Latest Pharma Insights
Five Decades Of Device Oversight, From Ford’s Pen To Today
On May 28, 1976, President Ford signed the Medical Device Amendments into law, creating the risk-based framework that the FDA still relies on today. Fifty years later, CDRH marked the anniversary at its Maryland HQ. The timeline below traces the milestones that built modern device regulation.
Medtech Insight - May 29, 2026
On May 28, 1976, President Ford signed the Medical Device Amendments into law, creating the risk-based framework that the FDA still relies on today. Fifty years later, CDRH marked the anniversary at its Maryland HQ. The timeline below traces the milestones that built modern device regulation.
Medtech Insight - May 29, 2026
Replimune’s Fortunes Reverse As US FDA Allows Speedy RP1 Resubmission
Replimune, which said it had no choice but to lay off employees after the FDA rejected its melanoma immunotherapy for a second time, will now submit the drug for its third review.
Scrip - May 29, 2026
Replimune, which said it had no choice but to lay off employees after the FDA rejected its melanoma immunotherapy for a second time, will now submit the drug for its third review.
Scrip - May 29, 2026
Agios Drops Tebapivat In Lower-Risk MDS, Continues In Sickle Cell
Failure to meet a predetermined threshold for transfusion independence causes Agios to give up on its second-generation PK activator in lower-risk myelodysplastic syndrome.
Scrip - May 29, 2026
Failure to meet a predetermined threshold for transfusion independence causes Agios to give up on its second-generation PK activator in lower-risk myelodysplastic syndrome.
Scrip - May 29, 2026
Serious Injuries Linked To Second Recall Of Certain Insulet Omnipod Patches
Insulet is recalling millions of Omnipod pump patches due to a manufacturing issue that can result in patients not receiving adequate doses of insulin. The company reports 24 serious adverse events associated with the recall, which is the second recall of the devices this year.
Medtech Insight - May 29, 2026
Insulet is recalling millions of Omnipod pump patches due to a manufacturing issue that can result in patients not receiving adequate doses of insulin. The company reports 24 serious adverse events associated with the recall, which is the second recall of the devices this year.
Medtech Insight - May 29, 2026
Moving Targets Complicate Eliminating ‘Lucrative’ US Market For Supplements Spiked With ED Drugs
FDA acknowledges that the same products containing ED drugs on recall could still be available from other “unscrupulous” sources, or with different labels from the same sellers. “Distributing these products can be lucrative for unscrupulous companies.”
HBW Insight - May 29, 2026
FDA acknowledges that the same products containing ED drugs on recall could still be available from other “unscrupulous” sources, or with different labels from the same sellers. “Distributing these products can be lucrative for unscrupulous companies.”
HBW Insight - May 29, 2026
Wrong Number: Court Nixes Bid To Pin Stanford’s LVAD Emergency Number Misstep On Abbott
Abbott Vascular recently came away with a victory in a California lawsuit concerning HeartMate 3 ventricular assist device, which was still an investigational device at the time of implant. However, at least one attorney believes that the concept of duty-to-innovate could feature in future cases.
Medtech Insight - May 29, 2026
Abbott Vascular recently came away with a victory in a California lawsuit concerning HeartMate 3 ventricular assist device, which was still an investigational device at the time of implant. However, at least one attorney believes that the concept of duty-to-innovate could feature in future cases.
Medtech Insight - May 29, 2026
ASCO: BMS’s Mezigdomide More Than Doubles PFS In Relapsed/Refractory Myeloma
The drug showed efficacy in patients previously exposed to both lenalidomide and pomalidomide, which the company’s new CELMoDs are designed to succeed.
Scrip - May 29, 2026
The drug showed efficacy in patients previously exposed to both lenalidomide and pomalidomide, which the company’s new CELMoDs are designed to succeed.
Scrip - May 29, 2026
FDA’s Latest Device Classifications Include TENS Unit, Condom, Anesthesia Tools
The US Food and Drug Administration has announced classifications for 11 device types that initially reached market via the de novo pathway, including diagnostics, the first condom specifically indicated for anal sex, and a TENS unit for pain management.
Medtech Insight - May 29, 2026
The US Food and Drug Administration has announced classifications for 11 device types that initially reached market via the de novo pathway, including diagnostics, the first condom specifically indicated for anal sex, and a TENS unit for pain management.
