Biotech startup incubator Curie.Bio has secured $380m in funding for its latest investment pool aimed at nurturing early-stage companies advancing towards clinical trials. The fundraising round – which boosts Curie.Bio’s total funds raised to nearly $1bn – specifically targets Series A investments in companies within its accelerator programme, focusing on advancing companies towards clinical proof-of-concept studies. The Massachusetts-based biotech investor launched with $520m in its pocket in February 2023, with investments from GV, ARCH Venture Partners, and Leaps by Bayer. The investor operates through two parts: one provides seed-stage funding to startups, while the other offers essential services to help advance scientific projects. Amid macroeconomic pressures, private biotech venture financing saw a significant downturn in 2022 and 2023. During 2023, funding decreased by 43.2% compared to 2022 and by 52.3% compared to 2021, as investors became more cautious and focused on existing portfolios. Curie.Bio was started by Alexis Borisy, Zach ...
On June 24, Yuan Lin, Director of Drug Safety of State Drug Administration, and his delegation went to Sinopharm for investigation, Zhao Bingxiang, Deputy Secretary of Party Committee and General Manager of Sinopharm, hosted the reception, and the two sides held a symposium on drug regulation and high-quality development. The meeting was presided over by Zhou Le, Deputy Director of the Department of Drug Administration. Director Yuan Lin and relevant comrades of the Department of Drug Registration and the Department of Drug Administration listened to the special reports on children’s medicines, vaccines and blood products, special medicines, traditional Chinese medicines injections and formula granules, and drug business of Sinopharm Group’s scientific and technological research and development, industrial manufacturing, and trading and circulation subsections, focusing on the research and development of medicines, manufacturing, supply management, quality assurance, informationization construction, modernization and logistics construction, and so on. Informatization construction, modern logistics construction ...
Lennox-Gastaut syndrome affects up to 5% of children living with paediatric epilepsy A new study sponsored by University College London (UCL) has begun, making it the UK’s first ever deep brain stimulation (DBS) trial for children with epilepsy. In collaboration between Great Ormond Street Hospital, UCL, King’s College London, the University of Oxford and Amber Therapeutics, the Children’s Adaptive Deep brain stimulation for Epilepsy Trial (CADET) pilot intends to recruit three additional patients living with Lennox-Gastaut syndrome (LGS). Affecting around 50 million people worldwide, epilepsy is a neurological condition where sudden bursts of electrical activity in the brain cause seizures or fits. Affecting up to 5% of children with paediatric epilepsy, LGS is a rare and severe form of epilepsy that is characterised by repeated seizures that begin early in life. The study will investigate the safety of a cranially-mounted DBS device called the Picostim with software called DyNeuMo-1, manufactured ...
The initiative’s proposals aim to tackle current challenges in health research and innovation The Innovative Health Initiative (IHI) has launched a new call for proposals, which include topics on cardiovascular disease (CVD) and arthritis, as part of the total budget worth €96.5m to tackle challenges in health research and innovation. As part of the total budget, Horizon Europe, the EU’s research and innovation programme, has contributed €47.6m, while an additional €40.9m comes from the IHI’s industry members, as well as €8.1m from IHI contributing partners. Dr Niklas Blomberg, executive director, IHI, commented: “This call for proposals is an excellent opportunity to be part of ambitious projects tackling major challenges in health research and innovation.” The IHI aims to identify and create models, interventions and best practices to improve the management of CVD in Europe’s cities, covering healthcare delivery, individual lifestyle changes and the living environment. It will include five pilot ...
Dive Brief The Food and Drug Administration published draft guidance on Wednesday for diversity action plans intended to increase enrollment of underrepresented groups in clinical trials. A year-and-a-half after Congress passed legislation requiring clinical trial diversity action plans, the agency explained which device trials must meet the requirements and presented a timeline for implementation. The draft is open for feedback for 90 days, giving sponsors a chance to comment on the FDA’s interpretation of legal requirements such as the need to share enrollment goals in the plans. Dive Insight Congress passed a law in 2022 that would require drug- and device-makers to submit diversity action plans to the FDA. Per the law, the FDA was required to publish draft guidance clarifying the format and content of the diversity action plans by Dec. 29, 2023. In the draft, the FDA says that, while the Act “refers to clinical studies broadly,” it ...
