Latest Pharma Insights
The Dog That Didn’t Bark: ODAC Gives Nod To Three Products Despite Negative FDA Reviews
Oncologic Drugs Advisory Committee was swayed by views of its disease area experts in favorably reporting out Geron’s imetelstat for...
Pink Sheet - March 18, 2024
Oncologic Drugs Advisory Committee was swayed by views of its disease area experts in favorably reporting out Geron’s imetelstat for...
Pink Sheet - March 18, 2024
Demi Moore’s Wonderbelly Antacid Investment Lands Supporting Role In Her Promotional Posts
Wonderbelly Antacids “free from” ad claims work but failing to disclose Demi Moore is an investor in her promotions doesn’t...
HBW Insight - March 18, 2024
Wonderbelly Antacids “free from” ad claims work but failing to disclose Demi Moore is an investor in her promotions doesn’t...
HBW Insight - March 18, 2024
UroGen Approaches A Big Expansion In Bladder Cancer
The oncology company is preparing for the launch of UGN-102 for bladder cancer. CEO Liz Barrett talked to Scrip about...
Scrip - March 18, 2024
The oncology company is preparing for the launch of UGN-102 for bladder cancer. CEO Liz Barrett talked to Scrip about...
Scrip - March 18, 2024
US FDA Alzheimer Guidance Update Reflects Changes In Biomarkers – And Leadership
Latest update to draft guidance on early Alzheimer’s drug development is the third iteration of a document first published in...
Pink Sheet - March 18, 2024
Latest update to draft guidance on early Alzheimer’s drug development is the third iteration of a document first published in...
Pink Sheet - March 18, 2024
AstraZeneca Joins The $35 Inhaler Club; Medicare Patients Waiting On Congress For Membership
AZ’s move follows Boehringer’s announcement earlier this month and parallels what insulin sponsors did – but almost in reverse. For...
Pink Sheet - March 18, 2024
AZ’s move follows Boehringer’s announcement earlier this month and parallels what insulin sponsors did – but almost in reverse. For...
Pink Sheet - March 18, 2024
AstraZeneca Joins The $35 Club With Cap On Inhaler Copays
The British drug maker’s move follows that of Boehringer Ingelheim earlier this month, which itself followed increasing political scrutiny on...
Scrip - March 18, 2024
The British drug maker’s move follows that of Boehringer Ingelheim earlier this month, which itself followed increasing political scrutiny on...
Scrip - March 18, 2024
Fennec Finds Ex-US Commercial Partner For Pedmark In UK’s Norgine
Norgine will market Pedmark, indicated to reduce risk of chemotherapy-related hearing loss in pediatric cancer, in the EU and UK...
Scrip - March 18, 2024
Norgine will market Pedmark, indicated to reduce risk of chemotherapy-related hearing loss in pediatric cancer, in the EU and UK...
Scrip - March 18, 2024
CDER, CBER Post FY 2023 Employee Gains, But Behind User Fee Hiring Goals
US FDA’s drug center reported a net increase of more than 300 employees in FY 2023, while the biologics center...
Pink Sheet - March 18, 2024
US FDA’s drug center reported a net increase of more than 300 employees in FY 2023, while the biologics center...
Pink Sheet - March 18, 2024
Finance Watch: Mega-Rounds Around The World As VCs Spread The Wealth
Private Company Edition: After US-based Alumis and Sionna raised $259m and $182m, respectively, in series C rounds, Tubulis in Munich...
Scrip - March 18, 2024
Private Company Edition: After US-based Alumis and Sionna raised $259m and $182m, respectively, in series C rounds, Tubulis in Munich...
Scrip - March 18, 2024
Artificial Intelligence: US FDA Plans Guidances On Algorithm Bias, Product Development
Cross-center AI strategy features collaboration between drug, biologic, device and combination product staff to ensure regulatory predictability. ‘Assurance labs’ offering...
Medtech Insight - March 18, 2024
Cross-center AI strategy features collaboration between drug, biologic, device and combination product staff to ensure regulatory predictability. ‘Assurance labs’ offering...
Medtech Insight - March 18, 2024
All Eyes On Pricing Model As EU Crunch Time Nears For First Ophthalmic Bevacizumab
If Outlook Therapeutics’ Lytenava secures EU approval for wet AMD, the company says it expects to price the drug as...
Pink Sheet - March 18, 2024
If Outlook Therapeutics’ Lytenava secures EU approval for wet AMD, the company says it expects to price the drug as...