Medtech Insight - May 29, 2026
Bemotrizinol Is Biggest Advance In Decades For US Sunscreen Market ‘Still Failing’ On UVA Protection
Bemotrizinol may be a "promising new ingredient" for US sunscreen products, but the Environmental Working Group still wants Congress to step up oversight of the market. Publishing its annual sunscreen guide, EWG says most products are failing to offer adequate UVA protection.
HBW Insight - May 29, 2026
Bemotrizinol may be a "promising new ingredient" for US sunscreen products, but the Environmental Working Group still wants Congress to step up oversight of the market. Publishing its annual sunscreen guide, EWG says most products are failing to offer adequate UVA protection.
HBW Insight - May 29, 2026
Biogen Faces Italian Investigation Over Blocking Sandoz’s Biosimilar Natalizumab
Biogen is being investigated by Italy’s AGCM competition authority over concerns that the company may have pursued a strategy designed to exclude and limit competition from Sandoz’s Tyruko (natalizumab) biosimilar rival to the originator’s Tysabri.
Generics Bulletin - May 29, 2026
Biogen is being investigated by Italy’s AGCM competition authority over concerns that the company may have pursued a strategy designed to exclude and limit competition from Sandoz’s Tyruko (natalizumab) biosimilar rival to the originator’s Tysabri.
Generics Bulletin - May 29, 2026
Execs On The Move: May 18–22, 2026
An interactive look at recent executive-level company changes and promotions in the medical device and diagnostics industries.
Medtech Insight - May 29, 2026
An interactive look at recent executive-level company changes and promotions in the medical device and diagnostics industries.
Medtech Insight - May 29, 2026
SERB Sizes Up €1bn Sales With M&A Savoir Faire
The Brussels-headquartered group has recently added Hansa's Idefirix to its portfolio, which should grow at a faster rate thanks to a strong sales network in Europe and the MENA region.
Scrip - May 29, 2026
The Brussels-headquartered group has recently added Hansa's Idefirix to its portfolio, which should grow at a faster rate thanks to a strong sales network in Europe and the MENA region.
Scrip - May 29, 2026
AstraZeneca Expands Imfinzi’s Bladder Cancer Reach With FDA Nod
Imfinzi's new NMIBC approval strengthens AstraZeneca's position in bladder cancer as the company expands the asset beyond its established indications.
Scrip - May 29, 2026
Imfinzi's new NMIBC approval strengthens AstraZeneca's position in bladder cancer as the company expands the asset beyond its established indications.
Scrip - May 29, 2026
Executives On The Move: Six CFOs And Five CMOs Among This Week’s Changes
Recent moves in the industry include the return of Thomas Dittrich to Amgen as CFO, plus more C-suite changes at Anaveon, HEPHAISTOS-Pharma and argenx.
Scrip - May 29, 2026
Recent moves in the industry include the return of Thomas Dittrich to Amgen as CFO, plus more C-suite changes at Anaveon, HEPHAISTOS-Pharma and argenx.
Scrip - May 29, 2026
Biopharma Ran Fewer, Better Trials In 2025
Citeline Clinical's 2026 annual completed clinical trials report finds that the biopharma industry ran fewer clinical trials in 2025 but with more trials meeting their endpoints.
Scrip - May 29, 2026
Citeline Clinical's 2026 annual completed clinical trials report finds that the biopharma industry ran fewer clinical trials in 2025 but with more trials meeting their endpoints.
Scrip - May 29, 2026
Diagnostics Manufacturers Are Falling Behind On Consumer Shift, Deloitte Warns
New research exposes a series of strategic disconnects between what providers need and what manufacturers deliver, just as patient-initiated testing threatens to reshape the market.
Medtech Insight - May 29, 2026
New research exposes a series of strategic disconnects between what providers need and what manufacturers deliver, just as patient-initiated testing threatens to reshape the market.
Medtech Insight - May 29, 2026
Elixir Medical’s DynamX Lowers Cardiovascular Death By 88% vs. Medtronic’s DES, Data Show
Four-year data showed Elixir Medical’s DynamX bioadaptor had a 66% lower target lesion failure rate and an 88% reduction in cardiovascular death versus Medtronic’s Resolute Onyx drug-eluting stent (DES).
