PharmaFocus Today – Page 208 – media

March 19, 2024

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:Today, the FDA provided an update on our evaluation of quality and performance issues related to plastic syringes made in China, and announced additional recommendations and actions the FDA is taking to address these issues. The FDA issued warning letters to three entities that describe violations related to the sale and distribution of unauthorized plastic syringes made in China that have not been cleared or approved by the FDA for sale or distribution in the U.S. The FDA expects these entities to fully address the violations described in the warning letters and will take additional steps as appropriate. We remain concerned that certain syringes manufactured in China may not provide consistent and adequate quality or performance, and our evaluation is ongoing. This is an evolving situation, and we will continue to keep the ...
- Source: drugdu
- 152
- March 21, 2024
New Blood Test Cuts Diagnosis Time for Nontuberculous Mycobacteria Infections from Months to Hours

Breathing in nontuberculous mycobacteria (NTM) is a common experience for many people. These bacteria are present in water systems, soil, and dust all over the world and usually don’t cause any problems. However, for individuals with certain underlying health conditions, these bacteria can lead to lung infections, showing symptoms similar to those of tuberculosis. Such infections can lead to chronic coughing, sometimes with blood, and scarring that increases susceptibility to respiratory infections like bronchitis and pneumonia. Diagnosing and treating these infections is a lengthy process due to the slow growth rate of the bacteria. With the number of NTM infection cases rising each year, partly due to climate change, there’s a pressing need for quick and precise diagnostic methods. Researchers have now introduced a CRISPR-based testing platform capable of identifying NTM infections using blood samples, providing results in as little as two hours. Researchers at Tulane University (New Orleans, LA, ...
- Source: drugdu
- 244
- March 20, 2024
Groundbreaking Test Monitors Radiation Therapy Toxicity in Cancer Patients

The concentration of circulating cell-free DNA (cfDNA) in the bloodstream is an important indicator that can help track how well cancer treatments are working. Before starting treatment, measuring cfDNA levels can give doctors a snapshot of the extent of the cancer’s spread in the body. High levels of cfDNA often mean the cancer is widespread or aggressive. As treatment goes on, doctors can keep an eye on cfDNA levels to see if the treatment is effective. A drop in cfDNA levels could mean the treatment is working and the tumor is getting smaller. But if cfDNA levels remain unchanged or rise, it might mean the treatment isn’t working, and the cancer is still growing or has become resistant to treatment. Now, a simple blood test monitors this liquid biomarker in real time to track how well a cancer treatment is working. DiaCarta’s (Pleasanton, CA, USA) RadTox Test is a liquid ...
- Source: drugdu
- 225
- March 20, 2024
With MS & Fibrosis Trials Planned, J&J-Partnered Contineum Now Preps for IPO

Contineum Therapeutics, which emerged from a Verant Ventures startup creation engine, has filed paperwork for an IPO. The biotech’s clinical-stage pipeline spans multiple sclerosis, idiopathic pulmonary fibrosis, and depression. By FRANK VINLUAN Jhnson & Johnson is a partner on Contineum Therapeutics’ most advanced program, which is currently in mid-stage clinical testing for multiple sclerosis. As that research continues and Contineum plans to advance the development of its wholly owned assets, the biotech is moving forward with plans for an IPO. Contineum, which traces its origins to a startup creation engine of venture capital firm Versant Ventures, filed its IPO paperwork with the Securities and Exchange Commission late Friday. The company has not yet set any financial terms for its planned stock market debut, but IPO research firm Renaissance Capital said the offering could reach up to $150 million. The San Diego-based biotech has applied for a Nasdaq listing under the ...
- Source: drugdu
- 145
- March 20, 2024
FDA’s Oncologic Drugs Advisory Committee Recommends Earlier Treatment with Carvykti for Relapsed or Refractory Multiple Myeloma

Don Tracy, Associate Editor In a unanimous decision, the committee recommended Carvykti based on promising data from the Phase III CARTITUDE-4 study, which showed a positive risk-benefit assessment. Johnson & Johnson (J&J) announced that the FDA’s Oncologic Drugs Advisory Committee (ODAC) recommended Carvykti (ciltacabtagene autoleucel, cilta-cel) in earlier lines of treatment for adult patients with relapsed or refractory multiple myeloma who have previously undergone at least one line of therapy, including both a proteasome inhibitor and an immunomodulatory agent, and who are also refractory to lenalidomide. The 11-0 unanimous vote in favor of the treatment resulted from Phase III CARTITUDE-4 study data, which showed an encouraging risk-benefit evaluation for its proposed indication.1 “We are pleased with the advisory committee’s support for Carvykti in earlier lines of treatment based on the CARTITUDE-4 data,” said Jordan Schecter, MD, VP, Disease Area Leader, Multiple Myeloma, Johnson & Johnson Innovative Medicine, in a press ...
- Source: drugdu
- 196
- March 20, 2024
AZ/Merck’s Lynparza approved by SMC to treat advanced prostate cancer in Scotland

