Search Results for “Novartis” – Page 4 – media

Novartis Inks Potential $1.3B Contract with Korean Biotech for Small Molecule

By Tristan Manalac Pictured: Novartis’ head office in Canada/iStock, JHVEPhoto Novartis on Monday inked a technology export contract with Korean biotech company Chong Kun Dang Pharmaceutical for an early-stage HDAC6 Inhibitor, according to Korea Biomedical Review. Under the agreement, Novartis will make an upfront payment of $80 million and pledge up to nearly $1.23 billion more in development and regulatory milestones. The Korean biotech will also remain eligible to future sales-based royalties, as well as an ongoing technology fee depending on net sales. In return, Novartis will gain the exclusive global rights—except in Korea—to develop and commercialize the investigational small-molecule HDAC inhibitor CKD-510. The candidate in 2021 cleared a Phase I first-in-human study in 87 healthy volunteers and the Korean company appears to be positioning the drug candidate as a potential treatment for Charcot-Marie-Tooth disease, a rare and heritable disease that afflicts the nerves in the limbs. However, a Chong ...
- Source: drugdu
- 107
- November 9, 2023
Novartis Wins FDA Approval for Intravenous Cosentyx Formulation

By Tristan Manalac The FDA on Friday approved an intravenous formulation of Novartis’ IL-17A antagonist Cosentyx (secukinumab) for the treatment of rheumatic diseases. This latest approval covers existing indications of Cosentyx, including ankylosing spondylitis (AS), psoriatic arthritis (PsA) and non-radiographic axial spondyloarthritis (nr-axSpA). Previously, Cosentyx was only authorized as a subcutaneous treatment for these conditions. With Friday’s approval, Cosentyx has become the first intravenous (IV) treatment that specifically targets and inhibits IL-17A and currently the only non-TNF-α IV therapy for these indications, according to Novartis’ announcement. The IV route of administration will improve treatment access for “a significant portion of patients” with AS, PsA and nr-axSpA, who are not comfortable with self-injections or simply prefer to receive treatments in their healthcare provider’s office, according to Philip Mease, clinical professor at the University of Washington School of Medicine. “The approval of Cosentyx as an IV formulation is an important milestone for ...
- Source: drugdu
- 176
- October 11, 2023
FDA Approves Novartis’ New Rheumatic Disease Treatment

Cosentyx is the first intravenous formulation interleukin-17A antagonist to focus on disease. Image Credit: Adobe Stock Images/Seventyfour Novartis officially announced that the FDA approved n intravenous (IV) formulation of Cosentyx (secukinumab) for the treatment of adults with psoriatic arthritis (PsA), ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA). Currently, Cosentyx is the only treatment approved in an IV formulation that specifically targets and blocks interleukin-17A (IL-17A), and the only non-tumor necrosis factor alpha (TNF-α) IV option available in all these indications. “At Novartis, we are committed to ensuring healthcare providers and patients have treatment options available to meet their unique needs. With this approval of Cosentyx as an IV formulation, along with the subcutaneous formulation, we can broaden the use of Cosentyx to help more patients manage their condition with a medicine backed by more than a decade of clinical research and eight years of real-world experience,” said Christy Siegel, ...
- Source: drugdu
- 110
- October 11, 2023
Novartis Launches Sandoz Spinoff, Creating Independent Company

Separate entity allows company to concentrate on status as focused medicines company. Image Credit: Adobe Stock Images/Livinskiy Novartis has officially completed the spinoff process for Sandoz, its generics and biosimilars division, with each shareholder receiving one Sandoz share for every five Novartis shares or one Sandoz American Depositary Receipt (ADR) for every five Novartis ADRs. In the future, Novartis intends to become solely a focused medicines company. “This is a truly historic moment for Novartis and Sandoz, as we begin new chapters as independent companies. With several consecutive quarters of sales growth, Sandoz starts out from a position of strength as a global leader in Generics and Biosimilars, and I am confident they are poised to deepen their impact on patients and society,” said Vas Narasimhan, MD, CEO, Novartis. “Today, after more than USD 100bn in transactions over the last few years, Novartis emerges as a fully focused innovative medicines ...
- Source: drugdu
- 206
- October 7, 2023
Novartis’ Lutathera Clears Phase III as Frontline Treatment for Rare Neuroendocrine Cancer

By Tristan Manalac Pictured: Novartis logo on its office in California/iStock, JHVEPhoto Novartis’ radioligand therapy Lutathera (lutetium Lu 177 dotatate) met its primary endpoint in the Phase III NETTER-2 trial in gastroenteropancreatic neuroendocrine tumors, the company announced Monday. NETTER-2 is a randomized and open-label trial that evaluated Lutathera as a first-line option in 222 patients with grade 2 or 3, advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs). Only those whose cancers were positive for the somatostatin receptor (SSTR) were eligible for enrolment into NETTER-2. When used in combination with high-dose long-acting octreotide, Lutathera led to a significant improvement in progression-free survival (PFS)—the study’s primary endpoint—compared with octreotide alone. In terms of safety, NETTER-2 did not find any new signals of concern and Lutathera’s adverse event profile in the study was consistent with what had been previously established. Novartis did not provide specific efficacy and safety figures, though it promised to do so ...
- Source: drugdu
- 135
- September 28, 2023
Novartis Returns Cancer Asset Tislelizumab to BeiGene

