Latest Pharma Insights
Asia-Pacific’s Medtech Pivot: From Factory Floor To Innovation Engine
A new Bain report says Asia-Pacific has shifted from medtech's factory floor to a genuine innovation source — 36% of global device research, two-thirds of patent filings, 30% of FDA 510(k) clearances. But a <5% share of FDA De Novo authorizations shows how far the region still has to climb.
Medtech Insight - August 12, 2026
A new Bain report says Asia-Pacific has shifted from medtech's factory floor to a genuine innovation source — 36% of global device research, two-thirds of patent filings, 30% of FDA 510(k) clearances. But a <5% share of FDA De Novo authorizations shows how far the region still has to climb.
Medtech Insight - August 12, 2026
Axing Self-Affirmed GRAS Pathway Without Notification Spurs Resource, Authority Questions
Demand on FDA resources and one-year deadline following effective date for notifications for ingredients already available self-GRAS but not notified could be more than FDA bargains for. Proposed rule also could order more than FDA has authority to do.
HBW Insight - August 12, 2026
Demand on FDA resources and one-year deadline following effective date for notifications for ingredients already available self-GRAS but not notified could be more than FDA bargains for. Proposed rule also could order more than FDA has authority to do.
HBW Insight - August 12, 2026
Finance Watch: Earnings, Data Updates Bring Strategic Shifts, Job Cuts
Restructuring Edition: Sionna ended development of one of the cystic fibrosis drugs it is advancing to compete with Vertex based on early Phase II data and it is cutting costs. Also, Aura Biosciences, aTyr Pharma and Emergent BioSolutions cut jobs in Q2 financial updates.
Scrip - August 11, 2026
Restructuring Edition: Sionna ended development of one of the cystic fibrosis drugs it is advancing to compete with Vertex based on early Phase II data and it is cutting costs. Also, Aura Biosciences, aTyr Pharma and Emergent BioSolutions cut jobs in Q2 financial updates.
Scrip - August 11, 2026
Attruby Poised To Lead First-Line ATTR-CM, BridgeBio Says
Sales of the transthyretin stabilizer were $222.4m in the second quarter, putting it on a blockbuster trajectory.
Scrip - August 11, 2026
Sales of the transthyretin stabilizer were $222.4m in the second quarter, putting it on a blockbuster trajectory.
Scrip - August 11, 2026
Zydus Deal Drops Mereo A Lifeline For Rare Disease Candidate Alvelestat
A staggered payment deal between Zydus subsidiary Sentynl and UK biotech Mereo BioPharma will help alvelestat, an investigational oral drug to treat AATD-LD, progress to global Phase III trials in early 2027. Meanwhile, Mereo expects an update on setrusumab by end-2026.
Scrip - August 11, 2026
A staggered payment deal between Zydus subsidiary Sentynl and UK biotech Mereo BioPharma will help alvelestat, an investigational oral drug to treat AATD-LD, progress to global Phase III trials in early 2027. Meanwhile, Mereo expects an update on setrusumab by end-2026.
Scrip - August 11, 2026
Vaderis Closes Series B Round To Fund Phase III HHT Asset Engasertib
The drugmaker raised $152m in venture capital and initiated the Phase III HEROIC trial of engasertib in hereditary hemorrhagic telangiectasia (HHT), which has no FDA-approved therapies.
Scrip - August 11, 2026
The drugmaker raised $152m in venture capital and initiated the Phase III HEROIC trial of engasertib in hereditary hemorrhagic telangiectasia (HHT), which has no FDA-approved therapies.
Scrip - August 11, 2026
Europe May Follow France’s Biosimilar Lead, Germany Reforms Cut Both Ways: Lupin CEO
France’s model of incentivizing biosimilars substitution to aid innovator drug purchases could be worthy of emulation while Germany’s recently announced changes cut both ways, says Lupin’s CEO Vinita Gupta as she also talks of South Africa semaglutide launch plans.
Scrip - August 11, 2026
France’s model of incentivizing biosimilars substitution to aid innovator drug purchases could be worthy of emulation while Germany’s recently announced changes cut both ways, says Lupin’s CEO Vinita Gupta as she also talks of South Africa semaglutide launch plans.
Scrip - August 11, 2026
Stock Watch: Why Investors Sold Sanofi Despite The Headline Beat
Sanofi's second quarter was strong on paper, but a Dupixent gross-to-net one-off, a stumbling vaccine franchise, and a weaker second-half outlook sent the stock down nearly 9% in Paris on results day.
