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Point Bio Prostate Cancer Therapy Meets Phase 3 Goal, But Results Still Disappoint

Despite achieving its Phase 3 study’s main goal, the results for Point Biopharma’s therapy are short of what Novartis radiopharmaceutical Pluvicto achieved in a similarly designed clinical trial. Nevertheless, the data readout should clear the way for Eli Lilly to complete its $1.4 billion acquisition of Point. By FRANK VINLUAN A Point Biopharma Global cancer therapy key to a $1.4 billion Eli Lilly M&A deal has met the main goal of its pivotal clinical trial in prostate cancer. But the results raise questions about how well the drug will match up against a radiopharmaceutical marketed by Novartis. The Point drug, PNT2002, is also a radiopharmaceutical. It offers targeted delivery of a radioactive particle by linking it to a ligand that targets PSMA, a protein abundant on the surface of prostate cancer cells. The open-label Phase 3 study evaluated the Point radiopharmaceutical in patients with cases of prostate cancer that has ...
- Source: drugdu
- 97
- December 20, 2023
Chilean President Gavriel Borich Meets with Yin Weidong, Chairman, President and CEO of SINOVAC

On December 12, 2023, local time, Chilean President Gavriel Borich met with Yin Weidong, Chairman, President and CEO of SINOVAC, and his delegation at the Presidential Palace. The two sides reached an agreement on the localization of vaccine production and cooperation in the research and development of health products, and the Chilean government will strongly support SINOVAC’s project promotion in the region. President Borich began by recalling his successful visit to China not long ago, emphasizing that when he met with President Xi Jinping, they jointly identified the need to further deepen cooperation in the health sector among the many bilateral cooperation between China and Chile. He also indicated that the Chilean government has set the strategic goal of developing vaccine R&D and industrialization in Chile. Chairman Yin Weidong responded, “His Excellency the President’s visit to China was indeed a great success, and the charisma you displayed attracted many Chinese ...
- Source: drugdu
- 98
- December 20, 2023
CanSino Bio and SPIMACO Signed a Cooperation Agreement on Innovative Vaccines, Continuing to Deepen the Comprehensive Strategic Partnership

Recently, China-Saudi Arabia Investment Conference was held in Beijing. As a representative of China’s innovative vaccine enterprises, CanSino Bio signed a vaccine cooperation framework agreement with SPIMACO, a Saudi Arabian pharmaceutical manufacturing company, at the Major Investment Collective Signing Ceremony, in which the two parties will cooperate in the commercialization of innovative vaccines, joint R&D and clinical research, as well as localized production. According to the agreement, the cooperation will focus on promoting the entry of CanSino Bio’s quadrivalent conjugate vaccine Manhexin® into Saudi Arabia and other markets in the Middle East and North Africa region. In Saudi Arabia, the quadrivalent conjugate vaccine has been included in the country’s childhood immunization program, and there is a strong demand for a quadrivalent conjugate vaccine with longer-lasting immunoprotection effect and higher safety in the local market. Post-marketing data shows that Mannhexin®, a quadrivalent conjugate vaccine from CanSino Bio, has a very impressive ...
- Source: drugdu
- 111
- December 20, 2023
GSK tees up AstraZeneca rivalry with positive Jemperli-Zejula readout in endometrial cancer

On a mission to grow in oncology, GSK has more positive data to report in endometrial cancer. This time, the company is touting results for its PD-1 inhibitor Jemperli and PARP inhibitor Zejula, which could become a threat to a rival therapy at AstraZeneca. Adding Jemperli and Zejula to chemotherapy significantly extended the time before tumor progression or death in patients with primary advanced or recurrent endometrial cancer that’s mismatch repair proficient or microsatellite stable (pMMR/MSS), GSK said Monday. The results came from the second part of the phase 3 RUBY trial. The trial also showed that the Jemperli-Zejula-chemo regimen was better at delaying disease worsening than chemo alone in the overall population, regardless of genetic stability. But GSK appears to think that the combo has more value in the pMMR/MSS subgroup. Patients with pMMR/MSS endometrial cancer have few treatment options, Hesham Abdullah, GSK’s head of oncology R&D, said in ...
- Source: drugdu
- 203
- December 20, 2023
Activist shareholders urge drugmakers to re-evaluate patent strategies, human rights policies

Over the years, shareholders at the Interfaith Center on Corporate Responsibility (ICCR) have repeatedly voiced concerns on a variety of subjects to top pharma companies. Now, as 2023 comes to a close, the group is taking pharma giants to task over their patenting strategies and potential human rights shortfalls. In proposals to AbbVie, Eli Lilly, Gilead, Johnson & Johnson, Merck and Pfizer, the group is pushing the companies to review how add-on patents for medicines can affect patient access. Additionally, Bristol Myers Squibb, Pfizer and Eli Lilly face calls to review and update their human rights policies. While ICCR has voiced pharma-related complaints plenty of times in the past, its proposals haven’t been met with much enthusiasm by the companies’ larger pools of shareholders. In 2019, for instance, investors at several large pharma companies rejected the group’s proposals to study the potential link between CEO pay and drug prices. In ...
- Source: drugdu
- 100
- December 20, 2023
Artificial Intelligence workplan to guide use of AI in medicines regulation