Medtech Insight - May 29, 2026
Four-year data showed Elixir Medical’s DynamX bioadaptor had a 66% lower target lesion failure rate and an 88% reduction in cardiovascular death versus Medtronic’s Resolute Onyx drug-eluting stent (DES).
Medtech Insight - May 29, 2026
Medicines Patent Pool Targets Xofluza Access Through New Roche Licensing Agreement
The Medicines Patent Pool has entered into a new licensing agreement with Roche for Xofluza, an innovative antiviral for influenza treatment. This agreement was announced alongside the launch of the MPP’s new five–year strategy, also aimed at improving global medicines access.
Generics Bulletin - May 29, 2026
The Medicines Patent Pool has entered into a new licensing agreement with Roche for Xofluza, an innovative antiviral for influenza treatment. This agreement was announced alongside the launch of the MPP’s new five–year strategy, also aimed at improving global medicines access.
Generics Bulletin - May 29, 2026
Outlook Sees The Finish Line As It Wins Appeal Against FDA
A favorable appeal ruling gives Outlook Therapeutics its clearest US regulatory signal yet, but with $7.7m in cash and European sales sliding, the timing has never mattered more.
Generics Bulletin - May 29, 2026
A favorable appeal ruling gives Outlook Therapeutics its clearest US regulatory signal yet, but with $7.7m in cash and European sales sliding, the timing has never mattered more.
Generics Bulletin - May 29, 2026
Apotex Opens Its Books As It Unveils IPO Plans
Apotex has announced plans to go public, filing a preliminary prospectus for an initial public offering that reveals detailed financial data, as it set out its ambition to “evolve from a leading generics manufacturer into a diversified, Canadian-based global health company.”
Generics Bulletin - May 29, 2026
Apotex has announced plans to go public, filing a preliminary prospectus for an initial public offering that reveals detailed financial data, as it set out its ambition to “evolve from a leading generics manufacturer into a diversified, Canadian-based global health company.”
Generics Bulletin - May 29, 2026
Pfizer Taps Early China Clinical Trials Via Innovent Deal
Deal Snapshot: Pfizer is following in the footsteps of its major pharma peers to tap into China’s cheaper, quicker early-stage clinical studies, after inking a potentially $10.5bn deal with Innovent for 12 preclinical assets to scale up its ADC and multi-specific antibodies pipeline.
Scrip - May 29, 2026
Deal Snapshot: Pfizer is following in the footsteps of its major pharma peers to tap into China’s cheaper, quicker early-stage clinical studies, after inking a potentially $10.5bn deal with Innovent for 12 preclinical assets to scale up its ADC and multi-specific antibodies pipeline.
Scrip - May 29, 2026
Podcast: Decoding Cell Stress At Soley Therapeutics
In this episode of the In Vivo podcast, Soley Therapeutics CEO and UCSF cardiologist Yerem Yeghiazarians explains how decoding cell stress with live?cell imaging and artificial intelligence is powering a first?in?class oncology pipeline and beyond.
In Vivo - May 29, 2026
In this episode of the In Vivo podcast, Soley Therapeutics CEO and UCSF cardiologist Yerem Yeghiazarians explains how decoding cell stress with live?cell imaging and artificial intelligence is powering a first?in?class oncology pipeline and beyond.
In Vivo - May 29, 2026
Proposed Government Nondisclosure Agreement Could Include US FDA Pre-Decisional Memos
OPM’s proposed agreement does not appear to add requirements or prohibitions beyond those already existing for FDA staff, but could formally memorialize obligations to not disclose pre-decisional deliberative information, a former official said.
HBW Insight - May 29, 2026
OPM’s proposed agreement does not appear to add requirements or prohibitions beyond those already existing for FDA staff, but could formally memorialize obligations to not disclose pre-decisional deliberative information, a former official said.
HBW Insight - May 29, 2026
US Consumer Health Industry News Digest: Business, Regulation, Science
Animal studies have recent House committee and FDA attention; comments reopened on solvents petitions; FDA launches resources for food safety ‘engagement and collaboration’; and former FTC commissioner named Utah US Attorney.
HBW Insight - May 29, 2026
Animal studies have recent House committee and FDA attention; comments reopened on solvents petitions; FDA launches resources for food safety ‘engagement and collaboration’; and former FTC commissioner named Utah US Attorney.
