Search Results for “FDA” – Page 125 – media

Darzalex Faspro in Multiple Myeloma, Imbruvica-Venclexta in Mantle Cell Lymphoma

By Tristan Manalac Ahead of the 65th Annual Meeting and Exposition of the American Society of Hematology, taking place Dec. 9 to 12, event organizers on Tuesday released late-breaking abstracts providing an early view of some of the most high-impact studies in blood disorders to be presented at the conference. Focus on two of those studies below. J&J, Genmab’s Darzalex Faspro Early data from the Phase III PERSEUS study showed that J&J and Genmab’s subcutaneous anti-CD38 antibody Darzalex Faspro (daratumumab and hyaluronidase-fihj) significantly prolonged progression-free survival (PFS) in patients with newly diagnosed multiple myeloma (NDMM). PERSEUS enrolled 709 patients in total, of whom 355 were randomly assigned to receive Darzalex Faspro combined with bortezomib, lenalidomide and dexamethasone (VRd). At a median follow-up of 47.5 months, patients treated with the Darzalex Faspro regimen saw a significantly better PFS versus comparators who received VRd alone. The effect had a hazard ratio of ...
- Source: drugdu
- 114
- November 25, 2023
Smith+Nephew to buy CartiHeal and its knee cartilage healing tech

Agili-C is a porous, biocompatible, and resorbable scaffold for cartilage regeneration in the knee. [Image courtesy of CartiHeal and Smith+Nephew] Smith+Nephew (LSE:SN, NYSE:SNN) announced today that it has agreed to acquire CartiHeal and its novel sports medicine technology. CartiHeal’s Agili-C is an off-the-shelf, porous, biocompatible, and resorbable scaffold. Approved by the FDA in 2022, it promotes natural regeneration of the articular cartilage — and restoration of its underlying subchondral bone. Under the acquisition agreement, Smith+Nephew will pay an initial $180 million for CartiHeal. There’s also the potential for CartiHeal’s present owners to receive a further $150 million contingent on financial performance. “The acquisition of this disruptive technology supports our strategy to invest behind our successful Sports Medicine business,” S+N CEO Deepak Nath said in a news release. “Agili-C’s superior clinical performance makes it highly complementary to our existing knee repair portfolio, and with our proven commercial expertise in high-growth biologics, ...
- Source: drugdu
- 136
- November 25, 2023
InDex Scraps Phase III Ulcerative Colitis Trial on Disappointing Data

By Tristan Manalac InDex Pharmaceuticals on Tuesday announced that it is discontinuing the Phase III CONCLUDE program, which was evaluating its investigational immunomodulatory therapeutic cobitolimod in ulcerative colitis. The decision to terminate the late-stage study is in line with the recommendations of an Independent Data Monitoring Committee, which found during a planned dose selection, safety and futility analysis that cobitolimod is “unlikely” to meet the study’s primary endpoint, according to the company’s announcement. At the same time, InDex noted that the committee’s advice to discontinue the study was not due to any safety concerns. InDex CEO Jenny Sundqvist in a statement called the committee’s recommendation “surprising and disappointing,” adding that cobitolimod’s failure in CONCLUDE highlights the “complexity of the disease” and points to the need for more research to address the “high unmet medical need” in ulcerative colitis. The company’s stock was trading approximately 59% lower on Wednesday morning in ...
- Source: drugdu
- 134
- November 24, 2023
Another medtech reports a cybersecurity incident

BY JIM HAMMERAND The London-based device developer disclosed the cybersecurity incident in a Securities and Exchange Commission filing this week, saying the incident disrupted portions of its information technology systems and business operations. “Promptly after detecting the issue, the company began an investigation with assistance from external cybersecurity experts and is coordinating with law enforcement,” LivaNova said in the filing. “The company continues to assess what information and systems were impacted and is executing its incident response plan, including implementing remediation measures to mitigate the impact of the incident.” “The company has and will continue to take actions to remediate the issue, such as taking certain systems offline,” the company continued. LivaNova said it expects continued disruption of its operations, and can’t yet determine “the extent of the impact from such event on its business, results of operations, cash flows or financial condition.” Earlier this year, the SEC launched new ...
- Source: drugdu
- 96
- November 24, 2023
Merz strengthens its global footprint with botulinum approval in Australian market

With approval granted from the Australian Therapeutic Goods Administration (TGA), Merz Therapeutics’ Xeomin (incobotulinumtoxinA) enters the Australian market as the first and only neurotoxin treatment for chronic sialorrhea or excessive drooling in adults and children. Xeomin, a botulinum toxin type A with accessory proteins, is designed to block the release of neurotransmitter acetylcholine, thereby inhibiting signal transduction and incapacitating the body’s ability to contract voluntary muscles. Sialorrhea is a common symptom associated with Parkinson’s disease, amyotrophic lateral sclerosis (ALS), cerebral palsy (CP), stroke, and acquired brain injuries. The TGA approval follows a series of greenlights by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). The drug, which is currently approved for adults and children in the US, was originally granted approval in the EU to treat chronic sialorrhea in adults in 2019. The EMA approval was awarded based on data from the Phase III SIAXI ...
- Source: drugdu
- 92
- November 24, 2023
To address shortage, Novo Nordisk will cut production of Victoza to boost supply of Ozempic

