Search Results for “GSK ” – Page 10 – media

OLYMVAX Trivalent Influenza Virus Cracking Vaccine (MDCK Cells) Clinical Trial Application Accepted

Recently, the State Drug Administration website announced that it agreed to accept OLYMVAX’s application for clinical trials of trivalent influenza virus lysate vaccine (MDCK cells), which is also the first cell-based trivalent influenza vaccine to be declared for clinical use in China. Influenza vaccination is an effective means of preventing influenza and reducing the burden of influenza-associated severe illness and death. Divided from the components of the vaccine and the types of preventive viruses, the influenza vaccines currently available in China include trivalent influenza vaccine and tetravalent influenza vaccine. Trivalent influenza vaccine mainly prevents H1N1 and H3N2 subtypes of Influenza A, as well as Influenza B Victoria lineage viruses, while tetravalent influenza vaccine is based on trivalent influenza vaccine, with added prevention against Influenza B Yamagata lineage viruses. OLYMVAX’s quadrivalent influenza virus lysate vaccine (MDCK cells) has been approved by the State Drug Administration for the issuance of the Notice ...
- Source: drugdu
- 123
- July 9, 2024
Phase III Trial Data Presented at ASCO Show Imfinzi Improves Survival in Limited-Stage Small Cell Lung Cancer

Don Tracy, Associate Editor Results of the ADRIATIC trial indicated that treatment with Imfinzi after standard-of-care concurrent chemoradiotherapy improves overall survival and progression-free survival in patients with limited-stage small cell lung cancer.AstraZeneca announced a significant milestone from the ADRIATIC trial, which is evaluating the safety and efficacy of Imfinzi (durvalumab) for the treatment of limited-stage small cell lung cancer (LS-SCLC) in patients who haven’t progressed following concurrent chemoradiotherapycCRT. According to the company, the trial found that administration of Imfinzi after standard-of-care cCRT greatly improves overall survival (OS) and progression-free survival (PFS) compared to placebo. These results were presented at the 2024 American Society of Clinical Oncology Annual Meeting during the Plenary Session.1 “The ADRIATIC results represent a breakthrough in limited-stage small cell lung cancer, a highly aggressive disease where recurrence rates are high and only 15 to 30 per cent of patients survive five years,” said David R. Spigel, chief ...
- Source: drugdu
- 128
- June 6, 2024
Data Presented at ASCO Show Improved Complete Response with Jemperli as a First-Line Treatment for Locally Advanced Rectal Cancer in Patients with Mismatch Repair Deficient Status

Don Tracy, Associate Editor Results of the Phase II AZUR-1 trial show that 100% of participants achieved a clinical complete response when treated with Jemperli for locally advanced rectal cancer in patients with mismatch repair deficient status. Updated results from the Phase II AZUR-1clinical trial of Jemperli (dostarlimab) show the promise of the medication as a treatment for mismatch repair deficient (dMMR) locally advanced rectal cancer in offering an alternative to surgery, according to GSK. The trial, performed in partnership with Memorial Sloan Kettering Cancer Center (MSK), found that Jemperli produced a 100% clinical complete response (cCR) in participants administered the drug, according to data presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting.1 “The data showing no evidence of disease in 42 patients is remarkable. These results bring us one step closer to understanding the potential of dostarlimab in this curative-intent setting for patients with dMMR ...
- Source: drugdu
- 103
- June 6, 2024
J&J Adds Another Bispecific Antibody for Atopic Dermatitis With $1.25B Acquisition

Johnson & Johnson is acquiring a bispecific antibody that Numab Therapeutics engineered to address two pathways associated with the inflammation and itching of atopic dermatitis. It’s J&J’s second immunology acquisition this month. By Frank Vinluan Johnson & Johnson is building up its immunology pipeline, striking a $1.25 billion deal for a bispecific antibody in development for atopic dermatitis — its second acquisition agreement in the indication in the past two weeks. The deal announced Tuesday will bring J&J a Numab Therapeutics drug codenamed NM26. The pharmaceutical giant is acquiring global rights to the experimental treatment, which is ready to enter Phase 2 testing. Atopic dermatitis, also known as eczema, is the most common inflammatory skin disease. While the disorder typically presents as red and itchy skin, it stems from multiple pathways that vary from one group of patients to another. NM26 is a bispecific antibody designed to address two of ...
- Source: drugdu
- 107
- May 31, 2024
Pharma companies urged to act on antimicrobials to combat drug resistance

A new report from the Access to Medicine Foundation calls for urgent changes in research and development (R&D) to ensure new antibiotics and antifungals reach patients facing drug-resistant infections. The report examines five late-stage antimicrobial projects targeting severe drug-resistant pathogens, revealing that structured advance planning for access and stewardship is not yet standard among companies. Four out of five companies—GSK, Pfizer, Innoviva, and Venatorx—are conducting clinical trials involving children, aiming to improve access for paediatric patients. Despite these efforts, only five low- and middle-income countries (LMICs)—China, India, Mexico, South Africa, and Thailand—have concrete commitments for drug registration. Many of the remaining 108 LMICs with high burdens of targeted diseases lack such commitments. The report underscores the need for partnerships and licensing agreements to enhance access in LMICs. SMEs have pursued wider access through collaborations, like those with the Global Antibiotic Research and Development Partnership (GARDP). However, the report finds that ...
- Source: drugdu
- 130
- May 25, 2024
The View from Investors

