Search Results for “cancer” – Page 91 – media

Biotheus’s PD-L1/VEGF dual antibody is planned to be included in breakthrough therapeutic category and has reached a licensing cooperation of over US$1 billion

Today (1st March), the official website of the Center for Drug Evaluation (CDE) of the NMPA announced that the PM8002 injection applied by Biotheus is planned to be included in the breakthrough therapy category, and the indication is the first-line treatment of inoperable locally advanced/recurrent metastatic triple-negative breast cancer with albumin-bound paclitaxel for combined injection. Public information shows that PM8002 is an anti-PD-L1/VEGF bispecific antibody independently developed by Biotheus. BioNTech has reached a cooperation agreement of more than US$1 billion with Biotheus to obtain the development, production and commercialization rights of this product worldwide (except Greater China). PM8002 is a bispecific antibody drug candidate consisting of a humanized anti-PD-L1 mono-antibody (VHH) fused to an anti-VEGF-A IgG1 antibody containing an Fc-silent mutation. This design can enrich PM8002 molecules into the tumor environment and reduce the systemic side effects caused by systemic VEGF blockade. According to an earlier press release fromBiotheus, PM8002 ...
- Source: drugdu
- 120
- March 5, 2024
MHRA grants first approval via the new International Recognition Procedure in 30 days

A new formulation for XGEVA (denosumab), a treatment used in adults to prevent serious bone-related complications caused by bone metastasis and to treat giant cell tumour of bone in adults and adolescents, is the first product to be authorised by the Medicines and Healthcare products Regulatory Agency (MHRA) via the new International Recognition Procedure (IRP). The product was authorised in 30 days, providing UK patients with earlier access to this treatment thanks to international recognition. Launched in January this year, the IRP allows the MHRA to accelerate the assessment of new medicines by taking into account the expertise and decision-making of trusted regulatory partners in the authorisation process. As a result, medicines that have been approved in other countries with stringent regulators will get to UK patients without delay, resulting in a more rapid, efficient, and cost-effective process for life sciences companies. Denosumab (XGEVA) was authorised on 29 February 2024 ...
- Source: drugdu
- 117
- March 5, 2024
Jacobio Pharma Receives IND Approval for P53 Y220C Activator JAB-30300 in the U.S.

BEIJING, SHANGHAI and BOSTON, March 1, 2024 /PRNewswire/ — Jacobio Pharma (1167.HK), a clinical-stage oncology company drugging the undruggable targets, today announced it received IND (Investigational New Drug) approval of its self-developed drug JAB-30300 (P53 Y220C activator) from the FDA of the U.S. Jacobio plans to initiate a Phase I/IIa advanced solid tumors clinical trial in the U.S., to evaluate safety and efficacy of JAB-30300. Jacobio also plans to submit IND in China, and will conduct clinical studies once receives the IND approval. P53 is the single most frequently altered gene in human cancers, with mutations being present in approximately 50% of all invasive tumors. JAB-30300 is an orally bioavailable small molecule activator for the treatment of patients with solid tumors harboring P53 Y220C mutation. Studies shows that, JAB-30300 has shown very high binding affinity to P53 Y220C mutant proteins. Tumor regression was achieved in multiple cancer models covering various ...
- Source: drugdu
- 149
- March 5, 2024
Researchers reveal COVID-19 could have small impacts on cognition and memory

Different factors, such as illness duration and virus variant, impacted patients cognitive abilities Imperial College London (ICL) researchers have revealed that people who have recovered from COVID-19 could have small but long-lasting impacts on the performance of cognitive and memory tasks. Published in the New England Journal of Medicine, the REACT Long COVID study enrolled over 140,000 participants, including long COVID patients, who undertook at least one cognitive task. COVID-19 is an infectious disease caused by the SARS-CoV-2 virus. For some patients, the condition can lead to long COVID, where symptoms can last up to 12 weeks. Using an innovative online cognitive assessment via the Cognitron platform, researchers detected subtle changes in different areas of brain function, including memory, reasoning, executive function, attention and impulsivity. The study revealed small deficits that were still detectable after a year or more following infection, including in people who had a short duration of ...
- Source: drugdu
- 92
- March 5, 2024
Profound Medical, Siemens Healthineers collab on ultrasound ablation

Profound Medical (Nasdaq:PROF) announced today that it entered into a non-exclusive collaboration with Siemens Healthineers. The two companies aim to lay the groundwork for Profound to begin marketing a complete therapeutics solution. They want to combine the Profound TULSA-PRO system with the Siemens Magnetom Free.Max magnetic resonance (MR) scanner. While this combination falls under the remit of Profound’s own sales force, the company also plan to market TULSA-PRO as a standalone offering. This enables customers to use the technology with the MR hardware of their choice. TULSA-PRO performs the company’s transurethral ultrasound ablation (TULSA) procedure. It employs real-time MR guidance for precision while killing targeted prostate tissue through sound absorption technology. The system enables surgeons to ablate whole- or partial-gland prostate tissue in patients with low- intermediate- or high-risk prostate cancer. It also treats benign prostatic hyperplasia (BPH). It can treat prostate cancer patients on active surveillance seeking treatment of ...
- Source: drugdu
- 88
- March 4, 2024
The marketing application for new indications of Anrotinib hydrochloride capsule and anti-PD-L1 “Behmosubaisumab (TQB2450 injection)” of Zhengda Tianqing has been accepted.

