Teva's laquinimod fails in Huntington's after striking out in MS

The generic giant's search for its next blockbuster drug may have hit a dead-end with laquinimod.

By Andrew Dunn • July 31, 2018

Otsuka's 'next-gen' cancer drug flunks its first Phase 3 study

Guadecitabine didn't significantly improve complete response rates and overall survival, but Otsuka plans to continue to assess it in multiple blood cancers.

By Jacob Bell • July 31, 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

Progenics picks up radiotherapeutic approval for rare cancers

Azedra is the first drug specifically developed for metastatic pheochromocytoma or paraganglioma, two uncommon adrenal gland tumors.

By Suzanne Elvidge • July 31, 2018

CytoDyn gets OK to increase dose in HIV trial

The biotech hopes adding a higher 700 mg dose of PRO 140 to its Phase 3 study will increase response rates.

By Suzanne Elvidge • July 31, 2018

Sienna's acne treatment-device flops in pivotal trials

The California-based company isn't giving up on the product, however. Its CEO said Sienna remains optimistic in its use for hair treatment.

By Andrew Dunn • July 30, 2018

Efficiency, transparency and standardization: The roadmap for improved data collection in medical device clinical trials

By adopting a unified solution for data collection, medical device clinical teams can address the need for efficiency, transparency and standardization.

July 30, 2018

RedHill drug for Crohn's clears first Phase 3 hurdle

RHB-104 is a combo of three antibiotics designed to attack a bacterial infection that's thought to play a role in Crohn's.

By Ned Pagliarulo • July 30, 2018

Merck, Bristol top earnings, but lung cancer rivalry remains the focus

With neck-and-neck sales for Opdivo and Keytruda, the big pharmas touted where they see each drug locking down market share in the NSCLC space.

By Jacob Bell • July 27, 2018

FDA puts clinical hold on Sarepta's DMD gene therapy program

The biotech has already created a plan to address the issue, with the aim of dosing patients by the end of 2018 pending an FDA go-ahead.

By Suzanne Elvidge • July 27, 2018

Celgene bets on fantastic 5 to save portfolio

Ozanimod, bb2121 and a few other late-stage assets should launch before 2021. Whether they'll quell investors' thirst for diversification remains uncertain.

By Jacob Bell • July 26, 2018

Sunovion drug cuts binge eating days at higher dose

In mixed results, the higher dose met the primary endpoint of fewer binge days per week, but the lower dose missed.

By Suzanne Elvidge • July 26, 2018

Positive Alzheimer's results from Biogen, Eisai spark 'cautious optimism'

Lingering questions, however, tempered hopes for a home run from BAN2401 and sent Biogen's stock sliding down by 10%.

By Ned Pagliarulo • July 25, 2018

Rice-sized form of Roche's Lucentis heads for advanced testing

Phase 2 data showed the majority of wet AMD patients implanted with the device went six months before needing a refill of a concentrated formulation of the popular eye drug.     

By Jacob Bell • July 25, 2018

ResTORbio rockets up on questionable data

Odd dosing results and pooled data muddy what otherwise would be positive results for the biotech's respiratory infection drug.

By Jacob Bell • July 25, 2018

Two-drug HIV regimen from GSK bolstered by Phase 3 data

Detailed results from the British pharma's GEMINI studies showed the doublet to be as effective as a standard three-drug cocktail in controlling the virus.

By Ned Pagliarulo • July 24, 2018

Reata stock surges on positive data in CKD patients

The results could mean a quicker route to approval for bardoxolone methyl in a rare form of chronic kidney disease.

By Suzanne Elvidge • July 24, 2018

Tecentriq misses another chance to catch Keytruda

In initial looks at two Phase 3 studies this year, Roche's immunotherapy has fallen short of the bar set by Merck's rival drug. 

By Ned Pagliarulo • July 19, 2018

Allergan's eye drug stacks up against Lucentis, but wider market still iffy

Late-stage tests showed abicipar was non-inferior to Roche's blockbuster. But greater inflammation suggests Allergan has more work to prove the drug's marketability.

By Jacob Bell • July 19, 2018

Pfizer, Lilly tout positive tanezumab data, but safety questions remain

Trial results showed the non-opioid pain drug improved physical function. But details on safety, a key issue for NGF inhibitors like tanezumab, were limited.

By Lisa LaMotta • July 18, 2018

Invokana renal trial stopped early for efficacy

A late-stage outcomes study could help reverse the fortunes of the multinational's aging diabetes medicine.

By Lisa LaMotta • July 17, 2018

Roche experimental flu drug clears second Phase 3

The Swiss pharma has already submitted the antiviral for U.S. approval, with a decision expected by late December. 

By Ned Pagliarulo • July 17, 2018

CytoDyn touts new data in drug-resistant HIV patients

Even amid an acquisition and new interest in cancer, HIV is still the main focus for CytoDyn and its lead candidate.

By Suzanne Elvidge • July 17, 2018

Cassiopea prospects fill in as hair loss drug shows promise

The small biotech believes these results, while preliminary, show efficacy to compete with Propecia.

By Ned Pagliarulo • July 16, 2018

Dermavant finds 'cornerstone' drug in GSK's pipeline

The British pharma will out-license tapinarof, in testing for psoriasis and atopic dermatitis, to Dermavant for nearly $200 million.

By Ned Pagliarulo • July 12, 2018

New epilepsy data sets Zogenix up for showdown with GW

More late-stage data showed patients with a rare form of epilepsy had greater reductions in monthly seizures when taking ZX008 compared to placebo.

By Jacob Bell • July 12, 2018