Roche takes on Pfizer with new lung cancer data

The trial results from the Swiss pharma will allow it to take on Pfizer's Xalkori in first-line lung cancer. 

By Lisa LaMotta • April 10, 2017

OncoMed slammed by fizzled Bayer deal, Phase 2 failure

The cancer-focused company saw shares slide nearly 43% in premarket trading on Monday.

By Jacob Bell • April 10, 2017

Explore the Trendline➔

Radiopharmaceuticals

A series of technological advances have led to an explosion of scientific progress — and dealmaking — involving medicines that can precisely deliver radioactive materials into tumors.   

By BioPharma Dive staff

5 trends shaping rare disease drug development

Sales of orphan drugs have grown rapidly, prompting drugmakers to invest in rare diseases. But with that growth has come new scrutiny.

By Ned Pagliarulo • April 10, 2017

Clinical trial enrollment gets harder as patient populations shrink

It can be a long shot to find patients for some rare disease clinical trials. Recruiting challenges, however, often make those odds even smaller.

By Jacob Bell • April 10, 2017

How the Orphan Drug Act changed the development landscape

The 1983 law opened the doors to a flood of treatments for rare diseases, but rising costs and hundreds of still-untreated conditions have raised questions about whether changes are needed. 

By Malorye A. Branca • April 10, 2017

Prescribed Reading: AACR, Gottlieb and recalls

Scott Gottlieb faced a Senate committee for the top slot at the FDA, while data pours in from AACR and Mylan and GSK issue U.S. recalls.

By Lisa LaMotta • April 7, 2017

Allergan moves Botox into Phase 3, despite mid-stage failure

Even after a failed Phase 2 , the specialty pharma will move the drug forward in major depressive disorder. 

By Lisa LaMotta • April 6, 2017

GAIN Act gives Zavante a shot at new antibiotic development

After getting extended exclusivity through the GAIN Act, Zolyd shows solid results in a late-stage study of patients with complicated urinary tract infections. 

By Suzanne Elvidge • April 6, 2017

AACR recap: IDOs under the microscope

Combination immunotherapy continued to draw attention at AACR. Elsewhere, survival data on several checkpoint inhibitors hinted at some long-term benefit.

By Ned Pagliarulo • April 5, 2017

Corbus pushes toward Phase 3 after positive meeting with FDA

A "successful" end of Phase 2 meeting with the FDA clears Corbus for rare disease Phase 3 and filing.

By Suzanne Elvidge • April 5, 2017

How real-world evidence is changing the game

A metaphor for our times: how the demand for real-world evidence is changing the offensive playbook for commercial success.

By David Thompson, Ph.D Senior Vice President, Real World Evidence & Insights at inVentiv Health • April 4, 2017

AACR: NewLink's IDO data shows promise, but is it enough?

Combining NewLink's indoximod with Keytruda improved response rates in advanced melanoma patients. Yet, it may not be enough to catch Incyte's rapidly advancing IDO1 inhibitor. 

By Ned Pagliarulo • April 4, 2017

AACR: Incyte hedges bet on combo strategy

The Delaware-based biotech plans to test its IDO1 inhibitor epacadostat in similarly targeted Phase 3 studies with Merck's Keytruda as well as Bristol-Myers' Opdivo. 

By Ned Pagliarulo • April 3, 2017

AACR: Busy start for Bristol-Myers Squibb's Opdivo

New data from two abstracts presented at the research conference gave a clearer picture of Opdivo's long-term survival benefit. 

By Ned Pagliarulo • April 3, 2017

CAR-T race heats up as Kite, Novartis complete filings to FDA

Which company reaches market first may not matter much at first, but the coming quarters should see a flurry of activity in the emerging CAR-T field. 

By Ned Pagliarulo • April 2, 2017

Prescribed Reading: All the approvals

FDA goes on an approval spree, drug manufacturers toe the line on pricing, and Vertex has both good and bad news. 

By Lisa LaMotta • March 31, 2017

J&J, Genmab abandon NHL indication for Darzalex

The companies chose not to move forward with a mid-stage study of Darzalex in non-Hodgkin's lymphoma after patients failed to reach the desired level of overall response rates. 

By Suzanne Elvidge • March 31, 2017

Karyopharm shakes off clinical hold for lead cancer med

The quick reversal of the FDA's partial clinical holds reaffirmed that administrative problems were the main culprit holding up the trials.

By Jacob Bell • March 30, 2017

Vertex boosted by strong trial data for next-gen CF drug

Success for the experimental treatment would bolster Vertex's cystic fibrosis portfolio and provide a foundation for future triple-combos. 

By Ned Pagliarulo • March 29, 2017

AACR preview: IDO1, CDK 4/6 and cancer combos

Biopharma dollars have been pouring into cancer research as new technologies make the leap to market. Next week's AACR conference will highlight some of what could come next. 

By Ned Pagliarulo • March 29, 2017

Investigator site portal reduces errors and improves communication for more efficient clinical trial management

CROs can reduce data discrepancies up to 80% by automating and streamlining routine tasks.

By Roni Robbins • March 28, 2017

Selecta shares surge on early positive signs for gout med

The company believes the design of SEL-212, its lead clinical candidate, should allow for repeat dosing and better control of the painful inflammatory condition. 

By Suzanne Elvidge • March 28, 2017

Allergan acne med shines in late-stage trials

The specialty drugmaker plans to file the treatment, developed through a collaboration with Paratek Pharmaceuticals, for approval in the latter half of 2017.

By Jacob Bell • March 27, 2017

Prescribed Reading: Avelumab OK'd, Ultragenyx fails trial

As Washington debates healthcare, pharma continues to make deals and Pfizer joins the checkpoint inhibitor race. 

By Lisa LaMotta • March 24, 2017

NEJM: Lyrica ineffective in sciatica

As Lyrica nears the end of its life cycle, a new study finds that the pain drug is not effective in treating sciatica. 

By Suzanne Elvidge • March 24, 2017