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Compound found to inhibit influenza virus replication by targeting host enzyme

How can the propagation of influenza viruses be stopped? For a new approach in the therapy of influenza infections, Prof. Hiroki Kato from the Institute of Cardiovascular Immunology at the University Hospital Bonn (UKB) and the Cluster of Excellence ImmunoSensation2 of the University of Bonn receives an Open Philanthropy grant of 2.2 million US dollars. Together with his team, he found a compound that inhibits the body’s own methyltransferase MTr1 and thus prevents the replication of influenza viruses. The funded project now aims to identify further MTr1 inhibitors with influenza-inhibiting activity that could be considered for clinical trials in the near future. When a virus enters our body, it binds to the host cell and introduces its genetic information in form of ribonucleic acid (RNA). Using these blueprints, the host cell is now forced to produce numerous new viruses. “This is because viruses have evolved various mechanisms, including modifications of ...
- Source: drugdu
- 95
- October 11, 2023
We’re Going To Find Out if Blue Shield of California’s New Drug Model Will Lower Costs

Blue Shield of California recently launched a new experiment for 2025: It will largely cut out CVS Caremark as its pharmacy benefit manager and will instead put the company in charge of just specialty pharmacy services. Meanwhile, Amazon Pharmacy will be in charge of home delivery of prescription drugs, Mark Cuban Cost Plus Drug Company will create a more transparent pricing model, Abarca will handle the payment of prescription drug claims and Prime Therapeutics will negotiate savings with drug manufacturers. Will this experiment of distributing pharmacy benefit responsibilities to different vendors work? Remains to be seen, said Creagh Milford, senior vice president of retail health at CVS Health, during a panel discussion on Sunday at Engage at HLTH in Las Vegas. CVS Health owns CVS Caremark. “The problem with that generally — and not saying this specific example [of California] — is that you actually see costs go up because ...
- Source: drugdu
- 156
- October 10, 2023
WHO experts recommend the use of Takeda’s dengue vaccine QDENGA

Takeda today announced that the World Health Organization’s (WHO) Strategic Advisory Group of Experts (SAGE) on Immunization shared recommendations for use of QDENGA® (Dengue Tetravalent Vaccine [Live, Attenuated]) (TAK-003). In the coming months, the WHO will consider the SAGE recommendation and update its position paper on dengue vaccines to include final guidance on the use of QDENGA in public vaccination programs. SAGE made the following recommendations: The vaccine to be considered for introduction in settings with high dengue disease burden and high transmission intensity to maximize the public health impact and minimize any potential risk in seronegative persons. The vaccine to be introduced to children aged 6 to 16 years of age. Within this age range, the vaccine should be introduced about 1-2 years prior to the age-specific peak incidence of dengue-related hospitalizations. The vaccine should be administered in a 2-dose schedule with a 3-month interval between doses. The vaccine ...
- Source: drugdu
- 121
- October 10, 2023
Takeda to Pull Lung Cancer Drug from Market After Failed Confirmatory Study

Takeda Pharmaceutical drug Exkivity failed the confirmatory study required of its 2021 accelerated approval. Our recap of other recent regulatory developments includes a partial clinical hold on a cancer drug, a Covid-19 vaccine authorization, and several drug approvals in the U.S. and beyond. By FRANK VINLUAN Accelerated approval offers a way to more quickly bring patients drugs for diseases that have few treatment options. But that speedy path to the market comes with the understanding that the FDA can take its regulatory blessing away—unless the company takes its drug away first. That is what Takeda Pharmaceutical has decided to do with its cancer drug, Exkivity. Following discussions with the FDA, the Japanese pharmaceutical giant is voluntarily withdrawing Exkivity from the market. Exkivity treats non-small cell lung cancer by targeting epidermal growth factor (EGFR). That cancer protein must have exon 20 mutations—the same genetic signature addressed by Johnson & Johnson’s Rybrevant. ...
- Source: drugdu
- 200
- October 10, 2023
FDA wants more testing in Philips recall

BY SEAN WHOOLEY The FDA has issued a communication stating its desire for more testing in the massive respiratory device recall at Philips (NYSE: PHG)+.The morning after the FDA’s evening announcement, PHG shares were down more than 7% on the NYSE to $18.31 apiece. PHIA shares in Amsterdam closed the day down more than 8%. (MassDevice’s MedTech 100 Index was up slightly.) Philips has been handling a Class I recall of certain respiratory devices since mid-2021. Respironics recalled millions of ventilators, bi-level positive airway pressure (BiPAP) and continuous positive airway pressure (CPAP) machines. Here’s a timeline of the events of the ongoing saga. FDA’s statement follows a scathing investigational report from ProPublica and the Pittsburgh Post-Gazette. The report outlined the alleged withholding of information around the issues with the devices even as they became more alarming. “The FDA remains unsatisfied with the status of this recall, and we continue to ...
- Source: drugdu
- 113
- October 10, 2023
Roche presents positive results for spinal muscular atrophy treatment Evrysdi in babies

