End-to-end drug & diagnostic development support for a new immuno-oncology agent: A case study

Immuno-oncology drug development is inherently complex and requires special considerations across the entire spectrum.

June 22, 2017

Low on cash, ImmunoCellular halts study and looks for a lifeline

The microcap biotech is evaluating "strategic alternatives," including a potential merger, restructuring or sale.

By Suzanne Elvidge • June 22, 2017

Explore the Trendline➔

Oncology's research boom

More than one quarter of the medcines cleared by the FDA's main review office since 2015 have been cancer drugs, a tally that reflects the advent of cancer immunotherapy as well as continued progress in matching treatment to genetics.

By BioPharma Dive staff

#BIO2017 Day 3 roundup: Building value and what it costs

There was a lot going on Wednesday at the BIO International Convention, as well as in and around the San Diego area — a major biotech hub. 

By Lisa LaMotta • June 21, 2017

#BIO2017 Day 2 roundup: A dearth of deals and Hung on Alzheimer's

The BIO International Convention was in full swing on Tuesday with high-profile talks, company presentations and panels on the state of the industry.

By Lisa LaMotta • June 20, 2017

Novartis eyes Regeneron's blockbuster Eylea franchise

Brolucizumab, pegged for a blockbuster future by Novartis, matched up to Regeneron's eye drug across two Phase 3 studies. 

By Jacob Bell • June 20, 2017

Gene therapy: What you need to know

As several promising gene therapies near potential approval, BioPharma Dive explored the challenges and commercial hurdles the treatments could face. 

By Lisa LaMotta • June 19, 2017

Safety concerns sideline Seattle Genetics' cancer candidate

The West Coast drugmaker stopped vadastuximab talirine investigations after the treatment arm of a Phase 3 study showed a higher rate of death.

By Jacob Bell • June 19, 2017

Humira shows its staying power

Pfizer had hoped head-to-head data comparing its JAK inhibitor Xeljanz to Humira would help steal market share, but the newer drug showed mixed results. 

By Suzanne Elvidge • June 19, 2017

Clovis soars on strong results for PARP inhibitor

Results from the ARIEL-3 study could expand Rubraca's market opportunity and position the drug more competitively versus rivals.

By Ned Pagliarulo • June 19, 2017

Prescribed Reading: ADA, Mylan, and an executive order?

The SGLT-2 category heats up at ADA, Mylan faces pressure from all sides, and President Trump might put his stamp on drug pricing.

By Lisa LaMotta • June 16, 2017

DIA: Exploring the impact of data and informatics technologies throughout the clinical trial journey

Sponsors are turning to intelligent, informatics-based solutions to help ensure that clinical trials are proceeding in the most effective manner possible.   

June 15, 2017

Aldeyra eyes Phase 3 after flunking Phase 2b

The biotech is itching to get on with a late-stage study of its eye allergy drug, which missed the primary endpoint of an earlier investigation.

By Suzanne Elvidge • June 15, 2017

How Merck hopes to win in I/O combos: Q&A with Roy Baynes

Combinations are pegged as the next step forward in immuno-oncology. Speaking with BioPharma Dive at ASCO, Merck's Roy Baynes cautioned how little is known about the best pairing and explained why monotherapy remains relevant.

By Ned Pagliarulo • June 14, 2017

Acceleron to dump dalantercept after bad data

Acceleron drops dalantercept after it misses its primary endpoint in a Phase 2 study for advanced kidney cancer, but investors barely blink.

By Suzanne Elvidge • June 14, 2017

Merck pauses Keytruda trials, raising concerns about class

The big pharma has hit a setback for its blockbuster checkpoint inhibitor in two multiple myeloma studies. 

By Lisa LaMotta • June 13, 2017

J&J's Invokana lowers CV risk, but by enough to compete?

The diabetes drug lowered risk in a cardiovascular outcomes study by 14%, yet still finds itself outpaced by some data from other competitors.

By Jacob Bell • June 13, 2017

Gene therapy by the numbers

In a field shaped by small patient populations and eye-popping cost considerations, understanding gene therapy's promise and challenges comes down, in part, to the numbers. 

By Ned Pagliarulo • June 12, 2017

A new wave of gene therapies ready to hit US shores

After decades of setbacks, a slew of next-gen gene therapies are ready to hit the U.S. market, prompting questions about manufacturing and pricing.

By Malorye Allison Branca • June 12, 2017

ADA: Praluent data positive in diabetes patients

Even as the PCSK9 inhibitors continue to falter in the cholesterol market, new data in diabetes patients could be a differentiator.

By Suzanne Elvidge • June 12, 2017

ADA: Merck, Pfizer notch success, but late with SGLT-2 data

The two pharmas' ertugliflozin met its goal in two Phase 3 studies, yet will face a competitive market already featuring three rival SGLT-2 inhibitors.

By Ned Pagliarulo • June 12, 2017

Lilly preps galcanezumab for 2017 filing

The migraine drug showed strong efficacy across a trio of late-stage studies, and its submission to the FDA should come later this year.

By Jacob Bell • June 10, 2017

Prescribed Reading: June filled with divestitures and data

Conference season is in full swing for the industry, big pharma is selling off assets and the FDA is making some surprising moves. 

By Lisa LaMotta • June 9, 2017

Actelion's antibiotic meets one endpoint, flunks another

Flagship C. diff diarrhea drug shows mixed results, prompting concerns that Johnson & Johnson overpaid for the big European biotech. 

By Suzanne Elvidge • June 9, 2017

Strokes on the rise, but NOACs not filling the gap

New oral anticoagulants have become the new standard of care for stroke treatment, but the drugs have not lived up to expectation. 

By Barbara Boughton • June 9, 2017

ADA preview: 5 things to watch in diabetes

Cardiovascular outcomes data, insulin pricing and technology are just a few of the things acting as major change agents in diabetes.

By Lisa LaMotta • June 9, 2017