Lilly's CGRP drug succeeds in 'worst kind of migraine'

Galcanezumab significantly lowered the number of weekly attacks experienced by patients with episodic cluster headache but failed to meet its goal for chronic cluster headaches.

By Jacob Bell • May 15, 2018

aTyr Pharma tumbles on corporate restructure, job cuts

The biotech is laying off 30% of its workforce and shuttering an immuno-oncology effort after preclinical failures.

By Suzanne Elvidge • May 15, 2018

Explore the Trendline➔

Cell therapy

The continued emergence of CAR-T therapy has fueled research into next-generation approaches and new applications, such as its use in autoimmune diseases.

By BioPharma Dive staff

AstraZeneca lung drug comes up short in COPD

Fasenra missed its primary endpoint in a key study designed to support broadening of the biologic's use beyond asthma. 

By Ned Pagliarulo • May 11, 2018

Prescribed Reading: ShiTake a go; Novartis in hot water

Takeda finally secured its takeover of Shire. Elsewhere, Novartis came under fire for payments it made to Trump's lawyer. 

By Lisa LaMotta • May 11, 2018

Puma shares plummet as results from key trial delayed

A slower-than-expected event rate in Puma's NALA study means results may not be available until Q4 or potentially as late as 2019.

By Suzanne Elvidge • May 11, 2018

Tecentriq stumbles in Phase 3 colon cancer study

The trial, which paired Tecentriq with the MEK blocker Cotellic, could have helped Roche gain an edge over its rivals in that tumor type. 

By Ned Pagliarulo • May 10, 2018

MedCo uses a Phase 2 analysis to build its PCSK9 case

A prespecified analysis of ORION-1 inclisiran data adds to the company's argument for the long-acting synthetic PCSK9.

By Suzanne Elvidge • May 8, 2018

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

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