Search Results for “antibody” – Page 47 – media

Merck’s Keytruda Poised for Bladder Cancer Expansion with New Phase III Data

By Tristan Manalac Pictured: Merck signage outside its office in California/iStock, hapabapa Merck on Thursday reported that its blockbuster PD-1 inhibitor Keytruda (pembrolizumab) met one of its dual primary endpoints in the Phase III AMBASSADOR trial in muscle-invasive urothelial carcinoma. Details of the study were limited but Merck said that at a pre-specified interim analysis review Keytruda treatment led to a statistically significant and clinically meaningful improvement in disease-free survival compared with simple observation. AMBASSADOR is ongoing and will continue to assess the effects of Keytruda on overall survival (OS), the study’s second primary endpoint. The promising initial data from AMBASSADOR point to the “potential of Keytruda to prevent recurrence” in patients who had undergone surgery, Marjorie Green, senior vice president and head of late-stage oncology, global clinical development at Merck Research Laboratories, said in a statement. AMBASSADOR, also known as KEYNOTE-123, is a randomized and open-label study enrolling approximately ...
- Source: drugdu
- 105
- October 9, 2023
Merck’s Keytruda Poised for Bladder Cancer Expansion with New Phase III Data

Merck on Thursday reported that its blockbuster PD-1 inhibitor Keytruda (pembrolizumab) met one of its dual primary endpoints in the Phase III AMBASSADOR trial in muscle-invasive urothelial carcinoma. Details of the study were limited but Merck said that at a pre-specified interim analysis review Keytruda treatment led to a statistically significant and clinically meaningful improvement in disease-free survival compared with simple observation. AMBASSADOR is ongoing and will continue to assess the effects of Keytruda on overall survival (OS), the study’s second primary endpoint. The promising initial data from AMBASSADOR point to the “potential of Keytruda to prevent recurrence” in patients who had undergone surgery, Marjorie Green, senior vice president and head of late-stage oncology, global clinical development at Merck Research Laboratories, said in a statement. AMBASSADOR, also known as KEYNOTE-123, is a randomized and open-label study enrolling approximately 740 patients with localized muscle-invasive or locally advanced urothelial carcinoma. Pembrolizumab was ...
- Source: drugdu
- 104
- October 8, 2023
New Alzheimer’s disease medication approved in Japan

Eisai and BioArctic have received approval for the Alzheimer’s disease drug Leqembi (lecanemab-irmb) in Japan, making it the second country to gain access to the treatment. Leqembi is a monoclonal antibody that targets and reduces insoluble amyloid-beta (Aβ) forms in the brain. It is the first and only approved treatment that has demonstrated a reduction in the rate of disease progression in patients with Alzheimer’s. The Japanese approval unlocked a milestone-based payment of EUR 17m ($18m) to BioArctic. The approval is based on Phase III data from the Clarity AD trial (NCT03887455) led by Eisai that showed that treatment with Leqembi reduced clinical decline in patients by 27% at 18 months compared to the placebo. The prescribing information for Leqembi includes a warning for amyloid-related imaging abnormalities (ARIAs), a concern for Alzheimer’s patients taking certain medication. Last week, BrainScope announced an investment from the Alzheimer’s Drug Discovery Foundation (ADDF) to ...
- Source: drugdu
- 109
- October 6, 2023
FDA Authorizes Novavax’s Covid-19 Vax, Set to Join Fall Rollout of Updated Shots

A Novavax Covid-19 vaccine developed for the fall vaccination season now has the FDA green light, bringing an alternative to the messenger RNA shots that are already rolling out to pharmacies, doctor’s offices, and other locations throughout the country. The FDA decision announced Tuesday afternoon is not an approval. Last year’s emergency authorization for the Novavax vaccine is now amended to include an updated formula, which reflects currently circulating variants. The initial Novavax vaccine was authorized for those 18 and older. For the updated shot, the FDA expanded the age range to 12 and older. The regulatory decision for the latest version of the Novavax vaccine means the company’s initial vaccine, developed for the original SARS-CoV-2 strain, is no longer authorized for use in the U.S. Gaithersburg, Maryland-based Novavax makes its protein-based vaccines with nanoparticle technology that engineers proteins that mimic antigens found on natural pathogens. For its Covid-19 vaccine, ...
- Source: drugdu
- 130
- October 4, 2023
Seagen and Astellas’ Padcev, in Keytruda combo, delivers ‘practice-changing’ bladder cancer win

As Seagen prepares for its takeover by Pfizer, the company’s Astellas-partnered cancer drug Padcev has chalked up a key trial win—in combination with Merck’s Keytruda—in previously untreated metastatic bladder cancer. In the study, Seagen and Astellas’ antibody-drug conjugate Padcev and Merck’s PD-1 superstar Keytruda scored on both overall survival and progression-free survival compared with chemotherapy. An independent data monitoring committee found that the combo’s life extension benefit surpassed the pre-specified efficacy boundary at an interim analysis, the companies said in a Friday release. The results could open the combo up to patients who are eligible for platinum-based chemotherapies cisplatin or carboplatin, regardless of their PD-L1 status. “This study has the potential to be practice changing and offer a new standard of care for first-line metastatic bladder cancer,” Seagen’s R&D head Roger Dansey, M.D., said in the release. “We look forward to presenting the results at an upcoming medical conference and ...
- Source: drugdu
- 110
- October 4, 2023
Roche scores—again—in hemophilia drug patent case against Takeda

