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Latest Pharma Insights



Quick Listen: Scrip's Five Must-Know Things
In this week's podcast edition of Five Must-Know Things: Japan’s Ono buys US oncology firm; strong growth but supply issues for...
Scrip - May 6, 2024
US FDA Inspectors, Product Centers Working Closer Together Ahead Of ORA Reorg
Compliance functions will be moved to the product centers when ORA becomes the Office of Inspections and Investigations, and centers...
HBW Insight - May 6, 2024
Without Additional Funding, US FDA's Inspections In Jeopardy – Regulatory Affairs Chief
Without additional funding, FDA’s ORA faces challenges in retaining and hiring staff, which will impact inspections, says office chief Michael...
HBW Insight - May 6, 2024
Herbalife's Rising Digital Platform Floats All Boats Other Than Marketing To GLP-1 Patients
Direct seller reports Q1 sales up 1% to $1.3bn but net sales off 17.1% from year-ago period to $24.3m. Its...
HBW Insight - May 6, 2024
Gossamer Partners With Chiesi To Accelerate Seralutinib Development
Already in Phase III for PAH, Gossamer said it can take seralutinib into Phase III for PH-ILD at least four...
Scrip - May 6, 2024
Pipeline Watch: Six Approvals And 13 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 - May 6, 2024
Don’t Stop Manufacturing Because of An Inspection, FDA’s Cavazzoni Says
The FDA drug center director is encouraging manufacturers to contact the agency’s shortage surveillance team before making rash decisions during...
Pink Sheet - May 6, 2024
Beauty Packaging Producers Facing Tedious EPR Work Should Consider Software Solutions
Cataloging materials by category across US states or even internationally, chasing down information from supply partners, and other aspects of...
HBW Insight - May 6, 2024
ORA Chief Says Inspections In Jeopardy Without Additional Funding
The US FDA’s Office of Regulatory Affairs is facing challenges in retaining and hiring new staff, which will impact inspections...
Pink Sheet - May 6, 2024
Expert Proposes AI Device Reimbursement Model ‘Like Netflix’
Johns Hopkins professor Tinglong Dai says a subscription model for AI is the most sustainable model for reimbursement. 
Medtech Insight - May 6, 2024
Drug Promotion: Sponsors Are Running Afoul Of US FDA’s CFL Guidance
Recent Office of Prescription Drug Promotion enforcement letters provide several learnings, including the need to be aware of a product’s...
Pink Sheet - May 6, 2024
The Future of ACIP: CDC Vaccine Policy Lead Looks Beyond COVID
The CDC’s Melinda Wharton discusses how the ACIP handled COVID-19 and how the pandemic will shape the committee’s work in...
Pink Sheet - May 6, 2024
Pfizer Finally Wins English Funding For Sickle Cell Drug Oxbryta After Bumpy Ride
After several rejections by NICE and an appeal by Pfizer, the company has reduced the price for its first-in-class sickle...
Pink Sheet - May 6, 2024
Novo Nordisk Foundation Strengthens Ties With Gates
The two heavyweights have joined forces with fellow major charitable foundation Wellcome and committed $300m to "accelerate global health equity...
Scrip - May 6, 2024
Robotic-Assisted Treatment For Enlarged Prostate Shows Promising Results
A novel robotic-assisted therapy could improve the lives of men with benign prostatic hyperplasia, real-world data presented at the annual...
Medtech Insight - May 6, 2024
GlycoMimetics Forges Ahead With Uproleselan In AML After Phase III Failure
The company said an NCI trial and a China study remain ongoing despite a Phase III study in relapsed/refractory disease...
Scrip - May 6, 2024
GE HealthCare’s New Investigational MRI Promises Advancements On Neurological Disease Research
GE HealthCare announced today a new investigational MRI, which will be used in collaboration with researchers at Boston’s Brigham and...
Medtech Insight - May 6, 2024
‘Dark Money’ Casts Shadow As Industry, Legislators Push For Litigation-Funding Transparency
AdvaMed is hopeful that legislation at the US federal and state levels will temper third-party litigation funding, which is wreaking...
Medtech Insight - May 6, 2024
Pfizer Recruits Industry Analyst Baum To Advance Corporate Strategy
Longtime pharmaceutical industry analyst Andrew Baum will join Pfizer’s executive leadership team.
Scrip - May 6, 2024
Supply Chain Derisking: The Case For US-India Partnering Amid China Clout
With just 14% of active pharmaceutical ingredients estimated to be made in the US and China’s overall dominance in the...
Scrip - May 6, 2024

Quick Listen: Scrip's Five Must-Know Things
In this week's podcast edition of Five Must-Know Things: Japan’s Ono buys US oncology firm; strong growth but supply issues for...
Scrip - May 6, 2024
Gossamer Partners With Chiesi To Accelerate Seralutinib Development
Already in Phase III for PAH, Gossamer said it can take seralutinib into Phase III for PH-ILD at least four...
Scrip - May 6, 2024
Pipeline Watch: Six Approvals And 13 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 - May 6, 2024
Novo Nordisk Foundation Strengthens Ties With Gates
The two heavyweights have joined forces with fellow major charitable foundation Wellcome and committed $300m to "accelerate global health equity...
Scrip - May 6, 2024
GlycoMimetics Forges Ahead With Uproleselan In AML After Phase III Failure
The company said an NCI trial and a China study remain ongoing despite a Phase III study in relapsed/refractory disease...
Scrip - May 6, 2024
Pfizer Recruits Industry Analyst Baum To Advance Corporate Strategy
Longtime pharmaceutical industry analyst Andrew Baum will join Pfizer’s executive leadership team.
Scrip - May 6, 2024
Supply Chain Derisking: The Case For US-India Partnering Amid China Clout
With just 14% of active pharmaceutical ingredients estimated to be made in the US and China’s overall dominance in the...
Scrip - May 6, 2024