UPDATE: June 28, 2024: Philips spokesperson Lu Yu wrote in an emailed statement that Philips does not recognize the number of reported injuries and deaths in yesterday’s FDA notice, and is in dialogue with the agency. The company said it has received reports of 10 serious injury and seven deaths over a 12-year period between 2011 and 2023 for the A30 and A40 devices. No reports of serious patient harm have been reported with the V30 devices, Philips said. Philips’ recall of bilevel positive airway pressure (BiPAP) machines has now been linked to reports of 952 injuries and 65 deaths, according to a Food and Drug Administration notice posted Thursday. Philips began a recall of its V30, A30 and A40 BiPAP machines in March because a false alarm can cause the devices to shut down. The company updated its instructions for use, but is not removing the affected devices from ...
Don Tracy, Associate Editor Reportedly, data from the IMROZ study marks the first time an anti-CD38 monoclonal antibody combined with standard-of-care therapy has demonstrated significant improvement in progression-free survival for newly diagnosed transplant-ineligible multiple myeloma. Results from the IMROZ Phase III trial show that Sanofi’s Sarclisa (isatuximab-irfc) in combination with standard-of-care therapy comprised of lenalidomide and dexamethasone (VRd) significantly reduced the risk of disease progression or death by 40% compared to a solo VRd regimen in patients with newly diagnosed transplant-ineligible multiple myeloma (MM). According to the company, the data represents the first time an anti-CD38 monoclonal antibody combined with VRdsupported a significant improvement in progression-free survival (PFS) for these patients. “The significant progression-free survival (PFS) benefit observed with Sarclisa combination therapy compared to VRd is important and encouraging for patients with newly diagnosed multiple myeloma. Effective frontline therapy has the potential to modify the course of the disease, which ...
These notes serve not only as a means to raise capital but also as a bridge to future financing rounds or significant liquidity events. By Jaylon M. ReynoldsIn the realm of biotech and pharmaceuticals, fundraising often plays a pivotal role in driving innovation and progress. Biotech and pharmaceutical companies, whether private startups or established public firms, frequently turn to convertible notes as a strategic financial instrument. These notes serve not only as a means to raise capital but also as a bridge to future financing rounds or significant liquidity events. Convertible notes are utilized, structured, valued, and accounted for in various ways within the context of the biotech and pharmaceutical industries. Private companies For burgeoning private biotech and pharmaceutical firms, navigating the journey from research and development to commercialization can be financially demanding. Convertible notes offer a flexible financing solution, providing companies with the necessary capital to fuel their operations ...
Breast cancer represents 30% of all new cancer diagnoses in women annually, with projections from the American Cancer Society indicating that 42,500 women will succumb to the disease in 2024. Researchers have now developed a new artificial intelligence (AI) architecture capable of detecting breast cancer with a remarkable 99.72% accuracy, demonstrating the potential to redefine digital pathology. This development follows a previous initiative by the same research team at Northeastern University (Boston, MA, USA) which launched a web-based AI application aimed at diagnosing prostate cancer more efficiently and accurately. These projects are part of a broader effort to establish an online platform that allows physicians to utilize advanced AI techniques for diagnosing various cancers. For the breast cancer project, the research team utilized the publicly accessible Breast Cancer Histopathological Database, which includes images of both malignant and benign breast tissues. Leveraging this resource, they built an ensemble deep learning model ...
Many patients with rare diseases (50-75%) do not receive a diagnosis after genomic sequencing, often due to insufficient information on the variants identified. Reassessing data over time with new genetic insights can improve diagnostic rates. However, reanalyzing genetic data in clinical laboratories is often hampered by time and resource limitations. Now, a novel semi-automated system enables rapid reanalysis of unresolved rare disease cases by regularly comparing patient genomic data with the latest global research findings, aiming to identify elusive disease-causing genetic variants. Developed by Mayo Clinic researchers in 2022 (Rochester, MN, USA), the system, named RENEW (REanalysis of NEgative Whole-exome/genome data), incorporates an advanced filtering system that scans new genetic data to identify the variants responsible for a patient’s condition. A recent study demonstrated RENEW’s effectiveness, providing likely diagnoses for 63 out of 1,066 previously undiagnosed cases. RENEW can review each of the 5,741 prioritized genomic variants in about 20 ...
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