Approvals & Launches
Are you sure you'd like to remove this alert? You will no longer receive email updates about this topic.
UroGen Approaches A Big Expansion In Bladder Cancer
The oncology company is preparing for the launch of UGN-102 for bladder cancer. CEO Liz Barrett talked to Scrip about the company’s next growth phase.
Pipeline Watch: Six Approvals And 26 Phase III Trial Updates
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.
US Tevimbra Approval Validates BeiGene’s Asia-Heavy Global Trial Approach
BeiGene's first US approval for Tevimbra (tislelizumab), based on an Asia-heavy global study, is expected to pave the way for the biopharma to win two more approvals within 2024.
With First US Approval, BeiGene’s Tevimbra To Start Small, Work Its Way Up
The FDA approved the PD-1 inhibitor for previously treated esophageal cancer, while BeiGene anticipates decisions on first-line ESCC as well as G/GEJ cancer later in the year.
Madrigal Has A Slow, Steady Launch Planned For Rezdiffra
Madrigal faces the challenge of opening the metabolic-associated steatohepatitis (MASH, also known as NASH) market, but the firm has been laying groundwork for over a year.
Madrigal’s FDA Approval In MASH Ends Years Of Industry Frustration
As the first approved MASH (formerly NASH) therapy, nearly four years after initially anticipated, Madrigal gets the opportunity to establish a MASH marketplace with Rezdiffra (resmetirom).
BeiGene’s Oncology Market 'Disruption' Gains Pace Despite Tevimbra Travails
The Sino-American company believes faster, lower-cost R&D and competitive pricing and access will give it an edge in oncology. Its chief commercial officer for North America and Europe told Scrip how it is now looking to repeat the success of Brukinsa and finally launch its much-delayed PD-1 inhibitor Tevimbra.
Pipeline Watch: Six Approvals And 18 Phase III Trial Updates
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.
CARSgen Wins China’s Fifth CAR-T Approval But Pricing Dilemma Unresolved
As China’s fifth approved CAR-T cell therapy, CARSgen/Huadong’s zevorcabtagene autoleucel is priced at $159,735 for a single infusion. Expanding patient access will become a formidable task for the companies, due to the poor prospects of reimbursement coverage by China’s public medical insurance program.
Roche Launches Eylea Competitor Vabysmo In India On The Heels Of Ocrevus
Roche is stepping up its game in India with the launch of blockbuster Vabysmo (faricimab), closely on the heels of Ocrevus (ocrelizumab). It hopes to drive access for the nAMD and DME drug via government procurement and insurance schemes and tiered pricing.
Pipeline Watch: Four Approvals And 21 Phase III Trial Updates
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.
BMS’ Boerner Bets On AI-Driven R&D In India, Points To Potential For MS, Lupus Drugs
Bristol Myers Squibb CEO Christopher Boerner is looking to India to house the the company’s largest R&D site outside of the US, channeling the country's IT expertise to expand its AI-driven small-molecule research. He also wants to bring its drugs to treat multiple sclerosis and Lupus to India.
As Vyvgart Surges To Blockbuster Status, Argenx Maps Out Expansion Plans
The European biotech is just getting started with its expansion plans for the drug in generalized myasthenia gravis, while multiple readouts in new autoimmune diseases are expected in 2024.
UCB Buoyant As Bimzelx Starts To Deliver
The Belgian drugmaker’s faith in the psoriasis drug is looking to be well placed and with other indications coming aboard, sales forecasts of around €5bn-6bn for the pipeline-in-a-product seem very achievable.
Moderna Prepares To Enter The RSV Vaccine Fray
Its mRNA-based RSV vaccine challenger has a more convenient administration than GSK and Pfizer’s frontrunners, but may not compete on durability of protection.
Pipeline Watch: Eight Approvals And Five Phase III Trial Updates
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.
You must sign in to use this functionality
Authentication.SignIn.HeadSignInHeader
Email Article
All set! This article has been sent to my@email.address.
All fields are required. For multiple recipients, separate email addresses with a semicolon.
Please Note: Only individuals with an active subscription will be able to access the full article. All other readers will be directed to the abstract and would need to subscribe.