Immunology

The pharmaceutical blockbuster model is wobbling. And no single franchise is safe. While king Keytruda, Merck’s stalwart oncology drug, continues to rule the first half of 2025 with $15.2B in sales (Q1 $7.2B, Q2 $8.0B), its U.S. patent expiry in 2028 the single biggest loss of exclusivity event on the horizon. In the U.S., Medicare…

Last Friday, the ACIP voted to recommend COVID vaccination “based on individual-based decision-making” for adults 65 and older. For individuals 6 months to 64 years old, the vaccine is recommended based on individual decision, “with an emphasis that the risk-benefit of vaccination is more favorable for individuals who are at an increased risk for severe…

The ACIP met this week to vote on recommendations for the MMRV, Hepatitis B and COVID vaccines. On Thursday, they voted to recommend separate MMR and varicella vaccines for children under four, instead of the combination MMRV vaccine. On Friday, they voted to table the Hepatitis B decision for another meeting.  Also on Friday, the…

Despite some vocal attacks against vaccines, a poll conducted by Republican pollsters — including Donald Trump’s chief pollster — shows “that there is broad unity across party lines supporting vaccines such as measles (MMR), shingles, tetanus, diphtheria and pertussis (TDAP), and Hepatitis B.” NBC News reported that the poll results were made known to Republican…

On Friday, Kevenue, the maker of Tylenol, saw its stocks drop more than 10% after the Wall Street Journal reported that Health and Human Services Secretary Robert F. Kennedy plans to release a federal report connecting prenatal use of Tylenol to autism.  As Kennedy and his appointed vaccine panel continue to erode vaccine recommendations, many…

Pfizer Inc. and BioNTech SE announced today that the FDA has approved their COVID-19 vaccine for adults ages 65 and older and individuals from 5 to 64 years old who have at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.  The approval comes amidst the development of a…

The U.S. Centers for Disease Control and Prevention chose Retsef Levi, a management and health analytics expert at MIT, to lead its COVID-19 immunization workgroup. Levi announced on X that he is “looking forward to working with colleagues… to pursue the truth through science and evidence-based approach.” Levi, one of the eight new ACIP members…

Dr. Katie Abouzahr, Johnson & Johnson’s new head of late-stage immunology development, draws on her NHS clinical roots and 11 years at Boston Consulting Group to tackle drug R&D’s most complex challenges. Having recently stepped into the role about a month ago, she oversees a portfolio that includes the newly FDA-approved nipocalimab for myasthenia gravis,…

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…