Latest Pharma Insights
PDUFA Reauthorization Discussions Acknowledge OTC NDAs Eligible For Stepwise Labeling Process
In latest meeting of PDUFA reauthorization nonprescription subgroup, FDAS officials acknowledged stepwise labeling submissions “already available under current regulations but may not be widely known or consistently applied.”
HBW Insight - February 11, 2026
In latest meeting of PDUFA reauthorization nonprescription subgroup, FDAS officials acknowledged stepwise labeling submissions “already available under current regulations but may not be widely known or consistently applied.”
HBW Insight - February 11, 2026
Coty’s New Head Unveils ‘Curation’ Strategy As Firm Withdraws FY26 Guidance
Coty interim CEO Markus Strobel, who took the helm from Sue Nabi starting Jan. 1, describes the company’s new “Coty. Curated.” growth initiative during the firm’s fiscal second quarter earnings presentation.
HBW Insight - February 11, 2026
Coty interim CEO Markus Strobel, who took the helm from Sue Nabi starting Jan. 1, describes the company’s new “Coty. Curated.” growth initiative during the firm’s fiscal second quarter earnings presentation.
HBW Insight - February 11, 2026
FDA Tosses Flu Vaccine Application Back To Moderna With RTF Letter
Moderna said the refusal-to-file (RTF) letter the US FDA issued declining to review the BLA for mRNA-1010 was not in line with guidance from the agency before and after the seasonal influenza vaccine candidate’s Phase III program.
Scrip - February 11, 2026
Moderna said the refusal-to-file (RTF) letter the US FDA issued declining to review the BLA for mRNA-1010 was not in line with guidance from the agency before and after the seasonal influenza vaccine candidate’s Phase III program.
Scrip - February 11, 2026
FDA Tosses Flu Vaccine Application Back To Moderna With RTF Letter
Moderna said the refusal-to-file (RTF) letter the US FDA issued declining to review the BLA for mRNA-1010 was not in line with guidance from the agency before and after the seasonal influenza vaccine candidate’s Phase III program.
Scrip - February 11, 2026
Moderna said the refusal-to-file (RTF) letter the US FDA issued declining to review the BLA for mRNA-1010 was not in line with guidance from the agency before and after the seasonal influenza vaccine candidate’s Phase III program.
Scrip - February 11, 2026
QSIT, Lose It! FDA Inspections Will Now Take a Comprehensive Risk-Based Approach
The US FDA has published an updated inspections manual detailing how it will conduct investigations going forward under its new regulatory framework. Medtech Insight talked to a couple of regulatory experts about the key changes to the new protocol.
Medtech Insight - February 10, 2026
The US FDA has published an updated inspections manual detailing how it will conduct investigations going forward under its new regulatory framework. Medtech Insight talked to a couple of regulatory experts about the key changes to the new protocol.
Medtech Insight - February 10, 2026
MDUFA VI Negotiations Turn To RWE Strategy, Presubmission Reforms
Recent MDUFA VI negotiations emphasized real-world evidence and potential reforms in de novo and presubmission programs. Both industry representatives and FDA staff discussed improving RWE quality and addressing device submission challenges.
Medtech Insight - February 10, 2026
Recent MDUFA VI negotiations emphasized real-world evidence and potential reforms in de novo and presubmission programs. Both industry representatives and FDA staff discussed improving RWE quality and addressing device submission challenges.
Medtech Insight - February 10, 2026
Illumina Looks To Clinical Consumables And China Restart To Offset Intensifying NGS Price Pressure
Illumina said it has a defined internal target for China, with potential upside if regulatory conditions improve further.
Medtech Insight - February 10, 2026
Illumina said it has a defined internal target for China, with potential upside if regulatory conditions improve further.
Medtech Insight - February 10, 2026
Philips Sets 3-Year Growth Plan And Ends 2025 On A Comparative High
Royal Philips’ 2025 2% comparable sales growth points to a company emerging from its respiratory recall depths and ready to give a vote of confidence to the CEO as a new three-year financial plan is unveiled.
Medtech Insight - February 10, 2026
Royal Philips’ 2025 2% comparable sales growth points to a company emerging from its respiratory recall depths and ready to give a vote of confidence to the CEO as a new three-year financial plan is unveiled.
