Search Results for “GSK ” – Page 11 – media

UK charities condemn continued drug shortages

Ahandful of UK charities and community pharmacists urged the UK government to find a fix for the ongoing drug shortage issue to prevent further patient suffering. The UK Epilepsy Society, SUDEP Action, Epilepsy Action and Parkinson’s UK, joined forces to call for a meeting with the Health Secretary, Victoria Atkins. The Association of Independent Multiple Pharmacies (AIMp) found that community pharmacists are spending an average of two hours every day to find patients’ medications due to the disruptions. In a 11 April press release, Dr. Leyla Hannbeck, AIMp’s CEO, said, “The system is overly complex and shrouded in secrecy – what we need is openness and transparency. Pharmacists are in the same position as patients – we are at the end of the supply chain but are the last people to find out about medication shortages. Consequently, we are unable to plan in advance and support the people who rely ...
- Source: drugdu
- 160
- April 16, 2024
Candel wins FDA orphan drug designation for pancreatic cancer drug

The US Food and Drug Administration (FDA) has granted Candel Therapeutics’ immunotherapy candidate CAN-2409 (aglatimagene besadenovec) orphan drug designation for the treatment of pancreatic cancer. Orphan drug designations are granted to medicines intended to treat rare conditions and come with benefits such as tax credits for US-based clinical trials and potentially seven years of market exclusivity in the designated indication upon agency approval. Pancreatic cancer is one of the most lethal forms of cancer, with a survival rate beyond ten years of around 5%. CAN-2409 was also granted fast track designation in pancreatic cancer by the FDA in December 2023, meaning the candidate is in line for expedited development and review times. CAN-2409 is an off-the-shelf immunotherapy that is a combination of a genetically modified adenovirus and the herpes simplex virus thymidine kinase (HSV-tk) gene. The drug works by inducing T cell response at both the targeted tumour and at ...
- Source: drugdu
- 74
- April 16, 2024
ViiV Healthcare Reveals Positive Results from Phase I Trial for a Potential Longer-Acting HIV Treatment

Don Tracy, Associate Editor Novel formulation of cabotegravir (CAB-ULA) allows for dosing intervals of at least four months.Image Credit: Adobe Stock Images/alexskopjeViiV Healthcare has announced promising results from a Phase I study on a new formulation of cabotegravir (Apretude), known as cabotegravir ultra long-acting (CAB-ULA) for HIV pre-exposure prophylaxis (PrEP). Findings suggested that CAB-ULA is well-tolerated and has a pharmacokinetic profile supportive of extended dosing intervals. According to a company press release, the formulation allows dosing intervals of four months, resulting in a reduction of clinical visits for HIV patients.1 “The HIV community has told us of their desire for longer-acting medicines that can help alleviate the burden of daily treatment,” said Kimberly Smith, MD, MPH, head of research and development, ViiV Healthcare, in the press release. “ViiV Healthcare is a pioneer and leader in the development of long-acting HIV medicine, having already brought innovations through injectable therapies to the ...
- Source: drugdu
- 78
- March 8, 2024
Changing protocol language and site actions are key to making trials inclusive

Changing the language used in trial protocols and continually conversing with sites are some ways by which trialists can make clinical research more inclusive of the LGBTQIA+ community, say experts. On the fourth and final day of the 2024 Summit for Clinical Ops Executives (SCOPE) Summit held in Orlando, a panel discussed the most important changes that can make clinical trials more inclusive of the community. Shir Netanel, associate director of patient advocacy and clinical trial advocacy for Janssen, spoke about her experience with the company launching a transgender-inclusive Phase III trial for prostate cancer. Netanel mentioned how changing the language to be gender neutral, for example, allowed the protocol and eligibility criteria to include any patients who are affected with prostate cancer, regardless of their gender. Additionally, Janssen has also created and deployed a toolkit at trial sites to help investigators be more inclusive, she added. Michel Reid, head ...
- Source: drugdu
- 98
- February 16, 2024
Across 25 industries, pharma staffers most satisfied with compensation

2023 was riddled with labor strikes across industries as workers lobbied for higher pay amid economic headwinds that shook up the global economy. As for the biopharma industry, employees are more content with their income compared with workers in other fields, a new report suggests. USA Today recently analyzed more than 3 million reviews on the employee review service Glassdoor, focusing on 500 large companies in 25 industries and seeking to identify the industries with the highest number of pay-related complaints. Employees in the pharma and biotechnology sector reported the fewest number of pay complaints, according to the report. On the flip side, the healthcare field took the second-highest position for pay frustration, second only to education. Some drugmakers in particular rose above their peers and others in terms of pay. Novartis, GSK, AstraZeneca and Genentech made the list of the top-10 companies overall where employees are most satisfied with ...
- Source: drugdu
- 94
- January 21, 2024
Bayer’s Cost-Cutting Plans Take Aim at Multiple Layers of Management

