2023 biopharma M&A trends M&A activity has rebounded to a degree in 2022 and 2023, but deal-making is still below some of the top years in recent decades, including 2011, 2014, and 2015. While M&A remains a fact of life in biopharma, buyers are selective about disease focus areas. Oncology, immunology and obesity/cardiometabolic therapies are…

Traditionally, the tech and biotech sectors in the U.S. have been concentrated in a handful of regions — most notably in areas such as Boston, Seattle, Silicon Valley and Southern California. But the Biden administration aims to distribute innovation more evenly through the U.S. To that end, the administration has designated 31 tech hubs across…

GSK (NYSE:GSK) is aiming to expand the label for its respiratory syncytial virus (RSV) vaccine Arexvy, which was the first to win FDA approval. The firm is now eyeing an extension of the label to include adults aged 50 to 59, bolstered by encouraging preliminary data from a phase 3 study. The recent data from…

The White House has released an executive order that contains what it hails as “the most sweeping actions ever taken to protect Americans from the potential risks of AI systems.” Relevant to drug development, a fact sheet on the order describes its aim to help further “the responsible use of AI in healthcare and the…

Santa Ana, California–based NKGen Biotech has received FDA clearance to begin a phase 1/2a trial for their “natural killer” cell therapy, SNK01, designed to treat Alzheimer’s Disease. The autologous, non-genetically modified natural killer (NK) cell therapy involves extracting a patient’s own cells through a blood draw, and then processing them to enhance their natural abilities…

The word “revolutionize” gets thrown around a lot in describing the potential of emerging technologies. But quantum computing could make good on the promise to disrupt healthcare applications ranging from drug discovery to medical imaging. Theoretically, a quantum computer with 300 quantum bits (qubits) could crunch more calculations in an instant than there are atoms…

In the realm of drug discovery, AI is making waves, and 2023 could potentially be a pivotal year for this technology. As the technology enters the popular consciousness, pharma employees are wondering “why they can’t have similar AI-driven tools for their professional tasks,” said Diane Wuest, head of digital R&D at Sanofi, in a recent…

The explosive sales growth of GLP-1 drugs has analysts projecting that the antiobesity drugs could be a $44 billion market by 2030. Some observers are more upbeat, projecting that the sector could be worth more than $100 billion in the coming years. Pfizer CEO Albert Bourla projects that the market will reach $90 billion by…

Clinical-stage AI company Insilico Medicine has nominated a novel small molecule inhibitor known as ISM9274 as a preclinical candidate for cancer treatment. The company used its PandaOmics AI platform to analyze genomic data from more than 90 tumor types and identified CDK12 as a promising target for multiple cancers including triple-negative breast cancer, lung cancer,…

In drug discovery and development, data sources are as diverse as they are plentiful. There are comprehensive databases brimming with molecular targets, cellular processes, genomic sequences, proteomic profiles, and metabolite patterns that shed light on disease pathways. Data possibilities in the patient care realm are similarly vast, spanning electronic medical records, imaging datasets, and even…

In the phase 3 SURMOUNT-3 trial, tirzepatide recipients saw some of the most impressive weight loss results among trials of GLP-1 drugs, including most notably semaglutide. In the study, participants’ total mean weight loss was 26.6% over 84 weeks following a 12-week intensive lifestyle intervention and subsequent tirzepatide treatment. In all, participants who received tirzepatide…

Lilly has announced that its interleukin-23 blocker mirikizumab demonstrated promise in patients with moderately to severely active ulcerative colitis (UC) in the ongoing open-label LUCENT-3 extension study. The trial evaluated two-year efficacy and safety of the monoclonal antibody in patients who had previously undergone UC treatments, including biologics, that were ineffective, stopped working, or were…

The interleukin-23 blocker guselkumab (Tremfya) continues to show promise in treating Crohn’s disease (CD). First winning FDA approval for plaque psoriasis in 2017, guselkumab recently demonstrated robust efficacy and a consistent safety profile in the long-term extension of the GALAXI Phase 2 study for CD. Some 54.1% of patients receiving guselkumab achieved clinical remission by…

