Search Results for “AI” – Page 42 – media

Sarepta enjoys early sales ramp for DMD gene therapy, maintains confidence in label expansion

The third quarter marked a momentous one for Sarepta Therapeutics, bringing the long-anticipated launch of its Duchenne muscular dystrophy (DMD) gene therapy Elevidys. After traveling a tumultuous road to the June approval, Sarepta reaped $69.1 million from Elevidys’ first quarter on the market. The number was more than enough to beat analysts’ expectations of between $20 million and $24 million. Sarepta stayed mum on exactly how many patients have received an infusion and instead provided revenue as a marker for uptake, CEO Doug Ingram said on Sarepta’s third-quarter earnings call. The drug is priced at $3.2 million per infusion. Also on the call, Sarepta reiterated its confidence that its phase 3 EMBARK study can potentially support a label expansion for Elevidys despite missing its primary endpoint. The company’s discussions with FDA leadership have shown that the agency is open to the idea of a label expansion “if supported by review ...
- Source: drugdu
- 101
- November 4, 2023
BioMarin’s longtime CEO Jean-Jacques Bienaimé hands the reins to Genentech’s Alexander Hardy

After 18 years at the helm, BioMarin’s CEO Jean-Jacques Bienaimé is hanging up the gloves. But he won’t be leaving the company without capable hands. Genentech CEO Alexander Hardy is leaving his current post—effective immediately—and will replace Bienaimé upon the BioMarin chief’s retirement on December 1. The transition comes after a “multi-year succession planning process” and a comprehensive search by BioMarin’s board, the company’s lead independent director Richard A. Meir said in a Wednesday statement. The Genentech CEO fit the bill as a candidate with “experience driving commercial growth and operational excellence,” Meier, who will now become chair of BioMarin’s board of directors, added. When Bienaimé took over BioMarin in 2005, the company was collecting some $26 million annually from its one marketed product, enzyme replacement therapy Naglazyme. Now, thanks to dwarfism med Voxzogo and hemophilia A gene therapy Roctavian, BioMarin recently turned a corner into profitability after many years ...
- Source: drugdu
- 104
- November 3, 2023
AI may help identify potential gonorrhea vaccine proteins

Gonorrhea, a sexually transmitted bacterial infection that affects more than 80 million people worldwide every year, has become resistant to almost all known antibiotics. That makes it notoriously difficult to treat, but left untreated, an infection could lead to serious or even fatal complications. It also increases a person’s risk of contracting HIV. A new study suggests artificial intelligence (AI) may help identify a vaccine’s key ingredients. This week in mBio, an international collaboration between academic and commercial researchers reported the identification of 2 promising antigens as candidates for a gonorrhea vaccine. The researchers used an AI model called Efficacy Discriminative Educated Network, or EDEN, to identify the protective proteins. They also used EDEN to generate scores that accurately predicted how well antigen combinations would reduce pathogenic bacterial populations of Neisseria gonorrhoeae, the microbe that causes gonorrhea. “To the best of our knowledge, this correlation has not been shown before,” ...
- Source: drugdu
- 183
- November 2, 2023
Sarepta Fails Confirmatory Trial for DMD Therapy, Still Eyes Label Expansion

By Tristan Manalac Sarepta Therapeutics on Monday posted topline data from the Phase III EMBARK study, showing that its Duchenne muscular dystrophy gene therapy Elevidys (delandistrogene moxeparvovec-rokl) fell short of its primary efficacy endpoint, unable to significantly improve functional mobility versus placebo. Nonetheless, based on what the company calls “robust evidence” of “clinically meaningful treatment benefit” across all EMBARK’s pre-specified key functional secondary endpoints, Sarepta will push through with filing for a label expansion for Elevidys. “We have shared the EMBARK topline results with FDA leadership and they have confirmed that, based on the totality of the evidence, they are open to such label expansion if supported by review of the data, and that they intend to proceed rapidly with consideration of the submission,” Sarepta CEO Doug Ingram said in a statement. In EMBARK, a randomized, two-part crossover and placebo-controlled study, Sarepta dosed 125 Duchenne muscular dystrophy (DMD) patients aged ...
- Source: drugdu
- 117
- November 2, 2023
Sarepta’s Elevidys fails on primary endpoint, but executives see path to wider DMD approval anyway

After Sarepta Therapeutics overcame several regulatory hurdles to finally win FDA approval for its Duchenne muscular dystrophy (DMD) gene therapy Elevidys, the company now faces the prospect of more FDA scrutiny because a pivotal study on the drug has failed on the primary endpoint. The endpoint, a measure of motor function called the North Star Ambulatory Assessment (NSAA), failed to reach statistical significance in the phase 3 EMBARK study, Sarepta said in a Monday release. Despite this result, Sarepta Chief Scientific Officer Louise Rodino-Klapac, Ph.D., touted “clinically meaningful” effects seen across the trial’s secondary endpoints. Speaking on a Monday conference call, Rodino-Klapac said Sarepta plans to file for a label expansion to treat “all DMD patients” and to convert the drug’s accelerated approval into a traditional nod. Sarepta CEO Doug Ingram said the study “met the standard” to show “evidence of effectiveness.” He added that the results show that the ...
- Source: drugdu
- 99
- November 2, 2023
Daiichi Sankyo, Merck Set to Collaborate on Three DXd Antibody-Drug Conjugates

