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 ...
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 ...
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 ...
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 ...
As Novartis’ Sandoz unit prepares to go it alone, the off-patent medicines specialist is buckling up for the biosimilars long haul. Sandoz on Tuesday struck an accord with Just – Evotec Biologics to develop and manufacture biosimilar candidates over a multiyear stretch. The deal, which includes an “option for expansion,” marks the latest step in Sandoz’s quest to strengthen itself as a standalone company, the generics unit said in a release. The companies did not say how much they are paying for the deal. Last summer, Novartis telegraphed plans to spin off Sandoz. The decision came as part of a wider strategic review at the company that kicked off in October 2021. As of last August, the spinoff was expected to wrap up in the second half of 2023. Under its latest pact, Sandoz will get its hands on Just – Evotec Biologics’ drug substance development platform and manufacturing technology. Sandoz will use that ...
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 company discontinued about 20 early-stage projects after reviewing their strategic fit and commercial potential. Novartis said Tuesday it will discontinue or license out 10% of its clinical development projects after reviewing their strategic fit and sales potential. The Swiss drugmaker has trimmed its drug pipeline to 136 projects, down by 16 from the 152 disclosed in its fourth quarter earnings report, according to a presentation Tuesday. The biggest cutbacks came to its early-stage projects, with 19 programs cut. Half of those were early-stage programs testing drugs for solid tumors. The move comes one year after Novartis resized its business and narrowed its research focus to five core therapeutic areas — cardiovascular, immunology, neuroscience, solid tumors and hematology. It expects to save at least $1 billion annually by 2024 as a result. “We systematically looked at the pipeline, identified projects that were outside the scope ...
On Thursday, the US Food and Drug Administration announced its final decision to withdraw its approval of Makena, a drug approved more than a decade ago to reduce the risk of preterm birth that had been the only medication approved for the condition. The FDA says that the drug is not effective and that the benefits of taking it do not outweigh the risks. “It is tragic that the scientific research and medical communities have not yet found a treatment shown to be effective in preventing preterm birth and improving neonatal outcomes – particularly in light of the fact that this serious condition has a disparate impact on communities of color, especially Black women,” FDA Commissioner Dr. Robert Califf said in a statement. “Fundamentally, however, the touchstone of FDA drug approval is a favorable benefit-risk assessment; without that favorable assessment, the drug should not have the status of ...
Drugs that combat obesity are under consideration for the first time for the World Health Organization’s “essential medicines list,” used to guide government purchasing decisions in low- and middle-income countries, the U.N. agency told Reuters. A panel of advisers to the WHO will review new requests for drugs to be included next month, with an updated essential medicines list due in September. The request to consider obesity drugs was submitted by three doctors and a researcher in the United States. It covers the active ingredient liraglutide in Novo Nordisk’s obesity drug Saxenda, which will come off patent soon, allowing for cheaper generic versions. The panel could reject the request or wait for more evidence. A decision by the WHO to include Saxenda and eventual generics on the list for adults would mark a new approach to global obesity by the health agency. It could also pave the way for a newer, more ...
The pressure on pharmacy benefit managers (PBMs) is ramping up. Both Congress and the Federal Trade Commission (FTC) are probing alleged anti-competitive practices by PBMs, and they’re doing so in parallel. Given the intense bipartisan pressure on PBMs, it’s increasingly likely that action of some kind will be taken to reform the drug pricing system. Last month, in a bipartisan vote of 18-9, the Senate Committee on Commerce, Science and Transportation advanced a bill, the Pharmacy Benefit Manager Transparency Act, to increase PBM transparency and crack down on what legislators and many policymakers are calling “deceptive practices.” Specifically, the bill stipulates what it deems are “unlawful activities” for PBMs to engage in. These include spread pricing – charging payers more than PBMs pay the pharmacy for a medication and then keeping the “spread” or difference as profit – and clawing back reimbursement payments from pharmacies. Regarding claw backs, PBMs assess direct and ...
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