Pink Sheet - March 18, 2024
EMA Decision Time For Aztreonam-Avibactam; High-Stakes Meeting For Lecanamab
The European Medicines Agency is this week deciding whether a number of new drugs should win EU approval.
Pink Sheet - March 18, 2024
The European Medicines Agency is this week deciding whether a number of new drugs should win EU approval.
Pink Sheet - March 18, 2024
Pakistan Explains Updated Risk-Based Criteria For GCP Inspections
Pakistan’s drug regulator is hoping that improved transparency on its inspection protocols will help research entities better prepare for good...
Pink Sheet - March 18, 2024
Pakistan’s drug regulator is hoping that improved transparency on its inspection protocols will help research entities better prepare for good...
Pink Sheet - March 18, 2024
Stada Grows Twice As Fast As CHC Market In 2023
Stada's local brand focus helped it deliver Consumer Healthcare sales growth of 16% in 2023 ensuring the German firm significantly...
HBW Insight - March 18, 2024
Stada's local brand focus helped it deliver Consumer Healthcare sales growth of 16% in 2023 ensuring the German firm significantly...
HBW Insight - March 18, 2024
Biosimilars Council Commends Nixing ‘Arbitrary’ Interchangeability Designation
The Biosimilars Council agreed with the US president’s proposal to remove the “unnecessary” designation for biosimilars, which strengthens the ongoing...
Generics Bulletin - March 18, 2024
The Biosimilars Council agreed with the US president’s proposal to remove the “unnecessary” designation for biosimilars, which strengthens the ongoing...
Generics Bulletin - March 18, 2024
Australia To Give Consumers More Formal Role In HTA Processes
The health department says consumers and patients should be able to initiate health technology assessments because many potentially helpful and...
Pink Sheet - March 18, 2024
The health department says consumers and patients should be able to initiate health technology assessments because many potentially helpful and...
Pink Sheet - March 18, 2024
‘Why Am I Not Seeing More Women In The Hiring Mix?’ MedExec Women Founder Says It’s Time For Change
Maria Shepherd, co-founder of MedExec Women, a nonprofit that seeks to empower executive leaders in medtech, is preparing to host...
Medtech Insight - March 18, 2024
Maria Shepherd, co-founder of MedExec Women, a nonprofit that seeks to empower executive leaders in medtech, is preparing to host...
Medtech Insight - March 18, 2024
US Off-Patent Legislation Could Save Over $1bn In Ten Years
If passed, the two bills favoring generics and biosimilar developers would not only result in federal savings but would also...
Generics Bulletin - March 18, 2024
If passed, the two bills favoring generics and biosimilar developers would not only result in federal savings but would also...
Generics Bulletin - March 18, 2024
Moonlake Aims To Defy The Single-Product Risk
The group is pushing sonelokimab into pivotal trials in two indications and starting from scratch in three more. What comes...
Scrip - March 18, 2024
The group is pushing sonelokimab into pivotal trials in two indications and starting from scratch in three more. What comes...
Scrip - March 18, 2024
CGT Is In Its Infancy For CNS Disorders, But Technical Strides Being Made
Technical challenges and lackluster investor sentiment about the near-term commercial potential of cell and gene therapies in neurological disorders may...
In Vivo - March 18, 2024
Technical challenges and lackluster investor sentiment about the near-term commercial potential of cell and gene therapies in neurological disorders may...
In Vivo - March 18, 2024
Pipeline Watch: Six Approvals And 26 Phase III Trial Updates
Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies...
Scrip - March 18, 2024
Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies...
Scrip - March 18, 2024
US Aspart Filing Kicks Off Amphastar’s Insulin Ambitions
Amphastar says a “milestone” submission of a US filing for insulin aspart underlines its ambitions in the diabetes segment. But...
Generics Bulletin - March 18, 2024
Amphastar says a “milestone” submission of a US filing for insulin aspart underlines its ambitions in the diabetes segment. But...
Generics Bulletin - March 18, 2024
Celltrion Takes Aim At US Infliximab Market With Subcutaneous Launch
Celltrion has delivered on its long-awaited US launch of its Zymfentra subcutaneous formulation of infliximab, sold in other territories as...
Generics Bulletin - March 18, 2024
Celltrion has delivered on its long-awaited US launch of its Zymfentra subcutaneous formulation of infliximab, sold in other territories as...
