Search Results for “generics” – Page 5 – media

Sandoz doubles down on biosimilars with $90M Slovenia site where it plans to hire 200

Sandoz is doubling down on its commitment to Slovenia in its globe-trotting biosimilar growth quest.The Novartis generics unit is plugging $90 million into a new biosimilar technical development center in Ljubljana, Slovenia, where the company aims to hire 200 new staffers. The new site, which Sandoz says will become “key” to its biosimilar development, will feature end-to-end drug substance and drug product development, the company said in a press release Thursday. This isn’t Sandoz’s first foray into the Balkan country. The announcement follows the company’s recent plan to invest a whopping $400 million in a new manufacturing plant there in Lendava. What’s more, Sandoz has already set up prior complex generic development capabilities in Ljubljana. Nearby, the company is also expanding its biosimilar development firepower in Holzkirchen, Germany. The latest move comes shortly after Sandoz unveiled its Act4Biosimilars action plan in June, under which it’s angling to triple global biosim ...
- Source: drugdu
- 120
- July 22, 2023
FDA Rejects Xspray’s Would-Be Rival to Bristol Myers’ Sprycel on Dosing, Manufacturing Concerns

With Xspray Pharma and Eversana’s cancer med hitting a regulatory setback, a launch in the second half of 2023 now looks unlikely. That’s good news for Bristol Myers Squibb, which has secured a few more competition-free months for its aging leukemia blockbuster Sprycel. Swedish drugmaker Xspray has received an FDA complete response letter on its application for its first product Dasynoc. In issuing the rejection, the FDA requested additional information on the drug’s dosing plus greater clarity around a third-party manufacturing facility. Xspray is seeking an FDA nod for Dasynoc to treat chronic myeloid leukemia (CML) and acute lymphatic leukemia (ALL). Despite issuing the rejection, Xspray said the FDA signed off on “critical aspects” of the application and did not identify any deficiencies pertaining to the drug’s stability or clinical data, the company said in a release Tuesday. Xspray is positioning its drug as a rival to BMS’ Sprycel, which clinched its first approval in CML back ...
- Source: drugdu
- 204
- July 13, 2023
Novartis Pledges to Appeal After Delaware Court Nixes Patent on Big-Selling Entresto

After a Delaware federal court ruled a Novartis combination patent on big-selling cardiovascular drug Entresto is invalid, the company pledged to continue its efforts to block generics with an appeal. The combination patent, which includes an extension thanks to a pediatric exclusivity award, is set to expire in July of 2025. Other patents on the drug run until 2026, 2027 and 2036. Now, Novartis will head to the U.S. Court of Appeals for the Federal Circuit (CAFC) in an effort to reverse the decision, the company said in a recent statement. The company will “continue to defend” its Entresto patents “vigorously” and warned that any generics that launch before the outcome of the appeal “may be at risk” of litigation. Currently, there are no Entresto copycats with tentative or official FDA approvals, the company noted. Just last week, the company chalked up a win against Mylan when a West Virginia court ruled that the ...
- Source: drugdu
- 134
- July 12, 2023
After nationwide deal, Teva reaches $193M opioid settlement with holdout Nevada

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 ...
- Source: drugdu
- 106
- June 11, 2023
Sandoz plans to stay local after Novartis separation, selecting new HQ in Basel

Paul Schloesser Associate Editor Sandoz, a generics maker that Novartis plans to spin off later this year, has picked its new headquarters — and it’s only 2.4 miles away from its current digs on the Novartis campus. The Novartis unit said Thursday that it plans to move to an office building in Basel called Elsässertor sometime in mid-2024. Sandoz CEO Richard Saynor said in a news release that the location in the heart of Basel “will allow us to create a working environment that meets our business needs,” citing the talent pool in the Swiss city. Sandoz added that the workspace is designed to allow for “closer collaboration and teamwork.” Sandoz did not immediately respond to queries from Endpoints News. Novartis announced back in August that it planned to spin out Sandoz as its own independent company, which is set to be listed on the SIX Swiss Exchange. Amid concerns ...
- Source: drugdu
- 112
- June 4, 2023
Lawmakers look to crack down on Big Pharma tax breaks

