Latest news with #Bayer
Indian Express
2 days ago
- Politics
- Indian Express
BKU Dakaunda opposes Punjab's NOC for GM maize trials, warns of agitation
The Bharatiya Kisan Union (BKU) Ekta Dakaunda strongly opposed the no-objection certificate (NOC) issued by the Punjab government to the Punjab Agricultural University (PAU), Ludhiana, for conducting field trials of genetically modified (GM) maize on Monday. This variety of maize is engineered to tolerate glyphosate, a toxic herbicide for which scientific evidence from across the world has shown adverse effects on human health, soil micro-organisms, and the environment. The Punjab government issued a NoC on May 29 for confined field trials of two kinds of GM maize at PAU by Bayer, formerly Monsanto, a German multinational biotechnology company. The union pointed out that the Punjab government had banned the use of glyphosate as early as 2018, thereby acknowledging its harmful impact. 'In a state like Punjab, already grappling with a health crisis, high cancer rates, and environmental degradation, allowing trials of such toxic crops is utterly irresponsible. If the current government has any new safety data regarding glyphosate, it must be made public immediately,' said Jagmohan Singh, state general secretary of the union. The union also raised concerns that out of 11 states approached, only Punjab has granted an NOC to Bayer. 'This raises the question: does the Punjab government possess any special safety data that other states do not? Moreover, PAU's past record on this issue is controversial. During herbicide-tolerant mustard trials, documented biosafety violations—including photographic evidence—had come to light, but no action was taken against the responsible officials. Under such circumstances, how can farmers place their trust?' asked Jagmohan Singh. 'Another serious concern is the absence of any legal protocol in India for assessing herbicide-tolerant crops. Even the Supreme Court's July 2024 ruling on GMOs is yet to be implemented. In this legal vacuum, such trials are not only unjustified but also anti-people and anti-nature. The union demanded clarity on who approved these trials—was it a political decision or merely a bureaucratic one?' asked Jagmohan Singh. BKU Ekta Dakaunda has made several demands from the Punjab government, including immediate withdrawal of the NOC granted for GM maize, public disclosure of all scientific and administrative documents related to the decision, formation of an independent inquiry committee to investigate the hidden reasons behind this decision, strong policy decisions to keep Punjab's agriculture free from GM crops and toxic chemicals and development and testing of new seeds transparently by PAU in consultation with farmers. 'Adding to the gravity of the issue is Punjab's 2018 executive order prohibiting the use of glyphosate across the state. The ban was based on recommendations from the Central Insecticide Board and Registration Committee, which allows glyphosate only in tea plantations and non-cropped areas—conditions not applicable to Punjab, where nearly 100 per cent of the agricultural land is under cultivation,' said Jagmohan Singh. 'The state's prohibition order also cited scientific findings that link glyphosate to cancer and DNA damage, drawing on expert opinions from institutions like the Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh,' said Jagmohan Singh, adding that if government possesses new safety data that overrides the scientific concerns and policy decisions made earlier, it must be made public immediately. Boota Singh Burjgill, state president, said BKU Dakaunda reiterated its firm opposition to GM crops and chemical-based farming and pledged to continue its struggle to protect Punjab's farmers, soil, and future generations.
