Search Results for “antibody” – Page 40 – media

Innovent and SanegeneBio Enter Strategic Collaboration to Develop siRNA Drug for the Treatment of Hypertension

ROCKVILLE, Md. and SUZHOU, China, Dec 20, 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, autoimmune, metabolic, ophthalmology and other major diseases, and Sanegene Bio USA Inc. (SanegeneBio) announce that they have entered into a collaboration agreement to co-develop SGB-3908, an siRNA drug candidate targeting angiotensinogen (AGT) for the treatment of hypertension. Innovent also obtains an exclusive option to license in the future development, manufacturing and commercialization rights of SGB-3908. SGB-3908 is an IND-enabling stage siRNA drug developed based on SanegeneBio’s proprietary LEAD™ (Ligand and Enhancer Assisted Delivery) platform. Under the terms of the agreement, both parties will be jointly responsible for the development of SGB-3908 to certain stage. Innovent will receive an exclusive option to pay different option exercise fees to obtain the exclusive development, manufacturing, and commercialization license of SGB-3908 in ...
- Source: drugdu
- 169
- December 29, 2023
Moderna and Merck’s Novel Cancer Vaccine, Keytruda Combo Cuts Risk of Skin Cancer Death, Recurrence by Half

Pharmaceutical Executive Editorial Staff Adjuvant treatment with Moderna’s mRNA-4157 (V940) in combination with Merck’s Keytruda lowered the risk of recurrence or death by 49% compared with Keytruda monotherapy. Findings from the KEYNOTE-942/mRNA-4157-P201 clinical trial show that Moderna’s investigational individualized neoantigen therapy plus Merck’s Keytruda (pembrolizumab) lowered the risk of death or relapse by nearly half in patients with resected high-risk melanoma (stage III/IV) following complete resection. A planned analysis of the Phase IIb randomized trial found that at a median follow-up of approximately three years, adjuvant treatment with Moderna’s mRNA-4157 (V940) in combination with Keytruda continued to show a clinically meaningful improvement in recurrence-free survival (RFS) by lowering the risk of recurrence or death by 49% compared with Keytruda monotherapy. “As we continue to follow participants in the KEYNOTE-942/mRNA-4157-P201 study, we are excited to see such a robust clinical benefit with mRNA-4157 (V940) as adjuvant treatment in combination with Keytruda ...
- Source: drugdu
- 225
- December 27, 2023
Big Pharma reworks China strategy, and job cuts are part of it

Big Pharma companies have often talked about the major opportunities that await in China. But as price cuts play out and internal priorities shift, multinational companies are reworking their business models in the country. In the last few months of 2023, Pfizer, GSK, Sanofi and Biogen have each tapped local partners to help commercialize their products in China. With marketing responsibilities shifting to other firms, job cuts were expected at each of those large drugmakers. It’s not a new approach for foreign drugmakers to tap local partners in China, Justin Wang, head of L.E.K. Consulting’s China practice, pointed out in an email interview with Fierce Pharma. But these deals are on the rise lately, Wang explained, partly because “there is increasing pricing and competitive pressure in the market, especially for mature products, leaving reduced [return on investment] for in-house commercial resources.” Pfizer in November unveiled a deal with Keyuan Pharma, ...
- Source: drugdu
- 196
- December 27, 2023
GSK’s Jemperli Plus Zejula Produces Significant Survival Improvement in Endometrial Cancer

Pharmaceutical Executive Editorial Staff Jemperli plus standard-of-care chemotherapy with carboplatin and paclitaxel, followed by Jemperli plus Zejula as maintenance therapy produced a statistically significant and clinically meaningful benefit in progression-free survival in patients with primary advanced or recurrent endometrial cancer. GSK’s Jemperli (dostarlimab) produced a significant improvement in survival among adults with primary advanced or recurrent endometrial cancer in a Phase III trial.1 Findings from the RUBY/ENGOT-EN6/GOG3031/NSGO trial show that Jemperli plus standard-of-care chemotherapy with carboplatin and paclitaxel, followed by Jemperli plus Zejula (niraparib) as maintenance therapy, achieved the primary endpoint of progression-free survival (PFS). The combination led to a statistically significant and clinically meaningful benefit across the overall patient population and among a subpopulation of patients with mismatch repair proficient/microsatellite stable (MMRp/MSS) tumors in those with primary advanced or recurrent endometrial cancer. “Patients with MMRp/MSS primary advanced or recurrent endometrial cancer have few approved treatment options,” Hesham Abdullah, senior ...
- Source: drugdu
- 201
- December 26, 2023
M&A saw an uptick in 2023. Analysts expect the trend to continue

Even with the Federal Trade Commission keeping a watchful eye on the biopharma industry and the economic landscape giving some players pause, mergers and acquisitions are back on the rise. And it is with cautious optimism that industry watchers see the trend continuing in 2024. Wielding plenty of firepower, drugmakers are more likely to make higher-value deals in the new year as they address growth challenges that loom later in the decade because of patent cliffs and the effects of the Inflation Reduction Act. “Executives will continue to deploy cash balances and seek out areas of innovation and clinical differentiation,” PricewaterhouseCoopers wrote in its Pharmaceutical and Life Sciences: U.S. Deals 2024 Outlook. “As regulators’ perspectives on key deal factors become better understood, there may be a return of larger deals, along with continued interest in the $5 billion to $15 billion deals to fill targeted strategic gaps.” Look no further ...
- Source: drugdu
- 230
- December 26, 2023
FDA Roundup

