Latest Pharma Insights
Prevagen Firm Hits Hurdle Too High To Dismiss Trial Verdict Finding Memory Claims Misleading
Federal circuit court ruling Quincy referenced in motion for reconsideration of jury’s verdict on New York state laws “offers nothing...
HBW Insight - July 26, 2024
Federal circuit court ruling Quincy referenced in motion for reconsideration of jury’s verdict on New York state laws “offers nothing...
HBW Insight - July 26, 2024
Sun’s Leqvelsi Must Now Shine In Crowded JAK Inhibitor Field
The US FDA approved Leqvelsi for alopecia areata, making it the third drug in the class for the indication after...
Scrip - July 26, 2024
The US FDA approved Leqvelsi for alopecia areata, making it the third drug in the class for the indication after...
Scrip - July 26, 2024
Pink Sheet Podcast: US FDA Device Director Retires, PBM Execs On Capitol Hill, Voucher Program Renewal Push
Editors from the Pink Sheet and Medtech Insight discuss the retirement of Jeff Shuren, PBM executives again appear unscathed after...
Pink Sheet - July 26, 2024
Editors from the Pink Sheet and Medtech Insight discuss the retirement of Jeff Shuren, PBM executives again appear unscathed after...
Pink Sheet - July 26, 2024
US Medicare To Codify Inflation Rebates, Adds Reconciliation Process
The US Medicare agency is creating a formal reconciliation process for new inflation rebates in Part B and Part D...
Pink Sheet - July 26, 2024
The US Medicare agency is creating a formal reconciliation process for new inflation rebates in Part B and Part D...
Pink Sheet - July 26, 2024
US FDA Bids Adieu To Allergenic Products Adcomm; Vaccines Panel To Take Over Duties
The effort and expense to maintain the committee, which met only 10 days in the past 15 years, can no...
Pink Sheet - July 26, 2024
The effort and expense to maintain the committee, which met only 10 days in the past 15 years, can no...
Pink Sheet - July 26, 2024
PDUFA Meetings: US FDA Wants Sponsors To Prioritize Issues For Discussion
But the agency should explain why different meeting types are granted than requested or denied entirely, industry representatives said during...
Pink Sheet - July 26, 2024
But the agency should explain why different meeting types are granted than requested or denied entirely, industry representatives said during...
Pink Sheet - July 26, 2024
BMS ‘Increasingly Confident’ It Can Handle The Impact Of Medicare Pricing For Eliquis
Bristol’s CEO offered assurances about Medicare negotiations under the IRA as the company delivered better-than-expected second quarter results across new...
Scrip - July 26, 2024
Bristol’s CEO offered assurances about Medicare negotiations under the IRA as the company delivered better-than-expected second quarter results across new...
Scrip - July 26, 2024
News We’re Watching: Edwards Scoops Up Cardio Firms, BD And Quest Partner, Admera Settles Kickback Case
This week, Edwards announced that it has purchased JenaValve and Endotronix; a New Jersey lab has agreed to pay the...
Medtech Insight - July 26, 2024
This week, Edwards announced that it has purchased JenaValve and Endotronix; a New Jersey lab has agreed to pay the...
Medtech Insight - July 26, 2024
DHCoE AI Lifecycle Management Plan To Serve As ‘Playbook’ For Standards
A new AI lifecycle management framework from the US FDA’s Digital Health Center of Excellence introduces considerations for the seven...
Medtech Insight - July 26, 2024
A new AI lifecycle management framework from the US FDA’s Digital Health Center of Excellence introduces considerations for the seven...
Medtech Insight - July 26, 2024
Registrar Unveils Software To Assist MoCRA Stakeholders In Filing Adverse Event Reports
Registrar Corp. introduces Adverse Event Management Software that ‘securely’ intakes sensitive consumer medical data, tracks adverse events for all products...
HBW Insight - July 26, 2024
Registrar Corp. introduces Adverse Event Management Software that ‘securely’ intakes sensitive consumer medical data, tracks adverse events for all products...
HBW Insight - July 26, 2024
EU Blow For Alzheimer’s Drug Leqembi; Eisai To Appeal
The EMA says the benefits of treatment with Leqembi are not large enough to outweigh its risks. Meanwhile, Alzheimer Europe...
Pink Sheet - July 26, 2024
The EMA says the benefits of treatment with Leqembi are not large enough to outweigh its risks. Meanwhile, Alzheimer Europe...
Pink Sheet - July 26, 2024
Pipeline Watch: Eight Approvals and Eight 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 - July 26, 2024
Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies...
