Latest news with #Wockhardt
Daily Mail
2 days ago
- Health
- Daily Mail
BREAKING NEWS Urgent warning as prescription drug taken by tens of thousands recalled due to cancer risk
Health officials have urgently recalled a common daily pill taken by cancer survivors over fears some batches may not work. UK medicines watchdog the Medicines and Healthcare Products Regulatory Agency (MHRA) stuck an alert on one batch of Tamoxifen 20mg tablets. It is feared the drug may not dissolve into the bloodstream effectively after failing routine dissolution tests. But the MHRA, which published the alert, said it had not yet received any complaints or reports of harm from patients who had taken the 30-pack tablets. The recall only impacts one batch of the pills, manufactured by Wockhardt UK Limited, with the batch number HZ10030 and an expiry date of April 30, 2027. Tamoxifen is a daily pill taken by around 550,000 British breast cancer survivors. It can slash their risk of recurrence after treatment by up to 45 per cent. It's also offered to women with a strong family history of the disease, as it cuts their odds of ever developing it. Tablets and capsules taken orally remain one of the most commonly used means of providing treatment. Dissolution tests are commonly conducted to check the time taken for the active ingredient in a dosage form to release into the body and help predict how the drug performs inside the body. The effectiveness of these drugs relies on the drug dissolving in the fluids of the gastrointestinal tract prior to absorption into the blood stream. The dissolution procedure is an important test both to evaluate safety, predict efficacy and stability with respect to manufacturing and storage conditions. The MHRA said patients should continue to take medicines as prescribed by your healthcare professional. The recall is being actioned at the pharmacy and wholesaler level as a precautionary measure.
Economic Times
2 days ago
- Business
- Economic Times
Wockhardt activates Zaynich push, eyes global licensing deals
Habil Khorakiwala Mumbai: Wockhardt is working on ambitious plans for Zaynich, a combination of zidebactam and cefepime that was found to be effective during clinical trials to fight superbugs or bacterial infections that show resistance to a range of existing antibiotic treatments. The drug maker has hired merchant bankers to identify possible out-licensing deals for the novel product, chairman Habil Khorakiwala told ET in an exclusive interview. Wockhardt in March sought regulatory approval for Zaynich in India and expects its commercial launch in the first half of '26. In the US, it plans to file for regulatory clearance in August.'We will get into the US market by the end of FY26 or latest by the second half of 2026 and Europe will be a year later,' Khorakiwala said. Zaynich is seen as a game-changing drug against drug-resistant gram-negative pathogens. These pathogens are difficult to kill. Zaynich is estimated to have a market opportunity of about $9 billion. Around a million people die due to multidrug resistance in India every year, while worldwide, the number is 5 million, Khorakiwala said. Currently there are very few effective treatments available for these infections. Mumbai-based Wockhardt completed the Phase-3 clinical trials for Zaynich earlier this year. In January it announced that the drug demonstrated more than 97% clinical efficacy in treating serious infections of bacteria resistant to carbapenem antibiotics, which are often used as a last resort to treat severe infections. The company is prepared to go solo to market Zaynich in India, the US and other markets if the licensing proposals do not meet its expectations on valuation, Khorakiwala said without revealing the valuation he is looking for.'We will evaluate how to go about and take an appropriate call, so we are keeping two options fully alive,' Khorakiwala said. 'One option is licensing out, the other is in some markets like in India we are doing ourselves,' he said. 'The US is another market where we are thinking of the possibility (of marketing on its own); you don't need too much marketing cost and you have talent available.'Wockhardt also plans to fully outsource manufacturing for the Western markets to eliminate issues related to the US Food and Drug Administration, and channel its focus on the clinical and research part.'For manufacturing, plenty of options are available in Europe and the US, so I am not getting into FDA-related manufacturing problems,' said Khorakiwala. 'Zaynich — we are manufacturing everything in Europe.' It will adopt the same strategy to outsource most of the manufacturing for all its other new company had in the past faced some issues with the US FDA over alleged violations of good manufacturing practices. 'That (FDA-elated manufacturing problems) was our weakness, and I am eliminating that completely from my western markets to only focus on the clinical and research part,' he said. COMPANY TURNAROUND Wockhardt has seen a remarkable turnaround in its stock price in the past year and a half with renewed confidence from investors, with developments on Zaynich being among the key drivers. Its stock price more than doubled in the last 12 months and increased over three-and-a-half times since January 2024. The shares closed at `1,713.20, up 4.5%, on BSE Monday. 'We have revisited what are the strengths and what are the opportunities — one obviously is our new drug discovery — in India and worldwide,' said also stressed on the company's focus on biologics as another key growth driver.'Within biologics we will stay in insulin and GLP1; we are not going to touch the rest of the biologics like monoclonal antibodies and others. Because we feel it is important to be focused,' he does not see itself as a generic company, he said. 'In fact, in the US we are exiting generics … we will be focused on the biological area and NCE (new chemical entities) and strictly on antibiotics,' he chairman said his research pipeline has a range of antibiotics under development, including early-stage work on an oral version of Zaynich. PRICING STRATEGY Khorakiwala said the treatment cost with most new products including antimicrobials launched in the last 10 years in the US has been in the range of $10,000-15,000 per treatment. Zaynich will also hover in that range in the US but in India, the price will be significantly lower, he said.
