In 2020, the average phase 3 protocol collected approximately 3.56 million data points. By 2025, that figure had reached about 5.96 million, a five-year increase of 67% and 6.4 times the 2012 average of 929,203, according to collaborative research from the nonprofit industry group TransCelerate BioPharma and the Tufts Center for the Study of…

Tufts Center for the Study of Drug Development (CSDD) and clinical trial platform company Medable recently announced an analysis estimating that Medable’s Clinical Monitoring Agent could deliver an 82x return on investment for phase 3 trials and 64x for phase 2. Based on expected net present value (eNPV), that equated to roughly $21 million in…

The FDA has approved ViiV Healthcare’s Tivicay PD (dolutegravir) for treating HIV-1 in pediatric patients weighing at least 2 kg, including eligible newborns, the company and FDA announced. FDA first approved Tivicay in August 2013 for adults and adolescents aged 12 or older weighing at least 40 kg (about 88.2 pounds). The agency approved the…

In April, The New York Times proclaimed that a gen-AI-driven company that hawked compounded GLP-1 drugs was potentially on track to have $1.8 billion in 2026 sales. The paper also reported that the company, MEDVi, had generated $401 million in sales in 2025, saying it had been given access to unspecified company financials. By then,…

New York City–based Definium recently announced positive data from its Phase 3 Voyage trial of DT120, an orally disintegrating 100 µg dose of LSD in adults with generalized anxiety disorder (GAD). The company announced positive Phase 3 results for the same compound for major depressive disorder (MDD) in June. Now the company needs to convince…

The demand for peptide therapeutics has grown rapidly in recent years, as the success of GLP-1 drugs has catapulted them to the forefront of developers’ and sponsors’ minds. Although peptides still represent a relatively small share of FDA-approved therapeutics, they offer distinct advantages in treating diseases where small-molecule drugs or therapeutic antibodies fall short. The…

2022 was a big year for layoffs in biopharma. So were the next three. Novartis, for instance, outlined plans to cut up to 8,000 jobs in 2022, after pharmaceutical industry job cuts jumped 280% in 2021. Biogen followed in 2023 with a “Fit for Growth” program that put roughly 1,000 roles on the block. Bristol…

OpenAI’s first international hospital partnership is taking shape at a giant medical center where English is not the default language and where the electronic health record does not come from Epic, the dominant U.S. EHR vendor. That institution is Sheba Medical Center, the Israel-based medical center with its own 50-plus-person AI Center within ARC, its…

The FDA has finalized new guidelines for meetings between the FDA and sponsors or applicants relating to the development and review of drugs or biological products under the Prescription Drug User Fee Act (PDUFA).   The FDA first published the draft guidance on Sept. 22, 2023, when it collected public comment on the guidelines. The final guidelines contain several changes from the draft, including modifying when INTERACT…

Antibody-drug conjugates (ADCs) have emerged as one of the busiest and most crowded niches within oncology, given their potential to use an antibody to ferry a potent cytotoxic payload toward tumor cells. The class now spans about 15 FDA-approved products, and the segment is growing steadily. Evaluate Pharma projects the ADC category will reach $57…

The 1990-founded scientific software firm Schrödinger recently announced a strategic collaboration and software agreement with Bristol Myers Squibb (BMS) built around Bunsen, Schrödinger’s newly announced agentic AI co-scientist. While the term “AI co-scientist” can have varying definitions, Schrödinger is positioning Bunsen as a sort of execution engine for computational chemistry, including workflows already used across…

By one measure, Alphabet-controlled Isomorphic Labs would tower over every company on this list. The AI drug discovery company has raised $2.7 billion in external financing, including a $2.1 billion Series B announced in May. Its corporate structure, however, puts it outside our definition of an independent biotech startup: Alphabet still controls at least 75%…

Negative biosensors have often been unusable because, as the sensors lose signal when activity is detected, regions of high enzyme activity can look identical to regions with no activity. Researchers at the University of Illinois Chicago have solved this problem with a new cell imaging method that allows scientists to see previously hidden enzyme activities by flipping the optical readout of…

