Latest Pharma Insights
US Proposal To Restrict China Biotech Investment Leaves Licensing In A Gray Area
The US Treasury has issued a long-awaited proposal that would restrict US investment in biotech in China and other countries of concern, but whether licensing deals are covered would depend on their structure.
Scrip - October 23, 2026
The US Treasury has issued a long-awaited proposal that would restrict US investment in biotech in China and other countries of concern, but whether licensing deals are covered would depend on their structure.
Scrip - October 23, 2026
Former FDA Officials In Boston Offer Device Makers Advice On Inspections Under New QMSR Protocol
Former FDA officials at a NAMSA-hosted panel urged medical device manufacturers to maintain inspection readiness under the new QMSR, emphasizing robust quality systems, proactive FDA engagement and documented corrective actions. They said inadequate remediation can trigger escalated enforcement.
Medtech Insight - October 23, 2026
Former FDA officials at a NAMSA-hosted panel urged medical device manufacturers to maintain inspection readiness under the new QMSR, emphasizing robust quality systems, proactive FDA engagement and documented corrective actions. They said inadequate remediation can trigger escalated enforcement.
Medtech Insight - October 23, 2026
Digital Endpoints: US FDA Says Start With Outcomes, Not Tech - Clone
A white paper on “Digitally Derived Measures” stresses that the process of incorporating them into clinical trials must start with outcomes that matter to patients, not the digital tools’ capabilities.
Medtech Insight - October 23, 2026
A white paper on “Digitally Derived Measures” stresses that the process of incorporating them into clinical trials must start with outcomes that matter to patients, not the digital tools’ capabilities.
Medtech Insight - October 23, 2026
China’s Pharma Five-Year Plan Targets 200 Innovative Medical Devices By 2030
Manufacturers of medical devices are assessing opportunities from China’s Five-Year Plan for the pharmaceutical industry as they await the medical equipment counterpart. Grace Wang and Helen Chen, of L.E.K. Consulting’s Shanghai office, explained the implications and the 2027 outlook for medtech.
Medtech Insight - October 23, 2026
Manufacturers of medical devices are assessing opportunities from China’s Five-Year Plan for the pharmaceutical industry as they await the medical equipment counterpart. Grace Wang and Helen Chen, of L.E.K. Consulting’s Shanghai office, explained the implications and the 2027 outlook for medtech.
Medtech Insight - October 23, 2026
L’Oréal CEO: GLP-1s Are Reshaping Skin Care Demand
L’Oréal CEO Nicolas Hieronimus says the company is responding to the GLP-1 weight loss trend with formulas that address the negative impact of the drugs on skin’s appearance, while also investing in formulas that address skin care needs before, during and after aesthetic treatments.
HBW Insight - October 23, 2026
L’Oréal CEO Nicolas Hieronimus says the company is responding to the GLP-1 weight loss trend with formulas that address the negative impact of the drugs on skin’s appearance, while also investing in formulas that address skin care needs before, during and after aesthetic treatments.
HBW Insight - October 23, 2026
Zydus Receives FDA Approval For First Generic Climara Pro
The US regulator has approved Zydus’s once-weekly transdermal hormone therapy patch for estradiol and levonorgestrel as a competitive generic therapy, triggering eligibility for a 180-day exclusivity period.
Generics Bulletin - October 23, 2026
The US regulator has approved Zydus’s once-weekly transdermal hormone therapy patch for estradiol and levonorgestrel as a competitive generic therapy, triggering eligibility for a 180-day exclusivity period.
Generics Bulletin - October 23, 2026
Biotechs Cash In On Priority Review Vouchers As Record Sales Signal Rising Demand
Disclosed priority review voucher sales have hit a record $1.78bn across nine deals this year, with average prices at their highest since 2016.
Scrip - October 23, 2026
Disclosed priority review voucher sales have hit a record $1.78bn across nine deals this year, with average prices at their highest since 2016.
