Latest news with #Stelara
Korea Herald
a day ago
- Business
- Korea Herald
Samsung Bioepis partners with Nipro for Japan market entry
Samsung Bioepis, the biosimilar unit of Samsung Group, announced Monday that it has signed a commercialization agreement with Japan-based pharmaceutical and medical device company Nipro to enter the Japanese market. The deal covers the licensing, development and commercialization of multiple biosimilars, including SB17, a biosimilar referencing Stelara (ustekinumab), used to treat autoimmune conditions. This marks the company's first partnership with a Japanese pharmaceutical company. Under the agreement, Samsung Bioepis will oversee development, manufacturing and supply, while Nipro will manage sales and distribution in Japan. 'The partnership is a major milestone for our entry into Japan,' said Samsung Bioepis CEO Kim Kyung-ah. 'We aim to enhance patient access to high-quality biopharmaceuticals through close collaboration with local partners.' SB17 is a biosimilar to Janssen's Stelara, which treats inflammatory diseases such as psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis. Samsung Bioepis launched its proprietary Stelara biosimilar, Pyzchiva, in the US earlier this year, followed by an increased market competition after Stelara's US patent expiry in 2023. After receiving approval in Europe last year, Pyzchiva went on to secure a 43 percent market share, emerging as a leading product in the region's biosimilar market. Founded in 2012, Samsung Bioepis has gained approval for 11 blockbuster biosimilar products and posted 1.54 trillion won ($1.13 billion) in revenue in 2024. Meanwhile, Samsung Bioepis is scheduled to separate from its parent company, Samsung Biologics, in October to operate as a new holding company, a strategic move aimed at easing client concerns over potential conflicts of interest between Samsung Biologics' contract development and manufacturing business and Samsung Bioepis' biosimilar unit.
Yahoo
4 days ago
- Business
- Yahoo
Nkarta Appoints Shawn Rose Chief Medical Officer & Head of R&D as Company Resets Senior Leadership Role for Autoimmune Focus
SOUTH SAN FRANCISCO, Calif., June 06, 2025 (GLOBE NEWSWIRE) -- Nkarta, Inc. (Nasdaq: NKTX), a clinical-stage biopharmaceutical company developing engineered natural killer (NK) cell therapies to treat autoimmune disease, today announced the appointment of Shawn Rose, M.D. Ph.D., as its next Chief Medical Officer (CMO) and Head of Research and Development (R&D) starting on June 23, 2025. He replaces David R. Shook, M.D., who will be stepping down from the role to pursue other opportunities in the oncology space. Dr. Rose has dedicated his career to immunology translational medicine and advancing new treatment options for autoimmune patients. In various leadership roles, he has brought forward more than a dozen programs from discovery into clinical development, and he has developed multiple pioneering approved medicines such as Sotyktu, Stelara, and Tremfya. 'Dr. Rose joins the Nkarta team at a critical threshold as we discover the power of our NK cell platform to treat autoimmune diseases,' said Paul J. Hastings, CEO of Nkarta. 'He is an enterprise leader with a deep clinical background in rheumatology and immunology that's ideally suited to maximize the potential of our allogeneic NK cell platform. Shawn's proven track record as an expert clinician gives me full confidence that he will hit the ground running on day one and meaningfully advance our work in the clinic.' Dr. Rose most recently served as Chief Development Officer, Immunology, at Vividion Therapeutics, working to expand their portfolio by advancing previously undruggable targets in immunology. He also served as interim CMO and Head of Clinical Development at Magenta Therapeutics, working on cell-based therapeutic approaches for patients with cancer, genetic disorders and immune-mediated inflammatory diseases. Dr. Rose also held multiple clinical and development leadership roles at Annexon Biosciences, Janssen Pharmaceuticals, and Bristol-Myers Squibb. He did his postdoctoral research training and clinical training in Internal Medicine and Rheumatology at the Northwestern University Feinberg School of Medicine. 'I am thrilled to join Nkarta to advance innovative cell therapies for patients,' said Dr. Rose. 'I strongly believe that Nkarta's allogeneic NK cell platform has the potential to be a transformational approach for patients with immune-mediated inflammatory disease. I look forward to working closely with Paul and the broader Nkarta team on developing more treatment options for patients.' During the transition, Dr. Rose will work with Dr. Shook, who will remain on as a consultant through July 11. 