Aurobindo Pharma arm's biosimilar gets marketing nod from U.K.'s MHRA
Aurobindo Pharma subsidiary CuraTeQ Biologics s.r.o. has received marketing authorisation for Zefylti, its filgrastim biosimilar version, from Medicines and Healthcare products Regulatory Agency (MHRA) of the U.K.
In February 2025, Zefylti had received the marketing authorisation in the European Union from the European Commission (EC). This is CuraTeQ's second biosimilar to be approved by MHRA. Bevqolva was the first in December 2024, Aurobindo Pharma said in a filing on Tuesday.
In December, announcing receipt of positive opinion for Zefylti from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), the company had said the product is intended for the treatment of neutropenia and the mobilisation of peripheral progenitor cells (PBPCs).
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First Post
7 days ago
- First Post
40 women using weight-loss drugs see unexpected pregnancies; prompt UK's warning over contraceptives
The weight loss drugs, by mimicking gut hormones, effectively reduce appetite and promote weight loss, which can in turn boost fertility in women with obesity read more There have been at least 40 cases of unexpected pregnancies associated with weight loss drugs. Pixabay British health authorities have issued a warning to women using weight-loss medications such as Ozempic, Wegovy and Mounjaro, urging them to use effective contraception after dozens of pregnancy reports linked to the drugs. The Medicines and Healthcare products Regulatory Agency (MHRA) on Friday (May 6) released its first public safety alert addressing the use of weight-loss drugs and contraception. The agency said it had received 40 reports of pregnancies involving users of medications that include the active ingredients semaglutide or tirzepatide, The Guardian reported. STORY CONTINUES BELOW THIS AD Ozempic and Wegovy, which both contain semaglutide, mimic a gut hormone called GLP-1 that helps reduce appetite by slowing digestion and increasing insulin production. Mounjaro, which contains tirzepatide, also targets a second hormone involved in blood sugar and appetite control. Though often referred to as 'weight-loss injections,' not all of the drugs are formally authorised for weight loss. Drugs not advised during pregnancy or attempts to conceive The MHRA said the drugs should not be taken during pregnancy, while trying to conceive, or while breastfeeding due to a lack of safety data. In some cases, the agency recommends that women continue contraception for up to two months after stopping the medication before attempting pregnancy. Among the 40 reports, eight were associated with semaglutide and nine with liraglutide, which is found in the weight-loss drug Saxenda. Two cases were explicitly reported as unintended pregnancies. Dr. Channa Jayasena, a reproductive endocrinologist at Imperial College Healthcare NHS Trust, said the drugs, by mimicking gut hormones, effectively reduce appetite and promote weight loss, which can in turn boost fertility in women with obesity. 'Obesity reduces fertility in women. So, women with obesity taking GLP-1 drugs are more likely to get pregnant than before they lost weight,' he said. He also noted that the medications may interfere with the absorption of oral contraceptives due to delayed stomach emptying, although further research is needed. Officials stress responsible use Dr. Alison Cave, the MHRA's chief safety officer, warned that the medications should not be used as quick fixes for weight loss or for cosmetic purposes. 'Skinny jabs are medicines licensed to treat specific medical conditions and should not be used as aesthetic or cosmetic treatments,' Cave said. 'They are not a quick fix to lose weight and have not been assessed to be safe when used in this way.' The MHRA said it has published updated guidance to help patients use the medications safely but emphasized that the advice should not replace consultation with a healthcare provider. STORY CONTINUES BELOW THIS AD Dr. Jayasena added that while the risks of GLP-1 drugs in pregnancy are not fully known, similar weight-loss interventions like surgery have been associated with higher miscarriage rates. 'So women are advised to do all they can to prevent pregnancy while taking GLP-1 drugs,' he said.
