Search Results for “Roche” – Page 5 – media

Roche’s fenebrutinib shows promise in relapsing forms of MS

Roche has announced positive new data from a mid-stage study of fenebrutinib in adults with relapsing forms of multiple sclerosis (MS). The phase 2 FENopta study met its primary and secondary endpoints, the company said, with oral fenebrutinib significantly reducing MRI markers of MS disease activity in the brain compared to placebo. MS is a disabling, neurological disease in which the immune system attacks the protective myelin sheath that covers the nerves and disrupts communication between the brain and the rest of the body. The disease affects approximately 2.8 million people worldwide. Relapsing forms of MS are characterised by clearly defined, but unpredictable, attacks of worsening neurologic function, followed by partial or complete recovery periods. Approximately 85% of patients are initially diagnosed with relapsing forms of MS, compared to 15% with progressive forms of the disease. Roche and Genentech’s fenebrutinib belongs to a class of drugs known as Bruton’s tyrosine ...
- Source: drugdu
- 115
- May 19, 2023
reports

The costs for Roche to decommission and demolish its former API manufacturing plant in County Clare, Ireland, continue to climb, with the bill now reaching 57.3 million euros ($62.7 million) over a three-year period, according to local reports. In documents filed with the Companies Registration Office of Ireland, the Swiss pharma giant said it spent 11.53 million euros ($12.6 million) on winding down the facility in 2022. That’s in addition to the 23.4 million euros ($25.6 million) it shelled out dismantling the facility in the previous two years, The Irish Times reports. Roche also spent 13.18 million euros ($14.4 million) in related environmental costs last year, plus 9.1 million euros in that category through 2020 and 2021, according to the publication. “The company is continuing with its plan to decommission and demolish its assets,” Roche said in the filing, as quoted by The Irish Times. “It has successfully transitioned from a manufacturer ...
- Source: drugdu
- 127
- May 15, 2023
Roche’s Genentech opens up the world with new ad for Vabysmo

Adults facing wet age-related macular degeneration (AMD) and diabetic macular edema (DME) fear their world getting smaller due to loss of eyesight. Roche’s Genentech addresses that issue head-on in its first DTC ad for Vabysmo. The new “Open up your world with Vabysmo” campaign was developed with input from patients, caregivers, advocacy groups and the retinal community impacted by wet AMD and DME. “One of the critical insights was that many of these patients felt when they were losing their vision it made their world feel really small—they didn’t get to go out as much, they weren’t necessarily doing their daily activities of living because they felt like they were losing their sight and therefore inhibiting that ability,” Jennifer Kim, Genentech’s vice president and head of ophthalmology, said. “So that’s how we developed that concept around open up your world. The idea of the campaign is ...
- Source: drugdu
- 137
- May 1, 2023
Roche Holding AG Receives FDA Approval for New Cancer Treatment

Roche Holding AG, a Swiss multinational healthcare company, has announced that the U.S. Food and Drug Administration (FDA) has granted approval for its new cancer treatment. The drug, known as Polivy, is designed to treat patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), a type of non-Hodgkin’s lymphoma. This approval is significant for Roche, as DLBCL is one of the most common types of non-Hodgkin’s lymphoma and a highly aggressive form of cancer. Polivy is a first-in-class antibody-drug conjugate that targets CD79b, a protein that is highly expressed on the surface of B-cell lymphomas. The drug is designed to bind to the CD79b protein and deliver a toxic payload directly to cancer cells, without affecting healthy cells. This approach is known as targeted therapy and is considered to be a significant advancement in cancer treatment. The FDA’s decision was based on the results of a phase ...
- Source: drugdu
- 145
- March 24, 2023
Roche teams up with Lilly to validate Alzheimer’s blood test

