Vertex builds case for non-opioid pain drug ahead of key study readouts

The closely watched medicine showed promise treating a form of chronic nerve pain, with the results suggesting comparable effects to an available therapy.

By Kristin Jensen • Dec. 13, 2023

ASH23: Pharma branding, Editas’ high bar and clinical trial diversity

Editas had the tall task Monday of convincing ASH attendees its gene therapy for sickle cell disease could improve on Casgevy and Lyfgenia.

By Gwendolyn Wu , Ned Pagliarulo • Dec. 11, 2023

Explore the Trendline➔

COVID-19 vaccines

The urgency of the pandemic’s first two years is giving way to questions of how to sustain public health responses and prepare for what could come next. In the U.S., health officials are urging booster shots and preparing for private sector distribution of vaccines.

By BioPharma Dive staff

Life sciences leaders invest in process mining to accelerate digital transformation

Research from Everest Group shows how life sciences leaders are investing in process mining to speed time-to-market, improve regulatory compliance and drive innovation.

By Rachel Stolba • Dec. 11, 2023

ASH23: CAR-T for autoimmune disease, real-world questions and sickle cell’s social media mentions

Results disclosed at the American Society of Hematology meeting suggested potential for cell therapy in lupus and pointed out drug trial limitations.

By Ned Pagliarulo • Dec. 9, 2023

Merck suffers bad week as 3 Keytruda combination trials fail

The setbacks for Merck demonstrate the challenge drug developers face in improving on Keytruda, which has brought in at least $18 billion so far this year for its maker.

By Jonathan Gardner • Dec. 8, 2023

Pharvaris shares spike as drug appears to prevent symptoms of rare disorder

The company moved quickly to capitalize on the stock surge, announcing plans to raise $300 million through a secondary stock offering.

By Jacob Bell • Dec. 6, 2023

German Merck’s MS drug falls short in pair of Phase 3 tests

The results dim the outlook of BTK inhibitors as potential autoimmune disease treatments and could have ramifications for Roche, Sanofi and Novartis. 

By Kristin Jensen • Dec. 6, 2023

EyePoint sees stock surge on AMD drug trial data

The biotech said Phase 2 study results showed its experimental medicine for age-related macular degeneration was "non-inferior" to Regeneron's Eylea.

By Ned Pagliarulo • Dec. 4, 2023

Revolutionizing clinical trials: Unlocking peak efficiency with total laboratory automation in bioanalysis

With clinical trials becoming more complex, finding ways to streamline and automate laboratory processes is vital when analyzing bioanalytical samples.

Dec. 4, 2023

Overcoming scalability challenges in real-world data processing for transformative patient care

Accurate and timely processing of data is imperative to create robust analytical datasets that can be used in the RWE setting.

By Rob Sullivan, Chief Data & Analytics Officer • Dec. 4, 2023

Pfizer plans for oral obesity drug hit new setback

The company won’t continue development of a twice-daily dose of its experimental weight loss medicine danuglipron after study data showed high rates of side effects.

By Ned Pagliarulo • Dec. 1, 2023

CRO disputes Acelyrin’s implication of trial misconduct

Trial contractor Fortrea is fighting back as Acelyrin unveils a CRO audit in the wake of a major late-stage study failure.

By Kristin Jensen • Nov. 30, 2023

GSK cancer drug Blenrep gets surprise trial win

One year after the U.K. drugmaker withdrew the multiple myeloma drug from the U.S. market because of negative data, new study results might crack open the door to a relaunch.

By Jonathan Gardner • Nov. 27, 2023

Regeneron, Sanofi to seek new Dupixent approval in US after COPD success

Results from the second of two Phase 3 trials testing the blockbuster drug in the respiratory condition showed treatment could reduce attacks and improve lung function. 

By Ned Pagliarulo • Nov. 27, 2023

Xenon drug misses main goal of depression study

Yet, the company believes there were enough positive findings in the mid-stage trial to warrant further study of its drug, called XEN1101, in depression.

By Jacob Bell • Nov. 27, 2023

Bayer ends large blood thinner trial for ‘inferior efficacy’

Company shares fell after study monitors called for halting a planned 18,000-person trial because Bayer’s drug wasn’t working as well as Eliquis.

By Jonathan Gardner • Updated Nov. 20, 2023

Biohaven hopes to muscle in on Ozempic with a different type of weight loss drug

Several biotech companies, Biohaven among them, are trying to develop medicines that could trim the waistline while building lean tissue.

By Kelly Bilodeau • Nov. 20, 2023

Paper details Astellas gene therapy study that led to patient deaths

The company, which is working with regulators to lift a clinical hold, said the treatment could still help people with X-linked myotubular myopathy.

By Kristin Jensen • Nov. 16, 2023

Anthos blood thinner bests Xarelto on safety in mid-stage study

Trial results add to evidence that so-called Factor XIa inhibitors could have less bleeding risk than currently available oral anticoagulants like Xarelto.

By Ned Pagliarulo • Updated Nov. 14, 2023

Real-world evidence in pharmaceutical drug development – faster, safer and more relevant?

Regulatory agencies have set the framework and use cases for RWE. How can these increase the probability of success or efficiency in a pre-clinical and clinical drug development program?

By Lutz Schlicht, PhD, Target RWE • Nov. 13, 2023

3 ways decentralized clinical trials could help advance research on rare diseases

Explore how decentralized clinical trials (DCTs) can enhance rare disease research in three key ways.

Nov. 13, 2023

First look at Verve study data offers base editing ‘proof of principle’

Early clinical trial results showed Verve’s therapy can substantially lower bad cholesterol. Still, investors sent the biotech’s shares down by 40% Monday.

By Ned Pagliarulo • Nov. 12, 2023

Detailed trial data confirm Wegovy heart benefit

As GLP-1 drugs for weight loss take off, the results for Novo Nordisk’s treatment could help convince insurers to expand coverage.

By Jonathan Gardner • Nov. 11, 2023

Atara’s cell therapy approach to MS falls short in study

Shares in the biotech tumbled by 75% as results from a Phase 2 trial showed more improvement in participants given a placebo.

By Kristin Jensen • Nov. 9, 2023

Celldex’s reinvention advances with inflammatory disease drug data

Shares in the biotech jumped higher Monday on positive results for the company's drug barzolvolimab in two chronic itching conditions.

By Ned Pagliarulo • Nov. 6, 2023