Clinical Trials
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7 questions on Biogen's revival of a failed Alzheimer's drug
Biogen plans to submit aducanumab for approval, a dramatic reversal from the biotech's March decision to halt two large studies of the drug. Here's a look at what's still unknown.
By Ned Pagliarulo , Jonathan Gardner • Oct. 22, 2019 -
Novartis downplays late-stage asthma drug failures
Fevipiprant failed the first pair of late-stage clinical trials in asthma. Novartis CEO Vas Narasimhan said a second pair of studies are more likely to succeed.
By Andrew Dunn • Oct. 22, 2019 -
In major surprise, Biogen will ask FDA to approve Alzheimer's drug aducanumab
New data from two trials halted earlier this year found the drug reduced clinical decline, Biogen said in an announcement likely to reverberate throughout the Alzheimer's research community.
By Jacob Bell • Oct. 22, 2019 -
Seattle Genetics stock hits record high on well-placed breast cancer bet
Positive results for tucatinib should help the Seattle biotech in its quest to expand beyond Adcetris, currently its only approved drug.
By Ned Pagliarulo • Oct. 21, 2019 -
Mirati data to test whether biotech can challenge Amgen in KRAS quest
Shares in Mirati soared this year, driven higher by optimism the drugmaker can replicate Amgen's KRAS success. Data due Oct. 28 will give the first look at whether Mirati's candidate holds promise.
By Ned Pagliarulo • Oct. 18, 2019 -
Merck's Ebola vaccine wins key European vote
Erevebo has already been administered to 274,000 people, and data indicate it is effective against the virus currently causing an African outbreak.
By Jonathan Gardner • Oct. 18, 2019 -
Lilly cancer drug pipeline hit by trial setback
Pegilodecakin, an immunotherapy acquired in the pharma's $1.6 billion deal for Armo BioSciences, failed to extend survival in patients with pancreatic cancer.
By Ned Pagliarulo • Oct. 16, 2019 -
Reata surprises with positive data in challenging rare disease
There are no FDA-approved drugs for Friedreich's Ataxia, an uncommon neurological disorder. Reata looks closer to changing that with its latest data.
By Jacob Bell • Oct. 15, 2019 -
Glenmark spin-out aims to challenge Amgen, others in cancer bispecific field
Newly launched as Ichnos, the spin-out company is led by former Gilead oncology chief Alessandro Riva.
By Ned Pagliarulo • Oct. 15, 2019 -
Parexel partners with Datavant on real-world data
The agreement reflects a growing hunger among drug developers for real-world data and analytics services.
By Kristin Jensen • Oct. 10, 2019 -
ProQR eye-disease data lend confidence that pivotal trial will succeed
The positive data also helps to keep the Netherlands drugmaker ahead of gene-editing specialists Editas and its partner, Allergan.
By Jonathan Gardner • Oct. 10, 2019 -
After more than a year, Gilead finds new chief medical officer
Coming from Roche's Genentech, Merdad Parsey will oversee clinical development and medical affairs starting Nov. 1.
By Jacob Bell • Oct. 07, 2019 -
Sarepta, in shadow of FDA setback, marks gene therapy progress
The biotech released the first functional data from a trial of an experimental gene therapy treating a different type of muscular dystrophy than Exondys 51.
By Jonathan Gardner • Oct. 04, 2019 -
Arbutus stops early hepatitis B study on safety concerns
Shares in the Pennsylvania biotech shed a quarter of their value Friday, putting the company down more than 70% for the year.
By Ned Pagliarulo • Oct. 04, 2019 -
Amicus rare disease data build hope for approval
The real test of the Pompe disease therapy, however, will be an enrolling Phase 3 study that's set to read out data in 2021.
By Jonathan Gardner • Oct. 02, 2019 -
FDA knocks back AstraZeneca's respiratory ambitions
The rejection of AstraZeneca's triple respiratory inhaler puts the company further behind its U.K. rival, GlaxoSmithKline.
By Jonathan Gardner • Oct. 01, 2019 -
Seattle Genetics makes case it can be more than Adcetris
Known best for its approved antibody drug conjugate, the biotech impressed at ESMO with positive results from two experimental drugs.
By Ned Pagliarulo • Sept. 30, 2019 -
Novartis, Lilly drugs set new survival bar in breast cancer
Study results detailing the survival benefit to Kisqali and Verzenio could help persuade more doctors to prescribe the targeted drugs.
By Ned Pagliarulo • Sept. 29, 2019 -
AstraZeneca, Merck strengthen lead in PARP drug class
AbbVie appears back on track with rival veliparib, but until it's approved Lynparza looks set to be a preferred option in first-line ovarian cancer.
By Jonathan Gardner • Sept. 28, 2019 -
Colon cancer proves tougher target for Amgen's KRAS drug
A much lower response rate in colorectal cancer than in lung could signal the two tumor types respond differently to blocking KRAS with AMG 510.
By Ned Pagliarulo • Sept. 28, 2019 -
Cancer immunotherapy boom showing no sign of slowdown
A new report from the Cancer Research Institute found nearly 3,900 drugs in preclinical and clinical development, up 91% from just two years ago.
By Ned Pagliarulo • UPDATED: Sept. 27, 2019 at 12:54 p.m. -
Pfizer's new JAK drug works, but class safety concerns linger
While effective, the class has come under regulatory scrutiny for increasing patients' risk of blood clots and cardiovascular events.
By Jacob Bell • Sept. 27, 2019 -
Investors conclude there are probably better NASH drugs than Enanta's
The biotech's stock plummeted more than 18% Thursday as data showed its FXR agonist barely cleared the threshold for success in a Phase 2 study.
By Jacob Bell • Sept. 26, 2019 -
Deep DiveFirst-of-its-kind trial in ALS spurs hope for brutal disease
A so-called platform study will test five drugs at once, a design that experts say could become a model in rare disease drug development.
By Andrew Dunn • Sept. 25, 2019 -
FDA warning slowed immunotherapy use in bladder cancer
Doctors appeared to shift their prescribing following an FDA decision to limit the approvals of Keytruda and Tecentriq in the tumor type, new research found.
By Ned Pagliarulo • Sept. 25, 2019