The Department of Health and Human Services (HHS) is soliciting nominations for appointment to the National Vaccine Advisory Committee (NVAC), the agency said in a notice published Wednesday.   A renewed NVAC charter filed in July estimates the committee’s annual operating cost at $756,918 and calls for staff support equivalent to two full-time employees. The committee has not met since September 2024. The…

Novo Nordisk’s ziltivekimab, an investigational human monoclonal antibody that targets the IL-6 ligand, a pro-inflammatory cytokine, to reduce cardiovascular inflammation, did not reduce the risk of major adverse cardiovascular events (MACE) in a Phase 3 trial.   “Although ziltivekimab produced the expected biological effect, this did not result in MACE benefits in this population,” Martin Holst Lange, executive vice president, chief…

The U.S. entered August with more measles cases so far this year than it recorded during all of 2025. With kindergarten MMR coverage down to 92.5% from 95.2% before the pandemic, and Stanford modeling published in JAMA projecting measles could become endemic again within roughly two decades at current rates, President Donald Trump issued a…

The clinical-stage biotech Cocrystal Pharma is developing a single treatment that targets the essential parts of the proteins a virus needs to replicate, meaning it could one day be used across multiple viruses. Its lead candidate, CDI-988, is in development for both norovirus and coronavirus.  Cocrystal’s CDI-988 is a pan-viral protease inhibitor. The company completed a Phase…

After kickstarting the GLP-1 wave that transformed the pharma landscape and briefly sending its market value above Denmark’s annual economic output, Novo Nordisk now trades about 5% below where its shares stood five years ago. After its shares hit an all-time closing high of $137.40 on June 25, 2024, the stock slid about 66% to…

Today’s pharmacovigilance (PV) teams face mounting pressure to analyze increasingly larger volumes of safety data while meeting progressively complex global reporting expectations. According to Deloitte’s 2026 Life Sciences Outlook, 48% of life sciences executives say the rapid adoption of digital technologies and data analytics will substantially impact their organizations. Another area of growing interest is…

The research and development (R&D) landscape for glucagon-like peptide-1 (GLP-1) receptor agonists and metabolic therapies is evolving beyond initial indications for treating glycemia in type 2 diabetes and weight reduction in obese/overweight with co-morbidities. Additional indications now include metabolic dysfunction-associated steatohepatitis (MASH), major adverse cardiovascular events (MACE) reduction, delay of renal disease progression, and treatment…

Micron Biomedical, a company working on painless, microneedle drug delivery, secured a National Institute of Allergy and Infectious Diseases (NIAID) $4.5 million contract through the institute’s Radiation and Nuclear Countermeasures Program, announced July 27.   The contract is for the development of a medical countermeasure against radiation injury that combines Micron’s dissolvable microarray delivery technology with Connext‘s TLR5 agonist, xempritolimod, aimed at Acute Radiation Syndrome (ARS), the illness that follows a high-dose radiation…

In a potential marriage that analysts said faces long odds, AstraZeneca and Bristol Myers Squibb have held talks on a merger that would create the world’s largest drugmaker by revenue and rank among the biggest deals in pharmaceutical history, the Financial Times reported. The merger would also mark the most significant reshaping of pharma’s top…

AAPS and the United States Pharmacopeia (USP) will again collaborate at the 2026 PharmSci 360 conference, scheduled for October 25-28 in New Orleans at the Ernest N. Morial Convention Center. USP has had a presence at recent meetings, including exhibit-hall stage sessions in 2025 and a talk on excipient and raw material grades in 2023.…

AbbVie’s Maviret, known as Mavyret (glecaprevir/pibrentasvir) in the U.S., just became the only therapy approved in the EU for both acute and chronic hepatitis C virus (HCV), removing the need to confirm chronicity before treatment.  While 2020 clinical guidance already recommended prompt treatment for acute HCV, the drug’s previous chronic-only indication could still lead to additional documentation, reimbursement hurdles or delays.The expanded indication brings the drug’s approved use in line with existing clinical recommendations. “We no longer have…

Why has it taken so long, historically, to bring a new drug to market? In a word: complexity. At one end of the spectrum, there is the complexity of disease, genetic variability, the presence of environmental variables that cause patients to respond differently to the same treatment. The thread extends into clinical development, where the…