Roche Pauses Commercial and Clinical Use of Elevidys After Fatal Liver Failures
Roche discontinued the commercial and clinical use of Elevidys after two cases of fatal acute liver failure.
The Swiss pharmaceutical company said Sunday that the dosing of non-ambulatory patients, irrespective of their age, is paused in the clinical setting with immediate effect. Enrolment and dosing of non-ambulatory patients will also be immediately paused until additional risk mitigation measures are implemented, it added. Meanwhile, non-ambulatory patients shouldn't receive Elevidys in commercial settings.
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Yahoo
33 minutes ago
- Yahoo
Aspirus Health starts expansion of the Aspirus Houghton Clinic
Aspirus Health has commenced construction on its $5m renovation and expansion at Aspirus Houghton Clinic to improve healthcare efficiency, access, and patient experience in the Upper Peninsula, Michigan, US. The construction is led by the company in collaboration with Miron Construction and Plunkett Raysich Architects. Site preparation and fencing installation works commenced last month. This expansion of the clinic is a response to the growing demand for improved healthcare services. Aspirus Health regional clinics director Laura Brogan said: 'This facility is designed to enhance our patients' overall experience by focusing on team-based care and efficiency—from the moment you enter the parking lot, throughout your visit with our care teams, and even as you leave the facility.' The renovation and expansion project includes the construction of two new procedure rooms, 13 new exam rooms, a drive-through pharmacy, and a redesigned central registration and waiting area. It will also update the existing space to better serve the community. This project follows Aspirus Health's recent announcement of a $31.1m investment to expand Aspirus Keweenaw Hospital in Laurium, Michigan. Aspirus Keweenaw Hospital chief administrative officer Melanee Tiura said: 'We're excited to enhance and broaden local care while also contributing to the growth of the local economy. 'We are committed to continuously improving healthcare for our community. While the clinic has served this community for many years, it became clear that to meet the growing needs of our patients, we needed to expand services and capacity.' The Aspirus Houghton Clinic's project is anticipated to be completed in January 2026. "Aspirus Health starts expansion of the Aspirus Houghton Clinic" was originally created and published by Hospital Management, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
43 minutes ago
- Yahoo
Innovative Molecules Completes Enrollment of Phase 1b Clinical Trial of IM-250
Innovative Molecules GmbH Announces Completion of Phase 1b Enrollment for IM-250 in Genital Herpes Clinical Trial MUNICH, June 16, 2025 /PRNewswire/ -- Innovative Molecules GmbH today announced the completion of enrollment in the Phase 1b portion of its ongoing Phase 1b/2a clinical trial evaluating IM-250, a next-generation helicase-primase inhibitor targeting herpes simplex virus (HSV). This placebo-controlled study is designed to assess the safety, efficacy, and pharmacokinetics of once-weekly oral dosing of IM-250 in patients with recurrent genital herpes. The successful completion of Phase 1b enrollment marks a key inflection point in the program, supporting the continued clinical development of IM-250 and its potential to reshape a market that has seen little therapeutic innovation in over four decades. "Completing Phase 1b enrollment represents a significant milestone not only for our clinical program but also for patients who continue to face the burden of recurrent genital herpes with limited treatment options," said Dr. Anja Glaessing, Head of Medical Affairs at Innovative Molecules. Topline results from the Phase 1b portion of the study are expected in H2, 2025. About IM-250 IM-250 is a novel, orally available, selective HSV-helicase primase inhibitor. Helicase primase inhibitors block DNA unwinding in the replication fork during viral DNA-replication by a potentially uncompetitive mechanism of action. IM-250, due to its optimized molecular structure, is likely to improve target tissue penetration (neural and brain tissue), achieving adequate therapeutic exposure at the site of HSV reservoir. About Innovative Molecules Innovative Molecules GmbH is a drug development company based in Munich, Germany. With the aim to set a new treatment standard for herpes simplex induced diseases, the company is focused on the development of IM-250, a potent, second-generation helicase-primase inhibitor of HSV-1 and HSV-2. For more information visit Logo - View original content: Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Fast Company
an hour ago
- Fast Company
China is catching up to the U.S. in pharmaceuticals, but it's not too late to turn that around
A decade ago, China had just a few hundred pharmaceutical drugs actively in development. Today, China has thousands of drugs in active development and is continually increasing investment to make even more. This transformation was not, however, a foregone conclusion: China faced incredibly high barriers to growing its pharmaceutical industry including weak research investment and a highly fragmented market of small drug development firms. However, through engineering an environment conducive to pharma innovation, China went from developing 2% of all drugs globally to 25%. Over the same period, the U.S. decreased its share from 45% to 36%, according to Evaluate's internal data. A boost in funding and regulatory changes opened the door, but access to the right talent has taken China across the threshold into a pharmaceutical golden age. Scientists from China and other parts of Asia used to come to the U.S. to work for the biggest drug companies and with the brightest minds. Now, many experts are heading East to fill China's labs, and this return began well before the current administration took office. The