Scrip - October 23, 2026
Investors Bet That Star Can Repeat Past Successes With $200m Financing
Star Therapeutics, which sold subsidiary Vega to Incyte for $1.26bn up front this year, raised $200m in private financing to take its next round of novel biologics into the clinic.
Scrip - October 23, 2026
Star Therapeutics, which sold subsidiary Vega to Incyte for $1.26bn up front this year, raised $200m in private financing to take its next round of novel biologics into the clinic.
Scrip - October 23, 2026
France’s Alma Urges Off-Patent Exemption From Latest Legislative Burdens
French off-patent industry association Alma has urged revisions to the country’s latest social security financing bill to avoid penalizing generics and biosimilars.
Generics Bulletin - October 23, 2026
French off-patent industry association Alma has urged revisions to the country’s latest social security financing bill to avoid penalizing generics and biosimilars.
Generics Bulletin - October 23, 2026
Formycon Goes After Its First Niche-Buster Biosimilar With A Latin American Partner
Formycon has partnered with Uruguay-based Biocelys to develop an undisclosed “niche-buster” biosimilar, FYB286, targeting a rare disease. The deal is financed upfront by Santo Biosimilar, an entity controlled by Athos KG, which also controls Biocelys and is Formycon’s largest anchor shareholder.
Generics Bulletin - October 23, 2026
Formycon has partnered with Uruguay-based Biocelys to develop an undisclosed “niche-buster” biosimilar, FYB286, targeting a rare disease. The deal is financed upfront by Santo Biosimilar, an entity controlled by Athos KG, which also controls Biocelys and is Formycon’s largest anchor shareholder.
Generics Bulletin - October 23, 2026
The Biological Case for Adopting New Approach Methodologies in Oncology
The FDA’s oncology draft guidance supports using human-relevant NAMs to replace or augment animal toxicology studies, with biologics and ADCs best positioned because their targeted behavior makes safety predictable.
In Vivo - October 23, 2026
The FDA’s oncology draft guidance supports using human-relevant NAMs to replace or augment animal toxicology studies, with biologics and ADCs best positioned because their targeted behavior makes safety predictable.
In Vivo - October 23, 2026
Gilead Licenses Rival To J&J’s Icotyde In IBD Race Catch-Up
Deal Snapshot: Gilead is paying Pepstar/Peptidstar $1.3bn upfront for an oral macrocyclic peptide inhibitor of IL-23R with an extended half-life in a bid to catch up with J&J’s Icotyde in inflammatory bowel disease.
Scrip - October 23, 2026
Deal Snapshot: Gilead is paying Pepstar/Peptidstar $1.3bn upfront for an oral macrocyclic peptide inhibitor of IL-23R with an extended half-life in a bid to catch up with J&J’s Icotyde in inflammatory bowel disease.
Scrip - October 23, 2026
Roche Diagnostics Says China Drag Is Easing As It Eyes Return To Mid-to-High Single-Digit Growth
Roche’s diagnostics division grew 4% in the first nine months of 2026, but the more telling number is what happened in China: a 13% year-to-date decline that is narrowing, with Q3 alone coming in at minus 9% as pricing reform pressure eases.
Medtech Insight - October 23, 2026
Roche’s diagnostics division grew 4% in the first nine months of 2026, but the more telling number is what happened in China: a 13% year-to-date decline that is narrowing, with Q3 alone coming in at minus 9% as pricing reform pressure eases.
Medtech Insight - October 23, 2026
Edwards Lands FDA Nod For PASCAL In Tricuspid Repair, Setting Up Direct Challenge To Abbott’s TriCli
FDA approved Edwards’ PASCAL Precision for tricuspid edge-to-edge repair, giving US clinicians a second clip-based option after Abbott’s TriClip, with Medicare coverage already in place but pivotal CLASP IITR data still to come.
Medtech Insight - October 23, 2026
FDA approved Edwards’ PASCAL Precision for tricuspid edge-to-edge repair, giving US clinicians a second clip-based option after Abbott’s TriClip, with Medicare coverage already in place but pivotal CLASP IITR data still to come.
