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At JPM, Top GSK Cancer Executive Talks Drug Targets and Oncology Strategy

Though GSK divested much of its oncology assets to Novartis in 2015, the company has built it back through a internal R&D and business development deals. GSK Senior Vice President, Global Head of Oncology, R&D Hesham Abdullah explained the company’s evolving cancer strategy in an interview during the J.P. Morgan Healthcare Conference in San Francisco. By FRANK VINLUAN GSK committed $270 million up front in recent months to gain access to early-stage assets in the class of cancer therapies known as antibody drug conjugates, or ADCs. The deals are part of a broad industry to acquire assets in this therapeutic modality, GSK’s top cancer executive Hesham Abdullah acknowledges. But for GSK, the deals are just one part of an evolving oncology strategy. The strategy has been years in the making. In 2015, GSK divested its oncology business, which Novartis acquired for $16 billion. Abdullah, who is GSK’s senior vice president, ...
- Source: drugdu
- 121
- January 11, 2024
Kanglin Biotech’s KL003 cell injection successfully obtained IND approval!

Recently, according to the public information on the NMPA official website, the KL003 cell injection independently developed by Kanglin Biotechnology (Hangzhou) Co., Ltd. successfully obtained the NMPA’s implicit clinical trial license, with the acceptance number CXSL2300699, and is clinically used to treat transfusion-dependent beta in adults or children. -Thalassemia. The microspectrum biosafety service platform provides cell bank testing and strain library testing services for this product. β-thalassemia is a hemolytic anemia caused by defects or mutations in the β-globin gene (Hemoglobin β, HBB) on chromosome 11, resulting in partial or complete loss of β-globin-related functions, which brings great consequences to the patient’s life and health. The patients is more common in children and adolescents. Traditional treatments for thalassemia (blood transfusion, hematopoietic stem cell transplantation, etc.) are accompanied by side effects that cannot be ignored. The vast majority of patients lack the opportunity for radical cure, and there are obvious unmet ...
- Source: drugdu
- 198
- January 11, 2024
WHO decision improves children’s access to safer polio vaccine

Three years after it received its Emergency Use Listing (EUL) and with 950 million doses now delivered worldwide, nOPV2 has been prequalified by the WHO, following analysis of outcomes in vaccinated populations, confirming the strong safety profile and effectiveness of the vaccine. The nOPV2 vaccine helps to protect children from polio while lowering the risk of vaccine-derived outbreaks. Prequalification is a mark of quality assurance granted by the WHO and will make it easier for more countries to access and use nOPV2. Now it is granted, WHO member countries can obtain and use nOPV2 without the need to meet the strict readiness and monitoring requirements previously required under EUL. Prequalification will therefore ensure broad and long-term accessibility for international agencies to distribute nOPV2 in developing countries. Dr Andrew Macadam, Principal Scientist at the MHRA said: Until it has been completely eradicated, polio will continue to be a threat to children ...
- Source: drugdu
- 125
- January 11, 2024
Pfizer PARP inhibitor Talzenna nabs EU combo nod

• Pfizer’s PARP inhibitor Talzenna has gained European approval when used in combination with Pfizer and Astellas’ Xtandi to treat adult patients with metastatic castration-resistant prostate cancer (mCRPC) in whom chemotherapy is not clinically indicated. This approval makes Talzenna the first PARP inhibitor in Europe to be licensed in combination with Xtandi in mCRPC, Pfizer said in a release. The European Commission approved Pfizer’s application based on data from the phase 3 TALAPRO-2 trial, which showed that the combo cut the risk of disease progression or death in patients with mCRPC compared with placebo and Xtandi. Last June, the FDA approved the combination to treat adults with HRR gene-mutated mCRPC. • In another regulatory win for Pfizer, the FDA is reviewing the company’s full approval application on Genmab-partnered Tivdak. Under its priority review timeline, the FDA is assessing whether to convert Tivdak’s accelerated approval into a full nod to treat ...
- Source: drugdu
- 125
- January 11, 2024
Merck expects $20B+ in new cancer sales thanks to Daiichi ADC deal, Moderna vaccine

While some Merck & Co. investors may still get the heebie-jeebies when thinking about Keytruda’s patent cliff in 2028, but the company’s CEO Rob Davis now thinks “it’s just another year.” Make no mistake, given Keytruda’s size, an overall business decline will likely still hit. But Merck is focused on making “the hill to dip as small as possible and the return to growth as fast as possible,” Davis said Monday at the 2024 annual J.P. Morgan Healthcare Conference. Davis and Merck Research Laboratories President Dean Li, M.D., Ph.D., pointed to the breadth of Merck’s portfolio across oncology, infectious disease, cardiometabolic, immunology and neuroscience to explain Merck’s potential for growth. “I know that the conversation continues to be about Keytruda and 2028,” Davis said. “But increasingly, we’re not focused on 2028. 2028, it’s just another year, it’s just another point. We’re focused on 2030 to 2040.” At last year’s J.P. ...
- Source: drugdu
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- January 11, 2024
NOVARTIS Cosentyx® (stuccizumab) approved in China for new indication in psoriatic arthritis

