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Drug Makers Look To Simplify Application Process With New ICH Guidance On Platform Methods
As ICH member countries prepare to implement Q2(R1)/Q14 guidelines, industry is focusing on provisions in both for platform analytical procedures...
Pink Sheet - March 1, 2024
In Investing, Oncology Is Still King, But Other Indications Joining The Royal Court
Investing in oncology has diminished as more focus goes to clinical-stage firms, while investment in preclinical companies in areas like...
Scrip - March 1, 2024
Cardiff’s Move Into First-Line mCRC Backed By Data From Discontinued Study
Based on advice from the FDA, Cardiff is testing its PLK1 inhibitor onvansertib in first-line metastatic colorectal cancer; data from...
Scrip - March 1, 2024
ViVE 2024: Start-Ups Using AI To Screen Children’s Mental Health, Prevent Post-Partum Depression, Health Equity, More
Medtech Insight features seven start-ups that pitched their innovative projects at ViVE’s inaugural Start-up Competition in Los Angeles.
Medtech Insight - March 1, 2024
A Sneak Peak At Pfizer’s Next-Generation ADC Pipeline
Antibody-drug conjugates remain a hot area of cancer drug development and Pfizer showed investors some of the novel targets and...
Scrip - March 1, 2024
Over The Counter 1 March 2024: The Emerging Benefits Of ‘Beauty-From-Within,’ Featuring Kenvue’s Paul LaTerra
In this episode of Over the Counter, HBW Insight speaks to Paul LaTerra, Director, R&D, Global Hair and Scalp for...
HBW Insight - March 1, 2024
Recent And Upcoming FDA Advisory Committee Meetings
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered. 
Pink Sheet - March 1, 2024
Warning Letters And Close-Outs – January/February 2024
The US Food and Drug Administration has released three warning letters and two close-outs so far this year, with missives...
Medtech Insight - March 1, 2024
Finance Watch: Denali, Avidity And Others Chase Big Money Via Private Placements
Public Company Edition: Denali, Crinetics and Ocular Therapeutix grossed $500m, $350m and $325m, respectively, in private placements ahead of data...
Scrip - March 1, 2024
'There Is Work To Do:' Sean Salmon Discusses Medtronic's Recent Hard-Won Cardio Breakthroughs
Medtech Insight caught up with Sean Salmon, the president of Medtronic's cardiovascular business, to talk about the long-awaited FDA approval...
Medtech Insight - March 1, 2024
Bayer Consumer Health Names New President In Surprise Move
Heiko Schipper is departing for Unilever with Bayer Consumer Health promoting Julio Triana to take over just days before a...
HBW Insight - March 1, 2024
Maxwellia Adds STI Home-Test To UK Lovi Line
UK sexual health specialist Maxwellia continues to expand its UK footprint with an STI home-test launch under the Lovi brand...
HBW Insight - March 1, 2024
Abingworth Adds Stakes To Gilead’s Trodelvy Gamble
The venture capital firm is putting $210m into NSCLC trials for the antibody drug conjugate – with an opportunity in...
Scrip - March 1, 2024
Taking On Vyvgart In Myasthenia Gravis
Argenx has aggressive market expansion plans for Vyvgart. It also has several late-stage challengers in what is becoming a dynamic...
Scrip - March 1, 2024
European Off-Patent Industry Welcomes Unitary SPC Pre-Grant Opposition
European off-patent industry association Medicines for Europe has welcomed the European Parliament’s “balanced stand” on unitary SPC regulation after “safeguard”...
Generics Bulletin - March 1, 2024
Three Major Regulators Launch Pilot To Reduce Duplication Of GMP Inspections
Regulatory bodies from Australia, Canada and the UK say a new pilot program will reduce the need for multiple inspections...
Pink Sheet - March 1, 2024
Amgen Wins First Approval Through UK’s New International Recognition Procedure
The UK MHRA approved a new version of Amgen’s established bone cancer complication drug Xgeva based on a review conducted...
Pink Sheet - March 1, 2024
NZ Govt Moves To Speed Drug Access While Planning To Wipe Out Major New Act
A parallel assessment mechanism that will allow new medicines in any therapeutic area to be considered for funding sooner is...
Pink Sheet - March 1, 2024
NZ Govt Moves To Speed Drug Access Amid Plans To Wipe Out Major New Act
A parallel assessment mechanism that will allow new medicines in any therapeutic area to be considered for funding sooner is...
Pink Sheet - March 1, 2024
Generic Drug Cluster: What Are Global Regulators Discussing?
In its ongoing attempt to embrace international harmonization, the US Food and Drug Administration invited stakeholders from both sides of...
Generics Bulletin - March 1, 2024
Biocon Stelara Settlement Places Firm Among Earlier US Rivals
Biocon Biologics has secured a launch date for its planned US biosimilar to Stelara that puts it ahead of some...
Generics Bulletin - March 1, 2024
Executives On The Move: Joseph Papa Joins Emergent BioSolutions As CEO Among Other Industry Moves
Recent moves within the industry include changes at the top for Ocular Therapeutix and Rayzebio, plus a new CEO for Bellicum Pharmaceuticals.  ...
Scrip - March 1, 2024
AI Clinical Summarization Tools Sit In 'Regulatory Grey Area', Experts Warn
The EU lacks concrete guidance on whether clinical summarization large language models are considered medical devices. Experts push for EU...
Medtech Insight - March 1, 2024
China In-Licensing Crossroads: Zai Lab, Everest March Towards Market But BioNova Returns Rights
China's Zai Lab and Everest are still pursuing profitability on the commercialization of in-licensed assets, while BioNova and others have...
Scrip - March 1, 2024
What’s Next? Five Things To Look Out For In March
Generics Bulletin previews the most noteworthy and anticipated events for March 2024.
Generics Bulletin - March 1, 2024
Lilly CEO: Affordable Generics And IP Support 'Not Incompatible Ideas'
Lilly’s CEO indicates that the long-standing IPR debate that has generally divided the developed and developing world is largely a...
Scrip - March 1, 2024
US Toning Down China CDMO Tension But New Restrictions Emerge
The latest developments in a US Congressional draft bill to curb Chinese biotech operations in the US is separating contract...
Pink Sheet - March 1, 2024