'Dave was an early pioneer of NK cell therapy while working under Nkarta's scientific founder, Dario Campana, at St. Jude Children's Research Hospital, and he has tirelessly pursued options that were more convenient for patients with safety utmost in mind,' Hastings said. 'Dave has devoted much of his career to make important contributions to the advancement of natural killer cell therapy, leading our early clinical work in cancer and overseeing key aspects of our strategic shift into a new disease area with agility and flexibility. But Dave is a dedicated oncologist, and he has decided to return to the field he loves. He is a fearless advocate for patients and their well-being and a very good friend who will be missed.' About NKX019NKX019 is an allogeneic, cryopreserved, off-the-shelf immunotherapy candidate that uses natural killer (NK) cells derived from the peripheral blood of healthy adult donors. It is engineered with a humanized CD19-directed chimeric antigen receptor (CAR) for enhanced cell targeting and a proprietary, membrane-bound form of interleukin-15 (IL-15) for greater persistence and activity without exogenous cytokine support. CD19 is a biomarker for normal B cells as well as those implicated in autoimmune disease and B cell-derived malignancies. Nkarta is evaluating NKX019 in multiple autoimmune conditions. About NkartaNkarta is a clinical-stage biotechnology company advancing the development of allogeneic, off-the-shelf natural killer (NK) cell therapies for autoimmune diseases. By combining its cell expansion and cryopreservation platform with proprietary cell engineering technologies, Nkarta is building a pipeline of future cell therapies engineered for deep therapeutic activity and intended for broad access in the outpatient treatment setting. For more information, please visit the company's website at Cautionary Note on Forward-Looking Statements Statements contained in this press release regarding matters that are not historical facts are 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Words such as "anticipates," "believes," "expects," "intends," 'plans,' 'potential,' "projects,' 'would' and "future" or similar expressions are intended to identify forward-looking statements. Examples of these forward-looking statements include, but are not limited to, statements concerning Nkarta's expectations regarding any or all of the following: Nkarta's position, plans, strategies, and timelines for the continued and future clinical development and commercial potential of NKX019 (including the future availability and disclosure of clinical data and other updates from Nkarta's clinical trials). Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, among others: Nkarta's limited operating history and historical losses; Nkarta's lack of any products approved for sale and its ability to achieve profitability; the risk that the results of preclinical studies and early-stage clinical trials may not be predictive of future results; Nkarta's ability to raise additional funding to complete the development and any commercialization of its product candidates; Nkarta's dependence on the clinical success of NKX019; that Nkarta may be delayed in initiating, enrolling patients in or completing its clinical trials; competition from third parties that are developing products for similar uses; Nkarta's ability to obtain, maintain and protect its intellectual property; Nkarta's dependence on third parties in connection with manufacturing, clinical trials and pre-clinical studies; the complexity of the manufacturing process for CAR NK cell therapies; and the success of Nkarta's recent (and any future) cost containment measures. These and other risks and uncertainties are described more fully in Nkarta's filings with the Securities and Exchange Commission ('SEC'), including the 'Risk Factors' section of Nkarta's Annual Report on Form 10-Q for the quarter ended March 31, 2025, filed with the SEC on May 14, 2025, and Nkarta's other documents subsequently filed with or furnished to the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except to the extent required by law, Nkarta undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. Nkarta Media/Investor Contact:Nadir MahmoodNkarta, in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
India Today
5 days ago
- Business
- India Today
Dr Reddy's shares jump over 3% today. Here's why
