The joint venture aims to address unmet needs in the treatment of mood and anxiety disorders through novel neuroplastogens.AbbVie and Gilgamesh Pharmaceuticals have announced a partnership focused on the development of therapies for psychiatric disorders. The collaboration seeks to leverage AbbVie’s experience in psychiatry and Gilgamesh’s research platform that focuses on neuroplastogens, which works to treat psychiatric conditions while minimizing adverse effects attributed to psychedelic compounds. According to the companies, the overall goal is to provide new opportunities in areas that haven’t provided manysolutions for patients with mood and anxiety disorders through the use of neuroplastogens. Under terms of the deal, AbbVie is expected to focus on future development and commercialization activities, while Gilgamesh will receive $65 million as an upfront payment. Upon the completion of specific milestones, including option fees and tiered royalties on net sales, Gilgamesh could potentially receive up to $1.95 billion.1 “Significant unmet need remains for ...
WHO has launched a new network for coronaviruses, CoViNet, to facilitate and coordinate global expertise and capacities for early and accurate detection, monitoring and assessment of SARS-CoV-2, MERS-CoV and novel coronaviruses of public health importance. CoViNet expands on the WHO COVID-19 reference laboratory network established during the early days of the pandemic. Initially, the lab network was focused on SARS-CoV-2, the virus that causes COVID-19, but will now address a broader range of coronaviruses, including MERS-CoV and potential new coronaviruses. CoViNet is a network of global laboratories with expertise in human, animal and environmental coronavirus surveillance. The network currently includes 36 laboratories from 21 countries in all 6 WHO regions. Representatives of the laboratories met in Geneva on 26 – 27 March to finalize an action plan for 2024-2025 so that WHO Member States are better equipped for early detection, risk assessment, and response to coronavirus-related health challenges. The CoViNet ...
Sosei Heptares’ schizophrenia drug candidate addresses a novel, difficult-to-drug target for neurological disorders. Boehringer Ingelheim can exercise its option on the small molecule following a Phase 1 test expected to yield data in 2025. By FRANK VINLUANAntipsychotic medications used to treat schizophrenia don’t work for all patients, and even when they do, side effects lead many people to stop taking them. Sosei Heptares is developing a novel drug that could bring patients better efficacy along with fewer side effects, and that potential has caught the interest of Boehringer Ingelheim. The German pharmaceutical company has inked a deal for an exclusive option on Sosei Heptares’s schizophrenia drug candidate, which is in early clinical development. Under deal terms announced Monday, Boehringer is paying its new partner €25 million up front. Sosei Heptares’s schizophrenia research address a G protein-coupled receptor (GPCR) called GPR52. This particular receptor is highly expressed in the brain, making ...
Recently, Suzhou Shengdia Biopharmaceutical Co., Ltd., a subsidiary of Hengrui Pharmaceuticals, received the “Notice of Acceptance” issued by the National Medical Products Administration. The company submitted the Class 1 new drug Vunakizumab Injection (SHR-1314) The drug marketing authorization application was accepted by the NMPA. This product is used for adult patients with active ankylosing spondylitis whose conventional treatment is not effective. This application for marketing is based on a multi-center, randomized, double-blind, placebo-controlled adaptive seamless phase II/III clinical trial (SHR-1314-302). Research shows that Vunakizumab injection provides statistically significant and clinically meaningful improvements in active ankylosing spondylitis compared with placebo. At the same time, SHR-1314 injection is safe and well tolerated in the long-term treatment of patients with active ankylosing spondylitis. About SHR-1314-302 Research In November 2023, the main research endpoint of the Phase III clinical trial (SHR-1314-302) of SHR-1314 injection for the treatment of active ankylosing spondylitis in subjects with ...
In a recent study published in Frontiers in Public Health, researchers from the United States of America (US) investigated the racial and ethnic variation in symptoms, activity level, health status, and missed work. They assessed this via follow-ups post-initial infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Although the symptoms were equally prevalent among the groups, they found that three and six months post-infection, Hispanic participants reported poorer health and reduced activity compared to non-Hispanic participants. Further, racial minority participants reported more negative impacts on health status, activity, and absence from work as compared to the White population. Background The coronavirus disease 2019 (COVID-19) pandemic highlighted disparities, wherein ethnic and racial minoritized populations were observed to face greater infection risks due to the essential nature of their work, limited remote work options, and challenges in practicing social distancing. The infected individuals faced barriers to care, including underinsurance and lack ...