Scrip - July 26, 2024
New Drugs For Gastric Cancer, Liver Disease Among 14 Products Heading For EU Approval
Two orphan drugs are among a host of products that the European Medicines Agency’s human medicines committee has OKd for...
Pink Sheet - July 26, 2024
Two orphan drugs are among a host of products that the European Medicines Agency’s human medicines committee has OKd for...
Pink Sheet - July 26, 2024
Take Five: Ipsen Bags Rights To Day One Brain Cancer Drug
The Paris-based group has inked five external deals already this year, this time paying $111m to get access internationally to...
Scrip - July 26, 2024
The Paris-based group has inked five external deals already this year, this time paying $111m to get access internationally to...
Scrip - July 26, 2024
EFPIA Calls For Active Inclusion Of Pharma Industry In Roll Out Of European Health Data Space
The implementation phase of the European Health Data Space is an opportunity to address “critical aspects” of the new regulation...
Pink Sheet - July 26, 2024
The implementation phase of the European Health Data Space is an opportunity to address “critical aspects” of the new regulation...
Pink Sheet - July 26, 2024
Leo’s New Growth Driver Anzupgo Poised For EU Approval
The JAK inhibitor cream for hand eczema will serve a large market in Europe and help the Danish dermatology specialist...
Scrip - July 26, 2024
The JAK inhibitor cream for hand eczema will serve a large market in Europe and help the Danish dermatology specialist...
Scrip - July 26, 2024
Sanofi In Midst Of ‘Very Competitive Process’ For Consumer Business
“The game is still totally open,” said Sanofi CFO François-Xavier Roger in response to questions about how the company intends...
HBW Insight - July 26, 2024
“The game is still totally open,” said Sanofi CFO François-Xavier Roger in response to questions about how the company intends...
HBW Insight - July 26, 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 - July 26, 2024
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
Pink Sheet - July 26, 2024
Six More Biosimilars Lined Up For Approval By EMA
Six biosimilars have received positive opinions from the European Medicines Agency’s Committee for Medicinal Products for Human Use at its...
Generics Bulletin - July 26, 2024
Six biosimilars have received positive opinions from the European Medicines Agency’s Committee for Medicinal Products for Human Use at its...
Generics Bulletin - July 26, 2024
Hyloris Follows On Transaction Scrutiny With Maxigesic IV Updates
Following its recently announced leadership changes, Hyloris has made two announcements linked to the marketing of its combined pain therapy...
Generics Bulletin - July 26, 2024
Following its recently announced leadership changes, Hyloris has made two announcements linked to the marketing of its combined pain therapy...
Generics Bulletin - July 26, 2024
Torrent On Acquisition And Licensing Strategy, Vonoprazan Trajectory
Amid deals activity in India, Torrent Pharma executives spelt out their acquisition expectations and licensing strategy while an in-licensed Takeda...
Scrip - July 26, 2024
Amid deals activity in India, Torrent Pharma executives spelt out their acquisition expectations and licensing strategy while an in-licensed Takeda...
Scrip - July 26, 2024
Medway NHS Trust Partners With Digostics To Launch At-Home Gestational Diabetes Test
Medway NHS Foundation Trust joined forces with Digostics to offer home oral glucose tolerance testing for pregnant women at risk...
Medtech Insight - July 26, 2024
Medway NHS Foundation Trust joined forces with Digostics to offer home oral glucose tolerance testing for pregnant women at risk...
Medtech Insight - July 26, 2024
RemeGen Rises, Falls Along With Chinese Antibody Ambitions
Everything seemed to be aligned for success, but shares in leading Chinese antibody developer RemeGen recently dropped by nearly 40%...
Scrip - July 26, 2024
Everything seemed to be aligned for success, but shares in leading Chinese antibody developer RemeGen recently dropped by nearly 40%...
Scrip - July 26, 2024
McKinsey Exec On Where India Innovation Could Head, Leveraging Pharma’s GCC Ecosystem
McKinsey & Company’s senior partner and lead, life sciences practice (Asia), talks to Scrip about innovation niches that could interest...
Scrip - July 26, 2024
McKinsey & Company’s senior partner and lead, life sciences practice (Asia), talks to Scrip about innovation niches that could interest...
Scrip - July 26, 2024
Sun’s Leqvelsi Must Now Shine In Crowded JAK Inhibitor Field
The US FDA approved Leqvelsi for alopecia areata, making it the third drug in the class for the indication after...
