Roche's Gazvya edges Rituxan in Phase 3

Yet the successor drug only slightly improved overall survival rates at 3 years, which coupled with riskier safety profile, could lessen its competitive advantage. 

By Suzanne Elvidge • Dec. 6, 2016

Karyopharm storms into ASH with updated Phase 2b data

Selinexor data reinforces safety and efficacy in heavily-pretreated multiple myeloma

By Suzanne Elvidge • Dec. 6, 2016

Explore the Trendline➔

Oncology's research boom

More than one quarter of the medcines cleared by the FDA's main review office since 2015 have been cancer drugs, a tally that reflects the advent of cancer immunotherapy as well as continued progress in matching treatment to genetics.

By BioPharma Dive staff

Juno turns to JCAR017 amid Rocket setback

Positive results presented at ASH Monday likely mean JCAR017 will be the focus moving forward, as Juno mulls axing JCAR015. 

By Ned Pagliarulo • Dec. 5, 2016

Spark teams up with Selecta on gene therapies

The gene therapy biotech will use Selecta's technology platform to bolster the efficacy of its hemophilia therapies. 

By Lisa LaMotta • Dec. 5, 2016

Alnylam scores ASH win in hemophilia

Encouraging results from an early study showed Alnylam's experimental drug fitusiran helps control bleeding even among hard-to-treat patients. 

By Ned Pagliarulo • Dec. 5, 2016

ASH: Spark highlights promise of gene therapy

Early clinical trial results offer hope for patients with the debilitating bleeding disorder. 

By Lisa LaMotta • Dec. 5, 2016

Novartis forges ahead with lead CAR-T

The Swiss pharma plans to file for approval of CTL019 in early 2017 after presenting encouraging data at ASH over the weekend. 

By Ned Pagliarulo • Dec. 5, 2016

Shire's Vonvendi controls surgical bleeding

Acquired through the Baxalta acquisition, Vonvendi hit its primary endpoint and data will contribute to a supplementary NDA.

By Suzanne Elvidge • Dec. 5, 2016

Prescribed Reading: Spotlight on CAR-T, Cures

AstraZeneca inks small deal that will fit into its new focus; the upcoming ASH meeting will highlight the progress in CAR-T; and the Cures Act gets support from the industry. 

By Lisa LaMotta • Dec. 2, 2016

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

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