PharmaFocus Today – Page 256 – media

FDA expands total product life cycle program to cover neurological devices

Dive Brief The Food and Drug Administration is expanding a program for accelerating device development to cover neurological and physical medicine technologies. Initially, the voluntary total product life cycle advisory program (TAP) pilot was limited to cardiovascular devices. This week, the FDA Office of Neurological and Physical Medicine Devices also began accepting enrollment requests. Expanding the program to cover cardiovascular, neurological and physical medicine devices is part of a scaling up of the pilot, which enrolled 12 products in its first year. The FDA could enroll up to 45 additional devices over the coming year. Dive Insight The FDA and industry agreed to the TAP pilot in MDUFA V. While the industry initially opposed the advisory program, the FDA secured a chance to show it can “spur more rapid development and more rapid and widespread patient access” by facilitating early engagement and coordination with external stakeholders. A year ago, the ...
- Source: drugdu
- 195
- October 4, 2023
908 Devices Launches Real-Time Monitoring Platform For Multiple Bioprocess Parameters

The device, Maverick, utilizes Raman spectroscopy for bioprocess control. 908 Devices Inc. launched Maverick, an optical in-line analyzer that provides real-time monitoring for multiple bioprocess controls. The device also provides control of glucose, lactate, and total biomass in mammalian cell cultures. According to a press release from 908 Devices, this is the first turn-key device that utilizes Raman spectroscopy for bioprocess control without also requiring modeling or development. Christopher D. Brown, chief product officer and co-founder of 908 Devices, said in a press release, “As the biopharmaceutical industry adopts Process Analytical Technologies to drive the advancement of Biopharma 4.0, scientists need an array of tools that enable them to monitor and control their process in real time.” He continued, “We are addressing this need with our full complement of devices. With MAVERICK, we are introducing a new platform that offers easy-to-integrate in-line analysis and control without the need for substantial ...
- Source: drugdu
- 112
- October 4, 2023
Zocdoc Takes Aim At Phreesia, NexHealth With New Free Suite of Patient Engagement Tools

Zocdoc launched a new suite of tools to compete with the solutions sold by Phreesia, NexHealth and Solutionreach. The product suite, which is free for any provider to use, includes tools to streamline the patient intake process, facilitate online scheduling and enable video visits. By KATIE ADAMS Zocdoc launched a new suite of tools on Tuesday — one that takes aim at the solutions sold by Phreesia, NexHealth and Solutionreach. The product suite, called Zocdoc Practice Solutions, includes tools to streamline the patient intake process, facilitate online scheduling and enable video visits. The suite is available free of charge to any practice or provider, regardless of whether they are a Zocdoc marketplace customer. Providers can use these tools for all their patients — not just the ones who book appointments through Zocdoc. Zocdoc’s decision to launch its new product suite was based on conversations the company has had with its ...
- Source: drugdu
- 148
- October 4, 2023
FDA clears Krystal Biotech’s IND for Type 1 AATD treatment KB408

The US Food and Drug Administration has approved Krystal Biotech’s Investigational New Drug (IND) for a Phase I clinical trial of the investigational alpha-1 antitrypsin deficiency (AATD) treatment KB408. Earlier this month, the FDA granted orphan-drug status for KB408 in AATD. The first patient in the planned Phase I trial is expected to receive treatment in Q1 2024. The Phase I trial, involving adult patients with AATD and the PI*ZZ genotype, will assess the safety, tolerability, and efficacy at three planned dose levels. AATD is a rare genetic disorder that occurs when there is insufficient production or impaired functionality of the alpha-1 antitrypsin (AAT) protein. Low AAT levels result in damage to lung tissue, leading to chronic obstructive pulmonary disorder (COPD). KB408 is a gene therapy consisting of a modified herpes simplex virus 1 (HSV-1) derived vector, which delivers two full-length copies of the SERPINA1 gene to enable AAT expression. ...
- Source: drugdu
- 141
- October 4, 2023
ICR and Merck renew strategic alliance for development of new cancer drugs

The Institute of Cancer Research (ICR) and Merck KGaA have announced a renewal of their strategic alliance to discover and develop new small-molecule cancer drugs. Throughout the multi-year, multi-target collaboration, both organisations will contribute their expertise in drug discovery to the partnership. As part of the agreement, significant financial and staff commitments from both organisations will be made, including the funding of nine full-time research posts at the ICR by Merck. Scientists at the ICR’s Centre for Cancer Drug Discovery will cooperate with researchers at German science and technology company Merck on a variety of projects that aim to discover and develop new small-molecule inhibitors of a new class of cancer targets. In 2021, the ICR opened a new building worth £70m as part of its site in Sutton, South London, which houses around 300 scientists working across a range of disciplines in cancer drug discovery. Earlier this month, ICR ...
- Source: drugdu
- 105
- October 4, 2023
Glenmark solves its ‘decade-long’ debt problem with $681M sale of API unit to Nirma