On January 9, 2024, NOVARTIS China announced that its innovative biologic Cosentyx® (stavudine) was approved by the NMPA for the treatment of adult patients with active psoriatic arthritis. This is the third indication for which Cosentyx® has been approved in China, following “moderate-to-severe plaque psoriasis” and “ankylosing spondylitis”. Psoriasis is an immune-related, chronic, relapsing, inflammatory, systemic disease. Currently, there are more than 7 million psoriasis patients in China. Psoriatic arthritis (PsA) is an inflammatory arthropathy closely related to psoriasis, with most patients experiencing joint symptoms secondary to skin lesions, and a few patients experiencing joint symptoms prior to or concurrently with skin lesions. Joint symptoms may include swelling, pain, morning stiffness and limited joint movement. Psoriatic arthritis is prone to recurrence. If not treated in time, the long-term inflammation caused by psoriatic arthritis will bring irreversible structural damage to the joints, which will seriously affect the patient’s physical function and ...
- Source: drugdu
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- January 11, 2024
MSD’s Nine-Valent Human Papillomavirus Vaccine, Gardasil®9, Receives Approval from China’s State Drug Administration for a New Two-Dose Vaccination Program for Females 9 to 14 Years of Age

SHANGHAI, China, January 9, 2024 – MSD announced that it has received approval from the State Drug Administration of China (SDA) for a new two-dose vaccination program (0, June to December) for females aged 9 to 14 years for its nine-valent human papillomavirus vaccine (brewer’s yeast) (trade name: Gardasil®9). This approval means that Gardasil®9 will be added to the previous three-dose vaccination program for women aged 9~45 years old, providing more economical and convenient health protection for more women of the appropriate age group, and helping them to stay away from cervical cancer and cervical lesions associated with HPV infection. 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 cervix caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58; and ...
- Source: drugdu
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- January 11, 2024
Novel Diagnostic Combines Inhalable Sensors with Urine Test for Early Lung Cancer Detection

Cancer, particularly lung cancer driven by pollution and smoking, is expected to increasingly afflict populations in low- and middle-income countries. To catch lung cancer at its earliest and most treatable stages, it’s recommended that heavy smokers over 50 years get annual CT scans. Yet, many in this demographic do not undergo these scans, and the high rate of false positives from the scans can lead to unwarranted and invasive follow-up tests. Now, a breakthrough diagnostic method that combines inhaling nanoparticle sensors with a simple urine test can detect the presence of a tumor. This innovative approach, which could potentially replace or complement low-dose computed tomography (CT) scans, could be especially promising for regions with limited access to CT technology. Developed by the Massachusetts Institute of Technology (MIT, Cambridge, MA, USA), this new technology is the culmination of a decade’s work on nanosensors aimed at cancer and other diseases diagnosis. These ...
- Source: drugdu
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- January 10, 2024
New Biomarkers for Diabetic Kidney Disease to Improve Diagnosis and Monitoring

Diabetic kidney disease (DKD) is a major microvascular complication arising from type 2 diabetes mellitus (T2DM), leading to end-stage renal disease (ESRD). Despite advancements in treatment options such as hyperglycemic and blood pressure control and renin-angiotensin system blockades, DKD continues to prevail at alarming rates. Clinically, DKD often progresses from microalbuminuria to macroalbuminuria, marked by increased levels of albumin in the urine and an initial hyperfiltration phase followed by a gradual decline in renal function. However, variations in clinical presentations and progression rates to ESRD have been noted in recent studies. As scientific understanding evolves, the need for specific biomarkers for DKD has become increasingly vital. Now, an analysis of urinary and exosome proteome profiling by a team of scientists has led to the discovery of biomarkers for DKD, offering the potential for early diagnosis and treatment. The research carried out by scientists at the Chinese Academy of Sciences (Beijing, ...
- Source: drugdu
- 130
- January 10, 2024
ProfoundBio’s Rinatabart Sesutecan Granted FDA Fast Track Designation for Ovarian Cancer

Pharmaceutical Executive Editorial Staff Rinatabart sesutecan (Rina-S; PRO1184) is under evaluation for the treatment of patients with FRα-expressing high-grade serous or endometrioid platinum-resistant ovarian cancer. The FDA has granted Fast Track designation to ProfoundBio’s rinatabart sesutecan (Rina-S; PRO1184) to treat patients with FRα-expressing high-grade serous or endometrioid platinum-resistant ovarian cancer.1 The novel folate receptor alpha (FRα)–targeted antibody-drug conjugate (ADC) is comprised of an FRα-directed antibody linked to sesutecan, which is an investigational, cleavable hydrophilic linker, and the topoisomerase 1 inhibitor payload exatecan. “Our receipt of Fast Track designation from the FDA underscores our belief in the tremendous promise of Rina-S as a potential best-in-class FRα ADC to address the significant need for improved treatment options for advanced ovarian cancer,” said Naomi Hunder, chief medical officer of ProfoundBio, in a press release.1 “FRα is a highly prevalent antigen in ovarian cancer and Rina-S has shown encouraging antitumor activity and tolerability in ...
- Source: drugdu
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- January 10, 2024

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