BioMarin talks down worries on gene therapy data differences

BioMarin's R&D head said timing of steroid treatment impacted interim Phase 3 data, which had spurred questions on valrox's durability.

By Andrew Dunn • Sept. 10, 2019

Biomarker data help Merck case for wide use of Keytruda combo

"In the setting of chemo combinations, it does not appear that PD-L1 or TMB influences the outcome," said Merck development head Roy Baynes.

By Ned Pagliarulo • Sept. 10, 2019

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

The evolution of the patient experience

With the healthcare business model constantly evolving the pharmaceutical landscape, the role of healthcare providers is sure to look radically different in a few decades.

By Ian Wilcox • Sept. 10, 2019

Trial win could drive Acadia's Nuplazid to new use

A data monitoring board stopped study of dementia-related psychosis patients early due to positive efficacy, setting Nuplazid up for another FDA filing.

By Jonathan Gardner • Sept. 9, 2019

Pfizer touts successor to Prevnar 13

Phase 2 data showed Pfizer's experimental pneumococcal vaccine to be safe, boosting confidence in what Pfizer hopes will be a follow-on to Prevnar 13.

By Andrew Dunn • Sept. 9, 2019

Cancer drug data back up Lilly's Loxo buyout

Updated study results show striking efficacy for LOXO-292 in an uncommon form of lung cancer, clearing the path for Lilly to file for approval this year. 

By Ned Pagliarulo • Sept. 9, 2019

Amgen update shows promise, limits of KRAS cancer drug

A 54% response rate among lung cancer patients will encourage, but several relapses could temper sky-high expectations for AMG 510. 

By Ned Pagliarulo • Sept. 8, 2019

Ultragenyx gene therapy data disappoints investors

The biotech said the current dose of DTX401 will be taken into Phase 3 testing, although a less potent dosage level showed similar efficacy.

By Jonathan Gardner • Sept. 5, 2019

UniQure stays a step ahead in hemophilia B

Seeing high interest from patients and study investigators, uniQure is enrolling six more participants than planned in its Phase 3 gene therapy study.

By Ned Pagliarulo • Sept. 3, 2019

Medicines Co.'s cholesterol drug looks good to take on PCSK9 rivals

Data show inclisiran more or less matched Repatha and Praluent on cholesterol lowering, but the drug will need a smart launch, and possibly a partner, to compete.

By Jonathan Gardner • Updated Sept. 3, 2019

Novartis vies for multiple sclerosis dominance with Arzerra trial

The repurposed cancer drug is aiming at Roche's Ocrevus, but an upcoming full data presentation will tell MS specialists more about its promise.

By Jonathan Gardner • Aug. 30, 2019

Amgen puts its KRAS hopes on 'Navy Seals' team of drug hunters

Found in many solid tumors, mutant KRAS is cancer research's white whale. Amgen's drug looks the most promising to emerge from decades of failed efforts, but others are close behind. 

By Ned Pagliarulo • Aug. 30, 2019

AbbVie ends Rova-T research after another study setback

A string of clinical failures derailed AbbVie's ambitions for the cancer drug, which was once predicted to earn billions of dollars in peak sales.

By Andrew Dunn • Aug. 29, 2019

AstraZeneca gets lupus win but past failure could slow progress

A miss in anifrolumab's first Phase 3 trial a year ago raises questions over whether regulators will need a third study to see the drug through to market. 

By Jonathan Gardner • Aug. 29, 2019

Amyloid's last hope? Prevention studies next big test for Alzheimer's research

The DIAN-TU trial, studying patients genetically predisposed to Alzheimer's, could help decide the fate of what's been the dominant hypothesis of the disease's cause.

By Jonathan Gardner • Aug. 29, 2019

Biopharma jobs boom in Massachusetts, though challenges still exist

Many more jobs have opened up in R&D than in manufacturing, which saw growth of just 1% between 2017 and 2018.

By Jacob Bell • Aug. 27, 2019

Lilly's case for Taltz helped by expanded approval

By prescription numbers, Taltz trails Novartis' rival drug Cosentyx. An approval for use in ankylosing spondylitis will go some ways to level the playing field.

By Ned Pagliarulo • Aug. 26, 2019

Medicines Co.'s PCSK9 drug succeeds in first Phase 3 test

Positive results are a "major milestone," said one Wall Street analyst, easing safety concerns and setting up the biotech to file for approval this year. 

By Andrew Dunn • Aug. 26, 2019

Moving quickly, GSK to advance myeloma drug on new data

Positive Phase 2 results are early validation of GSK R&D chief Hal Barron's decision to bet heavily on the BCMA-targeting therapy.

By Ned Pagliarulo • Aug. 23, 2019

Drug co-invented by Martin Shkreli fails, pressuring his former biotech

While the ex-CEO serves a seven-year prison sentence, one of his former companies said a drug he helped develop fell short in Phase 3 testing.

By Andrew Dunn • Aug. 22, 2019

GSK's ViiV reports positive data for long-acting two-drug HIV therapy

Topline results showed the cabotegravir-based treatment can hold the virus in check with just six injections a year, GSK said. 

By Kristin Jensen • Aug. 22, 2019

AstraZeneca lung cancer miss is Merck's gain

While Imfinzi is well established in early treatment, showing benefit in the metastatic setting has proven difficult, with survival data from NEPTUNE the latest stumble.

By Ned Pagliarulo • Aug. 21, 2019

Sarepta now needs flawless progress for gene therapy

An unexpected rejection for the biotech's Vyondys 53 puts investor focus even more tightly on the biotech's earlier-stage muscular dystrophy pipeline.

By Jonathan Gardner • Aug. 20, 2019

AstraZeneca diabetes drug posts more positive heart data

Fewer patients with a history of heart issues died from a cardiovascular event or experienced worsening heart failure when taking Farxiga.

By Jacob Bell • Aug. 20, 2019

The quest for patient centricity: The travel conundrum

Patient enrollment is a central part of a clinical trial. But without proper transport, how can trials enroll?  

By Alistair Neally, PSI CRO – Director, Vendor Management • Aug. 20, 2019