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AbbVie, AstraZeneca, Boehringer and more face FTC’s ire for ‘improper’ patent listings

Only two months after the Federal Trade Commission (FTC) said it was eyeing a crackdown on “improper” patents listed at the FDA, the agency has filed a challenge against more than 100 patents in the agency’s Orange Book. The patents cover drugs marketed by the likes of AbbVie, AstraZeneca, Boehringer Ingelheim, GSK and Teva, among other companies, the FTC said in a Tuesday release. In all, the commission has sent letters to 10 companies notifying them of the patent disputes. The FTC argues “improper” listings in the FDA’s Orange Book—the registry of patents on approved medicines—can throw up hurdles to competition in the drug industry. Specifically, improper patents can trigger regulatory delays for would-be generics challengers and throw up legal hurdles for generics players, the commission says. Some of the medicines targeted in this crackdown include AbbVie’s Restasis and Viatris’ EpiPen autoinjectors. As the antitrust agency points out, FDA regulations ...
- Source: drugdu
- 91
- November 9, 2023
New UK research institute launched for motor neurone disease

A new research institute in London has been launched aimed at discovering a cure and new treatments for motor neurone disease (MND). The UK Motor Neuron Disease Research Institute (UK MND RI) will bring together a virtual network of MND labs, clinical centres and researchers to carry out MND research across the UK. Affecting one in every 300 people in the UK, MND is a neurodegenerative disease which affects the nerve cells in the brain and spinal cord. Around one-third of patients with MND die within one year of diagnosis, and more than half within two years. Currently, Sanofi’s Rilutek (riluzole) is the only licenced drug for MND in the UK. Collaboratively, doctors, clinicians, scientists and people living with MND, along with funders and charities, will work to speed up drug discovery and drug development and aim to test potential treatments in clinical trials. LifeArc, the MND Association, MND Scotland, ...
- Source: drugdu
- 92
- November 9, 2023
Siemens Healthineers to lay off 300 workers, move some manufacturing to Ireland

Dive Brief Siemens Healthineers plans to lay off 300 workers amid a restructuring of the company’s diagnostics business, according to a filing last week with the New Jersey Department of Labor & Workforce Development. The filing represented 180 new layoffs and 120 layoffs announced in June, a Siemens spokesperson said in an emailed statement. The company also plans to consolidate some of its instrument manufacturing operations conducted in Flanders, New Jersey, to Dublin by September 2024. The spokesperson did not comment on whether the company expects to save money with the moves, writing that if Siemens makes any figures public, it will happen on its fourth-quarter earnings call on Wednesday. Dive Insight Siemens has been restructuring its diagnostics segment after telling investors last year that the business has been burdened by inflation, logistical and supply challenges and revenue hits due to the COVID-19 pandemic. The company announced it would cut ...
- Source: drugdu
- 98
- November 8, 2023
Enhanc3D Genomics expands leadership team with the appointment of Hazel Jones as Chief Operating Officer

Enhanc3D Genomics, a company developing disruptive technologies to unlock the 3D spatial genome for target and biomarker discovery, today announced the appointment of Hazel Jones as Chief Operating Officer. Following a £10 million Series A financing in October 2022, Hazel’s appointment is the next step in the Company’s drive to broaden the application of its technology and secure strategic collaboration agreements with pharmaceutical partners. Hazel’s new role involves leading, scaling, and growing the Company’s global business operations. She will play an instrumental part in delivering the Company’s strategy to commercial and academic partners. Her responsibilities also include long-term strategic planning of logistics and managing alliances with stakeholders. Hazel has over 10 years of senior leadership experience in oncology research. She has significant expertise in working across functions to develop effective partnerships aligned with complex operational procedures. This delivers clear business objectives and maximizes the outcome of partnerships to advance disease ...
- Source: drugdu
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- November 8, 2023
Apellis parries Astellas’ long-term Izervay data with 3-year results on its rival GA med Syfovre

After this summer’s FDA approval of Iveric Bio’s Izervay—the drug at the center of the $5.9 billion buyout by Japanese pharma Astellas—the battle for the geographic atrophy (GA) crown is on in the U.S. Now, Apellis Pharmaceuticals, which boasts embedded eye disease sales leader Syfovre, is putting up long-term data in a bid to outdo its new rival. Touting data from its GALE extension study, Apellis on Saturday said Syfovre yielded increasing treatment effects year over year and helped patients achieve more than a 40% reduction in non-subfoveal lesion growth at the study’s three-year mark. Apellis rolled out the latest GALE results as part of a presentation at this year’s meeting of the American Academy of Ophthalmology (AAO) in San Francisco. The timing coincides with the release of two-year data on Astellas and Iveric’s GA drug Izervay—also at AAO—which suggest the rival drug’s treatment benefit emerged in as few as ...
- Source: drugdu
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- November 8, 2023
Candel announces promising results for immunotherapy candidate in pancreatic cancer