Dr Reddy's Laboratories shares rose over 3% on Thursday, emerging as the top gainer on the Nifty Pharma index, which climbed 1.4%. Around 1:03 pm, the stock was up 3.39% at Rs 1, surge follows the announcement of a strategic partnership with US-listed biotech firm Alvotech to develop a biosimilar version of Merck's blockbuster cancer drug Keytruda (pembrolizumab). The PD-1 inhibitor, used to treat multiple cancer types, is expected to generate $29.5 billion in global sales in 2024, making it one of the most valuable targets in the biosimilars the agreement, Dr Reddy's and Alvotech will share development and manufacturing responsibilities and retain commercialisation rights globally, with a few Israeli, CEO of Dr Reddy's, called the deal a 'major step' in the company's oncology strategy. 'This collaboration enhances our capabilities in immuno-oncology and reinforces our focus on affordable, high-quality treatment options,' he which already markets biosimilars of Humira and Stelara, sees this partnership as a way to further leverage its R&D and manufacturing platform. 'This agreement demonstrates our ability to accelerate development of key biosimilars,' said chairman and CEO Rbert market has reacted positively to the development. While Dr Reddy's shares are down 5.3% on a year-to-date basis, they have gained 10.5% in the past month. Analysts see the move as a strategic bet to boost the company's global presence in the competitive biosimilar Direct described the Keytruda biosimilar as a 'decent pipeline opportunity' despite expected competition. At a forward 12-month PE of 18.8, Dr Reddy's remains the third-cheapest stock on the Nifty Pharma oncology being a core focus area and biosimilars gaining momentum globally, the collaboration with Alvotech marks a critical step in Dr Reddy's long-term growth The views, opinions, recommendations, and suggestions expressed by experts/brokerages in this article are their own and do not reflect the views of the India Today Group. It is advisable to consult a qualified broker or financial advisor before making any actual investment or trading choices.)Must Watch
Yahoo
27-05-2025
- Business
- Yahoo
1 Top Dividend Stock to Buy for a Lifetime of Passive Income
Johnson & Johnson faces challenges including legal and regulatory troubles, and slow top-line growth. The healthcare leader has a solid and diversified business that can overcome these headwinds. J&J has increased its dividend for 62 consecutive years. 10 stocks we like better than Johnson & Johnson › There are hundreds of dividend stocks on the market, but they don't all offer the same level of security. Some haven't increased their payouts in years. Others may provide irregular dividend hikes, which will likely stop if the economy tanks or company-specific issues hit. Still others have cut their payouts in recent years. These aren't the kind of stocks income seekers are looking for. Instead, dividend investors want corporations that consistently raise their payouts, preferably every year, and are unlikely to stop even when they face headwinds. One company that has what it takes to do that is Johnson & Johnson (NYSE: JNJ). Here's why this longtime dividend payer is worth holding on to for good. Let's start with the bear case for Johnson & Johnson. Over the past few years, it has dealt with several issues. We'll consider three. First, it is still facing a litany of lawsuits related to talc-based products that allegedly gave consumers cancer. The company recently failed to put a lid on most of these lawsuits when a judge stopped its attempt to settle with most plaintiffs. So it looks like this headwind will continue. Second, recent regulatory changes in the U.S. could eventually hurt its revenue. The U.S. Centers for Medicare and Medicaid Services (CMS) now has the authority to negotiate the prices of some of the drugs Medicare spends the most on. The first round of negotiations features three of J&J's medicines: Blood thinner Xarelto, immunosuppressant Stelara, and blood-cancer medicine Imbruvica. All will see significant price cuts for Medicare patients. Third, the company has dealt with relatively slow revenue growth. However, despite all that, Johnson & Johnson looks like an attractive long-term option for dividend-seekers. J&J didn't get to be one of the largest healthcare companies in the world by accident. The company has constantly developed newer and better products in its pharmaceutical and medical-technology businesses. It boasts a deep lineup of medicines across several therapeutic areas, including