Generics Bulletin - March 18, 2024
EU Institutions Reach Provisional Agreement On Proposed Health Data Regulation Amendments
Key changes have been agreed to the original European Commission text which would allow patients to opt out or restrict...
Medtech Insight - March 18, 2024
Key changes have been agreed to the original European Commission text which would allow patients to opt out or restrict...
Medtech Insight - March 18, 2024
Leading The Way From A Singular Position - An IWD Perspective
Anne Osdoit has learned how to transform what would be challenges in her career into sources of inspiration. With this...
Medtech Insight - March 18, 2024
Anne Osdoit has learned how to transform what would be challenges in her career into sources of inspiration. With this...
Medtech Insight - March 18, 2024
Quantum Outperforms Classical Computer, Finding New KRAS Inhibitors
In a breakthrough for drug discovery, quantum hardware outperformed classical hardware in generating two promising KRAS inhibitors.
In Vivo - March 18, 2024
In a breakthrough for drug discovery, quantum hardware outperformed classical hardware in generating two promising KRAS inhibitors.
In Vivo - March 18, 2024
Alys Is An Asset Play Wanting Big Pharma Attention
Leaders of a new dermatology-focused biotech, which has launched with 14 development programs in its pipeline, explain the rationale behind...
In Vivo - March 18, 2024
Leaders of a new dermatology-focused biotech, which has launched with 14 development programs in its pipeline, explain the rationale behind...
In Vivo - March 18, 2024
Could ASEAN Become Next Priority For Korean Pharma Firms?
Southeast Asia has so far not been a priority market for South Korean pharma firms, largely because of challenges such...
Scrip - March 18, 2024
Southeast Asia has so far not been a priority market for South Korean pharma firms, largely because of challenges such...
Scrip - March 18, 2024
Early Strides for Takeda’s Qdenga In Brazil, India Deal Adds New Dimension
Takeda’s head of multi-country organization, India and Southeast Asia, Dion Warren, tells Scrip how things are shaping for Qdenga in Brazil’s...
Scrip - March 18, 2024
Takeda’s head of multi-country organization, India and Southeast Asia, Dion Warren, tells Scrip how things are shaping for Qdenga in Brazil’s...
Scrip - March 18, 2024
UroGen Approaches A Big Expansion In Bladder Cancer
The oncology company is preparing for the launch of UGN-102 for bladder cancer. CEO Liz Barrett talked to Scrip about...
Scrip - March 18, 2024
The oncology company is preparing for the launch of UGN-102 for bladder cancer. CEO Liz Barrett talked to Scrip about...
Scrip - March 18, 2024
AstraZeneca Joins The $35 Club With Cap On Inhaler Copays
The British drug maker’s move follows that of Boehringer Ingelheim earlier this month, which itself followed increasing political scrutiny on...
Scrip - March 18, 2024
The British drug maker’s move follows that of Boehringer Ingelheim earlier this month, which itself followed increasing political scrutiny on...
Scrip - March 18, 2024
Fennec Finds Ex-US Commercial Partner For Pedmark In UK’s Norgine
Norgine will market Pedmark, indicated to reduce risk of chemotherapy-related hearing loss in pediatric cancer, in the EU and UK...
Scrip - March 18, 2024
Norgine will market Pedmark, indicated to reduce risk of chemotherapy-related hearing loss in pediatric cancer, in the EU and UK...
Scrip - March 18, 2024
Finance Watch: Mega-Rounds Around The World As VCs Spread The Wealth
Private Company Edition: After US-based Alumis and Sionna raised $259m and $182m, respectively, in series C rounds, Tubulis in Munich...
Scrip - March 18, 2024
Private Company Edition: After US-based Alumis and Sionna raised $259m and $182m, respectively, in series C rounds, Tubulis in Munich...
Scrip - March 18, 2024
Moonlake Aims To Defy The Single-Product Risk
The group is pushing sonelokimab into pivotal trials in two indications and starting from scratch in three more. What comes...
Scrip - March 18, 2024
The group is pushing sonelokimab into pivotal trials in two indications and starting from scratch in three more. What comes...
Scrip - March 18, 2024
Pipeline Watch: Six Approvals And 26 Phase III Trial Updates
Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies...
Scrip - March 18, 2024
Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies...
Scrip - March 18, 2024
Could ASEAN Become Next Priority For Korean Pharma Firms?
Southeast Asia has so far not been a priority market for South Korean pharma firms, largely because of challenges such...
