PharmaFocus Today – Page 237 – media

Sanofi Issues Update on Shortages of Beyfortus for Respiratory Syncytial Virus

Pharmaceutical Executive Editorial Staff Due to a higher than anticipated demand, Sanofi is carefully managing distribution of 50 mg doses of Beyfortus in the private market to fulfill existing orders and provide equitable access to remaining doses for the vaccine that protects infants against respiratory syncytial virus. Sanofi has announced that a higher than expected demand for nirsevimab-alip (Beyfortus) 50 mg and 100 mg injection to protect infants against respiratory syncytial virus (RSV) has caused a change in the company’s distribution plan. Sanofi said it developed an aggressive supply plan to outperform prior launches of pediatric vaccines, but the demand exceeded the supply. Image credit: MargJohnsonVA | stock.adobe.com “We previously communicated that new orders for the 100 mg dose were no longer being accepted, as the demand exceeded the available supply for the season,” Sanofi said in a statement.1 “Currently, due to demand, we are carefully managing distribution of the ...
- Source: drugdu
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- November 9, 2023
Covera Health Acquires CoRead, Secures up to $50M To Improve Radiology

Covera Health has finalized its acquisition of CoRead, the companies announced last week but did not disclose the terms of the deal. Covera also announced that it raised up to $50 million in additional Series C funding led by Insight Partners. By MARISSA PLESCIA Covera Health, an AI-enabled diagnostic technology company focused on radiology, has finalized its acquisition of CoRead, an AI quality assurance company, the organizations announced last week. In addition, Covera Health has secured up to $50 million in additional Series C funding. New York City-based Covera Health works with providers to help them improve the quality of their radiology care and works with payers and employers to ensure that members and employees are directed to the best radiology provider for their needs. Its customers include Walmart, Premera Blue Cross and Nuance. CoRead, based in Cary, North Carolina, offers a solution that helps radiologists identify blindspots and misdiagnoses. ...
- Source: drugdu
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- November 9, 2023
FDA warns of hidden drug ingredients in Dr Ergin’s SugarMD

The US Food and Drug Administration (FDA) has issued a warning against the use of the glucose management product, Dr Ergin’s SugarMD Advanced Glucose Support. The regulator asked consumers not to buy and to immediately stop using the product, promoted and sold for blood glucose management due to hidden drug ingredients. Several SugarMD products are sold online on Amazon as supplements for those with type 1 and type 2 diabetes. One of the supplements, GlucoDefense to maintain glucose metabolism is advertised to produce “truly remarkable [results] within just 6 weeks”. In laboratory tests carried out by the FDA, active ingredients glyburide and metformin were confirmed to be present in the drug. Glyburide and metformin are in several FDA drugs used to treat type-2 diabetes that can only be obtained with a prescription. Both of these ingredients can pose a serious risk to consumers. Glyburide can result in unsafe drops in ...
- Source: drugdu
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- November 9, 2023
EU pharma legislation may bring ‘more harm than good’ to the region

Debates across Europe are needed to ensure that other global markets do not overtake it following the infamous EU Pharmaceutical Legislation, says Ricardo Marek, president of the Europe and Canada business unit at Takeda. Speaking at the opening day of the FT Global Pharma and Biotech Summit in London, Marek noted how the reformed legislation, which was released by the European Commission (EC) in April, will establish the next few decades of the European market. While the new legislation shifts focus to garnering equal access to new medicines across the EU, certain policies may stifle innovation in the region. For example, there will be a shorter regulatory data protection period, meaning generic drug makers will not be able to refer to innovator drug’s data to obtain marketing authorisation. Also, approved drugs must be launched in all EU countries within two years. In the panel “Macro Focus – How is Pharma ...
- Source: drugdu
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- November 9, 2023
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
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- 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
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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
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- 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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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

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