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

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

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

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

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

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

Cardinal Health Reports 14% Revenue Growth For FY 2026 As Medical Segment Remains ‘Work In Progress’
Cardinal Health posted revenues of $254.2bn for FY 2026, up 14%, driven by its pharmaceutical segment. Its medical segment fell slightly in Q4 and continues to go through its recovery program.
Medtech Insight - August 11, 2026

GAO Flags Reimbursement Uncertainty And Liability Risk As Wearable Adoption Challenges
A GAO report finds wearables can improve clinical care but flags accuracy variability, workflow integration hurdles, and reimbursement uncertainty as barriers to broader adoption — and offers three policy options to address them.
Medtech Insight - August 11, 2026

Breakthrough Device Sponsors To Lose Key Payment Bridge As FDA And CMS Demands Climb
CMS is ending the alternative NTAP pathway after FY2029, raising the evidentiary bar for breakthrough devices at a moment when medtech valuations are at a multi-decade low and both FDA and CMS demands are rising. Attorney Mark Gardner says clear demonstration of benefit is crucial.
Medtech Insight - August 11, 2026

Dopl To Bring Remote Robotic Telecardiac Ultrasound To Rural Areas, Eyes Q3 2027 FDA Clearance
Dopl has raised $8m to date and plans to use the latest $6.3m to pursue FDA 510(k) clearance for its Traverse robotic teleultrasound system, targeting Q3 2027 clearance. CEO Ryan James envisions building a hardware-agnostic system that can integrate with existing robots.
Medtech Insight - August 11, 2026

Seeking Faster Oversight, Notified Bodies Request Full Access To EU Medtech Database
Team-NB says data from EUDAMED is vital for comprehensive risk-based surveillance.
Medtech Insight - August 11, 2026

Sweden’s Medicover Exits India After KKR Acquires Hospital Network Valued At $1.39bn
KKR is paying $1.39bn for a controlling stake in Medicover India's 24-hospital network, betting on India's consolidating hospital market even as the business it is buying posted a net loss and sits at a 46x EBITDA valuation.
Medtech Insight - August 11, 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

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

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

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

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

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

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