Biologics

AbbVie has been staging a generational handoff for years: as Humira’s U.S. exclusivity fell and biosimilars swarmed, the company groomed Rinvoq and Skyrizi as the next standard-bearers. Investors already know the script: AbbVie has guided the duo to more than $31 billion in combined sales by 2027, and Humira’s 2022 global peak north of $21…

Novo Nordisk has agreed to acquire Akero Therapeutics, a clinical-stage company that develops treatments for metabolic diseases, the company announced last week.  Akero’s EFX pipeline Akero Therapeutics’ treatment for metabolic-dysfunction-associated steatohepatitis (MASH) “is closely linked with Novo Nordisk’s expertise in diabetes and obesity,” the press release stated. More than 40% of patients with MASH, formerly…

New Jersey’s Department of Environmental Protection (DEP) has filed a lawsuit against Pfizer, Johnson & Johnson, Honeywell and several real estate companies, claiming there is toxic waste on an old pharmaceutical plant site, contaminating the groundwater.  The plant, located in Morris Plains, was operational from the 1950s to the 1980s under Warner-Lambert, which Pfizer acquired…

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…

Bispecific antibodies (BsAbs) are redefining the landscape of therapeutic design, offering dual-target precision that conventional antibodies can’t match. These specially engineered antibodies bind to either two different antigens or two distinct sites on the same antigen. BsAbs form a powerful new class of therapy which has caused excitement among the drug development community due to…

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…

Chronic obstructive pulmonary disease, a condition CDC estimates affects about 14.2 million (6.5%) U.S. adults, can be brutal. And for patients with COPD, exacerbations are an acute risk, a sudden flare-up where breathing becomes a potentially life-threatening struggle against inflamed airways. “Anecdotally… if I reflect back on some of my experiences in… emergency medicine departments…

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…

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…

Cell therapies hold immense promise but, traditionally, carry a similarly large price tag often linked to complex, manual manufacturing. In its latest move to help make these life-saving  and -enhancing treatments more scalable and potentially accessible, Cellares is partnering with the University of Wisconsin School of Medicine and Public Health to automate the clinical-scale manufacturing…

The market for monoclonal antibodies (mAbs) is worth over $330 billion and is expected to more than double by 2030. As the research pipeline continues to grow, developers are facing numerous challenges, not the least of which is measuring and maintaining critical quality attributes (CQAs).  One CQA that has drawn an increasing amount of attention…

The FDA’s approval of Omvoh (mirikizumab-mrkz) for Crohn’s disease—its second IBD authorization since 2023—establishes it as the first biologic in >15 years with Phase 3 two-year efficacy data at launch. In the pivotal VIVID-1 trial, 53% of Omvoh-treated patients achieved clinical remission at one year versus 36% on placebo*, with early endoscopic response tripling placebo…

Imagine a shape-shifting pathogen invisible to the naked eye, armed with toxin-laced barbs that rupture human cells. This isn’t fiction—it’s Clostridioides difficile, a superbug causing 29,000 U.S. deaths annually through severe diarrhea and colitis. After an initial infection, up to 35% of patients experience recurrence, with subsequent episodes becoming increasingly likely—up to 60% of these…

American Association of Pharmaceutical Scientists (AAPS) has announced that the program for its National Biotechnology Conference (NBC) is now available. The full agenda for the event, which will take place from May 4–7, 2025, spans a combination of live and pre-recorded sessions. The event will convene biopharma scientists, researchers, and industry professionals from around the…

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…

The development of Proteolysis Targeting Chimeras, or “PROTACs*,” has garnered significant attention in the pharmaceutical industry due to their potential to target and degrade disease-causing proteins previously considered undruggable. As a novel therapeutic modality, PROTACs offer a promising alternative to traditional small-molecule inhibitors and biologics. However, despite the excitement around these therapies, preclinical evaluations of…

Beckman Coulter Life Sciences has announced a new automated clone screening platform for biologic drug development. The Cydem VT system integrates several established technologies — microbioreactor arrays, liquid handling, and analytical measurements — into a single platform capable of monitoring up to 96 parallel bioreactors. The system provides continuous monitoring of pH, dissolved oxygen, and…

Large molecule therapies hold immense promise for treating an array of diseases, but their development presents unique challenges in preclinical testing. Toxicology studies form a cornerstone of this process, providing essential data on the drug’s biological effects. While small molecule drugs have been the focus of drug development for decades, large molecule therapies present unique challenges…

[Updated May 10, 2024] In the face of rising R&D costs and growing pricing pressures from payers, the pharma and biotech sectors continue to transform to adapt to an evolving landscape. While workforce reductions persist in 2024 for some companies, major players like AbbVie, AGC Biologics, Amgen, Novartis and Thermo Fisher Scientific are demonstrating confidence…

The pharmaceutical industry is at a critical juncture: AI and other technological advances offer unprecedented potential, yet the cost of developing new drugs has ballooned for decades, surpassing $2 billion in recent years with the projected return on investment (ROI) falling to a mere 1.2% in 2022, according to Deloitte. Another dimension of the problem…

In 2023, a year of accelerated regulatory success, a significant number of biotech labs sat empty in major hubs like San Francisco and Boston. The FDA approved 55 novel therapies in 2023, including Leqembi for early Alzheimer’s and Zurzuvae for postpartum depression. The approval number marked the second highest count in three decades (see graph…

Biotech startup Lindus Health just made a big splash by adding MIT professor and Moderna co-founder Robert Langer,  Sc.D., to its advisory board. Lindus aims to shake up the world of clinical trials with its “anti-CRO” approach that promises faster and more reliable trials for life sciences companies. The addition of Langer, described as the…