PharmaFocus Today – Page 317 – media

Intercept restructures as Ocaliva’s NASH hopes dashed again with FDA rejection

Even after a second application attempt, Intercept’s Ocaliva wasn’t the fatty liver disease breakthrough that the company had hoped it would be. Three years after an initial rejection, the FDA once again turned down Ocaliva, or obeticholic acid, for nonalcoholic steatohepatitis (NASH) patients with stage 2 or 3 liver fibrosis, Intercept said Thursday. The denial means patients with NASH will have to wait longer for the first FDA-approved therapy and that a market estimated to be worth multiple billions of dollars still awaits a winner. For Intercept, it also means it’s time for a new direction. Intercept has decided to discontinue all NASH-related investment and restructure its operations, with the goal to save about $140 million in operating costs, the company said Friday. Measures it’s taking include winding down a long-term patient outcomes follow-up of the phase 3 REGENERATE study for Ocaliva in NASH. All R&D, commercial, medical affairs and ...
- Source: drugdu
- 105
- June 27, 2023
Amgen’s supplemental Biologics License Application for Blincyto approved by FDA

Amgen has announced the full approval by the US Food and Drug Administration (FDA) of the supplemental Biologics License Application (sBLA) for Blincyto (blinatumomab). Blincyto is used to treat adults and children with CD19-positive B-cell precursor acute lymphoblastic leukaemia (B-ALL), who are in their first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%. Approved after additional data was submitted from two phase 3 studies, Blincyto’s accelerated approval is now a full approval. David Reese, executive vice president of research and development at Amgen commented that the treatment was “the first FDA-approved CD19-directed CD3 T-cell engager BiTE immunotherapy, and the first to be FDA-approved for MRD in 2018″. He added that the “full approval underscores the clinical benefit of Blincyto for people living with B-ALL”. Blincyto is a bispecific T-cell engager (BiTE) immune-oncology therapy that targets CD19 surface antigens on B cells. Helping the ...
- Source: drugdu
- 105
- June 27, 2023
Former Vice President and presidential candidate Mike Pence calls for tighter federal abortion restrictions, but others keep their distance

Two Republican 2024 presidential hopefuls talked up their opposition to abortion on Sunday on the one-year anniversary of the Supreme Court’s decision in Dobbs v. Jackson, the decision that overturned Roe v. Wade. Presidential candidate and former Vice President Mike Pence described last year’s landmark decision as “a historic victory” that condemned Roe v. Wade to “the ash heap of history.” Pence earlier this week called for all GOP candidates to commit to a nationwide ban on abortion after 15 weeks — but he said on Sunday that it was also important to “stand with compassion.” “With 62 million unborn lives lost, and just about as many women who have endured the two generations under abortion, I think we need to bring a message of grace, we need to bring a message of kindness,” Pence said in an interview on “Fox News Sunday.” “That’s how we’re going to win hearts ...
- Source: drugdu
- 138
- June 27, 2023
Rubella elimination target extended to 2023 in Southeast Asia amid challenges

By Tarun Sai Lomte Reviewed by Lily Ramsey, LLM A recent Morbidity and Mortality Weekly Report described the progress toward eliminating rubella in the South-East Asia region (SEAR) of the World Health Organization (WHO). In 2013, SEAR countries adopted goals to eliminate measles and control congenital rubella syndrome (CRS) and rubella by 2020. In 2019, these countries announced plans to eliminate rubella and measles by 2023. The authors discussed the progress in rubella elimination in the SEAR between 2013 and 2021 in the present study. Study: Progress Toward Rubella Elimination — World Health Organization South-East Asia Region, 2013–2021. Image Credit: NovikovAleksey/Shutterstock.com Vaccination programs for Rubella The rubella-containing vaccine (RCV) was only available in Bhutan, Maldives, Bangladesh, Thailand, and Sri Lanka before 2013; other SEAR countries introduced the vaccine during 2013-21. Of these, only three countries offered the second dose before 2013; the remaining offered the second between 2013 and 2021. The ...
- Source: drugdu
- 108
- June 27, 2023
ADA says all diabetes patients should be screened for nonalcoholic fatty liver disease

By Elaine Chen STAT – Reporting from the frontiers of health and medicine Liver illustration HYACINTH EMPINADO/STAT SAN DIEGO — The American Diabetes Association said Sunday that all adults with type 2 diabetes or prediabetes should be screened for nonalcoholic fatty liver disease, an increasingly prevalent condition that can lead to serious liver damage. There are no approved medications for the disease, but among available diabetes drugs, the ADA singled out GLP-1 treatments as an option doctors could consider, according to recommendations published during the annual ADA conference. GLP-1 treatments, such as Ozempic and Mounjaro, are a class of drugs that have grown widely popular for their efficacy not only in lowering blood sugar, but also cutting weight. Drugmakers have started to study them in liver disease, and while some trials have shown they may offer some benefits, they haven’t yet been shown to improve harmful liver scarring. The ADA ...
- Source: drugdu
- 112
- June 27, 2023
Type 2 diabetes is frequently overlooked in clinical trials, analysis reveals

