Brian Orelli

Menlo's serlopitant whiffs in two phase III studies

April 6, 2020

Menlo Therapeutics Inc. announced a double dose of bad news with negative results for two phase III trials testing its NK1 receptor antagonist, serlopitant, as a treatment for pruritus (itch) associated with prurigo nodularis, a skin disease characterized by hard, itchy nodules.

'It's really not going to scale'

Companies face challenges with increasing clinical trial data sources

March 24, 2020

By Brian Orelli

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A survey of 149 companies by Tufts Center for the Study of Drug Development found more than two-thirds of clinical trial sponsors were using or piloting at least four different data sources in their clinical trials.

Biocom Global Life Sciences Partnering Conference

Pharmas share their needs, wants and offer some advice

March 2, 2020

By Brian Orelli

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SAN DIEGO – At the Biocom 10th Annual Global Life Sciences Partnering Conference, panels of pharma executives highlighted what they're looking for to supplement their pipelines and offered advice that ran the gamut from company formation to the courting process to strategies for partnering pipeline drugs and platforms.

Sometimes it takes an advocate (or four)

Backstory of the FDA lifting its clinical hold and eventual approval of Inrebic

February 28, 2020

By Brian Orelli

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SAN DIEGO – At Biocom's 10th Annual Global Life Sciences Partnering Conference, a panel of players intimately familiar with last year's approval of myelofibrosis treatment Inrebic (fedratinib) explained the backstory of how they got the JAK2 kinase inhibitor off an FDA clinical hold, wrangled the rights to the drug back from the big pharma owner that had acquired the drug from Targegen Inc. and eventually helped the drug gain FDA approval after selling the rights to another large company.

Multiple spin-offs in the works

Pharmas break up to accelerate growth

February 11, 2020

By Brian Orelli

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Even as the volume of mergers and acquisitions in 2019 reached the highest level in the last 10 years, multiple big pharma companies are looking to get smaller, spinning off units into separate entities.

Inflammatory/Immune: Filgotinib

Filgotinib looks to JAK up sales with multiple indications

February 10, 2020

By Brian Orelli

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Filgotinib (GLPG-0634) has the potential to be a blockbuster drug, according to Cortellis Drugs to Watch analysis, but it may take a few approvals in various indications to reach the coveted mark of $1 billion in annual sales.

Gene therapies could add $45B to health care costs over next five years

January 27, 2020

By Brian Orelli

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New gene therapy treatments could add $45 billion to the cost of health care over the next five years, according to a new report from CVS Health Corp., of Woonsocket, R.I. While the number is staggering, without knowing the price of the currently unapproved therapies, how many patients will seek treatment and the likelihood of approval, the pharmacy benefit manager's estimate is basically an educated guess.

'Holy grail'

Adaptimmune SPEARs 4 partial responses in various tumor types

January 13, 2020

By Brian Orelli

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While companies have seen plenty of success treating blood cancers with T-cell therapies, solid tumors have largely remained the holy grail for T cells. But Adaptimmune Therapeutics plc has early data from its Specific Peptide Enhanced Affinity Receptor T-cell platform suggesting it may be on the right path for a platform with a wide breadth.

Let them eat steak

Ultragenyx flying high on responders to its gene therapy for ornithine transcarbamylase deficiency

January 10, 2020

By Brian Orelli

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The prospects for Ultragenyx Pharmaceutical Inc.'s adeno-associated virus (AAV) gene therapy, DTX-301, in patients with ornithine transcarbamylase (OTC) deficiency weren't looking too great after treatment of the first two cohorts in a phase I/II study.

The biotech industry remembers: In Memoriam

January 10, 2020

By Brian Orelli

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As the industry looks forward to 2020 at the 38th Annual J.P. Morgan Healthcare Conference next week, BioWorld is looking backward to those we lost in the past year.