In Investing, Oncology Is Still King, But Other Indications Joining The Royal Court
Investing in oncology has diminished as more focus goes to clinical-stage firms, while investment in preclinical companies in areas like...
Scrip - March 1, 2024
Cardiff’s Move Into First-Line mCRC Backed By Data From Discontinued Study
Based on advice from the FDA, Cardiff is testing its PLK1 inhibitor onvansertib in first-line metastatic colorectal cancer; data from...
Scrip - March 1, 2024
A Sneak Peak At Pfizer’s Next-Generation ADC Pipeline
Antibody-drug conjugates remain a hot area of cancer drug development and Pfizer showed investors some of the novel targets and...
Scrip - March 1, 2024
Finance Watch: Denali, Avidity And Others Chase Big Money Via Private Placements
Public Company Edition: Denali, Crinetics and Ocular Therapeutix grossed $500m, $350m and $325m, respectively, in private placements ahead of data...
Scrip - March 1, 2024
Abingworth Adds Stakes To Gilead’s Trodelvy Gamble
The venture capital firm is putting $210m into NSCLC trials for the antibody drug conjugate – with an opportunity in...
Scrip - March 1, 2024
Taking On Vyvgart In Myasthenia Gravis
Argenx has aggressive market expansion plans for Vyvgart. It also has several late-stage challengers in what is becoming a dynamic...
Scrip - March 1, 2024
Executives On The Move: Joseph Papa Joins Emergent BioSolutions As CEO Among Other Industry Moves
Recent moves within the industry include changes at the top for Ocular Therapeutix and Rayzebio, plus a new CEO for Bellicum Pharmaceuticals.  ...
Scrip - March 1, 2024
China In-Licensing Crossroads: Zai Lab, Everest March Towards Market But BioNova Returns Rights
China's Zai Lab and Everest are still pursuing profitability on the commercialization of in-licensed assets, while BioNova and others have...
Scrip - March 1, 2024
Lilly CEO: Affordable Generics And IP Support 'Not Incompatible Ideas'
Lilly’s CEO indicates that the long-standing IPR debate that has generally divided the developed and developing world is largely a...
Scrip - March 1, 2024