Scrip - August 11, 2026
Sanofi's second quarter was strong on paper, but a Dupixent gross-to-net one-off, a stumbling vaccine franchise, and a weaker second-half outlook sent the stock down nearly 9% in Paris on results day.
Scrip - August 11, 2026
Asia-Pacific’s Medtech Pivot: From Factory Floor To Innovation Engine
A new Bain report says Asia-Pacific has shifted from medtech's factory floor to a genuine innovation source — 36% of global device research, two-thirds of patent filings, 30% of FDA 510(k) clearances. But a <5% share of FDA De Novo authorizations shows how far the region still has to climb.
Medtech Insight - August 12, 2026
A new Bain report says Asia-Pacific has shifted from medtech's factory floor to a genuine innovation source — 36% of global device research, two-thirds of patent filings, 30% of FDA 510(k) clearances. But a <5% share of FDA De Novo authorizations shows how far the region still has to climb.
Medtech Insight - August 12, 2026
Axing Self-Affirmed GRAS Pathway Without Notification Spurs Resource, Authority Questions
Demand on FDA resources and one-year deadline following effective date for notifications for ingredients already available self-GRAS but not notified could be more than FDA bargains for. Proposed rule also could order more than FDA has authority to do.
HBW Insight - August 12, 2026
Demand on FDA resources and one-year deadline following effective date for notifications for ingredients already available self-GRAS but not notified could be more than FDA bargains for. Proposed rule also could order more than FDA has authority to do.
HBW Insight - August 12, 2026
Samsung Bioepis Launches Eylea Pre-Filled Syringe Biosimilar In Europe
Opuviz is now available in Europe in both vial and pre-filled syringe presentations, completing Samsung Bioepis' ophthalmology offering in the growing aflibercept market.
Generics Bulletin - August 11, 2026
Opuviz is now available in Europe in both vial and pre-filled syringe presentations, completing Samsung Bioepis' ophthalmology offering in the growing aflibercept market.
Generics Bulletin - August 11, 2026
Aveva Clears Appeals Hurdle In Bid To Launch Only Approved ZTlido Generic
Aveva’s only approved generic version of ZTlido has moved closer to potential US market entry after the Federal Circuit upheld a finding that its lidocaine patch does not infringe three Scilex patents.
Generics Bulletin - August 11, 2026
Aveva’s only approved generic version of ZTlido has moved closer to potential US market entry after the Federal Circuit upheld a finding that its lidocaine patch does not infringe three Scilex patents.
Generics Bulletin - August 11, 2026
FDA Remediation Puts Third Of Amphastar Sales Under Spotlight
Amphastar is bracing for higher costs and some sales pressure as it remediates its FDA-cited IMS facility, while newer generics support growth and the company keeps its insulin aspart biosimilar on track for a potential 2027 launch.
Generics Bulletin - August 11, 2026
Amphastar is bracing for higher costs and some sales pressure as it remediates its FDA-cited IMS facility, while newer generics support growth and the company keeps its insulin aspart biosimilar on track for a potential 2027 launch.
Generics Bulletin - August 11, 2026
Biocon’s ‘Unique Play’ Leaves It Bullish On US Eylea Biosimilar
Biocon expects to make the headstart for its Eylea biosimilar in the US count and indicates that its product pipeline stands to gain from recent regulatory streamlining.
Generics Bulletin - August 11, 2026
Biocon expects to make the headstart for its Eylea biosimilar in the US count and indicates that its product pipeline stands to gain from recent regulatory streamlining.
Generics Bulletin - August 11, 2026
Why Patient-Focused Drug Development Should Drive Corporate Strategy
The FDA's patient-focused guidance is a strategic framework, not a compliance exercise. Companies that define patient value early build durable commercial advantage.
In Vivo - August 11, 2026
The FDA's patient-focused guidance is a strategic framework, not a compliance exercise. Companies that define patient value early build durable commercial advantage.
In Vivo - August 11, 2026
Strategic Intent: First-in-class, two markets: Annexon’s GBS and GA Strategies
On the inaugural episode of the Strategic Intent video podcast, Annexon CEO Doug Love discusses commercializing tanruprubart in GBS and vonaprument in GA, building dual launch teams, oral complement strategy, and MFN-driven partnering and pricing considerations.
In Vivo - August 11, 2026
On the inaugural episode of the Strategic Intent video podcast, Annexon CEO Doug Love discusses commercializing tanruprubart in GBS and vonaprument in GA, building dual launch teams, oral complement strategy, and MFN-driven partnering and pricing considerations.
In Vivo - August 11, 2026