Search Results for “Clinical Trial” – Page 80 – media

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
- 91
- 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
- 102
- December 13, 2023
China Biopharm’s TQA3038 “siRNA” Phase I Clinic Completes Dosing in First Batch of Subjects

On December 5, China Biopharm announced that it is conducting a randomized, double-blind, placebo-controlled Phase I clinical trial to evaluate the safety, tolerability and pharmacokinetic profile of TQA3038, a small interfering RNA (siRNA) targeting the hepatitis B virus (HBV) developed independently by China Biopharm for the indication of chronic hepatitis B (CHB). TQA3038 is a small interfering RNA (siRNA) drug developed independently by China Biopharmaceuticals targeting HBV, with the indication of chronic hepatitis B. The first human clinical trial of TQA3038 has been completed with the enrollment of the first batch of subjects, and the dosing process went smoothly, and post-dosing observation has been completed. Chronic hepatitis B is a serious public health problem worldwide, with approximately 290 million chronically infected patients worldwide. China is a high prevalence area of hepatitis B. It is estimated that there are about 86 million chronic HBV-infected patients, and a large number of patients ...
- Source: drugdu
- 102
- December 12, 2023
Gates Foundation Delegation Visits Zhifei Biological Products Co., Ltd.

On December 1, a delegation of global health experts from the Bill & Melinda Gates Foundation (Gates Foundation) visited Beijing Zhifei Biological Products Co., Ltd., a wholly-owned subsidiary of Zhifei Biologicals, and visited the production workshop and related laboratories, and had an in-depth exchange of views on innovative topics, such as key conjugate vaccine projects. Mr. Du Lin, Executive Director of Beijing Zhifei Biological Products Co., Ltd., and others warmly received the delegation and attended the seminar. The visiting Gates Foundation delegation included clinical experts, vaccinologists and immunologists, and senior strategists. During the meeting, the Zhifei Biologicals team explained the clinical trials of key conjugate vaccine products, domestic and overseas sites and vaccine marketization, etc. The delegation introduced the incidence of relevant diseases and flow-regulation data, and made suggestions on planned clinical studies, etc. The Gates Foundation delegation fully recognized Beijing Zhifei Biological Products Co., Ltd.’s R&D strength and industrialization ...
- Source: drugdu
- 91
- December 12, 2023
FDA Approves Two Landmark Cell-Based Gene Therapies for Sickle Cell Disease

Pharmaceutical Executive Editorial Staff FDA approval of bluebird bio’s Lyfgenia and Vertex Pharmaceuticals’ and CRISPR Therapeutics’ Casgevy marks significant milestone in the treatment of sickle cell disease. The FDA has approved a pair of landmark treatments for sickle cell disease (SCD) in patients 12 years of age and older, marking the first cell-based gene therapies for SCD. As part of today’s regulatory action, both bluebird bio’s Lyfgenia (lovotibeglogene autotemcel [lovo-cel]) and Vertex Pharmaceuticals’ and CRISPR Therapeutics’ Casgevy (exagamglogene autotemcel [exa-cel]) gained approval for the inherited blood disorders, which affect approximately 100,000 people in the United States. “Sickle cell disease is a rare, debilitating and life-threatening blood disorder with significant unmet need, and we are excited to advance the field especially for individuals whose lives have been severely disrupted by the disease by approving two cell-based gene therapies today,” Nicole Verdun, MD, director of the Office of Therapeutic Products within the ...
- Source: drugdu
- 95
- December 12, 2023
On Heels of ASH Data, Pfizer Eyes FDA Submission for New Hemophilia Drug

Pfizer already reported its experimental drug for hemophilia A and B met a pivotal study’s goals of reducing bleeding episodes. During the annual meeting of the American Society of Hematology, the company presented a full look at the results, which are expected to support regulatory submissions soon. By FRANK VINLUAN Patients with hemophilia A or B can manage the inherited bleeding disorders with regular infusions of the clotting proteins they lack. This treatment helps—until it doesn’t. One problem with these infused factor replacement therapies is patients can develop inhibitors, which are antibodies that render the clotting proteins ineffective. Experimental Pfizer drug marstacimab takes a different approach to both forms of hemophilia. Results from a pivotal study show the subcutaneously injected drug met the main goals of reducing bleeding episodes. The company also has some additional long-term data showing continuing improvement beyond the initial clinical trial evaluation period. The full Phase ...
- Source: drugdu
- 90
- December 12, 2023
Edwards plans to spin off critical care business next year

