Clinical Trials
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GenFit delays data readout, raising doubts about its place in NASH
Thursday's update is the second time results from a large study of the French drugmaker's main drug, called elafibranor, have been pushed back.
By Jacob Bell • Feb. 21, 2020 -
Teva's neuroscience drug falls short at the finish line
Austedo, a main growth driver for Teva, failed two late-stage studies that were supposed to get the drug approved as a treatment for tics in young patients with Tourette's.
By Jacob Bell • Feb. 20, 2020 -
Cancer concerns knock Eisai's weight loss drug from market
Eisai has agreed to remove Belviq after the FDA said a post-marketing study found a "range of cancer types" appeared to develop more frequently in patients taking the drug.
By Jacob Bell • Feb. 14, 2020 -
Merck builds case for Keytruda use in breast cancer
When added to chemo, Merck's immunotherapy kept a difficult-to-treat form of breast cancer from progressing, provided patients had an important biomarker.
By Jonathan Gardner • Feb. 12, 2020 -
Exelixis prostate cancer data could help stave off competitive threats
As Pfizer makes inroads against Cabometyx in kidney cancer, Exelixis said it will ask the FDA next year for approval in prostate disease.
By Jonathan Gardner • Feb. 11, 2020 -
Bayer, looking to grow pharmaceutical sales, seeds new research center
The German drugmaker is transferring a "large part" of its small molecule research unit in Berlin to contract developer and manufacturer Nuvisan, with the aim of building a new facility on Bayer's R&D campus.
By Jacob Bell • Feb. 11, 2020 -
In Alzheimer's, a plan to treat patients earlier doesn't work out for Lilly, Roche
Results from the DIAN-TU study chip away at the amyloid hypothesis' foundation, just as Biogen prepares to file its drug aducanumab for approval.
By Jonathan Gardner • Feb. 10, 2020 -
Biogen dips as Alzheimer's drugs from Lilly, Roche fail again
Analysts have said that, should the DIAN-TU study miss, it may further paint Biogen's aducanumab and the positive Phase 3 data it generated as an "artifact of luck" within a series of failed amyloid-targeting drugs.
By Jacob Bell • Feb. 10, 2020 -
Biohaven misses a chance to prove it's more than migraine
One of Biohaven's late-stage drugs proved no better than placebo in a type of severe anxiety — a lost opportunity for the company to showcase a pipeline beyond its lead migraine therapy.
By Ned Pagliarulo • Feb. 10, 2020 -
SponsoredInnovations shaking up clinical trial patient recruitment
From voice assistants to study-specific patient portals, discover the newest innovations for clinical trial sponsors to leverage.
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In small study, hints of promise for 'natural killer' cell therapy
None of the 11 patients treated with the CAR NK treatment experienced the severe immune reactions or neurotoxicity that are associated with CAR-T.
By Ned Pagliarulo • Feb. 06, 2020 -
Sanofi MS drug results set stage for extensive late-stage testing
The drug, a type of enzyme inhibitor that's proven valuable in cancer treatment, will soon head into four late-stage studies across various types of MS.
By Jacob Bell • Feb. 06, 2020 -
SponsoredImplementing risk-based quality management: The importance of scalability
Regulators insist on making better use of advancements such as centralized monitoring and analytics to more efficiently maintain quality and safety standards.
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Regeneron partners with US government to develop coronavirus treatment
The biotech hopes to replicate its past success in quickly advancing a treatment for Ebola. But, as that experience showed, proving a new antiviral isn't easy.
By Ned Pagliarulo • UPDATED: Feb. 4, 2020 at 2:45 p.m. -
Antiviral drugmakers GSK, Gilead join fight against coronavirus' spread
Gilead will work with Chinese authorities to test its drug remdesivir in a randomized study, while GSK is providing its adjuvant platforms to groups partnered with CEPI.
By Ned Pagliarulo • Feb. 03, 2020 -
US cancels trial after finding vaccine doesn't prevent HIV
Research into preventive treatments will continue, however, as an NIH leader declared a vaccine "essential" to ending the widespread disease.
By Jonathan Gardner • Feb. 03, 2020 -
Preventive Alzheimer's trial data due within weeks, Lilly says
Lilly's top scientist, however, set low expectations that solanezumab will show a benefit for patients with genetic mutations that drive early and severe disease.
By Jonathan Gardner • Jan. 30, 2020 -
Deep DiveBig pharma backed away from brain drugs. Is a return in sight?
Biotech executives see a new era of neuroscience breakthroughs on the horizon. But in a historically challenging space, it's hard to pinpoint what would cause big pharma to dive back in — and what ripples that would create.
By Jacob Bell • Jan. 29, 2020 -
Decibel CEO steps down as company pares workforce
The Third Rock-backed company put an acting executive in place as it repositions for development in gene therapy and regenerative medicine.
By Jonathan Gardner • Jan. 29, 2020 -
Pfizer lays out gene therapy aspirations
With more Phase 3 trials on the near horizon, the big pharma plans to add one new gene therapy project per year to its pipeline.
By Jonathan Gardner • Jan. 28, 2020 -
Acceleron soars on blood pressure data despite lengthy road to market
While the biotech's drug succeeded in a mid-stage study of pulmonary arterial hypertension patients, analysts think a potential approval is four years off, at least.
By Jacob Bell • Jan. 28, 2020 -
J&J launches vaccine efforts as coronavirus spreads
The pharma says it has the manufacturing capacity to produce a vaccine at scale should its scientists hit upon a construct that appears effective.
By Ned Pagliarulo • UPDATED: Jan. 27, 2020 at 4:51 p.m. -
Ipsen pauses studies of drug for rare bone disease
The decision makes a mid-2020 approval and launch, which Ipsen expected when it acquired the drug, less likely.
By Jacob Bell • Jan. 24, 2020 -
Safety risks highlighted in FDA letter on Sarepta's Vyondys
In rejecting Vyondys last August, one FDA official wrote that, without confirmatory trials for either of Sarepta's muscular dystrophy drugs, it's difficult to judge whether they're worth the risk.
By Jonathan Gardner • Jan. 22, 2020 -
Drug trial success a consolation prize for Akcea, Ionis
Although Novartis chose not to license Akcea and Ionis' high triglyceride drug, positive data could open up new development opportunities.
By Ned Pagliarulo • Jan. 22, 2020
