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Weight-loss drug firm becomes Europe’s most valuable

By Mariko Oi The maker of weight-loss drug, Wegovy, has become Europe’s most valuable firm dethroning the French luxury conglomerate LVMH. Shares rose after the Danish pharmaceutical giant, Novo Nordisk, launched the popular drug in the UK. At the close of trading on Monday, the firm had a stock market valuation of $428bn (£339bn). The drug is now available in the UK public healthcare system and also on the private market. Wegovy is an obesity treatment that is taken once a week which tricks people into thinking that they are already full, so they end up eating less and losing weight. Famous personalities such as Elon Musk are among the reported users of the drug, which has captivated Hollywood and the public more widely since it was approved by regulators in the US in 2021. Wegovy and Ozempic – a diabetes treatment with similar effects – have been described as ...
- Source: drugdu
- 230
- September 6, 2023
New Biomarker Tests Aid Quick, Accurate Diagnosis of Alzheimer’s Disease

By Claire Jarvis Pictured: Close-up of an arm receiving a blood draw/iStock, montiannoowong Prior to the approval of effective therapies for Alzheimer’s disease, there was little need for biomarker tests. Now, with Eisai and Biogen’s anti-amyloid drug Leqembi on the market and approval of Eli Lilly’s donanemab expected to follow soon, the pipeline of Alzheimer’s drugs is expanding and the development of tests to detect the disease is accelerating. With Leqembi’s full approval, the Centers for Medicare and Medicaid Services (CMS) has instituted broader coverage of the drug—with stipulations. To ensure reimbursement, physicians must participate in a qualified registry and patients must be diagnosed with mild cognitive impairment or mild Alzheimer’s disease dementia with evidence of beta-amyloid deposits. To help facilitate this, CMS proposed in July 2023 to increase its coverage of PET scans to detect these amyloid plaques—however, cheaper and faster diagnostic methods are still being developed. The past ...
- Source: drugdu
- 190
- September 6, 2023
Amgen and Horizon Therapeutics settle FTC lawsuit

Amgen and Horizon Therapeutics have reached a consent order agreement with the Federal Trade Commission (FTC) to resolve an ongoing administrative lawsuit. This sets the stage for Amgen to proceed with the last steps in finalising the acquisition of Horizon. In December last year, Amgen reached an agreement to acquire the complete issued and to-be-issued ordinary share capital of Horizon Therapeutics for $116.50 (€107.82) per share in cash or nearly $27.8bn on a fully diluted basis. As a result of the agreement, Amgen and Horizon anticipate submitting joint proposals to dismiss the preliminary injunction motion and lift the temporary restraining order (TRO) in the US District Court for the Northern District of Illinois. In May this year, the FTC took legal action in federal court to prevent the transaction, arguing that it would allow Amgen to leverage rebates from its successful drugs to exert influence over insurance companies and pharmacy ...
- Source: drugdu
- 173
- September 6, 2023
Centogene finds diagnostic and predictive biomarker for Gaucher disease

Centogene has published data about the use of lyso-Gb1 (glucosylsphingosine) as a sensitive diagnostic and predictive biomarker for Gaucher disease. The study was published in the open-access MDPI journal, Diagnostics, and showed that lyso-Gb1 could be used to predict the clinical course of patients with Gaucher disease. Gaucher disease is a rare inherited metabolic disorder caused by mutations in the beta-glucocerebrosidase (GBA1) gene, responsible for producing a fat-breaking enzyme, glucocerebrosidase. Decreased activity of the enzyme causes fat accumulation in the cells causing symptoms such as liver enlargement, anaemia, bone pain, and spleen enlargement. Multiple biomarkers have been identified for the disease. However, these were present in other diseases and not exclusively in Gaucher disease. Lyso-Gb1 is a more specific biomarker for Gaucher’s, and it can be used to both diagnose the disease and monitor its progression. The confirmation of the biomarker serves as an important step forward in rare disease ...
- Source: drugdu
- 178
- September 6, 2023
Delaware’s Marlex Pharmaceuticals recalls 2 batches of heart failure drug after labeling mix-up

When it comes to heart failure medication, a labeling mix-up can have dire consequences. That’s why Marlex Pharmaceuticals of New Castle, Delaware, is recalling two lots of digoxin tablets at the 0.125-mg and 0.25-mg doses. The company is pulling the batches of the heart failure medication because certain bottles of 0.125-mg digoxin tablets are mislabeled with the 0.25-mg dose and vice versa. The labeling snafu could cause either overdosing of underdosing in patients who unknowingly take the wrong strength of medication, Marlex warned in a notice posted on the FDA’s website. Patients on 0.125-mg strength digoxin who take the higher dose could experience “significant drug toxicity” such as mental disorientation, dizziness, blurred vision, memory loss and fainting, the company added. Meanwhile, patients who take a subpotent dose may experience loss of control of heart rate and potential heart failure exacerbation, Marlex said. As of Thursday, Marlex said it hadn’t received ...
- Source: drugdu
- 224
- September 6, 2023
Following in Tecentriq’s footsteps, Alecensa gives Roche another win in early-stage lung cancer

