Search Results for “EC” – Page 255 – media

WuXi Biologics Releases 2023 ESG Report Demonstrating Strong Sustainability Commitment

HONG KONG, April 30, 2024 /PRNewswire/ — WuXi Biologics (“WuXi Bio”) (2269. HK), a leading global Contract Research, Development and Manufacturing Organization (CRDMO), today published its 2023 Environmental, Social and Governance (ESG) Report, highlighting the company’s substantial progress in advancing sustainable development. WuXi Biologics’ ESG strategy remains aligned with the company’s vision and mission, and embedded in its global operations. In 2023, the company joined the United Nations (UN) Global Compact, demonstrating its sustainability commitment. Its significant ESG progress was recognized by major ESG rating agencies in 2023 for its progress towards reaching its commitments. The company was added to the S&P Dow Jones Sustainability™ World Index and Emerging Markets Index; granted a “AAA” rating from MSCI ESG Ratings; awarded the distinguished Platinum Medal by EcoVadis; recognized as an Industry and Regional Top-Rated Company by Sustainalytics; named to the CDP Water Security “A list”; and awarded an “A-” CDP Climate ...
- Source: drugdu
- 82
- May 2, 2024
Takeda, Astellas & Sumitomo Mitsui Form Joint Venture to Lift Japanese Innovation From ‘Valley of Death’

Two Japanese pharmaceutical companies and a bank are teaming up to form a joint venture to advance therapeutic discoveries from academia. The focus will be innovation from universities in Japan. By Frank Vinluan Academic labs are starting points for many biopharmaceutical industry innovations, and Japan’s universities are no exception. But academic scientists often struggle to find the financing and support to turn their discoveries into new companies, leaving the research to languish in what is sometimes referred to as “the valley of death.” Now Takeda Pharmaceutical, Astellas Pharma, and Sumitomo Mitsui Banking Corporation are teaming up to form a joint venture intended to advance academic discoveries, primarily innovation from Japan. All three are sharing ownership in the joint venture, whose name has not yet been determined. The joint venture’s founders say the valley of death has become more pronounced in recent years. In response to this challenge, the companies said they engaged ...
- Source: https://medcitynews.com/author/fvinluan/
- 87
- May 2, 2024
FDA Approves Immunotherapy That Can Spare Bladder Cancer Patients From Radical Surgery

ImmunityBio therapy Anktiva is now FDA approved for treating patients with non-muscle invasive bladder cancer. The novel immunotherapy works by sparking activity from three types of immune cells. By Frank Vinluan Immunotherapy is already a treatment option for bladder cancer, but in many cases, these therapies fail or the cancer comes back. When it returns, the next option is removing the bladder. FDA approval of a novel immunotherapy gives bladder cancer patients an alternative to surgical removal of the organ. The FDA has approved ImmunityBio’s therapy, Anktivo, for the treatment of non-muscle invasive bladder cancer (NMIBC), which is cancer found only on the inner layer of the bladder wall. The regulatory decision announced late Monday covers adults whose disease is unresponsive to Bacillus Calmette-Guérin (BCG), a standard of care immunotherapy for bladder cancer. BCG is a benign type of bacteria. Delivered to the bladder via a catheter, the bacteria induce an immune ...
- Source: https://medcitynews.com/author/fvinluan/
- 106
- May 2, 2024
Repertoire and Bristol Myers Squibb link on autoimmune disease vaccines

Repertoire Immune Medicines has collaborated with Bristol Myers Squibb to develop tolerising vaccines for autoimmune diseases. The partnership will leverage Repertoire’s DECODE platform to map the immune synapse and create targeted treatments with the expertise of Bristol Myers Squibb in developing and commercialising new immune medicines. It will develop selective, efficacious and durable treatments for patients with autoimmune diseases by resetting the immune system. Repertoire will receive $65m upfront and could earn $1.8bn in additional payments, including development, regulatory and commercial milestones and tiered royalties. The company will utilise its DECODE T cell receptor (TCR)-epitope discovery platform and lipid nanoparticle delivery technology to develop the tolerising vaccine development candidates. The platform will also be used during clinical development to monitor immune responses to the tolerising vaccines in patients to provide insights into the vaccines’ pharmacodynamic effect. Repertoire CEO Torben Straight Nissen stated: “This agreement ...
- Source: https://www.pharmaceutical-technology.com/news/repertoire-bristol-vaccines/?cf-view
- 67
- May 2, 2024
FDA Approves Pfizer’s Beqvez for the Treatment of Adults with Moderate to Severe Hemophilia B

Don Tracy, Associate Editor Beqvez, a one-time gene therapy, offers hope to patients with moderate to severe hemophilia B who use regular factor IX prophylaxis, suffer severe hemorrhages, or recurrent serious bleeding.Pfizer announced that the FDA has approved Beqvez (fidanacogene elaparvovec-dzkt) as a one-time gene therapy for adults with moderate to severe hemophilia B. The therapy is indicated for patients who currently use factor IX (FIX) prophylaxis therapy, have a history of severe hemorrhage, or experience frequent serious bleeding with no neutralizing antibodies to the adeno-associated virus serotype. In clinical trials, Beqvez was found to help patients to produce their own FIX, lowering the need for regular intravenous (IV) infusions. The approval was based on promising data from the Phase III open-label, single-arm BENEGENE-2 trial, which evaluated the efficacy and safety of Beqvez in 45 males aged 18 to 65 years with moderately severe to severe hemophilia B. All participants ...
- Source: drugdu
- 81
- May 1, 2024
A Flawed Measure of Health