HBW Insight - May 29, 2026
Replimune’s Fortunes Reverse As US FDA Allows Speedy RP1 Resubmission
Replimune, which said it had no choice but to lay off employees after the FDA rejected its melanoma immunotherapy for a second time, will now submit the drug for its third review.
Scrip - May 29, 2026
Replimune, which said it had no choice but to lay off employees after the FDA rejected its melanoma immunotherapy for a second time, will now submit the drug for its third review.
Scrip - May 29, 2026
Agios Drops Tebapivat In Lower-Risk MDS, Continues In Sickle Cell
Failure to meet a predetermined threshold for transfusion independence causes Agios to give up on its second-generation PK activator in lower-risk myelodysplastic syndrome.
Scrip - May 29, 2026
Failure to meet a predetermined threshold for transfusion independence causes Agios to give up on its second-generation PK activator in lower-risk myelodysplastic syndrome.
Scrip - May 29, 2026
ASCO: BMS’s Mezigdomide More Than Doubles PFS In Relapsed/Refractory Myeloma
The drug showed efficacy in patients previously exposed to both lenalidomide and pomalidomide, which the company’s new CELMoDs are designed to succeed.
Scrip - May 29, 2026
The drug showed efficacy in patients previously exposed to both lenalidomide and pomalidomide, which the company’s new CELMoDs are designed to succeed.
Scrip - May 29, 2026
SERB Sizes Up €1bn Sales With M&A Savoir Faire
The Brussels-headquartered group has recently added Hansa's Idefirix to its portfolio, which should grow at a faster rate thanks to a strong sales network in Europe and the MENA region.
Scrip - May 29, 2026
The Brussels-headquartered group has recently added Hansa's Idefirix to its portfolio, which should grow at a faster rate thanks to a strong sales network in Europe and the MENA region.
Scrip - May 29, 2026
AstraZeneca Expands Imfinzi’s Bladder Cancer Reach With FDA Nod
Imfinzi's new NMIBC approval strengthens AstraZeneca's position in bladder cancer as the company expands the asset beyond its established indications.
Scrip - May 29, 2026
Imfinzi's new NMIBC approval strengthens AstraZeneca's position in bladder cancer as the company expands the asset beyond its established indications.
Scrip - May 29, 2026
Executives On The Move: Six CFOs And Five CMOs Among This Week’s Changes
Recent moves in the industry include the return of Thomas Dittrich to Amgen as CFO, plus more C-suite changes at Anaveon, HEPHAISTOS-Pharma and argenx.
Scrip - May 29, 2026
Recent moves in the industry include the return of Thomas Dittrich to Amgen as CFO, plus more C-suite changes at Anaveon, HEPHAISTOS-Pharma and argenx.
Scrip - May 29, 2026
Biopharma Ran Fewer, Better Trials In 2025
Citeline Clinical's 2026 annual completed clinical trials report finds that the biopharma industry ran fewer clinical trials in 2025 but with more trials meeting their endpoints.
Scrip - May 29, 2026
Citeline Clinical's 2026 annual completed clinical trials report finds that the biopharma industry ran fewer clinical trials in 2025 but with more trials meeting their endpoints.
Scrip - May 29, 2026
Pfizer Taps Early China Clinical Trials Via Innovent Deal
Deal Snapshot: Pfizer is following in the footsteps of its major pharma peers to tap into China’s cheaper, quicker early-stage clinical studies, after inking a potentially $10.5bn deal with Innovent for 12 preclinical assets to scale up its ADC and multi-specific antibodies pipeline.
Scrip - May 29, 2026
Deal Snapshot: Pfizer is following in the footsteps of its major pharma peers to tap into China’s cheaper, quicker early-stage clinical studies, after inking a potentially $10.5bn deal with Innovent for 12 preclinical assets to scale up its ADC and multi-specific antibodies pipeline.
Scrip - May 29, 2026
Five Decades Of Device Oversight, From Ford’s Pen To Today
On May 28, 1976, President Ford signed the Medical Device Amendments into law, creating the risk-based framework that the FDA still relies on today. Fifty years later, CDRH marked the anniversary at its Maryland HQ. The timeline below traces the milestones that built modern device regulation.
