| | By Angus Liu Eli Lilly has pushed back the deadline of its tender offer for radiotherapy company Point Biopharma’s shares for a second time. According to two senior executives, Lilly’s current predicament is caused not by any internal factors but by Point’s rival, Novartis. |
|
|
|
By Kevin Dunleavy Novartis has gained the first of what it hopes are several FDA approvals for its factor B inhibitor iptacopan, dubbed two months ago “a pipeline in pill,” by analysts at ODDO BHF. The U.S. regulator has given a thumbs up to iptacopan to treat paroxysmal nocturnal hemoglobinuria (PNH). Known commercially as Fabhalta, it becomes the first oral monotherapy approved by the FDA for the rare blood disorder, which affects 10 to 20 people per one million worldwide. |
By Nick Paul Taylor Pfizer is continuing to pinball between oral obesity assets. Months after making twice-daily danuglipron its top prospect, the Big Pharma has dropped the program after more than half of people taking the drug candidate dropped out of a midphase clinical trial. |
By Fraiser Kansteiner During an enterprise business review Tuesday, J&J laid out a range of expectations across the 2025 to 2030 timeframe. Chief among those, J&J says it will boast more than 10 drugs with peak sales potential of at least $5 billion, plus another 15-plus products with sales potential of at least $1 billion. |
By Nick Paul Taylor Merck KGaA just sent shockwaves through the BTK inhibitor space. Evobrutinib, the German drugmaker’s contender for a blockbuster opportunity, failed to beat Sanofi’s Aubagio in two phase 3 multiple sclerosis (MS) clinical trials, raising doubts about the prospects of a clutch of heavily backed rival candidates. |
By Fraiser Kansteiner WuXi Biologics expects to miss its original sales target for the year by around $400 million, thanks to reductions across its development and manufacturing services. WuXi Bio blamed the projected miss largely on a COVID-related revenue slowdown and a decline in projects. |
By Andrea Park The FDA is looking into a spate of quality complaints regarding plastic syringes manufactured in China. |
By Angus Liu When it comes to expanding radiotherapy manufacturing capacity for Lutathera and Pluvicto, Novartis is putting its money where its mouth is. The Swiss pharma is investing about $85 million to build a new radiotherapy facility in China. |
By Helen Floersh Researchers have used unaltered human tracheal cells to create self-assembling multicellular robots capable of healing wounded neurons in a petri dish. |
By Ben Adams Swiss major Novartis is leaning on its roots as it launches a new look for the company after this year’s Sandoz spinoff and pipeline refocus. |
Fierce podcastsDon’t miss an episode |
| Earlier this year, Fierce Healthcare, Fierce Pharma and Fierce Biotech recognized 50 individuals and companies that are pushing the industry forward. The Fierce 50 winners range from tech innovators to researchers developing novel therapies to providers on the frontlines of changing care. This week on "Podnosis," senior editor Paige Minemyer sat down with staff writers Dave Muoio and Anastassia Gliadkovskaya as well as senior editor Heather Landi to discuss a few of the honorees in more detail. |
|
---|
|
|
|
Thursday, December 14, 2023 | 2pm ET/ 11am PT Many teams struggle to keep up with maintenance and breakdowns of critical equipment. Join this webinar to explore the root causes of these issues and discover how integrating essential elements can increase equipment uptime and process reliability. Register now.
|
|
WhitepaperqPCR Assay Design - Quantify microbial biomarkers with high sensitivity and dynamic range Sponsored by: Diversigen |
WhitepaperStreamline your clinical cell therapy with our GMP-compliant ribonucleoprotein (RNP) manufacturing as you scale up without compromising on quality to tackle complex regulatory requirements. Sponsored by: Aldevron |
WhitepaperIf you find yourself grappling with bioanalytical challenges during the drug development process, rest assured that these obstacles can be overcome - discover more! Sponsored by: Sannova Analytical |
Whitepaper Discover how cloud-based HPC and AI can transform drug discovery and accelerate time-to-market. Download the free solution brief to learn more. Sponsored By: AWS, NVIDIA, and Rescale |
Executive SummaryBy 2030, the global demand for biologics is projected to grow at a CAGR of 8.7% and the challenges, risks, and costs of bringing large molecule products to market are growing exponentially. Sponsored by: ThermoFisher Scientific |
WhitepaperLearn about the untapped power of AI-driven insights — where innovation meetings precision, effortlessly unlocking benefits for your organization. Sponsored by: Planisware |
Whitepaper Medical devices & consumer wearables are starting to overlap, creating risks & opportunities for traditional medical device companies as well as consumer wearables manufacturers. This paper explores pros and cons from both perspectives. Sponsored by: Blue Matter Consulting |
Whitepaper Improving efficiency and productivity in biologics manufacturing is a longstanding goal within today’s industry, especially now as new and increasingly complex molecules are fundamentally changing technological and operational approaches to drug development. Process intensification can help accelerate this pace of innovation through advanced process development techniques and high productivity manufacturing platforms. Sponsored by: Lonza |
Whitepaper As a leader of technology transfer activities in the industry, Lonza understands the challenges associated with this critical step. Download this White Paper today to learn more. Sponsored by: Lonza |
eBookEmulate in vivo biology with next-generation in vitro technology. Sponsored by: Emulate |
WhitepaperDSCSA Compliance with a Trusted Partner Sponsored by: BioCare |
WhitepaperYour guide to accessing, managing, and licensing the content that fuels AI, machine learning, and data visualization projects across the enterprise. Sponsored by: CCC |
Whitepaper A critical area to consider in selecting a CDMO is their ability to successfully complete technology transfers, which involves an intricate set of activities and disciplines that, if done incorrectly, could result in delays and failures that impact the overall success of your end product. Recognizing what it takes to complete this process effectively and efficiently is crucial to selecting the best partner for your project and product needs. This white paper delivers an analysis of critical success factors for effective technology transfer. Sponsored by: Lonza |
WhitepaperWant to know the Top 5 criteria for selecting the ‘right’ CDMO for pDNA manufacturing? Sponsored by: Syngene |
| |
|