PharmaFocus Today – Page 212 – media

Announcement of New Coronavirus Variant mRNA Vaccine (Omicron XBB.1.5) Approved for Emergency Use

Walvax Biotechnology Co., Ltd. (hereinafter referred to as the “Company”), in cooperation with Fudan University and Shanghai Blue Magpie Biopharmaceutical Co. (hereinafter referred to as the “RQ3033 Vaccine” or the “Vaccine”) developed by the Company in cooperation with Fudan University and Shanghai Blue Magpie Bio-pharmaceutical Company Limited (hereinafter referred to as the “Shanghai Blue Magpie”), which was approved by the relevant state departments for inclusion in the Emergency Use Program after receiving a letter from the Vaccine Research and Development Task Force of the State Council’s Research and Development Group of the Joint Prevention and Joint Control Mechanism on December 1, 2023 The “Vaccine” was approved for emergency use by the relevant state departments. The RQ3033 vaccine is an iterative vaccine developed on the basis of the mRNA technology platform jointly established by the Company, Fudan University and Shanghai Blue Magpie, and on the basis of the first-generation vaccine, i.e., ...
- Source: drugdu
- 110
- December 13, 2023
Announcement of Changchun BCHT Biotechnology Co. on Voluntary Disclosure of Approval of Clinical Trial Application for Freeze-dried Human Rabies Vaccine (Human Diploid Cells)

Important Notice: Changchun BCHT Biotechnology Co. (hereinafter referred to as the “Company”) has recently received the Notice of Approval of Drug Clinical Trial from the State Drug Administration. 2, the freeze-dried human rabies vaccine (human diploid cells) subsequent clinical trials are uncertain, and there is a certain degree of uncertainty whether the commercial purpose can ultimately be achieved. Investors are kindly advised to make decisions with caution and pay attention to the prevention of investment risks. The relevant information is announced as follows: I. Main information of the Notice of Approval of Drug Clinical Trial Acceptance No.: CXSL2300615 Notification No.: 2023LP02456 Drug Name: Lyophilized Human Rabies Vaccine (Human Diploid Cells) Conclusion: Agree to carry out clinical trials for the prevention of rabies. Approval date: December 6, 2023 The freeze-dried human rabies vaccine (human diploid cell) approved by the Company this time is freeze-dried human rabies vaccine (MRC-5 cell). II. Introduction ...
- Source: drugdu
- 98
- December 13, 2023
As ICER places a spotlight on pharma’s price hikes, J&J, Roche and more hit back

After many years of tracking the pharmaceutical industry’s pricing tactics, the Institute for Clinical and Economic Review (ICER) is once again placing a spotlight on the price increases that end up costing the U.S. healthcare system the most. In an annual report (PDF) on “unsupported price increases” (UPIs), the independent nonprofit has placed scrutiny on hikes that it says aren’t supported by evidence of new clinical benefit, ranking the medicines by their contributions to excess healthcare spending. This year’s edition saw the return of AbbVie’s superstar Humira, which last year enjoyed a break from the annual list after being included in every other report since the series began in 2019. The fifth annual version, released Monday, evaluates the industry’s pricing moves in 2022. For Humira, 2022 was the last year of market exclusivity before the med’s dive off of the patent cliff. Humira captured ICER’s top spot on its UPI ...
- Source: drugdu
- 94
- December 13, 2023
Abecma’s survival data show why FDA wanted expert meeting on the Bristol Myers cell therapy

Last month, Bristol Myers Squibb made the surprise announcement that the FDA will convene an advisory committee meeting to discuss the company’s bid to move the CAR-T therapy Abecma into earlier lines of treatment. Now, we know at least one reason why the FDA wants more opinions on the application. Abecma showed no advantage in extending patients’ lives compared with standard combination regimens when used in multiple myeloma patients after two to four prior lines of therapy, according to an updated interim analysis of the phase 3 KarMMa-3 trial presented at the 65th American Society of Hematology annual meeting. The statistical analysis revealed a negligible 1% increased risk of death for Abecma. But median overall survival looks better for Abecma, as patients lived a median of 41.4 months versus 37.9 months for control. The lack of an overall survival showing came in stark contrast to the 51% reduction in the ...
- Source: drugdu
- 97
- December 13, 2023
Nanopore Sequencing Cuts Tumor Analysis Times and Costs, Finds Study

Copy number variations (CNVs), which activate oncogenes and inactivate tumor suppressor genes, play a crucial role in the development and progression of cancers. As such, CNV analysis is a vital component of tumor grading and diagnosis. Traditionally, this analysis relies on nucleotide hybridization and next-generation sequencing, methods confined to high-complexity centralized laboratories and requiring several days to complete. A more rapid, cost-effective, and straightforward approach to CNV analysis could significantly enhance clinical decision-making, refine surgical planning, and facilitate the identification of potential molecular therapies within the timeframe of surgical procedures. Researchers have now identified nanopore sequencing as a method to refine CNV analysis. A study conducted by researchers at Dartmouth-Hitchcock Medical Center (DHMC, Lebanon, NH, USA) has found nanopore sequencing to be a more efficient means for CNV analysis. They used Oxford Nanopore’s MinION device, which offers real-time interpretation of long-read nucleotide sequences. To adapt this technology for CNV detection, ...
- Source: drugdu
- 102
- December 13, 2023
Medtronic expands AI endoscopy partnership with Cosmo

