New approval for Roche's Tecentriq heats up lung cancer battle with Keytruda

One Wall Street analyst expects the FDA's OK will help Tecentriq outpace Bristol-Myers Squibb's Opdivo in 2020 in the non-small cell lung cancer market.

By Jonathan Gardner • Dec. 4, 2019

What to watch as Biogen presents its all-important Alzheimer's data

During what some have called the biotech event of the year, doctors will be paying close attention to how Biogen accounted for missing data in its pivotal aducanumab studies.

By Jacob Bell • Dec. 4, 2019

Explore the Trendline➔

Neuroscience drug development

Enthusiasm is running higher among drugmakers and investors for neuroscience drug development, buoyed by recent approvals of new Alzheimer’s, ALS and depression medicines.

By BioPharma Dive staff

Biogen scores a rare lupus win, lending support to its new immunology focus

In a two-part study, Biogen's BIIB059 hit both primary endpoints. But statistical significance, as well as a lack of safety data, create some uncertainty about the drug's future prospects.

By Jacob Bell • Dec. 3, 2019

Wave faces key test in bid to challenge Sarepta in DMD

Forthcoming trial results will show whether Wave's experimental drug can compete with Sarepta's Exondys 51 in Duchenne muscular dystrophy.

By Ned Pagliarulo • Nov. 27, 2019

Global Blood's sickle cell drug wins FDA approval, joining Novartis' Adakveo

A list price of roughly $10,000 a month puts Global Blood's Oxbryta slightly higher than what Novartis' Adakveo will cost.

By Jonathan Gardner • Updated Nov. 26, 2019

2 NASH drugmakers have wildly different Mondays

Shares of Intercept Pharmaceuticals rose on a positive FDA update, while CymaBay Therapeutics plummeted following a clinical trial setback.

By Jacob Bell • Nov. 25, 2019

'I believe the drug works.' Biogen CMO defends decision to submit Alzheimer's drug to FDA

The biotech is staking hopes for an approval of aducanumab on one Phase 3 trial it controversially declared a success last month.

By Ned Pagliarulo • Nov. 22, 2019

Payer perceptions of real world evidence in the rare disease space

In a new survey, Syneos Health® asked payers how they look at RWE in orphan drugs. 

Nov. 22, 2019

Myovant to submit lead drug for prostate cancer approval after Phase 3 results

Next year will be a test of Myovant's commercial ambition, as the Roivant spin-off also plans to file relugolix for clearance in uterine fibroids.

By Andrew Dunn • Nov. 19, 2019

Rubius delays first clinical readout, as crowded PKU field marches on

With patient enrollment advancing more slowly than expected, the biotech pushed back the first look at human clinical data for its red blood cell therapeutic platform.

By Andrew Dunn • Nov. 14, 2019

Reata's kidney data gets a tepid response from investors

Despite hitting the main goal of a Phase 3 study, Reata's drug showed that Alport syndrome patients must keep taking it to avoid further kidney decline.

By Jacob Bell • Nov. 12, 2019

Solid gene therapy trial halted again by FDA

Shares in Solid fell to a new low as the biotech's muscular dystrophy treatment dropped further behind the leader Sarepta Therapeutics.

By Jonathan Gardner • Nov. 12, 2019

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. 8, 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. 8, 2019

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

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

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

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