Search Results for “EC” – Page 380 – media

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
【EXPERT Q&A】Is it mandatory to conduct clinical trials for drug registration in India?

Drugdu.com expert’s response: Based on the years of experience from Drugdu.com, the number and cases of clinical trials conducted in India are related to the current clinical situation and whether the original research drug is marketed locally. Specific issues require case-by-case analysis. In general, for drug registration in India, if it is a chemical drug or a formulation, and the original research drug is already marketed in India, it can be registered as a generic drug in India, and clinical trials can be waived. Some orphan drugs, especially those that face recruitment challenges in clinical trials and are already marketed in the regulatory markets of Europe and the US, can also apply for exemption from local clinical trials. However, for biologics such as vaccines, monoclonal antibodies, and blood products, conducting phase III (bridging) clinical trials locally is mandatory for registration in India. Taking phase III clinical trials as an example, ...
- Source: drugdu
- 305
- August 9, 2023
Clinical Trials drug registration
Out-of-pocket costs a barrier to treatment for opioid use disorder

Most individuals diagnosed with opioid use disorder are not on recommended medications and even fewer remain in care, according to a research letter published today in JAMA Internal Medicine by lead author Ashley Leech, PhD, assistant professor in the Department of Health Policy at Vanderbilt University Medical Center (VUMC). In 2021, there were more than 100,000 overdose deaths in the United States, with the highest rates among those ages 25-54. Just 22% of the 40,000 individuals with opioid use disorder studied by VUMC researchers continuously used buprenorphine for a full year. And among those who discontinued, many were on the medication for just over a month, which is markedly below recommended levels, the authors said. Stephen Patrick (MD, MPH, senior author, director Center for Child Health Policy at VUMC) said, “Treatment with medications like buprenorphine is safe and highly effective, reducing risk of countless adverse outcomes including overdose death. Nationwide, ...
- Source: drugdu
- 109
- August 9, 2023
Potential treatment for inherited blindness wins FDA fast-track

The US Food and Drug Administration (FDA) is addressing inherited blindness in children after it granted HuidaGene Therapeutics a rare paediatric disease designation (RPDD) to expedite the development and review times of the company’s gene therapy candidate. China-headquartered HuidaGene’s HG004, which received an orphan drug designation in March, is a one-time gene replacement drug intended to treat patients who are affected by inherited retinal diseases (IRDs) caused by mutations in the RPE65 gene. The therapy delivers a functional version of the gene to the retinal pigment epithelium via an adeno-associated virus (AAV) vector. RPE65-induced IRDs include Leber’s congenital amaurosis (LCA), severe early childhood-onset retinal dystrophy (SECORD), early-onset severe retinal dystrophy (EOSRD), and retinitis pigmentosa (RP). The diseases are often present in toddlers and can cause night blindness and a loss of visual field and central vision. The impairment of vision at such an early age likely affects other areas of ...
- Source: drugdu
- 122
- August 9, 2023
Eli Lilly announces positive results for Retevmo in phase 3 lung cancer study

Eli Lilly has announced positive top-line results from a late-stage study of its targeted therapy Retevmo (selpercatinib) versus the current first-line standard of care in certain non-small cell lung cancer (NSCLC) patients. The phase 3 LIBRETTO-431 trial has been evaluating Retevmo versus platinum-based chemotherapy plus pemetrexed with or without Merck’s Keytruda (pembrolizumab) as an initial treatment for adults with rearranged during transfection (RET) fusion-positive advanced or metastatic NSCLC. A pre-specified interim efficacy analysis showed that the study met its primary endpoint, with Lilly’s therapy demonstrating a statistically significant and clinically meaningful improvement in progression-free survival. As the company outlined, LIBRETTO-431 is the first randomised study to compare the safety and effectiveness of a targeted therapy to a PD-1 inhibitor plus chemotherapy in cancer patients bearing a specific biomarker. David Hyman, chief medical officer at Loxo@Lilly, said: “The LIBRETTO-431 trial aims to answer an important question about the selection of initial ...
- Source: drugdu
- 197
- August 9, 2023
Bavarian Nordic’s chikungunya vaccine candidate shows promise in late-stage trial

