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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
- 119
- 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
New screening model shown to predict ten year breast cancer mortality risk

The University of Oxford’s Nuffield Department of Primary Care Health Sciences has successfully developed a new model to predict the likelihood of a person developing and dying of breast cancer within ten years. The new risk-based screening model works to identify those at the highest risk of deadly cancers. Despite the ability of breast cancer screening to reduce deaths, it can sometimes lead to unnecessary treatments due to overdiagnosis when innocuous tumours are detected. In the UK, for every 10,000 women aged 50 years invited to breast screening for the next 20 years, 43 breast cancer deaths will be prevented, but 129 will be overdiagnosed. Researchers analysed anonymised data from 11.9 million women aged 20 to 90 years between 2000 and 2020 from the OResearch database. The team tested four different modelling techniques to predict breast cancer mortality risk: two traditional statistical-based models and two artificial intelligence (AI) models, all ...
- Source: drugdu
- 108
- September 5, 2023
Sage Therapeutics Fires 40% Of Staff after FDA Rejected MDD Bid

Sage Therapeutics will reduce its workforce by 40% following the US Food and Drug Administration’s (FDA) rejection of its drug Zurzuvae (zuranolone) in adults with major depressive disorder (MDD). The US-based company will pause some undisclosed early-stage programs and focus instead on the refinement of its compounds SAGE-718 and SAGE-324, per the 31 August announcement. Sage’s leadership will also change with the departure of the current chief scientific officer (CSO) Al Robichaud and the chief development officer (CDO) Jim Doherty. The restructuring comes at a time when the company plans the commercial launch of Zurzuvae for treating postpartum depression which is expected in late 2023. On 4 August, the FDA approved Zurzuvae’s use in women with postpartum depression while simultaneously issuing a complete response letter (CRL) for the treatment’s use in MDD. The CRL stated that the drug’s application did not provide substantial evidence of effectiveness in MDD and that ...
- Source: drugdu
- 154
- September 5, 2023
Bayer bets big on Kerendia’s potential to treat heart failure

Approved two summers ago for chronic kidney disease (CKD) associated with type 2 diabetes, Bayer’s Kerendia (finerenone) isn’t off to the flying start expected of a potential blockbuster. In the second quarter, sales of Kerendia reached 67 million euros ($73 million). For Bayer to achieve its ambitious peak sales target of 3 billion euros ($3.3 billion), it will have to expand the label of the nonsteroidal mineralocorticoid receptor antagonist (MRA). To get there, Bayer is making a big play in heart failure. Thursday, the company said it’s planning three new phase 3 trials in the indication, in addition to one that’s already underway. The new studies will evaluate Bayer’s medicine in roughly 9,000 new heart failure patients with reduced, mildly reduced and preserved ejection fraction. The REDEFINE-HF trial will investigate finerenone as a monotherapy in approximately 5,200 patients with an ejection fraction of greater than 40%. The FINALITY-HF trial will ...
- Source: drugdu
- 108
- September 5, 2023
Amgen’s $28B Horizon buyout cleared for takeoff after FTC, states settle

After months of legal wrangling, Amgen is free to go forward with its $27.8 billion buyout of Horizon Therapeutics. Friday, the U.S. Federal Trade Commission (FTC) said it reached a proposed consent order with Amgen to address the “potential competitive harm” that could result from the merger deal. Alongside the FTC, attorneys general from six states—California, Illinois, Minnesota, New York, Washington and Wisconsin—are moving to dismiss their injunction requests. The FTC first filed its antitrust lawsuit against Amgen in May in an attempt to block the sale. In its suit, FTC argued that Amgen could leverage its lucrative product portfolio to “entrench the monopoly positions” of Horizon’s thyroid eye disease drug Tepezza and the company’s gout treatment Krystexxa. For its part, Amgen has promised not to use that tactic with Horizon’s drugs. In a press release Friday, the company said it “has consistently stated to the FTC, the courts and ...
- Source: drugdu
- 111
- September 5, 2023
【EXPERT Q&A】What are the regulations and requirements for exporting medical devices to the European Union?

Drugdu.com expert’s response: Entering the European Union market requires medical device products to adhere to a series of stringent regulations and quality standards. Firstly, products must obtain CE certification, a mark that signifies compliance with EU requirements for safety, health, and environmental protection. Before submitting an application, make sure that all relevant application forms are completed in detail, including key data such as product specifications and manufacturer information. Upon passing preliminary review, the product will be sent to an EU-designated third-party certification body for comprehensive and accurate testing and evaluation. This body will assess the product’s compliance with the EU Medical Device Directive (MDD) or Medical Device Regulation (MDR), depending on the case. After successfully completing the certification process, you will receive EU export product certification, an indispensable credential proving that your product can be legally sold in the EU market. It should be noted that due to the wide variety ...
- Source: drugdu
- 323
- September 5, 2023
European Union medical device regulations

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