| |
October 5-6, 2023 | San Diego, CA Registration is now open for MASS West 2023! This is your opportunity to come together with medical affairs, field medical, and medical communications teams to share best practices, gain actionable insights, and crowdsource ideas to unique challenges. Click here to register today.
|
|
| By Kevin Dunleavy Novo Nordisk filed five lawsuits in four states on Tuesday, charging health spas, clinics and pharmacies with false advertising, trademark infringement and unlawful sales of compounded versions of diabetes and weight loss drugs Ozempic and Wegovy. Novo also is planning action against other unlawful sellers, the company said. |
|
|
|
By James Waldron Eli Lilly has taken a high-stakes gamble on oral IL-17 inhibitors, betting $2.4 billion upfront that acquiring Dice Therapeutics will expand its autoimmune arsenal. |
By Nick Paul Taylor Bavarian Nordic has identified a “concern” with its investigational COVID-19 vaccine. With phase 3 data imminent, the Danish drugmaker has reported weakened immune responses against the omicron variant XBB.1.1 in a midstage study. |
By Kevin Dunleavy Merck is back home again in Rahway, New Jersey, at the site that it established 90 years ago as Merck Research Laboratories. After being headquartered for eight years, seven miles to the north in Kenilworth, and before that, for 23 years in Whitehouse Station, 35 miles to the west, Merck has returned to its “reimagined” Rahway facility. |
|
Tuesday, June 27, 2023 | 11am ET / 8am PT The global Medical Device industry is vulnerable to many market threats, which can put patient safety at risk. Join us for this important discussion to learn how to add visibility for tracking and tracing devices throughout the supply chain and introduce authentication capabilities to ensure genuine products have been received and put into use. Register today!
|
|
By Andrea Park As 2022 drew to a close, Siemens Healthineers announced that it would be embarking on a yearslong cost-cutting campaign within its diagnostics division that would include swaths of layoffs and a slimmed-down product portfolio. The medtech giant still hasn’t disclosed the total number of positions that will be affected by the layoffs, but several dozen are now on the chopping block in New Jersey. |
By Teresa Carey This week on "The Top Line," we discuss the most expensive drugs in the U.S., plus Eli Lilly's recent acquisition, the latest company to challenge the Inflation Reduction Act, and the rest of the week's headlines. |
By Kevin Dunleavy In the battle for diabetes and obesity superiority, Novo Nordisk holds a head start as the original developer of the metabolism-regulating treatment semaglutide. But Eli Lilly is quickly gaining ground and is primed to become the market leader with its GLP-1 treatment Mounjaro, according to GlobalData. |
By Max Bayer Mersana Therapeutics' lead antibody-drug conjugate (ADC) has had the clamps put down by the FDA over bleeding events in patients that have included five fatalities. |
By Kevin Dunleavy An announcement early this month by Mark Cuban’s deep discount drug company that it would sell Coherus Biosciences’ biosimilar version of AbbVie’s Humira has the Illinois drugmaker calling foul. In a regulatory filing, AbbVie claims that Coherus has violated a licensing agreement, which governs the commercializing of the biosimilar. |
By Angus Liu Less than a month after AbbVie and Genmab won FDA approval for Epkinly, Roche has crossed the finish line with its bispecific answer to large B-cell lymphoma, though with a narrower label. |
By Helen Floersh Brain aneurysms at risk of rupture can only be treated with surgery, and that may not be possible if the aneurysm is in a hard-to-access location. But a new study hints at another solution: the cancer drug sunitinib, commercialized by Pfizer as Sutent, which appears to prevent aneurysms in mice. |
By Nick Paul Taylor Gilead Sciences' $225 million bet on Arcellx’s CAR-T cell therapy has hit turbulence. Months after Arcellx closed the deal, the FDA has put a pivotal trial of the anti-BCMA therapy on hold in response to the death of a patient. |
By Zoey Becker After scoring accelerated approval to treat HER2-positive stomach cancer in 2021, the drug has now shown it can stave off tumor progression in patients with PD-L1 positive tumors. |
By Zoey Becker After Merck took the first legal stab at the Inflation Reduction Act with a lawsuit against the Department of Health and Human Services (HHS), Bristol Myers Squibb is the latest drugmaker to allege Constitutional violations. |
By James Waldron Two months after dropping one of its GLP-1 agonists, AstraZeneca has decided to scrap its remaining clinical candidate. A preliminary analysis of the phase 1 data convinced the company that the drug would not outperform the competition. |
Fierce podcastsDon't miss an episode |
| | This week on "The Top Line," we discuss the the top news from this year's annual ASCO meeting, plus contesting the Inflation Reduction Act, an ADHD video game, and the rest of the week's headlines. |
|
|---|
|
|
| WhitepaperLearn how to develop a high-performing supply chain for cGMP chemicals used throughout your bioprocessing workflows. Sponsored by: Thermo Fisher Scientific Production Chemicals and Services |
| WhitepaperModern software development and its impact on addressing clinical trial complexity. Sponsored by: YPrime |
| WhitepaperAutoantibody screening is promising for early cancer detection with the potential to improve the whole treatment decision tree, providing a less invasive, powerful approach. Sponsored by: Sengenics |
| WhitepaperExplore how clinical supply can be scaled up as decentralized programs progress, and how technological solutions can accelerate trial deployment. Sponsored by: Catalent Clinical Supply |
| WhitepaperLearn how Catalent’s extensive network across APAC can meet a wide range of clinical supply needs for sponsors conducting trials within the region. Sponsored by: Catalent |
| WhitepaperThis paper outlines various market archetypes and key considerations leaders must address when prioritizing new potential markets for gene therapies. Sponsored by: Blue Matter, strategic consultants in the life sciences |
| Executive SummaryTraditional real-world data isn’t truly from the real world – it’s from the clinical world, and it’s missing a big part of neuro patients’ stories. Sponsored by: Evidation Health |
| WhitepaperBuilding a Sustainable Blueprint for a Holistic Market Access Strategy Sponsored by: EVERSANA® |
| |
|
