Placebo response dulls otherwise shiny results for Gemphire drug

A higher than expected response in the control group of the cholesterol study pushed down shares, despite a positive outcome. 

By Jacob Bell • Aug. 7, 2017

Prescribed Reading: More portfolios reshuffled

Restructuring continued throughout the industry, as more companies attempt to cut costs or excess programs. Meanwhile, the FDA kept up its rapid pace of drug approvals.

By Lisa LaMotta • Aug. 4, 2017

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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

So far, so good for Spark in hemophilia A

Three patients dosed with SPK-8011 have demonstrated improved Factor VIII levels and no serious adverse effects.

By Jacob Bell • Aug. 3, 2017

Cytokinetics inches forward with heart failure program

Amgen and the smaller biotech have been developing omecamtiv mercabil since 2006, pushing through a clinical setback and dimming commercial prospects for the class. 

By Ned Pagliarulo • Aug. 2, 2017

Theravance downplays mixed data in GI study

In a Phase 2 study, Theravance's velusetrag turned up statistically significant results for one dose, but failed in others. 

By Lisa LaMotta • Aug. 2, 2017

23andMe, Lundbeck unveil mega investigation of genetics' role in depression

Enrollment has already begun for the 25,000-person investigation.

By Jacob Bell • Aug. 2, 2017

Bristol-Myers, Clovis ink industry's latest PARP deal

The companies plan to investigate the combination of Opdivo and Rubraca as a treatment for various cancers.

By Jacob Bell • Aug. 1, 2017

Unfazed by competition, Allergan sees room at CGRP table

Allergan believes it can break into the emerging CGRP migraine market, even as it lags behind other drugmakers' rival products.

By Ned Pagliarulo • July 28, 2017

Prescribed Reading: Pharma marked by restructuring and failures

A week of earnings announcements emphasized changes in portfolios against the backdrop of a major pipeline failure. 

By Lisa LaMotta • July 28, 2017

Bristol shrugs off comparisons to MYSTIC

The big pharma was faced with an onslaught of questions regarding the potential of its own PD-1/CTLA4 combination after AstraZeneca's failure.

By Lisa LaMotta • July 28, 2017

Vertex set up for CF monopoly due to data, contracts

The rollout of further data for its triple combination cystic fibrosis treatments, as well as agreements with payers, could allow the biotech to wipe out competition.

By Lisa LaMotta • July 27, 2017

Quark wins in Phase 2, raising the stakes for RNAi

The company is trying to best Alnylam in being the first to secure FDA approval for an RNAi therapy.

By Jacob Bell • July 27, 2017

MYSTIC flop a major blow to AstraZeneca's I/O hopes

Much-anticipated results from the Phase 3 lung cancer study showed a combination of Imfinzi and tremelimumab failed to deliver a progression-free survival benefit.

By Ned Pagliarulo • July 27, 2017

Tetraphase gains on strong antibiotic results

Shares of the biotech jumped on positive late-stage results, ahead of regulatory filings for the company's antibiotic.

By Lisa LaMotta • July 26, 2017

J&J reports positive results for HIV regimen

Patients taking a once-daily tablet comprised of darunavir and a regimen of Gilead drugs demonstrated low virologic rebound rates and high virologic suppression.

By Jacob Bell • July 25, 2017

Genocea readies Phase 3 for herpes drug

Genocea's Phase 2b immunotherapy data could be a shot in the arm for treatment of recurrent genital herpes.

By Suzanne Elvidge • July 25, 2017

Lilly maps out new approach to cancer R&D

Setting a new bar for its research efforts, the Indianapolis drugmaker will seek to out-license six assets while funneling R&D dollars toward priority projects.

By Ned Pagliarulo • July 25, 2017

Keytruda failure another setback for PD-1/L1 class

Merck's flagship immunotherapy didn't significantly improve overall survival for some head and neck cancer patients — adding to a string of recent setbacks for the anti-PD-1 class.

By Jacob Bell • July 25, 2017

Gilead's combo shows no resistance in HIV

As hepatitis C revenues fall, Gilead is leaning on its HIV franchise, which has been showing strong data. 

By Suzanne Elvidge • July 25, 2017

Bayer misses in mid-stage mesothelioma trial

The drug failed in a Phase 2 study as a treatment for patients with asbestos-linked cancer. Development will continue for other tumor types, however. 

By Suzanne Elvidge • July 24, 2017

Nektar secures $400M deal with Lilly for Phase 1 drug

Lilly liked what it saw in the immunological candidate, paying $150 million upfront to gain access to a compound Nektar discovered just over a year ago.

By Ned Pagliarulo • July 24, 2017

Prescribed Reading: Bolt-on deals for Sanofi

The big pharma tries to fill its pipeline, Vertex touts strong CF data and the FDA gives three approvals.

By Lisa LaMotta • July 21, 2017

Ironwood touts positive data, but investors aren't sold

The company intends to move the 1,500 mg dose of IW-3718 into Phase 3 after lower doses missed primary outcome measures.

By Jacob Bell • July 20, 2017

Neurotrope stock tumbles again on Alzheimer's data

Sea-derived bryostatin-1 still isn't quite hitting the spot for Neurotrope in Alzheimer's disease.

By Suzanne Elvidge • July 20, 2017

Positive triple combo data sets up Vertex for big growth

The new data on its cystic fibrosis treatments lifted shares more than 20%, adding billions to the company's market capitalization.

By Jacob Bell • July 19, 2017