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Almirall granted EC approval for Ebglyss in moderate-to-severe atopic dermatitis

Almirall has announced that its IL-13 inhibitor Ebglyss (lebrikizumab) has been approved by the European Commission (EC) to treat moderate-to-severe atopic dermatitis. The regulator has specifically approved the drug as a treatment option for adult and adolescent patients aged 12 years and older with a body weight of at least 40kg and who are candidates for systemic therapy. Typically referred to as eczema, atopic dermatitis is a chronic, inflammatory disease of the skin characterised by recurrent inflammation associated with intense pruritus or itching. The incidence of atopic dermatitis appears to have increased in recent decades, currently affecting an estimated 4.4% of adults in the EU. The EC’s decision, which follows a recent recommendation from the European Medicines Agency’s human medicines committee, is supported by results from the late-stage ADvocate1 and ADvocate2 trials evaluating Ebglyss as a monotherapy in adult and adolescent patients with moderate-to-severe atopic dermatitis, as well as data ...
- Source: drugdu
- 97
- November 22, 2023
NeoImmuneTech bags orphan drug tag for IL-7 acute radiation syndrome treatment

The US Food and Drug Administration (FDA) awarded an orphan drug designation to NeoImmuneTech’s investigational drug for the treatment of acute radiation syndrome (ARS). The purpose of FDA orphan designation is to advance treatments for rare diseases like ARS. According to the Centers for Disease Control and Prevention (CDC), current treatments are geared towards preventing subsequent infections and treating infections and injuries. NT-17 (efineptakin alfa) (rhIL-7-hyFc) is a long-acting human IL-7 fusion protein designed to exceed the developmental and functional capabilities of endogenous IL-7 and comparatively amplify and enhance the T cell immune response. The drug, currently in preclinical development as a monotherapy, is expected to promote T-cell recovery by restoring lymphocyte levels and fortifying the body’s immune system after individuals are exposed to ionizing radiation. The clinical-stage biotechnology company is collaborating with the National Institute of Allergy and Infectious Diseases (NIAID) to evaluate the efficacy of NT-17 in treating ...
- Source: drugdu
- 97
- November 22, 2023
Senate Democrats press Sanofi and AZ for answers as ‘unprecedented’ demand spurs shortage of RSV antibody Beyfortus

The shortage of Sanofi and AstraZeneca’s new respiratory syncytial virus (RSV) antibody Beyfortus continues to confound doctors and patients, with the Centers for Disease Control and Prevention (CDC) last week fast-tracking tens of thousands of extra doses into circulation to deal with a tough RSV season. Now, several Senate Democrats are pressing the drugmakers to get to the bottom of the issue. In a letter sent to the drugmakers Friday, Sen. Tammy Duckworth, D-Illinois, lamented that Sanofi and AZ “seem to have vastly underestimated” the amount of Beyfortus—also known nirsevimab—needed to protect young kids during this disease season. The partners’ immunization, approved back in July, has quickly run into supply problems, with the CDC last month issuing an advisory for doctors to prioritize available Beyfortus 100-mg doses for infants at the highest risk of severe RSV. At the time, Sanofi attributed the shortfall to “higher than anticipated demand,” which has ...
- Source: drugdu
- 200
- November 22, 2023
FDA pushes back decision date on BMS, 2seventy bio’s Abecma in earlier line of treatment

It appears Bristol Myers Squibb’s multiple myeloma cell therapy Abecma will not end the year on a happy note. The company’s effort to gain approval for the CAR-T in an earlier line of treatment—previously set for an FDA decision on Dec. 16—will have to be pushed back pending an advisory committee meeting. BMS revealed on Monday that the FDA’s Oncologic Drug Advisory Committee (ODAC) will meet to discuss data from the KarMMa-3 study. The United States regulator has not identified a date for the meeting, BMS said. BMS and its partner on the drug, 2seventy bio, said in the release that they expect the meeting has been called to review overall survival (OS) data, which is a secondary endpoint of the phase 3 study. The companies added that the meeting will not impact Abecma’s approval for multiple myeloma as a fifth-line treatment. This is another blow to the CAR-T medicine, ...
- Source: drugdu
- 92
- November 22, 2023
Stem-cell-derived brain cells hold promise for Alzheimer’s, Parkinson’s research

Researchers at the University of Wisconsin–Madison have identified a protein key to the development of a type of brain cell believed to play a role in disorders like Alzheimer’s and Parkinson’s diseases and used the discovery to grow the neurons from stem cells for the first time. The stem-cell-derived norepinephrine neurons of the type found in a part of the human brain called the locus coeruleus may enable research into many psychiatric and neurodegenerative diseases and provide a tool for developing new ways to treat them. Yunlong Tao, an investigator at Nanjing University in China who was a research professor at UW–Madison’s Waisman Center when the study was performed, and Su-Chun Zhang, a UW–Madison professor of neuroscience and neurology, published their work on the cells, which they call LC-NE neurons, today in the journal Nature Biotechnology. Norepinephrine neurons in the locus coeruleus regulate heartbeat, blood pressure, arousal, memory, attention and ...
- Source: drugdu
- 115
- November 21, 2023
Antibiotic consumption in Europe rebounds to pre-pandemic levels