India Today
05-06-2025
- India Today
UK watchdog warns of pregnancy risks linked to weight-loss drugs
Women are being advised to use effective contraception while on these medications. () UK health authorities recently cautioned against weight-loss drugs during pregnancy Mounjaro may reduce effectiveness of oral contraceptives Serious risks include acute pancreatitis with severe stomach pain Women using popular weight-loss and diabetes injections, also called "skinny jabs" are being warned to take extra care with contraception and pregnancy plans in the UK. Health authorities say these medicines should not be taken if you're pregnant, planning to get pregnant, or breastfeeding. If someone becomes pregnant while on these medicines, they should speak to a doctor immediately and stop using the medicine. This warning comes from the UK's Medicines and Healthcare products Regulatory Agency (MHRA) and includes well-known medicines like Ozempic, Mounjaro, Wegovy, Saxenda and Victoza. These drugs are known as GLP-1 receptor agonists, which help reduce hunger and control blood sugar levels by copying a natural hormone released after eating. Some newer medicines like Mounjaro act on a second hormone that also helps with appetite and blood sugar control. While they are approved for treating type 2 diabetes, and in some cases for weight loss, they are not meant for cosmetic or quick weight-loss purposes. The MHRA said Mounjaro may reduce the effectiveness of oral contraceptives such as the pill in people who are overweight, and that women taking the medication should use barrier contraceptives such as condoms, according to a report in The Guardian. The UK watchdog said it had received 26 pregnancy-related reports for Mounjaro. "These are powerful medications meant to treat serious medical conditions. They should not be used casually or bought from unregulated sources like beauty salons or social media," said Dr Alison Cave, Chief Safety Officer at MHRA. Women are being advised to use effective contraception while on these medications and in some cases for up to two months after stopping them. This is because there isn't enough data to confirm if these drugs are safe for the baby during pregnancy. Forms of contraception include: Oral contraceptives (the pill) Non-oral methods like condoms, the coil, or implants However, Mounjaro may reduce the effectiveness of oral contraceptives in people who are overweight. That means women using Mounjaro should also use a non-oral method of contraception, especially in the first four weeks of treatment or after a dose increase. Another rare but serious risk of GLP-1 medicines is acute pancreatitis, which is inflammation of the pancreas. A warning sign of this is severe stomach pain that moves to the back and doesn't go away. Anyone who feels this should get emergency medical help. The MHRA also reminds users: These medicines must be prescribed by a healthcare professional. Do not buy them online or from beauty clinics, it is illegal and dangerous. Talk to your doctor before starting the medicine to understand risks and benefits. Let your doctor know if you're using one of these medicines before any surgery. Report any side effects through the Yellow Card scheme, which collects safety information on medicines in the UK. The watchdog also warned against extracting leftover medicine from used syringes. Dispose of them safely after completing the recommended doses, the statement read. These reminders come amid rising concerns that many people may be misusing these injections without knowing the full risks, especially women who may become pregnant. Staying informed and cautious is key to using these medicines safely. Women using popular weight-loss and diabetes injections, also called "skinny jabs" are being warned to take extra care with contraception and pregnancy plans in the UK. Health authorities say these medicines should not be taken if you're pregnant, planning to get pregnant, or breastfeeding. If someone becomes pregnant while on these medicines, they should speak to a doctor immediately and stop using the medicine. This warning comes from the UK's Medicines and Healthcare products Regulatory Agency (MHRA) and includes well-known medicines like Ozempic, Mounjaro, Wegovy, Saxenda and Victoza. These drugs are known as GLP-1 receptor agonists, which help reduce hunger and control blood sugar levels by copying a natural hormone released after eating. Some newer medicines like Mounjaro act on a second hormone that also helps with appetite and blood sugar control. While they are approved for treating type 2 diabetes, and in some cases for weight loss, they are not meant for cosmetic or quick weight-loss purposes. The MHRA said Mounjaro may reduce the effectiveness of oral contraceptives such as the pill in people who are overweight, and that women taking the medication should use barrier contraceptives such as condoms, according to a report in The Guardian. The UK watchdog said