Time of India
2 days ago
- Business
- Time of India
Wockhardt activates Zaynich push, eyes global licensing deals
Mumbai: Wockhardt is working on ambitious plans for Zaynich , a combination of zidebactam and cefepime that was found to be effective during clinical trials to fight superbugs or bacterial infections that show resistance to a range of existing antibiotic treatments. The drug maker has hired merchant bankers to identify possible out-licensing deals for the novel product, chairman Habil Khorakiwala told ET in an exclusive interview. Wockhardt in March sought regulatory approval for Zaynich in India and expects its commercial launch in the first half of '26. In the US, it plans to file for regulatory clearance in August.'We will get into the US market by the end of FY26 or latest by the second half of 2026 and Europe will be a year later,' Khorakiwala said. Zaynich is seen as a game-changing drug against drug-resistant gram-negative pathogens. Play Video Pause Skip Backward Skip Forward Unmute Current Time 0:00 / Duration 0:00 Loaded : 0% 0:00 Stream Type LIVE Seek to live, currently behind live LIVE Remaining Time - 0:00 1x Playback Rate Chapters Chapters Descriptions descriptions off , selected Captions captions settings , opens captions settings dialog captions off , selected Audio Track default , selected Picture-in-Picture Fullscreen This is a modal window. Beginning of dialog window. Escape will cancel and close the window. Text Color White Black Red Green Blue Yellow Magenta Cyan Opacity Opaque Semi-Transparent Text Background Color Black White Red Green Blue Yellow Magenta Cyan Opacity Opaque Semi-Transparent Transparent Caption Area Background Color Black White Red Green Blue Yellow Magenta Cyan Opacity Transparent Semi-Transparent Opaque Font Size 50% 75% 100% 125% 150% 175% 200% 300% 400% Text Edge Style None Raised Depressed Uniform Drop shadow Font Family Proportional Sans-Serif Monospace Sans-Serif Proportional Serif Monospace Serif Casual Script Small Caps Reset restore all settings to the default values Done Close Modal Dialog End of dialog window. by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like 2025년 가장 여유 넘치는 농장 게임. 설치 없음 Taonga: 아일랜드 팜 플레이하기 Undo These pathogens are difficult to kill. Zaynich is estimated to have a market opportunity of about $9 billion. Around a million people die due to multidrug resistance in India every year, while worldwide, the number is 5 million, Khorakiwala said. Currently there are very few effective treatments available for these infections. Mumbai-based Wockhardt completed the Phase-3 clinical trials for Zaynich earlier this year. In January it announced that the drug demonstrated more than 97% clinical efficacy in treating serious infections of bacteria resistant to carbapenem antibiotics, which are often used as a last resort to treat severe infections. Live Events The company is prepared to go solo to market Zaynich in India, the US and other markets if the licensing proposals do not meet its expectations on valuation, Khorakiwala said without revealing the valuation he is looking for. 'We will evaluate how to go about and take an appropriate call, so we are keeping two options fully alive,' Khorakiwala said. 'One option is licensing out, the other is in some markets like in India we are doing ourselves,' he said. 'The US is another market where we are thinking of the possibility (of marketing on its own); you don't need too much marketing cost and you have talent available.' Wockhardt also plans to fully outsource manufacturing for the Western markets to eliminate issues related to the US Food and Drug Administration, and channel its focus on the clinical and research part. 'For manufacturing, plenty of options are available in Europe and the US, so I am not getting into FDA-related manufacturing problems,' said Khorakiwala. 'Zaynich — we are manufacturing everything in Europe.' It will adopt the same strategy to outsource most of the manufacturing for all its other new products. The company had in the past faced some issues with the US FDA over alleged violations of good manufacturing practices. 'That (FDA-elated manufacturing problems) was our weakness, and I am eliminating that completely from my western markets to only focus on the clinical and research part,' he said. COMPANY TURNAROUND Wockhardt has seen a remarkable turnaround in its stock price in the past year and a half with renewed confidence from investors, with developments on Zaynich being among the key drivers. Its stock price more than doubled in the last 12 months and increased over three-and-a-half times since January 2024. The shares closed at `1,713.20, up 4.5%, on BSE Monday. 'We have revisited what are the strengths and what are the opportunities — one obviously is our new drug discovery — in India and worldwide,' said Khorakiwala. He also stressed on the company's focus on biologics as another key growth driver. 'Within biologics we will stay in insulin and GLP1; we are not going to touch the rest of the biologics like monoclonal antibodies and others. Because we feel it is important to be focused,' he said. Wockhardt does not see itself as a generic company, he said. 'In fact, in the US we are exiting generics … we will be focused on the biological area and NCE (new chemical entities) and strictly on antibiotics,' he said. The chairman said his research pipeline has a range of antibiotics under development, including early-stage work on an oral version of Zaynich. PRICING STRATEGY Khorakiwala said the treatment cost with most new products including antimicrobials launched in the last 10 years in the US has been in the range of $10,000-15,000 per treatment. Zaynich will also hover in that range in the US but in India, the price will be significantly lower, he said.