By Tristan Manalac Pictured: Novartis’ head office in Canada/iStock, JHVEPhoto Novartis on Tuesday gave back the investigational monoclonal antibody tislelizumab to BeiGene, returning worldwide rights to develop, manufacture and commercialize the anti-PD-1 candidate to the cancer-focused biotech. Also on Tuesday, BeiGene announced that the European Commission had approved tislelizumab for patients with unresectable, locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) who had previously failed platinum-based chemotherapy. The treatment will be marketed under the brand name Tevimbra. After more than a year of regulatory delay, the FDA has also accepted BeiGene’s Biologics License Application (BLA) for tislelizumab as a first-line treatment option in this indication, according to Tuesday’s announcement. Novartis and BeiGene first entered into a collaboration and license agreement over tislelizumab in January 2021 to develop tislelizumab in ESCC, as well as other malignant diseases such as non-small cell lung cancer and hepatocellular carcinoma. In July 2022, however, ...
- Source: drugdu
- 115
- September 21, 2023
Novartis Shareholders Approve Sandoz Spin-Off as Product Plans Increase

By Connor Lynch Pictured: Novartis office in Germany/iStock, TBE Sandoz is finally nearing the end of its path towards independence. Over a year after Novartis finalized its plans to spin off its generics and biosimilars division, the Swiss pharma’s shareholders on Friday approved the move, which is expected to take effect on or around Oct. 4. The Novartis board of directors also approved the move back in July, paving the way for it to go ahead once the shareholders had signed off. The deal will see Novartis shareholders receive one Sandoz share for every five Novartis shares they hold, and the same ratio of American Depository Receipts (ADRs). Board of Directors Chair Joerg Reinhardt said in a statement that with “this step, both Sandoz and Novartis will be able to optimize management focus, allocate capital on business priorities, and be in a better position to create sustainable shareholder value in ...
- Source: drugdu
- 126
- September 19, 2023
Bausch + Lomb seeks funding for $1.75B eye drop acquisition from Novartis

Dive Brief Bausch + Lomb is seeking to raise almost $2 billion to fund the planned acquisition of Xiidra eye drops from Novartis. The eye health company struck a deal in June to buy the dry eye disease treatment Xiidra and other assets for $1.75 billion upfront, and followed up by agreeing to pay Johnson & Johnson $107 million for a line of eye and contact lens drops. It has the cash to fund the J&J deal but needs to arrange financing to close the larger acquisition of the Novartis assets. Fitch Ratings, in a note to investors, said the Xiidra deal will boost Bausch + Lomb’s ophthalmic pharmaceutical market presence while the company’s R&D efforts help drive revenue growth and support margins longer term. Dive Insight Bausch + Lomb, which split from parent company Bausch Health last year, has identified two ways to strengthen its balance sheet ahead of ...
- Source: drugdu
- 123
- September 14, 2023
Novartis Confirms Sandoz Spin-Off Plans, Sets Oct. 4 Completion Date

By Tristan Manalac Pictured: Novartis Institutes for BioMedical Research building in California/iStock, JHVEPhoto Novartis on Tuesday confirmed that it is pushing through with the spin-off of its generics and biosimilars division Sandoz, pending the final approval of its shareholders. To secure approval, the Swiss pharma group will hold an extraordinary general meeting set for Sept. 15. If given the go-ahead, Novartis expects to complete Sandoz’s spin-off “on or around” Oct. 4, the company said in Tuesday’s announcement. Novartis is also planning to list Sandoz on the SIX Swiss Exchange, with an American Depository Receipt (ADR) program in the U.S., for which the pharma group will likewise need to secure regulatory approvals. Novartis first launched a strategic review of its generics unit in October 2021, when it announced that it was exploring options for the business moving forward—including a potential sale. At the time, Sandoz was seeing better volume sales figures ...
- Source: drugdu
- 106
- September 7, 2023
CMS

The day drugmakers have been dreading has arrived: Tuesday, the Centers for Medicare & Medicaid Services (CMS) unveiled its list of 10 drugs up for the first price negotiations under the Inflation Reduction Act (IRA). The drugs that made the price negotiation cut are Johnson & Johnson’s Imbruvica, Stelara and Xarelto plus Bristol Myers Squibb’s Eliquis, Merck & Co.’s Januvia, Novartis’ Entresto, Eli Lilly’s Jardiance, AstraZeneca’s Farxiga, Novo Nordisk’s Fiasp and Amgen’s Enbrel. Together, the drugs accounted for more than $45 billion in Medicare Part D spending from June 2022 to May 2023, according to a CMS fact sheet (PDF). Next up, these companies will get a chance to submit data and information on their medications to CMS by Oct. 2. Meanwhile, many of the companies are challenging the legality of the IRA in court. It remains to be seen whether any of those efforts can stop the IRA process ...
- Source: drugdu
- 92
- August 31, 2023

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