Search Results for “FDA” – Page 101 – media

RAPT terminates Phase II trials for lead candidate following clinical hold

RAPT Therapeutics has announced plans to terminate two Phase II trials for its lead candidate, zelnecirnon (RPT193), three months after the US Food and Drug Administration (FDA) placed a clinical hold on them. In February, the US regulatory agency placed a clinical hold on the Phase IIa (NCT05935332) and Phase IIb trials (NCT05399368) that evaluated zelnecirnon in atopic dermatitis and moderate to severe asthma, respectively. The hold was placed after a patient in the atopic dermatitis trial suffered liver failure possibly caused by zelnecirnon. Following the trial termination news, RAPT’s stock was down by 41.7% at market close on 9 May, compared to market close on the previous day. Since the clinical hold was announced on 20 February, the company’s stock has dropped by over 82% compared to its peak before the news. RAPT ended Q1 with $141.6m in cash reserves and a net loss of $30.5m. Rapt’s market cap ...
- Source: drugdu
- 73
- May 14, 2024
Sanofi signs $1.2bn licensing agreement for Novavax’s Covid-19 vaccine

Sanofi has signed a $1.2bn licensing agreement with Novavax to co-commercialise its stand-alone adjuvanted Covid-19 vaccine. Starting in 2025, the drugmaker will co-commercialise the vaccine worldwide, except for in countries such as India, South Korea, and Japan where Novavax already has existing partnerships in place. As per the “co-exclusive” agreement, Sanofi will also support certain R&D, regulatory, and commercial expenses. The American vaccine company has faced tough times in the post-Covid-19 landscape, going as far as to issue a “going concern” warning in 2023 about its ability to continue operating. At the time, Novavax said it was subject to “significant uncertainty” concerning future sales and funding from the US Government. Following the deal with Sanofi, the removal of this warning was noted in Novavax’s first quarter 2024 financial results and operational highlights released today. Novavax CEO John Jacobs told CNBC that the agreement with Sanofi would allow it to lift ...
- Source: drugdu
- 65
- May 14, 2024
The Impact of Micropayments in Clinical Trials

Micropayments provide an additional incentive for patients to complete required tests, procedures, and diary entries, ensuring that sites, sponsors, and CROs are able to collect the required data needed to complete a clinical trial on time and on budget. By Tanya Kogan on May 10, 2024 Clinical trials today require more patient involvement than ever before. Yet longer, more frequent site visits or participation that requires extensive travel can impact a patient’s willingness to participate in and remain in a clinical trial over the long term. As a result, patient recruitment and retention can be a challenge for sites and pharmaceutical companies, especially when the target patient population is small or geographically dispersed. Sadly, the average dropout rate across clinical trials is 30 percent. With the increasing need for consistent and accurate patient data, sponsors and sites are investing in electronic patient-reported outcomes (ePRO) and electronic clinical outcomes assessment (eCOA) ...
- Source: drugdu
- 99
- May 13, 2024
Securing Audience Measurement in Pharma Marketing

Ray Kingman The industry must find a way to balance consumer privacy and a return on investment in pharma marketing. Promoting advances in pharmaceuticals is full of challenges. From recruiting clinical trial participants, to engaging patients with their permission at the point of care, to creating brand lift and awareness, the marketing landscape for pharma presents both logistical and regulatory obstacles when it comes to constructing and executing a successful marketing program. Identity, and how it is managed, presents special challenges for audience targeting and especially measurement of campaign performance in an evolving identity resolution environment. Across our multi-channel, multi-platform and multi-media landscape the signals that avail us for targeting and measurement are often impeded by the requirement to block or exercise restraint when it comes to sensitive data and patient privacy rights. Building privacy-compliant audiences for pharma campaigns takes special care, but identifying audience engagement that measures campaign outcomes ...
- Source: drugdu
- 84
- May 10, 2024
Otsuka Launches New Company to Commercialize Rejoyn, the First Digital Therapeutic for Depression

Otsuka Pharmaceutical is launching a subsidiary that will commercialize its digital therapeutic Rejoyn — as well as other digital therapeutics and connected health products down the line. Last month, Rejoyn became the first FDA-cleared digital therapeutic for patients with depression.Last month, an app named Rejoyn became the first FDA-cleared prescription digital therapeutic for patients with major depressive disorder. The app, which changes users’ behavior through various lessons and exercises, was developed by Otsuka Pharmaceutical and Click Therapeutics. On Monday, Otsuka announced that it is launching a new data and technology-focused subsidiary that will commercialize Rejoyn — as well as other digital therapeutics and connected health products down the line. The new company — named Otsuka Precision Health — is a subsidiary of Otsuka America, which is a subsidiary of Tokyo-based Otsuka Pharmaceutical. Rejoyn is a six-week program intended to be used alongside antidepressants. The app leverages clinically validated cognitive emotional ...
- Source: drugdu
- 107
- May 10, 2024
Automated Sepsis Test System Enables Rapid Diagnosis for Patients with Severe Bloodstream Infections

