Approvals & Launches
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With Vertex Pain Drug Filed At FDA, Commercial Ramp Is Under Way
The company initiated a rolling NDA submission for suzetrigine for acute pain, positioning the drug for a launch in 2025.
Pipeline Watch: Six Approvals And 13 Phase III 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.
Avistone Wins China Approval For First C-Met Inhibitor In Glioblastoma
A China green light for domestic firm Avistone's c-Met inhibitor was based on positive outcomes from the Phase II/III FUGEN study in Chinese patients with recurrent relapsing glioma with the rare PTPRZ1-MET fusion gene. Avistone’s overseas partner Apollomics is also studying the molecule in a Phase II program outside China.
X4 Gets First Approval In Ultra-Rare Disorder, Needs Time To Build A Market
Xolremdi was OKed as the first drug for WHIM syndrome and X4 set pricing at $372,000-$496,000 a year, but the drug’s bigger opportunity may be in chronic neutropenia.
Pipeline Watch: Eighteen Approvals And Six 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.
Pfizer Matches Beqvez Price To Hemgenix In Hemophilia B, Plans Warranty Program
The drug maker said the program would allow for continued reimbursement when patients change insurance plans. A Sangamo-partnered gene therapy for hemophilia A is also in the works.
BMS Will Cut $1.5bn And 2,200 Jobs To Reinvest In Needed Growth
Revlimid and Eliquis beat expectations in the first quarter, but the products have dwindling exclusivity, making new drugs the main focus for Bristol. So the company will reinvest cost savings in R&D.
Merck Investors Keeping A Close Watch On Winrevair Uptake
Some patients have already been prescribed the new drug for pulmonary arterial hypertension but Merck & Co. did not provide any sales or guidance.
Sanofi To Pursue Smart M&A Pacts And Stick With Early-Stage Oncology R&D
CEO Paul Hudson says that the French major will continue to progress early-stage cancer projects despite jettisoning some oncology programs in favor of reallocating much of its research budget to immunology.
Biogen Sees Improving Momentum In Slow Leqembi Launch
Sales of the company’s new drugs have a lot of growing to do to make up for older products’ declines, but Biogen highlighted signs of strength for new launches in its Q1 report.
Day One Springs Into Commercial Action With Ojemda Approval
The company is targeting around 200 centers that treat the vast majority of the few thousand pediatric low-grade glioma patients who are candidates for the RAF-targeting drug.
ImmunityBio Will Aim Anktiva At Large Share Of Bladder Cancer Market
Execs Richard Adcock and Patrick Soon-Shiong told Scrip the company sees an addressable US population of about 20,000 and is aiming for ease of physician adoption.
BMS Has A Strong Pipeline, But Access Challenges Remain
Bristol Myers Squibb’s head of major markets, Monica Shaw, wants to improve patients’ access to lifesaving therapies. And the group has several new products ready to roll.
Roche Gets Adjuvant ALK+ Lung Cancer To Itself With Alecensa Approval
The US FDA cleared Roche’s supplemental approval request for ALK inhibitor Alecensa in ALK-positive non-small cell lung cancer following tumor resection.
Investors Go Berserk For Viking, Putting It Top Of Q1 Winners
The top 10 biggest share price winners and losers in Q1 from Evaluate show the investor frenzy for obesity drugs continues, while companies with governance doubts see shareholders retreat.
Pipeline Watch: Five Approvals And 23 Phase III 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.
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