it had received 26 pregnancy-related reports for Mounjaro. "These are powerful medications meant to treat serious medical conditions. They should not be used casually or bought from unregulated sources like beauty salons or social media," said Dr Alison Cave, Chief Safety Officer at MHRA. Women are being advised to use effective contraception while on these medications and in some cases for up to two months after stopping them. This is because there isn't enough data to confirm if these drugs are safe for the baby during pregnancy. Forms of contraception include: Oral contraceptives (the pill) Non-oral methods like condoms, the coil, or implants However, Mounjaro may reduce the effectiveness of oral contraceptives in people who are overweight. That means women using Mounjaro should also use a non-oral method of contraception, especially in the first four weeks of treatment or after a dose increase. Another rare but serious risk of GLP-1 medicines is acute pancreatitis, which is inflammation of the pancreas. A warning sign of this is severe stomach pain that moves to the back and doesn't go away. Anyone who feels this should get emergency medical help. The MHRA also reminds users: These medicines must be prescribed by a healthcare professional. Do not buy them online or from beauty clinics, it is illegal and dangerous. Talk to your doctor before starting the medicine to understand risks and benefits. Let your doctor know if you're using one of these medicines before any surgery. Report any side effects through the Yellow Card scheme, which collects safety information on medicines in the UK. The watchdog also warned against extracting leftover medicine from used syringes. Dispose of them safely after completing the recommended doses, the statement read. These reminders come amid rising concerns that many people may be misusing these injections without knowing the full risks, especially women who may become pregnant. Staying informed and cautious is key to using these medicines safely. Join our WhatsApp Channel
Time of India
05-06-2025
- Time of India
API prices fall sharply, easing pressure on India's pharmaceutical industry
India's pharmaceutical industry is experiencing relief as active pharmaceutical ingredient (API) prices plummet due to overcapacity and aggressive pricing strategies from Chinese suppliers. Increased domestic API production, driven by government incentives and reduced raw material costs, further contribute to the decline. This trend is expected to continue, boosting profit margins for Indian pharma companies. Tired of too many ads? Remove Ads Tired of too many ads? Remove Ads New Delhi: Prices of active pharmaceutical ingredients (API) used for manufacturing drugs are seeing a significant drop, bringing relief to India's pharmaceutical pharma industry depends largely on China for sourcing APIs, intermediates and bulk drugs. API prices had shot up during the Covid period and stayed elevated until last year. The situation has now started to change, reducing raw material cost and boosting profit margins for pharma instance, the price of paracetamol API has dropped from ₹900 per kg during the pandemic and ₹600 immediately after to ₹250 now, market sources told ET. The API for antibiotic meropenem has become cheaper at ₹45,000 per kg compared with ₹75,000."Prices of APIs have gone down significantly. It's largely due to over-capacity. We are seeing a huge impact on the prices of antibiotics, steroids, hormones, statins, among others," said Mehul Shah, who tracks the Chinese pharmaceutical expects this trend to continue through this industry expert said the prices have come down because of the aggressive strategy of Chinese suppliers to maintain market dominance. "This aggressive pricing has made Chinese APIs more attractive to Indian pharmaceutical companies, leading to increased imports when prices are low," he said on the condition of anonymity. Dinesh Dua , former chairman of the Pharmaceutical Export Promotion Council, said there were several factors that led to the price decline."While China scaled up significantly after Covid-19, the demand for APIs has gone down too as India has taken steps to become self-reliant," he said. "India's government has implemented the production-linked incentive scheme to boost domestic API production. As a result, companies like Aurobindo Pharma and Torrent Pharmaceuticals have initiated local production of APIs such as penicillin-G. This increased domestic output has contributed to a surplus in supply, exerting downward pressure on prices."Dua said a decline in the prices of raw materials, such as acetic acid and para-aminophenol, essential for API production, has also contributed to lower costs. "Additionally, easing geopolitical tensions and improved logistics have reduced freight charges, further decreasing the overall cost of API," he to industry experts, a gradual return of demand to pre-pandemic levels has also contributed to this situation.
