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J&J’s Darzalex Stays on its Upward Trajectory as Company Adds $1B to Annual Sales Projection

In 2017, when Genmab CEO Jan van de Winkel declared its multiple myeloma drug Darzalex—which is marketed by Johnson & Johnson—had the potential for peak sales of $13 billion, he relented that it was a best-case scenario.Six years later, that best-case scenario appears possible. On Thursday, J&J reported another quarter of strong sales for the monoclonal antibody. Darzalex generated $2.43 billion in the period, a 22% increase from the second quarter of last year. After realizing sales of $6 billion in 2021 and $8 billion last year, Darzalex is on track to approach revenue of $10 billion in 2023. The drug, which was approved in 2015, was boosted in 2020 with the development of Darzalex Faspro, a subcutaneous version of the treatment which allows patients to receive doses in minutes compared to hours for the previous intravenous administration. A year ago, J&J reported that 85% of patients receiving Darzalex were using Faspro. ...
- Source: drugdu
- 117
- July 24, 2023
Sandoz Invests $90m to Build a Biosimilar Centre in Slovenia

Sandoz has invested $90m to build a biopharma development centre in Ljubljana, Slovenia by 2026. The site will serve to develop biosimilar products and is expected to create 200 new jobs. This follows Novartis’ financial report stating $2.4bn in net sales for Sandoz biosimilars in Q2 2023, along with the proposed 100% separation of Sandoz from Novartis to form an independent company by the end of this year. The fully independent Sandoz will be headquartered in Basel, Switzerland, and listed on the SIX Swiss Exchange and American Depositary Receipt (ADR) programme in the US, as per a 1 June press release. To that end, the development centre is the company’s second major investment in Slovenia. In March, the Novartis spin-off announced plans to construct a biologics production plant in Lendava, Slovenia, to support the increasing product demand. According to a press release, Sandoz chief ...
- Source: drugdu
- 112
- July 24, 2023
J&J Exceeds Q2 Expectations, Oncology and Immunology Top Pharma Drivers

Pictured: Johnson & Johnson Sign in Silicon Valley/Shutterstock, Michael Vi Johnson & Johnson exceeded Wall Street expectations in its second quarter performance. The healthcare products giant posted sales of $25.5 billion in its earnings report on Thursday. Worldwide sales numbers reflected a 6.3% growth for J&J with revenue close to $1 billion higher than analysts expected, thanks in particular to a nearly 10% increase in its medtech sales. Medtech has been on the rebound since patients have returned to non-emergent surgeries like knee and hip replacements, which saw a significant drop during the pandemic. Operational sales for the company’s pharma arm, suffering growth points due to dwindling COVID-19 vaccine sales, was up 3.9%. The second quarter posted no U.S. sales of J&J’s COVID vaccine, with no domestic revenue expected beyond the $747 million from outside the U.S. reported last quarter. Its government contracts are now complete. Primary growth drivers were J&J’s oncology and immunology ...
- Source: drugdu
- 112
- July 24, 2023
GSK Returns Shigella Vaccine Candidate to LimmaTech as Drug-Resistant Cases Rise

Pictured: GSK headquarters office in Poland/iStock, Wirestock GSK has licensed out its Shigella vaccine candidate to LimmaTech Biologics, giving the Swiss biotech rights to further develop and eventually commercialize the quadrivalent bioconjugate investigational vaccine, the companies announced Thursday. LimmaTech is aiming to complete the Phase I/II clinical trial for this quadrivalent candidate and post data from this study within the year. The investigational Shigella shot joined GSK’s portfolio in 2015, when the pharma giant bought Swiss vaccine specialist GlycoVaxyn for $190 million. Aside from shigellosis, the disease caused by Shigella bacteria, GlycoVaxyn also handed over early-stage vaccines for pneumonia and infectious conditions caused by Pseudomonas bacteria and Staphylococcus aureus. LimmaTech spun out of this acquisition and started its operations in August of the same year. The clinical-stage biotech is focused on engineering complex carbohydrate molecules to come up with next-generation vaccine candidates. It has since signed partnerships with GSK for its Shigella and Klebsiella development programs. ...
- Source: drugdu
- 108
- July 24, 2023
Researchers Identify Genes that Directly Influence What We Eat

In one of the first large-scale studies of genes related to diet, researchers have uncovered almost 500 genes that appear to directly influence the foods we eat. The findings represent an important step toward using a person’s genetics to develop precision nutrition strategies that help improve health or prevent disease. “Some genes we identified are related to sensory pathways—including those for taste, smell, and texture—and may also increase the reward response in the brain,” said research team leader Joanne Cole, Ph.D., assistant professor in the Department of Biomedical Informatics at the University of Colorado School of Medicine. “Because some of these genes may have clear paths toward influencing whether someone likes a food or not, they could potentially be used to create sensory genetic profiles for fine-tuning a person’s dietary recommendations based on foods they like to eat.” For the study, the researchers used the UK ...
- Source: drugdu
- 105
- July 24, 2023
U.S. Healthcare Pandemic Recovery Requires Focused Support of Independent Primary Care

