New Products
CEO Matt Gline talked to Scrip about preparing for the launch of brepocitinib in dermatomyositis, lessons learned from Vtama, and how smaller biopharmas are delivering launch successes.
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.
The approval of Wegovy HD brings a more effective version to the lower-dose version and the oral formulation, but the company has struggled to compete with obesity rival Eli Lilly.
The drug is the first oral IL-23 receptor antagonist to clear the US FDA. Johnson & Johnson and partner Protagonist Therapeutics are banking on its convenience as well as efficacy and safety to make the drug competitive.
The company licensed worldwide rights to the IBAT inhibitor from GSK just days ahead of the drug’s US FDA approval for cholestatic pruritus associated with primary biliary cholangitis.
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.
The BLA for the company’s enzyme replacement therapy tividenofusp alfa has an April 5 action date, following on the heels of a complete response letter for Regenxbio’s Hunter syndrome gene therapy.
With J&J’s CAR-T Carvykti also approved for second-line disease, an oncologist told Scrip multiple factors will determine who gets which therapy option.
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.
China has granted a world-first approval to a cAMP-biased GLP-1R agonist, Sciwind's ecnoglutide, for weight management, following convincing Phase III results.
Hansa Biopharma was not awarded a priority review for imlifidase but analysts nevertheless predict an ‘inflection point’ for the Swedish company.
A new wave of commercial-stage biopharmas are interested in launching drugs in Europe but weighing risks related to US drug pricing policies
Ascendis Pharma’s accelerated US approval of once-weekly Yuviwel introduces the first competitor to BioMarin’s Voxzogo in achondroplasia, setting up a dosing-driven competitive dynamic in the CNP segment.
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.
China’s National Medical Products Administration grants global-first approval to oral JAK/ROCK inhibitor for adult primary and secondary myelofibrosis.
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.
Gilead’s takeover of Arcellx tightens its grip on anito-cel as it readies for a US FDA ruling and a high stakes entry into the crowded myeloma market.
As Vanda prepares to shift promotional focus from Fanapt ahead of generic competition, Bysanti’s approval and pending MDD readout are expected to play a key role in sustaining momentum within the company’s psychiatry portfolio.
The companies touted the anti-BCL-2/BTK combination as the first oral-only, fixed-duration regimen for CLL, but Lilly’s BTK inhibitor Jaypirca presents potential competition.
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.