PharmaFocus Today – Page 222 – media

Thermo Fisher to cut the lights at California plastics plant, lay off 74

After pumping millions into its manufacturing capacity to keep up with COVID-related demand and bolster longer-term efforts during the pandemic, Thermo Fisher is winding down operations for good at its Petaluma, California, plant and letting go of 74 employees in the process. The 74 layoffs will take effect on February 1, according to the state’s recent Worker Adjustment and Retraining Notification (WARN) update. The site itself will close its doors in July, a company spokesperson confirmed over email. Thermo Fisher’s ten-year lease on the property ends that month, according to the North Bay Business Journal. The decision to not renew the lease aligns with the company’s “ongoing effort” to “continuously evaluate its global operations to identify opportunities to improve efficiency and effectiveness in meeting our customers’ needs,” the spokesperson said. “Decisions that impact colleagues and their families are never taken lightly,” Thermo Fisher’s spokesperson added. “All impacted colleagues will receive ...
- Source: drugdu
- 120
- January 6, 2024
Inbound HCP communication channels double digital engagement, Veeva finds

Biopharma companies that provide healthcare professionals (HCPs) with compliant chat channels benefit from increased engagement, according (PDF) to Veeva Systems. Analyzing interactions captured in its customer relationship management platform, Veeva found HCPs start 30% of conversations with reps when a compliant chat channel is available. The software provider framed the use of the channels by HCPs in light of the rise of precision therapies, saying the focus on smaller patient populations means physicians have questions when they come to start patients on drugs. Inbound channels offer HCPs a way to get answers to questions about reimbursement, site certification and more. Veeva found that, on average, reps can respond to queries in compliant chat channels in less than five minutes and use the medium to arrange samples for new patient starts and schedule meetings. Text messaging and standalone chat apps may also support timely responses but in the view of Veeva, ...
- Source: drugdu
- 118
- January 6, 2024
Bluebird bio’s Lyfgenia launch progresses with 2nd major outcomes-based coverage deal

Despite competitive pressure from a buzzy CRISPR therapy, bluebird bio keeps striding forward with its sickle cell disease gene therapy Lyfgenia. The Massachusetts biotech has signed a second outcomes-based reimbursement agreement for Lyfgenia, according to a securities filing. The deal pushes Lyfgenia’s coverage range to nearly 200 million people in the U.S., up from the previous 100 million when bluebird signed the first agreement three weeks ago. Bluebird pulled off the feat within a month of winning FDA approval for Lyfgenia in SCD patients who have a history of the painful blood flow blockade episodes known as vaso-occlusive events. And it comes despite the company pricing Lyfgenia at a wholesale acquisition cost that’s about 40% higher than Vertex and CRISPR Therapeutics’ rival gene therapy Casgevy. Under these outcomes-based agreements, bluebird is offering a discount if a patient is hospitalized because of vaso-occlusion events within three years after treatment. In addition ...
- Source: drugdu
- 92
- January 6, 2024
Novo Nordisk, Eli Lilly’s weight-loss drugs under FDA scrutiny for suicidal thoughts, hair loss

Use of Novo Nordisk and Eli Lilly’s popular diabetes and weight loss drugs come with warnings about a rare intestinal blockage condition called ileus, which can be life threatening. Could cautions about more common side effects soon be added to the labels of popular treatments such as Novo’s Ozempic and Lilly’s Mounjaro? On Tuesday, the FDA revealed that it is investigating patient reports of suicidal thoughts and hair loss from the use of the blood sugar-modulating products. The U.S. regulator also is looking into cases of aspiration, a condition often associated with surgery in which people breathe food, liquids, vomit or saliva into their lungs. The investigation was triggered by information gathered on the FDA Adverse Event Reporting System (FAERS), a database that allows the regulator to track potential problems by collecting side effect reports from patients and healthcare providers. Each quarter, the FDA posts a list of drugs that ...
- Source: drugdu
- 105
- January 6, 2024
CVS Caremark to kick AbbVie’s Humira off some formularies in favor of cheaper biosimilars

This year, CVS Health plans to employ the classic “out with the old, in with the new” mantra when it comes to AbbVie’s Humira. Come April 1, the branded drug will be replaced by cheaper biosimilars across the company’s major commercial formularies nationwide. The move is part of CVS Caremark’s efforts to expand the adoption of biosimilars. As it stands, the U.S. biosimilar market is expected to grow from less than $10 billion in 2022 to more than $100 billion by 2029, CVS Caremark cited in a recent press release. The company is “committed” to ramping up adoption of the cheaper biologic drugs and enabling customer choice, CVS Health’s executive vice president and president of CVS Caremark David Joyner noted in a statement. “By preferring biosimilars that have a significantly lower list price than their reference product, CVS Caremark is putting our customers in the driver’s seat to best meet ...
- Source: drugdu
- 147
- January 6, 2024
Wearing hearing aids could extend people’s lifespan