Scrip - March 18, 2024
Southeast Asia has so far not been a priority market for South Korean pharma firms, largely because of challenges such...
Scrip - March 18, 2024
Early Strides for Takeda’s Qdenga In Brazil, India Deal Adds New Dimension
Takeda’s head of multi-country organization, India and Southeast Asia, Dion Warren, tells Scrip how things are shaping for Qdenga in Brazil’s...
Scrip - March 18, 2024
Takeda’s head of multi-country organization, India and Southeast Asia, Dion Warren, tells Scrip how things are shaping for Qdenga in Brazil’s...
Scrip - March 18, 2024
The Dog That Didn’t Bark: ODAC Gives Nod To Three Products Despite Negative FDA Reviews
Oncologic Drugs Advisory Committee was swayed by views of its disease area experts in favorably reporting out Geron’s imetelstat for...
Pink Sheet - March 18, 2024
Oncologic Drugs Advisory Committee was swayed by views of its disease area experts in favorably reporting out Geron’s imetelstat for...
Pink Sheet - March 18, 2024
US FDA Alzheimer Guidance Update Reflects Changes In Biomarkers – And Leadership
Latest update to draft guidance on early Alzheimer’s drug development is the third iteration of a document first published in...
Pink Sheet - March 18, 2024
Latest update to draft guidance on early Alzheimer’s drug development is the third iteration of a document first published in...
Pink Sheet - March 18, 2024
AstraZeneca Joins The $35 Inhaler Club; Medicare Patients Waiting On Congress For Membership
AZ’s move follows Boehringer’s announcement earlier this month and parallels what insulin sponsors did – but almost in reverse. For...
Pink Sheet - March 18, 2024
AZ’s move follows Boehringer’s announcement earlier this month and parallels what insulin sponsors did – but almost in reverse. For...
Pink Sheet - March 18, 2024
CDER, CBER Post FY 2023 Employee Gains, But Behind User Fee Hiring Goals
US FDA’s drug center reported a net increase of more than 300 employees in FY 2023, while the biologics center...
Pink Sheet - March 18, 2024
US FDA’s drug center reported a net increase of more than 300 employees in FY 2023, while the biologics center...
Pink Sheet - March 18, 2024
All Eyes On Pricing Model As EU Crunch Time Nears For First Ophthalmic Bevacizumab
If Outlook Therapeutics’ Lytenava secures EU approval for wet AMD, the company says it expects to price the drug as...
Pink Sheet - March 18, 2024
If Outlook Therapeutics’ Lytenava secures EU approval for wet AMD, the company says it expects to price the drug as...
Pink Sheet - March 18, 2024
EMA Decision Time For Aztreonam-Avibactam; High-Stakes Meeting For Lecanamab
The European Medicines Agency is this week deciding whether a number of new drugs should win EU approval.
Pink Sheet - March 18, 2024
The European Medicines Agency is this week deciding whether a number of new drugs should win EU approval.
Pink Sheet - March 18, 2024
Pakistan Explains Updated Risk-Based Criteria For GCP Inspections
Pakistan’s drug regulator is hoping that improved transparency on its inspection protocols will help research entities better prepare for good...
Pink Sheet - March 18, 2024
Pakistan’s drug regulator is hoping that improved transparency on its inspection protocols will help research entities better prepare for good...
Pink Sheet - March 18, 2024
Australia To Give Consumers More Formal Role In HTA Processes
The health department says consumers and patients should be able to initiate health technology assessments because many potentially helpful and...
Pink Sheet - March 18, 2024
The health department says consumers and patients should be able to initiate health technology assessments because many potentially helpful and...
Pink Sheet - March 18, 2024
Artificial Intelligence: US FDA Plans Guidances On Algorithm Bias, Product Development
Cross-center AI strategy features collaboration between drug, biologic, device and combination product staff to ensure regulatory predictability. ‘Assurance labs’ offering...
Medtech Insight - March 18, 2024
Cross-center AI strategy features collaboration between drug, biologic, device and combination product staff to ensure regulatory predictability. ‘Assurance labs’ offering...
Medtech Insight - March 18, 2024
‘Why Am I Not Seeing More Women In The Hiring Mix?’ MedExec Women Founder Says It’s Time For Change
Maria Shepherd, co-founder of MedExec Women, a nonprofit that seeks to empower executive leaders in medtech, is preparing to host...