immunology, oncology, infectious diseases, and neuroscience. It has more than 10 drugs that each generate more than $1 billion in annual sales. Its med-tech unit is also diversified across several areas. Its pipeline features several dozen programs. And the drugmaker constantly earns brand-new approvals or label expansions. In other words, it has an incredibly robust underlying business that's well equipped to handle the challenges it faces. The price cuts for Xarelto, Stelara, and Imbruvica will only take effect next year. And even then, they will have a minimal impact on the company's results because none of these drugs feature in its long-term growth plans. Sales of Stelara and Imbruvica are already declining due to competitive pressure (from generics or otherwise). And while Xarelto's revenue moved in the right direction in the first quarter, the U.S. Food and Drug Administration recently approved the first generic of this medicine. There will be more Medicare price negotiations, and nobody knows yet which drugs they will target. But in the long run, Johnson & Johnson should be able to handle this problem. It can avoid price negotiations by decreasing its exposure to therapies for which Medicare -- a program for the elderly -- spends the most. And that's just one possibility, which the company's deep pipeline and ability to generate consistent cash flow should allow it to do. J&J has been around for more than 100 years; it's had to deal with changes in regulatory regimes before. Although the company's revenue growth has been slow, its recent decision to spin off its consumer health unit to focus on its biopharma and med-tech segments was partly to address that problem. Expect stronger revenue growth as it focuses more on higher-growth opportunities within its two remaining units. Lastly, Johnson & Johnson has a higher credit rating than the U.S. government. Even the barrage of lawsuits has not changed that, which is strong evidence that it has the financial capabilities to handle these challenges. A previous judge shot down J&J's attempt to settle these lawsuits via a bankruptcy maneuver for one of its subsidiaries, partly because the company's robust financial position does not put it at risk of insolvency despite the lawsuits it faces. What about the dividend? Johnson & Johnson is a Dividend King with 62 years of consecutive payout increases under its belt. The healthcare leader should continue hiking its dividend, which now yields a market-beating 3.4% yield, for a long time. Before you buy stock in Johnson & Johnson, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the for investors to buy now… and Johnson & Johnson wasn't one of them. The 10 stocks that made the cut could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you'd have $639,271!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you'd have $804,688!* Now, it's worth noting Stock Advisor's total average return is 957% — a market-crushing outperformance compared to 167% for the S&P 500. Don't miss out on the latest top 10 list, available when you join . See the 10 stocks » *Stock Advisor returns as of May 19, 2025 Prosper Junior Bakiny has positions in Johnson & Johnson. The Motley Fool recommends Johnson & Johnson. The Motley Fool has a disclosure policy. 1 Top Dividend Stock to Buy for a Lifetime of Passive Income was originally published by The Motley Fool Sign in to access your portfolio
Business Standard
21-05-2025
- Business
- Business Standard
Biocon Biologics and Yoshindo Inc. launch Ustekinumab Biosimilar in Japan
Biocon Biologics, subsidiary of Biocon, announced today that its commercial partner in Japan, Yoshindo Inc., has launched Ustekinumab BS Subcutaneous Injection [YD], a biosimilar to the reference product Stelara (ustekinumab). The biosimilar ustekinumab, developed and manufactured by Biocon Biologics, is commercialized and marketed in Japan by Yoshindo Inc. Ustekinumab, a monoclonal antibody, is approved for the treatment of psoriasis vulgaris and psoriatic arthritis (PsA). In April 2024, the Company entered into a settlement and licensing agreement with Janssen Biotech Inc., Janssen Sciences Ireland, and Johnson & Johnson (collectively known as Janssen) to commercialize Ustekinumab in Japan upon regulatory approval. Biocon Biologics' biosimilar Ustekinumab BS Subcutaneous Injection [YD] was approved by the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan in December 2024. Biocon Biologics has already launched Ustekinumab in the United States and Europe in February 2025 to help patients manage their chronic conditions.