Hearing loss affects approximately 40 million American adults, yet only one in 10 people who need hearing aids use them, research shows. Those who don’t use hearing aids but should may want to make wearing them one of their New Year’s resolutions, according to a new study from Keck Medicine of USC published today in The Lancet Healthy Longevity.  Janet Choi, MD, MPH, an otolaryngologist with Keck Medicine and lead researcher of the study said, “We found that adults with hearing loss who regularly used hearing aids had a 24% lower risk of mortality than those who never wore them. These results are exciting because they suggest that hearing aids may play a protective role in people’s health and prevent early death.” Previous research has shown that untreated hearing loss can result in a reduced life span (as well as other poor outcomes such as social isolation, depression and dementia). ...
- Source: drugdu
- 177
- January 5, 2024
AI Tool Rapidly Analyzes Gene Activities in Medical Images to Highlight Hidden Cancers

A novel artificial intelligence (AI) tool, designed to interpret medical images with exceptional clarity, is set to revolutionize the way clinicians approach disease diagnosis and image analysis. This advanced tool, named iStar (Inferring Super-Resolution Tissue Architecture), was developed by researchers at the Perelman School of Medicine at the University of Pennsylvania (Philadelphia, PA, USA). It can assist healthcare professionals in diagnosing and treating cancers that might otherwise remain undetected. iStar offers an in-depth view of individual cells and a broader look at the full range of human gene activity, potentially revealing cancer cells that were nearly invisible earlier. This tool could play a crucial role in confirming whether cancer surgeries have fully removed malignancies and provide automatic annotations for microscopic images, marking a significant leap toward molecular-level disease diagnosis. One of the standout capabilities of iStar is its automatic identification of crucial anti-tumor immune formations known as “tertiary lymphoid structures,” ...
- Source: drugdu
- 102
- January 5, 2024
FDA Fast Tracks Candel Therapeutics’ Novel Treatment for Pancreatic Ductal Adenocarcinoma

Pharmaceutical Executive Editorial Staff Study results show an estimated 71.4% survival rate after both 24 and 36 months with aglatimagene besadenovec (CAN-2409) in combination with valacyclovir for the treatment of patients with pancreatic ductal adenocarcinoma compared with 16.7% in the control group. The FDA granted Fast Track Designation to Candel Therapeutics, Inc’s aglatimagene besadenovec (CAN-2409) in combination with valacyclovir for the treatment of patients with pancreatic ductal adenocarcinoma (PDAC).1 The novel off-the-shelf therapy is administered by a localized injection that is believed to provide a safety benefit compared with standard systemic administration in this patient population. “We are pleased with the FDA’s decision to grant fast track designation for CAN-2409 in pancreatic cancer,” said Paul Peter Tak, MD, PhD, FMedSci, president and chief executive officer of Candel Therapeutics, in a press release.1 “This milestone follows our first interim data report from the randomized Phase II clinical trial in patients with ...
- Source: drugdu
- 186
- January 5, 2024
Goldman Sachs Closes $650M Fund to Invest in ‘Golden Era’ of Biotech Innovation

Goldman Sachs’s new fund—its first dedicated to life sciences—will focus on early- to mid-stage therapeutics companies with multiple assets. Genetic medicine, cell therapy, immunotherapy, and artificial intelligence are among the areas of investment interest for the firm. By FRANK VINLUAN Goldman Sachs Asset Management has expanded to biotech investments in recent years. The investment firm is now preparing to ramp up its investment activity in the sector with a new $650 million fund, its first dedicated to the life sciences. Goldman on Wednesday announced the final close of the new fund, called West Street Life Sciences I. About $90 million from this fund has already been committed to five biotech companies in its portfolio: MOMA Therapeutics, Nested Therapeutics, TORL Biotherapeutics, Septerna, and Rapport Therapeutics. With the new fund, Goldman said the focus will be on growth-oriented private equity investments in the life sciences, which it’s defining as early- to mid-stage ...
- Source: drugdu
- 169
- January 5, 2024
百济神州PD-1抑制剂百泽安®（替雷利珠单抗）在中国获批第12项适应症,用于肝细胞癌一线治疗