Sepsis affects up to 50 million people globally each year, with bacteraemia, formerly known as blood poisoning, being a major cause. In the United States alone, approximately two million individuals are affected by sepsis annually, resulting in around 250,000 deaths. Similar statistics are reported in the European Union. Sepsis is characterized by life-threatening organ failure due to a dysfunctional systemic immune response. Rapid and accurate diagnostic methods are essential for timely and effective treatment, which is critical for patient survival. Now, a fully automated system for rapid antimicrobial susceptibility testing (AST) significantly reduces the time required to obtain clinically actionable results, thereby speeding up the administration of optimal treatments from days to just hours. The ASTar System from Q-linea AB (Uppsala, Sweden) revolutionizes the treatment of sepsis by enabling a rapid therapeutic response directly from a positive blood culture in about six hours. This system equips physicians with the necessary ...
- Source: drugdu
- 112
- May 9, 2024
TOFIDENCE™ (tocilizumab-bavi) tocilizumab biosimilar launched for sale in the U.S.

BIO-THERA Biopharmaceutical Co., Ltd (SSE: 688177) is a global science-based and innovative biopharmaceutical company based in Guangzhou, China, hereinafter referred to as “BIO-THERA” or the “Company”. The Company is committed to developing a new generation of innovative drugs and biosimilars for the treatment of oncology, autoimmune diseases, cardiovascular diseases, ophthalmology and other major diseases that threaten human life or health. The Company today announced that its partner, Bojian (NASDAQ: BIIB), has recently begun marketing and selling TOFIDENCE™ (tocilizumab-bavi) tocilizumab biosimilar in the United States. TOFIDENCE™, a biosimilar developed by BIO-THERA with reference to Amero® (tocilizumab), was approved by the U.S. FDA in September 2023 for the treatment of moderate-to-severe rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis.TOFIDENCE™ is currently available in the U.S. as an intravenous infusion of 80 mg/4 ml, and is sold as an intravenous injection of 80 mg/4 ml. sales, 80 mg/4 mL, 200 ...
- Source: drugdu
- 69
- May 9, 2024
Cipla and Glenmark initiate recall of certain products in the US

Cipla and Glenmark Pharmaceuticals are recalling specific products from the US market due to distinct manufacturing issues, the latest Enforcement Report issued by the US Food and Drug Administration (USFDA) noted. The recalls involve inhalation solutions and extended-release capsules used for treating respiratory conditions and high blood pressure, respectively. New Jersey-based subsidiary of Cipla, Cipla USA is recalling 59,244 packs of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution. This product is manufactured at Indore SEZ plant of the company in India. It is prescribed for controlling the symptoms of lung diseases such as chronic bronchitis, asthma, and emphysema. The recall of the affected inhalation solution lot is claimed to be due to complaints of “short fill”. The US regulator detailed that the affected lot was recalled after reports of less fill volume in respules and the presence of a few drops of liquid in the intact pouch. Simultaneously, Glenmark Pharmaceuticals, ...
- Source: drugdu
- 124
- May 8, 2024
Cue Health to cut 230 employees

Dive Brief Cue Health plans to cut 230 employees, or nearly half of its staff, as it looks to reduce costs amid declining COVID-19 test sales. The San Diego-based company grew quickly during the pandemic when it brought in government and private contracts for its point-of-care molecular tests. Now, Cue faces questions about its ability to continue as losses add up and revenue declines. The changes are intended to refocus Cue’s business on its Cue Health Monitoring System, including developing and deploying point-of-care tests, spokesperson Rachel Rudo wrote in an email. “In alignment with this strategy, Cue has significantly reduced, or removed altogether, functions that don’t directly support this strategy,” Rudo said. Dive Insight Cue has gone through several rounds of layoffs as the testing company looks to control costs. In January, the company cut more than 200 positions across two rounds of layoffs, and Cue also slashed hundreds of ...
- Source: drugdu
- 96
- May 6, 2024
Lupin Digital Health’s Lyfe Platform gets Class C Medical Device License from CDSCO

Lupin Digital Health’s Lyfe platform has received approval as a Class C Medical Device from the Central Drugs Standard Control Organisation (CDSCO). A press statement informed that Lyfe is now India’s first clinically proven remote cardiac rehabilitation program, designed to enhance heart health and quality of life. By providing tailored, accessible solutions in the comfort of patients’ homes, Lyfe empowers individuals to confidently manage their heart health. Rajeev Sibal, President – India Region Formulations, Lupin, stated, “This approval reaffirms our dedication to excellence in cardiac care. We are proud to be at the forefront of digital therapeutics in India, signifying our commitment to supporting cardiologists with patient-centric solutions and improving cardiovascular outcomes.” Elaborating on the significance of receiving this license, Sidharth Srinivasan, CEO, Lupin Digital Health added, “Securing the Class C Medical Device license for Lyfe is a significant achievement. It validates Lyfe as a best-in-class platform to support millions ...
- Source: drugdu
- 76
- May 5, 2024

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