Roche has presented positive results from an ongoing study evaluating its spinal muscular atrophy (SMA) treatment Evrysdi (risdiplam) in babies aged from birth to six weeks with pre-symptomatic disease. SMA is a severe and progressive neuromuscular disease affecting approximately one in every 10,000 babies. Those living with the condition have insufficient levels of the SMN protein, which is essential to the function of nerves that control muscles and other functions such as swallowing, speaking, breathing and movement. Roche’s Evrysdi, which can be administered at home in liquid form by mouth or by feeding tube, is designed to treat the disease by increasing and sustaining the production of SMN protein in the central nervous system and peripheral tissues. Clinical studies have shown that the loss of motor neurons may begin before symptoms start, so beginning treatment early is seen as critical for improved outcomes. Results from the ongoing RAINBOWFISH study, which ...
- Source: drugdu
- 213
- October 10, 2023
Korean CDMO Lotte Biologics buys land, sets out to build 3 new plants by 2030

Aiming to hit a corporate value of around $15 billion by the end of the decade, Korean CDMO Lotte Biologics has laid out plans to stand up three new manufacturing facilities in the same time frame. Lotte this week unveiled a land purchase agreement with the Incheon Free Economic Zone Authority in Incheon, Korea. With the new real estate, Lotte plans to build out three separate bio plants by 2030. Each plant will be capable of cranking out 120 kiloliters of antibody drugs for a total planned production capacity of 360 kiloliters, Lotte explained in a press release. The company is also weighing whether to add small-scale bioreactors for clinical material production. Plants 1, 2 and 3 are expected to be completed in 2025, 2027 and 2030, respectively. Once full-scale operations kick off around 2034, Lotte will boast 400 kiloliters of total production capacity, the company said. Groundbreaking for the ...
- Source: drugdu
- 111
- October 10, 2023
FDA panel says Amgen’s Phase III lung cancer KRAS drug data is unreliable

AUS Food and Drug Administration (FDA’s) Oncology Advisory Committee (AdCom) has raised questions about the upcoming decision to grant traditional approval of Amgen’s high-profile KRAS G12C inhibitor Lumakras (sotorasib). Lumakras was granted accelerated approval in May 2021 for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with KRAS G12C mutations, who had received at least one prior systemic therapy. This approval was based on the CodeBreaK 200 trial (NCT04303780) of sotorasib versus docetaxel. Lumakras generated $285m in sales last year worldwide, according to Amgen’s 2022 annual report to shareholders. The latest AdCom questioned the reliability of the data In the briefing document released by the FDA from the meeting, several features of the Codebreak trial were listed that were inconsistent with a sufficient well-controlled trial. The main issue noted was that too many patients were allowed to swap between the treatment and control arms ...
- Source: drugdu
- 175
- October 10, 2023
Ocular launches ocular implant trial to combat macular degeneration

US biopharmaceutical firm, Ocular Therapeutix has announced the start of its first clinical trial of an intravitreal eye implant intended to combat macular degeneration. Named OTX-TKI, the axitinib intravitreal implant is intended to treat wet age-related macular degeneration (wet AMD). Alongside the announcement the company has requested a Special Protocol Assessment (SPA) from the US Food and Drug Administration (FDA) as to how the trial is designed. Overall, the trial will recruit approximately 300 evaluable wet AMD patients. Antony Mattessich, CEO of Ocular Therapeutix said: “With the activation of our first clinical site in the US, we believe we are on target to enrol our first subject before year-end. “The trial is a crucial step forward for our clinical program as we make progress toward our goal of bringing a transformative new treatment that can truly make a difference for wet AMD to patients coping with vision loss.” The company ...
- Source: drugdu
- 177
- October 10, 2023
Catheter ablation beats drugs in J&J retrospective study of AFib heart failure risk

Dive Brief Catheter ablation is better than antiarrhythmic drugs at cutting heart failure risk as a second-line treatment for atrial fibrillation patients, according to a retrospective study funded by Johnson & Johnson. The study, which was published in Heart Rhythm O2, compared the incidence of heart failure in a claims database to evaluate whether patients who have previously tried an antiarrhythmic drug should receive catheter ablation or a different medicine. Across a dataset of more than 18,000 patients, people who received catheter ablation had a 57% lower risk of developing heart failure than their counterparts on antiarrhythmic drugs. Dive Insight In 2019, a randomized clinical trial funded by the National Institutes of Health and medtech companies including J&J’s Biosense Webster found catheter ablation is no better at reducing the composite risk of death and major cardiovascular events than antiarrhythmic drugs. However, the trial linked ablation to a lower risk of ...
- Source: drugdu
- 145
- October 9, 2023

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