Mike Hollan Industry experts gather to discuss the current investor market and how the IRA may impact the industry in the coming years. Financial Times US Pharma and Biotech Summit 2024After the post-Covid crash, investors are seeing promising trends in the pharma and biotech industry in 2024. The following speakers presented a panel discussing the industry from an investors perspective at the Financial Times’ US Pharma and Biotech Summit 2024 in New York City: Harmeet Dhillon, head of public policy at GSK; Amit Sinha, chief investment officer at Goldman Sachs; Darius Lakdawalla, quintiles chair in pharmaceutical development at the University of Southern California; and Johanna Grossman, head of healthcare and US life sciences at the US Stock Exchange. Oliver Barnes, a US pharmaceutical and biotech correspondent for the Financial Times moderated the event. The conversation focused on both the current state of the industry and where each of the speakers ...
- Source: drugdu
- 131
- May 20, 2024
Blackstone Unveils Immunology Startup With $300M and a Phase 2-Ready Drug From Merck

Blackstone Life Sciences startup Uniquity Bio emerged from stealth with an in-licensed drug candidate that could treat a wide range of immunology and inflammation indications. The antibody’s target puts it in competition with drugs from AstraZeneca, Pfizer, and Sanofi.Immunology and inflammation continues to be one of the hottest areas for research, and investment firm Blackstone is joining in with the launch of Uniquity Bio, a new startup whose lead asset from Merck addresses a clinically validated target that puts it in direct competition with some big pharmaceutical companies. Uniquity is backed by up to $300 million in financing from Blackstone Life Sciences, the firm’s biotechnology investment division. The in-licensed Merck drug, solrikitug, is ready to begin Phase 2 development in its lead indications, chronic obstructive pulmonary disease (COPD) and asthma. The Uniquity pipeline includes a third undisclosed gastrointestinal indication. Solrikitug is a monoclonal antibody designed to block thymic stromal lymphoprotein ...
- Source: drugdu
- 77
- May 17, 2024
Long-acting HIV pre-exposure prophylaxis drugs Catilavir Sodium Tablets and Catilavir Injection formally approved in China

On May 13, 2024, GlaxoSmithKline (“GSK”) announced that ViiV Healthcare (“ViiV”), its joint venture company specializing in HIV medicines, has received approval from the China State Drug Administration (“SDA”) for both cathiravir sodium tablets and cathiravir injection for use in adults and adolescents at risk of infection (weight ≥35kg). ViiV Healthcare (“ViiV”), its joint venture company specializing in HIV, has received approval from the State Drug Administration of China (“SDA”) for HIV-1 pre-exposure prophylaxis (“PrEP”) in adults and adolescents (≥35kg) at risk for infection to reduce the risk of sexually transmitted infections (“STIs”) in conjunction with safer sexual behavioral practices to achieve better HIV-1 PrEP outcomes. It is the first therapy to prevent HIV infection without the need for daily medication, the FDA noted in a December 20, 2021 official press release. Pre-exposure prophylaxis (PrEP) is an effective biological prophylaxis to prevent HIV infection through the use of antiviral drugs. ...
- Source: drugdu
- 121
- May 15, 2024
AstraZeneca’s Lynparza to dominate PARP inhibitors market with $4 bn in sales by 2027

In 2014, the FDA approved the first (adenosine diphosphate-ribose) polymerase (PARP) inhibitor AstraZeneca/Merck’s Lynparza (olaparib) for use in breast cancer gene (BRCA)-mutated metastatic ovarian cancer patients who have received three or more prior lines of chemotherapy. Since then, the PARP inhibitors market has made significant strides, but Lynparza maintains its dominance with projected global sales of $4 billion by 2027, according to an analyst consensus forecast by GlobalData. GlobalData’s analyst consensus reveals that high sales projections underscore Lynparza’s role in treating multiple cancer types, including ovarian, pancreatic, prostate, and human epidermal growth factor receptor 2 (HER2)-negative breast cancer. Expected revenues in these indications will reach over 68 per cent of the global PARP inhibitors market by 2027. GlaxoSmithKline’s (GSK) Zejula (niraparib) holds the second position with over $1.6 billion in sales and 28 per cent of the market share. Most of Lynparza’s sales come from ovarian and HER2-negative breast cancer treatment. Biswajit Podder, ...
- Source: https://www.expresspharma.in/astrazenecas-lynparza-to-dominate-parp-inhibitors-market-with-4-bn-in-sales-by-2027-globaldata/
- 167
- May 4, 2024
Gilead writes $2.4B off Trodelvy as CEO underscores ‘time of focused execution’

The flurry of Trodelvy developments accentuates what Gilead CEO Dan O’Day called “a time of focused execution” at the California biotech. (Jim Watson/AFP/Getty Images) After a negative phase 3 readout, Gilead Sciences is taking a $2.4 billion impairment charge on Trodelvy, which serves as the cornerstone of the company’s solid tumor ambition. Gilead has cut the carrying value of Trodelvy to $3.5 billion in its first-quarter report, from $5.9 billion at the end of 2023, CFO Andrew Dickinson told investors during a call Thursday. The move comes after a January report of a phase 3 trial that the TROP2-directed antibody-drug conjugate failed to significantly extend the lives of patients with previously treated non-small cell lung cancer compared with chemotherapy. The bad news at that time caused a 10% slide in Gilead’s stock price. The write-off reflects a “smaller addressable market that Trodelvy could serve among second-line-plus metastatic non-small cell lung ...
- Source: drugdu
- 126
- April 30, 2024

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