Celgene's last hurrah at ASH a defining moment for Bristol-Myers' buyout

With pivotal data for a Celgene CAR-T therapy expected soon, 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. 7, 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. 6, 2019

Explore the Trendline➔

Oncology's research boom

More than one quarter of the medcines cleared by the FDA's main review office since 2015 have been cancer drugs, a tally that reflects the advent of cancer immunotherapy as well as continued progress in matching treatment to genetics.

By BioPharma Dive staff

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. 6, 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. 4, 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. 1, 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 that reverberated 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. 7, 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. 4, 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. 4, 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. 2, 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. 1, 2019