Search Results for “Sanofi” – Page 5 – media

SCOTUS hands win to Sanofi, Regeneron in long-running PCSK9 feud with Amgen

After numerous twists and turns, a highly divisive patent infringement case between Amgen and partners Sanofi and Regeneron has come to an end at the U.S. Supreme Court.The nine justices voted unanimously to uphold (PDF) a lower court ruling invalidating a pair of patents on Amgen’s PCSK9 cholesterol med Repatha. The case stretches back to 2014, when Amgen first sued Sanofi and Regeneron for allegedly treading on Amgen intellectual property with their rival PCSK9 drug Praluent, under development at the time as alirocumab. Praluent and Amgen’s Repatha won U.S. approvals just weeks apart in 2015. Both drugs work to help lower “bad” LDL cholesterol by blocking the protein PCSK9. In 2019, a judge ruled that certain claims of two Amgen patents covering Repatha were invalid. Amgen took that loss to federal appeals court, where it was rejected. The company ultimately petitioned the U.S. Supreme Court to hear the case in ...
- Source: drugdu
- 120
- May 21, 2023
Protalix, Chiesi challenge Sanofi with EU approval for Fabry disease med as FDA decision looms

Protalix BioTherapeutics and Chiesi Farmaceutici have endured a rejection from the FDA and conducted multiple readouts of a phase 3 trial of their Fabry disease candidate. After many stops and starts, the companies have finally scored a marketing approval in Europe for PRX-102 (pegunigalsidase alfa), an enzyme replacement therapy for the rare, genetic, progressive disorder, which causes an accumulation of fatty deposits in the lysosomes and strikes roughly 1 in 50,000 people. The authorization is based on results from a clinical program that has tested PRX-102 in more than 140 patients with up to 7.5 years of treatment. A head-to-head trial pitting PRX-102 against Sanofi’s Fabrazyme (agalsidase beta) demonstrated noninferior efficacy in controlling the kidney disease that accompanies the disorder. Fabrazyme, which was approved 20 years ago, is the longtime dominant drug in the Fabry disease market, generating sales of 938 million euros ($986 million) last year. Amicus Therapeutics of Philadelphia, which earned an FDA approval for its ...
- Source: drugdu
- 183
- May 8, 2023
Sanofi, Regeneron unveil ‘blow-out’ smoker’s lung drug data

March 23 (Reuters) – Sanofi’s (SASY.PA) asthma drug Dupixent met all targets in a trial to treat “smoker’s lung”, potentially adding billions to the French drugmaker’s growth prospects, but also underscoring a heavy reliance on its bestseller. In a late stage trial Dupixent, jointly developed with Regeneron (REGN.O), led to a 30% reduction in moderate or severe acute exacerbations of chronic obstructive pulmonary disease (COPD), a potentially deadly disease marked by progressive lung function decline. Shares in Sanofi and Regeneron surged after they said in a joint statement on Thursday a Phase III trial involving 939 current or former smokers also showed improvements in lung function, quality of life and respiratory symptoms. The French group’s stock was up 5.2% at 1205 GMT, reaching a seven-month high and far outperforming the STOXX Europe 600 Health Care index (.SXDP), which was little changed. Regeneron jumped 8.6% in U.S. ...
- Source: drugdu
- 177
- April 28, 2023
Sanofi, BARDA break ground on another flu vaccine plant at Pennsylvania campus

[Sanofi and the Biomedical Advanced Research and Development Authority have broken ground on a new formulation and fill facility at the company’s Swiftwater, Pennsylvania, campus. The plant is part of a third major manufacturing investment for BARDA at the site as part of a contract which was signed in 2019 to increase domestic production capabilities. (Photo by Chesnot/Getty Images)] Sanofi and the Biomedical Advanced Research and Development Authority (BARDA) are expanding their capacity to manufacture flu shots. They are breaking ground on a two-story formulation and filling facility at the company’s sprawling campus in Swiftwater, Pennsylvania. Sanofi will fill syringes and vials using isolator barrier technology as well as single-use technology to provide flexibility. This is the third major manufacturing investment for BARDA at the site as part of a contract signed in 2019 to increase domestic production capabilities for pandemic flu vaccines. The contract supports the ...
- Source: drugdu
- 144
- April 7, 2023
Sanofi Reports Strong Quarterly Earnings, Driven by Success of Key Products