Medtech Insight - May 29, 2026
On May 28, 1976, President Ford signed the Medical Device Amendments into law, creating the risk-based framework that the FDA still relies on today. Fifty years later, CDRH marked the anniversary at its Maryland HQ. The timeline below traces the milestones that built modern device regulation.
Medtech Insight - May 29, 2026
Serious Injuries Linked To Second Recall Of Certain Insulet Omnipod Patches
Insulet is recalling millions of Omnipod pump patches due to a manufacturing issue that can result in patients not receiving adequate doses of insulin. The company reports 24 serious adverse events associated with the recall, which is the second recall of the devices this year.
Medtech Insight - May 29, 2026
Insulet is recalling millions of Omnipod pump patches due to a manufacturing issue that can result in patients not receiving adequate doses of insulin. The company reports 24 serious adverse events associated with the recall, which is the second recall of the devices this year.
Medtech Insight - May 29, 2026
Wrong Number: Court Nixes Bid To Pin Stanford’s LVAD Emergency Number Misstep On Abbott
Abbott Vascular recently came away with a victory in a California lawsuit concerning HeartMate 3 ventricular assist device, which was still an investigational device at the time of implant. However, at least one attorney believes that the concept of duty-to-innovate could feature in future cases.
Medtech Insight - May 29, 2026
Abbott Vascular recently came away with a victory in a California lawsuit concerning HeartMate 3 ventricular assist device, which was still an investigational device at the time of implant. However, at least one attorney believes that the concept of duty-to-innovate could feature in future cases.
Medtech Insight - May 29, 2026
FDA’s Latest Device Classifications Include TENS Unit, Condom, Anesthesia Tools
The US Food and Drug Administration has announced classifications for 11 device types that initially reached market via the de novo pathway, including diagnostics, the first condom specifically indicated for anal sex, and a TENS unit for pain management.
Medtech Insight - May 29, 2026
The US Food and Drug Administration has announced classifications for 11 device types that initially reached market via the de novo pathway, including diagnostics, the first condom specifically indicated for anal sex, and a TENS unit for pain management.
Medtech Insight - May 29, 2026
Execs On The Move: May 18–22, 2026
An interactive look at recent executive-level company changes and promotions in the medical device and diagnostics industries.
Medtech Insight - May 29, 2026
An interactive look at recent executive-level company changes and promotions in the medical device and diagnostics industries.
Medtech Insight - May 29, 2026
Diagnostics Manufacturers Are Falling Behind On Consumer Shift, Deloitte Warns
New research exposes a series of strategic disconnects between what providers need and what manufacturers deliver, just as patient-initiated testing threatens to reshape the market.
Medtech Insight - May 29, 2026
New research exposes a series of strategic disconnects between what providers need and what manufacturers deliver, just as patient-initiated testing threatens to reshape the market.
Medtech Insight - May 29, 2026
Elixir Medical’s DynamX Lowers Cardiovascular Death By 88% vs. Medtronic’s DES, Data Show
Four-year data showed Elixir Medical’s DynamX bioadaptor had a 66% lower target lesion failure rate and an 88% reduction in cardiovascular death versus Medtronic’s Resolute Onyx drug-eluting stent (DES).
Medtech Insight - May 29, 2026
Four-year data showed Elixir Medical’s DynamX bioadaptor had a 66% lower target lesion failure rate and an 88% reduction in cardiovascular death versus Medtronic’s Resolute Onyx drug-eluting stent (DES).
Medtech Insight - May 29, 2026
Moving Targets Complicate Eliminating ‘Lucrative’ US Market For Supplements Spiked With ED Drugs
FDA acknowledges that the same products containing ED drugs on recall could still be available from other “unscrupulous” sources, or with different labels from the same sellers. “Distributing these products can be lucrative for unscrupulous companies.”
HBW Insight - May 29, 2026
FDA acknowledges that the same products containing ED drugs on recall could still be available from other “unscrupulous” sources, or with different labels from the same sellers. “Distributing these products can be lucrative for unscrupulous companies.”
HBW Insight - May 29, 2026
Bemotrizinol Is Biggest Advance In Decades For US Sunscreen Market ‘Still Failing’ On UVA Protection
Bemotrizinol may be a "promising new ingredient" for US sunscreen products, but the Environmental Working Group still wants Congress to step up oversight of the market. Publishing its annual sunscreen guide, EWG says most products are failing to offer adequate UVA protection.