Bavarian Nordic has shared positive top-line results from a late-stage study of its chikungunya virus vaccine candidate in adults and adolescents. Chikungunya is a mosquito-borne viral disease for which there is currently no approved vaccine or effective treatment. Infection leads to symptomatic disease after four to eight days following the bite of an infected mosquito, with clinical symptoms including acute onset of fever, debilitating joint and muscle pain, headache, nausea, rash and chronic arthralgia. More than 3,200 people aged 12 to 64 years were enrolled and randomised to receive either a single intramuscular injection of Bavarian Nordic’s virus-like particle-based vaccine candidate, CHIKV VLP (PXVX0317), or placebo. Results showed that the vaccine was highly immunogenic in healthy adolescents and adults at up to 22 days post-vaccination, as demonstrated by the strong induction of chikungunya neutralising antibodies in 98% of those in the active group. CHIKV VLP induced significant neutralising antibodies in ...
- Source: drugdu
- 102
- August 9, 2023
Iveric Gets FDA Approval in Geographic Atrophy After Being Acquired by Astellas

By Tristan Manalac Pictured: Astellas’ American headquarters in Illinois/iStock, JHVEPhoto The FDA on Friday approved Iveric Bio’s intravitreal avacincaptad pegol, now to be marketed as Izervay, for the treatment of geographic atrophy secondary to age-related macular degeneration. The regulatory win comes three months after the New Jersey biotech was bought by Astellas Pharma for $5.9 billion. The companies completed the acquisition last month. Friday’s approval makes Izervay the first authorized geographic atrophy (GA) treatment that has significantly slowed down GA progression at 12 months across two Phase III studies, according to Astellas’ announcement. The eye injection also offers a new treatment option to physicians and patients across the U.S., Iveric Bio President Pravin Dugel said in a statement. Discovered and developed by Iveric, Izervay is an intravitreally administered inhibitor of the complement C5 protein. By blocking the cleavage of C5, the eye injection also disrupts more downstream processes, including the formation ...
- Source: drugdu
- 208
- August 9, 2023
unrNektar Flags Lilly’s Miscalculations in Rezpeg Atopic Dermatitis Trials

By Tristan Manalac Pictured: Nektar signage at its headquarters in California/iStock, Sundry Photography Nektar Therapeutics on Monday revealed that former partner Eli Lilly had incorrectly calculated efficacy data for its investigational regulatory T-cell stimulator rezpegaldesleukin (rezpeg), which the company is developing as a treatment for atopic dermatitis. At the 31st Congress of the European Academy of Dermatology and Venereology (EADV), held in September 2022, Lilly presented data from a Phase Ib study of rezpeg, showing that while the candidate elicited positive and dose-dependent improvements in key efficacy measures, these effects ultimately fell short of statistical significance. At 12 weeks, Lilly erroneously reported the 12-µg/kg and 24-µg/kg doses of rezpeg were associated with a 53% and 66% improvement in Eczema Area and Severity Index (EASI) scores, respectively, whereas placebo induced a 49% improvement relative to baseline, Nektar reported. Neither dose was significantly superior to placebo, according to the company. However, Nektar’s ...
- Source: drugdu
- 105
- August 9, 2023
Study helps understand how RNA modification promotes pancreatic cancer

Chemical modifications of RNA molecules, such as m6A, can critically impact gene expression, influencing various aspects of cancer development and progression. However, while studies into m6A modification of messenger RNA (mRNA) have been extensive, exploration of its impact on lncRNAs, especially within the context of PDAC, has been relatively limited. In an innovative study published in the Genes & Diseases journal, a team from The Children’s Hospital, Zhejiang University School of Medicine, People’s Hospital of Hangzhou Medical College and University of Mississippi Medical Center employed a methylated RNA immunoprecipitation (MeRIP) strategy to uncover the role of LINC00901, an m6A-modified long noncoding RNA (lncRNA), in promoting the proliferation, survival, and invasiveness of pancreatic ductal adenocarcinoma (PDAC) cells, thus leading to tumor growth. Intriguingly, the study suggests that the m6A reader protein YTHDF1 negatively regulates LINC00901 expression. The team identified two m6A sites on LINC00901 essential for its interaction with YTHDF1. Their ...
- Source: drugdu
- 204
- August 8, 2023
Two people caught swine flu after visiting pig exhibits at agricultural fairs, CDC reports

By Brenda Goodman, CNN The CDC reported that two people in Michigan caught flu strains, such as the virus particles shown in green, that typically circulate in pigs. NIAD/NIH/Universal Images Group/Getty Images CNN — Two people have caught flu strains that normally circulate in pigs, the US Centers for Disease Control and Prevention said on Friday, and pig exhibits at agricultural fairs appear to be to blame. Each patient became ill with flu-like symptoms about 10 days after visiting pig exhibits at two different agricultural fairs in early and late July. Neither was hospitalized, and their infections do not appear to have spread to other people, the CDC said. Both cases were identified by the Michigan Department of Health. There are a few such cases in the U.S. each year, usually linked to swine exhibits at fairs. Still, the illnesses highlight the possibility that flu viruses have the ability jump ...
- Source: drugdu
- 100
- August 8, 2023

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