It’s time we move beyond BMI and adopt a holistic approach to truly gauge health. By Gretchen Zimmermann Body Mass Index (BMI) has long been regarded as a standard measure for assessing weight-related health risks and, more recently, determining eligibility for anti-obesity medications like GLP-1 receptor agonists semaglutide (Wegovy) and tirzepatide (Zepbound), according to the FDA. BMI, calculated from weight and height, offers a simplistic yet flawed assessment of health. It was initially designed for non-Hispanic white populations and overlooks nuances like muscle mass, fat distribution, and ethnic background, which can influence certain risk factors. It’s an antiquated measure that perpetuates inequities in healthcare and misses the mark for calculating cardiometabolic conditions. The perception that a “normal” BMI is ideal and an “overweight to obese” BMI is not ideal only exacerbates bias within the medical community and complicates our efforts to solve the obesity crisis. Individuals with an overweight to ...
- Source: drugdu
- 81
- May 1, 2024
Blood Test Predicts Knee Osteoarthritis Eight Years Before Signs Appears On X-Rays

Osteoarthritis (OA) is the most prevalent form of arthritis, impacting millions worldwide and resulting in significant economic and social costs. Although no cure exists currently, the effectiveness of emerging therapies might depend on early detection and slowing the disease’s progression before severe debilitation occurs. Traditional diagnostic methods typically do not catch the disease until it has already caused structural damage to the joint. For example, an abnormal X-ray can reveal definitive signs of knee OA, but by the time these signs are visible, the disease has often been advancing for years. Now, a novel blood test has been developed that can predict the onset of knee OA at least eight years before its signs become visible on X-rays. Researchers at Duke Health (Durham, NC, USA) validated the accuracy of the blood test, which detects key biomarkers of OA. Their findings indicate that the test not only predicts the onset of ...
- Source: drugdu
- 112
- May 1, 2024
Study reveals high levels of antibiotic resistance in meat sold for consumption

New research presented at the ESCMID Global Congress (formerly ECCMID) in Barcelona, Spain (27-30 April) has found substantial levels of resistance to critically important antibiotics in meat sold for human and animal consumption. The study is by Dr Jordan Sealey, Professor Matthew Avison and colleagues from the University of Bristol, UK. Meat sold for consumption by humans and companion animals in the UK is regulated by the UK Government Food Standards Agency (FSA) to ensure it falls within bacterial limits deemed safe. However, while meat is tested for the types and amounts of pathogens present, it is not tested for resistant opportunistic pathogens (e.g. Escherichia coli). Multiple studies have shown a strong association between feeding dogs a diet of uncooked meat (raw dog food) and an increased risk of excreting E. coli resistant to critically important antibiotics in their faeces. It is possible that pet animals eating raw meat increases ...
- Source: drugdu
- 90
- April 30, 2024
Pfizer scores FDA nod for hemophilia B gene therapy, will charge $3.5M per dose

Pfizer will offer a warranty program for its first FDA-approved gene therapy. The hemophilia B treatment will go for $3.5M, matching the price tag on CSL and uniQure’s hemophilia B gene therapy Hemgenix. (Pfizer) Ten years after dipping its toes into the gene therapy pool in a licensing deal with Spark Therapeutics, Pfizer has gained FDA approval for the acquired treatment. The U.S. regulator has endorsed Beqvez (fidanacogene elaparvovec-dzkt) for adults with the bleeding disorder hemophilia B. It becomes the first FDA-approved gene therapy for Pfizer and the second in the indication following CSL and uniQure’s hemophilia B treatment Hemgenix, which became the world’s most expensive drug at $3.5 million when it was approved in 2022. Pfizer had the chance to undercut its rival on price but decided to charge the same $3.5 million for Beqvez. The therapy will be available to patients this quarter, a spokesperson confirmed on Friday ...
- Source: drugdu
- 81
- April 30, 2024
【EXPERT Q&A】What is the relationship between FDA registration and 510K registration for medical devices and what is the difference?

Drugdu.com expert’s response: The relationship between FDA registration and 510(k) clearance for medical devices involves overlap but also key distinctions. Relationship: 1.FDA Registration: This encompasses the process of submitting product information to the U.S. Food and Drug Administration (FDA) and obtaining FDA approval. It includes various types of registrations, such as 510(k) clearance, Premarket Approval (PMA), among others. 2.510(k) Clearance: This is a specific certification process within FDA’s regulatory framework, typically applicable to certain medical devices for which there are similar existing products on the market. In the 510(k) clearance process, manufacturers need to demonstrate that their product is substantially equivalent to an existing marketed device and does not pose an unreasonable risk to the user. Differences: 1.FDA registration is a broader concept encompassing various registration pathways, of which 510(k) clearance is one. 2.Within FDA registration, if a medical device can demonstrate substantial equivalence to a predicate device and meets ...
- Source: drugdu
- 165
- April 30, 2024

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