J&J's ketamine-based antidepressant sees mixed results in Phase 3

The near-miss in a second late-stage study somewhat complicates the case J&J is building for esketamine, a nasal spay it hopes to soon file for approval.

By Ned Pagliarulo • May 7, 2018

Merck bets Moderna's mRNA tech can unlock KRAS puzzle

The pharma will invest $125 million in the well-funded biotech, partnering on a mRNA cancer vaccine designed to target the notoriously undruggable mutation.

By Ned Pagliarulo • May 5, 2018

Explore the Trendline➔

Neuroscience drug development

Enthusiasm is running higher among drugmakers and investors for neuroscience drug development, buoyed by recent approvals of new Alzheimer’s, ALS and depression medicines.

By BioPharma Dive staff

On a roll, Alnylam pushes another RNAi drug toward late-stage study

If all goes according to plan, Alnylam thinks it could file its rare disease drug lumasiran for approval in early 2020. 

By Suzanne Elvidge • May 4, 2018

Prescribed Reading: Small deals mark tail end of Q1 earnings

First quarter earnings have largely wrapped up, with no major M&A announced. Several smaller deals, however, sparked investor interest. 

By Lisa LaMotta • May 3, 2018

Esperion tumbles as patient deaths weigh on cholesterol drug

The biotech claims the safety issues aren't related to the drug, but investors weren't buying it. 

By Jacob Bell • May 2, 2018

IDO drug development scaled back in wake of Incyte trial miss

Incyte will stop enrollment into six trials testing epacadostat with Keytruda and Opdivo, the latest sign of the dimming prospects for IDO inhibitors.

By Ned Pagliarulo • May 2, 2018

CRO Charles River expands screening capabilities

Adding new tools in early-stage drug discovery could help Charles River broaden its contract service offerings.

By Suzanne Elvidge • May 2, 2018

Tech Success: Increase retention in clinical trials with patient-empowering technology

Today's patients are active participants in their health care. However, many clinical trial sponsors haven't embraced this new era of patient-centric medicine resulting in high drop-out rates.

May 1, 2018

Karyopharm impresses with positive results for selinexor

Positive data in hand, the biotech is ready to head to the FDA later this year with an application for approval of the multiple myeloma drug.

By Lisa LaMotta • May 1, 2018

Q1 earnings preview: Novo, Celgene still to come

A final wave of biopharma earnings is on tap, with updates on pipeline misses and new drug hopes expected.

By Ned Pagliarulo , Lisa LaMotta , Jacob Bell , Randi Hernandez • May 1, 2018

FDA calls for more studies for Vertex's VX-561

Though the request could slow down development, Vertex intends to keep moving the potentiator forward as part of a once-daily regimen.

By Suzanne Elvidge • April 30, 2018

Allergan defends ubrogepant's marketability

While data supports the efficacy of Allergan's CGRP drug, some safety signals could limit its ability to compete in the marketplace.

By Jacob Bell • April 27, 2018

Vertex keeps focus on CF as sales climb 33%

Triple combinations took center stage as Vertex announced new studies during first quarter earnings.

By Suzanne Elvidge • April 27, 2018

A metabolite will make or break Celgene's ozanimod

Analysts speculate this metabolite, and lack of information about it, were the probable cause of a Refuse to File letter issued for ozanimod earlier this year.

By Jacob Bell • April 26, 2018

ADC Therapeutics axes HER2 program

The Swiss company decided to drop its Phase 1 cancer antibody drug conjugate after finding insufficient efficacy at doses still tolerable to patients.

By Suzanne Elvidge • April 26, 2018

Epizyme nosedives following clinical hold

Though shares of the biotech fell 15% after the FDA halted recruitment for a tazemetostat trial, analysts remained optimistic.

By Suzanne Elvidge • April 25, 2018

Immunotherapies, biosimilars to dominate next week of earnings

AbbVie, Bristol-Myers, Roche and others will report first quarter earnings over the coming days. 

By Ned Pagliarulo , Lisa LaMotta , Jacob Bell • April 24, 2018

Setback for AstraZeneca cancer combo raises MYSTIC stakes

The failure of Imfinzi plus tremelimumab in third-line lung cancer makes an upcoming readout from the MYSTIC study even more important for the pharma.

By Ned Pagliarulo • April 24, 2018

Prothena pulls Phase 3 drug, stock plummets

The Irish biotech scrapped its amyloidosis candidate after a late-stage futility analysis returned disappointing results.

By Suzanne Elvidge • April 24, 2018

Novartis bolsters case for siponimod with new data

The results support Novartis' filing of the drug, which the pharma hopes will secure FDA approval for secondary progressive MS.

By Suzanne Elvidge • April 23, 2018

Merck antibiotic data positive in Phase 3

The promising data moves the pharma closer to a submission to the FDA.

By Suzanne Elvidge • April 23, 2018

Prescribed Reading: Shire on the block; FDA flip-flops

There are potentially multiple suitors looking to take out Shire. Elsewhere, the FDA is making surprise reversals.

By Lisa LaMotta • April 20, 2018

Tagrisso wins first-line lung cancer approval, boosting AstraZeneca

Securing the FDA OK is a key step in AstraZeneca's plan to turn Tagrisso into a multi-billion dollar drug franchise.

By Suzanne Elvidge • April 20, 2018

FDA seeks info on DMD drug as hold remains

Solid Biosciences said it will respond within weeks to the latest agency questions regarding its experimental gene therapy.

By Suzanne Elvidge • April 19, 2018

ImmuPharma dives on late-stage lupus failure

A high placebo response threatens to squash interest from larger pharma companies in the U.K. biotech's drug, Lupuzor.

By Jacob Bell • April 18, 2018