Search Results for “FDA” – Page 129 – media

First U.S. procedure performed with ZimVie 4.5mm Mobi-C device

BY SEAN WHOOLEY The Mobi-C cervical disc. ZimVie (Nasdaq: ZIMV)+ announced today that the first U.S. patient received its new 4.5mm Mobi-C cervical disc. Mobi-C became the first cervical disc approved for one and two levels by the FDA in 2013. Ten years later, in August of this year, ZimVie picked up FDA approval for a smaller height for the device. The updated 4.5mm Mobi-C comes in seven footprints to match patient anatomy. Dr. Gregory D. Lopez of Midwest Orthopaedics at Rush in Chicago implanted the first of these devices in the U.S. on Oct. 30. “The 59-year-old patient presented with a significantly collapsed C5-6 disc, and the new lower profile Mobi-C implant allowed me to avoid over-distracting the facet joints,” Lopez said in a news release. “The 4.5mm height Mobi-C makes it possible for me to offer pain relief and motion preservation to more of my patients with cervical ...
- Source: drugdu
- 99
- November 2, 2023
Eli Lilly Strikes $250M Deal to Add Gene-Editing Medicines for Cardio Conditions

Eli Lilly is acquiring Beam Therapeutics’ opt-in rights to three Verve Therapeutics gene-editing therapies for cardiovascular conditions. The deal comes four months after the pharmaceutical giant began a partnership on a preclinical Verve gene-editing therapy for a different target. By FRANK VINLUAN Eli Lilly signaled its growing interest in genetic medicines for cardiovascular conditions when it partnered with Verve Therapeutics earlier this year, committing to share in development of a preclinical gene-editing therapy addressing a key heart target. The pharmaceutical giant is now adding more cardiovascular disease drug prospects, pledging $250 million to secure the right to opt into development and commercialization of three additional Verve gene-editing therapies for other key targets. This time, however, the cash isn’t going to Verve. Lilly is paying Beam Therapeutics, whose base-editing technology is used in Verve’s experimental genetic medicines. Their original alliance, started in 2019, gave Beam the option to share in the ...
- 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
- 111
- November 2, 2023
Shorla acquires methotrexate solution from Therakind in the US

Shorla Oncology has acquired the oncology and autoimmune drug Jylamvo (methotrexate) from Therakind, for commercialisation in the US market. Jylamvo was approved by the US Food and Drug Administration (FDA) approval in November 2022, to treat adults with acute lymphoblastic leukaemia, mycosis fungoides, relapsed or refractory non-Hodgkin lymphoma, rheumatoid arthritis and severe psoriasis. Shorla is headquartered in Ireland and has operations in the US. The company had raised $35m earlier this month to advance its oncology pipeline. Jylamvo is an oral solution, making the treatment accessible to patients who may struggle taking tablets or other dosage forms. Commercialisation is set to begin immediately in the US. Chief Technical Officer and founder of Shorla Oncology Orlaith Ryan said: “This acquisition will provide a much-needed treatment to patients in need. It brings a crucial oral treatment to a larger patient population who suffer from cancer and other debilitating illnesses.” In March, Shorla ...
- Source: drugdu
- 100
- 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
- 94
- 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
- 100
- November 2, 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/
- 209
- October 31, 2023
Royalty Boosts Struggling PTC with Additional $1B for Royalties on Roche’s Evrysdi

Pictured: Handshake over a deal/iStock, PeopleImages Biopharma’s biggest royalties buyer is upping its stake in a popular spinal muscular atrophy drug. Royalty Pharma announced Thursday a $1 billion upfront payment to beleaguered PTC Therapeutics for additional royalties in Evrysdi, licensed and marketed by Roche. Royalty initially bought into Evrysdi in July 2020, just before its approval by the FDA. The drug has already been used to treat over 11,000 patients worldwide. Spinal muscular atrophy (SMA) is a rare and often fatal genetic disease that typically presents in infants and young children. The deal increases Royalty’s ownership of the Evrysdi royalty from 43% to 81%, equating to 13% of the royalties Roche pays on worldwide net product sales. Roche reported $801.4 million in sales for the first half of 2023. GlobalData predicts sales to rise to just under $3 billion in 2029. In Thursday’s announced deal, PTC has the option to sell the remainder of the Evrysdi royalty to Royalty for up ...
- Source: Kate Goodwin
- 117
- October 21, 2023
After launch limitations, Johnson & Johnson exec touts manufacturing progress on CAR-T drug Carvykti

As Johnson & Johnson and Legend Biotech have sought to grow the reach of their multiple myeloma CAR-T drug Carvykti since winning FDA approval last year, they’ve occasionally run into manufacturing pitfalls. Now, with an eye on a big market expansion, J&J is laying out the state of its cell therapy production writ large. Over the past several months, J&J has been “progressively adding more and more capacity” to churn out Carvykti, John Reed, M.D., Ph.D., executive vice president of pharmaceuticals R&D, said on a Tuesday conference call. Aside from the company’s original launch site in New Jersey, Reed said J&J is close to having an additional Carvykti manufacturing site “up and rolling” in Belgium. The company also plans to boost output by leveraging excess capacity from Novartis under a relatively new partnership. Reed described the lentivirus portion of Carvykti as a “rate-limiting” component of the therapy. Lentiviral vectors are pricey delivery components used to ...
- Source: drugdu
- 108
- October 20, 2023
Ultimovacs Rebounds on New Universal Cancer Vaccine Data for Mesothelioma

Pictured: Artistic rendering of doctor diagnosing lungs on screen/iStock, greenbutterfly Despite missing the primary endpoint mark in June 2023, Ultimovacs hasn’t given up on trying to prove its universal cancer vaccine has a benefit for deadly mesothelioma. The Norwegian biotech reported new data Tuesday, proving strong clinical responses with extended overall survival in a follow up analysis. When combined with Bristol Myers Squibb’s Opdivo and Yervoy as a second-line treatment to platinum chemotherapy, Ultimovacs’ UV1 reduced risk of death by 27% for patients with malignant pleural mesothelioma, a cancer in the lining of the lungs. Caused by asbestos fibers that have embedded in the pleura, eventually leading to mesothelioma tumors, this cancer is aggressive and often incurable. The five-year survival rate for localized pleural mesothelioma, the most treatable type, is 24%. Median overall survival for patients receiving the vaccine combined with the checkpoint inhibitors was 15.4 months, compared to 11.1 months on the immunotherapy treatments alone. ...
- Source: drugdu
- 103
- October 20, 2023

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