Medtech Insight - October 23, 2026
US Proposal To Restrict China Biotech Investment Leaves Licensing In A Gray Area
The US Treasury has issued a long-awaited proposal that would restrict US investment in biotech in China and other countries of concern, but whether licensing deals are covered would depend on their structure.
Scrip - October 23, 2026
The US Treasury has issued a long-awaited proposal that would restrict US investment in biotech in China and other countries of concern, but whether licensing deals are covered would depend on their structure.
Scrip - October 23, 2026
Biotechs Cash In On Priority Review Vouchers As Record Sales Signal Rising Demand
Disclosed priority review voucher sales have hit a record $1.78bn across nine deals this year, with average prices at their highest since 2016.
Scrip - October 23, 2026
Disclosed priority review voucher sales have hit a record $1.78bn across nine deals this year, with average prices at their highest since 2016.
Scrip - October 23, 2026
Investors Bet That Star Can Repeat Past Successes With $200m Financing
Star Therapeutics, which sold subsidiary Vega to Incyte for $1.26bn up front this year, raised $200m in private financing to take its next round of novel biologics into the clinic.
Scrip - October 23, 2026
Star Therapeutics, which sold subsidiary Vega to Incyte for $1.26bn up front this year, raised $200m in private financing to take its next round of novel biologics into the clinic.
Scrip - October 23, 2026
Gilead Licenses Rival To J&J’s Icotyde In IBD Race Catch-Up
Deal Snapshot: Gilead is paying Pepstar/Peptidstar $1.3bn upfront for an oral macrocyclic peptide inhibitor of IL-23R with an extended half-life in a bid to catch up with J&J’s Icotyde in inflammatory bowel disease.
Scrip - October 23, 2026
Deal Snapshot: Gilead is paying Pepstar/Peptidstar $1.3bn upfront for an oral macrocyclic peptide inhibitor of IL-23R with an extended half-life in a bid to catch up with J&J’s Icotyde in inflammatory bowel disease.
Scrip - October 23, 2026
Former FDA Officials In Boston Offer Device Makers Advice On Inspections Under New QMSR Protocol
Former FDA officials at a NAMSA-hosted panel urged medical device manufacturers to maintain inspection readiness under the new QMSR, emphasizing robust quality systems, proactive FDA engagement and documented corrective actions. They said inadequate remediation can trigger escalated enforcement.
Medtech Insight - October 23, 2026
Former FDA officials at a NAMSA-hosted panel urged medical device manufacturers to maintain inspection readiness under the new QMSR, emphasizing robust quality systems, proactive FDA engagement and documented corrective actions. They said inadequate remediation can trigger escalated enforcement.
Medtech Insight - October 23, 2026
Digital Endpoints: US FDA Says Start With Outcomes, Not Tech - Clone
A white paper on “Digitally Derived Measures” stresses that the process of incorporating them into clinical trials must start with outcomes that matter to patients, not the digital tools’ capabilities.
Medtech Insight - October 23, 2026
A white paper on “Digitally Derived Measures” stresses that the process of incorporating them into clinical trials must start with outcomes that matter to patients, not the digital tools’ capabilities.
Medtech Insight - October 23, 2026
China’s Pharma Five-Year Plan Targets 200 Innovative Medical Devices By 2030
Manufacturers of medical devices are assessing opportunities from China’s Five-Year Plan for the pharmaceutical industry as they await the medical equipment counterpart. Grace Wang and Helen Chen, of L.E.K. Consulting’s Shanghai office, explained the implications and the 2027 outlook for medtech.
Medtech Insight - October 23, 2026
Manufacturers of medical devices are assessing opportunities from China’s Five-Year Plan for the pharmaceutical industry as they await the medical equipment counterpart. Grace Wang and Helen Chen, of L.E.K. Consulting’s Shanghai office, explained the implications and the 2027 outlook for medtech.