ITV News
4 days ago
- Business
- ITV News
UK-India trade deal sparks fears over access to cheap medicines for millions
A newly signed trade agreement between India and the UK has triggered concerns that millions of poor Indians may lose access to affordable life-saving medicines. Civil society groups and health experts say the UK-India Free Trade Agreement (FTA), finalised between two countries, tilts the balance in favour of multinational pharmaceutical corporations and threatens to erode long-standing protections that have allowed India to produce low-cost generic drugs. 'This is not just about trade. It's about whether a person living on ₹200 (£2) a day can afford cancer treatment or survive tuberculosis,' said Jyotsna Singh, co-convenor of the Working Group on Access to Medicines and Treatments. At the heart of the controversy are the agreement's intellectual property (IP) provisions, which activists say may restrict the Indian government's ability to issue compulsory licences—legal tools that allow domestic companies to manufacture patented drugs at reduced prices during public health emergencies. India used this provision in 2012 to dramatically cut the price of sorafenib, a cancer drug sold by Bayer under the brand Nexavar. Generic versions slashed the monthly cost by nearly 97%, from ₹2.8 lakh (£2,600) to around ₹8,800 (£80), making it affordable to thousands. 'By discouraging compulsory licensing and promoting voluntary licences, the deal hands over control of access to medicines to the market,' said Prof Biswajit Dhar, a trade expert and former professor at New Delhi's Jawaharlal Nehru University. 'Voluntary licences often come with strings attached and don't bring the same price reductions.' Weakening India's Patent Safeguards Under the FTA, companies will no longer need to report annually how their patents are being 'worked'—or used—in India. Instead, disclosures can be made every three years, and some information can be kept confidential. Activists say this undermines transparency and makes it harder to prove that a drug isn't available to the public, a key step in applying for a compulsory licence. There are also concerns the deal could open the door to 'evergreening'—a tactic in which companies make minor changes to existing drugs and claim new patents. Indian law currently limits this practice under Section 3(d) of the Patents Act, but experts warn the FTA's emphasis on 'harmonisation' of IP standards with Western countries could override such protections. 'This is effectively a backdoor entry for TRIPS-plus provisions,' said K.M. Gopakumar, co-convenor of the Working Group. 'It would push India to grant unnecessary patents, prolonging monopolies and delaying cheaper alternatives.' The Indian pharmaceutical industry supplies more than 60% of global vaccines and a significant share of affordable generics to low- and middle-income countries. Critics say the FTA may limit this capacity and ultimately have consequences well beyond India's borders. Government response The Indian government has promoted the FTA as a landmark deal that will boost exports and attract UK investment in manufacturing, services, and digital trade. Officials insist that India has preserved its ability to protect public health. But rights groups remain unconvinced. 'You cannot negotiate away access to life-saving drugs in the name of free trade,' said Gargeya Telakapalli, a public health campaigner based in Hyderabad. 'The poorest Indians—those with cancer, HIV, diabetes, or TB—are being quietly sacrificed.' Broader implications The deal follows a similar agreement India signed last year with the European Free Trade Association (EFTA), which also faced criticism for diluting IP safeguards. Observers say the trend may reflect a shift in India's trade policy as it seeks closer ties with Western economies. But for many in India's healthcare and legal communities, the question remains: how much access to medicine is the country willing to give up for a better trade balance? From Westminster to Washington DC - our political experts are across all the latest key talking points. Listen to the latest episode below...
Reuters
4 days ago
- Health
- Reuters
US FDA extends review of Bayer's menopause relief drug
July 25 (Reuters) - The U.S. Food and Drug Administration has extended its review of Bayer's ( opens new tab experimental menopause relief drug, the German drugmaker said on Friday. The non-hormonal treatment, elinzanetant, is being reviewed for relieving moderate to severe vasomotor symptoms, also known as hot flashes, associated with menopause. The FDA has extended the review by up to 90 days and did not raise any concern regarding the general approvability of the drug, Bayer said. The drug, branded as Lynkuet, is approved in the United Kingdom and Canada.
Yahoo
4 days ago
- Health
- Yahoo
Bayer Provides Regulatory Update on Elinzanetant for the Treatment of Moderate to Severe Hot Flashes Due to Menopause
WHIPPANY, N.J., July 25, 2025--(BUSINESS WIRE)--Bayer today announced that the U.S. Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) for elinzanetant. Elinzanetant is the first neurokinin 1 and neurokinin 3 receptor antagonist in late-stage clinical development for the hormone-free treatment of moderate to severe vasomotor symptoms (VMS) due to menopause. The FDA has determined additional time is needed for a full review of the NDA submission, including information provided to support the application. The extension to the Prescription Drug User Fee Act (PDUFA) review period is up to 90 days. The FDA did not raise any concern regarding the general approvability of elinzanetant in its correspondence. "We are confident in the potential of elinzanetant to provide meaningful clinical benefit to women pending regulatory approval," said Yesmean Wahdan, M.D., Senior Vice President and Head of Medical Affairs, North America, Pharmaceuticals. "We continue to work with the FDA to make this treatment available for women in menopause with moderate to severe hot flashes. Despite the universal experience of menopause, social stigma and misinformation persist, leaving many women to suffer without treatment and support. It's critical we advance innovation and education in