Unable to scale up its manufacturing fast enough to meet the spiraling demand for its GLP-1 weight loss products, Novo Nordisk is employing a new strategy—reducing production of diabetes drug Victoza to make more Ozempic. Novo and the European Medicines Agency (EMA) divulged (PDF) the move in a letter to healthcare professionals, warning of a growing shortage of both medicines that is set to intensify during the rest of the fourth quarter. With the shortage of Victoza expected to continue into the second quarter of next year, the EMA has instructed healthcare providers not to start new patients on the drug until then. While Victoza (liraglutide) and Ozempic (semaglutide) are both GLP-1 drugs, the former—which was originally approved in 2010—is not used for weight loss. Intermittent shortages of Ozempic are expected to persist throughout 2024, though the overall supply situation should improve in the first quarter of next year, according ...
- Source: drugdu
- 151
- November 24, 2023
The Impact of US Drug Shortages on the Supply Chain

Nicholas Saraceno IQVIA report explores why these shortages are increasing, and how they can be mitigated. Image Credit: Adobe Stock Images/Julia Drug shortages are an issue that continue to grow in news coverage, due to their impact on patient care and public health. Data suggests that the amount of drug shortages in the US is increasing as more shortages continue to be reported than resolved. As a report by IQVIA titled Drug Shortages in the US 2023: A Closer Look at Volume and Price Dynamics1suggests, stakeholders have suggested various tactics to mitigate shortages, including prioritizing essential medicines, stockpiling, and making changes to reimbursement or statutory rebates. Shortages appear to be driven by a variety of causes that need to be better understood, as they may impact which solutions will best address them. This aforementioned report assesses shortages reported by the FDA, alongside sales and volume data of these medicines in ...
- Source: drugdu
- 106
- November 23, 2023
Merck & Co bolsters neurogenerative portfolio with Caraway acquisition

MSD has entered a definitive agreement to acquire Caraway Therapeutics in a deal worth up to $610m. MSD will acquire the Massachusetts-based small molecule therapeutics company through one of its subsidiaries. The $610m consideration includes undisclosed upfront and milestone-based payments. MSD plans to expense the upfront payment as part of its Q4 2023 expenses, as per a 21 November press release. MSD has been a Caraway shareholder through its subsidiary, MRL Ventures Fund. As per the agreement, the company will “acquire all outstanding shares of Caraway with earnout milestones associated with the development of certain pipeline candidates”. The transaction has already been approved by Caraway’s board of directors. Caraway has a preclinical pipeline of therapies for neurogenerative diseases, especially Parkinson’s disease. Caraway’s lead preclinical candidate targets the transient receptor potential cation channel subfamily (TRPML1), which is located on lysosomes and regulates their enzymatic activity. As lysosomal dysregulation has been seen ...
- Source: drugdu
- 104
- November 23, 2023
With filing in Sanofi and Mylan insulin lawsuit, FTC amps up scrutiny on pharma’s patent tactics

The U.S. Federal Trade Commission isn’t letting up in its effort to crack down on pharma’s alleged misuse of a patent mechanism in the FDA’s regulatory process. And it’s Sanofi’s turn to land in the crosshairs. The FTC is weighing in on an antitrust lawsuit that Viatris’ Mylan brought against Sanofi in May centered on the French pharma’s popular insulin product Lantus. Although the agency didn’t pick sides in the case, it’s using the lawsuit as an opportunity to criticize the type of behavior accused of Sanofi. Specifically, the FTC argues “improper” listings in the FDA’s “Orange Book” can “cause significant harm to competition, and that harm can extend beyond the delay” in access to a competing drug, the FTC said in an amicus brief filed in the case. In the lawsuit, Mylan accused Sanofi of running a “multifaceted monopolization scheme” to protect Lantus. One of the alleged illegal practices ...
- Source: drugdu
- 98
- November 23, 2023
What One Medicaid Insurer Looks for From Potential Health Tech Vendors

Digital health companies often start in the commercial market and thereafter target Medicaid plans. But not all startups are suited to serve the Medicaid population, according to Dr. Pooja Mittal, vice president and chief health equity officer at Health Net. That’s why Health Net created a vetting process to understand which companies have the potential to be the most effective with Medicaid members. The California-based insurer offers health plans for individuals, families and businesses and has three million members, including those who qualify for Medi-Cal or Medicare. Mittal noted that when the company started bringing in new vendors about four or five years ago, some were very successful working with its Medicaid population, while others struggled with engagement. “What we realized was that there were a lot of companies that didn’t have experience in the Medicaid space that were trying to enter into that space without a good understanding of ...
- Source: drugdu
- 97
- November 22, 2023

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