Latest Pharma Insights
Proof Of Concept: How A Charity Bridges Lab And Clinic
Why the gap between lab and clinic isn't a science problem but a coordination one, and how a charity is stepping in to bridge it.
In Vivo - September 4, 2026
Why the gap between lab and clinic isn't a science problem but a coordination one, and how a charity is stepping in to bridge it.
In Vivo - September 4, 2026
From ISH Downclassification To RAPID Exclusion: FDA Maps The Diagnostics Landscape
FDA's in vitro diagnostics chief outlined regulatory advances including a companion diagnostic downclassification and a Dec. 26 COVID EUA deadline at a recent conference, while industry pushed back on IVDs' continued exclusion from RAPID, a new CMS reimbursement pathway for breakthrough devices.
Medtech Insight - September 4, 2026
FDA's in vitro diagnostics chief outlined regulatory advances including a companion diagnostic downclassification and a Dec. 26 COVID EUA deadline at a recent conference, while industry pushed back on IVDs' continued exclusion from RAPID, a new CMS reimbursement pathway for breakthrough devices.
Medtech Insight - September 4, 2026
US FDA, SEC Will Share Information, Not Trade Secrets
Memorandum of understanding allows two agencies to share non-public information in order to improve enforcement and compliance, but agreement maintains FDA’s prohibition on sharing trade secrets.
HBW Insight - September 4, 2026
Memorandum of understanding allows two agencies to share non-public information in order to improve enforcement and compliance, but agreement maintains FDA’s prohibition on sharing trade secrets.
HBW Insight - September 4, 2026
Finance Watch: US Biopharma Job Cuts Hit The East And West Coasts
Restructuring Edition: A new MassBio report showed Massachusetts biopharma employment dropped in 2025, echoing job cuts outlined in two recent California industry updates. Also, TScan and ArsenalBio reduced their workforces to focus on in vivo cell therapies.
Scrip - September 3, 2026
Restructuring Edition: A new MassBio report showed Massachusetts biopharma employment dropped in 2025, echoing job cuts outlined in two recent California industry updates. Also, TScan and ArsenalBio reduced their workforces to focus on in vivo cell therapies.
Scrip - September 3, 2026
AbbVie’s Etentamig Suits Community Setting With Monthly Dosing, Low Toxicity
The BCMAxCD3-directed bispecific for myeloma would be late to the game, but it could address a significant uptake gap in immunotherapy treatment for the disease.
Scrip - September 3, 2026
The BCMAxCD3-directed bispecific for myeloma would be late to the game, but it could address a significant uptake gap in immunotherapy treatment for the disease.
Scrip - September 3, 2026
Ionis’ Zanvastro Is First Disease-Modifying Drug For Alexander Disease
Only a few hundred individuals in the US are diagnosed with the progressive neurological disease; Ionis will focus on building disease awareness and diagnosis.
Scrip - September 3, 2026
Only a few hundred individuals in the US are diagnosed with the progressive neurological disease; Ionis will focus on building disease awareness and diagnosis.
Scrip - September 3, 2026
UniQure Has Huntington’s Gene Therapy Approval In Its Sights Again
Its initial filing was rejected in April by the FDA’s now-departed Vinay Prasad but a new leadership agrees with UniQure that a new sham-controlled trial is not necessary raising hopes that its first product could soon be approaching the market.
Scrip - September 3, 2026
Its initial filing was rejected in April by the FDA’s now-departed Vinay Prasad but a new leadership agrees with UniQure that a new sham-controlled trial is not necessary raising hopes that its first product could soon be approaching the market.
Scrip - September 3, 2026
GSK Ups KRAS Efforts With Hutchmed Pact
Deal Snapshot: The UK major is linking up with the prolific Chinese R&D company to license an experimental antibody-drug conjugate that delivers a KRAS inhibitor to EGFR-expressing tumors.
Scrip - September 3, 2026
Deal Snapshot: The UK major is linking up with the prolific Chinese R&D company to license an experimental antibody-drug conjugate that delivers a KRAS inhibitor to EGFR-expressing tumors.
Scrip - September 3, 2026
Ultragenyx’s Angelman Syndrome Failure Raises Big Questions About Its Pipeline
The Phase III failure of Ultragenyx’s apazunersen (GTX-102) in Angelman syndrome greatly diminishes investor enthusiasm over the biotech’s pipeline, sending shares crashing over 40%.
Scrip - September 3, 2026
The Phase III failure of Ultragenyx’s apazunersen (GTX-102) in Angelman syndrome greatly diminishes investor enthusiasm over the biotech’s pipeline, sending shares crashing over 40%.