menopause so women can work with their healthcare provider to determine the best option for them." The NDA is based on the positive results from the OASIS 1, 2 and 3 Phase III studies evaluating the efficacy and safety of the investigational compound elinzanetant versus placebo. Results from OASIS 1 and 2 were published in August 2024 in The Journal of the American Medical Association (JAMA). Detailed results of the Phase III study OASIS 3 providing supporting efficacy and additional long-term safety data were presented at The Menopause Society (TMS) annual meeting in September 2024. In the last 30 days, elinzanetant was approved under the brand name Lynkuet™ in the United Kingdom and Canada. Submissions for marketing authorizations for elinzanetant are also ongoing in the EU and other markets around the world. About Women's Healthcare at BayerWomen's Health is in Bayer's DNA. As a global leader in women's healthcare, Bayer has a long-standing commitment to delivering science for a better life by advancing a portfolio of innovative treatments. Bayer offers a wide range of effective short- and long-acting birth control methods as well as therapies for menopause management and gynecological diseases. Bayer is also focusing on innovative options to address the unmet medical needs of women worldwide and to broadening treatment choices such as in menopause. Additionally, Bayer intends to provide 100 million women per year in low- and middle- income countries by 2030 with access to family planning by funding multi-stakeholder aid programs for capacity building and by ensuring the supply of affordable modern contraceptives. This is part of the comprehensive sustainability measures and commitments from 2020 onwards and in line with the Sustainable Development Goals of the United Nations. About BayerBayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, "Health for all, Hunger for none," the company's products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2024, the Group employed around 93,000 people and had sales of 46.6 billion euros. R&D expenses before special items amounted to 6.2 billion euros. For more information, go to Find more information at Follow us on Facebook: Follow us on X: @BayerPharma Forward-Looking StatementsThis release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer website at The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments. View source version on Contacts Media Contact: Colleen Murphy+1 Sign in to access your portfolio
Business Wire
4 days ago
- Health
- Business Wire
Bayer Provides Regulatory Update on Elinzanetant for the Treatment of Moderate to Severe Hot Flashes Due to Menopause
WHIPPANY, N.J.--(BUSINESS WIRE)--Bayer today announced that the U.S. Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) for elinzanetant. Elinzanetant is the first neurokinin 1 and neurokinin 3 receptor antagonist in late-stage clinical development for the hormone-free treatment of moderate to severe vasomotor symptoms (VMS) due to menopause. The FDA has determined additional time is needed for a full review of the NDA submission, including information provided to support the application. The extension to the Prescription Drug User Fee Act (PDUFA) review period is up to 90 days. The FDA did not raise any concern regarding the general approvability of elinzanetant in its correspondence. 'We are confident in the potential of elinzanetant to provide meaningful clinical benefit to women pending regulatory approval,' said Yesmean Wahdan, M.D., Senior Vice President and Head of Medical Affairs, North America, Pharmaceuticals. 'We continue to work with the FDA to make this treatment available for women in menopause with moderate to severe hot flashes. Despite the universal experience of menopause, social stigma and misinformation persist, leaving many women to suffer without treatment and support. It's critical we advance innovation and education in menopause so women can work with their healthcare provider to determine the best option for them.' The NDA is based on the positive results from the OASIS 1, 2 and 3 Phase III studies evaluating the efficacy and safety of the investigational compound elinzanetant versus placebo. Results from OASIS 1 and 2 were published in August 2024 in The Journal of the American Medical Association (JAMA). Detailed results of the Phase III study OASIS 3 providing supporting efficacy and additional long-term safety data were presented at The Menopause Society (TMS) annual meeting in September 2024. In the last 30 days, elinzanetant was approved under the brand name Lynkuet™ in the United Kingdom and Canada. Submissions for marketing authorizations for elinzanetant are also ongoing in the EU and other markets around the world. About Women's Healthcare at Bayer Women's Health is in Bayer's DNA. As a global leader in women's healthcare, Bayer has a long-standing commitment to delivering science for a better life by advancing a portfolio of innovative treatments. Bayer offers a wide range of effective short- and long-acting birth control methods as well as therapies for menopause management and gynecological diseases. Bayer is also focusing on innovative options to address the unmet medical needs of women worldwide and to broadening treatment choices such as in menopause. Additionally, Bayer intends to provide 100 million women per year in low- and middle- income countries by 2030 with access to family planning by funding multi-stakeholder aid programs for capacity building and by ensuring the supply of affordable modern contraceptives. This is part of the comprehensive sustainability measures and commitments from 2020 onwards and in line with the Sustainable Development Goals of the United Nations. About Bayer Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, 'Health for all, Hunger for none,' the company's products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2024, the Group employed around 93,000 people and had sales of 46.6 billion euros. R&D expenses before special items amounted to 6.2 billion euros. For more information, go to Forward-Looking Statements This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer website at The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