Scrip - July 26, 2024
The US FDA approved Leqvelsi for alopecia areata, making it the third drug in the class for the indication after...
Scrip - July 26, 2024
BMS ‘Increasingly Confident’ It Can Handle The Impact Of Medicare Pricing For Eliquis
Bristol’s CEO offered assurances about Medicare negotiations under the IRA as the company delivered better-than-expected second quarter results across new...
Scrip - July 26, 2024
Bristol’s CEO offered assurances about Medicare negotiations under the IRA as the company delivered better-than-expected second quarter results across new...
Scrip - July 26, 2024
Pipeline Watch: Eight Approvals and Eight 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 - July 26, 2024
Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies...
Scrip - July 26, 2024
Take Five: Ipsen Bags Rights To Day One Brain Cancer Drug
The Paris-based group has inked five external deals already this year, this time paying $111m to get access internationally to...
Scrip - July 26, 2024
The Paris-based group has inked five external deals already this year, this time paying $111m to get access internationally to...
Scrip - July 26, 2024
Leo’s New Growth Driver Anzupgo Poised For EU Approval
The JAK inhibitor cream for hand eczema will serve a large market in Europe and help the Danish dermatology specialist...
Scrip - July 26, 2024
The JAK inhibitor cream for hand eczema will serve a large market in Europe and help the Danish dermatology specialist...
Scrip - July 26, 2024
Torrent On Acquisition And Licensing Strategy, Vonoprazan Trajectory
Amid deals activity in India, Torrent Pharma executives spelt out their acquisition expectations and licensing strategy while an in-licensed Takeda...
Scrip - July 26, 2024
Amid deals activity in India, Torrent Pharma executives spelt out their acquisition expectations and licensing strategy while an in-licensed Takeda...
Scrip - July 26, 2024
RemeGen Rises, Falls Along With Chinese Antibody Ambitions
Everything seemed to be aligned for success, but shares in leading Chinese antibody developer RemeGen recently dropped by nearly 40%...
Scrip - July 26, 2024
Everything seemed to be aligned for success, but shares in leading Chinese antibody developer RemeGen recently dropped by nearly 40%...
Scrip - July 26, 2024
McKinsey Exec On Where India Innovation Could Head, Leveraging Pharma’s GCC Ecosystem
McKinsey & Company’s senior partner and lead, life sciences practice (Asia), talks to Scrip about innovation niches that could interest...
Scrip - July 26, 2024
McKinsey & Company’s senior partner and lead, life sciences practice (Asia), talks to Scrip about innovation niches that could interest...
Scrip - July 26, 2024
Pink Sheet Podcast: US FDA Device Director Retires, PBM Execs On Capitol Hill, Voucher Program Renewal Push
Editors from the Pink Sheet and Medtech Insight discuss the retirement of Jeff Shuren, PBM executives again appear unscathed after...
Pink Sheet - July 26, 2024
Editors from the Pink Sheet and Medtech Insight discuss the retirement of Jeff Shuren, PBM executives again appear unscathed after...
Pink Sheet - July 26, 2024
US Medicare To Codify Inflation Rebates, Adds Reconciliation Process
The US Medicare agency is creating a formal reconciliation process for new inflation rebates in Part B and Part D...
Pink Sheet - July 26, 2024
The US Medicare agency is creating a formal reconciliation process for new inflation rebates in Part B and Part D...
Pink Sheet - July 26, 2024
US FDA Bids Adieu To Allergenic Products Adcomm; Vaccines Panel To Take Over Duties
The effort and expense to maintain the committee, which met only 10 days in the past 15 years, can no...
Pink Sheet - July 26, 2024
The effort and expense to maintain the committee, which met only 10 days in the past 15 years, can no...
Pink Sheet - July 26, 2024
PDUFA Meetings: US FDA Wants Sponsors To Prioritize Issues For Discussion
But the agency should explain why different meeting types are granted than requested or denied entirely, industry representatives said during...
Pink Sheet - July 26, 2024
But the agency should explain why different meeting types are granted than requested or denied entirely, industry representatives said during...
Pink Sheet - July 26, 2024
EU Blow For Alzheimer’s Drug Leqembi; Eisai To Appeal
The EMA says the benefits of treatment with Leqembi are not large enough to outweigh its risks. Meanwhile, Alzheimer Europe...
Pink Sheet - July 26, 2024
The EMA says the benefits of treatment with Leqembi are not large enough to outweigh its risks. Meanwhile, Alzheimer Europe...
