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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
- 128
- 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
- 145
- March 20, 2024
BeiGene’s Tevimbra receives FDA approval to treat advanced oesophageal cancer

BeiGene’s PD-1 inhibitor Tevimbra (tislelizumab-jsgr) has been approved by the US Food and Drug Administration (FDA) to treat advanced oesophageal squamous cell carcinoma (ESCC). The authorisation specifically applies to adult patients with unresectable or metastatic ESCC after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor. Oesophageal cancer is the sixth most common cause of cancer-related deaths globally and ESCC accounts for almost 90% of cases. More than two-thirds of patients with oesophageal cancer have advanced or metastatic disease at the time of diagnosis, with an expected five-year survival rate of less than 6% for those with distant metastases. BeiGene’s Tevimbra, which is already approved in the EU for advanced or metastatic ESCC after prior chemotherapy, is designed to aid the body’s immune cells to detect and fight tumours. The FDA’s decision on the therapy was based on positive results from the late-stage RATIONALE 302 trial, which compared its ...
- Source: drugdu
- 123
- March 20, 2024
A Startup’s Flexibility With ADC Cancer Drugs Attracts €128M for Clinical Trials

Tubulis’s next-generation ADC cancer drugs are designed to overcome limitations of currently available therapies in this drug class. The new financing will support clinical trial plans, but first, preclinical proof-of-concept data will be presented during the American Association for Cancer Research annual meeting. By FRANK VINLUAN The concept of an antibody drug conjugate, or ADC, is straightforward: a cancer-killing drug is chemically linked to an antibody that targets the delivery of the therapy to a tumor. This drug class has made progress with several approved products and many more on their heels in clinical development. But there’s still plenty of room to improve on this type of targeted cancer therapy, contends Dominik Schumacher, CEO of Tubulis. When an ADC releases its drug payload too early, it hits healthy tissue and sparks toxic effects, Schumacher said. Also, current ADC designs are restricted in their ability to match the biology of cancer ...
- Source: drugdu
- 153
- March 19, 2024
FDA Approves Tevimbra, BeiGene’s Treatment for Adults with Unresectable or Metastatic Esophageal Squamous Carcinoma

Don Tracy, Associate Editor Tevimbra (tislelizumab-jsgr) has been approved as a monotherapy for adult patients with unresectable or metastatic esophageal squamous cell carcinoma who have previously undergone systemic chemotherapy excluding PD-L1 inhibitors. The FDA has approved BeiGene’s Tevimbra (tislelizumab-jsgr) for patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) who have previously undergone systemic chemotherapy excluding PD-L1 inhibitors. The FDA based the approval on findings from the Phase III RATIONALE 302 trial (NCT03430843), which showed a significant survival benefit with Tevimbra compared to chemotherapy, with an overall survival rate of 8.6 months compared with 6.3 months in patients administered chemotherapy. Further, the treatment was found to be safer altogether, with manageable adverse effects.1 “Today’s FDA approval of Tevimbra for patients with ESCC who have previously received chemotherapy, along with its ongoing review of our [biologics license application] for first line ESCC patients, represents a significant step in our commitment ...
- Source: drugdu
- 127
- March 19, 2024
NHS to roll out AI to improve waiting times and reduce missed appointments

Every year, missed hospital appointments are estimated to cost the NHS £1.2bn The NHS has announced that it’s set to roll out artificial intelligence (AI) to help improve waiting times for elective care and reduce the number of missed appointments. New data has shown that 6.4% of over 125 million outpatient appointments across the NHS in England last year were not attended by the patient, specifically for physiotherapy, cardiology, ophthalmology, trauma and orthopaedics. Additionally, missed appointments are predicted to cost the NHS a total of £1.2bn, annually. Created by Deep Medical, the AI software uses algorithms and anonymised data to predict missed appointments and uses a range of external insights as to why, such as the weather, traffic, jobs and back-up bookings. Piloted for the last six months at Mid and South Essex NHS Foundation Trust, the software will expand to ten more NHS trusts following the success of the ...
- Source: drugdu
- 123
- March 19, 2024
NIHR reveals phase 1/2 trial to evaluate an investigational vaccine for mpox in the UK