This year’s European Antibiotic Awareness Day (EAAD) focuses on the targets outlined in the 2023 Council Recommendation to step up efforts in the European Union (EU) against antimicrobial resistance in a One Health approach. Those recommendations formulate the 2023 goal to reduce total antibiotic consumption (community and hospital sectors combined) by 20%, using consumption data from 2019 as baseline. Consumption of antibiotics in the community accounts for around 90% of the total use. This means, that a substantial and consistent decline in the use of antibiotics in this sector will be key on the way towards reaching the set goals for 2030 which aim at preventing and reducing antimicrobial resistance overall. During the first year of the COVID-19 pandemic, data from the European Union (EU)/European Economic Area (EEA) showed an unprecedented 18.5% decrease in community consumption of antibiotics in 2020 compared with the 2019 baseline. This drop has been related ...
- Source: drugdu
- 109
- November 21, 2023
AstraZeneca’s AKT Inhibitor Wins FDA Approval for Combo Breast Cancer Treatment

By Tyler Patchen Pictured: AstraZeneca office in Gothenburg, Sweden AstraZeneca announced Friday that its adenosine triphosphate (ATP)-competitive inhibitor Truqap (capivasertib), in combination with its endocrine therapy Faslodex (fulvestrant), has been approved by the FDA to treat adults with hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer. According to AstraZeneca, the first-in-class inhibitor of all three AKT isoforms (AKT1/2/3) “has potential to reshape treatment for breast cancer patients” with specific biomarker alterations (PIK3CA, AKT1 or PTEN). The company also announced that the FDA has approved a “companion” diagnostic test meant to detect the “relevant” alterations. The FDA approval was based on the CAPItello-291 Phase III trial, which showed that the combination of Faslodex and Truqap reduced the risk of disease progression or death by 50%, compared to Faslodex alone, in patients with tumors having PI3K/AKT pathway biomarker alterations. “The combination of capivasertib and fulvestrant, a first-of-its-kind combination, provides a much-needed ...
- Source: drugdu
- 130
- November 21, 2023
Merck Expands Keytruda’s Label as a First-Line Option for Gastric Cancer

By Tristan Manalac Pictured: Merck Research Laboratories building in California The FDA on Thursday approved Merck’s anti-PD-1 blockbuster Keytruda (pembrolizumab) for the first-line treatment of adult patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma. Thursday’s label expansion is Keytruda’s seventh approval in gastrointestinal cancer and its 38th indication overall in the U.S., according to Merck’s announcement. This latest approval covers patients with HER2-negative cancers and authorizes the use of the PD-1 blocker in combination with fluoropyrimidine- and platinum-containing chemotherapy. Previously, Keytruda was indicated for gastric cancer only in patients who had progressed after at least two prior lines of systemic therapy, including fluoropyrimidine- and platinum-containing chemotherapy. Marjorie Green, senior vice president and head of late-stage oncology, global clinical development at Merck Research Laboratories, in a statement called Keytruda’s label expansion an “important milestone” in the care of gastric or gastroesophageal junction adenocarcinoma. Data from the Phase ...
- Source: drugdu
- 101
- November 21, 2023
New York Proposes Regulations For Stronger Hospital Cybersecurity

New York Governor Kathy Hochul released a proposed set of cybersecurity regulations that require hospitals to establish new policies and procedures to protect themselves from ever-intensifying cyber threats. The state also put aside $500 million in funding to help hospitals upgrade their technology systems to comply with these new rules. By KATIE ADAMS If newly proposed regulations are finalized in New York, hospitals in the state will soon have to beef up their cybersecurity measures. This week, New York Governor Kathy Hochul released a proposed set of cybersecurity regulations that require hospitals to establish new policies and procedures to protect themselves from ever-intensifying cyber threats. The governor’s budget for next year includes $500 million in funding to help hospitals upgrade their technology systems to comply with these new rules. Some experts think the proposed rules will serve as a blueprint for other states to draft similar sets of regulations. New ...
- Source: drugdu
- 106
- November 21, 2023
Eli Lilly Plans New $2.5B Manufacturing Site in Germany for Injectable Meds

The German manufacturing site is the latest capital infrastructure move for Eli Lilly, which has already made $11 billion in investments in its global manufacturing capabilities in the past three years. The new site will help Lilly meet strong demand for its diabetes and obesity drugs. By FRANK VINLUAN Eli Lilly’s cardiometabolic drug portfolio is expanding with newly approved therapies. To meet demand for those therapies and additional products to come, the company is building a new $2.5 billion manufacturing site in Germany. Construction on the new plant is on track to begin next year. Lilly expects the site will start operations in 2027, becoming its sixth manufacturing site in Europe. The company said it has invested more than $11 billion in its global manufacturing capabilities in the past three years to support the production of medicines across its portfolio. Some of Lilly’s capital investments have been closer to the ...
- Source: drugdu
- 106
- November 21, 2023

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