Search Results for “cancer” – Page 116 – media

Galera Lays Off 70% of Staff After FDA Rejection in Severe Oral Mucositis

Pictured: FDA sign in its headquarters/iStock, Grandbrothers The FDA rejected on Wednesday Galera Therapeutics’ avasopasem manganese, which the company was proposing as a treatment for radiotherapy-induced severe oral mucositis in patients with head and neck cancer. Galera shares fell 83% in after-hours trading in response to the FDA’s rejection. In its Complete Response Letter, the regulator said that Galera’s data were “not sufficiently persuasive to establish substantial evidence of avasopasem’s effectiveness and safety for reducing severe oral mucositis in patients with head and neck cancer.” The FDA noted that it will need results from an additional trial if the company wants to file a resubmission. The New Drug Application for avasopasem manganese included data from the Phase III ROMAN study, topline data from which showed that treatment with Galera’s candidate significantly reduced the incidence of radiotherapy-induced severe oral mucositis (SOM). The company supported these findings with results from the Phase ...
- Source: drugdu
- 118
- August 14, 2023
Illumina Lowers Outlook as Business Challenges, Exec Departures Continue

By Tristan Manalac Pictured: Illumina signage at California office/iStock, Georgejason During its second-quarter earnings report on Wednesday, Illumina lowered its financial outlook for fiscal year 2023 and is now only expecting revenue growth of 1% compared to the previous forecast of 7% to 10%. The news comes as the DNA sequencing company grapples with an activist investor, leadership shake-ups and strong antitrust pushback over its acquisition deal with GRAIL. In the second quarter, Illumina generated $1.18 billion in revenue, representing a modest but nevertheless positive 1% increase from its earnings during the same period last year. Without taking exchange rates into consideration, Illumina’s revenue grew 3%. Illumina also reported financial results for GRAIL, which it moved to buy for $8 billion in September 2020. The cancer detection company made $22 million in the second quarter, up from $12 million during the same timeframe last year. Despite better revenues, Illumina is ...
- Source: drugdu
- 110
- August 12, 2023
A promising new treatment for hematological malignancies

A new research perspective was published in Oncotarget’s Volume 14 on August 7, 2023, entitled, “CDK9 INHIBITORS: a promising combination partner in the treatment of hematological malignancies.” In their new perspective, researchers Daniel Morillo, Gala Vega and Victor Moreno from Hospital Fundación Jiménez Díaz discuss Cyclin-dependent kinases (CDK) in hematological malignancies. CDKs belong to a family of serine/threonine kinases that need to form heterodimeric complexes with cyclins to perform their functions. These kinases are involved in multiple processes within cells, including cell cycle, apoptosis, transcription and differentiation. These kinases are often overexpressed in different malignancies, making them potential targets for new drugs. Most hematological malignancies are characterized by overexpression of certain cancer-promoting genes, such as MYC, MCL1 and cyclin D1. Preclinical studies in animal models have shown that CDK9 inhibitors suppress the transcription of these anti-apoptotic and pro-survival proteins, and suggest their potential synergism with other drugs. In its first ...
- Source: drugdu
- 112
- August 11, 2023
BioNTech and Duality Biologics add third ADC candidate to oncology partnership

BioNTech and Duality Biologics have expanded their existing agreement to include a third antibody-drug conjugate (ADC) for solid tumours. The companies announced the first deal covering two ADCs in April this year. Under the terms of the agreement, DualityBio would receive upfront payments totalling $170m and be eligible to receive development, regulatory and commercial milestone payments of potentially more than $1.5bn. ADCs are a class of potent cancer therapies combining the selectivity of antibodies with the potent cell-killing properties of chemotherapy or other anti-cancer agents. Unlike chemotherapy, which works by attacking lots of different cells as well as the cancer, ADCs are designed to target and kill tumour cells while sparing healthy cells. Professor Ugur Sahin, chief executive officer and co-founder of BioNTech, said at the time of the first announcement: “Over the last years, the ADC field has made significant progress, overcoming several limitations and demonstrating its potential as ...
- Source: drugdu
- 103
- August 11, 2023
Guardant, Illumina agree to end litigation, extend commercial partnership

Dive Brief Guardant Health and Illumina have reached an agreement to settle litigation and extend a long-standing commercial partnership to advance cancer research, Guardant announced last week. The three-year agreement includes a joint request to dismiss with prejudice the pending litigation between the companies, including allegations of intellectual property theft. In addition, the companies will collaborate by sharing specimen samples and entering into a new long-term purchase and supply commitment, the Palo Alto, California-based cancer test maker said. Dive Insight DNA sequencing company Illumina last year sued Guardant co-CEOs and founders Helmy Eltoukhy and AmirAli Talasaz for breach of contract and alleged misappropriation of trade secrets. The lawsuit accused Eltoukhy and Talasaz of working on technology for Guardant while still employed by Illumina. Guardant at the time called the lawsuit an attempt to stifle competition and retaliate against the company for registering concerns about the antitrust implications of Illumina’s acquisition ...
- Source: drugdu
- 177
- August 10, 2023
Dendritic cells found to kill CD47-deficient T cells

