Search Results for “FDA” – Page 105 – media

Rallybio and J&J collaborate to tackle maternal-foetal blood disorder

Following Johnson & Johnson’s (J&J) recent US Food and Drug Administration (FDA) fast track designation of nipocalimab for the reduction of foetal and neonatal alloimmune thrombocytopenia (FNAIT) risk in pregnant adults, Rallybio has announced a collaboration with the pharma giant to advance complementary therapeutic solutions for the rare disorder. The collaboration will see the development of therapeutic approaches that comprehensively address FNAIT, as J&J aims to treat patients who have already alloimmunised while Rallybio focuses on preventing alloimmunisation altogether, Dr. Steve Uden, Rallybio’s CEO, told Pharmaceutical Technology in an exclusive interview. “They are very much complementary and not competitive approaches; and both are needed,” said Uden. As per the 10 April press release, the clinical-stage biotech received an equity investment of $6.6m from J&J, with eligibility for future milestone payments. The funds will be deployed to support a FNAIT natural history study that will be conducted across North America and ...
- Source: drugdu
- 104
- April 13, 2024
PureTech Startup Gets $100M to Try For Success Where Sage & Others Fall Short in Depression

Seaport Therapeutics’ drug candidates are delivered through the lymphatic system, an approach that could overcome some limitations of neuropsychiatric medicines, including products from Sage Therapeutics. The startup stems from the research of PureTech Health.Even when depression drugs address known and validated targets, their commercial potential can be constrained by dosing or safety limitations. Seaport Therapeutics’ drugs use a novel delivery approach to overcome those limitations. The startup launched on Tuesday, backed by $100 million in financing. Boston-based Seaport was formed by PureTech Health, a company that creates startups, typically around a platform technology. One notable example is neuropsychiatric drugs developer Karuna Therapeutics, which grew and eventually spun out of PureTech as a publicly traded company with a lead drug taking a novel approach to schizophrenia. Bristol Myers Squibb last year struck a $14 billion deal to acquire Karuna, whose schizophrenia drug is currently under FDA review. Former Karuna CEO Steven ...
- Source: drugdu
- 141
- April 12, 2024
Lonza, NeuroSense Strike Deal Focused on Exploring Biological Markers for Neurodegenerative Diseases

Don Tracy, Associate Editor Collaboration aims to advance the development of treatments for multiple neurodegenerative conditions, including amyotrophic lateral sclerosis. Lonza and NeuroSense Therapeutics have announced a collaboration focused on evaluating biological markers in neurodegenerative diseases, such as amyotrophic lateral sclerosis (ALS). According to both companies, the joint venture intends to utilize Lonza’s expertise in extracellular vesicles in combination with NeuroSense’s experience in biomarker utilization for neurodegenerative diseases. The overall goal of this partnership is to enhance development of neurodegenerative disease treatments. This deal comes amid NeuroSense revealing positive results from the Phase IIb PARADIGM trial for PrimeC, focused on treating adults living with ALS. Under terms of the agreement, Lonza will focus on utilizing neuron-derived exosomes (NDEs) for assimilation into the development of PrimeC.1 “We believe this collaboration could be a game-changer for the ALS and neurodegeneration field, as findings in such biomarkers may advance early diagnosis and treatment, ...
- Source: drugdu
- 101
- April 12, 2024
Philips restricted from selling respiratory machines in DOJ consent decree

Dive Brief The Department of Justice filed a consent decree of permanent injunction against Philips on Tuesday in response to the company’s ongoing recall of sleep apnea and respiratory devices. The settlement would restrict Philips from producing or selling new continuous positive airway pressure (CPAP) and bi-level positive airway pressure (BiPAP) machines and other devices in the U.S. until the company meets certain requirements. Philips also faces restrictions on exporting devices that are being provided to patients impacted by the recall “to help ensure remediation of U.S. patients is prioritized over export for commercial distribution.” Philips is required to implement a recall remediation plan that the Food and Drug Administration must agree on, including providing patients with new or reworked devices, or a partial refund. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a Tuesday statement that the finalization of the decree is a ...
- Source: drugdu
- 76
- April 12, 2024
AstraZeneca, Daiichi Sankyo Drug Enhertu Becomes First Tumor-Agnostic ADC Cancer Med

The FDA expanded Enhertu’s approval to encompass advanced solid tumors positive for the HER2 cancer protein, regardless of tumor type. Analysts say the regulatory decision paves the way for similar broader approvals of other medications in the ADC cancer drug class.The AstraZeneca and Daiichi Sankyo targeted cancer drug Enhertu is now the first therapy in its class approved for treating solid tumors regardless of either the cancer type or where the disease started in the body. Enhertu had previously won FDA approvals for treating certain advanced cases of breast, gastric, and lung cancers that express a protein called HER2. Late Friday, the FDA expanded the drug’s approval to broadly include the treatment of adults who have HER2-expressing solid tumors. These patients must have a cancer that cannot be removed surgically or has advanced following a prior systemic treatment. The expanded approval came nearly two months ahead of the May 30 ...
- Source: drugdu
- 80
- April 11, 2024
Bristol Myers Squibb Reveals Promising Data for KarXT, a Potential Treatment for Schizophrenia