Medtech Insight - February 10, 2026
PDUFA Reauthorization Discussions Acknowledge OTC NDAs Eligible For Stepwise Labeling Process
In latest meeting of PDUFA reauthorization nonprescription subgroup, FDAS officials acknowledged stepwise labeling submissions “already available under current regulations but may not be widely known or consistently applied.”
HBW Insight - February 11, 2026
In latest meeting of PDUFA reauthorization nonprescription subgroup, FDAS officials acknowledged stepwise labeling submissions “already available under current regulations but may not be widely known or consistently applied.”
HBW Insight - February 11, 2026
Coty’s New Head Unveils ‘Curation’ Strategy As Firm Withdraws FY26 Guidance
Coty interim CEO Markus Strobel, who took the helm from Sue Nabi starting Jan. 1, describes the company’s new “Coty. Curated.” growth initiative during the firm’s fiscal second quarter earnings presentation.
HBW Insight - February 11, 2026
Coty interim CEO Markus Strobel, who took the helm from Sue Nabi starting Jan. 1, describes the company’s new “Coty. Curated.” growth initiative during the firm’s fiscal second quarter earnings presentation.
HBW Insight - February 11, 2026
Lupin Strikes $90m Settlement With Astellas On Myrbetriq
Following a $90m settlement with Astellas over Myrbetriq (mirabegron) in the US, Lupin can continue selling its generic product even as Zydus says the Delaware district court has directed mediation but the trial is proceeding. How have the generics fared and what does this mean now?
Generics Bulletin - February 10, 2026
Following a $90m settlement with Astellas over Myrbetriq (mirabegron) in the US, Lupin can continue selling its generic product even as Zydus says the Delaware district court has directed mediation but the trial is proceeding. How have the generics fared and what does this mean now?
Generics Bulletin - February 10, 2026
Fresenius Kabi And Phlow Partner On End-To-End US Epinephrine Supply Chain
Phlow and Fresenius Kabi are partnering in the US to establish a fully domestic manufacturing pathway for epinephrine injection, with launch targeted for 2027 pending approvals. The collaboration is aimed at addressing the current lack of a US-based API producer.
Generics Bulletin - February 10, 2026
Phlow and Fresenius Kabi are partnering in the US to establish a fully domestic manufacturing pathway for epinephrine injection, with launch targeted for 2027 pending approvals. The collaboration is aimed at addressing the current lack of a US-based API producer.
Generics Bulletin - February 10, 2026
Organon And Henlius Settle US Perjeta Litigation
Organon and Henlius have agreed to settle US litigation with Roche and Genentech over their Poherdy pertuzumab biosimilar rival to Perjeta. But when will they launch?
Generics Bulletin - February 10, 2026
Organon and Henlius have agreed to settle US litigation with Roche and Genentech over their Poherdy pertuzumab biosimilar rival to Perjeta. But when will they launch?
Generics Bulletin - February 10, 2026
From CF To Big Pulmonary Markets: SpliSense’s Strategy To Make Inhaled RNA Work
SpliSense is the first company to show inhaled antisense oligos improve lung function in cystic fibrosis, validating its platform for larger COPD and asthma markets.
In Vivo - February 9, 2026
SpliSense is the first company to show inhaled antisense oligos improve lung function in cystic fibrosis, validating its platform for larger COPD and asthma markets.
In Vivo - February 9, 2026
Deal-Making Quarterly Statistics, Q4 2025
During Q4, biopharma merger and acquisition deal value reached $94.8bn and drew in $74.7bn in potential deal value from alliances. Device company M&A values reached $3.5bn, while in vitro diagnostics and research tools players’ M&A activity totaled $39.8m.
In Vivo - February 9, 2026
During Q4, biopharma merger and acquisition deal value reached $94.8bn and drew in $74.7bn in potential deal value from alliances. Device company M&A values reached $3.5bn, while in vitro diagnostics and research tools players’ M&A activity totaled $39.8m.
In Vivo - February 9, 2026
Biogen’s Alisha Alaimo On The Company’s Next Big Commercial Build
Biogen’s president and head of North America talked to Scrip about the company’s commercial expansion into new areas in immunology and nephrology.
In Vivo - February 9, 2026
Biogen’s president and head of North America talked to Scrip about the company’s commercial expansion into new areas in immunology and nephrology.
In Vivo - February 9, 2026