Latest Pharma Insights
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...
Scrip - April 19, 2024
The US FDA cleared Roche’s supplemental approval request for ALK inhibitor Alecensa in ALK-positive non-small cell lung cancer following tumor...
Scrip - April 19, 2024
MoCRA’s Adulteration Ambiguity And FDA’s New Cosmetic Recall Authority: Attorney Weighs In
The US FDA should use guidance or rulemaking to clarify MoCRA provisions related to adulteration, Amin Wasserman Gurnani attorney Angela...
HBW Insight - April 19, 2024
The US FDA should use guidance or rulemaking to clarify MoCRA provisions related to adulteration, Amin Wasserman Gurnani attorney Angela...
HBW Insight - April 19, 2024
Medtronic Launches Remote Live-Stream Surgery, New AI Capabilities
Medtronic will launch a new feature that allows for live streaming of surgical procedures in more than 20 countries and...
Medtech Insight - April 19, 2024
Medtronic will launch a new feature that allows for live streaming of surgical procedures in more than 20 countries and...
Medtech Insight - April 19, 2024
News We’re Watching: AI Safety Partnership; Boston Scientific Recalls; New Cancer, STI Tests; VR
This week, the US and UK announced a partnership to promote AI safety. Boston Scientific recalls embolic agent. LumiCell received...
Medtech Insight - April 19, 2024
This week, the US and UK announced a partnership to promote AI safety. Boston Scientific recalls embolic agent. LumiCell received...
Medtech Insight - April 19, 2024
Finance Watch: Canaan, Regeneron Reveal New Funds For Start-Ups
Private Company Edition: Regeneron launched a $500m venture fund and Canaan added $100m, bringing the venture firm’s recent total to...
Scrip - April 19, 2024
Private Company Edition: Regeneron launched a $500m venture fund and Canaan added $100m, bringing the venture firm’s recent total to...
Scrip - April 19, 2024
Pink Sheet Podcast: Leqembi Spending, Woodcock’s Next Act, Pneumococcal Vaccine Development
Pink Sheet editors discuss Medicare spending projections for the Alzheimer’s treatment Leqembi, Janet Woodcock’s new post-FDA role, and ongoing preparations...
Pink Sheet - April 19, 2024
Pink Sheet editors discuss Medicare spending projections for the Alzheimer’s treatment Leqembi, Janet Woodcock’s new post-FDA role, and ongoing preparations...
Pink Sheet - April 19, 2024
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...
Scrip - April 19, 2024
The top 10 biggest share price winners and losers in Q1 from Evaluate show the investor frenzy for obesity drugs...
Scrip - April 19, 2024
Investors Go Beserk 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...
Scrip - April 19, 2024
The top 10 biggest share price winners and losers in Q1 from Evaluate show the investor frenzy for obesity drugs...
Scrip - April 19, 2024
EU Consults On What Constitutes Personal & Commercially Confidential Data In Marketing Applications
Based on their experience with dealing with requests for access to documents over the past 12 years, EU regulators have...
Pink Sheet - April 19, 2024
Based on their experience with dealing with requests for access to documents over the past 12 years, EU regulators have...
Pink Sheet - April 19, 2024
Industry & Regulators To Align Advice on COVID-19 Vaccine Updates
A multi-stakeholder workshop looked at the data needed to support updates to vaccine composition and the time required by manufacturers...
Pink Sheet - April 19, 2024
A multi-stakeholder workshop looked at the data needed to support updates to vaccine composition and the time required by manufacturers...
Pink Sheet - April 19, 2024
Sanofi Skates To Where The Puck Is With Immunology
The French drugmaker has not abandoned oncology but has made it very clear that immunology and inflammation is the priority...
Scrip - April 19, 2024
The French drugmaker has not abandoned oncology but has made it very clear that immunology and inflammation is the priority...
Scrip - April 19, 2024
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...
Scrip - April 19, 2024
Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies...
Scrip - April 19, 2024
Lack Of Industry Involvement In EU HTA Scoping Process Exacerbates ‘Unworkable’ Timelines
Scientific advice could help companies make up for the lack of involvement in scoping, but slots are in short supply.
Pink Sheet - April 19, 2024
Scientific advice could help companies make up for the lack of involvement in scoping, but slots are in short supply.
Pink Sheet - April 19, 2024
Lack Of Industry Involvement In Scoping Process Exacerbates ‘Unworkable’ Timelines
Scientific advice could help companies make up for the lack of involvement in scoping, but slots are in short supply.
Pink Sheet - April 19, 2024
Scientific advice could help companies make up for the lack of involvement in scoping, but slots are in short supply.
Pink Sheet - April 19, 2024
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...
Scrip - April 19, 2024
The US FDA cleared Roche’s supplemental approval request for ALK inhibitor Alecensa in ALK-positive non-small cell lung cancer following tumor...
Scrip - April 19, 2024
Finance Watch: Canaan, Regeneron Reveal New Funds For Start-Ups
Private Company Edition: Regeneron launched a $500m venture fund and Canaan added $100m, bringing the venture firm’s recent total to...
Scrip - April 19, 2024
Private Company Edition: Regeneron launched a $500m venture fund and Canaan added $100m, bringing the venture firm’s recent total to...
Scrip - April 19, 2024
Investors Go Beserk 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...
Scrip - April 19, 2024
The top 10 biggest share price winners and losers in Q1 from Evaluate show the investor frenzy for obesity drugs...