Drug pricing crackdowns aren’t the only way lawmakers are looking to reign in pharma’s business practices. With scrutiny of the industry intensifying on Capitol Hill, a Senate committee is now shining a spotlight on how Big Pharma is paying taxes, too. Earlier this month, Senate Finance Committee Chair Ron Wyden, D-Ore., released a memo revealing the latest findings of an ongoing investigation into how the industry has used a Trump-era law to reap massive decreases in tax rates. “Big Pharma gets us coming and going — they charge Americans sky-high prices and they pay absolute rock-bottom taxes,” Wyden said in a statement. According to Wyden, the industry has been leveraging a 2017 law that triggered a 40% reduction in the industry’s tax rate since it was enacted. All told, Wyden’s investigation found that in 2019 and 2020, the industry paid an effective tax rate of 11.6%, down from 19.6% on ...
- Source: drugdu
- 162
- June 3, 2023
Gilead, Teva reach 11th-hour settlements with some groups in HIV antitrust case

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 ...
- Source: drugdu
- 113
- May 31, 2023
VarmX raises funds to seek IND approval for VMX-C001

Biotechnology company VarmX has raised an additional €30m in a Series B2 financing round to obtain investigational new drug (IND) approval for its lead compound VMX-C001. VMX-C001 is a modified recombinant human blood clotting factor X that enables patients taking direct oral anticoagulant blood thinners to undergo emergency surgery without the risk of bleeding. It also enables blood to clot normally in the presence of factor Xa blood clotting inhibitors. VarmX also intends to use the financing to complete preparations for the pivotal clinical trial including large scale manufacturing. The company’s first-in-human study will demonstrate the safety of VMX-C001 and provide clinical proof of concept. Enrolment for this study is completed. Full study results are expected to be announced later this year. Led by Sound Bioventures, the Series B2 financing round has also seen participation from another new investor, the European Innovation Council (EIC) Fund. Existing investors include EQT Life ...
- Source: drugdu
- 111
- May 30, 2023
After IRA, Minnesota’s drug affordability proposal draws PhRMA’s ire

Even after Congress and the Biden administration passed the Inflation Reduction Act (IRA) last summer, some states are looking to further strengthen their drug pricing laws.This week, Minnesota’s legislature endorsed a proposal to create a statewide Prescription Drug Affordability Board. The board would have the power to set upper payment limits on certain high-cost pharmaceuticals, local newspaper Red Lake Nation News reports. The bill also includes provisions to stop price gouging on generics. It’s now on its way to Minnesota Governor Tim Walz for a signature. But that’s where the pharmaceutical industry’s lobby group is hoping to stop the proposal. Wednesday, the Pharmaceutical Research and Manufacturers of America (PhRMA) called on the governor to not sign the bill. The board would “do little to help patients and likely harm future access to medicines,” PhRMA’s senior vice president of state advocacy, Scott LaGanga, said in a statement. “This is a bad ...
- Source: drugdu
- 101
- May 22, 2023
Novartis brings on 8 business vets for Sandoz’s new board, including 4 women

Novartis has taken another step toward spinning off its generics and biosimilars business Sandoz, identifying eight of its new board of directors.The group includes Nestle chief financial officer Francois-Xavier Roger and former Eli Lilly chief information and digital officer Aarti Shah, Ph.D. They are among eight approved by Novartis after being recommended by Gilbert Ghostine, who was designated as Sandoz’s chairman of the board three months ago. Ghostine been the CEO of Swiss perfume and taste company Firmenich since 2014. Other new members of the board—which will begin prep work for the spinoff—include Urs Riedener, formerly the CEO of Swiss dairy company Emmi; Remco Steenburgen, the CFO at Deutsche Lufthansa AG; and Yannis Skoufalos, a former executive at Proctor & Gamble. In addition to Shah, the board will have three other women including Shamiram Feinglass, M.D., formerly the VP of medical affairs and policy at Danaher; Maria Varsellona, J.D., the ...
- Source: drugdu
- 126
- May 17, 2023

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