HBW Insight - May 29, 2026
Bemotrizinol may be a "promising new ingredient" for US sunscreen products, but the Environmental Working Group still wants Congress to step up oversight of the market. Publishing its annual sunscreen guide, EWG says most products are failing to offer adequate UVA protection.
HBW Insight - May 29, 2026
Proposed Government Nondisclosure Agreement Could Include US FDA Pre-Decisional Memos
OPM’s proposed agreement does not appear to add requirements or prohibitions beyond those already existing for FDA staff, but could formally memorialize obligations to not disclose pre-decisional deliberative information, a former official said.
HBW Insight - May 29, 2026
OPM’s proposed agreement does not appear to add requirements or prohibitions beyond those already existing for FDA staff, but could formally memorialize obligations to not disclose pre-decisional deliberative information, a former official said.
HBW Insight - May 29, 2026
US Consumer Health Industry News Digest: Business, Regulation, Science
Animal studies have recent House committee and FDA attention; comments reopened on solvents petitions; FDA launches resources for food safety ‘engagement and collaboration’; and former FTC commissioner named Utah US Attorney.
HBW Insight - May 29, 2026
Animal studies have recent House committee and FDA attention; comments reopened on solvents petitions; FDA launches resources for food safety ‘engagement and collaboration’; and former FTC commissioner named Utah US Attorney.
HBW Insight - May 29, 2026
Biogen Faces Italian Investigation Over Blocking Sandoz’s Biosimilar Natalizumab
Biogen is being investigated by Italy’s AGCM competition authority over concerns that the company may have pursued a strategy designed to exclude and limit competition from Sandoz’s Tyruko (natalizumab) biosimilar rival to the originator’s Tysabri.
Generics Bulletin - May 29, 2026
Biogen is being investigated by Italy’s AGCM competition authority over concerns that the company may have pursued a strategy designed to exclude and limit competition from Sandoz’s Tyruko (natalizumab) biosimilar rival to the originator’s Tysabri.
Generics Bulletin - May 29, 2026
Medicines Patent Pool Targets Xofluza Access Through New Roche Licensing Agreement
The Medicines Patent Pool has entered into a new licensing agreement with Roche for Xofluza, an innovative antiviral for influenza treatment. This agreement was announced alongside the launch of the MPP’s new five–year strategy, also aimed at improving global medicines access.
Generics Bulletin - May 29, 2026
The Medicines Patent Pool has entered into a new licensing agreement with Roche for Xofluza, an innovative antiviral for influenza treatment. This agreement was announced alongside the launch of the MPP’s new five–year strategy, also aimed at improving global medicines access.
Generics Bulletin - May 29, 2026
Outlook Sees The Finish Line As It Wins Appeal Against FDA
A favorable appeal ruling gives Outlook Therapeutics its clearest US regulatory signal yet, but with $7.7m in cash and European sales sliding, the timing has never mattered more.
Generics Bulletin - May 29, 2026
A favorable appeal ruling gives Outlook Therapeutics its clearest US regulatory signal yet, but with $7.7m in cash and European sales sliding, the timing has never mattered more.
Generics Bulletin - May 29, 2026
Apotex Opens Its Books As It Unveils IPO Plans
Apotex has announced plans to go public, filing a preliminary prospectus for an initial public offering that reveals detailed financial data, as it set out its ambition to “evolve from a leading generics manufacturer into a diversified, Canadian-based global health company.”
Generics Bulletin - May 29, 2026
Apotex has announced plans to go public, filing a preliminary prospectus for an initial public offering that reveals detailed financial data, as it set out its ambition to “evolve from a leading generics manufacturer into a diversified, Canadian-based global health company.”
Generics Bulletin - May 29, 2026
Podcast: Decoding Cell Stress At Soley Therapeutics
In this episode of the In Vivo podcast, Soley Therapeutics CEO and UCSF cardiologist Yerem Yeghiazarians explains how decoding cell stress with live?cell imaging and artificial intelligence is powering a first?in?class oncology pipeline and beyond.
In Vivo - May 29, 2026
In this episode of the In Vivo podcast, Soley Therapeutics CEO and UCSF cardiologist Yerem Yeghiazarians explains how decoding cell stress with live?cell imaging and artificial intelligence is powering a first?in?class oncology pipeline and beyond.
In Vivo - May 29, 2026