Don’t Stop Manufacturing Because of An Inspection, FDA’s Cavazzoni Says
The FDA drug center director is encouraging manufacturers to contact the agency’s shortage surveillance team before making rash decisions during...
Pink Sheet - May 6, 2024
ORA Chief Says Inspections In Jeopardy Without Additional Funding
The US FDA’s Office of Regulatory Affairs is facing challenges in retaining and hiring new staff, which will impact inspections...
Pink Sheet - May 6, 2024
Drug Promotion: Sponsors Are Running Afoul Of US FDA’s CFL Guidance
Recent Office of Prescription Drug Promotion enforcement letters provide several learnings, including the need to be aware of a product’s...
Pink Sheet - May 6, 2024
The Future of ACIP: CDC Vaccine Policy Lead Looks Beyond COVID
The CDC’s Melinda Wharton discusses how the ACIP handled COVID-19 and how the pandemic will shape the committee’s work in...
Pink Sheet - May 6, 2024
Pfizer Finally Wins English Funding For Sickle Cell Drug Oxbryta After Bumpy Ride
After several rejections by NICE and an appeal by Pfizer, the company has reduced the price for its first-in-class sickle...
Pink Sheet - May 6, 2024

Expert Proposes AI Device Reimbursement Model ‘Like Netflix’
Johns Hopkins professor Tinglong Dai says a subscription model for AI is the most sustainable model for reimbursement. 
Medtech Insight - May 6, 2024
Robotic-Assisted Treatment For Enlarged Prostate Shows Promising Results
A novel robotic-assisted therapy could improve the lives of men with benign prostatic hyperplasia, real-world data presented at the annual...
Medtech Insight - May 6, 2024
GE HealthCare’s New Investigational MRI Promises Advancements On Neurological Disease Research
GE HealthCare announced today a new investigational MRI, which will be used in collaboration with researchers at Boston’s Brigham and...
Medtech Insight - May 6, 2024
‘Dark Money’ Casts Shadow As Industry, Legislators Push For Litigation-Funding Transparency
AdvaMed is hopeful that legislation at the US federal and state levels will temper third-party litigation funding, which is wreaking...
Medtech Insight - May 6, 2024

US FDA Inspectors, Product Centers Working Closer Together Ahead Of ORA Reorg
Compliance functions will be moved to the product centers when ORA becomes the Office of Inspections and Investigations, and centers...
HBW Insight - May 6, 2024
Without Additional Funding, US FDA's Inspections In Jeopardy – Regulatory Affairs Chief
Without additional funding, FDA’s ORA faces challenges in retaining and hiring staff, which will impact inspections, says office chief Michael...
HBW Insight - May 6, 2024
Herbalife's Rising Digital Platform Floats All Boats Other Than Marketing To GLP-1 Patients
Direct seller reports Q1 sales up 1% to $1.3bn but net sales off 17.1% from year-ago period to $24.3m. Its...
HBW Insight - May 6, 2024
Beauty Packaging Producers Facing Tedious EPR Work Should Consider Software Solutions
Cataloging materials by category across US states or even internationally, chasing down information from supply partners, and other aspects of...
HBW Insight - May 6, 2024

EU Urban Wastewater Directive Update ‘Unfairly Targets Pharmaceutical Industry’
The European Parliament has voted for a deal agreed with the council of minister to ensure polluters pay for cleaning...
Generics Bulletin - May 3, 2024
Amgen Kicks Off Pembrolizumab Program As It Delivers Q1 Results
Amgen has revealed a program for a biosimilar rival to Keytruda, as it reported Q1 results that saw its biosimilars...
Generics Bulletin - May 3, 2024
Lupin Enters Canadian Biosimilars Market With Etanercept
Lupin has pushed into the Canadian biosimilars market with the launch of its Rymti rival to Amgen’s Enbrel. The launch...
Generics Bulletin - May 3, 2024
Are Jubilant Pharmova’s US Plant Closure, FDA Observations At Canada Unit A Concern?
The US FDA’s observations at its radiopharma manufacturing facility in Canada could be a headwind for Jubilant Pharmova, but reorientation...
Generics Bulletin - May 3, 2024
FDA-EMA Advice Pilot For Complex Generics: What Does Industry Have To Say?
The FDA and EMA have shared perspectives on the parallel scientific advice pilot for complex generics. Now industry stakeholders discuss...
Generics Bulletin - May 3, 2024

Addex Gets Creative To Secure Funding And Its Future
Addex Therapeutics’ Tim Dyer has seen the company through 22 years of ups and downs. He has kept the company...
In Vivo - May 2, 2024