Scrip - September 3, 2026
Positive Early Data For NEC/Transgene’s Neoantigen Vaccine
Early clinical data for Transgene/NEC's individualized neoantigen therapeutic vaccine show 100% three-year disease-free survival in head and neck cancer patients.
Scrip - September 3, 2026
Early clinical data for Transgene/NEC's individualized neoantigen therapeutic vaccine show 100% three-year disease-free survival in head and neck cancer patients.
Scrip - September 3, 2026
Chia Tai Tianqing’s First ADC Looking Good In HER2-Low Breast Cancer
World-first Phase III success for Chia Tai Tianqing's anti-HER2 bispecific in interim analysis for HER2-low breast cancer paves way for China approval filing.
Scrip - September 3, 2026
World-first Phase III success for Chia Tai Tianqing's anti-HER2 bispecific in interim analysis for HER2-low breast cancer paves way for China approval filing.
Scrip - September 3, 2026
Head Start For Ivonescimab Over ADCs With OS Win Vs Keytruda In 1L NSCLC
The China-only, head-to-head Phase III HARMONi-2 trial with Akeso's ivonescimab has met the key secondary endpoint of overall survival in the first-line treatment of patients with PD-L1-positive NSCLC, with numerical findings to be presented at WCLC.
Scrip - September 3, 2026
The China-only, head-to-head Phase III HARMONi-2 trial with Akeso's ivonescimab has met the key secondary endpoint of overall survival in the first-line treatment of patients with PD-L1-positive NSCLC, with numerical findings to be presented at WCLC.
Scrip - September 3, 2026
From ISH Downclassification To RAPID Exclusion: FDA Maps The Diagnostics Landscape
FDA's in vitro diagnostics chief outlined regulatory advances including a companion diagnostic downclassification and a Dec. 26 COVID EUA deadline at a recent conference, while industry pushed back on IVDs' continued exclusion from RAPID, a new CMS reimbursement pathway for breakthrough devices.
Medtech Insight - September 4, 2026
FDA's in vitro diagnostics chief outlined regulatory advances including a companion diagnostic downclassification and a Dec. 26 COVID EUA deadline at a recent conference, while industry pushed back on IVDs' continued exclusion from RAPID, a new CMS reimbursement pathway for breakthrough devices.
Medtech Insight - September 4, 2026
US FDA, SEC Will Share Information, Not Trade Secrets
Memorandum of understanding allows two agencies to share non-public information in order to improve enforcement and compliance, but agreement maintains FDA’s prohibition on sharing trade secrets.
HBW Insight - September 4, 2026
Memorandum of understanding allows two agencies to share non-public information in order to improve enforcement and compliance, but agreement maintains FDA’s prohibition on sharing trade secrets.
HBW Insight - September 4, 2026
Mylan Conflict Challenge Derails September Humana Bellwether
Mylan has secured a temporary stay of Humana’s generic price-fixing bellwether after raising conflict allegations over special discovery master Lawrence Stengel, forcing a September 15 jury trial to be rescheduled.
Generics Bulletin - September 3, 2026
Mylan has secured a temporary stay of Humana’s generic price-fixing bellwether after raising conflict allegations over special discovery master Lawrence Stengel, forcing a September 15 jury trial to be rescheduled.
Generics Bulletin - September 3, 2026
Viagra For Women: Daré Bioscience Focuses On Female Sexual Health With Topical Sildenafil
With no FDA-approved treatment for female sexual arousal disorder, Daré Bioscience is entering an unaddressed market by developing a 505(b)(2) sildenafil cream, while concurrently launching a 503B compounded version.
Generics Bulletin - September 3, 2026
With no FDA-approved treatment for female sexual arousal disorder, Daré Bioscience is entering an unaddressed market by developing a 505(b)(2) sildenafil cream, while concurrently launching a 503B compounded version.
Generics Bulletin - September 3, 2026
Natco Rules Out Semaglutide Filings In Canada And Brazil
Natco has ruled out generic semaglutide filings in Canada and Brazil as competition intensifies in both markets, while its Indian brand faces aggressive pricing and limited profitability.
Generics Bulletin - September 3, 2026
Natco has ruled out generic semaglutide filings in Canada and Brazil as competition intensifies in both markets, while its Indian brand faces aggressive pricing and limited profitability.
Generics Bulletin - September 3, 2026
Proof Of Concept: How A Charity Bridges Lab And Clinic
Why the gap between lab and clinic isn't a science problem but a coordination one, and how a charity is stepping in to bridge it.
In Vivo - September 4, 2026
Why the gap between lab and clinic isn't a science problem but a coordination one, and how a charity is stepping in to bridge it.
In Vivo - September 4, 2026