The field of digital pathology went from a specialist interest to a practical necessity during the pandemic, when many pathologists couldn’t get to the microscope. Digitizing slides let them keep working remotely. Since then, researchers have developed ways to extract more information from those images, including patterns linked to molecular changes in tissue. Traditionally, the…

AAPS PharmSci 360 delivers research spanning the pharmaceutical product lifecycle. Thousands of scientists and leaders, representing large and small pharma from across the globe converge at this science-first event to discuss cutting-edge approaches and technologies. Sessions and posters highlight recent innovations that can benefit early-stage researchers. RX-360, AstraZeneca, Mayo Clinic, and Merck are just some…

After more than a year of threats and six months after President Donald Trump signed a national-security proclamation, U.S. tariffs on imported patented medicines and their ingredients expanded Sept. 29 to mid-sized and smaller drugmakers that were left off the first company list. Duties that began July 31 for 17 large manufacturers now apply to…

Few software releases have shaken drug discovery like AlphaFold. Its creators shared a Nobel Prize, and its public database put predicted structures for more than 200 million proteins open to researchers worldwide. Turning those structures into drugs poses another set of problems. Seattle-based Talus Bio is going after proteins that resist that approach, notably transcription…

Google parent Alphabet and Meta reported a combined $118.5 billion in R&D expense for 2025, close to the $123.7 billion spent by the 10 largest drugmakers by revenue, a figure that includes J&J’s medtech and Roche’s diagnostics units. While Big Tech’s R&D budgets keep swelling, Big Pharma is aligning itself with Big Tech firms. In…

For pharma companies preparing to launch a drug or expand commercial operations, choosing vendors for distribution, pricing, and customer relationship management is a world away from comparing common business software. Buyers of mainstream business software can consult reviews on the software comparison sites G2 and Gartner Peer Insights, along with analyst evaluations such as the…

The magic mushroom compound psilocybin, which has had favorable results in two Phase 3 trials of depression and could be available as soon as 2027, has shown promise in rodents as a potential preventative for Chemotherapy‑Induced Peripheral Neuropathy (CIPN), a disabling pain condition caused by chemotherapy that affects about 30% to 50% of patients receiving chemotherapy. A 2014 review found that 68.1% of chemotherapy patients across 31 studies had CIPN when measured in…

On August 25-26, the U.S. Drug Enforcement Administration (DEA) followed up on two Federal Register notices published on July 1 that signaled its intent to temporarily place several synthetic alkaloids associated with Mitragyna speciosa (commonly known as kratom leaf or kratom) in Schedule I of the Controlled Substances Act (CSA). One notice concerned three synthetic…

The COVID-19 pandemic left most of the world’s population with an immune memory for COVID. A Cleveland-based biotech wants to use that memory to fight cancer. Celloram, a preclinical stage company focusing on therapies for cancer, autoimmune diseases and chronic inflammatory and metabolic disorders, in partnership with Case Western Reserve University and University Hospitals Cleveland Medical Center, published preclinical results for a…

The Arlington, Virginia–based nonprofit American Association of Pharmaceutical Scientists (AAPS) will launch two Innovator-Curated tracks at its 2026 PharmSci 360 conference, scheduled for October 25–28, 2026, at the Ernest N. Morial Convention Center in New Orleans, Louisiana. The organization announced that the tracks will explore the current state of scientific research integrity in an AI…

A new investigational cancer vaccine developed by Merck & Co. and Moderna is customized based on the genome of each patient’s tumor, designed to teach their immune system to recognize the cancer as a foreign body. The companies are investigating the vaccine as a combination treatment with Merck’s Keytruda, a monoclonal antibody that targets the PD-1 receptor on T-cells, breaking a pathway…

Proteolysis Targeting Chimera (PROTAC) drugs have evolved from a promising concept to a clinically validated modality. In May 2026, the U.S. FDA approved vepdegestrant (Veppanu®), the first PROTAC drug, marking an important milestone for targeted protein degradation and reinforcing the approach across a multitude of disease areas. PROTACs usually consist of three parts: a target-binding…

An estimated 69,000 Americans acquired hepatitis C in 2023, roughly double the mid-2010s rate, even though the disease has been curable with an eight- to 12-week course of oral antivirals for more than a decade. AbbVie’s MAVYRET became the first of those antivirals cleared for acute infection in June 2025, with a 96% cure rate in trial. In the EU,…

  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%…