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 ...
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, ...
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 ...
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 ...
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 ...
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). ...
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,” ...
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 ...
BIO-THERA Biopharmaceutical Co., Ltd (SSE: 688177), a global science-based and innovative biopharmaceutical company based in Guangzhou, China, hereinafter referred to as “BIO-THERA” or the “Company”, today announced that it has entered into a license and commercialization agreement with Macter International Limited (“Macter”) for BAT1706, an Anviva reference product. The Company announced today that it has entered into a license and commercialization agreement with Macter International Limited (“Macter”) for BAT1706, a biosimilar developed with reference to Avastin® bevacizumab. Under the terms of the agreement, Macter will have exclusive distribution and marketing rights for BAT1706 in Pakistan and Afghanistan. BAT1706 has completed global Phase III clinical studies, demonstrating a high degree of safety, efficacy, and immunogenicity similarity to the originator, and BAT1706 (PuperChi®) has been approved for marketing by the National Drug Administration (NMPA) of China in November 2021, and BAT1706 (Avzivi®) has been approved for marketing by the U.S. Food and ...
Shanghai, China, January 3rd, 2024 – Shanghai Henlius Biotech, Inc. (2696. HK) announced that the latest clinical data of two Henlius products, HLX22, an innovative anti-HER2 mAb, and the approved anti-PD-1 monoclonal antibody (mAb) HANSIZHUANG (serplulimab), will be presented in posters at the 2024 ASCO Gastrointestinal Cancers Symposium (ASCO GI) in San Francisco, United States from January 18-20. HLX22 is an innovative anti-HER2 mAb that was introduced from AbClon, Inc. and further researched and developed by Henlius. HLX22 can bind to HER2 subdomain IV at a different binding site from trastuzumab, which allows the simultaneous binding of HLX22 and trastuzumab to HER2. The pre-clinical studies showed that the combination therapy of HLX22 and trastuzumab would inhibit the cell proliferation induced by epidermal growth factor (EGF) and Histidine-Rich Glycoprotein 1 (HRG1) and enhance the antitumor activity in vitro and in vivo. The phase 1 clinical trial of HLX22 demonstrates that HLX22 ...
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