Recently, Anrotinib Hydrochloride Capsules and anti-PD-L1 “Behmosubaisumab (TQB2450 Injection)” developed by Zhengda Tianqing have submitted a new indication application to the Center for Drug Evaluation of the State Drug Administration (CDE), which has been accepted, with the indications of non-microsatellite patients who have previously failed to receive or cannot tolerate the first- or second-line chemotherapy regimens. Recurrent or metastatic endometrial cancer that is not microsatellite highly unstable (non-MSI-H) or non-DNA mismatch repair defective (non-dMMR), or intolerant. Bemosumab is an innovative, fully humanized anti-PD-L1 monoclonal antibody with a new sequence developed by AstraZeneca.In April 2022, Bemosumab in combination with amrutinib hydrochloride capsules for the treatment of recurrent or metastatic endometrial cancer was included in the Breakthrough Therapeutic Classification by the CDE.In January 2023, Bemosumab’s application for marketing in the first-line treatment of recurrent or metastatic endometrial cancer in combination with amrutinib hydrochloride capsules was formally accepted by the CDE.The application was ...
- Source: drugdu
- 141
- March 2, 2024
AstraZeneca’s “CD19/CD3 dual antibody” receives clinical approval in China

According to the CDE official website, AstraZeneca’s Class 1 therapeutic biological product AZD0486 has obtained implicit approval for clinical trials and is intended to be used to treat relapsed or refractory B-cell acute lymphoblastic leukemia. AZD0486 (TNB-486) is a new, fully human CD19xCD3 IgG4 bispecific antibody, originally developed by TeneoTwo. In 2022, AstraZeneca acquired TeneoTwo for US$1.265 billion and also obtained its clinical-stage drug TNB-486. According to public information, AZD0486 can bind to CD19 on the surface of B lymphocytes and CD3 receptors on the surface of T lymphocytes, thereby initiating the immune response of T lymphocytes. A Phase I clinical study (NCT04594642) published in the journal “OncLive” in August 2023 showed that AZD0486 has a durable tumor inhibitory effect on relapsed/refractory follicular lymphoma, regardless of the expression level of CD20, and it is also independent of the type and dosage of existing drugs. Currently, AZD0486 has entered the Phase ...
- Source: drugdu
- 92
- March 2, 2024
FDA Approves Imbruvica Label Expansion to Include Oral Suspension Formulation

Don Tracy, Associate Editor New label marks the first Bruton’s tyrosine kinase inhibitor to be approved with an oral suspension formulation. The FDA has approved an addendum to the Imbruvica (ibrutinib) label to include an oral suspension formulation across the drug’s indications. Johnson & Johnson (J&J), in partnership with Pharmacyclics LLC, an AbbVie Company, announced that the new formulation is approved to treat patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), Waldenström’s macroglobulinemia (WM), and chronic graft versus host disease (cGVHD) following the failure of one or more lines of systemic therapy. This option is designed for patients who have difficulty swallowing pills, part of J&J’s ongoing efforts to provide multiple patient-friendly treatment options, the company stated in a press release.1 “As the most comprehensively studied therapy in its class, Imbruvica has helped change the standard of care for adults living with certain blood cancers and cGVHD. Nearly 300,000 ...
- Source: drugdu
- 128
- February 29, 2024
Inclusion of noncommunicable disease care in response to humanitarian emergencies will help save more lives

Noncommunicable diseases (NCDs), such as cardiovascular disease, cancer, chronic respiratory disease and diabetes, are responsible for 75% of deaths worldwide. People affected by humanitarian emergencies are at increased risk of NCDs. It is estimated that strokes and heart attacks are up to 3 times more likely following a disaster. However, care and treatment for NCDs are often not included as a standard part of humanitarian emergency preparedness and response, which focus on the most immediate needs. To support integration of essential services for NCDs into emergency preparedness and humanitarian response, the World Health Organization (WHO), the Kingdom of Denmark, the Hashemite Kingdom of Jordan, the Republic of Kenya, and UNHCR, the UN Refugee Agency, are jointly convening a global high-level technical meeting on NCDs in humanitarian settings on 27-29 February in Copenhagen, Denmark. Humanitarian emergencies in recent years are becoming more complex and interconnected. Hunger and shortages of essential goods ...
- Source: drugdu
- 118
- February 29, 2024
February 23, 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 announced its final decision to withdraw approval of Pepaxto (melphalan flufenamide), which was approved for use in combination with dexamethasone to treat certain patients with multiple myeloma. The agency determined the following grounds for withdrawal were met: (1) the confirmatory study conducted as a condition of accelerated approval did not confirm Pepaxto’s clinical benefit, and (2) the available evidence demonstrates that Pepaxto is not shown to be safe or effective under its conditions of use. The final decision was issued by the FDA’s Center for Biologics Evaluation and Research Director Peter Marks, M.D., Ph.D., as the Commissioner’s designee. The decision is effective immediately. The FDA plans to publish a Federal Register notice announcing the availability of today’s decision and remove Pepaxto from the Orange Book. It is the FDA’s ...
- Source: drugdu
- 82
- February 27, 2024

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