FDA limits first-line bladder cancer labels for Keytruda, Tecentriq

Labels for the checkpoint inhibitors will now include a requirement for PD-L1 expression testing. 

By Suzanne Elvidge • June 22, 2018

Disruptive innovation – the impact on clinical trials

Senior pharma executives weigh in on how the industry is experiencing a digital disruption, impacting the entire spectrum of drug development.

June 21, 2018

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

Novo's case for oral semaglutide bolstered by Phase 3 trial wins

The key diabetes drug for Novo beat out the Danish drugmaker's own Victoza as well as Merck & Co.'s Januvia in two late-stage studies. 

By Ned Pagliarulo • June 21, 2018

Incyte preps Jakafi expansion into graft-versus-host disease

With positive topline results from the pivotal REACH1 study in hand, Incyte plans to file an application next quarter.

By Jacob Bell • June 21, 2018

Heron shares jump on pain drug's Phase 2b successes

The biotech plans to submit the non-opioid analgesic to the FDA later this year, aiming to secure an approval in postoperative pain management. 

By Suzanne Elvidge • June 21, 2018

Anika shares slump on Phase 3 miss

The regenerative medicine company's osteoarthritis treatment failed to meet its goal, spurring investor worries about approval in the U.S. 

By Ned Pagliarulo • June 20, 2018

3 patients add $2.5B to Sarepta's value

Preliminary results from a few DMD patients given the biotech's gene therapy widely beat expectations, stoking hopes of a truly disease-modifying treatment.

By Jacob Bell • June 19, 2018

Electronic platforms drive improvements in vaccine study efficiency and data quality

Electronic diary (eDiary) cards are helping sponsors overcome the unique data collection challenges associated with vaccine trials.

By Tim Davis, VP Digital Patient, ERT • June 19, 2018

Vertex opens doors to new research site in San Diego

Research at the new complex, which is one of three hubs for the biotech, will focus on cystic fibrosis as well as other therapeutic areas, including pain.

By Suzanne Elvidge • June 19, 2018

Ziopharm shares tumble as clinical hold delays CAR-T

The FDA put a halt to the company's Phase 1 trial before it even began, seeking more information on the company's manufacturing plans.

By Suzanne Elvidge • June 19, 2018

Solid finds its footing as FDA lifts trial hold

Shares rose on news the biotech will resume enrollment into a Phase 1/2 study of its experimental gene therapy for DMD.

By Ned Pagliarulo • June 18, 2018

Valeant hit with CRL for key dermatology drug

While the pharma seems hopeful of a quick resolution, the red light from the FDA is a blow to Valeant's plans to turn around its dermatology business. 

By Ned Pagliarulo • June 18, 2018

ObsEva's endometriosis win puts it back in investors' good graces

The biotech is now looking to take two doses of linzagolix into Phase 3 for pain associated with the condition.

By Jacob Bell • June 18, 2018

Cytokinetics says early SMA treatment shows promise

Investors, however, were not so convinced, sending shares in the biotech sliding Monday morning.

By Suzanne Elvidge • June 18, 2018

Prescribed Reading: J&J sells off units; another Alzheimer's defeat

Big pharma extended its string of divestitures and portfolio streamlining this week. Meanwhile, manufacturers can't seem to beat Alzheimer's disease.

By Lisa LaMotta • June 15, 2018

Bluebird's changes to LentiGlobin begin to pay off

The gene therapy continued to show promise in two genetic blood disorders, but questions of durability remain.

By Ned Pagliarulo • June 15, 2018

Lilly's Olumiant delivers positive Phase 2 lupus data

The trial win is likely welcome news for Lilly and partner Incyte in light of the drug's narrow and disappointing approval in rheumatoid arthritis.

By Suzanne Elvidge • June 15, 2018

GSK touts two-drug HIV therapy, intends to file this year

Success of the doublet should help GSK better compete with Gilead, its main competitor in the HIV market. 

By Jacob Bell • June 14, 2018

Flex calling it quits after trial stop

Safety concerns for its lead candidate are forcing the company to abandon development and pursue strategic options.

By Lisa LaMotta • June 13, 2018

Galmed stock jumps sky-high on mixed results for NASH drug

While the company touted the drug's impact on liver fat, a closer look at the study results raises questions about how effective the treatment really is.

By Suzanne Elvidge • June 13, 2018

Lilly, AstraZeneca pull the plug on Alzheimer's trials

Two late-stage trials for the debilitating neurological condition were stopped for futility, further weakening the amyloid hypothesis. 

By Lisa LaMotta • June 12, 2018

Allergan notches another CGRP success, but faces changing migraine market

The pharma's atogepant succeeded in a late-stage study, advancing its plans in the space. Rivals, however, look set to jump ahead.

By Ned Pagliarulo • June 11, 2018

Vical abandons herpes vaccine after mid-stage miss

It's the latest in a series of trial failures that have pummeled the San Diego biotech's stock over the last several years.

By Jacob Bell • June 11, 2018

FDA lays out biosimilar guidance for agency meetings

One aim of the draft guidance is to speed biosimilars' path to market by improving communication with the regulator. 

By Suzanne Elvidge • June 6, 2018

ASCO18: 3 unanswered questions from oncology's largest conference

This year's ASCO meeting showcased dozens of major advances in cancer care, but several major questions remain in the red-hot field of immunotherapy. 

By Ned Pagliarulo • June 6, 2018