Economic Times
11-06-2025
- Business
- Economic Times
Wockhardt shares jump 17%, hit fresh 52-week high
Live Events (You can now subscribe to our (You can now subscribe to our ETMarkets WhatsApp channel Shares of Wockhardt surged 17% to hit their 52-week high of Rs 1,809 on the NSE. The stock has extended its unbeaten streak to the third session in a row. The stock garnered strong interest from the investors with a spurt in volume of more than 4.5 times on the stock gained amid buying action in the pharma pack, with Nifty among the top-performing sectors in a lacklustre trade today. The Nifty Bank was up 0.4% with 14 stocks trading in the green in the 20-stock pharma company, which is into branded manufacturing of drugs, contract manufacturing, API and vaccines, released its forward-looking statements last week on company said that it has filed for its Zaynich drug with the Drug Controller General of India (DCGI) for approval, and the India launch is expected in H2 FY25- company recently reported fourth quarter results for the financial year 2024-25. The company's revenue for Q4FY25 stood at Rs 743 crore compared to Rs 750 crore in the previous year. The Earnings Before Interest, Taxes, Depreciation and Amortisation (EBITDA) grew 13% QoQ in the quarter under review at Rs 79 crore compared to Rs 70 crore in the previous company's net losses in the January-March quarter of FY25 narrowed to Rs 45 crore versus Rs 177 crore in the year-ago period. The PAT margins were reported at -6.1% versus -23.6% versus those in the year-ago company reported 7 filings for new product launches in FY2024- 25 and 6 launches in Wockhardt UK, along with 1 filing and 6 new launches in the biosimilars & NCE segments, 19 filings & 5 approvals were India-branded business stood at Rs 95 crore in Q4FY25, and for FY25, the revenue was Rs 456 crore. The UK Business stood at Rs 292 crore in Q4FY25 with a growth of 9%, and for FY25, the revenue was Rs 1,169 crore with a growth of 12%. Meanwhile, the Irish Business stood at Rs 47 crore in Q4FY2,5 and for FY25, the revenue was Rs 181 crore.
Time of India
11-06-2025
- Business
- Time of India
Wockhardt shares jump 17%, hit fresh 52-week high
Wockhardt extended its winning streak for the third straight session, drawing strong investor interest with trading volumes surging over 4.5 times on the BSE. The stock rallied alongside broader buying momentum in the pharma sector. Tired of too many ads? Remove Ads Tired of too many ads? Remove Ads Shares of Wockhardt surged 17% to hit their 52-week high of Rs 1,809 on the NSE. The stock has extended its unbeaten streak to the third session in a row. The stock garnered strong interest from the investors with a spurt in volume of more than 4.5 times on the stock gained amid buying action in the pharma pack, with Nifty among the top-performing sectors in a lacklustre trade today. The Nifty Bank was up 0.4% with 14 stocks trading in the green in the 20-stock pharma company, which is into branded manufacturing of drugs, contract manufacturing, API and vaccines, released its forward-looking statements last week on company said that it has filed for its Zaynich drug with the Drug Controller General of India (DCGI) for approval, and the India launch is expected in H2 FY25- company recently reported fourth quarter results for the financial year 2024-25. The company's revenue for Q4FY25 stood at Rs 743 crore compared to Rs 750 crore in the previous year. The Earnings Before Interest, Taxes, Depreciation and Amortisation (EBITDA) grew 13% QoQ in the quarter under review at Rs 79 crore compared to Rs 70 crore in the previous company's net losses in the January-March quarter of FY25 narrowed to Rs 45 crore versus Rs 177 crore in the year-ago period. The PAT margins were reported at -6.1% versus -23.6% versus those in the year-ago company reported 7 filings for new product launches in FY2024- 25 and 6 launches in Wockhardt UK, along with 1 filing and 6 new launches in the biosimilars & NCE segments, 19 filings & 5 approvals were India-branded business stood at Rs 95 crore in Q4FY25, and for FY25, the revenue was Rs 456 crore. The UK Business stood at Rs 292 crore in Q4FY25 with a growth of 9%, and for FY25, the revenue was Rs 1,169 crore with a growth of 12%. Meanwhile, the Irish Business stood at Rs 47 crore in Q4FY2,5 and for FY25, the revenue was Rs 181 crore.
