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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
Amid COVID slump, Pfizer turns attention to RSV launch and a potential future in obesity

As COVID revenues dwindle for pandemic stalwart Pfizer, the company is turning attention to its respiratory syncytial virus (RSV) vaccine launch and a potential entry into the hot obesity market. With only five months of sales under its belt, Pfizer’s RSV vaccine Abrysvo is “doing better than we thought,” Chief Commercial Officer Angela Hwang said on the company’s third-quarter earnings call, touting “very fast uptake” for the new shot. After a pair of approvals in late May and August, Abrysvo pulled in revenues of $375 million during the third quarter, Pfizer said Tuesday. Earlier this year, the shot won FDA nods to immunize older adults and then as a maternal vaccination to protect infants. In both settings, the Pfizer offering is facing off against Big Pharma competition. In the adult RSV vaccine marketplace, Pfizer is challenging GSK and its immunization Arexvy. GSK is set to report its third-quarter results Wednesday. ...
- Source: drugdu
- 106
- November 2, 2023
Intuitive stock drops on mixed Q3 financial results

BY JIM HAMMERAND The Da Vinci Xi robotic surgery system. Intuitive continues to dominate the space. [Image courtesy of Intuitive] Intuitive Surgical (Nasdaq: ISRG)+ stock declined after the surgical robotics developer missed on revenue for the third quarter but beat analysts’ expectations on profit. Shares of ISRG dropped 8% to $251 in after-hours trading when Intuitive released the results. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — was down slightly on the day. The Sunnyvale, California-based surgical robotics leader posted profits of $416 million, or $1.16 per share for the three months ended Sept. 30, 2023. That was a 28% bottom-line gain compared to Q3 2022. The company reported sales of $1.74 billion, up 12% from the same quarter last year. Intuitive attributed the gains to growth in da Vinci surgical robot procedures and an increase in the installed base of systems. Adjusted earnings per share ...
- Source: drugdu
- 139
- October 31, 2023
Roche Cuts Pipeline as COVID, Currency Headwinds Impact Q3 Results

Pictured: Roche tower in Switzerland/iStock, olli0815 Roche is eliminating four clinical programs amid drooping sales brought about by a sharp decline in demand for COVID-19 products and a strong Swiss franc, the pharma group announced Thursday morning in its third-quarter earnings results. According to a development pipeline document released alongside the quarterly report, Roche will end a Phase I solid tumor trial for its investigational CEA/CD3 bispecific antibody cibisatamab. The company will also stop Phase II trials of its antipsychotic drug candidate ralmitaront in schizophrenia and the developmental cannabinoid receptor agonist vicasinabin in diabetic retinopathy. Roche discontinued the mid-stage study of ralmitaront after it failed a Phase II trial in May 2023, unable to elicit significant improvements on negative symptoms in a preliminary analysis. The vicasinabin and cibisatamab programs were likewise scrapped following underwhelming reviews of their efficacy in their respective studies. However, in a media call Thursday morning, a Roche spokesperson said that these two ...
- Source: By Tristan Manalac
- 143
- October 31, 2023
Supply disruptions are delaying surgeries and compromising patient care, survey finds

Dive Brief Shortages of medical devices and therapies are compromising patient care by delaying treatment and driving unsafe practices, according to a survey of healthcare professionals conducted by the patient safety nonprofit ECRI and the Institute for Safe Medication Practices. The survey found that supply shortages have caused surgical cases to be rescheduled, postponed or canceled, and that a lack of endotracheal tubes and pulmonary artery catheters is on the cusp of impacting the ability to provide adequate clinical care. ECRI and the Institute for Safe Medication Practices used the findings to call for “long-term, nationally coordinated solutions” to stop persistent shortages. Dive Insight The Food and Drug Administration currently lists 11 medical devices that are in short supply. More than 120 drugs face shortages, according to another FDA list. The tendency for some products to become hard to source, for reasons such as manufacturing problems and rising demand, predates ...
- Source: https://www.medtechdive.com/news/supply-disruptions-delaying-surgeries-ecri/697140/
- 215
- October 31, 2023
Pupil size may predict response to TMS treatment for depression

New findings from researchers at UCLA Health suggest that measuring changes in how pupils react to light could help predict recovery from depression and personalize transcranial magnetic stimulation (TMS) treatment of major depressive disorder. TMS is a safe, non-invasive therapy that uses magnetic fields to stimulate parts of the brain involved in mood regulation. While TMS is proven effective, not all patients respond equally well to the therapy. The ability to predict who will benefit most could allow doctors to better customize and target treatments. In two recent studies, UCLA scientists found that the pupil’s response to light before treatment correlated with improvements in depression symptoms over the course of therapy. Pupil size reflects activation of the autonomic nervous system, which controls involuntary functions and is negatively impacted in people with depression. The first study, appearing in the Journal of Affective Disorders, reports on outcomes for 51 patients who underwent ...
- Source: https://www.news-medical.net/news/20231020/Pupil-size-may-predict-response-to-TMS-treatment-for-depression.aspx
- 119
- October 31, 2023
Five pharma firms fined €13.4m over EC’s cartel investigation

