Search Results for “Novartis” – Page 13 – media

Chongqing’s first Class 1 innovative biological drug is launched

On August 27, Chongqing’s first Class 1 biological innovative drug, Celici monoclonal antibody injection, was approved for marketing, achieving a “zero” breakthrough in Chongqing’s biological product innovative drug track. According to Zhixiang Jintai’s official microblog, Celici monoclonal antibody injection is its first product approved for marketing and the first fully human IL-17A target drug in China. Indications for the birth of the “king of medicine” Moderate to severe plaque psoriasis as an indication is regarded as the “Gold Coast” in the field of autoimmune indications. The former “king of medicine” Humira was born from it. Due to the complexity of the psoriasis pathway itself, there are also many antigens that can be targeted in the pathway. The more typical one is the previous generation of “king of medicine” Humira. Adalimumab is a monoclonal antibody targeting TNF-α. This target has a wide range of adaptability for autoimmune diseases. Its indications range ...
- Source: drugdu
- 74
- August 31, 2024
Q&A with Michael Abrams

By Mike Hollan Abrams discusses how both new pharma and big pharma are reacting to each other and the current market.The last few years have been a rollercoaster ride for the pharma industry. Michael Abrams, managing partner at Numeroff & Associates, spoke with Pharmaceutical Executive about the current state of the industry and what factors are driving M&A and layoffs at the moment. Pharmaceutical Executive: What is driving layoffs in the Pharma sector? Michael Abrams: Despite hopes that the wave of layoffs in 2023 would mark the peak industry pain point, they have continued well into 2024. For big pharma companies, the language used in press releases varies, but the underlying causes are similar: growing pressure on price from government and private sector payers, combined with patent expirations that threaten to cut into revenue. While these are the main real issues, there is, after the surprise passage of the IRA, ...
- Source: drugdu
- 92
- August 17, 2024
CMT Research Foundation invests in research project to develop treatments for CMTs

The CMT Research Foundation (CMTRF) has invested in a research project based at Nationwide Children’s Hospital, US, to develop new vehicles for delivering gene therapies to treat several types of Charcot-Marie-Tooth disease (CMT). The new project aims to improve the treatment efficacy and safety of gene therapies for forms of CMTs, including CMT1A, the most prevalent form, which accounts for 50% of all patients with nerve-damaging disorder. Recognised as a rare peripheral neuropathy disease that affects nearly three million people globally, CMT is a group of inherited conditions that damage the peripheral nerves, which are found outside the main central nervous system. The development of safe and effective gene therapies for CMT requires the delivery of a therapeutic genetic payload into the peripheral nervous system, which specifically targets Schwann cells, a type of glial cells that help form the myelin sheath around the nerve fibres, for types of CMT including ...
- Source: drugdu
- 91
- August 15, 2024
FDA approves Sandoz’s Enzeevu as Eylea biosimilar saga continues

The US Food and Drug Administration (FDA) has approved Sandoz’s Enzeevu (aflibercept-abzv), the drugmaker’s biosimilar for wet age-related macular degeneration (AMD). Available as a 2mg vial kit and pre-filled syringe, the biosimilar– which references Regeneron and Bayer’s Eylea (aflibercept) – is indicated to improve and maintain visual acuity in patients with the eye disease. Enzeevu joins Biocon Biologics’s Yesafili (aflibercept-jbvf) and Samsung Bioepis’ Opuviz (aflibercept-yszy) in the list of FDA-approved biosimilars to Eylea. Yesafili and Opuviz were both greenlit by the agency as the first biosimilars in May this year. They were both designated as interchangeable products. The FDA has provisionally said Enzeevu would be interchangeable with Eylea as “it is currently subject to an unexpired exclusivity for the first interchangeable biosimilar products”, as per a 12 August press release. Interchangeable biosimilars are eligible for a year of market exclusivity if they are the first biosimilar of a given product ...
- Source: drugdu
- 92
- August 14, 2024
Chinese CAR-T Pioneer Legend Biotech in Profile

Chinese player Legend Biotech reached a new turning point last month when its Johnson & Johnson-partnered Carvykti became the first BCMA-targeted CAR-T cell therapy to be approved by the FDA for second-line treatment of multiple myeloma. From its original roots in China to its first FDA approval in 2022, the company has remained uniquely focused on CAR-T cells targeting the BCMA protein. Humble Beginnings and a Breakthrough Approval Back in 2014, a team of Chinese scientists began investigating cell therapies for cancer under the banner of the “Legend Project,” operating in what the company calls “a room the size of a freight elevator.” After making the decision to focus its research solely on chimeric antigen-receptor T-cells (CAR-T) targeting the BCMA protein in 2015, Legend began conducting its first clinical trials in 2016. The pioneering biotech landed its first major vote of confidence from the global life sciences community in 2017, ...
- Source: drugdu
- 75
- August 9, 2024
Buyout of China’s drug companies by global pharma giants sparks national security fears

