Aradigm's inhaled antibiotic shows mixed results, shares fall

The specialty pharmaceutical company's lead product candidate, Pulmaquin, outperformed placebo in only one of two late-stage trials.

By Judy Packer-Tursman • Dec. 2, 2016

Cerecor drops on Phase 2 failure, remains optimistic

The company is building future hopes for the drug on secondary endpoint signals. 

By Suzanne Elvidge • Dec. 1, 2016

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

Alnylam touts hemophilia drug's edge over Roche rival

With revusiran nixed, Alnylam hopes to launch Phase 3 studies of fitusiran early next year and catch up to Roche's experimental hemophilia drug. 

By Ned Pagliarulo • Nov. 30, 2016

CytRx touts latest trial data on sarcoma drug

The company's CEO contends that previous negative data, released in July, were incomplete.

By Judy Packer-Tursman • Nov. 30, 2016

Arrowhead nixes clinical pipeline, trims staff

Staring down substantial regulatory delays, the RNAi drug developer will restructure and pivot to its preclinical pipeline.

By Ned Pagliarulo • Nov. 30, 2016

ASH preview: CAR-Ts, mixed results and pipeline progress

Release of abstracts in early November caused stocks of several biotechs to crash. With ASH set to kick off Saturday, a look ahead at what's in store. 

By Ned Pagliarulo • Nov. 30, 2016

Intec Pharma taps Michael J. Fox Foundation for Parkinson's recruitment

The company, which recently reduced its trial's sample size, hopes the Foundation will help it attract and retain advanced-stage Parkinson's patients.

By Judy Packer-Tursman • Nov. 29, 2016

Positive trial results push Santen eye drug toward approval

The Osaka, Japan-based specialty drugmaker plans to file for the drug's approval in early 2017.

By Jacob Bell • Nov. 28, 2016

Recro Pharma notches second Phase 3 win for pain drug

The Pennsylvania-based specialty pharma hopes intravenous meloxicam can be an alternative to opiod painkillers for treatment of postoperative pain.

By Ned Pagliarulo • Nov. 28, 2016

House nears vote on 21st Century Cures bill

The legislation includes $1 billion in opioid-addiction treatment funding for states, as well as measures to speed the FDA approval process for certain medical devices. 

By Judy Packer-Tursman • Nov. 28, 2016

With data in hand, GSK readies to expand Nucala label

The asthma monoclonal antibody met its primary endpoint in a Phase 3 trial aimed at expanding its label. 

By Suzanne Elvidge • Nov. 28, 2016

Allergan builds Alzheimer's portfolio with Chase acquisition

The deal came just hours before Eli Lilly announced its highly anticipated Alzheimer's treatment failed in Phase 3. 

By Jacob Bell • Nov. 23, 2016

Lilly's sola failure throws Alzheimer's theory into doubt

Solanezumab failed to improve cognition in patients with mild cognitive impairment, putting the final nail in the coffin for Lilly's Alzheimer's hopes. 

By Lisa LaMotta • Nov. 23, 2016

Juno halts CAR-T trial after new patient deaths

Two leukemia patients in Juno's ROCKET study died from cerebral edema, throwing the future of the CAR-T treatment into doubt. 

By Ned Pagliarulo • Nov. 23, 2016

Anavex touts topline data for Alzheimer's drug trial

The study is small and a larger cohort must confirm positive results, but data seem promising.

By Judy Packer-Tursman • Nov. 23, 2016

AstraZeneca restarts halted durvalumab trials

The FDA placed a partial clinical hold on studies of the checkpoint inhibitor in head and neck cancer late last month, sparking investor concerns.  

By Ned Pagliarulo • Nov. 22, 2016

Mast Therapeutics considers post-failure strategy

Stocks traded higher as Mast management looked to the future in a new plan. 

By Suzanne Elvidge • Nov. 22, 2016

Chiesi buys asthma company, pitting it against Novartis

Novartis has moved into Phase 3 testing of its oral asthma drug fevipiprant, which works in a similar manner to Chiesi's newly acquired asthma candidate. 

By Suzanne Elvidge • Nov. 22, 2016

Trial miss derails Acorda's Ampyra plans

Acorda will halt further development of Ampyra as a treatment for post-stroke walking difficulties, crimping its lifecycle management strategy.

By Judy Packer-Tursman • Nov. 21, 2016

Spectrum's Qapzola turned down by FDA

Following the failure of two earlier trials, Spectrum is stepping up to another study to try to prove efficacy.

By Suzanne Elvidge • Nov. 21, 2016

Prescribed Reading: Data, arrests, pricing batter pharma

Gilead falters, ex-Valeant exec indicted, combo data dominates in hep C and pricing worries continue. 

By Lisa LaMotta • Nov. 18, 2016

Tetraphase antibiotic holds up in Phase 3

The Massachusetts biopharma is developing several antibiotics against multidrug-resistant bacterial infections. 

By Suzanne Elvidge • Nov. 18, 2016

The ODYSSEY continues for PCSK9s

Regeneron and Sanofi will continue their cardiovascular outcomes study, prolonging the uncertainty surrounding the drug class. 

By Lisa LaMotta • Nov. 17, 2016

Mixed results for Gilead slow momentum

As hepatitis C sales fall, Gilead is under pressure to prove its pipeline's potential. A hit and a miss in two studies of momelotinib won't go far to ease those concerns. 

By Suzanne Elvidge • Nov. 17, 2016

Amgen, Novartis tout top-line migraine results

The drug's success would offer Amgen an entry into the neuroscience space while giving Novartis's Innovative Medicines division a boost.

By Jacob Bell • Nov. 16, 2016