How the FDA is trying to demystify clinical trial data

The Safety Graphics Working Group has created a publicly available, web-based database of graphical designs for reporting clinical trial data. 

By Nicole Gray • Sept. 24, 2015

After Harvoni: A pangenotype hep C combo could be Gilead's next breakthrough

In three phase 3 trials, Sovaldi combined with velpatasvir provided a durable cure in 98% of patients 12 weeks after therapy.

By Nicole Gray • Sept. 22, 2015

Explore the Trendline➔

Cell therapy

The continued emergence of CAR-T therapy has fueled research into next-generation approaches and new applications, such as its use in autoimmune diseases.

By BioPharma Dive staff

Merck's antibody-in-development reduces risk of C. difficile re-infection

In pivotal studies, bezlotoxumab reduced the risk of Clostridium difficile (C. difficile) recurrence from 25% to 15% in infected patients. 

By Nicole Gray • Sept. 21, 2015

Lilly/BI's Jardiance found to be first diabetes med to cut CV deaths in study

CV death risk plunged nearly 40% with Jardiance, according to the study.

By Nicole Gray • Sept. 21, 2015

Aerie Pharma's glaucoma eye drop shows promise in late-stage trial

In a phase 3 study, Rhopressa demonstrated non-inferiority to timolol. 

By Nicole Gray • Sept. 17, 2015

Merck's once-weekly diabetes med as effective as daily Januvia in study

If the results hold steady in trials, Merck could have a diabetes med with a major convenience factor on its hands. 

By Nicole Gray • Sept. 17, 2015

Intra-Cellular shares fly as schizophrenia drug shown effective at higher doses

The company's stock is up nearly another 8% in Thursday morning trading after surging on Wednesday.

By Nicole Gray • Sept. 16, 2015

Xenoport shares dive as psoriasis drug shows serious GI side effects

22% to 40% of patients treated with the drug experienced diarrhea, compared with 15% of placebo-treated patients. 

By Nicole Gray • Sept. 16, 2015

The next hope for GW Pharma's cannabis med: Schizophrenia treatment

In mid-stage trials, GW's drug cannabidiol was superior to placebo for treatment of schizophrenia in patients who were non-responsive to antipsychotics.

By Nicole Gray • Sept. 16, 2015

2 new studies show Gilead's Truvada extremely effective for HIV prevention

According to data used by Gilead to obtain the drug's indication, PrEP prevents HIV infection in 92% of at-risk individuals who take it. Now there is new data confirming those findings. 

By Nicole Gray • Sept. 14, 2015

Glaxo takes a big blow as 'son of Advair' fails to extend COPD patients' lives

The company and its partner, Theravance, was strongly hoping that the asthma/COPD medication Breo would shine where other such drugs have failed by demonstrating a survival benefit. 

By Nicole Gray • Sept. 9, 2015

Novartis to join forces with Google, launch human tests for 'smart' contacts

Think of it as "auto-focus" for aging eyes.

By Sy Mukherjee • Sept. 8, 2015

New study claims Pfizer's Chantix not linked to depression, heart attacks after all

The controversial anti-smoking medication got a big boost from researchers in the U.K. But will it be enough to convince regulators that it's safer than once thought?

By Nicole Gray • Sept. 8, 2015

A big win for AZ as FDA clears Brilinta for long-term use

Brilinta (ticagrelor) was approved in 2011 for secondary prevention of acute coronary syndrome (ACS) events for up to one year.

By Nicole Gray • Sept. 8, 2015

Bristol-Myers is testing out a dual-threat Opdivo/Yervoy lung cancer combo

It's proven safe so far in early stage trials. But just how much of an improvement will it be over standalone therapy with the rock star Opdivo?

By Nicole Gray • Sept. 8, 2015

Bayer lines up a phase III trial for its dual-threat heart failure hopeful

Researchers are evaluating finerenone for treatment of chronic heart failure and diabetic kidney disease. 

By Nicole Gray • Aug. 31, 2015

Asterias stem cell therapy shows promise in spinal cord injury patients

The trial was small, but the results were promising.

By Nicole Gray • Aug. 31, 2015

An experimental anti-cholesterol drug could outperform approved PCSK9 meds

Watch out, Amgen and Sanofi/Regeneron.

By Nicole Gray • Aug. 31, 2015

J&J/Genmab unveil promising data for a potential multiple myeloma superstar

Daratumumab made waves at the American Society of Clinical Oncology meeting earlier this summer.

By Nicole Gray • Aug. 27, 2015

Novo jumping into phase III trials for major oral diabetes candidate

If approved, oral semaglutide will become the first non-injectable GLP-1 agonist. 

By Nicole Gray • Aug. 27, 2015

Could an aspirin a day keep colon cancer away?

Taking low-dose aspirin daily for at least five years reduces the risk of colorectal cancer by 27%, according to a new Danish study. 

By Nicole Gray • Aug. 26, 2015

Study: Common beta blockers can extend ovarian cancer patients' lives

In a retrospective study of women with ovarian cancer, taking non-selective beta blockers increased survival by an average of four years. 

By Nicole Gray • Aug. 25, 2015

US Army testing drug to protect soldiers' hearing

In 2013, tinnitus (consistent ringing in the ers) and hearing loss were the most prevalent service-connected disabilities for veterans.

By Nicole Gray • Aug. 24, 2015

Excitement over Jardiance may come at Merck's expense

A recent study suggested that Lilly/BI's Jardiance could be the first diabetes med to cut CVD risk.

By Nicole Gray • Aug. 24, 2015

Rare disease companies' existential challenge: Patient enrollment

Three companies are recruiting patients with Nieman Pick Type C (NPC), a very rare and deadly disease, for clinical trials.

By Nicole Gray • Aug. 21, 2015