Immunology

A new foundation model called GREmLN from a Columbia and Chan Zuckerberg Biohub team, delivers superior cell-type classification with only 10.3 million parameters, outpacing rivals like the 100-million-parameter scFoundation. Released July 9 on bioRxiv, it taps gene regulatory networks to achieve a 0.929 macro F1 score on immune cell data. “Instead of using large language…

Nektar Therapeutics’ (NKTR) stock has skyrocketed 287% over the past five days to $33.20 after its experimental drug rezpegaldesleukin hit all primary endpoints in a Phase 2b atopic dermatitis trial, prompting H.C. Wainwright to raise its price target to $120 from $6.50, a 1,746% increase. This represents one of the largest single-day gains in the…

Dupixent (dupilumab) has been approved by the FDA for the treatment of adult patients with bullous pemphigoid (BP), a chronic autoimmune skin disorder, Sanofi announced Friday. Dupixent is now approved to treat eight diseases with underlying type 2 inflammation and is the only targeted medicine for the treatment of BP.  FDA approval based on clinical…

Earlier this year, at the JP Morgan Healthcare conference, Regeneron CEO Leonard Schleifer referred to Dupixent (dupilumab), the fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways, as “a pipeline in a single product.”  The drug, co-developed by Sanofi and Regeneron, is following a similar course to AbbVie’s…

Health and Human Services Secretary Robert F. Kennedy Jr. announced eight new members to the CDC’s advisory committee on immunization practices on Wednesday, just two days after he removed all 17 sitting members.  Kennedy announced on X that he is appointing Joseph R. Hibbeln, MD; Martin Kulldorff, MD, Ph.D.; Retsef Levi, Ph.D.; Robert W. Malone,…

Merck announced yesterday that the FDA has approved ENFLONSIA (clesrovimab-cfor), a preventive monoclonal antibody, for the prevention of RSV lower respiratory tract disease in newborns and infants entering their first RSV season.  ENFLONSIA is the only RSV preventative option that is administered with the same 105 mg dose regardless of the patient’s weight. It is…

Respiratory syncytial virus (RSV) already represents a blockbuster business with Sanofi reporting that Beyfortus (nirsevimab) hit global sales of €1.7 billion (roughly $1.77 billion) in its first full year on the market in 2024. Beyfortus protects infants from lung infections caused by RSV Beyfortus can help prevent a serious lung disease associated with RSV in…

Just over three-quarters, 76%, of patients receiving Sanofi and Regeneron’s Dupixent (dupilumab) achieved at least a 75% improvement in overall disease severity (EASI-75), the primary endpoint of the DISCOVER Phase 4 study.   The study, presented at the Revolutionizing Atopic Dermatitis Conference in Nashville, focused on patients with moderate-to-severe atopic dermatitis with skin of color.  Unmet…

At next week’s National Biotechnology Conference, Berlin-based clinical research firm CheckImmune GmbH will showcase how layering single-cell multi-omics provides insights into drug action and immune responses that bulk readouts (averaged measurements from a large population of cells) often miss. In rapid-fire talks on May 6, the Berlin startup will show how single-cell multiomics and spatial…

Digital pathology software developer Proscia raised $50 million in new funding to accelerate the adoption of its AI-powered pathology platform. The Series C fundraising round was led by Insight Partners, with participation from AI Capital Partners, Triangle Peak Partners and several other healthcare-focused investors. The financing brings Proscia’s total capital raised to $130 million. Proscia…

Current RA treatments, while effective for some, often fall short of providing long-term remission owing to the disease’s complexity, leaving many patients cycling through therapies like methotrexate and biologics without sustained relief. Here, rosnilimab stands out as novel by targeting the PD-1 pathway, aiming to reset the immune system through the selective depletion of pathogenic…

After several muted years, the 2025 J.P. Morgan Healthcare Conference signaled a return to big-ticket deals. J&J’s proposed $14.6 billion acquisition of Intra-Cellular Therapies and GSK’s $1 billion purchase of IDRx catapulted this year’s meeting to the largest M&A showing since at least 2019. But behind those high-profile acquisition announcements, JPM speakers and insiders also…