In a patent case centered on two rival hemophilia medicines, Roche’s Genentech unit has scored its second straight win. After a U.S. district court last year ruled in favor of Roche and invalidated a patent held by Takeda’s Baxalta unit, the U.S. Court of Appeals for the Federal Circuit reaffirmed the ruling. In the decision, U.S. Circuit Judge Timothy B. Dyk wrote that in order to be valid, patents must describe inventions “in such full, clear, concise and exact terms” so that any skilled person can make and use the same product “without undue experimentation.” In this case, Baxalta’s patent describes an antibody that binds to a protein that’s key to enable blood clotting. In its appeal, Baxalta argued that skilled practitioners can use a screening process that doesn’t amount to undue experimentation. But the circuit court shot down this argument, supporting the decision that the patent should be invalidated. ...
- Source: drugdu
- 188
- October 1, 2023
Novartis’ Lutathera Clears Phase III as Frontline Treatment for Rare Neuroendocrine Cancer

By Tristan Manalac Pictured: Novartis logo on its office in California/iStock, JHVEPhoto Novartis’ radioligand therapy Lutathera (lutetium Lu 177 dotatate) met its primary endpoint in the Phase III NETTER-2 trial in gastroenteropancreatic neuroendocrine tumors, the company announced Monday. NETTER-2 is a randomized and open-label trial that evaluated Lutathera as a first-line option in 222 patients with grade 2 or 3, advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs). Only those whose cancers were positive for the somatostatin receptor (SSTR) were eligible for enrolment into NETTER-2. When used in combination with high-dose long-acting octreotide, Lutathera led to a significant improvement in progression-free survival (PFS)—the study’s primary endpoint—compared with octreotide alone. In terms of safety, NETTER-2 did not find any new signals of concern and Lutathera’s adverse event profile in the study was consistent with what had been previously established. Novartis did not provide specific efficacy and safety figures, though it promised to do so ...
- Source: drugdu
- 137
- September 28, 2023
Morphic’s Ulcerative Colitis Pill Misses Expectations in Mid-Stage Study, Stock Falls

By Tristan Manalac Pictured: Woman grasping her stomach in pain/iStock, Doucefleur New data from the Phase IIa EMERALD-1 study showed that Morphic Therapeutic’s investigational ulcerative colitis pill MORF-057 induced endoscopic improvement, the company announced Friday. However, investors were underwhelmed with the candidate’s new efficacy findings and Morphic’s stock price dropped around 25% after the data was released. The new data, presented in a moderated poster session at the United European Gastroenterology Week (UEGW) 2023, showed that at 12 weeks, 25.7% of treated patients demonstrated endoscopic improvement. Clinical response, measured using the modified Mayo Clinic Score (mMCS), was documented in 45.7% of participants at 12 weeks. The UEGW data follow a prior readout from EMERALD-1, posted in April 2023, which showed that patients treated with MORF-057 saw a significant 6.4-point improvement in the Robarts Histopathology Index, a validated tool that measures histological disease activity in ulcerative colitis. This was accompanied by ...
- Source: drugdu
- 164
- September 27, 2023
Novartis Returns Cancer Asset Tislelizumab to BeiGene

By Tristan Manalac Pictured: Novartis’ head office in Canada/iStock, JHVEPhoto Novartis on Tuesday gave back the investigational monoclonal antibody tislelizumab to BeiGene, returning worldwide rights to develop, manufacture and commercialize the anti-PD-1 candidate to the cancer-focused biotech. Also on Tuesday, BeiGene announced that the European Commission had approved tislelizumab for patients with unresectable, locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) who had previously failed platinum-based chemotherapy. The treatment will be marketed under the brand name Tevimbra. After more than a year of regulatory delay, the FDA has also accepted BeiGene’s Biologics License Application (BLA) for tislelizumab as a first-line treatment option in this indication, according to Tuesday’s announcement. Novartis and BeiGene first entered into a collaboration and license agreement over tislelizumab in January 2021 to develop tislelizumab in ESCC, as well as other malignant diseases such as non-small cell lung cancer and hepatocellular carcinoma. In July 2022, however, ...
- Source: drugdu
- 117
- September 21, 2023
Anthos Stops Mid-Stage Atrial Fibrillation Trial Due to ‘Unprecedented’ Efficacy

By Tristan Manalac Pictured: Illustration of a blood clot in a blood vessel/iStock, libre de droit Anthos Therapeutics is ending the Phase II AZALEA-TIMI 71 study ahead of schedule after its investigational monoclonal antibody abelacimab demonstrated an “overwhelming reduction” in bleeding compared to Bayer and Johnson & Johnson’s Xarelto (rivaroxaban), the company announced Monday. Patients treated with abelacimab saw a sharp reduction in the composite endpoint of major and clinically relevant non-major bleeding events compared with counterparts given rivaroxaban, the current standard-of-care oral anticoagulant. The Massachusetts-based biopharma did not provide specific data in Monday’s announcement but said that the Data Monitoring Committee stopped the study early following these data. Anthos will share the full results and analysis of the trial in an upcoming medical meeting. Due to the “overwhelming reduction in bleeding” reported in AZALEA-TIMI 71, abelacimab may represent a “paradigm shift” in atrial fibrillation care particularly in the prevention ...
- Source: drugdu
- 98
- September 20, 2023

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