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Intercept’s NASH Approval Timeline Shuffled Again With FDA Delay
The company said a planned 9 June advisory committee to review the NDA for obeticholic acid in NASH has been postponed a second time, which means OCA likely will not be approved by 26 June.
Kadmon’s ROCKstar Is Rising On GvHD Therapy Data
Kadmon’s treatment for graft-versus-host disease, belumosudil continues to perform well in its pivotal ROCKstar study, setting the stage for a US filing under the FDA’s pilot Real-Time Oncology Review program.
Strides Optimistic On Prospects Of Antiviral Portfolio For COVID-19
Optimistic about the potential of repurposing its antiviral portfolio, Strides plans to soon begin bioequivalence studies for favipiravir, a molecule that has found favor as a COVID-19 therapy in a few countries. It also aims to introduce new products to fill the gap left by the withdrawal of ranitidine from the US market.
Coronavirus Spotlight
Trump Is Taking Hydroxychloroquine – But Global Prevention Trial Is Deadly Serious
Experts fear Trump’s unregulated use of the malaria drug is dangerous, and muddies the waters around research which could still find chloroquine useful in preventing SARS-CoV-2 infection.
Rolling Coverage Of The Coronavirus Outbreak And The Biopharma Industry's Response Is Here.
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COVID-19 Pipeline Tracker
Product candidates in development worldwide to address the 2019-nCoV pandemic, categorized by treatment and prevention. Subscription required.
Commercial Explore this Topic
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Tech Transfer Roundup: Hoth Teams With VCU On Therapy To Block COVID-19 Replication
Pandemic-related collaborations between Hoth/VCU; Sorrento/Mt. Sinai Health; Audax/Northeastern U.; Alkido/U. of Maryland, Baltimore; Active Motif/Hisun BioRay/Fudan U. and more.
‘Friendly Breakup’: Sanofi And Regeneron Agree Equity Revamp
Sanofi to sell most of its Regeneron stake, with much of it being re-purchased by Regeneron, but both stressed the move would not hurt their long established and very profitable drug-development collaboration.
Stockwatch: Reading The Entrails Of Biotech Vaccine Development
As generalist investors continue to push higher the stock prices of biotech companies that announce the most tenuous of coronavirus developments, the track record of biotech companies developing even vaccines for which the antigen is proven to be safe and efficacious remains poor.
Latecomer Alunbrig Faces Entrenched Rivals After US 1L Approval
First-line lung cancer approval will expand potential market for Takeda's ALK contender but the latecomer is also facing some well-established class competition in the setting.
Sunovion Plans September Launch For Parkinson’s 'Off' Episode Drug Kynmobi
Kynmobi is an important approval for parent company Sumitomo Dainippon ahead of the loss of exclusivity for Latuda. Sunovion hopes to launch after COVID-19 social distancing requirements ease.
Strides Optimistic On Prospects Of Antiviral Portfolio For COVID-19
Optimistic about the potential of repurposing its antiviral portfolio, Strides plans to soon begin bioequivalence studies for favipiravir, a molecule that has found favor as a COVID-19 therapy in a few countries. It also aims to introduce new products to fill the gap left by the withdrawal of ranitidine from the US market.
Policy & Regulation Explore this Topic
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No Love From US: Senate Bill Deals Blow To Aspiring China Biotechs
In a bipartisan move, the US Senate is moving to impose new rules on companies - including those from China - seeking US initial public offerings, adding further uncertainty over such plans and further stoking trade tensions.
Intercept’s NASH Approval Timeline Shuffled Again With FDA Delay
The company said a planned 9 June advisory committee to review the NDA for obeticholic acid in NASH has been postponed a second time, which means OCA likely will not be approved by 26 June.
Kancera Targets COVID-19 With Fractalkine Inhibitor
Sweden-based Kancera hopes to advance its investigative anti-inflammation drug in a Phase II trial to treat severe COVID-19 patients and then build its applications from there.
Research & Development Explore this Topic
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‘Friendly Breakup’: Sanofi And Regeneron Agree Equity Revamp
Sanofi to sell most of its Regeneron stake, with much of it being re-purchased by Regeneron, but both stressed the move would not hurt their long established and very profitable drug-development collaboration.
Pipeline Watch: Phase III Readouts For Cabotegravir, Filgotinib
Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.
Latecomer Merck Enters Coronavirus Vaccine Field With Themis Acquisition
While Moderna and others frontrunners aim for a 2020 emergency use approval, Merck believes a more deliberate approach will pay off in the long term.
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