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Approvals

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Pipeline Watch: Phase III Trials Announced For AD04, Pegzilarginase And Trigriluzole

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events 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

Pipeline Watch: Phase III Starts With Elacestrant, Crizanlizumab And Vutrisiran

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events 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

Roche's Tecentriq Becomes Second In PD-1/L1 Family To Gain First-Line Lung Cancer Approval

The PD-L1 inhibitor's label excludes NSCLC patients with EGFR or ALK mutations, which could have been an advantage, but the indication largely reflects the registrational IMpower150 clinical trial's population.

Approvals ImmunoOncology

AML Paradigm Shift: Doctors Welcome Many New Approvals And Approaches

This year's ASH meeting reflected a peak of development success, with many new approvals and many more in the pipeline.

Clinical Trials Cancer

World First Korea Darbepoetin Biosimilar Approval To Speed CKD's Global Entry?

With a global first marketing authorization for its darbepoetin biosimilar in South Korea, Chong Kun Dang aims to speed up the product’s entry into the Japanese and other international markets and progress clinical rials with other biosimilars and novel biologics.

South Korea Biosimilars

Pipeline Watch: Phase III Starts With PRN1008, JZP-258 And Nolasiban

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events 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

Novartis's Blockbuster Gilenya Cleared For Children And Adolescents In Europe

Novartis's blockbuster MS drug is now approved for children and adolescent use in the EU as well as the US, as the big pharma continues to build its MS franchise in advance of the start of generic competition to Gilenya, expected sometime after mid-2019.

 

Neurology Approvals

Bayer's Hemophilia A Portfolio Boosted by Jivi's EU Approval

EU approval and coming launch there of Jivi will complement Bayer's two existing Factor VIII treatments, Kogenate and its successor Kovaltry.

Approvals Blood & Coagulation Disorders

FDA Nod For Loxo/Bayer Tissue Agnostic Drug Marks Paradigm Shift In Cancer

Vitrakvi is effective against a wide variety of cancers driven by NTRK fusion. But finding the patients who will benefit will be a challenge, given there are expected to be only around 2,500 to 3,000 new cases in the US and testing for the mutation is uncommon. 

Cancer Personalized Medicine
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