EMA and the Heads of Medicines Agencies (HMAs) have published an Artificial Intelligence (AI) workplan to 2028, setting out a collaborative and coordinated strategy to maximise the benefits of AI to stakeholders while managing the risks. The workplan will help the European medicines regulatory network (EMRN) to embrace the opportunities of AI for personal productivity, automating processes and systems, increasing insights into data and supporting more robust decision-making to benefit public and animal health. The AI workplan, prepared under the joint HMA-EMA Big Data Steering Group (BDSG), ensures the EMRN remains at the forefront in benefiting from AI in medicines regulation. The workplan was adopted by EMA’s Management Board at its December meeting. The field of AI is developing swiftly. Pharmaceutical companies increasingly use AI-powered tools in research, development and monitoring of medicines. National competent authorities are responding to the new opportunities and challenges by starting to use and develop ...
- Source: drugdu
- 100
- December 20, 2023
Innovent Announces Publication of Mazdutide (IBI362) Phase 2 Full Results in Chinese Patients with Overweight or Obesity in Nature Communications

ROCKVILLE, U.S. and SUZHOU, China, Dec 18, 2023，— Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, metabolic, autoimmune, ophthalmology and other major diseases, announces that results of a Phase 2 clinical trial of mazdutide (Innovent R&D code: IBI362), a glucagon-like peptide-1 receptor (GLP-1R) and glucagon receptor (GCGR) dual agonist, in Chinese patients with overweight or obesity were published in Nature Communications. Professor Linong Ji, the leading principal investigator of the study, Peking University People’s Hospital, stated, “As a chronic disease with complex underlying causes, obesity is one of the leading risk factors of type 2 diabetes, fatty liver, cardiovascular and cerebrovascular diseases, joint diseases, sleep apnea in addition to cancers. Obesity requires increased public awareness of long-term treatment and management with effective and science-backed approaches. China has the largest obese population; however, no safe and efficacious ...
- Source: drugdu
- 118
- December 20, 2023
Self-Heating Microfluidic Devices Can Detect Diseases in Tiny Blood or Fluid Samples

Microfluidics, which are miniature devices that control the flow of liquids and facilitate chemical reactions, play a key role in disease detection from small samples of blood or other fluids. Commonly known examples include at-home Covid-19 test kits, which use basic microfluidic technology. However, more complex microfluidic applications often require chemical reactions at precise temperatures. Typically, these advanced devices are produced in clean rooms and include heating elements made of expensive materials like gold or platinum, making the manufacturing process costly and challenging to scale. Researchers have now made a breakthrough by employing 3D printing to build self-heating microfluidic devices, potentially paving the way for the creation of affordable and efficient tools that could detect various diseases. Scientists at the Massachusetts Institute of Technology (MIT, Cambridge, MA, USA) innovatively utilized multimaterial 3D printing to fabricate microfluidic devices with integrated heating elements. This development allows for precise temperature control of fluids ...
- Source: drugdu
- 87
- December 19, 2023
Glaukos wins FDA approval for drug-releasing eye implant to treat glaucoma

Dive Brief Glaukos Corporation received Food and Drug Administration approval for a drug-releasing implant that is designed to reduce intraocular pressure in patients with ocular hypertension or open-angle glaucoma. The implant was approved for single administration per eye. The device continuously delivers a formulation of travoprost, an established treatment for high pressure in the eye, to provide patients with an alternative to eye drops and remove the risk that noncompliance with the treatment regimen will affect outcomes. Glaukos failed to secure approval for repeat dosing but plans to work with the FDA to change the label. The wholesale acquisition cost (WAC) is $13,950 per dose, or implant, well above analysts’ expectations. William Blair analysts estimated the price would fall in a range of from $3,000 to $4,000 per implant, while BTIG analysts said they modeled a price of $5,000. Dive Insight Glaukos expects to generate up to $310 million in ...
- Source: drugdu
- 92
- December 19, 2023
FDA Approves Padcev/Keytruda Combo for Locally Advanced, Metastatic Urothelial Cancer

Pharmaceutical Executive Editorial Staff In clinical trials, Padcev (enfortumab vedotin-ejfv) plus Keytruda (pembrolizumab) produced a statistically significant improvement in survival compared to platinum-based chemotherapy alone in patients with locally advanced or metastatic urothelial cancer. Image credit: Olivier Le Moal | stock.adobe.com The FDA has approved Padcev (enfortumab vedotin-ejfv; Astellas Pharma and Seagen [now owned by Pfizer]) plus Keytruda (pembrolizumab; Merck) for patients with locally advanced or metastatic urothelial cancer (la/mUC).1 The FDA previously granted the application with priority review and breakthrough designation. The efficacy of the combination was evaluated in the open-label, randomized EV-302/KN-A39 (NCT04223856) trial, which enrolled 886 patients with la/mUC who received no prior systemic therapy for advanced disease. Patients were randomly assigned 1:1 to receive either Padcev with Keytruda or platinum-based chemotherapy consisting of gemcitabine with either cisplatin or carboplatin. The trial’s major efficacy outcomes were overall survival (OS) and progression-free survival (PFS) as assessed by blinded ...
- Source: drugdu
- 97
- December 19, 2023

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