Scrip - April 19, 2024
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...
Scrip - April 19, 2024
The top 10 biggest share price winners and losers in Q1 from Evaluate show the investor frenzy for obesity drugs...
Scrip - April 19, 2024
Sanofi Skates To Where The Puck Is With Immunology
The French drugmaker has not abandoned oncology but has made it very clear that immunology and inflammation is the priority...
Scrip - April 19, 2024
The French drugmaker has not abandoned oncology but has made it very clear that immunology and inflammation is the priority...
Scrip - April 19, 2024
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...
Scrip - April 19, 2024
Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies...
Scrip - April 19, 2024
Pink Sheet Podcast: Leqembi Spending, Woodcock’s Next Act, Pneumococcal Vaccine Development
Pink Sheet editors discuss Medicare spending projections for the Alzheimer’s treatment Leqembi, Janet Woodcock’s new post-FDA role, and ongoing preparations...
Pink Sheet - April 19, 2024
Pink Sheet editors discuss Medicare spending projections for the Alzheimer’s treatment Leqembi, Janet Woodcock’s new post-FDA role, and ongoing preparations...
Pink Sheet - April 19, 2024
EU Consults On What Constitutes Personal & Commercially Confidential Data In Marketing Applications
Based on their experience with dealing with requests for access to documents over the past 12 years, EU regulators have...
Pink Sheet - April 19, 2024
Based on their experience with dealing with requests for access to documents over the past 12 years, EU regulators have...
Pink Sheet - April 19, 2024
Industry & Regulators To Align Advice on COVID-19 Vaccine Updates
A multi-stakeholder workshop looked at the data needed to support updates to vaccine composition and the time required by manufacturers...
Pink Sheet - April 19, 2024
A multi-stakeholder workshop looked at the data needed to support updates to vaccine composition and the time required by manufacturers...
Pink Sheet - April 19, 2024
Lack Of Industry Involvement In Scoping Process Exacerbates ‘Unworkable’ Timelines
Scientific advice could help companies make up for the lack of involvement in scoping, but slots are in short supply.
Pink Sheet - April 19, 2024
Scientific advice could help companies make up for the lack of involvement in scoping, but slots are in short supply.
Pink Sheet - April 19, 2024
Lack Of Industry Involvement In EU HTA Scoping Process Exacerbates ‘Unworkable’ Timelines
Scientific advice could help companies make up for the lack of involvement in scoping, but slots are in short supply.
Pink Sheet - April 19, 2024
Scientific advice could help companies make up for the lack of involvement in scoping, but slots are in short supply.
Pink Sheet - April 19, 2024
Medtronic Launches Remote Live-Stream Surgery, New AI Capabilities
Medtronic will launch a new feature that allows for live streaming of surgical procedures in more than 20 countries and...
Medtech Insight - April 19, 2024
Medtronic will launch a new feature that allows for live streaming of surgical procedures in more than 20 countries and...
Medtech Insight - April 19, 2024
News We’re Watching: AI Safety Partnership; Boston Scientific Recalls; New Cancer, STI Tests; VR
This week, the US and UK announced a partnership to promote AI safety. Boston Scientific recalls embolic agent. LumiCell received...
Medtech Insight - April 19, 2024
This week, the US and UK announced a partnership to promote AI safety. Boston Scientific recalls embolic agent. LumiCell received...
Medtech Insight - April 19, 2024
MoCRA’s Adulteration Ambiguity And FDA’s New Cosmetic Recall Authority: Attorney Weighs In
The US FDA should use guidance or rulemaking to clarify MoCRA provisions related to adulteration, Amin Wasserman Gurnani attorney Angela...
HBW Insight - April 19, 2024
The US FDA should use guidance or rulemaking to clarify MoCRA provisions related to adulteration, Amin Wasserman Gurnani attorney Angela...
HBW Insight - April 19, 2024
Who’s Hired? Hikma Recruits New US Generics President
A flurry of top level recruitments made headlines in the past weeks, with the likes of Hikma, Lupin, and Viatris...
Generics Bulletin - April 18, 2024
A flurry of top level recruitments made headlines in the past weeks, with the likes of Hikma, Lupin, and Viatris...
Generics Bulletin - April 18, 2024
Organon And Henlius Complete Phase III For Denosumab
Having earlier this year reported positive Phase I data for their partnered denosumab biosimilar candidate, Organon and Shanghai Henlius Biotech...
Generics Bulletin - April 18, 2024
Having earlier this year reported positive Phase I data for their partnered denosumab biosimilar candidate, Organon and Shanghai Henlius Biotech...
Generics Bulletin - April 18, 2024
Taro Agrees $36m Securities Settlement Over US Price-Fixing Claims
Sun’s Taro subsidiary is looking to move forward with an eight-figure settlement deal in the US, after plaintiffs including a...
Generics Bulletin - April 18, 2024
Sun’s Taro subsidiary is looking to move forward with an eight-figure settlement deal in the US, after plaintiffs including a...
Generics Bulletin - April 18, 2024
As Casgevy, Lyfgenia Launches Proceed, CRISPR And bluebird bio CEOs Reassure
The CEOs of bluebird bio and CRISPR Therapeutics hope to inspire investor confidence that their gene-based therapies for sickle cell...
In Vivo - April 18, 2024
The CEOs of bluebird bio and CRISPR Therapeutics hope to inspire investor confidence that their gene-based therapies for sickle cell...
In Vivo - April 18, 2024