Search Results for “Novartis” – Page 20 – media

Sandoz partners with Samsung Bioepis to license Stelara biosimilar

Sandoz has partnered with Samsung Bioepis to develop and market a Stelara (ustekinumab) biosimilar in the US, Canada, and Europe. Stelara is an interleukin (IL)-12/IL-23 inhibitor monoclonal antibody developed by Janssen Pharmaceutical Companies of Johnson and Johnson (J&J). It was first approved by the US Food and Drug Administration (FDA) for treating moderate to severe plaque psoriasis in adults in 2009. Its approval was later expanded to include Crohn’s disease, active psoriatic arthritis, and ulcerative colitis. With Stelara being a high-grossing drug for J&J, generating $3.2bn in sales in H1 2023, as per the company’s Q2 financial report, multiple companies are developing biosimilars. J&J has already settled three lawsuits with multiple companies, including Amgen, to push the launch of the Stelara biosimilar’s release date to 2025. Samsung Bioepis is expected to present Phase III trial data with the Stelara biosimilar, SB17, by the end of 2023. The Phase I trial ...
- Source: drugdu
- 103
- September 13, 2023
analysts

Biopharma M&A is on an uptick compared to the post-pandemic doldrums of the last two years. Analysts anticipate that the trend will continue in 2023 and into 2024 as companies attempt to beef up their portfolios.During second quarter earnings calls, many heavy-hitters—including Johnson & Johnson, Bristol Myers Squibb and Merck—expressed urgency in their quest for deals. With so many buyers in competition, sellers are finding offers that are more attractive. For example, Merck’s $10.8 billion proposal to acquire Prometheus in April came at a 75% premium. In July, Biogen’s $7.3 billion deal for Reata represented a 59% markup. “There’s been such a consistent pick up in momentum in anything above a billion [dollars],” Cody Powers, an M&A expert with ZS Principal, said in an interview. “I think we’re back on the gravy train of where we were a couple of years ago in terms of premiums.” In 2019, the industry ...
- Source: drugdu
- 118
- September 11, 2023
Astellas withdraws IRA lawsuit after avoiding CMS’ price negotiations list

Expecting to be subject to Medicare pricing negotiations, Astellas in July challenged the legality of the Inflation Reduction Act (IRA). But now that the Centers for Medicare & Medicaid Services (CMS) has released the first 10 drugs set for governmental bargaining, the company is ready to abandon its litigation. When CMS last week revealed its list of the first 10 drugs eligible for Medicare price negotiations, Astellas’ Xtandi did not make the cut. This surprised some pharma watchers, who had expected the Pfizer-partnered cancer blockbuster to be among the first drugs to face the controversial new process. Now, without Xtandi on the list, Astellas is pulling its lawsuit, Reuters reports. The 10 drugs on the CMS’ list are blockbusters marketed by Johnson & Johnson, Bristol Myers Squibb, Merck & Co., Novartis, Eli Lilly, AstraZeneca, Novo Nordisk and Amgen. Many of the companies whose drugs made the cut had already filed ...
- Source: drugdu
- 189
- September 8, 2023
Following in Tecentriq’s footsteps, Alecensa gives Roche another win in early-stage lung cancer

After a groundbreaking approval for Tecentriq, Roche has another positive early-stage lung cancer trial to celebrate. This time, the honor belongs to a targeted therapy in Alecensa. Alecensa, compared with chemotherapy, reduced the risk of tumor recurrence or death when used after surgery in certain non-small cell lung cancer patients, Roche said Friday. The patients had ALK-positive, stage 1b to 3a tumors that were completely resected before taking Alecensa. The positive readout, from the ALINA trial, makes Alecensa the first ALK inhibitor to show a benefit in early-stage NSCLC in a phase 3 trial, Roche noted. Data on patient survival remain immature. But the Swiss pharma said it’ll submit the results to the FDA and the European Medicines Agency for a potential label expansion. “If approved, Alecensa has the potential to treat cancer before it has spread in a setting where treatment can increase the chances of cure,” Roche’s chief ...
- Source: drugdu
- 117
- September 6, 2023
Novo Bolsters Obesity Pipeline with Potential $500M Embark Biotech Buy

By Kate Goodwin Novo Nordisk has again bought a weight-loss focused biotech, as the obesity market heats up. Announced Wednesday, the Danish pharma plans to buy Embark Biotech for $16.3 million up front with close to $500 million on the line in milestone payments—Novo’s second obesity-focused acquisition in three weeks. Novo participated in the seed round for Embark in 2017 when the biotech spun out from Novo Nordisk Foundation Center for Basic Metabolic Research at the University of Copenhagen. The company said it was founded on the discovery of a “novel target that suppresses appetite increases energy expenditure and enhances insulin sensitivity.” The acquisition announced Wednesday gives Novo full rights to develop and commercialize Embark Biotech’s lead metabolic program, currently in preclinical stages. Included is a three-year R&D collaboration with Embark Laboratories, a new company being formed by the biotech’s team to develop therapies for obesity and related conditions, with ...
- Source: drugdu
- 209
- September 1, 2023
US announces first ten drugs up for Medicare price negotiation