Kathy Fernando, the senior vice president, head of Pfizer Ignite and Pfizer CentreOne, has had a professional trajectory marked by pivotal serendipities. One occurred when attending a seminar at the University of Pennsylvania, where she met Dr. Drew Weissman, a prominent immunologist and RNA vaccine researcher. Weissman, along with Katalin Karikó, recently received the Nobel…

The biopharma industry faced mounting headwinds in 2023, with several major players announcing significant restructuring efforts. Faced with expiring patents, inflation and rising interest rates, and heightened FTC scrutiny, companies looked to trim expenses and refocus their businesses. The ebbing tied of the pandemic posed a challenge for a number of drug developers as well.…

The potential for artificial intelligence (AI) and machine learning (ML) to reshape drug discovery and development is immense. From expediting learning and driving discoveries to managing large-scale data sets and generating fresh insights, the true scale of AI’s influence on the industry is only starting to be understood. But with great potential comes great responsibility.…

Novo Nordisk will halt the phase 3b FLOW trial, which investigated the effects of once-weekly injectable semaglutide on kidney outcomes in individuals with type 2 diabetes (T2D) and chronic kidney disease (CKD). The company reached the decision following the recommendation of the independent Data Monitoring Committee (DMC), following an interim analysis that met pre-specified criteria…

In June 2023, the click chemistry-focused startup Shasqi revealed a research pact with Johnson & Johnson Enterprise Innovation. More recently, the company announced that it had expanded the research alliance, furthering work on its intratumorally injected biopolymer, known as SQL70. The collaboration will also apply its clinically validated Click Activated Protodrugs Against Cancer (CAPAC) technology…

AbbVie has shared new efficacy and safety data for Rinvoq (upadacitinib) in adults and adolescents with atopic dermatitis (AD) from a trio of ongoing phase 3 studies. Spanning 140 weeks, these studies sustained the co-primary endpoints of Eczema Area and Severity Index 75 (EASI 75) and validated Investigator’s Global Assessment for Atopic Dermatitis 0/1 (vIGA-AD…

2023 is shaping up to be a blockbuster year for Eli Lilly. With the company’s stock soaring by almost 54% since the beginning of the year, analysts are largely upbeat about Lilly’s expanded focus on obesity and diabetes treatments. While the company has developed insulin for a century, the company is now broadening its horizons…

Alzheimer’s disease research appears to be hitting its stride, thanks to recent therapeutic advances in drug development and the emergence of biomarkers to detect the condition. “All the pieces of the puzzle of precision medicine, which is already quite common in oncology, are now in place,” said Hartmuth Kolb, vice president, neuroscience biomarkers and R&D…

The biopharma industry is pushing back against increased scrutiny of mergers and acquisitions from the Federal Trade Commission (FTC). More than 30 biopharma companies and industry associations announced the formation of the Partnership for the U.S. Life Science Ecosystem (PULSE) to advocate for the role of M&A activity in the biopharma sector. A M&A landscape…

San Francisco-based oncology startup, Shasqi, announced an expansion of its research collaboration with Johnson & Johnson Enterprise Innovation. The partnership centers on Shasqi‘s CAPAC platform, which is an abbreviation for Click-Activated Protodrugs Against Cancer. The platform separates tumor-targeting from the actual drug payload with the aim of maximizing potency while minimizing toxic side effects.  Shasqi’s…

Conventional wisdom holds that rising interest rates curb M&A activity, but an analysis of the pharma and biotech M&A data from 2018 to early October 2023 reveals a counterintuitive trend — at least over the short term. As interest rates have risen in 2023, pharma deal-making has remained strong although the deal size has dipped.…

The GLP-1 drug market continues to boom lately thanks to highly effective new medications like Novo Nordisk’s Wegovy and continued demand for the drug class in diabetes. The runaway success of Wegovy and Ozempic (both formulations of semaglutide) has caused Novo Nordisk’s share price to skyrocket in 2023, briefly making the Danish pharmaceutical company the most…