Researchers at Kobe University discovered an entirely new and unexpected mechanism by which the immune system can get rid of cells lacking molecules that identify them as part of the self in mice. The finding, published in PNAS, has possible implications for cancer treatment. The immune system comprises many types of cells that work together to fight off diseases. Two important types are dendritic cells and T cells. Dendritic cells are located in strategic positions throughout the body including the gut and skin, as well as in the lymph nodes, sample their environment and present small components derived from these samples on their surface. T cells check these samples and if they recognize them as foreign (or “non-self”), they will initiate an immune response, otherwise they will move on. The ability to distinguish self from non-self is therefore a key characteristic of the immune system and T cells undergo very ...
- Source: drugdu
- 113
- August 10, 2023
MSD and Astex announce expansion to oncology drug discovery collaboration

MSD – known as Merck & Co in the US and Canada – and Astex Pharmaceuticals have expanded their drug discovery collaboration, with the goal of identifying small-molecule candidates with activity towards a tumour suppressor protein. The partnership will see Astex apply its fragment-based drug discovery platform to develop therapeutics targeting forms of the p53 tumour suppressor protein. The candidates will then be handed off to MSD for further optimisation and preclinical development. MSD is granted an exclusive global licence to research, develop, and commercialise candidates arising under the collaboration. In exchange, Astex will receive an upfront payment of $35m and is eligible for milestone payments totalling approximately $500m per programme, as well as tiered royalties on sales. Harren Jhoti, president and chief executive officer of Astex, said: “Astex is applying its fragment-based drug discovery capability to design and generate small molecule modulators tailored to a wide range of potentially ...
- Source: drugdu
- 113
- August 10, 2023
As COVID revenues disappoint, once-high-flying Pfizer looks at possible cost cuts

As COVID-19 revenues ebb and flow—but mostly ebb—Pfizer is eyeing the cost-cutting shears. “Clearly, there is a higher level of uncertainty regarding the demand projections for our COVID-19 products than for the rest of our business,” Pfizer chief Albert Bourla, Ph.D., admitted on a conference call Tuesday. While the shift to a traditional commercial market for Paxlovid and Comirnaty could help, a veil of uncertainty persists. In turn, “we are also preparing to have the ability to adjust our 2024 total cost base” to align with future COVID needs, the CEO added. “In fact, we have already identified specific areas where we can make adjustments primarily within our COVID-19 cost base,” he said. Paxlovid generated just $143 million in worldwide sales for the second quarter, down 98% from the $8.1 billion it pulled down over the same stretch in 2022. MRNA vaccine Comirnaty, for its part, brought home $1.4 billion, ...
- Source: drugdu
- 166
- August 3, 2023
UKHSA data reveals a 45% decline in hepatitis C prevalence in England

The UK Health Security Agency (UKHSA) has published new data showing that there were an estimated 70,649 people living in England with hepatitis C in 2022, marking a 45% decrease from the number recorded in 2015. Since 2015, NHS England has treated over 80,000 people for the infection as part of its national elimination programme. Of those treated, more than 80% were from the most deprived areas in England, which the UKHSA says highlights “the role of eliminating hepatitis C as a key driver of reducing health inequalities”. Hepatitis C is a blood-borne virus that can cause life-threatening liver disease, including cancer. However, those infected often have no symptoms until years later when their liver has already been badly damaged. Spread through blood-to-blood contact, the virus is commonly contracted through sharing needles contaminated with the infection, but it can also be contracted through the sharing of razors or toothbrushes. Dr ...
- Source: drugdu
- 126
- August 1, 2023
FDA Adopts New Sterilization Standard to Support Switch From Ethylene Oxide

Dive Brief The U.S. Food and Drug Administration has adopted an international sterilization standard to give medical device manufacturers another alternative to ethylene oxide (EtO). Manufacturers can now make declarations of conformity to the International Organization for Standardization’s recommendations on low-temperature vaporized hydrogen peroxide in submissions to the FDA. The FDA framed the addition of the ISO test to its Recognized Consensus Standards database as a response to pressure to reduce EtO use and the need to support supply chain resiliency. Dive Insight In April, the U.S. Environmental Protection Agency proposed limiting EtO emissions from sterilization facilities by 80% to minimize the risk of people developing cancer from exposure to the gas. AdvaMed has warned the limit could halve capacity at commercial sterilizing plants, and the FDA has cautioned that there is a lack of viable alternatives to EtO for many devices. The ...
- Source: drugdu
- 144
- July 28, 2023

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