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A step towards global harmonisation of GMP inspection protocols

In a letter dated March 21, the US FDA India office country director Sarah McMullen said that four states (Gujarat, Telangana, Goa and Karnataka) had been ‘sensitised to FDA’s inspection process and, as such, are eligible for inclusion as observers for relevant inspection in their respective states.’ The letter goes on to mention, ‘We would appreciate relevant opportunities being made available to state inspectors to attend as observers as practical.’ US FDA’s ‘Observed Inspection Program‘ involves interaction between the USFDA India office and State Drug Control Authorities, with the former inviting the latter as observers during inspections. As the letter indicates, ‘FDA has shared best practices and inspectional protocols in regulatory forums with several states.’ It is logical that the US FDA would now turn to replicate these efforts in other states, especially those with many FDA-registered facilities, like Maharashtra, for instance, and explore the possibility of adding to this ...
- Source: drugdu
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- April 3, 2024
GlobalData

In the dynamic landscape of the pharma industry, collaboration often serves as the key to innovation and expanding market presence. In recent years, the Asia-Pacific (APAC) market has emerged as a hub for pharmaceutical development and investment, attracting attention from both local and global players. While cooperation between APAC-based pharmaceutical companies and their global counterparts has been on the rise, active cooperation among pharma companies within the APAC region is gaining traction, observes GlobalData. According to GlobalData’s Pharmaceutical Intelligence Center, from 2019 to 2023, 673 deals (strategic alliances) occurred among companies that are purely based in APAC, with 360 deals* of them being for unique therapy areas. It is interesting to note that 44 per cent of these deals* are for oncology, followed by infectious diseases (20 per cent), central nervous system disorders (12 per cent), cardiovascular disorders (4 per cent), and ophthalmology (4 per cent). The infectious disease space ...
- Source: drugdu
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- April 3, 2024
WHO publishes new guidelines on hepatitis B

WHO has released new Guidelines on prevention, diagnosis and treatment of chronic hepatitis B (HBV) infection at the 2024 Asian Pacific Conference for the Study of Liver Disease (APASL) in Kyoto, Japan. These guidelines provide a substantial simplification and expansion of eligibility for treatment to overcome barriers in access to HBV testing and treatment. More than 250 million people live with chronic hepatitis B infection, leading to increasing deaths each year. Most of the global burden of chronic hepatitis B (CHB) is due to mother-to-child transmission at or shortly after birth. WHO’s Global health sector strategy sets actions and targets to eliminate viral hepatitis by 2030 by driving new infections and deaths down to half a million each globally – a reduction of 90% and 65%, respectively. Considerable progress has been made towards eliminating mother-to-child transmission of HBV through universal infant HBV immunization, including the timely hepatitis B birth dose. ...
- Source: drugdu
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- April 3, 2024
Promoting a risk-based approach for the regulatory oversight of vaccines used in pandemics

Global guidelines on regulatory preparedness for pandemic influenza vaccines have been revised to strengthen the regulating of vaccines risk-based approaches to vaccine regulation in the event of a pandemic. During the 2009 H1N1 influenza pandemic, the deployment of pandemic influenza vaccines in importing countries was delayed or disrupted due to the lack of regulatory preparedness. This resulted in WHO developing guidelines for non-vaccine producing countries on the appropriate regulatory approaches to the marketing authorization and lot release of pandemic influenza vaccines in public health emergency conditions. These guidelines were developed in the context of the Pandemic Influenza Preparedness (PIP) Framework’s Partnership Contribution High Level Implementation Plan, covering regulatory capacity-building and strengthening of pandemic preparedness and response. However, subsequent public health emergencies such as the Ebola epidemic and COVID-19 pandemic further exposed gaps in regulatory preparedness for other types of pandemic vaccines. The role of national regulatory authorities was not acknowledged ...
- Source: drugdu
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- April 3, 2024
Alebund’s Innovative Investigational Drug AP303 Receives FDA Orphan Drug Designation (ODD) for the Treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD)

SHANGHAI, March 29, 2024 /PRNewswire/ — Alebund Pharmaceuticals (“Alebund” or the “Company”), an integrated biopharmaceutical company focusing on developing innovative therapies for the treatment of renal diseases and related chronic conditions, announced today that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to AP303 for the treatment of autosomal dominant polycystic kidney disease (ADPKD). “We are very excited that AP303 has been granted Orphan Drug Designation by the FDA”, Dr. Gavin Xia, Co-founder, Chairman, and CEO of Alebund commented. “It is an important milestone for Alebund as well as our efforts to address the significant unmet medical needs with ADPKD. We look forward to advancing AP303 to improve future treatment options for patients in need.” AP303, a novel drug candidate developed in-house by Alebund, has demonstrated a meaningful improvement of renal survival in an ADPKD mice model. AP303 has completed its first-in-human study in healthy ...
- Source: drugdu
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- April 3, 2024
IASO Bio Announces NMPA’s IND Approval for Equecabtagene Autoleucel in Second- and Third-Line Treatment of Multiple Myeloma