Up to 20% of prostate cancer cases are classified as castration-resistant AstraZeneca (AZ) and Merck & Co – known as MSD outside the US and Canada – have announced that the Scottish Medicines Consortium (SMC) has approved Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone to treat adult patients with metastatic castration-resistant prostate cancer (mCRPC). Affecting around one in ten men in Scotland, approximately 10% to 20% of prostate cancer cases are classified as castration resistant, evolving to resist androgen deprivation therapy, the standard of care. mCRPC occurs when the cancer has spread to other parts of the body, which is challenging to treat and results in a poor prognosis. The SMC’s decision was based on results from the phase 3 randomised, double-blind PROpel trial, which evaluated the efficacy, safety and tolerability of Lynparza versus placebo when given in addition to abiraterone in men with mCRPC who had ...
- Source: drugdu
- 181
- March 20, 2024
Birmingham’s VR-assisted training centre for excellence to support future vaccine makers

The centre will deliver free training, outreach materials and programmes The University of Birmingham is set to lead UK-wide virtual reality (VR)-assisted training in medicines manufacturing to address critical skills demand in life sciences. Set to benefit future medicine and vaccine makers, the new RESILIENCE Centre for Excellence for UK Medicines Manufacturing Skills Centre aims to deliver free training, outreach materials and programmes. Supported by £4.5m of funding from Innovate UK and the Office for Life Sciences, the centre will be led by an academic consortium of UK universities, including University College London, Teesside University and Heriot-Watt University. The training centre aims to work with healthcare and pharmaceutical organisations to provide a single-entry point for training and career input, which includes a pipeline of continuing professional development courses. Hundreds of students across the UK are set to benefit from the training developed by the RESILIENCE Centre, including VR and mixed ...
- Source: drugdu
- 132
- March 20, 2024
CanSinoBio (Shanghai) and AsymBio have entered into a strategic cooperation.

Recently, CanSinoBio (Shanghai) Biotechnology Co., Ltd (hereinafter referred to as “CanSinoBio Shanghai”) and AsymBio (hereinafter referred to as “AsymBio”) reached a strategic cooperation. (hereinafter referred to as “Kalein Biotech”). The two parties will aim at the cutting-edge technology innovation and industry market demand, and realize innovative collaboration and complementary advantages in the field of plasmid, mRNA, LNP biopharmaceutical macromolecules, and jointly promote the research and development and industrialization of mRNA technology. As a leading company in the vaccine field, CanSinoBio Shanghai has established an advanced mRNA technology platform in the industry, with independently designed and developed sequence optimization software, which can obtain the key sites affecting the stability and the optimal sequence to effectively improve the expression of antigens, and the CMC process is simple and concise, which can shorten the time of product development and quickly realize the industrialization of scientific research results. In addition, CanSinoBio has an advanced ...
- Source: drugdu
- 113
- March 20, 2024
Merck Sharp & Dohme Announces Plans to Conduct Clinical Trials of New Multivalent HPV Vaccine and Gardasil®9 Single-Dose Vaccination Regimen

Rowe, N.J., March 13, 2024 – Merck Sharp & Dohme (Merck is the corporate trading name of Merck & Co. of Rowe, N.J., U.S.A.) announced at the European Organization for the Study of Genital Infections and Neoplasms (EUROGIN) Congress 2024 plans to initiate a novel multivalent human papillomavirus (HPV) vaccine clinical trial designed to provide broader protection against HPV types. At the same time, Merck Sharp & Dohme also plans to conduct additional clinical trials to evaluate the protective efficacy and safety of Gardasil®9 [nine-valent human papillomavirus vaccine (brewer’s yeast)] single-dose regimen1 compared to the already approved three-dose regimen. Within China, Gardasil®9 is indicated for the prevention of cervical cancer caused by HPV types 16, 18, 31, 33, 45, 52, and 58; cervical intraepithelial neoplasia (CIN grades 1/2/3) and adenocarcinoma in situ (AIS) of the uterine cervix caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and ...
- Source: drugdu
- 180
- March 20, 2024
FDA Approves First Gene Therapy for Children with Metachromatic Leukodystroph

Today, the U.S. Food and Drug Administration approved Lenmeldy (atidarsagene autotemcel), the first FDA-approved gene therapy indicated for the treatment of children with pre-symptomatic late infantile, pre-symptomatic early juvenile or early symptomatic early juvenile metachromatic leukodystrophy (MLD). Metachromatic leukodystrophy is a debilitating, rare genetic disease affecting the brain and nervous system. It is caused by a deficiency of an enzyme called arylsulfatase A (ARSA), leading to a buildup of sulfatides (fatty substances) in the cells. This buildup causes damage to the central and peripheral nervous system, manifesting with loss of motor and cognitive function and early death. It is estimated that MLD affects one in every 40,000 individuals in the United States. There is no cure for MLD, and treatment typically focuses on supportive care and symptom management. “This is the first FDA-approved treatment option for children who have this rare genetic disease,” said Peter Marks, M.D., Ph.D., director of ...
- Source: drugdu
- 255
- March 20, 2024

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