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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.

Drug Approval Standards Advisory Committees Liver & Hepatic

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.

Clinical Trials Companies Research & Development

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.

Commercial Sales & Earnings Coronavirus COVID-19


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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.

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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.

Deals Coronavirus COVID-19

‘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.

Companies Commercial

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.

Stockwatch Vaccines

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.

United States Approvals

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.

Approvals Neurology

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.

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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.

Policy & Regulation Financing

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.

Drug Approval Standards Advisory Committees

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.

Clinical Trials Companies
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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.

Companies Commercial

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.

Pipeline Watch Approvals

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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