By divesting 75% of its active pharmaceutical ingredient (API) business, Glenmark Pharmaceuticals has finally resolved its debt problem, described by an Indian news outlet as a “decade-long troubled affair.”The buyer is Nirma Limited, which will pay 615 Indian rupees per share, which comes to Rs 5,651 crore ($681 million) in total. Based in Ahmedabad, Nirma specializes in cosmetics, detergents, salt and injectables. In a press conference, Glenmark’s chairman and managing director Glenn Saldanha said the company was facing a gross debut of approximately Rs 4,600 crore ($555 million). “The total debt gets extinguished after the deal,” he added. In revealing (PDF) the sale, Glenmark said the deal allows it to become an innovative and brand-led company, focusing on its core therapeutic areas of dermatology, respiratory and oncology. The sale leaves the company with a 7.8% share in the API subsidiary, named Glenmark Life Sciences, which will continue to operate as ...
- Source: drugdu
- 146
- October 4, 2023
Seagen and Astellas’ Padcev, in Keytruda combo, delivers ‘practice-changing’ bladder cancer win

As Seagen prepares for its takeover by Pfizer, the company’s Astellas-partnered cancer drug Padcev has chalked up a key trial win—in combination with Merck’s Keytruda—in previously untreated metastatic bladder cancer. In the study, Seagen and Astellas’ antibody-drug conjugate Padcev and Merck’s PD-1 superstar Keytruda scored on both overall survival and progression-free survival compared with chemotherapy. An independent data monitoring committee found that the combo’s life extension benefit surpassed the pre-specified efficacy boundary at an interim analysis, the companies said in a Friday release. The results could open the combo up to patients who are eligible for platinum-based chemotherapies cisplatin or carboplatin, regardless of their PD-L1 status. “This study has the potential to be practice changing and offer a new standard of care for first-line metastatic bladder cancer,” Seagen’s R&D head Roger Dansey, M.D., said in the release. “We look forward to presenting the results at an upcoming medical conference and ...
- Source: drugdu
- 108
- October 4, 2023
Socioeconomic status may not clearly predict the heart health of racial and ethnic groups

Improvements in socioeconomic status (education, income, employment status and health insurance) on ideal cardiovascular health may not benefit people from all racial or ethnic groups equally, as white adults were more likely to benefit than Black, Hispanic and Asian adults in the U.S., according to new research published today in the Journal of the American Heart Association, an open access, peer-reviewed journal of the American Heart Association. Joshua J. Joseph (M.D., M.P.H., FAHA, senior study author, associate professor of internal medicine, The Ohio State University College of Medicine in Columbus) said, “The goal of economic interventions and societal policies, such as improving employment, health care access and education, is that they will lead to improvements in health for everyone. However, our study found that improvements in these socioeconomic interventions may not benefit people in all racial or ethnic groups equally.” The researchers suggest that additional factors including psychosocial stress experienced ...
- Source: drugdu
- 246
- October 3, 2023
Study highlights the importance of support for caregivers in optimizing child behavior outcomes

Emotional support and tangible aid for caregivers benefited all families during the COVID-19 pandemic, not just those facing higher stress levels, according to a study funded by the Environmental influences on Child Health Outcomes (ECHO) Program at the National Institutes of Health. During the COVID-19 pandemic, many families experienced social isolation, economic hardship, and disruptions in daily routines. Communities of color suffered higher infection rates and greater financial hardship and disruption. ECHO researchers wanted to learn how these stressors on caregivers affected their children. Researchers looked separately at a subset of Black participants, who likely experienced unique discrimination during the pandemic. They found caregiver experiences of discrimination strengthened the relationship between COVID-19 pandemic stress and child behavior problems, specifically those related to anxiety and depression. The study found that higher levels of support for caregivers were associated with fewer behavior problems overall. On the other hand, higher amounts of stress ...
- Source: drugdu
- 129
- October 3, 2023
Developer of miniaturized surgical robot extends funding round

Dive Brief Virtual Incision, the startup that is getting ready to send a tiny surgical robot into space, said it has raised $30 million in an extension of its previous $46 million series C financing. The funding round will support the company’s operations “well into 2025” as it prepares to commercialize the compact robotic system designed for abdominal surgery, Virtual Incision said. The Lincoln, Nebraska-based company in May submitted a de novo request to the Food and Drug Administration to market the robot for use in bowel resection procedures, after completing an investigational device exemption study. Dive Insight A modified version of Virtual Incision’s MIRA system is headed to the International Space Station in 2024 on a test mission to perform simulated surgical tasks, in a collaboration between NASA and the University of Nebraska-Lincoln. The goal is to pave the way for performing telesurgery in space, according to the company. ...
- Source: drugdu
- 202
- October 3, 2023

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