BY SEAN WHOOLEY Edwards Lifesciences (NYSE: EW)+ announced today that it intends to spin off its critical care business by the end of 2024. The company shared a number of key plans going forward as it outlined its plans for future growth. Among its plans, Edwards expects to spin off the critical care unit and its full range of smart monitoring technologies next year. “During 2024, Edwards plans to support the growth and leadership of innovations in advanced patient monitoring, with the goal of improving the quality of care for millions of patients annually,” Edwards wrote in a news release. Analysts expect shares of Edwards to move up on the news today. Shares of EW rose 1% at $70.17 apiece in early-morning trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — remained even. Edwards intends to complete the spin-off tax-free. The ...
- Source: drugdu
- 99
- December 11, 2023
Eli Lilly Announces Availability of Obesity Drug Zepbound at US Pharmacies

Pharmaceutical Executive Editorial Staff Patients with obesity are now able to access Zepbound (tirzepatide) with a prescription at retail and mail-order pharmacies across six dose strengths. Eli Lilly and Company announced today that its obesity treatment Zepbound (tirzepatide) is now commercially available at pharmacies in the United States.1 Last month, the FDA approved Zepbound injection as the first and only approved treatment for obesity that activates both glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) hormone receptors.2 Image credit: Kurhan | stock.adobe.com Patients with obesity are now able to access Zepbound with a prescription at retail and mail-order pharmacies across six dose strengths—2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, 15 mg. “Today opens another chapter for adults living with obesity who have been looking for a new treatment option like Zepbound,” said Rhonda Pacheco, group vice president, Lilly Diabetes and Obesity, US, in a press release.1 The ...
- Source: drugdu
- 182
- December 7, 2023
Roche Jumps into Lucrative Weight-Loss Space with $2.7B Carmot Buy

By Tristan Manalac Pictured: Roche’s building in California Roche on Monday announced it has entered into a definitive merger agreement with Berkeley, California-based Carmot Therapeutics, a move that could place it in the thick of the lucrative and increasingly competitive weight-loss market. As per the terms of the acquisition, Roche will make an upfront payment of $2.7 billion at the transaction’s close, which the companies anticipate will occur in the first quarter of 2024, pending regulatory and anti-trust clearance. Carmot’s equity holders will also be eligible for up to $400 million in additional payments, contingent on the achievement of certain milestones. In return, Roche will gain access to Carmot’s portfolio of preclinical and clinical assets, including three GLP-1 receptor agonists, which have “best-in-class potential to treat obesity,” according to Monday’s news release. Carmot’s lead asset is CT-388, a dual agonist of both the GLP-1 and GIP receptors that is ready ...
- Source: drugdu
- 100
- December 6, 2023
Elli Lilly Cancer Drug Lands Its Second FDA Approval This Year

Eli Lilly cancer drug Jaypirca is closing 2023 the same way it started—with an FDA approval. The latest regulatory nod adds two additional types of blood cancers to the list of indications for the therapy. Friday’s accelerated approval for Jaypirca covers the treatment of adults with either chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The once-daily oral drug is a small molecule designed to block Bruton’s tyrosine kinase, or BTK, a cancer-driving enzyme. While other drugs already do this, Lilly’s molecule has an edge. The FDA based its decision on the results of an open-label, single-arm Phase 1/2 study in blood cancers that included more than 100 patients with CLL or SLL previously treated with at least two prior lines of therapy. Participants had received a median of five prior lines of therapy; the FDA said 77% of these patients had discontinued a BTK inhibitor after their cancer ...
- Source: drugdu
- 105
- December 6, 2023

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