New Products

Boehringer’s CMO On How AI, Integrated Evidence Generation Underpin Its Ambitious Launch Plans

 

The German company has big plans for the next five years or so. Scrip speaks to its chief medical officer Lykke Hinsch Gylvin about how it is using AI and other innovative approaches to make good on its ambitions.

Pipeline Watch: Eight Approvals And Nineteen Phase III Readouts

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.

In Brief: US FDA Delay Sends Biohaven Shares Down

 

The US regulator’s decision has taken Biohaven and investors by surprise, with the reason for a ‘major amendment’ status not clear.

Strong Showing For Bayer’s Pharma Business In Uncertain Times

 
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As CEO Anderson backs high prices for innovative drugs in Europe


Biopharma Deals ROI Has Fallen And Market Instability Could Make It Worse

 

Rising biotech valuations mean return on investment on some deals is non-existent for big pharma, though certain strategies will improve chances of success, a new analysis has found.

Pipeline Watch: Six Approvals And Thirteen Phase III Readouts

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.

Verastem Wins Approval For Novel Drug Combo In Rare Ovarian Cancer

 

The novel RAF/MEK inhibitor and FAK inhibitor are the first treatment approved specifically for KRAS-mutated recurrent low-grade serious ovarian cancer (LGSOC).

Pipeline Watch: Thirteen Approvals And Ten Phase III Readouts

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.


J&J’s Imaavy Approval Is The Starting Line For Pipeline-In-A-Product Strategy

 

The company’s FcRn inhibitor nipocalimab was approved by the US FDA for generalized myasthenia gravis (gMG), where it will join a competitive market.

Pipeline Watch: Five Approvals And One Phase III Readout

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.

Merck KGaA Seals SpringWorks Buy

 
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The German group is paying $3.9bn to get hold of the US firm and its two approved products.

Akeso Wins US Approval For PD-1 Antibody In NPC, Partly On US Data

 

Akeso’s penpulimab will be the second to hit the US market for nasopharyngeal carcinoma, but the first to win FDA approval for the indication based on clinical findings in US patients.


Pipeline Watch: Eight Approvals And Three Phase III Readouts

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.

In Brief: US FDA Rejects Regeneron’s Bid to Extend Eylea HD Dosing

 

Regeneron is disappointed by the knock-back for longer dosing intervals for its high-dose version of Eylea, but its supplemental application for a more commercially important shorter four-week regimen has received a priority review.

Seven Up For Sanofi and Regeneron With Dupixent CSU Approval

 
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The IL-4/IL-13 inhibitor has been approved in the US as the first targeted therapy in over a decade for chronic itching.

Leqembi Launch Set For Germany And Austria As EU Approval Finally Comes

 

Eisai is working on securing reimbursement across the EU for Leqembi now that the Alzheimer’s disease treatment has secured marketing approval from the European Commission.


Pipeline Watch: Ten Approvals And Eleven Phase III Readouts

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.

Pipeline Watch: 13 Approvals And 13 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.

Vanrafia Approval Plays Into Novartis’s Multipronged IgAN Approach

 

The approval of another Novartis drug with a different mechanism means the company is further cornering multiple parts of IgAN pathogenesis.

Orphans Cling On To Growth Advantage As Market Share Heads Towards 20%

 

It might be the beginning of the end for the orphan drugs party but there is still sales growth enjoyment to be had for the sector, whose star performers are now looking increasingly like mainstream drugs.