Drug Makers Look To Simplify Application Process With New ICH Guidance On Platform Methods
As ICH member countries prepare to implement Q2(R1)/Q14 guidelines, industry is focusing on provisions in both for platform analytical procedures...
Pink Sheet - March 1, 2024
Recent And Upcoming FDA Advisory Committee Meetings
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered. 
Pink Sheet - March 1, 2024
Three Major Regulators Launch Pilot To Reduce Duplication Of GMP Inspections
Regulatory bodies from Australia, Canada and the UK say a new pilot program will reduce the need for multiple inspections...
Pink Sheet - March 1, 2024
Amgen Wins First Approval Through UK’s New International Recognition Procedure
The UK MHRA approved a new version of Amgen’s established bone cancer complication drug Xgeva based on a review conducted...
Pink Sheet - March 1, 2024
NZ Govt Moves To Speed Drug Access While Planning To Wipe Out Major New Act
A parallel assessment mechanism that will allow new medicines in any therapeutic area to be considered for funding sooner is...
Pink Sheet - March 1, 2024
NZ Govt Moves To Speed Drug Access Amid Plans To Wipe Out Major New Act
A parallel assessment mechanism that will allow new medicines in any therapeutic area to be considered for funding sooner is...
Pink Sheet - March 1, 2024
US Toning Down China CDMO Tension But New Restrictions Emerge
The latest developments in a US Congressional draft bill to curb Chinese biotech operations in the US is separating contract...
Pink Sheet - March 1, 2024

ViVE 2024: Start-Ups Using AI To Screen Children’s Mental Health, Prevent Post-Partum Depression, Health Equity, More
Medtech Insight features seven start-ups that pitched their innovative projects at ViVE’s inaugural Start-up Competition in Los Angeles.
Medtech Insight - March 1, 2024
Warning Letters And Close-Outs – January/February 2024
The US Food and Drug Administration has released three warning letters and two close-outs so far this year, with missives...
Medtech Insight - March 1, 2024
'There Is Work To Do:' Sean Salmon Discusses Medtronic's Recent Hard-Won Cardio Breakthroughs
Medtech Insight caught up with Sean Salmon, the president of Medtronic's cardiovascular business, to talk about the long-awaited FDA approval...
Medtech Insight - March 1, 2024
AI Clinical Summarization Tools Sit In 'Regulatory Grey Area', Experts Warn
The EU lacks concrete guidance on whether clinical summarization large language models are considered medical devices. Experts push for EU...
Medtech Insight - March 1, 2024

Over The Counter 1 March 2024: The Emerging Benefits Of ‘Beauty-From-Within,’ Featuring Kenvue’s Paul LaTerra
In this episode of Over the Counter, HBW Insight speaks to Paul LaTerra, Director, R&D, Global Hair and Scalp for...
HBW Insight - March 1, 2024
Bayer Consumer Health Names New President In Surprise Move
Heiko Schipper is departing for Unilever with Bayer Consumer Health promoting Julio Triana to take over just days before a...
HBW Insight - March 1, 2024
Maxwellia Adds STI Home-Test To UK Lovi Line
UK sexual health specialist Maxwellia continues to expand its UK footprint with an STI home-test launch under the Lovi brand...
HBW Insight - March 1, 2024

European Off-Patent Industry Welcomes Unitary SPC Pre-Grant Opposition
European off-patent industry association Medicines for Europe has welcomed the European Parliament’s “balanced stand” on unitary SPC regulation after “safeguard”...
Generics Bulletin - March 1, 2024
Generic Drug Cluster: What Are Global Regulators Discussing?
In its ongoing attempt to embrace international harmonization, the US Food and Drug Administration invited stakeholders from both sides of...
Generics Bulletin - March 1, 2024
Biocon Stelara Settlement Places Firm Among Earlier US Rivals
Biocon Biologics has secured a launch date for its planned US biosimilar to Stelara that puts it ahead of some...
Generics Bulletin - March 1, 2024
What’s Next? Five Things To Look Out For In March
Generics Bulletin previews the most noteworthy and anticipated events for March 2024.
Generics Bulletin - March 1, 2024

Advice From Investors On Early-Stage Financing
Startup financing may be hard to come by, but now is not the time to ask for less cash. 
In Vivo - February 27, 2024