Don Tracy, Associate Editor A combination of data from the EMERGENT-4 trial and pooled data from the EMERGENT program showed the promise of KarXT (xanomeline-trospium) in providing symptom improvement for people with schizophrenia. Bristol Myers Squibb announced results from its Phase III EMERGENT-4 trial analyzing the long-term efficacy, safety, and tolerability of KarXT (xanomeline-trospium) in adults with schizophrenia, which was showcased at the Annual Congress of the Schizophrenia International Research Society (SIRS). Additionally, the company revealed promising pooled data from EMERGENT-4 and EMERGENT-5 for the long-term safety, tolerability, and metabolic effects of KarXT in schizophrenia over 52 weeks. EMERGENT-4 is a 52-week, open-label extension trial assessing long-term efficacy, safety, and tolerability of KarXT in adults who completed earlier phases of the trial for schizophrenia. Investigators found that over 75% of patients administered KarXT achieved a 30% improvement in symptoms.1 “We are pleased to see a continued and consistent meaningful reduction ...
- Source: drugdu
- 147
- April 11, 2024
Next Generation Instrument Screens for Hemoglobin Disorders in Newborns

Hemoglobinopathies, the most widespread inherited conditions globally, affect about 7% of the population as carriers, with 2.7% of newborns being born with these conditions. The spectrum of clinical manifestations ranges from mild cases with minimal symptoms to severe disorders like sickle cell disease and Hb Bart’s hydrops fetalis, which can cause extensive organ damage and necessitate lifelong blood transfusions. Capillary electrophoresis has been established as a reliable method for newborn screening of hemoglobin disorders, offering high-quality outcomes. Now, a next-generation instrument dedicated to newborn hemoglobin screening offers a smooth workflow and excellent analytical capabilities. Sebia’s (Lisses, France) CAPILLARYS 3 DBS instrument is an automated, multitasking capillary electrophoresis instrument that uses 12 capillaries simultaneously for hands-free electrophoretic separation at high throughput. Designed to detect both standard (F and A) and abnormal hemoglobins (S, C, E, D, and Bart’s) in dried blood samples collected on filter paper from newborns, this instrument provides ...
- Source: drugdu
- 78
- April 11, 2024
Pfizer meets Phase III primary endpoints for RSV vaccine Abrysvo

Pfizer has reported positive top-line results from its Phase III MONeT study (NCT05842967) evaluating the efficacy of single-dose Abrysvo for adults at risk of developing severe respiratory syncytial virus (RSV)-associated lower respiratory tract disease (LRTD). As per the 9 April press release, Abrysvo met its co-primary immunogenicity and safety endpoints, with patients demonstrating non-inferior RSV-A and RSV-B neutralising responses compared to the Phase III RENOIR study (NCT05842967) where the vaccine previously showed efficacy. Compared to pre-vaccination, the vaccinated patients also demonstrated a minimum of a four-fold increase in serum-neutralising titers for RSV-A and RSV-B a month after being vaccinated. The MONeT trial did not identify any new safety signals for Abrysvo. The pharma giant plans to publish the findings in a peer-reviewed journal and submit the results to regulatory agencies in a bid to expand the vaccine’s label from its current indication to include adults 18 years and older, the ...
- Source: drugdu
- 99
- April 11, 2024
KOREA PHARM & BIO 2024

Organiser: KFDA、KPMA Time:23 – 26 April 2024 address：217-59 Kintekseu-ro, Daehwa-dong, Ilsanseo-gu, Goyang-si, Gyeonggi-do,Korea Exhibition hall: KINTEX Product range: Pharmaceutical: Pharmaceutical raw materials, API, pharmaceutical fine chemicals, intermediates, pharmaceutical additives, pharmaceutical agents, natural extracts, biotechnology, pharmaceutical outsourcing and services, laboratory equipment, pharmaceutical equipment, etc Chemical: chemical raw materials, chemical equipment, instrumentation, automatic control technology, heat exchanger, crystallization, gas absorption, drying, filtration, centrifuge, dust removal, chemical reactor, mill, blender, etc Cosmetics: cosmetic raw materials, cosmetic additives, functional materials, natural extracts, etc About KOREA PHARM & BIO： The KOREA PHARM & BIO event includes a variety of events, including a policy briefing on raw materials and pharmaceuticals, an export fair, and a variety of pharmaceutic-related seminars. The broad development space creates good opportunities for companies interested in exploring and developing the Korean market, and will undoubtedly become the best platform for companies to reach deals.
- Source: drugdu
- 152
- April 11, 2024
Diagonal Therapeutics’ New Slant Attracts $128M to Reactivate Antibody Drug R&D

Diagonal Therapeutics develops agonist antibodies to treat rare cardiovascular conditions. Using artificial intelligence, the startup’s technology sorts through billions of antibody/receptor combinations to identify the ones that reactivate signaling pathways lost to disease.In a drug discovery career spanning more than two decades, Alex Lugovskoy has seen a lot of antibodies come and go. The vast majority of them work by inhibiting a cellular function. Lugovskoy, now the CEO of startup Diagonal Therapeutics, said he long hoped someone would come up with a way to develop antibodies that activate their targets. With each passing year, no one did. So he took up the challenge himself. Diagonal uses computational and experimental techniques to understand what happens when an antibody binds to a receptor and which binding combinations will yield the desired effect. After developing its platform for the past two years, the startup this past week pulled back the curtain on its ...
- Source: drugdu
- 88
- April 9, 2024

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