SHANGHAI and NANJING, China and SAN JOSE, Calif., March 29, 2024 /PRNewswire/ — IASO Bio, a biopharmaceutical company engaged in discovering, developing, manufacturing and marketing innovative cell therapies and antibody products, today announced that China National Medical Products Administration (NMPA) has approved the Investigational New Drug (IND) application for Equecabtagene Autoleucel (IASO Bio R&D code: CT103A), a self-developed fully-human anti-B cell maturation antigen (BCMA) chimeric antigen receptor (CAR) autologous T-cell injection, for an expanded indication in treating relapsed and/or refractory multiple myeloma (R/RMM) patients who have undergone 1-2 lines of prior therapies and are refractory to lenalidomide. The New Drug Application (NDA) for FUCASO ® (Equecabtagene Autoleucel) was approved by NMPA for the treatment of relapsed and/or refractory multiple myeloma (R/R MM) who received ≥3 lines of prior therapies containing at least one proteasome inhibitor and an immunomodulatory agent on June 30, 2023. The NDA approval was based on the ...
- Source: drugdu
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- April 3, 2024
Labcorp’s $237M Tuck-In Deal Brings Lab Testing Assets From BioReference Health

Labcorp is buying the clinical diagnostics and reproductive women’s health businesses of BioReference Health, excluding those assets in New York and New Jersey. Labcorp has returned to being fully focused on lab testing after last year’s spinoff of Fortrea, its former clinical trial services business. By FRANK VINLUANLabcorp’s testing capabilities are getting a little broader with the $237.5 million acquisition of certain laboratory assets from BioReference Health, a subsidiary of Opko Health. The BioReference assets going to Labcorp span clinical diagnostics and reproductive women’s health across the U.S. and account for about $100 million in annual revenue. The deal announced Thursday excludes those assets in New York and New Jersey, where BioReference will continue to maintain its full operations. BioReference will also continue to offer oncology and urology diagnostic services nationwide. Burlington, North Carolina-based Labcorp was founded as a laboratory testing company in 1969. In 2015, it entered drug development ...
- Source: drugdu
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- April 2, 2024
FDA Hands Expanded Indication to Gilead’s Vemlidy for Chronic HBV Infection in Pediatric Patients

Don Tracy, Associate Editor Phase II clinical study showed that children as young as six years of age with hepatitis B virus could benefit from treatment with Vemlidy. The FDA has approved an expanded indication for Gilead’s Vemlidy (tenofovir alafenamide), to treat chronic hepatitis B virus (HBV) infection in pediatric patients aged six years and older who weigh at least 25 kg and have compensated liver disease. In 2016, the medication was initially approved for adults with chronic HBV and compensated liver disease, with an extended use approved in 2022 for children aged 12 years and above. Approval for the expanded indication was based on positive results stemming from Gilead’s Phase II clinical trial (Trial 1092) after 96 weeks, showing safety and efficacy in younger children. According to the study data, participants experienced progressive increases in the rates of virological suppression compared to those administered a placebo.1 “Chronic hepatitis B ...
- Source: drugdu
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- April 2, 2024
Innovative Blood Collection Device Overcomes Common Obstacles Related to Phlebotomy

The discomfort associated with traditional blood draws leads to a significant issue: approximately 30% of diagnostic tests prescribed by physicians are never completed by patients. This avoidance is often due to the fear of pain from needle sticks and a reluctance to visit medical facilities where there’s a perceived risk of encountering illness. Now, a virtually pain-free, low-cost, easy-to-use, whole blood and plasma collection and dispensing system solves the problem of the physical pain of a traditional blood draw, making it easier, cheaper, and faster to potentially receive a diagnosis. RedDrop Dx’s (Fort Collins, CO, USA) innovative blood collection device, RedDrop One, aims to enhance blood collection technology and patient care practices. With its user-centric design, RedDrop One eliminates many of the drawbacks associated with traditional blood collection methods, allowing for the collection of larger blood volumes more efficiently and with significantly less discomfort for the patient. This device is ...
- Source: drugdu
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- April 2, 2024
Upgraded Syndromic Testing Analyzer Enables Remote Test Results Access

QIAGEN (Venlo, the Netherlands) has released the QIAstat-Dx Analyzer 2.0, including the Software 1.6 upgrade. This represents a significant advancement from the initial QIAstat-Dx Analyzer 1.0, offering enhanced capabilities for the accurate, rapid, and cost-effective identification of complex syndromes. The system, which is designed for laboratory settings, incorporates economical, disposable cartridges that integrate sample preparation with all necessary reagents on board. Leveraging multiplex real-time PCR technology, it can identify and distinguish between various pathogens, delivering results within approximately one hour. Additionally, the system enables the display of cycle threshold (Ct) values and amplification curves, providing deeper analytical insights beyond those achievable with endpoint PCR or alternative methodologies. A key feature of this upgraded system is the introduction of the QIAstat-Dx Operational Module PRO, which is equipped with a 64-bit processor and 4GB of RAM. This enables the Remote Results Application, a pioneering tool in syndromic testing that allows for the ...
- Source: drugdu
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- April 2, 2024

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