Biotech: Page 90
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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 -
Yujin Kim / MedTech Dive, original photo courtesy of U.S. Food and Drug Administration
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 -
Explore the Trendline➔
National Institutes of Allergy and Infectious Diseases. (2016). "Human natural killer cell" [Micrograph]. Retrieved from Flickr.
TrendlineCell 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 -
Q&A
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 -
Jacob Bell/BioPharma Dive
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 -
Getty / Edited by BioPharma Dive
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 -
Jacob Bell/BioPharma Dive
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 -
Yujin Kim / MedTech Dive, original photo courtesy of U.S. Food and Drug Administration
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. 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 -
Jacob Bell/BioPharma Dive
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 -
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 -
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. 6, 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 -
Courtesy of Regeneron Pharmaceuticals
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. 5, 2019 -
Sponsored by MilliporeSigma
Shifting the biomanufacturing paradigm - intensifying upstream processes
Game-changing technologies to intensify upstream processes.
Nov. 5, 2019 -
Aveo's cancer drug runs into a skeptical FDA
The regulator told the Cambridge, Massachusetts-based biotech to hold off on filing its cancer drug, sending shares in the company down 40%.
By Andrew Dunn • Nov. 4, 2019 -
China approves Alzheimer's drug, inviting fresh debate in field with few successes
Developed by a little-known Shanghai drugmaker, the therapy joins a short list of approved Alzheimer's treatments. Yet how well it works is an open question.
By Ned Pagliarulo • Updated Nov. 4, 2019 -
Amgen exits neuroscience R&D as pharma pulls back from field
About 180 roles, primarily based in Cambridge, Massachusetts, will be affected by the decision, which comes several months after a setback in Alzheimer's.
By Andrew Dunn • 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
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