Biotech
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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. 06, 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. 05, 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. 05, 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. 04, 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. 03, 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. 03, 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 at 10:04 a.m. -
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 -
Deep DiveBankrupt 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 -
Deep DiveThe 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 -
Deep Dive31 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 at 8:38 a.m. -
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 -
Q&AWhat'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
