Clinical Trials
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Roche's oral SMA drug scores in older patients
As Novartis' gene therapy Zolgensma remains under scrutiny, the Swiss rival's risdiplam delivered positive results in older, less severely affected patients.
By Jonathan Gardner • Nov. 11, 2019 -
Fibrogen, AstraZeneca confirm roxadustat's heart safety months after confusing first readout
Pooled data from seven studies showed the red blood cell-boosting pill to be as safe as placebo and safer than Epogen on some heart measures in kidney disease patients.
By Jonathan Gardner • Nov. 08, 2019 -
AnaptysBio shares collapse after 'worst case scenario' for key drug
Etokimab, an anti-inflammatory drug key to AnaptysBio's future, missed its goal in a Phase 2 study, a result that erased $700 million from the company's value.
By Ned Pagliarulo • Nov. 08, 2019 -
Celgene's last hurrah at ASH a defining moment for Bristol-Myers' buyout
With pivotal data for a Celgene CAR-T therapy set to soon be unveiled, the clock is ticking on a timeline that will determine whether Bristol-Myers pays billions more to the biotech's shareholders.
By Jonathan Gardner • Nov. 07, 2019 -
Regenxbio hit with FDA clinical hold, pushes back gene therapy timelines
It's the second trial hold for the gene therapy field in recent weeks, after the FDA partially suspended a Novartis study testing the SMA treatment Zolgensma.
By Andrew Dunn • Nov. 06, 2019 -
AstraZeneca's China ambitions grow with new R&D investments
Already a leader in China, the British pharma is doubling down with plans to open two new centers and launch a $1 billion biotech investment fund.
By Jonathan Gardner • Nov. 06, 2019 -
Halozyme laying off 160 after pancreatic cancer trial comes up short
The clinical setback, and Halozyme's plans to focus on its money-making drug delivery technology, ends for now the company's bid to launch a cancer drug.
By Jonathan Gardner • Nov. 04, 2019 -
Novartis' Cosentyx falls short vs. AbbVie's Humira in head-to-head trial
The blockbuster biologics were tested in active psoriatic arthritis, with the Swiss pharma saying Cosentyx "narrowly missed statistical significance for superiority."
By Andrew Dunn • Nov. 01, 2019 -
Novartis gene therapy ambitions dealt another blow by FDA hold on Zolgensma
A partial trial suspension threatens to delay the gene therapy's expansion into older children, as the FDA works through safety findings from an animal study.
By Jonathan Gardner • Oct. 30, 2019 -
CF Foundation puts half a billion dollars toward drugs for all patients
About 90% of cystic fibrosis patients can take one of Vertex's drugs. The remaining 10% have no options — something the foundation wants to change.
By Jacob Bell • Oct. 30, 2019 -
Mirati keeps pace with Amgen in hunt for KRAS cancer drug
Initial trial results showed Mirati's closely watched KRAS inhibitor led to responses in patients with lung and colon cancers, although data remain early.
By Ned Pagliarulo • Oct. 28, 2019 -
AstraZeneca joins Bristol-Myers' run at Merck in lung cancer
Imfinzi plus chemotherapy kept patients from progressing as quickly as chemo alone in a key study, but oncologists will need to see survival and safety data.
By Jonathan Gardner • Oct. 28, 2019 -
GSK advances new antibiotic into Phase 3 studies
The drug is the first in a new antibiotic class, said the British pharma, which is one of just a few large drugmakers still developing antibacterial treatments.
By Andrew Dunn • Oct. 28, 2019 -
AstraZeneca blood cancer drug heading for showdown with AbbVie's
Competitive data from a Calquence leukemia study could help the U.K.-based big pharma add to its growing oncology sales.
By Jonathan Gardner • Oct. 24, 2019 -
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 -
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