Dive Brief Medtronic will pay Cosmo Intelligent Medical Devices $100 million upfront to expand a partnership that makes Medtronic the exclusive global distributor of Cosmo’s GI Genius platform. GI Genius received de novo clearance in 2021 and uses machine learning to flag regions of interest during a colonoscopy, helping physicians detect lesions, such as polyps or suspected tumors. In addition, Medtronic said it would pay a double-digit royalty on net sales and another $100 million in milestone payments that it expects the partnership to reach by the end of 2024. Dive Insight Medtronic first started working with Cosmo Intelligent Medical Devices, a subsidiary of Cosmo Pharmaceuticals, in 2019. When the Food and Drug Administration cleared GI Genius a few years later, the agency said it was the first device that used machine learning to help clinicians detect lesions in the colon. Now, Cosmo and Medtronic are expanding their partnership, including ...
- Source: drugdu
- 96
- December 13, 2023
Merck and Moderna to Launch Trial of mRNA-4157 Plus Keytruda in Non-Small Cell Lung Cancer

Pharmaceutical Executive Editorial Staff Phase III trial to investigate novel individualized neoantigen therapy V940 (mRNA-4157) in combination with Keytruda (pembrolizumab) as an adjuvant treatment for patients with completely resected Stage II, IIIA, or IIIB non-small cell lung cancer. Image credit: Axel Kock | stock.adobe.com Merck and Moderna, Inc., have announced plans to launch the pivotal Phase III INTerpath-002 (NCT06077760) clinical trial of the novel individualized neoantigen therapy V940 (mRNA-4157) in combination with Keytruda (pembrolizumab) as an adjuvant treatment for patients with completely resected Stage II, IIIA, or IIIB non-small cell lung cancer (NSCLC). V940 is comprised of synthetic mRNA coding for up to 34 neoantigens that are designed and produced based on the unique mutational signature of a patient’s tumor. After administration of the drug, the algorithmically derived and RNA-encoded neoantigen sequences are endogenously translated and undergo natural cellular antigen processing and presentation. “As lung cancer is the leading cause ...
- Source: drugdu
- 98
- December 13, 2023
With More 2024 FDA Filings Planned, Novartis Drug Starts Showing Blockbuster Potential

Novartis drug iptacopan, which won its first FDA approval in early December in a rare blood disorder, has met the main goal of a pivotal test in an ultra-rare kidney disease. The small molecule’s potential to address many diseases has stirred up blockbuster expectations. By FRANK VINLUAN The blockbuster potential for new Novartis drug iptacopan rests on the molecule’s ability to reach many diseases. The drug is on the way to its first one, following a recent FDA approval in a rare blood disorder. Now Novartis has data in a different rare disease with no approved treatment options. The Swiss pharmaceutical giant says these results could support regulatory submissions in 2024. While Novartis has said iptacopan could achieve peak sales topping $3 billion, the company has provided no breakdown of that projection by indication. The results announced Monday are from a Phase 3 test of iptacopan in C3 glomerulopathy (C3G), ...
- Source: drugdu
- 103
- December 13, 2023
Seagen’s Adcetris and Bristol’s Opdivo boost hopes for another ADC, PD-1 combo

If you can’t beat them, join them. After Bristol Myers Squibb’s Opdivo topped Seagen’s classical Hodgkin lymphoma (cHL) therapy Adcetris in a head-to-head trial, Seagen has trotted out new datasets suggesting the two drugs—a PD-1 inhibitor and an antibody-drug conjugate—hold potential when paired together as part of a combination. In a midstage study, all patients with early-stage cHL who received a combination of Adcetris, Opdivo and the chemotherapy regimen AD (doxorubicin and dacarbazine) were alive without disease progression after one year of treatment. The analysis came from 150 patients enrolled in part C of the phase 2 SGN35-027 trial and was shared at the 65th American Society of Hematology annual meeting. The data look promising, but cHL is known to be relatively easy to treat. In an interview, Megan O’Meara, M.D., Seagen’s head of clinical development, acknowledged that people want to see longer-term data—and ultimately a survival benefit—in frontline cHL. ...
- Source: drugdu
- 109
- December 12, 2023
Vertex, CRISPR score landmark FDA approval for sickle cell disease gene therapy Casgevy

Groundbreaking? Game-changing? Transformational? Historic? None of the buzzwords sound adequate to describe Friday’s FDA approval of Vertex Pharmaceuticals and CRISPR Therapeutics’ Casgevy (exa-cel) to treat sickle cell disease (SCD). The therapy is a long-awaited potential cure for the debilitating and life-threatening disease which affects more than 100,000 in the United States, most of them Black. It’s also the first medicine using the revolutionary CRISPR gene-editing system, which earned its inventors a Nobel Prize in 2020 and holds tantalizing potential to cure diseases for which there is no treatment. Friday, in surprising timing, the FDA approved a second gene therapy for SCD, bluebird bio’s Lyfgenia (lovo-cel), which was due for a decision Dec. 20. Both approvals are for people 12 and older. The FDA has signed off on roughly two dozen cell or gene therapies, beginning with Novartis’ Kymriah in 2017, but none have the potential impact of Casgevy and Lyfgenia. ...
- Source: drugdu
- 113
- December 12, 2023

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