Leukemia rivals try to stay ahead as Merck, Lilly chase

Merck's surprise buyout of ArQule will heat up competition in a class of cancer drugs that includes AbbVie and J&J's Imbruvica and AstraZeneca's Calquence.

By Jonathan Gardner • Dec. 10, 2019

New drugs for sickle cell excite but, at ASH, a recognition that more is needed

Approvals for Adakveo and Oxbryta double the number of treatment options for sickle cell disease in the U.S., bringing hope that more may soon follow.

By Ned Pagliarulo • Dec. 9, 2019

Explore the Trendline➔

Emerging biotech

New biotechs continue to emerge despite a challenging market environment that has forced venture firms to build their drug startups more cautiously.

By BioPharma Dive staff

As CAR-T presses ahead in multiple myeloma, alternative approaches gain supporters

Three different ways of attacking the blood disease are emerging, raising hopes for life-extending drugs for the sickest patients.

By Jonathan Gardner • Dec. 9, 2019

Merck's ArQule buy showcases pharma appetite for targeted cancer drugs

The biotech's experimental drug targeting the BTK protein is of particular interest to Merck & Co., which is acquiring ArQule at more than a 100% premium.

By Jacob Bell • Dec. 9, 2019

Biotech of the Year: Galapagos

The Belgian drugmaker pulled off a rare feat, retaining its independence while collecting a multibillion-dollar investment from Gilead. Now it needs to prove its partner's bet was well placed.

By Jacob Bell • Dec. 9, 2019

Executive of the Year: Josh Bilenker, Loxo Oncology

Along with other recently acquired cancer companies like Ignyta and Array, Loxo proved out a drug development model that Bilenker likens to baseball's "moneyball" thesis. 

By Ned Pagliarulo • Dec. 9, 2019

Disruptor of the Year: The Federal Trade Commission

A more active FTC, suggested by the surprise delay for Roche's takeover of Spark, could slow dealmaking in an industry that relies on big pharma buyouts.

By Jonathan Gardner • Dec. 9, 2019

The BioPharma Dive Awards for 2019

A busy year brought an upswing in a storied pharma's fortunes, an industry-shaking mega-merger and the surprise revival of an Alzheimer's drug. 

Dec. 9, 2019

We're not for sale, Alexion executives declare

After meeting with hedge fund Elliott Advisors, the biotech said its product switching strategy and drug pipeline will drive more value than seeking buyers.

By Jonathan Gardner • Dec. 6, 2019

Cancer gene therapy backed by Blackstone gets trial win

Results released Thursday are the first to be presented from a Phase 3 study of the therapy, which was recently made the cornerstone of a new company launched by Blackstone and Ferring.

By Jonathan Gardner • Dec. 5, 2019

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

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