中国北京、美国麻省剑桥和瑞士巴塞尔——2024年1月2日——百济神州（纳斯达克代码：BGNE；香港联交所代码：06160；上交所代码：688235）是一家全球性生物科技公司。公司今日宣布其PD-1抑制剂百泽安®（替雷利珠单抗）新适应症已获中国国家药品监督管理局（NMPA）批准，单药用于不可切除或转移性肝细胞癌（HCC）患者的一线治疗。肝癌是中国常见的高发恶性肿瘤。2020年中国肝癌新发病例约41万，约占全球总数的一半；死亡病例约39.1万，是中国第二大肿瘤致死病因1。70%-80%的肝癌患者在诊断时已经是中晚期2，失去了手术或其他局部治疗机会，临床预后较差，5年生存率仅为12.1%3，亟需更多治疗手段改善患者生存。百济神州高级副总裁、全球研发负责人汪来博士表示：“中国的HCC发病率近年来持续上升，存在较大的未被满足的临床需求。此次获批是替雷利珠单抗在肝癌领域的又一突破性进展，丰富了晚期HCC患者的一线治疗选择。我们期待这一全新的治疗方案能够惠及更多肝癌患者，进一步提升肝癌患者的生存获益。” 本次获批是基于RATIONALE 301（NCT03412773）的临床试验数据。该试验是一项随机、开放性的全球3期临床研究，从亚洲、欧洲和美国各研究中心共入组674例患者，旨在评估替雷利珠单抗对比索拉非尼作为不可切除的HCC成人患者一线治疗的效果。此前，RATIONALE 301试验结果以最新突破口头报告的形式，公布于2022年在法国巴黎举办的欧洲肿瘤内科学会（ESMO）大会，并于今年荣登肿瘤领域著名期刊《美国医学会杂志-肿瘤学》（JAMA Oncology）。研究结果显示：与索拉非尼相比，替雷利珠单抗展示出在总生存期（OS）上的非劣效性结果。替雷利珠单抗的中位OS为15.9个月，而索拉非尼的OS为14.1个月；替雷利珠单抗具有更高的客观缓解率（ORR）（14.3% vs 5.4%）和更持久的缓解（中位缓解持续时间DoR分别为36.1个月和 11.0个月）；替雷利珠单抗和索拉非尼治疗的安全性特征与既往研究一致。中国药科大学附属南京天印山医院消化系统肿瘤首席专家和RATIONALE 301 试验的全球牵头研究者（Leading PI）秦叔逵教授表示：“RATIONALE 301是一项由中国专家主导的、具有前瞻性的、随机对照、全球多中心3期注册临床试验。在设计和优化研究方案阶段，就兼顾东、西方肝癌的高度异质性，同时充分结合中国国情、病人特点和实践经验；试验过程中科学实施，严格质控，数据翔实，从而获得了预期的结果，为晚期肝细胞癌患者的一线免疫治疗提供了新的选择和可靠的依据。” 秦教授进一步表示，“替雷利珠单抗在本项试验中，单药一线治疗肝癌即展现出优良的有效性、安全性和耐受性，带来了明显的生存获益，具有重要的临床价值。可以相信此次替雷利珠单抗获批一线治疗晚期肝细胞癌适应症后，除了可以单药使用，还将推动含替雷利珠单抗联合方案的临床应用及研究进展，为众多的肝癌患者带来生的希望。” 至此，替雷利珠单抗已有12项适应症获得NMPA批准，是目前在中国获批适应症数量最多的PD-1抑制剂，其中11项适应症已全部纳入国家医保药品目录，也是纳入国家医保药品目录获批适应症数量最多的PD-1抑制剂。网址： https://www.beigene.com.cn/pressreleases/%e7%99%be%e6%b5%8e%e7%a5%9e%e5%b7%9epd-1%e6%8a%91%e5%88%b6%e5%89%82%e7%99%be%e6%b3%bd%e5%ae%89%ef%bc%88%e6%9b%bf%e9%9b%b7%e5%88%a9%e7%8f%a0%e5%8d%95%e6%8a%97%ef%bc%89%e5%9c%a8%e4%b8%ad%e5%9b%bd/
- Source: drugdu
- 198
- January 5, 2024

your submission has already been received.

OK

Subscribe

Please enter a valid Email address！

Submit

The most relevant industry news & insight will be sent to you every two weeks.

more

more

Customer Services
Contact Us
Help Center

Buy on Drugdu.com
Browse Product Categories

Free APP

Follow Us

Terms & Conditions | Privacy Policy

粤ICP备16008861号

Copyright © 2016-2018 Drugdu.com. All Rights Reserved.