Five pharmaceutical companies have been fined €13.4m ($14.1m) by the European Commission as part of an antitrust cartel settlement revolving around a key ingredient for the antispasmodic drug, Buscopan. The European Commission (EC) has confirmed that Alkaloids of Australia, Alkaloids Corporation, Boehringer, Linnea, and Transo-Pharm all admitted involvement in the cartel and agreed to settle the investigation with the fine. A sixth company, C2 Pharma, was also involved in the plot but was not fined as it revealed the cartel to the EC under the leniency programme. The EC investigation revolved around N-butylbromide scopolamine/ hyoscine (SNBB), an important input material used to produce the abdominal antispasmodic drug, Buscopan, as well as its generic versions. The investigation found that the six companies had coordinated and agreed to fix the minimum sales price of SNBB to customers, as well as allocate quotas. Additionally, the six companies exchanged commercially sensitive information. In a ...
- Source: https://www.pharmaceutical-technology.com/news/five-pharma-firms-fined-e13-4-million-over-ecs-cartel-investigation/
- 134
- October 30, 2023
PTC inks Royalty deal worth up to $1.5B on Genentech-partnered SMA drug Evrysdi

Amid a cost-cutting drive and a looming commercial threat in Europe, PTC Therapeutics is raising cash in a new royalty deal. In an agreement with Royalty Pharma worth up to $1.5 billion, PTC agreed to sell 67% of its royalty interest in the Roche-partnered spinal muscular atrophy drug Evrysdi. The deal includes an upfront payment of $1 billion, plus the option for PTC to sell its remaining royalty interest down the line for up to $500 million. As it stands, PTC will hold onto approximately 19% of its royalty interest on the drug, which it licensed to Roche’s Genentech in 2011. The deal gives PTC “added financial flexibility as we pursue our strategic objectives,” PTC’s chief Matthew Klein, M.D., said in a statement. The company recently disclosed more than 300 layoffs in New Jersey as its Duchenne muscular dystrophy drug Translarna faces a potential market withdrawal in Europe. PTC says it will use the capital to pay off its debt from Blackstone Life Sciences, which invested up ...
- Source: https://www.reuters.com/business/healthcare-pharmaceuticals/royalty-pharma-pay-1-bln-roches-sma-drug-royalties-2023-10-19/
- 109
- October 30, 2023
Roche announces positive phase 3 results for Alecensa in early-stage lung cancer

Roche has shared new results from a late-stage study of its anaplastic lymphoma kinase (ALK) inhibitor Alecensa (alectinib) in early-stage lung cancer. The phase 3 ALINA study has been evaluating the targeted drug as an adjuvant therapy in patients with completely resected stage 1B to 3A ALK-positive non-small cell lung cancer (NSCLC). Alecensa was shown to reduce the risk of disease recurrence by 76% compared with platinum-based chemotherapy, Roche said. A clinically meaningful improvement of central nervous system disease-free survival was also observed in those receiving Alecensa, and the safety and tolerability of the therapy were consistent with previous trials in the metastatic setting. Overall survival data was immature at the time of this analysis and the company has outlined that follow-up is ongoing to “report a more mature estimate”. Levi Garraway, Roche’s chief medical officer and head of global product development, said: “By reducing the risk of recurrence or ...
- Source: https://www.pmlive.com/pharma_news/roches_alecensa_shows_promise_in_phase_3_early-stage_lung_cancer_trial_1502267
- 124
- October 30, 2023
Drugdu.com Unveils Digital Medical Trade Solutions at CPhI Barcelona

The prestigious CPhI Worldwide Europe 2023 once again provided a dynamic platform for global suppliers, innovators, and pharmaceutical professionals to showcase their offerings and engage in valuable exchanges. The event, staged at the Barcelona Exhibition Center from October 24th to 26th, saw a remarkable gathering of 2,500 exhibitors and 45,000 attendees from around the globe. Amidst this impressive assembly, Drugdu.com made a notable appearance, unveiling its avant-garde digital solutions. Marking its eighth consecutive participation at the CPhI exhibition, Drugdu.com stood out with a captivating booth design that emanated vibrancy and creativity, attracting a multitude of industry experts. As a B2B platform heralding the integration of digitization in medical trade, Drugdu.com utilized this opportunity to share groundbreaking digital solutions, showcasing its profound expertise and market insight. The innovative approach was met with high acclaim and recognition from attendees, asserting a pivotal role in enhancing industry efficiency and spearheading the digital transformation ...
- Source: drugdu
- 247
- October 27, 2023

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