Sanofi, the French multinational pharmaceutical company, has reported strong quarterly earnings for the fourth quarter of 2022, driven by the success of several key products. The company’s performance beat analysts’ profit forecast, and shares rose in response to the news. Sanofi’s revenue for the quarter was €10.2 billion, up 6.7% from the same period the previous year. Net income was €1.3 billion, an increase of 28.6% compared to the same quarter in 2021. The strong results were driven by the success of several of the company’s products, including Dupixent, Aubagio, and Lantus. Dupixent, a treatment for atopic dermatitis and asthma, was a particular standout, with sales of €1.3 billion in the quarter, up 42.9% from the same period in 2021. The drug has been a major growth driver for Sanofi, with sales expected to reach €10 billion by 2025. Aubagio, a treatment for multiple sclerosis, also performed ...
- Source: drugdu
- 123
- March 24, 2023
Sanofi to cut US insulin prices by up to 78% in January 2024

Sanofi has said it will cut the US list price of its most widely prescribed insulin by 78%, following similar moves by Novo Nordisk and Eli Lilly earlier this month. The changes will come into effect in January 2024 and will also include a $35 price cap on the same insulin, Lantus (insulin glargine injection), for those with commercial insurance. Around 8.4 million of the 37 million people in the US with diabetes use insulin, but the rising cost of the lifesaving medicine has been a pressing concern for many patients. Sanofi, Novo Nordisk and Eli Lilly produce over 90% of the US insulin supply and have come under recent fire over the rising costs of their products. In January, California attorney general Rob Bonta filed a lawsuit against the three drugmakers and leading pharmacy benefit managers for allegedly using their market power to overcharge patients for insulin. Other states ...
- Source: drugdu
- 139
- March 21, 2023
Sanofi halts venglustat clinical programme in ADPKD

French pharma company Sanofi has announced that it has halted the clinical programme of venglustat in autosomal dominant polycystic kidney disease (ADPKD). Although the safety profile of venglustat remains consistent with previously reported results, a Phase II/III trial of the drug did not meet its futility criteria. In addition, the study confirmed venglustat effectively inhibits the glycosphingolipid (GSL) pathway by demonstration a reduction in the lip GL-1. The STAGED-PKD study was stopped for futility after an independent analysis of the annualised rate change in total kidney volume (TKV) in patients receiving venglustat compared to placebo. In a statement, Sanofi said that trends from this analysis showed venglustat did not provide meaningful reduction in TKV growth rate – the primary endpoint of stage one of the study. The company added that the analysis suggests the reduction of GSLs may not play a significant role in the prevention of kidney cyst growth, meaning ...
- Source: drugdu
- 285
- June 2, 2021
Sanofi
European Commission approves Sanofi’s recombinant influenza vaccine

The European Commission has granted a marketing authorization for Sanofi’s Supemtek, a quadrivalent (four-strain) recombinant influenza vaccine: representing the first and only recombinant influenza vaccine approved in the European Union. The European Commission has granted a marketing authorization for Sanofi’s Supemtek, a quadrivalent (four-strain) recombinant influenza vaccine: representing the first and only recombinant influenza vaccine approved in the European Union. The vaccine is already approved in the US under the tradename Flublok Quadrivalent (where it is also the only recombinant influenza vaccine). The first European launches could become available for the 2021-2022 influenza season in certain countries; with the main launch set for the 2022-2023 season. The flu vaccine’s new recombinant technology is also being used in Sanofi’s lead COVID-19 vaccine candidate with GSK: which is expecting to launch a pivotal Phase 3 study before the year is out. This could be followed by a request for regulatory approval in ...
- Source: drugdu
- 383
- November 20, 2020
influenza vaccine
Manufacturing hiccup in China trips up Sanofi’s vaccine sales momentum

After a strong 2017, Sanofi Pasteur got off to a less-than-stellar start this year. In China, inspectors put a temporary kibosh on imports of the pediatric shot Pentaxim, thanks to vaccine batches that failed to pass inspection. That move hobbled the shot's sales—and dragged the rest of the unit down, too.
- Source: fiercepharma
- 630
- May 2, 2018
Company Insights Pentaxim Sanofi
Sanofi’s PD-1 inhibitor starts EU review for skin cancer

The EMA has kicked off its review of Sanofi and Regeneron’s immuno-oncology drug cemiplimab, which is aiming to become the sixth drug in the PD-1/PD-L1 inhibitor class to reach the market.
- Source: Pmlive
- 552
- April 8, 2018
cemiplimab immuno-oncology New Approvals

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