New analysis of official records from the National Institute of Health (NIH) have revealed that just 365,000 people took part in a clinical trial for Type 2 Diabetes in 2021, despite 37.3 million people in the US living with the condition – or more than 11% of the population. By taking part in a clinical trial, people affected by conditions like diabetes can access innovative new treatments and drugs and help bring the medicines to market much faster, benefiting millions of others. The new findings were uncovered by Lindus Health, a clinical trials start-up, who analyzed the official clinical trial records across multiple diseases and found that diabetes was clearly being under-represented – with the equivalent of fewer than 1% of people affected by the disease being involved in a trial. Despite the number of people affected by diabetes, the condition is frequently overlooked in clinical trials. This is despite ...
- Source: drugdu
- 135
- June 26, 2023
Psylo signs research deal with Daiichi Sankyo for psychiatric therapies

Biotech start-up Psylo and Daiichi Sankyo have signed a sponsored research deal to advance the development of non-hallucinogenic psychiatric therapies. The therapies will be developed as new antidepressants for patients suffering from chronic mental illness. The biotech company will use its knowledge of neuropsychiatric therapies and the experience of Daiichi Sankyo in drug discovery and clinical development to advance the new therapies’ research and development. Psylo CEO Josh Ismin stated: “We are thrilled to receive support from Daiichi Sankyo in our mission to develop new and effective treatments for chronic mental illness. “This sponsorship represents a step forward in our efforts to harness the therapeutic potential of compounds to address mental health challenges.” The company develops next-generation therapeutics inspired by a new class of neuropsychiatric compounds. It also plans to open a new office at the B+labs incubation space in Philadelphia, Pennsylvania, US. This will provide Psylo with access to ...
- Source: drugdu
- 178
- June 26, 2023
After delays, Sarepta’s DMD gene therapy Elevidys finally crosses FDA finish line at $3.2M

After several delays and a narrow advisory committee vote, Sarepta’s Duchenne muscular dystrophy (DMD) gene therapy has finally won an accelerated approval. The FDA’s approval for Elevidys comes one month behind the agency’s prior schedule and in a restricted patient population. But a win is a win for Sarepta. Specifically, the drug is approved to treat ambulatory patients ages 4 to 5 years with a confirmed mutation in the DMD gene. Sarepta is charging Elevidys, a one-time gene therapy, at a list price of $3.2 million, CEO Douglas Ingram told investors during a call Thursday. He pointed to an analysis suggesting the drug could be cost-effective at $5 million. Ingram expects the launch to take a few months to pick up, based on logistical and policy issues to address, he told investors. As opposed to an treatment outcome-based payment approach that has been adopted by other existing gene therapies to ...
- Source: drugdu
- 109
- June 26, 2023
World Health Organization publishes research agenda for antimicrobial resistance

The World Health Organization (WHO) has published its first global research agenda for scientists to address the ‘most urgent’ human health priorities to tackle antimicrobial resistance (AMR), which has been declared by the organisation as one of the top ten threats to global public health. Associated with the deaths of 4.95 million people in 2019, AMR occurs when bacteria, viruses, fungi and parasites change and adapt to antibiotics over time. As a result, infections become harder to treat, and the risk of disease spread, severe illness and death increases. The WHO Global Research Agenda for AMR in human health outlines 40 research topics on drug-resistant bacteria, fungi and Mycobacterium tuberculosis that the organisation said “must be answered by 2030”. WHO said the aim of the agenda is to guide key stakeholders, including policymakers, researchers and funders, in generating new evidence to inform AMR policies and interventions as part of efforts ...
- Source: drugdu
- 106
- June 26, 2023
Gilead’s chronic hepatitis D antiviral shows long-term efficacy in late-stage trial

Gilead Sciences has shared positive results from a late-stage study of its chronic hepatitis D virus (HDV) treatment, Hepcludex (bulevirtide). Gilead said the new 96-week data from the phase 3 MYR301 trial, which was presented at this year’s European Association for the Study of the Liver Congress, “reinforces the role of Hepcludex as an efficacious and well-tolerated treatment for the management of chronic HDV”. Data shows that the combined virological and biochemical response rates continued to increase through week 96, with response rates of 55% and 56% at the 2mg and 10mg dose levels, respectively. An additional analysis from the trial, presented in a late-breaker, also showed that study participants who appeared to not respond or only partially respond to the antiviral at week 24 went on to achieve a virological response at 96 weeks. The safety profile at week 96 was consistent with what was observed at week 48, ...
- Source: drugdu
- 109
- June 26, 2023

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