MC2 Therapeutics' psoriasis drug succeeds in Phase 3 trial

The private Danish company unveiled topline data showing its topical cream was superior to Taclonex, supporting plans to file an NDA in 2019.

By Andrew Dunn • Aug. 21, 2018

Seven deadly sins of trial supply management: Is penny-pinching worth it?

Supply chain logistics can make or break a clinical trial. In many cases, failure to provide and manage trial supplies on time has resulted in costly delays. So how does a CRO partner work with a sponsor to ensure supplies are properly managed?

Aug. 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

Regeneron, Teva boast positive Phase 3 results for osteoarthritis drug

Data showed significant improvements in pain and function, although safety worries for the anti-NGF drug class have tempered expectations.

By Barbara Boughton • Aug. 20, 2018

Eisai-Merck partnership picks up first-line Lenvima approval

While Keytruda combo trials remain in progress, the companies secured an important OK for the kinase inhibitor in hepatocellular carcinoma.

By Suzanne Elvidge • Aug. 20, 2018

Fewer worries for Biohaven as it reports positive anxiety data

The biotech's sublingual riluzole hit a Phase 2/3 trial's primary endpoint on social anxiety disorder and public speaking anxiety.

By Suzanne Elvidge • Aug. 17, 2018

Catalyst gives positive hemophilia update as 2 more subjects complete study

Consistent with the first patient, all three who have wraped up the Phase 2/3 trial of MarzAA have yet to exhibit bleeding or develop anti-drug antibodies.

By Andrew Dunn • Aug. 16, 2018

J&J, ViiV tout positive data for two-drug HIV therapy

The ATLAS study provides even more evidence to back up the two-drug approach to HIV.

By Jacob Bell • Aug. 15, 2018

Entasis optimistic on safety trial results for UTI drug

Both the privately-held biotech's treatment and placebo achieved 100% clinical success in the Phase 2 trial.

By Suzanne Elvidge • Aug. 15, 2018

Realm Therapeutics faces another Phase 2 failure in eczema

The small biotech saw its only clinical trial fail, leaving its stock tattered and execs with a murky path forward.

By Andrew Dunn • Aug. 14, 2018

Gemphire's lead drug worsened disease, investigators conclude in ending trial

Shares in the Michigan-based biopharma have plunged nearly 80% this week, as its only drug candidate has suffered multiple setbacks.

By Andrew Dunn • Aug. 10, 2018

Torque touts modular approach to T cell manufacturing

Dubbed "Slipstream," Torque's platform is designed to be scalable and less labor-intensive than current cell manufacturing methods.

By Suzanne Elvidge • Aug. 9, 2018

Bellerophon halts Phase 3 trial for futility after interim data check

The biotech turned its focus to two Phase 2 programs, but the setback sunk shares in the company. 

By Barbara Boughton • Aug. 8, 2018

Regenxbio dips as gene therapy platform yields mixed results

While the biotech is moving full steam ahead with an eye disease treatment, safety and efficacy appear less solid for its genetic cholesterol disorder therapy.

By Jacob Bell • Aug. 8, 2018

Gemphire stock drops to all-time low as lead drug delayed

Phase 3 studies of gemcabene can't begin until a partial clinical hold on the drug's class is lifted — something Gemphire now needs more data to do. 

By Andrew Dunn • Aug. 7, 2018

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

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