Medtech Insight - March 18, 2024
Maria Shepherd, co-founder of MedExec Women, a nonprofit that seeks to empower executive leaders in medtech, is preparing to host...
Medtech Insight - March 18, 2024
EU Institutions Reach Provisional Agreement On Proposed Health Data Regulation Amendments
Key changes have been agreed to the original European Commission text which would allow patients to opt out or restrict...
Medtech Insight - March 18, 2024
Key changes have been agreed to the original European Commission text which would allow patients to opt out or restrict...
Medtech Insight - March 18, 2024
Leading The Way From A Singular Position - An IWD Perspective
Anne Osdoit has learned how to transform what would be challenges in her career into sources of inspiration. With this...
Medtech Insight - March 18, 2024
Anne Osdoit has learned how to transform what would be challenges in her career into sources of inspiration. With this...
Medtech Insight - March 18, 2024
Demi Moore’s Wonderbelly Antacid Investment Lands Supporting Role In Her Promotional Posts
Wonderbelly Antacids “free from” ad claims work but failing to disclose Demi Moore is an investor in her promotions doesn’t...
HBW Insight - March 18, 2024
Wonderbelly Antacids “free from” ad claims work but failing to disclose Demi Moore is an investor in her promotions doesn’t...
HBW Insight - March 18, 2024
Stada Grows Twice As Fast As CHC Market In 2023
Stada's local brand focus helped it deliver Consumer Healthcare sales growth of 16% in 2023 ensuring the German firm significantly...
HBW Insight - March 18, 2024
Stada's local brand focus helped it deliver Consumer Healthcare sales growth of 16% in 2023 ensuring the German firm significantly...
HBW Insight - March 18, 2024
Biosimilars Council Commends Nixing ‘Arbitrary’ Interchangeability Designation
The Biosimilars Council agreed with the US president’s proposal to remove the “unnecessary” designation for biosimilars, which strengthens the ongoing...
Generics Bulletin - March 18, 2024
The Biosimilars Council agreed with the US president’s proposal to remove the “unnecessary” designation for biosimilars, which strengthens the ongoing...
Generics Bulletin - March 18, 2024
US Off-Patent Legislation Could Save Over $1bn In Ten Years
If passed, the two bills favoring generics and biosimilar developers would not only result in federal savings but would also...
Generics Bulletin - March 18, 2024
If passed, the two bills favoring generics and biosimilar developers would not only result in federal savings but would also...
Generics Bulletin - March 18, 2024
US Aspart Filing Kicks Off Amphastar’s Insulin Ambitions
Amphastar says a “milestone” submission of a US filing for insulin aspart underlines its ambitions in the diabetes segment. But...
Generics Bulletin - March 18, 2024
Amphastar says a “milestone” submission of a US filing for insulin aspart underlines its ambitions in the diabetes segment. But...
Generics Bulletin - March 18, 2024
Celltrion Takes Aim At US Infliximab Market With Subcutaneous Launch
Celltrion has delivered on its long-awaited US launch of its Zymfentra subcutaneous formulation of infliximab, sold in other territories as...
Generics Bulletin - March 18, 2024
Celltrion has delivered on its long-awaited US launch of its Zymfentra subcutaneous formulation of infliximab, sold in other territories as...
Generics Bulletin - March 18, 2024
CGT Is In Its Infancy For CNS Disorders, But Technical Strides Being Made
Technical challenges and lackluster investor sentiment about the near-term commercial potential of cell and gene therapies in neurological disorders may...
In Vivo - March 18, 2024
Technical challenges and lackluster investor sentiment about the near-term commercial potential of cell and gene therapies in neurological disorders may...
In Vivo - March 18, 2024
Quantum Outperforms Classical Computer, Finding New KRAS Inhibitors
In a breakthrough for drug discovery, quantum hardware outperformed classical hardware in generating two promising KRAS inhibitors.
In Vivo - March 18, 2024
In a breakthrough for drug discovery, quantum hardware outperformed classical hardware in generating two promising KRAS inhibitors.
In Vivo - March 18, 2024
Alys Is An Asset Play Wanting Big Pharma Attention
Leaders of a new dermatology-focused biotech, which has launched with 14 development programs in its pipeline, explain the rationale behind...
In Vivo - March 18, 2024
Leaders of a new dermatology-focused biotech, which has launched with 14 development programs in its pipeline, explain the rationale behind...
In Vivo - March 18, 2024