Trial setback strikes blow to Sage antidepressant ambitions

SAGE-217 failed to meet the main goal of a Phase 3 depression study, a result that cut the drugmaker's market value by roughly $4 billion.

By Ned Pagliarulo • Dec. 5, 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➔

Cell 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

After FDA rejection, Immunomedics tries again with breast cancer drug

Sacituzumab govitecan would be Immunomedics' first commercial product if the biotech succeeds on its second attempt to convince the FDA.

By Andrew Dunn • Dec. 3, 2019

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

Karuna's 'A-ha moment': A billion-dollar stock swing and new expectations

Promising results from a schizophrenia study sent Karuna's shares soaring, putting the newly minted public biotech on the map in a difficult field. 

By Ned Pagliarulo • Nov. 26, 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

FDA's rapid review pace nets an early approval for Alnylam's second drug

Givosiran, which will be sold as Givlaari, is the second RNAi therapeutic cleared by the agency after Alnylam's Onpattro.

By Jonathan Gardner • Nov. 20, 2019

Bankrupt biopharmas are rare. 2019 has some worried that's changing.

Eleven biopharmas declared bankruptcy in 2019, more than any other year since at least 2011. Rising market pressures, coupled with legal liabilities, risk more companies falling to zero, experts warn.

By Andrew Dunn • Nov. 19, 2019

The running list of 2019 biopharma bankruptcies

From antibiotic developers like Achaogen to opioid drugmakers like Purdue and Insys, 2019 saw an uptick in biopharmas filing for Chapter 11.

By Andrew Dunn • Nov. 19, 2019

31 biopharmas at high risk of bankruptcy in 2020

BioPharma Dive dug into data from a credit monitoring firm to identify drugmakers at high risk of going bankrupt, including companies like Teva, Bausch Health and Novavax.

By Andrew Dunn • Nov. 19, 2019

First look at CRISPR, Vertex gene-editing therapy hints at treatment potential

Results from two patients, one with sickle cell disease and the other with beta-thalassemia, offer an initial glimpse at the disease-altering potential of CRISPR gene-editing. 

By Ned Pagliarulo • Updated Nov. 19, 2019

Alkermes follows up restructuring with Rodin acqusition

Worth up to $950 million, the deal will give Alkermes access to a preclinical pipeline aimed at diseases rooted in disrupted synapses like Alzheimer's and Parkinson's.

By Jonathan Gardner • Nov. 18, 2019

BeiGene FDA cancer drug nod seen as breakthrough for Chinese biopharma

The drug, branded as Brukinsa, will go up against J&J and AbbVie's Imbruvica and AstraZeneca's Calquence in lymphoma.

By Jonathan Gardner • Nov. 15, 2019

What's next for Amarin? CEO John Thero talks Vascepa's label, pricing and future partnerships

Amarin will consider adding a partner in Europe, CEO John Thero told BioPharma Dive, adding he views the heart drug as a volume, not pricing, opportunity.

By Andrew Dunn • Nov. 15, 2019

FDA expert panel unanimously recommends Amarin's Vascepa in closely-watched vote

Debates about side effects and the mineral oil placebo failed to dissuade any member of the FDA's advisory committee from voting against an expanded indication.

By Andrew Dunn • Nov. 14, 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

Sarepta brings in more gene therapies with StrideBio deal

The deal adds four more neuromuscular candidates to the Exondys maker's already-rich pipeline.

By Jonathan Gardner • Nov. 14, 2019

Sage's new drug starts slow, as Wall Street waits for depression data

Few expected Sage's postpartum depression drug Zulresso to start fast. Sales of $1.5 million in its first full quarter on market confirmed those expectations.

By Ned Pagliarulo • Nov. 13, 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

FDA documents appear to clear Amarin path to wider heart drug approval

The documents, released ahead of Thursday's advisory panel meeting, suggest the FDA is open to an expanded label for Vascepa, Amarin's fish oil-derived pill.

By Ned Pagliarulo • 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