International data questions the assumption that chronic myeloid leukaemia is now a ‘solved’ disease Novartis’ survey of unmet (SUN) needs in chronic myeloid leukaemia (CML) data has highlighted the requirement for an increased patient voice during treatment discussions. It concludes that such exchanges would balance quality of life, efficacy and tolerability across therapies. The data has emerged from research in Australia, Brazil, Canada, France, Germany, Italy, Japan, South Korea, Spain, the UK and US. The final analysis is expected to be published later this year. The results reveal necessity for greater communication and shared decision-making between patients and physicians, as well as more tolerable therapy options that do not sacrifice quality of life (QoL) for efficacy. The survey also underlines an opportunity for physicians, patients, and other stakeholders to collaborate and better meet expectations for CML. Across the 11 nations, similar themes emerged around treatment goals, joint decision-making and treatment ...
After a yearslong investigation involving politicians and medical professionals alike, Novartis is looking to close the books on its Greek bribery imbroglio. The probe into allegations that the company paid kickbacks between 2006 to 2015 has culminated in Greece’s Council of Misdemeanor Courts clearing four former Novartis executives and a former politician of bribery charges, Greece’s Kathimerini reports. Former Novartis Greece Vice President Konstantinos Frouzis, alongside three other Novartis execs and former Health Ministry adviser Nikos Maniadakis, couldn’t be charged of bribing nonpolitical individuals due to the expiration of the statute of limitations, according to the publication. Ten other politicians were investigated, but no evidence was found to prove passive bribery, according to Kathimerini. Meanwhile, 15 doctors who allegedly received financial benefits for prescribing Novartis drugs have been charged for passive bribery and money laundering, according to the publication. Novartis did not immediately reply to Fierce Pharma’s request for comment. ...
Novartis’ Cosentyx (secukinumab) has been approved by the European Commission (EC) to treat adults with active moderate to severe hidradenitis suppurativa (HS). Cosentyx, which is now the first new treatment option for the inflammatory skin disease in nearly a decade, is specifically indicated for patients who have had an inadequate response to conventional systemic therapy. There are currently around 200,000 people in Europe living with moderate to severe stages of HS, which causes boil-like abscesses that can burst, creating open wounds and irreversible scarring. Until now, there has only been one approved biologic treatment for HS, with around half of patients potentially losing response to this. Surgery is usually considered in advanced cases to remove abscesses and prevent the disease from spreading further, which Novartis describes as an invasive procedure that frequently results in additional scarring. Currently approved to treat a range of inflammatory conditions such as psoriatic arthritis and ...
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 ...
The European Medicines Agency’s (EMA) human medicines committee has recommended revoking the conditional marketing authorisation for Novartis’ sickle cell disease (SCD) drug Adakveo (crizanlizumab). The recommendation follows a review by the Committee for Medicinal Products for Human Use (CHMP) that concluded the benefits of the drug, which is indicated for preventing painful crises in SCD patients aged 16 years and older, did not outweigh its risks. The CHMP’s review looked at results from the phase 3 STAND study, which compared the safety and efficacy of Adakveo with placebo. While the study did not raise new safety concerns, it showed a higher rate of severe and serious treatment-related side effects for Adakveo compared with placebo, the regulator said. The study also showed that Adakveo did not reduce the number of painful crises leading to a healthcare visit, with patients in the Adakveo group experiencing an average of 2.5 over the first ...
After Novartis’ sickle cell disease medicine Adakveo flopped in a phase 3 trial, European regulators promised to take a closer look at its prior approval. Now, the re-examination has come back with a recommendation to revoke authorization. The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) recommended snatching back Novartis’ approval after concluding that the med’s benefits did not outweigh the risks. The decision was based on the results of the phase 3 STAND trial, where the drug didn’t outperform placebo. Specifically, Adakveo (crizanlizumab) couldn’t reduce the number of painful crises leading to a healthcare visit. Adakveo-treated patients saw an average of 2.5 painful crises resulting in a healthcare visit over their first year of treatment, while patients in the placebo group had an average of 2.3. Another nail in the coffin was the average number of crises requiring a home healthcare visit or treatment, which ...
Two cancers studies are slated to grab significant attention at the upcoming American Society of Clinical Oncology 2023 annual meeting, and each could lead to a major label expansion for the companies involved. With KEYNOTE-671, Merck is looking to shake up how nonmetastatic non-small cell lung cancer (NSCLC) is treated by testing Keytruda both before and after surgery. For its part, Novartis will elaborate on the postsurgery data for Kisqali in early breast cancer from the NATALEE trial. When the company said the trial met its endpoint, investors sent the Big Pharma’s stock price up by 8% in a single day. Before the official data revelations on June 2 for NATALEE and June 3 for KEYNOTE-671, Fierce Pharma gathered expectations for the two studies from oncology leaders at Penn Medicine and MD Anderson Cancer Center plus market analysts at multiple firms. The NATALEE study could open a market that’s worth ...
Eli Lilly is throwing more money behind breast cancer drug Verzenio as it prepares to fend off a challenge from Novartis. Having seen growth hit 100% late last year, the Big Pharma has released a TV spot to push the message that Verzenio can help patients make new memories every day. Ads for Verzenio are a frequent sight on TV screens, with the estimated $111.8 million that Lilly spent on spots last year landing the drug in the 10 top most promoted products. Lilly has continued the promotional push in 2023. The “School Play” Verzenio spot was the second most seen pharma TV ad at the 65th Annual Grammy Awards early this year, and Lilly rolled out a fresh video earlier this month. The latest ad opens with a gray-haired Black woman sitting on a sofa looking at a photo album. As the camera zooms in and flips to an over-the-shoulder shot, a voice-over by the woman says ...
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 ...
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 ...
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