Don Tracy, Associate Editor Collaboration aims to leverage Nhwa’s expertise in the country’s neuro-psychiatric health sector. Today, Teva announced that it has entered into a collaboration with Nhwa Pharmaceutical Co., Ltd with the goal of providing easier access to Teva’s drug Austedo in China. Austedo focuses on the treatment of neurodegenerative and movement disorders, particularly chorea associated with Huntington disease (HD) and tardive dyskinesia (TD) in adults. According to Teva, the partnership is a part of its goal of expanding the medication as a global brand, as it earned approximately over $1.2 billion in profits last year. Further, Teva reported that Austedo is the first deuterated drug to be approved in China. Deuteration involves replacing hydrogen atoms with deuterium, which can slow down the drug’s metabolism, allowing for less frequent dosing and potentially improving patient compliance.1 “We are committed to addressing the pressing needs of patients in China with more ...
Collaboration to focus on ulcerative colitis and Crohn’s disease. Image Credit: Adobe Stock Images/SciePro Sanofi and Teva Pharmaceuticals, a US subsidiary of Teva Pharmaceutical Industries Ltd., announced in a company press release plans to partner on development and commercialization of TEV’574, currently in Phase IIb clinical trials for the treatment of ulcerative colitis and Crohn’s disease, two types of inflammatory bowel disease. Under terms of the collaboration, Teva will receive an initial payment of $500 million with the potential to earn up to $1 billion in development and launch milestones. “This is a new era for Teva, and our robust, innovative pipeline is key to our Pivot to Growth strategy,” said Richard Francis, president, CEO, Teva, in the aforementioned release. “This collaboration further validates the great science that Teva has to offer with our internally developed anti-TL1A. We are honored to partner with Sanofi to bring their proven capabilities, leadership, ...
For three years, Teva has been defending against claims from the U.S. government that it paid illegal kickbacks to boost sales of its multiple sclerosis drug Copaxone. Now, with a trial just weeks away, Teva has scored a delay to pursue a unique appeal strategy. The trial was previously scheduled for September but has been postponed because of “substantial ground for difference of opinion” in one important aspect of the case, U.S. District Judge Nathaniel Gorton wrote in a Monday order (PDF) published by Reuters. The case centers on allegations from the government that Teva paid two patient foundations hundreds of millions of dollars to cover Medicare co-pays for patients on Copaxone for many years. The company made payments to the foundations even as it repeteadly raised prices, according to the government. The U.S. also alleges violations of the Anti-Kickback Statute, which prohibits drugmakers from directly funding Medicare co-pays. The ...
Another biosimilar product copying Johnson & Johnson’s top-selling drug Stelara may enter the U.S. market without a patent infringement challenge by early 2025 thanks to a new settlement.J&J has signed an agreement granting Alvotech and Teva a license for their proposed Stelara biosimilar, AVT04, in the U.S. The settlement allows the biosimilar makers to launch their version no later than Feb. 21, 2025, the companies said Monday. The new Stelara biosim deal follows another one J&J recently inked with Amgen, which gives the latter a license to launch its copycat no later than Jan. 1, 2025. Like Amgen, Alvotech and Teva haven’t gotten the FDA’s blessing for AVT04. The pair in January said the FDA had accepted its application with a decision targeted for the second half of this year. A verdict for Amgen’s version is expected by the end of the third quarter. Settling those biosimilar entry dates is ...
When Teva proposed its sweeping $4.25 billion opioid settlement to resolve thousands of claims across the country, all U.S. states except for Nevada and New Mexico jumped on board. Now, the company has worked out a separate $193 million deal with one of the holdouts.Under the deal, the generics giant will make annual payments to Nevada on a sliding scale starting next July and lasting through July 2043. The payouts will start at $7 million and rise to $9 million through 2037, then increase to $27 million in 2042. The cash will be divvied between Nevada and members of the One Nevada Agreement on Allocation of Opioid Recoveries, a group formed to distribute opioid-related funds to local governments. The deal also includes injunctive relief to put a stop to opioid misuse in the state. For one example, Teva is required to halt the promotion of opioid products, according to a ...
Right before opening arguments were set to begin in Gilead Sciences and Teva’s HIV antitrust trial, the two came to a last-minute settlement with some of the plaintiff groups. Both companies settled with the pharmacy plaintiffs, a group that includes CVS Pharmacy, Rite Aid and Walgreens, while Gilead made a deal with the direct purchasers. Now, indirect purchasers and others involved in the suit can take their claims to a California federal jury. Gilead and Teva confirmed the settlements, and Gilead noted that the lawsuit with the other parties is ongoing. “The claims against Gilead in this lawsuit lack merit, do not accurately reflect antitrust laws, and ignore Gilead’s history of innovation and scientific advancements to help address the pressing challenges of the HIV epidemic,” a Gilead spokesperson said over email. The deals mark an eleventh hour end to a sprawling case that dates back to 2019, when plaintiffs including ...
After a little over four months as Teva’s CEO, Richard Francis is getting ready to debut his long-term vision for the drugmaker. In Francis’ first quarter as Teva’s CEO, the Israeli pharma giant pulled down $3.7 billion in sales, a flat number versus the same period last year. In Europe, the company posted a 9% sales gain, Teva said Wednesday. Huntington’s disease and tardive dyskinesia med Austedo delivered a 10% global revenue gain to $170 million during the first quarter, while migraine prevention drug Ajovy posted a 35% increase to $95 million. Overall, first-quarter revenues came in around estimates, Barclays analysts wrote in a note to clients. In an investor presentation (PDF), Francis highlighted key attributes of the company, including its innovative pipeline and a “balanced risk portfolio.” The generics group is “a strong business that generates significant cash,” he added on Teva’s first-quarter earnings conference call. But what has ...
The U.S. Food and Drug Administration (FDA) issued two Complete Response Letters (CRLs) to South Korean manufacturer Celltrion. One was for a proposed biosimilar for Genentech and Biogen’s Rituxan for lymphomas and leukemias, and a proposed biosimilar to AbbVie’s Humira for rheumatoid arthritis, plaque psoriasis, Crohn’s disease and other autoimmune disorders.
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) announced that the U.S. Food and Drug Administration (FDA) has approved the use of TRISENOX® (arsenic trioxide) injection in combination with tretinoin for the treatment of adults with newly-diagnosed low-risk acute promyelocytic leukemia (APL) whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression. The approval was based on a Priority Review by the FDA on data from published scientific literature and a review of Teva’s global safety database for arsenic trioxide
As the world’s largest generics maker, Teva still doesn’t have much of a presence in China, even though it is a country relies heavily on generics. The Israeli company is looking to remedy that by reportedly forming a joint venture with local company Guangzhou Pharma
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