March 22 (Reuters) – Roche (ROG.S) and Eli Lilly and Co (LLY.N) are joining forces to develop a blood test for Alzheimer’s disease, and plan to kick off a two-year clinical trial involving hundreds of volunteers with the aim of winning U.S. regulatory approval. The effort, unveiled in a statement on Wednesday, comes as Lilly as well as Eisai (4523.T) and Biogen (BIIB.O) are gearing up to sell drugs aimed at slowing the advance of the mind-robbing illness, but their use will require a diagnosis at earlier disease stages than is the norm today. Roche Holding AG would recruit several hundred volunteers with early signs of dementia over the next 18 to 24 months with trial data potentially ready for a U.S. regulatory filing in 2025, Bruce Jordan, leader of Personalized Healthcare Solutions at Roche Diagnostics, told Reuters. The U.S. Food and Drug Administration has asked Roche to recruit a significant number of patients at primary care facilities ...
- Source: drugdu
- 142
- March 22, 2023
Roche’s faricimab hits primary endpoint in wet AMD studies

Roche’s investigational bispecific antibody faricimab has hit the primary endpoint in two Phase III studies in people living with neovascular or wet age-related macular degeneration (nAMD). In the identically designed studies – TENAYA and LUCERNE – faricimab, administered via injections at fixed intervals, met the primary endpoint, showing that people receiving the treatment achieved visual acuity outcomes that were non-inferior to those receiving Regeneron’s Eylea (aflibercept) injections every eight weeks. Within both studies, nearly half (45%) of participants were treated with faricimab every 16 weeks during the first year. “These results show the potential of faricimab as a new class of medicine that could extend time between treatments for people living with neovascular age-related macular degeneration,” said Levi Garraway, chief medical officer and head of Global Product Development, Roche. “We have now seen positive and consistent results in four Phase III studies for faricimab across both neovascular age-related macular degeneration ...
- Source: drugdu
- 279
- January 31, 2021
Roche
Roche to pay Sarepta $1B upfront for DMD gene therapy rights

Roche is paying more than $1 billion upfront for the ex-U.S. rights to Sarepta Therapeutics’ Duchenne muscular dystrophy (DMD) gene therapy SRP-9001. The deal comes days after Roche advanced its push into gene therapies by closing the takeover of Spark Therapeutics. Sarepta has linked SRP-9001 to microdystrophin expression levels of up to 96% in early clinical tests, leading it to start a 24-patient placebo-controlled trial that is due to deliver data next year. Coupled to a safety profile that so far makes SRP-9001 look a better prospect than rival gene therapies from Pfizer and Solid Biosciences, the efficacy data have put Sarepta at the forefront of efforts to develop a one-shot treatment for DMD. That has attracted the attention of Roche. The Swiss drugmaker is set to pay $750 million in cash and $400 million in equity upfront for the ex-U.S. rights to SRP-9001. Sarepta is also in line to ...
- Source: drugdu
- 265
- December 24, 2019
Nonprofit Report Discloses Worst Patent ‘Offenders’; AbbVie, Roche and Pfizer

A new report by nonprofit group Initiative for Medicines, Access & Knowledge (I-MAK) exposes the prime offenders of the U.S. patent system, the pharma giants who are taking advantage of its loopholes to amass huge profits.
- Source: FiercePharma
- 609
- August 8, 2018
Market Views pharmaceutical company pharmaceutical drugs
First-line use of Roche’s Tecentriq given priority review

US regulators are undertaking a priority review of Roche unit Genentech’s PD-L1 inhibitor Tecentriq, in combination with Avastin and standard chemotherapy for some patients with lung cancer.
- Source: pharmatimes
- 628
- May 9, 2018
Chemotherapy lung cancer Roche Tecentriq
Flatiron Health, acquired By Roche, Signs Three-Year Deal with Bristol-Myers

Flatiron announced a three-year agreement with Bristol-Myers Squibb (BMS) a leading pharma company from the US. BMS is planning to use Flatiron’s expertise to expand real-world evidence to develop Bristol’s experimental cancer drugs.
- Source: drugdu
- 668
- May 4, 2018
BMS Company Insights Roche

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