy to expand our global footprint beyond the US and Europe for Peptides," Biocon CEO and MD Siddharth Mittal said in a statement. This is also in line with the growth strategy of bringing to market a portfolio of complex, GLP-1 drug-device combination products, he added. "We are confident that our collaboration with Biomm will provide patients in Brazil, who are livi

Anti-ageing tech, 'happiness medicines' to shape healthcare demand: Report

Wearables, anti-ageing hormone therapy, controlled psychedelics among 40 areas that will likely grow, it says

Indian pharmaceutical market registers a growth of 9.5% in March 2024

Moving annual turnover of Rs 1.98 tr between April 2023 and March 2024 marked a 6.5% growth, despite a 1% decrease in domestic market volumes

Sanofi eyes speedy growth in India, plans fast-tracking of product pipeline

Aiming for a "fair share" in the Indian pharmaceutical market, French drug major Sanofi plans to introduce new drugs and enhance localisation while expanding the reach of its existing brands through collaboration with domestic drug firms, according to a top company official. The company plans to enhance its presence in the diabetes segment and grow its consumer healthcare business after spinning it off into a new entity while also looking at local production of its various best-in-class products in India. In an interaction with PTI, Sanofi India Managing Director Rodolfo Hrosz stated that the company has embarked on a mission to prepare for an accelerated growth path in the country. "We believe we're under-represented (in India) and we see a significant opportunity right now and in the future as well. The potential of this market is phenomenal," he said. He further said: "We are seeking the route to be better represented ... with a fair share of the Indian pharmaceutical ...

NPPA revises ceiling prices of 923 scheduled drug formulations from April 1

The formulations in the new revised rate list include essential drugs such as painkillers, antivirals, antibiotics, antimalarials, and drugs for type 2 diabetes