&w=3840&q=100)
Alembic Pharma gets USFDA nod for generic cancer treatment injection
The approval by the US Food & Drug Administration (USFDA) for the abbreviated new drug application (ANDA) is for Doxorubicin Hydrochloride Liposome injection of strengths 20 mg/10 mL (2 mg/mL) and 50 mg/25 mL (2 mg/mL) single-dose vials, Alembic Pharmaceuticals said in a statement.
The approved ANDA is therapeutically equivalent to the reference-listed drug product (RLD), Doxil Liposome Injection, 20 mg/10 mL (2 mg/mL) and 50 mg/25 mL (2 mg/mL), of Baxter Healthcare Corporation, it added.
Doxorubicin Hydrochloride Liposome Injection is indicated for the treatment of ovarian Cancer, AIDS-Related Kaposi's sarcoma, and multiple myeloma, the company said.
Citing IQVIA data, Alembic said Doxorubicin Hydrochloride Liposome injection, 20 mg/10 mL (2 mg/mL) and 50 mg/25 mL (2mg/mL) single-dose vials have an estimated market size of $29 million for the 12 months ended March 2025.
(Only the headline and picture of this report may have been reworked by the Business Standard staff; the rest of the content is auto-generated from a syndicated feed.)
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
NDTV
9 hours ago
- NDTV
Trump's 'Wealthy' TikTok Buyer Is Same Group Behind A Previous Stalled Bid
The prospective buyer of TikTok's American operations cited by President Donald Trump is the same investor consortium including Oracle Corp., Blackstone Inc. and venture capital firm Andreessen Horowitz, whose bid for the app had stalled amid US-China trade tensions, according to a person familiar with the matter. Trump said in an interview aired on Sunday that he had identified a contender to purchase the popular social media app from its Chinese parent ByteDance Ltd. but stopped short of naming the winning bidder. He also said that completion of any sale would be contingent on the Chinese government, including President Xi Jinping, dropping its longstanding opposition. "We have a buyer for TikTok, by the way. I think I'll need probably China approval and I think President Xi will probably do it," Trump said in a pretaped interview with Fox News's Sunday Morning Futures with Maria Bartiromo. "It's a group of very wealthy people." A person familiar with the discussions confirmed that the buyers group cited by the president was the one involving Oracle and Blackstone that had come close to reaching agreement with ByteDance in April but was halted when China withheld its approval following the US president's decision to impose sweeping tariffs. That potential agreement would have granted new outside investors 50% of TikTok's US business in a unit that would be spun off from ByteDance. ByteDance's existing US investors would also own about 30% of the business, cutting the Chinese firm's stake to just below 20% and allowing it to meet the ownership requirements of the US security law. Oracle would take a minority stake in the operations and provide security assurances for user data. White House Press Secretary Karoline Leavitt said Monday that discussions were continuing "at the highest level" with China. "We have another 90-day extension, and it's just to continue to work out this deal and make sure that TikTok stays on for the American people," she told reporters. Blackstone declined to comment, while representatives from Oracle, Andreessen Horowitz, ByteDance and TikTok didn't respond to requests for comment. Trump addressed the fate of the video-sharing platform days after the US and China signed an agreement to ease trade tensions that had flared since he imposed tariffs of as much as 145% on Chinese imports. Under the accord finalized last week, the US dropped those tariffs to 30% and promised to resume shipments of ethane, jet engines and chip-design software as long as China honored a pledge to remove some barriers on rare earths exports. That deal, though, left unanswered whether China might drop its objections to a sale of TikTok by ByteDance. When asked about the buyers mentioned by Trump, Chinese Foreign Ministry spokeswoman Mao Ning told reporters at a regular press briefing in Beijing earlier Monday that on TikTok-related issues, China "has reiterated its principled position," saying she had nothing further to add. Under a law signed by then-President Joe Biden last year, ByteDance was directed to divest TikTok's US unit by Jan. 19 or face a ban of the app over national security concerns. The company has balked at selling a lucrative business valued from $20 billion to as high as $150 billion depending on the proposed terms and technology included. Trump has since extended the deadline three times to allow more time for a deal to take shape that would spare TikTok's US operations from a shutdown. His latest extension carries through mid-September, and Trump said during the interview aired Sunday that he would reveal the buyers group "in about two weeks."
Economic Times
18 hours ago
- 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.
Mint
a day ago
- Mint
Boeing-Spirit merger faces UK antitrust probe: Here's why the $4.7 billion deal is under lens
Boeing's proposed $4.7 billion deal to acquire Spirit AeroSystems Holdings will face an antitrust investigation in the United Kingdom, the country's antitrust watchdog said. The deal, valued at $8.3 billion including Spirit's net debt, was announced last year. It aims to reunite the aviation giants two decades after Spirit was spun off from Boeing in 2005 to trim costs, reported Bloomberg. The Competition and Markets Authority (CMA) has initiated a probe to determine whether the transaction poses a risk of 'substantial lessening of competition' in the UK. This investigation is said to be a standard procedure for acquisitions of this magnitude. The inquiry 'was anticipated and is part of the normal process for acquisitions of this nature,' a Spirit spokesperson told the news agency. The UK antitrust watchdog is expected to make a decision on whether to close the investigation or launch a more in-depth probe by August 28 of this year, it said in a notice published on Monday. The Boeing-Spirit merger will bring a key supplier for the 737, 787 Dreamliner and other commercial jets back to Boeing. In July 2024, Boeing announced that it is acquiring Spirit, which will include substantially all Boeing-related commercial operations, as well as additional commercial, defence and aftermarket operations. The objective of the purchase is to streamline Boeing's operations and improve quality control, years after spinning off the key supplier, according to Reuters. In July, former Boeing CEO Dave Calhoun told the media at the time of the acquisition announcement that the deal 'is in the best interest of the flying public, our airline customers, the employees of Spirit and Boeing, our shareholders and the country more broadly'. As part of the transaction, Boeing was expected to work with Spirit to ensure the continuity of operations supporting Spirit's customers and programmes it acquires, including working with the US Department of Defense and Spirit's defence customers regarding defence and security missions, Boeing said in a statement.
