Latest Pharma Insights
Quick Listen: Scrip’s Five Must-Know Things
In this week's episode: what Lilly’s Centessa buy brings; Apellis brings capabilities to Biogen: Chinese firms’ rapid obesity progress; orals take center stage in obesity; and a dip in the global pharma pipeline.
Scrip - April 6, 2026
In this week's episode: what Lilly’s Centessa buy brings; Apellis brings capabilities to Biogen: Chinese firms’ rapid obesity progress; orals take center stage in obesity; and a dip in the global pharma pipeline.
Scrip - April 6, 2026
US FDA Foods Program Chief Outlines ‘Nimble And Adaptable’ Supplement Industry Regulation
“The industry has grown and changed tremendously in the last 30 plus years, yet the regulatory framework has largely stayed the same,” says FDA Deputy Commissioner Kyle Diamantas. “We'll be setting up the agency to lower costs and enabling regulated industries to increase access to automation.”
HBW Insight - April 6, 2026
“The industry has grown and changed tremendously in the last 30 plus years, yet the regulatory framework has largely stayed the same,” says FDA Deputy Commissioner Kyle Diamantas. “We'll be setting up the agency to lower costs and enabling regulated industries to increase access to automation.”
HBW Insight - April 6, 2026
‘Dietary Substance For Use By Man To Supplement The Diet’: Open Or Closed Door For Innovation?
The phrase “a dietary substance for use by man to supplement the diet by increasing the total dietary intake,” known as “Clause E” [21 USC 321 (ff)(E)], is prompting what will comparatively be countless words in comments to FDA about the future of NDIs for the US.
HBW Insight - April 6, 2026
The phrase “a dietary substance for use by man to supplement the diet by increasing the total dietary intake,” known as “Clause E” [21 USC 321 (ff)(E)], is prompting what will comparatively be countless words in comments to FDA about the future of NDIs for the US.
HBW Insight - April 6, 2026
Quick Listen: Scrip’s Five Must-Know Things
In this week's episode: what Lilly’s Centessa buy brings; Apellis brings capabilities to Biogen: Chinese firms’ rapid obesity progress; orals take center stage in obesity; and a dip in the global pharma pipeline.
Scrip - April 6, 2026
In this week's episode: what Lilly’s Centessa buy brings; Apellis brings capabilities to Biogen: Chinese firms’ rapid obesity progress; orals take center stage in obesity; and a dip in the global pharma pipeline.
Scrip - April 6, 2026
LSI Panel Says Women’s Health Breaks Out Of ‘Bikini Box’ As New Business Models Catch Investors’ Eye
At the LSI USA conference in Dana Point, CA, a panel of women’s health leaders from Hologic, Teal Health, Bloomlife, Pretika Medtech as well as investors discussed the need to expand the definition of women’s health to attract investors, plus new monetization models and their outlook.
Medtech Insight - April 3, 2026
At the LSI USA conference in Dana Point, CA, a panel of women’s health leaders from Hologic, Teal Health, Bloomlife, Pretika Medtech as well as investors discussed the need to expand the definition of women’s health to attract investors, plus new monetization models and their outlook.
Medtech Insight - April 3, 2026
FDA Releases Trove Of Data On Use of Real-World Evidence In Device Clearances
A new report outlines use of real-world evidence in 73 post-2021 device submissions, reflecting the agency’s growing comfort with data drawn from medical records, registries and even data generated by the devices themselves.
Medtech Insight - April 3, 2026
A new report outlines use of real-world evidence in 73 post-2021 device submissions, reflecting the agency’s growing comfort with data drawn from medical records, registries and even data generated by the devices themselves.
Medtech Insight - April 3, 2026
No Evidence Of Benefit: Two Trials Prompt Calls to End Routine Use Of J&J’s Impella Heart Pump
Two randomized trials presented at a recent American College of Cardiology annual meeting failed to show benefit for J&J's Impella pumps – and one found higher mortality in the device arm.
Medtech Insight - April 3, 2026
Two randomized trials presented at a recent American College of Cardiology annual meeting failed to show benefit for J&J's Impella pumps – and one found higher mortality in the device arm.
Medtech Insight - April 3, 2026
Washington Sleep Doctor Gets Year In Prison For Distributing Recalled Philips CPAP, BiPAP Devices
Eric Haegar pleaded guilty to medical device adulteration. He bought recalled Philips Respironics devices online and pried out the hazardous foam inside before passing the products along to Medicaid patients. He then billed Medicaid as though the devices were new.