Medicare will soon be able to negotiate the prescription drug prices for the first time, under US President Joe Biden’s Inflation Reduction Act (IRA), which was enacted last year. Earlier today, the US Department of Health and Human Services (HHS) released a list of ten drugs that will be up for price negotiations. Aimed at driving down healthcare costs and increasing patient power, the IRA allows the Centers for Medicare and Medicaid Services (CMS), the US Government’s national insurance programme, to provide drugs at reduced prices. The price negotiation process will consider elements like the drug’s clinical benefit, the unmet clinical need, and the costs associated with the drug’s production. The negotiations with manufacturing companies will occur in 2023 and 2024, with any price changes rolling in by 2026. Blockbuster drugs are aplenty on the list. Bristol-Myers Squibb (BMS) and Pfizer’s co-developed drug Eliquis (apixaban) and Amgen’s Enbrel (etanercept) are ...
- Source: drugdu
- 103
- August 31, 2023
Sandoz’s Tyruko approved by FDA as first biosimilar for relapsing multiple sclerosis

Sandoz, a Novartis division, has announced that its biosimilar Tyruko (natalizumab-sztn) has been approved by the US Food and Drug Administration (FDA) to treat adults with relapsing forms of multiple sclerosis (MS). The disease-modifying therapy, developed by Polpharma Biologics, is a version of Tysabri (natalizumab) and is now the first FDA-approved biosimilar for this patient population. A biosimilar, according to the FDA, is a biological product that is highly similar to one already approved in the US. This means patients can expect the same safety and effectiveness from the biosimilar as they would from the reference product, but may potentially benefit from lower healthcare costs. “Biosimilar medications offer additional effective treatment options that have the potential to increase access for people living with relapsing forms of MS,” said Paul Lee, director of the Division of Neurology 2 in the FDA’s Center for Drug Evaluation and Research. Tyruko, which is administered ...
- Source: drugdu
- 232
- August 30, 2023
FDA Approves Sandoz Biosimilar to Biogen’s MS Therapy Tysabri

By Tristan Manalac Pictured: Novartis office in Switzerland/iStock, Michael Derrer Fuchs The FDA on Thursday approved Sandoz’s Tyruko (natalizumab-sztn), a biosimilar of Biogen’s blockbuster treatment Tysabri (natalizumab), a monotherapy for the treatment of adults with relapsing forms of multiple sclerosis. Tyruko is also indicated for inducing and maintaining clinical response and remission in patients with Crohn’s disease with evidence of inflammation, and who are either unable to tolerate or show an inadequate response to conventional therapies. Sandoz is the generics and biosimilars arm of Swiss pharma Novartis, which in August 2022 announced that it was spinning the division off into a standalone entity, scheduled for the fourth quarter of this year. With Thursday’s approval, Tyruko becomes “the first biosimilar product indicated to treat relapsing forms of multiple sclerosis,” Sarah Yim, director of the FDA’s Office of Therapeutic Biologics and Biosimilars, said in a statement. The regulator’s decision will also contribute ...
- Source: drugdu
- 112
- August 29, 2023
Sandoz says its biosimilar matches Eylea in another threat to Regeneron’s blockbuster

With its blockbuster eye drug Eylea, Regeneron is already juggling between a recent FDA rejection and new competition. Meanwhile, biosimilar players are also eying a piece of the pie. Tuesday, Novartis’ Sandoz said its biosimilar to Eylea showed no clinically meaningful differences with the originator in a phase 3 trial in patients with wet macular degeneration. The two versions were therapeutically equivalent in improving the best vision that patients can achieve. Sandoz now expects to file the Eylea biosimilar in the U.S. and EU in the coming months. The Sandoz drug is only the latest copycat to be closing in on Eylea. Viatris was the first to file an Eylea biosimilar in the U.S. in 2021. That asset now belongs to Biocon Biologics through a $3 billion transaction. In addition, the partnership between Formycon and Coherus BioSciences filed its biosimilar in June, followed on the heels by a separate filing ...
- Source: drugdu
- 146
- August 17, 2023
Eco-minded AstraZeneca doubles down on renewable energy push in Sweden

AstraZeneca is often at the forefront when it comes to sustainability efforts among pharma companies. Now, the British drugmaker is doubling down on its clean energy commitments in Sweden. AstraZeneca and Stratkraft—Europe’s largest renewable energy producer—have entered into an agreement on wind power deliveries that will increase the supply of renewable electricity in Sweden based on the commissioning of new wind farms, the companies said Wednesday. Under the deal, AZ will purchase 200 gigawatt-hours per year for 10 years, the partners explained. That amount corresponds to roughly 80% of the company’s total electricity needs at its research facility in Gothenburg and its manufacturing plant in Södertälje. The wind farms for this project will be located in Strömstad and Årjäng, in the same region as AZ’s research and manufacturing facilities. Across its Swedish operations, AstraZeneca is also working to cut back on its electricity consumption. One way it’s meeting this goal ...
- Source: drugdu
- 114
- August 11, 2023

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