To the untrained eye, psoriasis might look like a simple skin condition, marked by itching, scaly patches. Yet psoriasis is an immune-mediated disease with systemic consequences. As Dr. Graham Heap, vice president and global program leader at Takeda, explained during a recent interview, “Psoriasis might manifest as plaques on the skin, but it’s an immune…

YTD 2024 FDA approvals: By the numbers 44 Novel Drug Approvals As of December 5, 2024, the FDA had approved a total of 44 novel drugs, spanning a diverse array of therapeutic areas and patient populations. These new treatments address both widespread public health concerns, such as cardiovascular disease and COPD, and more narrowly defined…

For millions living with rheumatoid arthritis (RA), the path to effective treatment is often a frustrating cycle of trial and error. Typically beginning with disease-modifying antirheumatic drugs (DMARDs) like methotrexate, the goal is low disease activity. Yet RA’s heterogeneity means many patients cycle through various therapies—biologic DMARDs like anti-TNF agents, JAK inhibitors, IL-6 receptor antagonists,…

Introduction Endometriosis is a chronic incurable gynecological condition with cyclical pelvic pain, heavy bleeding, infertility, and reduced quality of life as its main manifestations. Almost half of women with it experience infertility. [1] No symptoms are specifically pathognomonic or characteristic of endometriosis. Often referred to as a ‘silent disease’ because of how often the diagnosis…

Boston-based DeepCure may be an AI-focused biotech, but it sets itself apart by focusing its AI-powered platform on historically challenging drug targets that have eluded traditional approaches. “While AI in drug discovery is often viewed as a means to accelerate and reduce costs, our focus at DeepCure is on achieving true novelty in drug development…

Immunotherapies, including cellular immunotherapies, have dramatically impacted the treatment of cancer. Recent advances in the field, such as autologous (patient-derived) chimeric antigen receptor (CAR)-T cell therapies, have yielded remarkable results in relatively rare blood-based cancers. These results have driven an explosion in the research and development of different cellular products, including both autologous and allogeneic…

 In the first five months of 2024, there was a surge in high-value deals, though none have yet matched the scale of Pfizer’s $43 billion acquisition of Seagen, which closed in December 2023. With Novo Holdings’ $16.5 billion purchase of Catalent leading the pack, 2024 reflects a mixed but strong trend toward sizable M&A…

[Updated May 21, 2024.] 2023 may not go down as the brightest year for the pharma sector, but the entry of Novo Nordisk’s Ozempic (semaglutide) into the ranks of top-selling drugs like Keytruda, Dupixent, and Eliquis signals a new era in the treatment of metabolic disease. Novo Nordisk’s sales jumped by more than one-third in…

Is aging a disease or a natural process? That question has emerged as a point of debate among researchers, medical professionals and philosophers. Some, like biogerontologist David Gems, argue that lines between aging and disease are frequently blurry, and that intervening in the aging process “protects against the totality of age-related diseases.” Other researchers such…

The recent emergence of H5N1 avian influenza in humans and many other animals has intensified global efforts to prepare for a potential pandemic. Public health agencies and international organizations are collaborating with pharmaceutical companies and academic institutions to develop vaccines, treatments, and strategies to mitigate the impact of an outbreak. The CDC, for instance, has…

Sanofi revealed that its investigational BTK inhibitor rilzabrutinib notched a significant win in the LUNA 3 phase 3 study, hitting the primary endpoint of durable platelet response in adults with persistent or chronic immune thrombocytopenia (ITP). The study showed a significantly higher proportion of rilzabrutinib-treated patients achieved the platelet response goal compared to placebo in…

The bioinformatics startup Culmination Bio had received financial backing from Merck’s venture arm. Now, the Utah-based company is collaborating directly with the pharmaceutical giant on an autoimmune disease research project. According to Culmination Bio‘s CEO Dr. Lincoln Nadauld, the collaboration highlights the value of the startup’s ability to provide rapid access to high-quality longitudinal patient…

Clostridioides difficile, commonly known as C. diff, is a significant health threat in the U.S. Recent estimates suggest that C. diff, a common bacteria, can cause infection in roughly 500,000 patients annually in the U.S., with around 30,000 of these cases resulting in death. “Actually, it’s more like 5 million when you think about it…