Spark sheds $1B in value on hemophilia gene therapy data

Despite Spark's plans to move quickly into Phase 3 testing, questions remain around the treatment's safety and efficacy profile.

By Ned Pagliarulo • Aug. 7, 2018

Allergan and Editas exercise CRISPR option

The big pharma will develop and commercialize EDIT-101 globally, while its smaller partner will co-develop and share profits and losses in the U.S.

By Suzanne Elvidge • Aug. 7, 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

Ovid's Angelman syndrome drug shows mixed results in Phase 2

OV101 is trying to be the first treatment for Angelman syndrome, a rare genetic disorder. While it achieved its primary clinical trial goal focused on safety, the efficacy endpoints were mixed, leading Ovid's stock to sink.

By Andrew Dunn • Aug. 6, 2018

With no partner, MorphoSys drops MOR202 in myeloma

The focus on MOR202 is shifting after three years of Phase 1/2 testing in multiple myeloma.

By Suzanne Elvidge • Aug. 3, 2018

Epizyme trims back blood cancer trials for lead drug, stock sinks

Investor patience looks to be wearing thin as the biotech works to clear a clinical hold on tazemetostat. Epizyme's shuttering of two studies won't help.

By Andrew Dunn • Aug. 2, 2018

Latest PRV sale further evidence of sliding value

Ultragenyx and Kyowa Kirin sold a PRV for just $81 million, reinforcing the downward trend in prices commanded by the regulatory "fast passes."

By Ned Pagliarulo • Aug. 2, 2018

Celtaxsys CF drug misses mark on lung function

While the biotech focused on the "clinically meaningful" benefit its acebilustat had on pulmonary exacerbations, the drug failed to hit the Phase 2 trial's primary endpoint.

By Jacob Bell • Aug. 2, 2018

Gencaro back from the brink as FDA gives Phase 3 go-ahead

Regulators have told Arca a single Phase 3 study could be sufficient to support an NDA for the heart medicine.

By Suzanne Elvidge • Aug. 1, 2018

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

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