Medtech Insight - October 23, 2026
Roche Diagnostics Says China Drag Is Easing As It Eyes Return To Mid-to-High Single-Digit Growth
Roche’s diagnostics division grew 4% in the first nine months of 2026, but the more telling number is what happened in China: a 13% year-to-date decline that is narrowing, with Q3 alone coming in at minus 9% as pricing reform pressure eases.
Medtech Insight - October 23, 2026
Roche’s diagnostics division grew 4% in the first nine months of 2026, but the more telling number is what happened in China: a 13% year-to-date decline that is narrowing, with Q3 alone coming in at minus 9% as pricing reform pressure eases.
Medtech Insight - October 23, 2026
Edwards Lands FDA Nod For PASCAL In Tricuspid Repair, Setting Up Direct Challenge To Abbott’s TriCli
FDA approved Edwards’ PASCAL Precision for tricuspid edge-to-edge repair, giving US clinicians a second clip-based option after Abbott’s TriClip, with Medicare coverage already in place but pivotal CLASP IITR data still to come.
Medtech Insight - October 23, 2026
FDA approved Edwards’ PASCAL Precision for tricuspid edge-to-edge repair, giving US clinicians a second clip-based option after Abbott’s TriClip, with Medicare coverage already in place but pivotal CLASP IITR data still to come.
Medtech Insight - October 23, 2026
L’Oréal CEO: GLP-1s Are Reshaping Skin Care Demand
L’Oréal CEO Nicolas Hieronimus says the company is responding to the GLP-1 weight loss trend with formulas that address the negative impact of the drugs on skin’s appearance, while also investing in formulas that address skin care needs before, during and after aesthetic treatments.
HBW Insight - October 23, 2026
L’Oréal CEO Nicolas Hieronimus says the company is responding to the GLP-1 weight loss trend with formulas that address the negative impact of the drugs on skin’s appearance, while also investing in formulas that address skin care needs before, during and after aesthetic treatments.
HBW Insight - October 23, 2026
Zydus Receives FDA Approval For First Generic Climara Pro
The US regulator has approved Zydus’s once-weekly transdermal hormone therapy patch for estradiol and levonorgestrel as a competitive generic therapy, triggering eligibility for a 180-day exclusivity period.
Generics Bulletin - October 23, 2026
The US regulator has approved Zydus’s once-weekly transdermal hormone therapy patch for estradiol and levonorgestrel as a competitive generic therapy, triggering eligibility for a 180-day exclusivity period.
Generics Bulletin - October 23, 2026
France’s Alma Urges Off-Patent Exemption From Latest Legislative Burdens
French off-patent industry association Alma has urged revisions to the country’s latest social security financing bill to avoid penalizing generics and biosimilars.
Generics Bulletin - October 23, 2026
French off-patent industry association Alma has urged revisions to the country’s latest social security financing bill to avoid penalizing generics and biosimilars.
Generics Bulletin - October 23, 2026
Formycon Goes After Its First Niche-Buster Biosimilar With A Latin American Partner
Formycon has partnered with Uruguay-based Biocelys to develop an undisclosed “niche-buster” biosimilar, FYB286, targeting a rare disease. The deal is financed upfront by Santo Biosimilar, an entity controlled by Athos KG, which also controls Biocelys and is Formycon’s largest anchor shareholder.
Generics Bulletin - October 23, 2026
Formycon has partnered with Uruguay-based Biocelys to develop an undisclosed “niche-buster” biosimilar, FYB286, targeting a rare disease. The deal is financed upfront by Santo Biosimilar, an entity controlled by Athos KG, which also controls Biocelys and is Formycon’s largest anchor shareholder.
Generics Bulletin - October 23, 2026
The Biological Case for Adopting New Approach Methodologies in Oncology
The FDA’s oncology draft guidance supports using human-relevant NAMs to replace or augment animal toxicology studies, with biologics and ADCs best positioned because their targeted behavior makes safety predictable.
In Vivo - October 23, 2026
The FDA’s oncology draft guidance supports using human-relevant NAMs to replace or augment animal toxicology studies, with biologics and ADCs best positioned because their targeted behavior makes safety predictable.
In Vivo - October 23, 2026




