Ketabon GmbH revealed positive top-line results from its phase 2 KET01-02 study investigating KET01, an oral slow-release formulation of oral ketamine, for treatment-resistant depression (TRD). Results were promising initially. Investigators noted improvements in depression severity as early as day 4, but data were not statistically significant over placebo at day 21. A look at Ketabon…
Prices of top 25 Medicare Part D drugs more than doubled since market entry; AARP offers new insights in drug pricing report
Medicare Part D drug prices have seen a significant surge in recent years. The price of the arthritis drug Enbrel has soared 701% since its launch in 1998, and the diabetes drug Januvia has jumped 275% since its debut 2006. All in all, the average price increase for the 25 brand-name drugs with the highest…
Working backwards: AWS’s strategy for pharma’s cloud-enabled transformation
The meteoric rise of the AI sector is hard to fathom. Projections from Precedence Research suggest that the global AI market could balloon by 2600% from 2022 to 2032, hitting $1.87 trillion — an annual growth rate of 39%. In pharma, AI and data science demand is surging though overall growth is sluggish. Despite advances…
CGT demands vision, partnership and patient-centricity to transform healthcare
As personalized medicine continues to progress, cell and gene therapy (CGT) development is poised to enable tremendous medical breakthroughs. Unlike traditional treatments which merely manage symptoms, CGT could treat the root biological cause of many diseases: the faulty genes. “The cell and gene therapy space is truly exciting. What this ultimately means for patients and…
Amgen v. Sanofi: A Supreme Court decision steers drug developers into uncharted waters
The Supreme Court’s recent decision in the case of Amgen Inc. v. Sanofi (No. 21-757) could chart a new course for both the pharmaceutical industry and patent law. In this decision, the Supreme Court provided clarity on what the Patent Act means by ‘enablement,’ raising the bar for the level of detail needed in certain…
The big spenders: The top 25 pharma companies in R&D investments
In the throes of the COVID-19 pandemic, when the world was desperate for a lifeline, the global pharma sector’s R&D prowess was thrust into the limelight. Now, as the pandemic begins to loosen its grip, the sector continues to make aggressive investments in research and development (R&D). At the tip of the spear of this…
Navigating generative AI in drug discovery and data analysis: Seizing the opportunity and avoiding pitfalls
Along with predictive AI, generative AI is emerging as a promising tool in drug discovery. Thanks in part to the rise of ChatGPT, interest in the technology in drug discovery is on the upswing. In March, a preprint appeared examining the potential to use generative AI to enable de novo antibody design. Also this year,…
Discover the 25 top pharma employers of 2023
The pharma and biotech sectors continue to face rapid change. On one hand, top pharma employers have continued to face talent shortages as demand increases for experienced workers. But on the other, the pharma sector has not been immune to layoffs. One factor driving the trend is the increased clip of mergers and acquisitions (M&A)…
Speed up regulatory submissions: A guide for efficiency
Drug development involves many rounds of regulatory approval and oversight, including multiple stages of regulatory submissions. In the U.S., these include the Investigational New Drug Application (IND) before clinical trials in humans, the New Drug Application (NDA) or Biologics License Application (BLA), prior to commercial sale and Annual Product Quality Reviews (APQR) to monitor ongoing…
Science 37, Crinetics and Gritstone Bio announce inducement grants to boost talent acquisition
Science 37 Holdings (Nasdaq:SNCE), Crinetics Pharmaceuticals (Nasdaq: CRNX) and Gritstone Bio (Nasdaq:GRTS) have announced recent inducement grants to attract new non-executive employees under Nasdaq Listing Rule 5635(c)(4). This move showcases the companies’ focus on talent acquisition and retention in the competitive pharmaceutical and biotechnology markets. A clinical trial research organization based in Durham, North Carolina,…
The new National Cancer Plan launches with goal of cutting cancer death rate by half in 25 years
Today, the U.S. Department of Health and Human Services (HHS) debuted the National Cancer Plan with an ambitious albeit vague quest to “end cancer as we know it.” Specifically, the initiative will serves as a guideline to support President Biden’s Cancer Moonshot objectives, which aims to reduce the cancer mortality rate by 50% over a…
Pharmaceutical industry trends: 2023 outlook
If your only tool is a hammer, everything looks like a nail. Such was the state of the pharmaceutical industry a decade ago. Gone are the days of pharmaceutical companies predominantly specializing in single modalities such as traditional vaccines, monoclonal antibodies, plasma-derived therapies or small molecules. Today’s Big Pharma, fueled by the acquisition of countless…
Simplifying safety reporting as part of clinical trial investigator retention
The pharmaceutical industry is like many others today in that there is a high turnover rate. The surge in new clinical trials starting and post-pandemic changes in hiring amplify these concerns for clinical investigators. For example, a 2017 study using the FDA’s Bioresearch Monitoring Information system classified 54.2% of principal investigators as “one-and-done,” meaning they had only…