Search Results for “Roche” – Page 16 – media

Lilly Puts Potential $660M on the Line for Protein-Protein Interaction Blockers

By Tristan Manalac Pictured: Eli Lilly’s Biotechnology Center in California Eli Lilly on Tuesday signed a license and collaboration agreement with Tokyo-based biotech PRISM BioLab to discover and develop small molecule inhibitors of protein-protein interactions. Under the terms of the deal, Lilly will make an upfront payment and pledges up to $660 million in preclinical, clinical and commercial development milestones. The Japanese biotech will also be eligible for royalties on future sales of any pharmaceutical product that emerges from the partnership. In return, Lilly will gain access to PRISM’s proprietary PepMetics platform, which synthesizes small molecule drug candidates that can behave like peptides, according to the biotech’s ...
- Source: drugdu
- 159
- December 1, 2023
EirGenix and Sandoz win EU approval for Herceptin biosimilar

The European Commission has granted marketing authorisation to EirGenix’s Herceptin (trastuzumab) biosimilar for marketing in the European Union. The biosimilar has been approved as a treatment for human epidermal growth factor receptor 2 positive (HER2-positive) breast cancer and metastatic gastric cancers, as per a 22 November press release. Herceptin is a monoclonal antibody that binds to HER2 receptors, thereby priming these receptors for immune system targeting. The drug generated SFr1.26bn ($1.4bn) in year-to-date (YTD) sales in September, as per Roche’s Q3 financials. Sandoz is responsible for the worldwide commercialisation of EirGenix’s Herceptin biosimilar, except in Taiwan, China, Russia, and some Asian countries, based on the 22 November press release. Meanwhile, EirGenix holds the developmental, commercialisation and manufacturing rights for the biosimilar in countries not covered by Sandoz. In September, EirGenix’s Herceptin biosimilar received a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines ...
- Source: drugdu
- 177
- November 26, 2023
InDex Scraps Phase III Ulcerative Colitis Trial on Disappointing Data

By Tristan Manalac InDex Pharmaceuticals on Tuesday announced that it is discontinuing the Phase III CONCLUDE program, which was evaluating its investigational immunomodulatory therapeutic cobitolimod in ulcerative colitis. The decision to terminate the late-stage study is in line with the recommendations of an Independent Data Monitoring Committee, which found during a planned dose selection, safety and futility analysis that cobitolimod is “unlikely” to meet the study’s primary endpoint, according to the company’s announcement. At the same time, InDex noted that the committee’s advice to discontinue the study was not due to any safety concerns. InDex CEO Jenny Sundqvist in a statement called the committee’s recommendation “surprising and disappointing,” adding that cobitolimod’s failure in CONCLUDE highlights the “complexity of the disease” and points to the need for more research to address the “high unmet medical need” in ulcerative colitis. The company’s stock was trading approximately 59% lower on Wednesday morning in ...
- Source: drugdu
- 142
- November 24, 2023
Novartis drops subpoena request in trade-secret spat with Takeda

Novartis has withdrawn its request to access Takeda’s documents as part of an investigation over potential trade secrets theft. Novartis originally filed the complaint in Massachusetts Superior Court in October. The Swiss pharma wanted to find out whether a former employee in Egypt took sensitive documents to his new job with Takeda. After being “stonewalled” by Takeda, Novartis resorted to legal action, attempting to subpoena the Japanese pharma’s business records and depose an employee. Takeda, on Nov. 10, filed a motion to dismiss the complaint for recovery. According to Novartis, a former employee named Khaled Shams Eldin transferred some 10,000 files to his personal email before departing the company in May. After leaving his post as operations lead for cell and gene therapy at Novartis’ Egyptian unit, Eldin joined Takeda in July in a similar position, the company said. Earlier this week, Novartis dropped the case, according to a court ...
- Source: drugdu
- 113
- November 24, 2023
Bayer’s trial flop, courtroom setback could restrict CEO’s options amid strategic review

After suffering setbacks in the clinic and in court over the last week, Bayer’s ability to overhaul its corporate structure is becoming more constricted, one group of analysts contends. Still, the German conglomerate is trying to keep its head up as it presses on with a strategic review under new CEO Bill Anderson. Bayer’s very bad week started with the failure of its potential blockbuster-in-waiting asundexian to top Bristol Myers Squibb and Pfizer’s Eliquis in a phase 3 trial. In light of the blood thinner’s inferior efficacy, Bayer elected to stop the study early while continuing to advance the asset in stroke. Bayer is counting on new drugs like asundexian to offset the upcoming loss of exclusivity on its Johnson & Johnson-partnered med Xarelto. Separately, a Missouri jury on Monday ordered Bayer to shell out $1.56 billion to four plaintiffs over claims the company’s Roundup weedkiller caused their cancer. Bayer ...
- Source: drugdu
- 96
- November 23, 2023
NeoImmuneTech bags orphan drug tag for IL-7 acute radiation syndrome treatment

