Target to $220 from $300
Thursday, March 3, 2022
Why NuCana Stopped Phase 3 Biliary Tract Cancer Trial
NuCana plc (NASDAQ: NCNA) will discontinue its NuTide:121 study following a pre-planned futility analysis by the study's Independent Data Monitoring Committee (IDMC).
The NuTide:121 Phase 3 trial assessed Acelarin plus Cisplatin in patients with previously untreated advanced biliary tract cancer.
Although a higher objective response rate was observed in the Acelarin plus cisplatin arm, this did not translate into an overall survival benefit.
The IDMC concluded that Acelarin plus cisplatin was unlikely to achieve its primary objective of demonstrating at least a 2.2-month improvement in overall survival compared to the standard of care, gemcitabine plus cisplatin.
Acelarin plus cisplatin was generally well tolerated.
In September, the FDA has granted Fast Track designation to Acelarin (NUC-1031) for the first-line treatment of advanced biliary tract cancer.
The Company is moving forward with other ProTides in clinical development, NUC-3373, and NUC-7738.
The Company expects dosing the first patients in the Phase 3 study of NUC-3373 combined with other agents for colorectal cancer in 2H of 2022.
NUC-7738 is entering Phase 2 development in solid tumors and lymphoma patients and expects to announce additional data in 2022.
Civica aims to launch low-cost insulin in U.S. by 2024
Non-profit drugmaker Civica said on Thursday it expects to launch lower-cost versions of insulin in the United States by 2024, to help diabetic patients struggling with high prices for the life-sustaining medicine.
Civica, launched in 2018 to make generic drugs, said it would produce three copycat versions of insulin, and make them available at roughly the same price for all customers, once approved by U.S. health regulators.
The company's products, which would be available as both vials and pre-filled pens, are biosmilars to Sanofi SA's SASY.PA Lantus, Eli Lilly and Co's LLY.N Humalog and Novo Nordisk's NOVOb.CO Novolog.
The maximum price for all three of Civica's products would be no more than $30 per vial and no more than $55 for a box of five pen cartridges, the company said.
That compares with $300 per vial and $500 for five pens, which are the average wholesale prices, according to Civica.
More than 34 million people in the United States have diabetes, according to the U.S. Centers for Disease Control and Prevention (CDC).
https://www.userwalls.com/n/civica-aims-launch-low-cost-insulin-2024-2903652/
U.S. Healthcare Agencies Request Data on COVID Misinformation
The U.S. Department of Health & Human Services and the Office of the Surgeon General will request input on COVID-19 misinformation online as they seek to understand the role it played during the pandemic and its impact on health decisions made by individuals.
The agencies will put out a Request For Information (RFI) on Thursday to collect public comments and data within 60 days from stakeholders such as academic institutions, advocacy groups, government entities and community-based organizations.
"This RFI seeks to understand both the impact of health misinformation during the COVID-19 pandemic and the unique role that technology and social media platforms play in the dissemination of critical health information during a public health emergency," the agencies said.
The RFI will look for details on how rampant COVID misinformation is on tech platforms, their policies to fight suh content and sources who spread such lies online. It will also look for data on how such content impacted trust in the healthcare system, morale of healthcare workers and the implications for future public health emergencies.
Reuters reported in February the White House has eased up in its fight against vaccine misinformation after Biden accused Facebook last year of "killing people" by spreading vaccine lies.
Novo Nordisk more than doubles sales target for obesity drugs
Danish drugmaker Novo Nordisk has more than doubled its target for sales of obesity drugs by 2025 after overwhelming demand for its new Wegovy drug.
Novo Nordisk now aims to generate annual obesity drug sales of more than 25 billion Danish crowns ($3.72 billion) by 2025, the company said at its capital markets day on Thursday.
Its previous goal was to double its 2019 obesity drug sales totalling 5.7 billion crowns.
The company had a breakthrough with Wegovy, which was released in the United States in June last year and helps to achieve weight loss of 17% on average over almost two years.
Novo Nordisk was overwhelmed by initial demand for Wegovy, leading to supply shortages.
The company took a further hit in December, when a contract manufacturer filling syringes for pens to inject the drug temporarily halted deliveries and manufacturing after issues relating to good manufacturing practice.
I-Mab Gets Orphan Drug Designation for Gastric-Cancer Treatment
I-Mab said on Thursday that it has been granted an orphan drug designation by the U.S. Food and Drug Administration for its gastric-cancer treatment.
The drug, TJ-CD4B, is a novel Claudin bispecific antibody that treats gastric cancer, gastroesophageal junction cancer and related cancers.
The clinical-stage biopharmaceutical company said the designation would help it expedite its global clinical development and bring to market a novel treatment for the group of cancers.
I-Mab said it is undergoing Phase 1 trials in the U.S. and China in patients with advanced solid tumors stemming from gastric and related cancers.
Roche teams up with research institutions for new Alzheimer's trial
Roche Holding is launching with three research institutions a new late-stage clinical trial of its gantenerumab treatment in Alzheimer's disease, the Swiss drugmaker said on Thursday.
The trial aims to evaluate the potential of gantenerumab to slow disease progression in people with the earliest biological signs of Alzheimer's disease, before too much permanent neurological damage is done, it said in a statement.
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