Clinical Trials: Page 52
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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 -
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 -
Explore the Trendline➔
National Institutes of Allergy and Infectious Diseases. (2016). "Human natural killer cell" [Micrograph]. Retrieved from Flickr.
TrendlineCell 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 -
Sponsored by BBK Worldwide
Innovations shaking up clinical trial patient recruitment
From voice assistants to study-specific patient portals, discover the newest innovations for clinical trial sponsors to leverage.
Feb. 10, 2020 -
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. 6, 2020 -
Courtesy of Sanofi
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. 6, 2020 -
Sponsored by Remarque Systems
Implementing 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.
Feb. 6, 2020 -
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 -
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. 3, 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. 3, 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 -
Adeline Kon/BioPharma Dive
Deep Dive // Brain drug revivalBig 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 -
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 -
Yujin Kim / MedTech Dive, original photo courtesy of U.S. Food and Drug Administration
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 -
Elizabeth Regan/BioPharma Dive
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 -
Jonathan Gardner/BioPharma Dive
BeiGene cancer drug data sets up China duel with Merck
Merck's Keytruda won the first PD-1 approval in China for a type of lung cancer, but Beigene's tislelizumab could make a run.
By Jonathan Gardner • Jan. 21, 2020 -
A biotech startup launches with unusual goal: invent new drugs, and sell them for less
Founded by venture capitalist Alexis Borisy, EQRx will launch with $200 million in funding to prove out a vision as daunting as it is ambitious.
By Ned Pagliarulo • Jan. 13, 2020 -
Sponsored by BBK Worldwide
3 myths that may be sabotaging your clinical trial enrollment effort
Survey insights from patients, physicians, and study sponsors reveal missed opportunities for enrollment success.
Jan. 13, 2020 -
Ultragenyx boosted by trial data for 2nd gene therapy
One analyst called the results, which sparked a 30% jump in Ultragenyx's stock price, better than expected. The biotech is now preparing a Phase 3 trial.
By Jonathan Gardner • Jan. 10, 2020 -
Blueprint wins 1st FDA approval with targeted cancer drug
The Boston-area biotech advanced Ayvakit from initial human testing to regulatory approval in just four years, a rapid timeline reflective of the drug's gene-targeted profile.
By Ned Pagliarulo • Jan. 10, 2020 -
Moderna, though early in development, prepares its vaccine for market
The vaccine just began mid-stage testing, but Moderna is already preparing for the next steps, which include a large Phase 3 study and hiring of sales associates.
By Jacob Bell • Jan. 9, 2020 -
Sponsored by Remarque Systems
Risk-based quality management: Your key to safety and effectiveness
Why is the FDA and other regulators urging clinical trial sponsors to rethink the way they design and run clinical trials?
Jan. 9, 2020
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