Medtech Insight - April 3, 2026
Eric Haegar pleaded guilty to medical device adulteration. He bought recalled Philips Respironics devices online and pried out the hazardous foam inside before passing the products along to Medicaid patients. He then billed Medicaid as though the devices were new.
Medtech Insight - April 3, 2026
US FDA Foods Program Chief Outlines ‘Nimble And Adaptable’ Supplement Industry Regulation
“The industry has grown and changed tremendously in the last 30 plus years, yet the regulatory framework has largely stayed the same,” says FDA Deputy Commissioner Kyle Diamantas. “We'll be setting up the agency to lower costs and enabling regulated industries to increase access to automation.”
HBW Insight - April 6, 2026
“The industry has grown and changed tremendously in the last 30 plus years, yet the regulatory framework has largely stayed the same,” says FDA Deputy Commissioner Kyle Diamantas. “We'll be setting up the agency to lower costs and enabling regulated industries to increase access to automation.”
HBW Insight - April 6, 2026
‘Dietary Substance For Use By Man To Supplement The Diet’: Open Or Closed Door For Innovation?
The phrase “a dietary substance for use by man to supplement the diet by increasing the total dietary intake,” known as “Clause E” [21 USC 321 (ff)(E)], is prompting what will comparatively be countless words in comments to FDA about the future of NDIs for the US.
HBW Insight - April 6, 2026
The phrase “a dietary substance for use by man to supplement the diet by increasing the total dietary intake,” known as “Clause E” [21 USC 321 (ff)(E)], is prompting what will comparatively be countless words in comments to FDA about the future of NDIs for the US.
HBW Insight - April 6, 2026
US Shields Generics From Tariffs Amid Supply Chain Concerns
New US tariffs of up to 100% on patented drugs have spared generics and biosimilars for now, highlighting their role in supply chains, but officials have ordered a review of the sector within one year.
Generics Bulletin - April 3, 2026
New US tariffs of up to 100% on patented drugs have spared generics and biosimilars for now, highlighting their role in supply chains, but officials have ordered a review of the sector within one year.
Generics Bulletin - April 3, 2026
‘It’s Day And Night’ – Haruvi On How The AAM Has Evolved
In the second part of Generics Bulletin’s interview with Keren Haruvi, the Sandoz executive talks about her role as outgoing chair of the US Association for Accessible Medicines, and the achievements made by the group since it came under new leadership.
Generics Bulletin - April 3, 2026
In the second part of Generics Bulletin’s interview with Keren Haruvi, the Sandoz executive talks about her role as outgoing chair of the US Association for Accessible Medicines, and the achievements made by the group since it came under new leadership.
Generics Bulletin - April 3, 2026
Hyloris Warns Valacyclovir Launch Could Slip Into 2027
Hyloris has received a CRL from the US FDA for its valacyclovir oral liquid due to manufacturing issues at its CDMO, with no concerns on the product itself, and warns resolution could delay approval into 2027 as it explores alternative production options.
Generics Bulletin - April 3, 2026
Hyloris has received a CRL from the US FDA for its valacyclovir oral liquid due to manufacturing issues at its CDMO, with no concerns on the product itself, and warns resolution could delay approval into 2027 as it explores alternative production options.
Generics Bulletin - April 3, 2026
GDUFA IV: US FDA Worries About Revenue Shortfalls, Industry Does Not
The FDA said chronic under-collection of GDUFA revenue could create budget problems going forward unless the system is changed, but industry does not want to endanger the generic sector with higher fees.
Generics Bulletin - April 3, 2026
The FDA said chronic under-collection of GDUFA revenue could create budget problems going forward unless the system is changed, but industry does not want to endanger the generic sector with higher fees.
Generics Bulletin - April 3, 2026
Europe’s Biotech Edge Lies In Science-First Investing
Despite tough markets and geopolitical uncertainty, Matthieu Coutet sees strong deal flow, rising investor appetite and big opportunities in fibrosis, with Sofinnova Partners taking an active role in building companies through series A and beyond.
In Vivo - April 2, 2026
Despite tough markets and geopolitical uncertainty, Matthieu Coutet sees strong deal flow, rising investor appetite and big opportunities in fibrosis, with Sofinnova Partners taking an active role in building companies through series A and beyond.
In Vivo - April 2, 2026