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA issued a guidance for industry titled, “Rare Diseases: Considerations for the Development of Drugs and Biological Products” This guidance clarifies the FDA’s thinking on important considerations in rare disease drug development to ultimately assist rare disease drug and biologic product developers in conducting successful drug development programs. For more information and to submit a comment about this guidance, please visit Rare Diseases: Considerations for the Development of Drugs and Biological Products; Guidance for Industry; Request for Comments. On Thursday, the FDA warned consumers not to use counterfeit Ozempic (semaglutide) found in U.S. drug supply chain. The FDA continues to investigate counterfeit Ozempic (semaglutide) injection 1 milligram (mg) in the legitimate U.S. drug supply chain and has seized thousands of units of the product. The agency advises wholesalers, retail pharmacies, ...
- Source: drugdu
- 111
- December 26, 2023
Henlius Passes Its Second EU GMP Inspection

Shanghai, China, December 22, 2023 – Shanghai Henlius Biotech, Inc. (2696.HK) announces that the company has received the European Union (EU) GMP Certificates (Certificates of GMP Compliance of a Manufacturer) for the production lines of anti-PD-1 mAb HANSIZHUANG (serplulimab) from Netherlands’ health supervision agency Health and Youth Care Inspectorate, marking that the company’s Xuhui Facility and Songjiang First Plant have successfully passed the EU GMP on-site inspection for HANSIZHUANG and meet the EU GMP standards. The inspection success, as well as the previous certification by the EU GMP for Henlius’ self-developed trastuzumab HANQUYOU in 2020, confirms the company’s longstanding reputation in maintaining quality systems fully compliant with the highest international standards. The inspection-related product HANSIZHUANG is the first anti-PD-1 therapy approved for first-line treatment of small-cell lung cancer (SCLC). At present, HANSIZHUANG has been approved for 4 indications in China including MSI-H solid tumour, squamous non-small cell lung cancer (sqNSCLC), ...
- Source: drugdu
- 100
- December 26, 2023
Previously unrecognized class of antibodies can broadly neutralize multiple virus strains

Researchers have identified a previously unrecognized class of antibodies-;immune system proteins that protect against disease-;that appear capable of neutralizing multiple forms of flu virus. These findings, which could contribute to development of more broadly protective flu vaccines, will publish December 21st by Holly Simmons of the University of Pittsburgh School of Medicine, US, and colleagues in the open access journal PLOS Biology. A flu vaccine prompts the immune system to make antibodies that can bind to a viral protein called hemagglutinin on the outside of an invading flu virus, blocking it from entering a person’s cells. Different antibodies bind to different parts of hemagglutinin in different ways, and hemagglutinin itself evolves over time, resulting in the emergence of new flu strains that can evade old antibodies. New flu vaccines are offered each year based on predictions of whatever the most dominant strains will be. Extensive research efforts are paving the ...
- Source: drugdu
- 214
- December 25, 2023
FDA Approves Expanded Indication for LEO Pharma’s Adbry for Pediatric Patients With Atopic Dermatitis

Pharmaceutical Executive Editorial Staff Indication of Adbry (tralokinumab-ldrm) expanded to include patients 12 to 17 years of age with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or for whom those therapies are not advisable. The FDA has approved an expanded indication for LEO Pharma’s Adbry (tralokinumab-ldrm) for patients 12 to 17 years of age with moderate-to-severe atopic dermatitis (AD) whose disease is not adequately controlled with topical prescription therapies or for whom those therapies are not advisable. Adbry is a human immunoglobulin G4 monoclonal antibody that specifically binds to human interleukin (IL)-13 and inhibits its interaction with the IL-13 receptor α1 and α2 subunits. Adbry is the first and only biologic FDA-approved for this indication. “This is an important milestone on our path towards making a fundamental difference for those who need it most. This critical patient group now has access to a much-needed ...
- Source: drugdu
- 149
- December 25, 2023
Gracell Biotechnologies Announces China NMPA Clearance for IND Application for Phase 1/2 Clinical Trial of FasTCAR-T GC012F

Gracell is pioneering use of a CD19/BCMA dual-targeted CAR-T cell therapy in rSLE, aiming for deeper and wider depletion of disease-causing antibody secreting cells and B-cells FasTCAR-T GC012F has demonstrated a favorable safety profile in clinical investigator-initiated trials in 60 patients with multiple myeloma and B-cell non-Hodgkin lymphoma SAN DIEGO and SUZHOU, China and SHANGHAI, China, Dec. 21, 2023 (GLOBE NEWSWIRE) — Gracell Biotechnologies Inc. (“Gracell” or the “Company”, NASDAQ: GRCL), a global clinical-stage biopharmaceutical company dedicated to developing innovative and highly efficacious cell therapies for the treatment of cancer and autoimmune disease, today announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has cleared Gracell’s Investigational New Drug (IND) application for GC012F, an autologous CAR-T therapeutic candidate, for the treatment of refractory systemic lupus erythematosus (rSLE). Under the IND, Gracell plans to initiate a Phase 1/2 clinical study in China to further evaluate ...
- Source: drugdu
- 84
- December 25, 2023

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