The MedCity INVEST conference is scheduled for May 21-22 at the Ritz Carlton hotel in Chicago, The companies will offer a window into some of the promising treatments under development such as different types of cancers to muscular dystrophy. Space is limited so register today! By Stephanie Baum Biopharma companies are responsible for some of the most transformative, life-changing technologies in medicine from gene therapy to immunotherapy. At the MedCity INVEST conference scheduled for May 21-22 at the Ritz Carlton hotel in Chicago, six biopharma companies will give attendees a window into some of the promising treatments under development. MedCity News Senior Biopharma Reporter Frank Vinluan will moderate the biopharma track of the startup contest Pitch Perfect. One judge confirmed for the track is Meredith Wilkerson, an investment principal with Plains Ventures who serves as the primary subject matter expert for evaluating life sciences and biotech investment opportunities. Wilkerson will also ...
The FDA has approved Beqvez, a Pfizer gene therapy developed for moderate-to-severe hemophilia B. The one-time treatment carries a $3.5 million price tag, the same as a CSL Behring gene therapy already available for treating the inherited bleeding disorder. By Frank Vinluan Pfizer’s first FDA-approved gene therapy is the second such treatment for the inherited bleeding disorder hemophilia B, introducing some competition to a therapeutic area that now has two of the most expensive medicines in the world. The FDA approval announced Friday covers the treatment of adults with moderate-to-severe hemophilia B. Known in development as fidanacogene elaparvovec, the Pfizer therapy will be marketed under the brand name Beqvez. The company expects this therapy will become available to patients later in the current quarter. Hemophilias stem from genetic mutations that lead to abnormally low levels of clotting proteins. These disorders mainly affect males and make patients susceptible to bleeding events ...
On Wednesday, 3 April, 2024, a letter from the House’s Select Committee on the Chinese Communist Party recommended more companies to add to the Pentagon’s list of firms that are allegedly working with the Chinese military. The letter identifies several companies, including two headquartered in California—Innomics (Sunnyvale, CA, US) and Axbio (Santa Clara, CA, US)—as potentially Chinese military-backed companies, and implied the companies may have tried to hide their affiliation with Chinese-headquartered BGI Genomics (Shenzhen, China), which has been on the security risk list since 2022. Other Chinese companies recommended for the list are Origincell (Shanghai, China), Vazyme Biotech (Nanjing, China), and STOmics (Shenzhen, China). The letter states that Innomics recently registered to conduct business operations in Kentucky under BGI. Innomics provides sequencing services to institutional and corporate clients for research purposes and STOmics sells lab kits and reagents. BGI asserts that both Innomics and STOmics belong to BGI but ...
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 ...
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 ...
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 ...
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 ...
CHENGDU, China, April 29, 2024 /PRNewswire/ — Technoderma Medicines, Inc. (“the Company”), a clinical stage biopharmaceutical company, is pleased to report the Company has begun dosing patients in its Phase 2a clinical trial (NCT06363461) of topical TDM-180935 ointment. This clinical trial in the Atopic Dermatitis (AD) program includes 8 weeks dosing of two different active formulation strengths and placebo in a study entitled, “A Randomized, Vehicle-Controlled, Parallel Group Study of Topical TDM-180935 to Evaluate the Preliminary Efficacy, Safety, Tolerability, and Pharmacokinetics in Atopic Dermatitis Patients”. It is a randomized, vehicle-controlled, parallel group comparison study with an open-label PK sub-study. Objectives are to evaluate the safety and efficacy of topical TDM-180935 as well aspharmacokinetics. Seven U.S. clinical sites are currently participating in this study under an open IND with FDA. Arthur P. Bertolino, MD, PhD, MBA, Chief Medical Officer at Technoderma Medicines commented, “We expect the current study to support ...
Tonghua Dongbao Pharmaceutical Co., Ltd (hereinafter referred to as “Tonghua Dongbao”) has recently obtained the clinical trial approval notification of Degu Insulin Liraglutide Injection issued by the Center for Drug Evaluation (CDE) of the State Drug Administration. The clinical approval of Degu Insulin Liraglutide Injection is another significant progress in the research and development of insulin analog GLP-1RA compound preparation, which will further enhance the company’s competitiveness in the field of endocrine therapy. In the future, the Company is expected to accelerate the process of clinical trials and speed up the approval and listing of its products by virtue of its R&D advantages accumulated in the field of diabetes treatment over the years, so as to provide richer and better choices for clinical medication. Degu Insulin Liraglutide Injection has a broad market prospect in the future, and the market scale shows a rapid growth trend. Its original Degu Insulin Liraglutide ...
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 ...
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