More than 3,700 cases of mpox have been identified in the UK since May 2022 The National Institute for Health and Care Research (NIHR) has announced a new phase 1/2 trial, delivered by the NIHR Clinical Research Network and sponsored by Moderna, to test the effectiveness of an investigational mRNA vaccine for mpox. The mPower trial will evaluate the safety and immune response to mRNA-1769, which aims to protect against illness caused by the mpox virus. Currently a global public health threat, mpox is an infectious disease caused by the monkeypox virus, which is spread through physical contact with someone who is infected, leading to symptoms including painful rashes, enlarged lymph nodes and fever. Since May 2022, over 3,700 cases of mpox have been identified in the UK, the majority of which have been from the Clade II B.1 lineage, predominantly in gay, bisexual and other men who have sex ...
- Source: drugdu
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- March 19, 2024
BeiGene’s “tislelizumab” FDA approved

On March 15, 2024, BeiGene announced that the U.S. Food and Drug Administration (FDA) has approved tislelizumab (Chinese trade name: BAIZEAN®; English trade name: TEVIMBRA®) as mono-therapy to treat adult patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic chemotherapy (without PD-1/L1 inhibitors). Tislelizumab is expected to be available in the United States in the second half of 2024. The approval was based on results from the RATIONALE 302 trial, which met its primary endpoint in the intention-to-treat (ITT) population. Tislelizumab demonstrated a statistically significant and clinically meaningful survival benefit compared with chemotherapy. In the ITT population, median overall survival (OS) was 8.6 months (95% CI: 7.5, 10.4) in the tislelizumab group compared with 6.3 months (95% CI: 5.3, 7.0) in the chemotherapy group (p=0.0001; hazard ratio [HR]=0.70 [95% CI: 0.57, 0.85]). The safety profile of tislelizumab is superior to that of chemotherapy. The most common ...
- Source: drugdu
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- March 19, 2024
FDA approves Mirum’s Livmarli to treat cholestatic pruritus in rare liver disease patients

The US Food and Drug Administration (FDA) has approved Mirum Pharmaceuticals’ Livmarli (maralixibat) oral solution to treat cholestatic pruritus in patients aged five years and older with progressive familial intrahepatic cholestasis (PFIC). Estimated to affect one in every 50,000 to 100,000 births in the US and Europe, PFIC is a rare genetic disorder that causes progressive liver disease, typically leading to liver failure. Signs and symptoms of the condition usually begin in infancy and include severe pruritus (itching), jaundice and a failure to grow at the expected rate. The FDA’s decision on the therapy covers a broad range of PFIC subtypes and is supported by positive results from the late-stage MARCH study, which included 93 patients across a range of genetic PFIC forms as well as unidentified mutational status. Results showed a “highly statistically significant” reduction in pruritus severity for those receiving Livmarli compared with placebo, Mirum outlined. Chris Peetz, ...
- Source: drugdu
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- March 19, 2024
Biotheus Expanded Their Partnership with Hansoh Pharma for Developing EGFR/cMET Bispecific Antibody-Drug Conjugates

ZHUHAI, China, March 15, 2024 /PRNewswire/ — On March 14, 2024, Biotheus Inc. (Biotheus), a clinical-stage biotech company focusing on the discovery and development of biologics for oncology and inflammatory diseases, and Hansoh Pharmaceutical Group Co., Ltd. (Hansoh Pharma,03692.HK), China’s leading innovation-driven pharmaceutical company, jointly announced that the two parties will further expand their strategic collaboration, following their current partnership since 2022. Biotheus will grant Hansoh Pharma a license to use the proprietary anti-EGFR/cMet bispecific antibody PM1080/HS-20117 independently developed by Biotheus for the development of antibody-drug conjugates products (ADC Product). Under the terms of the agreement, Hansoh Pharma will obtain exclusive worldwide rights from Biotheus to use PM1080/HS-20117 for the development, production, and commercialization of ADC Product, with the right of sublicense. Biotheus will be eligible to receive up to 5 billion RMB in upfront and success-based milestones for ADC Product, as well as tiered royalties based on global net ...
- Source: drugdu
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- March 19, 2024

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