Chinese pharmaceutical industry insiders have warned that foreign takeovers may damage the sector and even threaten national security. Since December, five Chinese biotech drug makers have been sold to global pharmaceutical giants. Industry insiders have warned that this could have a negative impact, especially given the risk that the United States could extend its technology sanctions to essential medicines. John Cai, chairman of China Healthcare Innovation Platform Academy, a healthcare think tank in Shanghai, said: “When national conflicts occur and drugs are sanctioned as strategic products, it will affect the health of a country’s population. “Considering that China’s biopharmaceutical and broader healthcare industry are now facing international competition and restrictions, Beijing should act with a sense of urgency.” He also said that research and development was a long process and if innovative products were sold as soon as they were developed, it would be difficult for China to cultivate world-class ...
- Source: drugdu
- 65
- August 8, 2024
Pfizer Hemophilia Gene Therapy Meets Phase 3 Goals, But Its Success Matters More to Sangamo

Pfizer’s hemophilia A gene therapy reduced annualized bleeding rates in a Phase 3 clinical trial, setting the stage for discussions with regulators. However, the market for such one-time treatments is uncertain, as uptake of commercialized hemophilia gene therapies remains slow. By Frank Vinluan A Pfizer gene therapy for hemophilia A reduced bleeding rates in patients with the inherited blood disorder, meeting goals of its Phase 3 study. The preliminary results announced Wednesday are measures taken at 15 months in a study that will follow patients for up to five years, meaning the one-time treatment’s durability remains an open question. The pharmaceutical giant now plans to meet with regulators to discuss next steps for the therapy. In hemophilia A, insufficient levels of a clotting protein called factor VIII make patients susceptible to frequent bleeding events. Treatment includes regular infusions of this clotting protein to prevent these events. The Pfizer gene therapy, giroctocogene fitelparvovec, delivers ...
- Source: https://medcitynews.com/author/fvinluan/
- 115
- July 27, 2024
New study suggests CAR-T therapy monitoring time could be slashed

The US Food and Drug Administration (FDA)-mandated monitoring time for CAR-T therapy patients could be halved, according to a new study. Chimeric antigen receptor (CAR)-T therapy involves modifying a patient’s T cells to recognise and attack cancer cells. There are three approved therapies to treat diffuse large B-cell non-Hodgkin lymphoma (DLBCL), notably Gilead’s Yescarta (axicabtagene ciloleucel) and Novartis’s Kymriah (tisagenlecleucel), which were approved by the FDA in 2017; and Bristol Myers Squibb’s Breyanzi (lisocabtagene maraleucel), which won approval in 2021. Safety concerns surrounding CAR-T cell therapies related to cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS), led to strict FDA-mandated monitoring requirements when the therapies were first approved in 2017. To allow for the safe use of these therapies, the FDA established a risk evaluation and mitigation strategy (REMS) programme, which covered these monitoring requirements. Under the REMS programme, patients need to stay near the treatment centre ...
- Source: drugdu
- 87
- July 26, 2024
Telix raises $398m to advance kidney and brain cancer radiotherapies

Not long after pulling a last-minute plug on a $232m initial public offering (IPO) on Nasdaq, Telix Pharmaceuticals has raised $398m (A$600m) via the issue of convertible bonds. The bonds, which are convertible into ordinary shares, will yield a 2% – 2.75% interest, the radiopharmaceutical specialist said in a 23 July press release. The maturity date is set for five years from now, at the end of July 2029. Australia-based Telix said it intends to list the convertible bonds on the Official List of Singapore Exchange Securities Trading Limited (SGX-ST). While Telix had been planning on going public on Nasdaq earlier this year, the company U-turned on the IPO citing market conditions at the time. Telix had been on course to raise $232m in the listing, though the company maintained that the decision was not “predicated on the need to raise capital”. Instead, the convertible bonds bring low-cost financing to ...
- Source: drugdu
- 65
- July 25, 2024
New Blood Test Aims to Improve Management of Multiple Sclerosis

Multiple Sclerosis (MS) is an autoimmune, inflammatory, and neurodegenerative condition where axonal loss leads to irreversible neurological damage and disability. Currently, approximately 2.8 million people globally are affected by MS, though this figure is likely underestimated due to underdiagnosis in underserved and remote areas lacking adequate neurological care and imaging facilities. While no cure exists for MS, available treatments aim to reduce the frequency of relapses, which are linked to nerve cell damage and the progression of the disease. There is a critical need for an accessible, affordable, and accurate blood test that can detect early signs of neuronal injury and disease activity. The neurofilament light chain (NfL) protein has been identified as a key biomarker for nerve cell damage. Now, a new blood test that measures levels of NfL could facilitate earlier detection of MS-related neuronal injury and improve disease management. Siemens Healthineers (Forchheim, Germany), in collaboration with Novartis ...
- Source: drugdu
- 91
- July 16, 2024

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