The US Food and Drug Administration (FDA) awarded an orphan drug designation to NeoImmuneTech’s investigational drug for the treatment of acute radiation syndrome (ARS). The purpose of FDA orphan designation is to advance treatments for rare diseases like ARS. According to the Centers for Disease Control and Prevention (CDC), current treatments are geared towards preventing subsequent infections and treating infections and injuries. NT-17 (efineptakin alfa) (rhIL-7-hyFc) is a long-acting human IL-7 fusion protein designed to exceed the developmental and functional capabilities of endogenous IL-7 and comparatively amplify and enhance the T cell immune response. The drug, currently in preclinical development as a monotherapy, is expected to promote T-cell recovery by restoring lymphocyte levels and fortifying the body’s immune system after individuals are exposed to ionizing radiation. The clinical-stage biotechnology company is collaborating with the National Institute of Allergy and Infectious Diseases (NIAID) to evaluate the efficacy of NT-17 in treating ...
- Source: drugdu
- 96
- November 22, 2023
BMS strengthens NSCLC market share with ROS1 drug Augtyro

The US Food and Drug Administration (FDA) has approved Bristol Myer Squibs’ (BMS) Augtyro (repotrectinib) for adults with non-small cell lung cancer (NSCLC). Augtyro is an orally administered tyrosine kinase inhibitor (TKI) designed to selectively bind to active kinase formations in ROS1-positive NSCLC and suppress uncontrolled cell proliferation and tumor growth caused by ROS1 oncogenic fusions. It is the only FDA-approved TKI for ROS1-positive NSCLC. The FDA approval was based on data from the ongoing Phase I/II TRIDENT-1 (NCT03093116) trial, which is evaluating repotrectinib in 500 patients with advanced solid tumours characterized by ALK, ROS1, or NTRK1-3 fusions. The Phase I portion assessed the safety, tolerability, and pharmacokinetics of repotrectinib. Patients previously treated with a TKI and no chemotherapy demonstrated an overall response rate (ORR) of 38% and a median DOR of 14.8 months. Patients with no prior treatment with a TKI had an ORR of 79% and a median ...
- Source: drugdu
- 102
- November 20, 2023
Takeda Wins FDA Approval for Fruquintinib in Certain Colorectal Cancer Patients

The FDA on Wednesday approved Takeda’s fruquintinib for previously treated adults patients with metastatic colorectal cancer. The oral targeted therapy of the VEGF-1, -2 and -3 receptors will carry the brand name Fruzaqla. Fruzaqla’s label covers patients who had received prior lines of treatment with fluoropyrimidine, oxaliplatin and irinotecan chemotherapy, as well as an anti-VEGF agent. In wild-type RAS metastatic colorectal cancer (mCRC), and if medically appropriate, the therapy is also indicated for patients who had previously received anti-EGFR treatment. Wednesday’s approval comes more than 20 days before its scheduled target action date and makes Fruzaqla the “first and only selective inhibitor of all three VEGF receptor kinases approved in the U.S. for previously treated mCRC regardless of biomarker status,” according to Takeda’s announcement. “Fruzaqla is the first novel chemotherapy-free treatment option approved for patients in the U.S. regardless of biomarker status in more than a decade,” Teresa Bitetti, president ...
- Source: drugdu
- 108
- November 13, 2023
Bayer Eyes Break-Up, Management Cuts on Disappointing Q3 Results

By Kate Goodwin Bayer is looking to shake things up with some major company changes after reporting “not acceptable” cash flow for the third quarter on Wednesday. “We’re not happy with this year’s performance,” CEO Bill Anderson said in a statement accompanying third-quarter results that were down against the previous year, while emphasizing a need for redesigning the company to focus only on what’s essential for its mission of “health for all, hunger for none.” As part of a significant, unspecified reduction in its workforce, Bayer will remove “several layers” of management, according to Wednesday’s announcement. The goal is to shift the majority of decision-making from the managers to the people doing the work, Anderson said, adding that 12 layers of management between him and the company’s customers were “simply too much.” The company reported nearly 50 billion euros, or $53.3 billion, in revenue with what Anderson called “zero cash ...
- Source: drugdu
- 123
- November 10, 2023
Sarepta Fails Confirmatory Trial for DMD Therapy, Still Eyes Label Expansion

By Tristan Manalac Sarepta Therapeutics on Monday posted topline data from the Phase III EMBARK study, showing that its Duchenne muscular dystrophy gene therapy Elevidys (delandistrogene moxeparvovec-rokl) fell short of its primary efficacy endpoint, unable to significantly improve functional mobility versus placebo. Nonetheless, based on what the company calls “robust evidence” of “clinically meaningful treatment benefit” across all EMBARK’s pre-specified key functional secondary endpoints, Sarepta will push through with filing for a label expansion for Elevidys. “We have shared the EMBARK topline results with FDA leadership and they have confirmed that, based on the totality of the evidence, they are open to such label expansion if supported by review of the data, and that they intend to proceed rapidly with consideration of the submission,” Sarepta CEO Doug Ingram said in a statement. In EMBARK, a randomized, two-part crossover and placebo-controlled study, Sarepta dosed 125 Duchenne muscular dystrophy (DMD) patients aged ...
- Source: drugdu
- 115
- November 2, 2023

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