Candel Therapeutics has announced positive results from a mid-stage trial of its viral immunotherapy candidate in non-metastatic pancreatic cancer. The ongoing phase 2 trial has been evaluating the candidate CAN-2409 plus valacyclovir together with standard of care (SoC) chemo-radiation followed by resection in patients with borderline resectable pancreatic ductal adenocarcinoma (PDAC). Interim results demonstrated an estimated survival rate of 71.4% at months 24 and 36 months in patients who received the CAN-2409 regimen prior to surgery, compared to 16.7% in those receiving SoC chemo-radiation alone. Five out of seven patients who received CAN-2409 were still alive at the time of the data cut-off, with two patients surviving more than 45 months from enrolment, while only one patient randomised to control SoC chemotherapy remained alive at the data cut-off. A “consistent and robust activation of immune response” was also observed after dosing with CAN-2409, the company said, and that the candidate ...
- Source: drugdu
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- November 8, 2023
Eli Lilly doubles down on obesity pipeline’s potential

Amidst the rapidly growing revenue share of metabolic disease drugs in its pipeline, Eli Lilly is looking to delve deeper into its pharmaceutical exploration of obesity therapeutics, said medical director Axel Haupt. Haupt was speaking at a panel at the ongoing Bio-Europe 2023 conference, where he said drugs like Lilly’s Mounjaro (tirzepatide) carry potential to be used in for several conditions. The US Food and Drug Administration approved Eli Lilly’s Mounjaro for diabetes in May 2022, followed by the European Union in September 2022. The drug is administered via injection in a once-weekly regimen. Haupt revealed that an FDA approval for Mounjaro for treating obesity could be expected within the next 12 months. Obesity and diabetes treatment would likely not be the only use for Mounjaro, given the presence of GIP receptors in other locations like the adipose tissue, Haupt said. Eli Lilly sees potential use for the drug in ...
- Source: drugdu
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- November 8, 2023
NRx and Nephron join hands to formulate ketamine for depression

NRx Pharmaceuticals and Nephron Pharmaceuticals have come together in a bid to develop the first FDA-approved intravenous ketamine treatment for suicidal depression. The partnership will see NRx developing the drug while giving Nephron the responsibility of manufacturing the product. As per chief scientist and director Dr. Jonathan Javitt, NRx aims to deliver a two-year shelf-stable ketamine formulation to patients by November 2024. Nephron is in the process of setting the stage for submitting an New Drug Application (NDA) to the US Food and Drug Administration (FDA) for the drug. The target deadline for filing the application is 1 March, 2024, said Nephron CEO Lou Kennedy. According to the US Centers for Disease Control and Prevention (CDC), suicide rates have risen by approximately 36% from 2000-2021, with suicide being the second leading cause of death in 2021 for individuals in the age groups of 10 –14 years and 20 –34 years. ...
- Source: drugdu
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- November 8, 2023
Align Technology makes $100M open market stock repurchase

BY SEAN WHOOLEY Align Technology (Nasdaq:ALGN) announced today that it plans to repurchase $100 million of its own common stock. Tempe, Arizona-based Align Technology’s open market repurchase falls under its $1 billion stock repurchase program. The company’s board approved the program in January 2023. Align Technology executed a $250 million repurchase in February of this year with Citibank. Last month, the company triggered another $250 million repurchase in an accelerated program. As with other repurchase efforts, Align Technology President and CEO Joe Hogan intends to personally purchase $1 million in common stock. He did the same in the company’s accelerated program last month. The company expects to complete the repurchases by mid-December 2023, funding them with cash on hand. As of Sept. 30, 2023, it had approximately 76.6 million shares outstanding with $1.3 billion in cash on hand. “Invisalign is the most trusted brand in the Orthodontic industry globally and ...
- Source: drugdu
- 133
- November 8, 2023
RCM Staff Shortages Are Making It a Lot Harder for Providers to Get Paid

Discussions around healthcare’s workforce crisis usually center around providers’ lack of clinicians, but there’s a sweeping shortage of revenue cycle workers, too. In a new report, Experian Health surveyed 200 employees who are responsible for staffing the revenue cycle function at providers — every respondent said that staff shortages are having a significant negative impact on their organization’s ability to get paid for care and/or patient engagement. By KATIE ADAMS Healthcare’s workforce shortage is one of the most pressing — perhaps the most pressing — issue plaguing the industry. Discussions around this topic usually center around providers’ lack of physicians and nurses, but there’s a sweeping shortage of front and back office staff members, too. Experian Health, a company that sells revenue cycle management and patient engagement technology to providers, released a report last week shining light on this issue. To understand more about the healthcare sector’s workforce shortage among ...
- Source: drugdu
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- November 8, 2023

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