From today, fluoroquinolone antibiotics given systemically (by mouth, injection, or inhalation) must only be administered when no other antibiotics are appropriate for use, the Medicines and Healthcare products Regulatory Agency (MHRA) has announced. This means that fluoroquinolones should only be prescribed when other recommended antibiotics have failed, will not work due to resistance, or are unsafe to use in an individual patient. This is a strengthening of the previous regulations which stated that fluoroquinolones should not be prescribed for mild to moderate or self-limiting infections, or non-bacterial conditions.The MHRA conducted a thorough review into the effectiveness of current measures to reduce the risk of potentially long-term adverse reactions to fluoroquinolone antibiotics and sought advice from the Commission on Human Medicines (CHM). The review process considered available evidence, including Yellow Card reports submitted by patients and healthcare professionals, and the experiences of people affected by these side effects. The restrictions have ...
In a recent study published in the journal Environmental Health Perspectives, researchers examined published studies investigating the genotoxicity of potentially carcinogenic chemicals and their roles in inducing mammary tumors and activating progesterone or estradiol signaling. The researchers aimed to identify chemicals that could present breast cancer risk to humans. Background Recent statistics indicate that breast cancer is the most prevalent form of cancer and the major cause of cancer-related mortality among women across the world. In the United States (U.S.), the lifetime risk of women developing breast cancer is double that of the risk of developing lung cancer. Furthermore, the incidence of breast cancer among younger women is increasing, with mortality rates due to breast cancer among women between the ages of 20 and 49 years being double that of other forms of cancers affecting individuals of both sexes. A nine-year assessment since 2010 also indicates that the diagnostic rate ...
Hearing loss affects approximately 40 million American adults, yet only one in 10 people who need hearing aids use them, research shows. Those who don’t use hearing aids but should may want to make wearing them one of their New Year’s resolutions, according to a new study from Keck Medicine of USC published today in The Lancet Healthy Longevity. Janet Choi, MD, MPH, an otolaryngologist with Keck Medicine and lead researcher of the study said, “We found that adults with hearing loss who regularly used hearing aids had a 24% lower risk of mortality than those who never wore them. These results are exciting because they suggest that hearing aids may play a protective role in people’s health and prevent early death.” Previous research has shown that untreated hearing loss can result in a reduced life span (as well as other poor outcomes such as social isolation, depression and dementia). ...
The MHRA has reminded healthcare professionals prescribing aripiprazole to be alert to the known risk of patients developing addictive gambling, following a rise in the number of reports received in 2023 Aripiprazole is an important medicine for the treatment of schizophrenia and bipolar disorder. Patients are advised to tell their doctor if they or their family and friends notice they are having unusual urges or cravings that they cannot resist, including behaviours such as addictive gambling, excessive eating or spending, or an abnormally high sex drive. Patients should continue taking aripiprazole as advised. Stopping aripiprazole without medical advice can be harmful. In the last 14 years, the MHRA’s Yellow Card scheme received 69 reports of gambling or gambling disorder where aripiprazole was suspected to be the cause. Thirty-two of these reports were received between 1 January and 31 August this year. In March 2023, the MHRA asked gambling clinics to ...
Pharmaceutical Executive Editorial Staff MAPS Public Benefit Corporation filed a new drug application for MDMA (midomafetamine capsules) for use with psychological intervention for the treatment of post-traumatic stress disorder. MAPS Public Benefit Corporation has submitted a new drug application (NDA) to the FDA in what would represent the first approved psychedelic treatment for post-traumatic stress disorder (PTSD). MAPS is seeking approval of MDMA (midomafetamine capsules) for use with psychological intervention comprised of psychotherapy and additional supportive services provided by a qualified healthcare provider for PTSD.1 MAPS was previously granted Breakthrough Therapy Designation by the FDA for MDMA and is seeking a priority review for the NDA submission. “The filing of our NDA is the culmination of more than 30 years of clinical research, advocacy, collaboration and dedication to bring a potential new option to adults living with PTSD, a patient group that has experienced little innovation in decades,” Amy Emerson, ...
Go to Page Go
your submission has already been received.
OK
Please enter a valid Email address!
Submit
The most relevant industry news & insight will be sent to you every two weeks.