Biotech
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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 -
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. 08, 2019 -
FDA approves first drug for anemia tied to rare blood disorder
Developed by Celgene and biotech partner Acceleron, Reblozyl is one of five drugs Bristol-Myers Squibb highlighted in its $74 billion buyout of Celgene.
By Ned Pagliarulo • UPDATED: Nov. 8, 2019 at 4:47 p.m. -
Sarepta tries softer approach to resolve FDA setback
Departing from the combative tack taken by Sarepta with Exondys 51, CEO Doug Ingram appears to be reading from a new playbook in handling Vyondys 53's rejection.
By Jonathan Gardner • Nov. 08, 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. 08, 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. 07, 2019 -
Trump administration sues Gilead over HIV drug patents
Accused of unfairly profiting from government research, Gilead said it will ask the district court to stay HHS' suit until the U.S. Patent Office reviews the disputed patents.
By Ned Pagliarulo • UPDATED: Nov. 7, 2019 at 5:43 p.m. -
Biogen broadens biosimilar bet to go after top-selling eye drugs
A new deal with existing biosimilar partner Samsung Bioepis gives Biogen exclusive rights to market copycat versions of Lucentis and Eylea.
By Ned Pagliarulo • Nov. 06, 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. 06, 2019 -
Regeneron defends bid to challenge Merck in lung cancer
Merck's Keytruda is far and away the leading immunotherapy for treating lung cancer. In typical fashion, Regeneron thinks its rival drug can compete.
By Ned Pagliarulo • Nov. 05, 2019