After a groundbreaking approval for Tecentriq, Roche has another positive early-stage lung cancer trial to celebrate. This time, the honor belongs to a targeted therapy in Alecensa. Alecensa, compared with chemotherapy, reduced the risk of tumor recurrence or death when used after surgery in certain non-small cell lung cancer patients, Roche said Friday. The patients had ALK-positive, stage 1b to 3a tumors that were completely resected before taking Alecensa. The positive readout, from the ALINA trial, makes Alecensa the first ALK inhibitor to show a benefit in early-stage NSCLC in a phase 3 trial, Roche noted. Data on patient survival remain immature. But the Swiss pharma said it’ll submit the results to the FDA and the European Medicines Agency for a potential label expansion. “If approved, Alecensa has the potential to treat cancer before it has spread in a setting where treatment can increase the chances of cure,” Roche’s chief ...
- Source: drugdu
- 117
- September 6, 2023
Respiratory patients are most vulnerable to the effects of climate change

People living with lung conditions, such as asthma and chronic obstructive pulmonary disease (COPD), face even greater risks from climate change, according to an expert report published today (Monday) in the European Respiratory Journal. The report brings together evidence on how the effects of climate change, such as heatwaves, wildfires and flooding, will exacerbate breathing difficulties for millions of people around the world, particularly babies, young children and the elderly. On behalf of the European Respiratory Society, which represents more than 30,000 lung specialists from 160 countries, the authors are calling on the European Parliament and governments around the world to urgently reduce emissions of greenhouse gasses and mitigate effects of climate change. Professor Zorana Jovanovic Andersen, Chair of the European Respiratory Society’s Environment and Health Committee and based at the University of Copenhagen, was an author of the report, ‘Climate change and respiratory health: a European Respiratory Society position ...
- Source: drugdu
- 110
- September 5, 2023
Children participating in sports have better long term mental health

A study led by University of Queensland researchers has found children who regularly participate in sports from an early age will have better long term mental health. Associate Professor Asad Khan from UQ’s School of Health and Rehabilitation Sciences led the study, which analyzed the data of more than 4,200 Australian children over an eight-year period from the Longitudinal Study of Australian Children. Dr. Asad Khan (Associate Professor, UQ’s School of Health and Rehabilitation Sciences) said, “Consistent participation in sports from childhood is associated with better mental wellbeing amongst adolescents. Our research looked at the benefits of team sports such as football, cricket, or netball, and individual sports like karate, tennis, or gymnastics. We found there was a positive impact on mental health regardless of the type of sport, however children who played in a team experienced greater benefit. This could be due to the social aspects involved such as ...
- Source: drugdu
- 111
- September 5, 2023
BioNTech, DualityBio Move ADC into Phase III for HER2-Low Breast Cancer

By Kate Goodwin Pictured: 3D rendering of antibody-drug conjugate/iStock, Love Employee BioNTech’s licensed antibody-drug conjugate is moving on to Phase III testing in a potential effort to challenge AstraZeneca and Daiichi Sankyo’s blockbuster Enherto in a heavily treated breast cancer subpopulation. DualityBio, BioNTech’s partner and the ADC’s creator, posted the trial plans Wednesday. BioNTech added the ADC, DB-1303, to its portfolio in April 2023 when it paid China’s DualityBio $170 million upfront for rights to it plus a second preclinical asset. Another $1.5 billion is on the line in milestone payments, plus tiered royalties. DB-1303 will be pitted against chemotherapy in the open-label Phase III for patients with HER2-low, HR+ metastatic breast cancer patients whose disease has progressed despite endocrine therapy. ADC therapy is like a targeted missile for cancer, with an antibody targeted to deliver the cancer killing payload. DB-1303 is a topoisomerase-1 inhibitor. Phase I/II trial results showed ...
- Source: drugdu
- 110
- September 5, 2023
Bavarian Nordic Drops COVID Booster After Poor Phase III Results

By Connor Lynch Pictured: Syringe drawing up drug from vial/iStock, Kuzmik_A Bavarian Nordic is dropping its experimental, Phase III COVID-19 booster after clinical data showed limited effectiveness against new and emerging variants of concern. The Danish company announced that despite its COVID booster ABNCov2 demonstrating non-inferior levels of neutralizing antibodies as compared to Pfizer’s Comirnaty against the SARS-CoV-2 variant, the original COVID virus, the company would nevertheless not be pursuing commercialization of the vaccine. “In a follow-up analysis, when looking at this more distant variant, the levels of neutralizing antibodies induced by ABNCoV2 were lower than those stimulated by the non-adapted Wuhan-based Comirnaty, and fewer people had detectable antibodies following ABNCoV2 (64%) versus Comirnaty (85%),” the company said. The booster’s commercial viability was called into question because the new variants, such as XBB.1.5, are now the primary variants of concern. Bavarian Nordic said that the data “support the current position ...
- Source: drugdu
- 105
- September 5, 2023

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