result? A huge increase in the quality and quantity of novel Chinese medicines in development. Licensing deals To understand the threat China poses, look to major drug companies' product portfolios. Increasingly, instead of acquiring homegrown innovations, pharma giants including Novo Nordisk, Merck & Co., AstraZeneca, and most recently Pfizer are entering into high-profile licensing deals with Chinese firms. In 2024, 31% of big pharma licensing deals involved a Chinese biotech and that number is projected to grow this year. China now offers a dizzyingly abundant source of innovative, high-quality therapies at—by pharma standards—reasonable prices. Could the U.S. pharmaceutical industry, long a shining example of innovation on the world stage, soon be eclipsed? While China's pharma industry is close to becoming the world leader, the U.S. still holds key advantages to maintain dominance. Where China Has The U.S. Beat There are three hot spots of innovation in next-generation therapies where China's lead is becoming pronounced: Bispecific Antibodies ('Bispecifics): Engineered antibodies that bind to two different targets simultaneously, offering a novel way to fight cancers. They garnered billions of dollars in sales last year and 56% of those currently in development originated in China, according to Evaluate's internal data. Antibody-Drug Conjugates ('ADCs'): These antibodies deliver a highly potent chemotherapy drug directly to cancer cells. The ADC market is projected to reach $50B by 2030 and 55% of those currently in development originated in China. Chimeric Antigen Receptor T-Cells ('CAR-Ts'): T-cells modified to recognize and kill cancer cells. The CAR-T market is expected to reach over $21B by 2030 and 51% of therapies currently in development originated in China. GLP-1s Notably, despite the increasingly crowded nature of the obesity and diabetes space, Evaluate's internal data shows 46% of GLP-1 therapies in development are from Chinese sponsors. Merck, for example, made its first move into the obesity space not by developing its own drug but by licensing a Chinese GLP-1 pill late last year. Questions remain, though, about whether Chinese players can catch Western pharma leaders which have a huge head start in the obesity space. Realistically, it's unlikely that the U.S.—or any other country—will beat China in these top three areas, though many of these Chinese drugs will be acquired by U.S. companies before they reach the market. Despite China's formidable drug development pipeline, the nation still faces outsized challenges around financing innovative and late stage trials, multiple competitors racing to patent highly similar versions of a single drug, and pricing pressure from generic versions of drugs whose patents have expired—all of which might stall China's influence. U.S. Pharma's Secret Weapons While China ramps up novel cancer treatments, the U.S. remains a powerhouse with the infrastructure, academic institutions, and regulatory systems that will ensure it continues to play a critical role in the global market. While the U.S. does not have an overwhelmingly large global share of the development of any kind of drug, it still has a significant portion of many of the largest, and most exciting types. These include: Radiopharmaceuticals: Radioactive molecules injected into the body for both targeted cancer irradiation and medical imaging. They're already a multi-billion-dollar market, and the U.S. controls 40% of those currently in development. Traditional Small Molecules: The foundation of medicine (Lipitor is an example), these drugs are still extremely widely used and the U.S. controls 37% of those currently in development. Discovery advantages Beyond dominating in these two treatment types, the U.S. has a few key advantages that will be its saving grace in the competition for biopharma dominance. The United States' ace-in-the-hole is making initial scientific discoveries. It is still the best at finding new disease processes and ways of designing drugs while China's strength is iterating on already-established successes. Take the aforementioned ADCs and CAR-Ts: these innovations were discovered in U.S. labs and China has run with tweaked versions. While China is starting to break ground on developing new biology, the U.S. still has the drug discovery edge. Secondly, U.S. investors are willing to take risks. While the Chinese state is working to create a strong environment for biotechs, private investors in China are more risk-averse than their Western counterparts. So, there is opportunity in the U.S. to support potentially high-growth areas, such as cell and gene therapy. Thirdly, don't underestimate manufacturing. Since the announcement of potential tariffs hitting the pharma industry, a number of large drug companies have announced huge investment in their U.S. manufacturing sites. Many of these were almost certainly in the cards already but more investment in the U.S. will help bolster the wider industry. The Biosecure Act also supports this effort, enforcing stricter regulations on the supply chain. Innovation insurance Finally, dealmaking is innovation insurance. U.S. big pharma is well used to sourcing innovation and drug development programs through dealmaking, so one can argue that simply extending their gaze East to draw from the new pool in China is not such a shift anyway. Many, if not most, of the next generation therapies are likely to be acquired from abroad before completing their late-stage trials in the U.S. and reaching the market. Continued international licensing will ultimately benefit the bottom lines of American companies. China's genie is out of the bottle and there is no doubt that the country's ability to develop innovative drugs will continue to thrive. As the landscape diversifies, both countries will play crucial roles in advancing pharmaceutical innovation. Both the U.S. and China hold unique advantages; now is the moment America can reinvest in theirs to come out on top.
