Page 24 - Pharma Sector

Piramal Pharma Q4 profit Jumps 102% to Rs 101.3 cr, FY24 revenue Up 18%

On a sequential basis, the company's profit jumped more than nine-fold

US drug regulator delaying decision on RSV vaccine approval, says Moderna

The FDA hasn't informed Moderna of any issues related to vaccine safety, efficacy or quality that would prevent approval, Moderna said Friday in a statement

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 ..

Cipla Q4 Results Preview: Profits may jump up to 75% on higher volumes

Cipla may show a 3-10 per cent jump in its topline year-on-year (Y-o-Y), registering revenues in the range of Rs 5,939 crore and Rs 6,292 crore

USFDA issues Form 483 with 1 inspectional observation to Cipla's Maha unit

Pharma major Cipla Ltd on Wednesday said it has received one inspectional observation in Form 483 from the US health regulator for its manufacturing facility at Kurkumbh in Maharashtra. As per the US Food and Drug Administration (USFDA), Form 483 is issued to a firm's management at the conclusion of an inspection when the investigator has observed any conditions that may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts. A routine current Good Manufacturing Practices (cGMP) inspection was conducted by the USFDA at the company's manufacturing facility at Kurkumbh, Maharashtra from April 29, 2024, to May 8, 2024, Cipla said in a regulatory filing. "On conclusion of the inspection, the company has received one inspectional observation in Form 483," it added. The company will work closely with the USFDA and is committed to addressing this observation comprehensively within the stipulated time, Cipla said.

Dr Reddy's Labs Q4 profit jumps 36% led by US growth, new products

During the quarter, the company launched 5 new products, of which 4 were launched in the US. A total of 21 products were launched during the year

Lupin Q4 result: Net profit up 52% at Rs 359 cr, revenue from ops rises 12%

'Our US sales remain healthy driven by inhalation products, and our India formulation business is delivering ahead of market,' said Nilesh Gupta, MDirector, Lupin

The absence of a quality mindset

Policymakers and the corporate sector need to understand that without adopting global quality standards, India cannot become a global manufacturing hub

India, New Zealand look to boost collaboration in pharma, digital trade

India and New Zealand are looking to increase collaboration in goods and services sectors like pharmaceuticals, digital trade, and cross-border payment systems to promote bilateral trade. Issues to promote trade through these collaborations were discussed during the recent visit of Commerce Secretary Sunil Barthwal to New Zealand from April 26-27. The commerce ministry said that huge potential is there in both economies to further promote bilateral trade. "The meetings reviewed progress on market access issues, economic cooperation projects and explored opportunities for new initiatives," it said. Both sides discussed the establishment of robust bilateral economic dialogue architecture and the creation of working groups in sectors like Agriculture, Food Processing, Storage and Transportation, Forestry and Pharmaceuticals to facilitate ongoing collaboration on key trade and economic issues. Deliberations also included increasing cooperation in kiwi fruit as well as the dairy ...

Online pharmacy PharmEasy raises $216 million at a 90% cut in valuation

According to a report, the Mumbai-based firm has also been trying to raise Rs 3,500 crore since August 2023 to repay the debt it took from Goldman Sachs

India becoming attractive for clinical trials, says pharma industry leaders

Over the past 10 years, clinical trials in India have become easier, more accessible and accelerated, experts from the pharma sector have said as top multinationals are increasingly looking at the country as their base for clinical trials. Data from 2017 to 2023 shows that phase two and phase three clinical trials are growing at about 15 per cent to 18 per cent in India. This is primarily because of the 10 modifications done to the Drugs and Cosmetics Act of 1940, according to Badhri Srinivasan, head of Global Clinical Operations, Novartis. Novartis is one of the largest pharmaceutical companies in the world and was the fourth largest by revenue in 2022. Given where we are, given what the landscape in the international community has happened, the regulators in India are starting to move and make changes to it. Since 2013, there have been 10 modifications to that act to try to make clinical trials easier, more accelerated, more accessible, et cetera, Srinivasan said at the 18th Annua

Pharma exports rise around 10% to $27.9 billion, US biggest importer

The country's drugs and pharmaceuticals exports increased 9.67 per cent year-on-year to USD 27.9 billion in 2023-24, even as the total exports dipped by 3 per cent in the last fiscal. According to the commerce ministry data, pharma exports in March grew by 12.73 per cent to USD 2.8 billion. In 2022-23, the exports stood at USD 25.4 billion. The top five export markets, for the sector during the last fiscal, are the US, the UK, the Netherlands, the United Kingdom, South Africa and Brazil. The US accounts for over 31 per cent of India's total pharma exports, followed by the UK and Netherlands (about 3 per cent each). In 2023-24, the outbound shipments also entered new geographies like Montenegro, South Sudan, Chad, Comoros, Brunei, Latvia, Ireland, Chad, Sweden, Haiti and Ethiopia. An industry expert said that increasing market opportunities and healthy demand in countries like the US are helping exports to record healthy growth rates month after month. Experts have said that Indi

Zydus Lifesciences unit gets 10 observations from USFDA after inspection

Zydus Lifesciences on Wednesday said the US health regulator has issued ten observations after inspecting its injectable manufacturing plant near Vadodara in Gujarat. The US Food and Drug Administration (USFDA) inspected the facility at Jarod near Vadodara from April 15 to April 23, the drug maker said in a regulatory filing. The inspection closed with ten observations, it added. The company will closely work with the USFDA to address and respond to the observations in an expeditious manner, Zydus Lifesciences said. Shares of the company were trading 2.79 per cent down at Rs 932.80 apiece on the BSE.

Zydus Lifesciences gets China nod for drug to treat CKD-linked anaemia

It is estimated that more than 120 million people are living with chronic kidney disease in China

Entod Pharma receives CDSCO approval to commercialise presbyopia treatment

The company had completed the development of these eye drops in late 2022, after which it was subjected to clinical testing in India

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

Here are some potential risks, benefits of weight-loss drugs like Ozempic

As they've grown in popularity, we've also heard more about the potential side effects - from common gastrointestinal discomforts, to more serious mental health concerns

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 ...

Prices of essential medicines will not be increased in FY25: Mandaviya

Union Minister Mansukh Mandaviya said on Thursday said there will be no increase in prices of essential medicines this fiscal year in view of negligible growth in wholesale price-based inflation. In an interaction with PTI editors at the news agency's headquarters here, Mandaviya -- the Union Chemicals and Fertilisers Minister -- assured that this is "Modiji's guarantee". When asked about reports and speculations of hike in rates of essential drugs, he said, "It is absolutely incorrect. There will be no increase in the price of medicines". The minister said the National Pharmaceutical Pricing Authority (NPPA), which is under the Department of Pharmaceuticals, annually revises the ceiling prices of scheduled medicines on the basis of Wholesale Price Index (WPI). "NPPA monitors and fixes the prices of essential medicines based on WPI," Mandaviya said. When inflation rises, it leads to a hike in prices and when it goes down, the prices come down, the minister said. "This year the ..

Aurobindo's Eugia recalls pain-relieving injection Methocarbamol in US

The recall comes after a consumer complained about possible contamination