Independent primary care practices are at risk of extinction. The U.S. must re-dedicate itself to the preservation of independent primary care over the long run and must undergo a radical reorientation of the health system toward primary care. The first step to repairing the U.S. healthcare system is focusing on primary healthcare workers and restoring their under-resourced ranks. Evidence shows that primary care teams are capable of remarkable health improvements when appropriately trained, paid, and given the capacity to reach out to every population they serve. Primary health workers deliver nearly all the services responsible for longer lives, including those services for potentially stopping the next pandemic. They are the backbone of a functional and effective health system. They also play a vital role in closing gaps in access to other kinds of lifesaving care. And, for those segments of the population that remain underserved by the ...
- Source: drugdu
- 105
- July 24, 2023
Immune systems develop specific genes to fight against common bacteria, study finds

Immune systems develop specific genes to combat common bacteria such as those found in food, new research shows. Previous theories have suggested that antimicrobial peptides – a kind of natural antibiotics – have a general role in killing a range of bacteria. However, the new study, published in Science, examined how the immune systems of fruit flies are shaped by the bacteria in their food and environment. The researchers, from the Swiss Federal Institute of Technology and the University of Exeter, found two peptides that each control a single bacterial species commonly encountered by the flies. Dr Mark Hanson (Centre for Ecology and Conservation on Exeter’s Penryn Campus in Cornwall) said, “We know that an animal’s food and environment determine the bacteria it encounters. This in turn shapes its ‘microbiome’ – the collection of microbes that live in and on its body – and our study shows how immune systems ...
- Source: drugdu
- 132
- July 22, 2023
New ultra-flexible neural implant records single-neuron activity in deep-brain regions

A new ultra-small and ultra-flexible electronic neural implant, delivered via blood vessels, can record single-neuron activity deep within the brains of rats, according to new study. “This technology could enable long-term, minimally invasive bioelectronic interfaces with deep-brain regions, writes Brian Timko in a related Perspective. Brain-machine interfaces (BMIs) enable direct electrical communication between the brain and external electronic systems. They allow brain activity to directly control devices such as prostheses or modulate nerve or muscle function, which can help individuals with paralysis or neurological disorders regain function. However, most conventional BMIs are limited to measuring neural activity at the brain’s surface. Recording single-neuron activity from deep brain regions often requires invasive intracranial surgery to implant probes, which can result in infection, inflammation, and damage to brain tissues. An alternative approach to implanting bioprobes into deep-brain regions is via the brain’s vascular network. Here, Anqi Zhang and colleagues present ultra-flexible micro-endovascular ...
- Source: drugdu
- 110
- July 22, 2023
Novartis acquires DTx Pharma in deal worth up to $1bn

Novartis has announced its acquisition of DTx Pharma, a preclinical stage biotech focused on developing siRNA therapies for neuroscience indications, in a deal worth up to $1bn. The transaction gives Novartis access to DTx’s fatty acid ligand-conjugated oligonucleotide (FALCON) platform as well as its lead preclinical therapy for Charcot-Marie-Tooth disease type 1A (CMT1A). Approximately 150,000 people in the US and Europe are affected by CMT1A, a slow-progressing and degenerative disease of the peripheral nervous system. There are currently no approved treatments to address the underlying genetic cause of the condition: the over-expression of PMP22, a protein that causes the myelin sheath that supports and insulates nerves in the peripheral nervous system to function abnormally. DTx-1252, which was recently granted Orphan Drug Designation by the US Food and Drug Administration, decreases the expression of this protein. “The FALCON platform facilitates this targeted approach by conjugating siRNAs to naturally occurring fatty acids ...
- Source: drugdu
- 140
- July 22, 2023
AstraZeneca/Sanofi’s RSV antibody receives FDA approval for use in infants

AstraZeneca and Sanofi’s Beyfortus (nirsevimab) has been approved in the US for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) in newborns and infants born during or entering their first RSV season, the companies announced. The US Food and Drug Administration’s (FDA) decision makes the long-acting antibody the first preventive option approved to protect a broad infant population, including those born healthy at term, preterm, or with specific health conditions that make them vulnerable to severe RSV disease. The approval, which also applies to children aged up to 24 months who remain vulnerable to severe RSV disease through their second RSV season, was based on results from the Beyfortus clinical development programme spanning three pivotal late-stage clinical trials and follows a unanimous vote by the Antimicrobial Drugs Advisory Committee on the favourable benefit-risk profile of the drug. Across all clinical endpoints, a single dose of Beyfortus ...
- Source: drugdu
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- July 22, 2023

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