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

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

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

Price, safety will test blockbuster billing for AbbVie's new arthritis drug

Rinvoq​ adds another oral option to rheumatologists' tool kits, but at a list price of $59,000 per year. 

By Jacob Bell • Aug. 16, 2019

Roche cancer drug the 3rd approved for pan-tumor use

Entrectinib, which will be sold as Rozlytrek, joins Bayer's Vitrakvi as a treatment for solid cancers featuring a rare genetic fusion.

By Ned Pagliarulo • Updated Aug. 15, 2019

Study success strengthens case for Lynparza in ovarian cancer

Lynparza, approved since December as a first-line maintenance therapy in the tumor type, is now supported by positive results from a second trial in that setting.

By Ned Pagliarulo • Aug. 14, 2019

Regeneron gets cholesterol drug win where Praluent won't go

The experimental therapy cut "bad" cholesterol levels almost 50% compared to placebo in patients with a hard-to-treat metabolic disorder.

By Jonathan Gardner • Aug. 14, 2019

Lilly bests J&J, with implications for AbbVie's new immunology star

A study of psoriasis patients found Lilly's Taltz outperformed J&J's Tremfya, which works the same way as AbbVie's new-to-market offering, Skyrizi. 

By Jacob Bell • Aug. 13, 2019

Deciphera success sets up 2-horse race in gastrointestinal cancer

The small biotech rejoined the billion-dollar club after trial results for its experimental drug look to have bested those of a rival from Blueprint.

By Jonathan Gardner • Aug. 13, 2019

Adapting the research model for the real world – A case for change?

The widespread adoption of electronic health record systems provides an opportunity to reimagine the traditional clinical research model.

Aug. 13, 2019

As Ebola outbreak rages, researchers find promise in Regeneron drug

The antibody-based therapy yielded higher survival rates than standard of care in a large clinical trial, which is now advancing to an expansion stage.

By Jacob Bell • Aug. 12, 2019

AstraZeneca cancer drugs build as primary care shrinks

Top-seller Tagrisso shined in the front-line lung cancer setting, which should help offset declines to respiratory and cardiovascular drugs.

By Jonathan Gardner • Aug. 12, 2019

Nektar battered over manufacturing issues and Bristol-Myers pullback

A study of skin, kidney and bladder cancer found disease progressed faster after patients received inactive doses of a Nektar drug paired with Opdivo.

By Jonathan Gardner • Aug. 9, 2019

Hospitalized gene therapy patient triggers Sarepta sell off

An erroneous report of rhabdomyolysis in a patient enrolled in a Duchenne trial was the latest safety worry to send shares in a gene therapy biotech spiraling. 

By Jonathan Gardner • Aug. 8, 2019