CEO Bill Anderson said despite prior cost-cutting measures, Bayer still has too many layers of management and bureaucracy. A new restructuring will come with layoffs but the corporate shakeup plan does not yet include a separation of Bayer’s business units. By FRANK VINLUAN Bayer is implementing a corporate restructuring that will slash an unspecified number of jobs, particularly within management. But the strategy does not include a breakup of the conglomerate—at least not yet. In announcing its new strategy late Wednesday, Bayer said it aims to reduce hierarchies and eliminate bureaucracy in the company. The job cuts will happen over the coming months and will be completed by the end of next year at the latest, the company said. Bayer’s corporate shakeup is not entirely a surprise. CEO Bill Anderson, who joined Bayer last June after serving as the chief executive of Roche’s pharmaceuticals division, has been critical of bloat ...
- Source: drugdu
- 118
- January 20, 2024
J&J, AZ/Daiichi Sankyo cancer therapies lead Clarivate’s annual rundown of notable new meds

Two cancer therapies have topped Clarivate Analytics’ Drugs to Watch in 2024, an annual report that identifies potential blockbusters and other medicines that could “transform treatment paradigms.” Clarivate predicts Johnson & Johnson’s combination treatment Akeega and Daiichi Sankyo and AstraZeneca’s datopotamab deruxtecan will generate $2.7 billion in sales each in 2029. On the list of 15 transformative medicines, these are the only ones expected to exceed $2 billion in sales by 2029. Clarivate’s report, which is in its 12th year, highlights drugs that have recently been approved or are expected to be approved in 2024. Its sales estimates cover the G7 countries—U.S., U.K., Japan, France, Italy, Germany and Canada. J&J was the only company with more than one drug on the list. Clarivate also spotlighted J&J’s Talvey, a first-in-class bispecific antibody to treat multiple myeloma. The analysts forecast Talvey’s sales will reach $850 million in 2029. The only other cancer ...
- Source: drugdu
- 151
- January 19, 2024
Pfizer CEO promises ‘year of execution’ after recent struggles, Seagen buyout

Pfizer knows it had a bad year in 2023. Speaking to reporters at the 2024 J.P. Morgan Healthcare Conference on Monday, the company’s CEO, Albert Bourla, spoke bluntly about the hits the company took, and he acknowledged the underperformance of certain key launches. But 2024 represents a fresh opportunity for the pharma giant, Bourla said. “In essence, you should expect 2024—after all the changes in the setup that we did in year ’23—to be a year of execution,” he told the JPM audience. Pfizer will attempt to execute, in part, by leveraging its recent $43 billion buyout of antibody-drug conjugate specialist Seagen, Bourla explained. Further, the company hopes to advance its presence in respiratory syncytial virus (RSV), where Pfizer recently launched its vaccine Abrysvo. Still, Bourla was frank about the challenges Pfizer faced in 2023. “The year for us, we missed our internal projections. And also we missed the expectations ...
- Source: drugdu
- 92
- January 13, 2024
Nucala® (Mepolizumab Injection) Approved for the Treatment of Severe Eosinophilic Asthma in China

GlaxoSmithKline (“GSK”) announced that NMPA has recently approved Nucala® (Mepolizumab injection) for the maintenance treatment of severe eosinophilic asthma (SEA) in adults and adolescents aged 12 years and above. Nucala® is the first targeted human anti-interleukin-5 (IL-5) monoclonal antibody biologic in China for this indication. Asthma is a major health burden in China, where approximately 46 million adults suffer from asthma. About 6% of them have severe asthma, which can cause an increased risk of acute exacerbations requiring hospitalization and even potentially fatal asthma attacks. The daily lives of people with severe asthma are severely affected and treatment is costly. In China, 15.5% of people with asthma have experienced an exacerbation requiring hospitalization in the past 12 months. The Guidelines for the Prevention and Management of Bronchial Asthma (2020 edition), developed by the Chinese Medical Association’s Section of Respiratory Diseases, cites an unmet need for treatment of this disease in ...
- Source: drugdu
- 144
- January 12, 2024
Pfizer PARP inhibitor Talzenna nabs EU combo nod

• Pfizer’s PARP inhibitor Talzenna has gained European approval when used in combination with Pfizer and Astellas’ Xtandi to treat adult patients with metastatic castration-resistant prostate cancer (mCRPC) in whom chemotherapy is not clinically indicated. This approval makes Talzenna the first PARP inhibitor in Europe to be licensed in combination with Xtandi in mCRPC, Pfizer said in a release. The European Commission approved Pfizer’s application based on data from the phase 3 TALAPRO-2 trial, which showed that the combo cut the risk of disease progression or death in patients with mCRPC compared with placebo and Xtandi. Last June, the FDA approved the combination to treat adults with HRR gene-mutated mCRPC. • In another regulatory win for Pfizer, the FDA is reviewing the company’s full approval application on Genmab-partnered Tivdak. Under its priority review timeline, the FDA is assessing whether to convert Tivdak’s accelerated approval into a full nod to treat ...
- Source: drugdu
- 124
- January 11, 2024

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