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Preparing For Next Pandemic, FDA Offers Guidance For Validating Emergency Authorization Tests
FDA finalizes guidance on validating diagnostic tests for emerging pathogens during declared emergency. Allows developers to send some data after submission and use synthetic samples early in an outbreak; also covers study design, home-use testing and more.
HBW Insight - November 12, 2026

Teva Leans Into Innovation With A Goal To Generate $6bn-$7bn By 2030
During an R&D day, Teva’s management team laid out its ambition to continue building out the company’s presence in innovative medicines through a cadence of launches.
Scrip - November 11, 2026
Merck KGaA Expands Rare Disease Presence With Pimjetmi Approval
The German drugmaker won US FDA approval for the CSF-1R inhibitor for tenosynovial giant cell tumor, where it will compete with two approved drugs and potentially a third.
Scrip - November 11, 2026
Oyster Therapeutics Raises $60m To Target Alzheimer’s With Protein Degraders
UK-headquartered biotech believes its new generation of protein degraders can target tau and other disease-causing proteins in the central nervous system.
Scrip - November 11, 2026
Stock Watch: Lilly’s 52-Week High Meets Alnylam’s 52-Week Low
Lilly’s stock hit a 52-week high while Alnylam’s hit a 52-week low when both reported third-quarter results on Oct. 29. Both depend heavily on a dominant franchise.
Scrip - November 11, 2026
Beam Eyes Risto-Cel BLA As Early As Year-End After Positive Sickle Cell Data
Beam's risto-cel hits primary efficacy endpoint of freedom from severe VOCs in the Phase I/II BEACON study, setting up a potential BLA filing with the US Food and Drug Administration.
Scrip - November 11, 2026
ACR 2026: Can ImmuneOnco’s Bispecific Take On Roche’s Gazyva In SLE?
In a major update to an ongoing Phase Ib program, ImmuneOnco's amulirafusp ? showed an up to 90.9% SRI-4 response rate at 24 weeks in Chinese patients with active systemic lupus erythematosus.
Scrip - November 11, 2026
Divamics Targeting Differentiation In Application Of AI To Drug Design
Executives from Chinese AI-driven biotech Divamics sit down with Scrip to talk about the rationale behind the founding of the company, its in-house AI platforms, R&D and business strategies and approach to differentiation in a fast-changing area.
Scrip - November 11, 2026

Oura Adds AI-Driven Primary Care To Its App With $625M Counsel Health Purchase
Smart ring firm Oura has agreed to pay $625m for AI-driven primary care telemedicine service Counsel Health. The deal will allow Oura to expand further into the patient care sector, possibly allaying investor concerns that company revenues were too dependent on hardware sales.
Medtech Insight - November 11, 2026
Olympus Lifts Full-Year Revenue Floor As FDA Import Alerts Weigh On Surgical Shipments
Olympus posted JPY269.2bn ($1.7bn) in Q2 revenue, up 9% reported but only 1% in constant currency, as FDA import alerts linger.
Medtech Insight - November 11, 2026
CMS Revises Remote Monitoring Payments, Sets Medicare Rates For 14 Software-Based Diagnostic Tools
The 2027 Medicare Physician Fee Schedule final rule revises remote monitoring payments, establishes pricing for 14 software-based diagnostic analyses and updates reimbursement for technologies including fluorescence wound imaging. CMS is also changing clinical laboratory payment policies.
Medtech Insight - November 11, 2026
‘Warning Shot’: Medtech’s IT Breaches Could Hand Hackers A Blueprint For Device Attacks
The cyberattacks that hit Stryker and Boston Scientific this year stopped short of devices. A security executive warns that what intruders learn inside corporate networks could one day be turned on products in hospitals.
Medtech Insight - November 11, 2026
EU Provides More Breakthrough Device Details As Pilot Enters Next Phase
Six devices have been successfully assessed under the program, but the European Commission is taking a cautious approach to expansion.
Medtech Insight - November 11, 2026
FDA Finalizes Guidance On Validating Emergency Tests For The Next Pandemic
The FDA has finalized guidance on validating diagnostic tests for emerging pathogens during a declared emergency. It lets developers send some data after submission and use synthetic samples early in an outbreak. It also covers study design, home-use testing and more.
Medtech Insight - November 11, 2026

Preparing For Next Pandemic, FDA Offers Guidance For Validating Emergency Authorization Tests
FDA finalizes guidance on validating diagnostic tests for emerging pathogens during declared emergency. Allows developers to send some data after submission and use synthetic samples early in an outbreak; also covers study design, home-use testing and more.
HBW Insight - November 12, 2026

‘We Want Partners Who Can Grow With Us’ – CinnaGen Chair Hamedifar On The Firm’s Plans For Europe
After receiving an EU approval for its Zandoriah teriparatide biosimilar earlier this year, Iran’s CinnaGen is looking to build up a broader portfolio while also seeking European marketing partners who can “grow with us beyond one product,” chairperson Haleh Hamedifar tells Generics Bulletin.
Generics Bulletin - November 11, 2026
Bio-Thera Claims First Simponi Biosimilar Approval In China
China’s NMPA has approved Bio-Thera’s golimumab biosimilar Ashuli for rheumatoid arthritis and ankylosing spondylitis, which the firm says is the country’s first rival to J&J’s Simponi.
Generics Bulletin - November 11, 2026

Headline Risk, Bottom-Line Risk: Pharma’s Guide To Democratic Control Of Congress
Oversight of the Most Favored Nation deals is coming, but the larger financial stakes for the pharma industry in the next Congress are a Democratic push for Medicare pricing expansion as well as risks to FDA stability if user fee reauthorization becomes a political football.
In Vivo - November 11, 2026