Safety signal derails expected approval of Amgen bone drug

Amgen no longer expects to win U.S. approval this year for romosuzumab after reporting an imbalance of cardiovascular adverse events in a comparator study.

By Ned Pagliarulo • May 22, 2017

Prescribed Reading: ASCO dominates, Icahn BMS interest just a rumor

The abstracts have arrived! Carl Icahn's first quarter holdings are released and J&J gets a black box warning. 

By Lisa LaMotta • May 19, 2017

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

Albireo rises on Phase 3 plans for liver drug

Following discussions with the FDA and EMA, the Boston-based biotech plans to kick off its Phase 3 trial in the second half of this year. 

By Suzanne Elvidge • May 19, 2017

7 Areas to watch from the ASCO abstracts

With oncology's biggest meeting less than two weeks away, here are seven highlights from the recently released abstracts that are worth keeping an eye on. 

By Ned Pagliarulo • May 18, 2017

Shire's angioedema drug scores in Phase 3

Patients receiving a 300 mg dose of lanadelumab every other week had an 87% reduction in average number of hereditary angiodema attacks versus those on placebo.

By Jacob Bell • May 18, 2017

J&J claims higher R&D productivity than peers

The pharma giant laid out a future filled with billion-dollar products for investors, promising 10 new blockbusters by 2021. 

By Suzanne Elvidge • May 17, 2017

Concert trial on hold while FDA reviews tox studies

The biotech's baldness drug was put on clinical hold by the regulatory agency in order to assess non-clinical toxicology studies. 

By Lisa LaMotta • May 17, 2017

Editas delays CRISPR move to human trials

The biotech announced a delay for its planned IND filing, giving competitors an opening to start trials in the closely watched field first. 

By Lisa LaMotta • May 16, 2017

Minerva's schizophrenia drug heads to late stages

The central nervous system drug developer has completed an end-of-Phase 2 meeting with the FDA, and plans to kick off late-stage testing later this year.

By Jacob Bell • May 16, 2017

Drug adherence: What you need to know

One of the biggest problems in the medical field is patients not taking their drugs or using them improperly. When patients are non-adherent, drugs don't work. 

By Lisa LaMotta • May 15, 2017

5 trends changing drug adherence for the better

Many things can affect whether a patient takes a drug as prescribed, but stakeholders are intervening in order to make patients more compliant with their meds.

By Lisa LaMotta • May 15, 2017

Ionis safety issues are a win for Alnylam

A Phase 3 study of Ionis' drug inotersen met both its primary endpoints. But new safety concerns pushed shares in the biotech down nearly 10% Monday. 

By Lisa LaMotta • May 15, 2017

Solutions to clinical trial adherence remain elusive

Making sure patients take their medications is crucial to clinical trial success, but exactly how to do that remains a daunting task for investigators.

By Jacob Bell • May 15, 2017

Medication adherence: The secret sauce for better outcomes?

Rates of non-adherence vary widely and depend on condition, price and other issues. But unfilled prescriptions and missed doses cost the healthcare system billions annually.

By Malorye Allison Branca • May 15, 2017

Prescribed Reading: Checkpoint inhibitors change cancer

Approvals and failures of checkpoint inhibitors have dramatically changed the cancer landscape, and could even have an impact on how the FDA approaches approvals. Elsewhere, Pfizer's getting into genes and Advair avoids competition.

By Lisa LaMotta • May 12, 2017

Interim results from Capricor's ALLSTAR trial were anything but

The clinical-stage biotech's stock tanked roughly 60% Friday morning after interim analysis gave a grim outlook for the success of its lead candidate. 

By Jacob Bell • May 12, 2017

AstraZeneca rises after positive lung cancer results for key drug

Imfinzi improved progression-free survival in the Phase 3 PACIFIC study, building confidence in the drug's chances in a crowded field.

By Ned Pagliarulo • May 12, 2017

Roche's Tecentriq fails trial, raising questions about approval

The late-stage failure in bladder cancer now calls into question the FDA's initial decision to OK the drug.

By Lisa LaMotta • May 10, 2017

AstraZeneca relies on biomarkers for Phase 3 asthma studies

A failure in the STRATOS 1 study has prompted the company to look at a sub-population in a second ongoing Phase 3 study. 

By Lisa LaMotta • May 10, 2017

AbbVie's JAK-1 inhibitor hits the mark in Crohn's disease

A Phase 2 study showed upadacitinib significantly reduced patients' intestinal inflammation, results that should push the drug into late-stage testing.

By Jacob Bell • May 10, 2017

New partnership will advance novel platform for I/O

Takeda and GammaDelta Therapeutics will collaborate to develop a T-cell platform for use in cancer and auto-inflammatory disease treatments.    

By Barbara Boughton • May 10, 2017

Kite discloses patient death in CAR-T trial, sparking safety worries

The death was the first in Kite's testing of axi-cel related to cerebral edema, a potentially fatal condition which had derailed a competing treatment from Juno Therapeutics.

By Ned Pagliarulo • May 8, 2017

Teva crashes out of laquinimod MS program

The Israeli pharma's Copaxone follow-on laquinimod fails in the CONCERTO trial, forcing the company to abandon the drug in multiple sclerosis. 

By Suzanne Elvidge • May 8, 2017

Prescribed Reading: Deals to come, but when?

Pfizer and Gilead could be in a deal-making mood, while the FDA continues to approved drugs at a rapid clip and clinical failures keep coming. 

By Lisa LaMotta • May 5, 2017

Abivax shares soar on mid-stage HIV results

Treatment with ABX464, in addition to current anti-retroviral drugs, reduced viral reservoirs in the blood — positive results that have pushed shares of the biotech up.

By Suzanne Elvidge • May 3, 2017