Pink Sheet - July 26, 2024
New Drugs For Gastric Cancer, Liver Disease Among 14 Products Heading For EU Approval
Two orphan drugs are among a host of products that the European Medicines Agency’s human medicines committee has OKd for...
Pink Sheet - July 26, 2024
Two orphan drugs are among a host of products that the European Medicines Agency’s human medicines committee has OKd for...
Pink Sheet - July 26, 2024
EFPIA Calls For Active Inclusion Of Pharma Industry In Roll Out Of European Health Data Space
The implementation phase of the European Health Data Space is an opportunity to address “critical aspects” of the new regulation...
Pink Sheet - July 26, 2024
The implementation phase of the European Health Data Space is an opportunity to address “critical aspects” of the new regulation...
Pink Sheet - July 26, 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 - July 26, 2024
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
Pink Sheet - July 26, 2024
News We’re Watching: Edwards Scoops Up Cardio Firms, BD And Quest Partner, Admera Settles Kickback Case
This week, Edwards announced that it has purchased JenaValve and Endotronix; a New Jersey lab has agreed to pay the...
Medtech Insight - July 26, 2024
This week, Edwards announced that it has purchased JenaValve and Endotronix; a New Jersey lab has agreed to pay the...
Medtech Insight - July 26, 2024
DHCoE AI Lifecycle Management Plan To Serve As ‘Playbook’ For Standards
A new AI lifecycle management framework from the US FDA’s Digital Health Center of Excellence introduces considerations for the seven...
Medtech Insight - July 26, 2024
A new AI lifecycle management framework from the US FDA’s Digital Health Center of Excellence introduces considerations for the seven...
Medtech Insight - July 26, 2024
Medway NHS Trust Partners With Digostics To Launch At-Home Gestational Diabetes Test
Medway NHS Foundation Trust joined forces with Digostics to offer home oral glucose tolerance testing for pregnant women at risk...
Medtech Insight - July 26, 2024
Medway NHS Foundation Trust joined forces with Digostics to offer home oral glucose tolerance testing for pregnant women at risk...
Medtech Insight - July 26, 2024
Prevagen Firm Hits Hurdle Too High To Dismiss Trial Verdict Finding Memory Claims Misleading
Federal circuit court ruling Quincy referenced in motion for reconsideration of jury’s verdict on New York state laws “offers nothing...
HBW Insight - July 26, 2024
Federal circuit court ruling Quincy referenced in motion for reconsideration of jury’s verdict on New York state laws “offers nothing...
HBW Insight - July 26, 2024
Registrar Unveils Software To Assist MoCRA Stakeholders In Filing Adverse Event Reports
Registrar Corp. introduces Adverse Event Management Software that ‘securely’ intakes sensitive consumer medical data, tracks adverse events for all products...
HBW Insight - July 26, 2024
Registrar Corp. introduces Adverse Event Management Software that ‘securely’ intakes sensitive consumer medical data, tracks adverse events for all products...
HBW Insight - July 26, 2024
Sanofi In Midst Of ‘Very Competitive Process’ For Consumer Business
“The game is still totally open,” said Sanofi CFO François-Xavier Roger in response to questions about how the company intends...
HBW Insight - July 26, 2024
“The game is still totally open,” said Sanofi CFO François-Xavier Roger in response to questions about how the company intends...
HBW Insight - July 26, 2024
Six More Biosimilars Lined Up For Approval By EMA
Six biosimilars have received positive opinions from the European Medicines Agency’s Committee for Medicinal Products for Human Use at its...
Generics Bulletin - July 26, 2024
Six biosimilars have received positive opinions from the European Medicines Agency’s Committee for Medicinal Products for Human Use at its...
Generics Bulletin - July 26, 2024
Hyloris Follows On Transaction Scrutiny With Maxigesic IV Updates
Following its recently announced leadership changes, Hyloris has made two announcements linked to the marketing of its combined pain therapy...
Generics Bulletin - July 26, 2024
Following its recently announced leadership changes, Hyloris has made two announcements linked to the marketing of its combined pain therapy...
Generics Bulletin - July 26, 2024
Medtechs Are Fully Engaged In Climate Change: ‘They Have No Choice’
The E in ESG: SUDs, reuse, disposables, refurbishing, reprocessed devices? Multiple panelists at the 2024 MedTech Forum addressed the role...
In Vivo - July 25, 2024
The E in ESG: SUDs, reuse, disposables, refurbishing, reprocessed devices? Multiple panelists at the 2024 MedTech Forum addressed the role...
In Vivo - July 25, 2024