Image Credit: Adobe Stock Images/huenstructurebio.com Daiichi Sankyo and Merck announced that they have entered into a global development and commercialization agreement for three of Daiichi Sankyo’s DXd antibody-drug conjugate (ADC) candidates: patritumab deruxtecan (HER3-DXd), ifinatamab deruxtecan (I-DXd) and raludotatug deruxtecan (R-DXd). Reportedly, the companies will jointly develop and potentially commercialize the candidates globally, except for Japan where Daiichi Sankyo will maintain exclusive rights. “The promising results from clinical trials of patritumab deruxtecan, ifinatamab deruxtecan and raludotatug deruxtecan continue to demonstrate the broad applicability of Daiichi Sankyo’s DXd ADC technology across multiple targets, with each of these medicines having the potential to change clinical practice as has been already seen with Enherti,” said Sunao Manabe, representative director, executive chairperson, CEO, Daiichi Sankyo Company, Limited. “As Daiichi Sankyo continues its transformation into a global oncology leader by increasingly building our infrastructure and talent, we recognize that a collaboration with Merck, a company ...
- Source: drugdu
- 138
- October 27, 2023
Disruptors of This Industry Are Already in It

A Formula 1 racing car is no joke. It’s purpose built, at great cost, at state of the art facilities with wind tunnels to improve aerodynamic performance and speed. The goal is simple: to win on tracks like the iconic Silverstone. It would be dangerously pointless to take an F1 car to the desert, smashing it through sand and into rocks, and expect it to perform the same. But today in healthcare, a host of new entrants and stakeholders is doing exactly that.Companies built for other businesses are attempting to offroad their skills into a brand new field. These fairweather healthcare players are unprepared for the terrain. Meanwhile, the true disruptors of this industry are already in it. When you hear newbies and big tech brands hyping AI, for example, delivered via ChatGPT, Microsoft, and others, as a way to transform healthcare, listen up. The bluster is a giveaway. Sure, ...
- Source: drugdu
- 112
- October 27, 2023
Surgery to straighten a crooked septum more effective than nasal sprays, trial suggests

Surgery to straighten a crooked septum (the thin wall of bone and cartilage dividing the space between the two nostrils) is more effective than nasal sprays, and should be offered to adults with at least moderate symptoms such as breathing disruption, suggests a UK trial published by The BMJ today.A crooked (deviated) septum often means that one nasal passage is narrower than the other, making it feel blocked, which can affect breathing, sleep or exercising. Surgery to correct this (septoplasty) is a common operation. In 2019-20, 16,700 septoplasties were carried out in England, but there’s a lack of high quality evidence evaluating septoplasty and therefore no clear guidelines for its use.To address this, a team of UK researchers designed the Nasal Airways Obstruction Study (NAIROS) to provide definitive evidence and recommendations for use of septoplasty. Their aim was to inform guidance on which patients may benefit from this treatment, and ...
- Source: drugdu
- 145
- October 20, 2023
Air pollution linked to increased breast cancer risk in women

Women living and working in places with higher levels of fine particle air pollution are more likely to get breast cancer than those living and working in less polluted areas. Results of the first study to take account of the effects of both residential and workplace exposure to air pollution on breast cancer risk are presented at the ESMO Congress 2023 in Madrid, Spain. Professor Béatrice Fervers, Head of Prevention Cancer Environment Department, Léon Bérard Comprehensive Cancer Centre, France, said, “Our data showed a statistically significant association between long term exposure to fine particle air pollution, at home and at work, and risk of breast cancer. This contrasts with previous research which looked only at fine particle exposure where women were living, and showed small or no effects on breast cancer risk.” In the study, home and workplace exposure to pollution in 2419 women with breast cancer was compared to ...
- Source: drugdu
- 207
- October 19, 2023
High-flying Novo Nordisk again dials up its 2023 sales and profit expectations

The popular diabetes med Ozempic and its sister weight-loss drug Wegovy are boosting Novo Nordisk to new highs again and again. The Danish company now expects full-year sales to grow between 32% and 38% at constant exchange rates. The new projection, released on Friday, represents a 5-percentage-point increase on both ends of the range from an August estimate, which itself was 3 percentage points higher than a previous forecast from April. Novo’s share price at one point traded at around $104 on the New York Stock Exchange on Friday, a new all-time high. Huge demand for Ozempic—which is often used off-label to treat obesity—plus new discount adjustments for Ozempic and Wegovy in the U.S. drove the updated sales outlook, Novo explained in a release. Novo on Friday also dialed up its estimated profit growth rate by 9 percentage points to a range of 40% to 46%. The company released the ...
- Source: drugdu
- 196
- October 17, 2023

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