Consumer Refunds For False COVID-19 Claims Follow Civil Settlement, Criminal Convictions
FTC’s sending checks totaling more than $40,700 to 578 consumers who purchased deceptively marketed treatment plans from Golden Sunrise between July 2017 and July 2020. Company owner and chief medical officer both pleaded guilty to criminal charges.
HBW Insight - March 11, 2026

Solid Bio’s SGT-003 Data Show DMD Gene Therapy Efficacy Without Liver Toxicity
The company remains blinded to data on functional gains, holding that for future US FDA accelerated approval discussions, but Phase I/II results show microdystrophin production without liver toxicity seen with Sarepta’s Elevidys.
Scrip - March 11, 2026

Finance Watch: Samsung Biologics And Lilly Aim To Open Gateway Labs Site In Korea
Private Company Edition: A Lilly Gateway Labs location for biotech start-ups is set to open on Samsung Biologics’ Bio Campus II in South Korea in 2027. Atavistik Bio and Vima Therapeutics each add $40m to their last financings, bringing the totals to $160m and $100m, respectively.
Scrip - March 11, 2026

FDA Weighs Second Citizen Petition On Bamboo Health’s NarxCare
The FDA’s device center has received a second citizen petition relating to the NarxCare algorithm by Bamboo Health. Both petitions argue that NarxCare qualifies as a regulated clinical decision support product, but it is not clear whether the second petition will succeed where the first failed.
Medtech Insight - March 11, 2026

At The Immune Frontier, The Hardest Questions Are Commercial
As immune-system science attracts record capital and scientific talent, five companies at the vanguard of the field reveal a shared conviction: the immunome is the organizing principle of human health. The harder question is how to build a business around it.
In Vivo - March 11, 2026

Biogen Unveils Phase III Salanersen Program To Bring Longer-Acting SMA Option
As Spinraza’s sales have slumped, Biogen is developing the once-yearly salanersen, showing efficacy in patients with suboptimal responses to Novartis’s Zolgensma.
Scrip - March 11, 2026

FDA Announces May Rollout For MAUDE Replacement
The US FDA is replacing its individual product type adverse event reporting portals with a unified database, known as AEMS. While adverse event reports for some sectors such as drugs and vaccines joined the new portal on March 11, devices, human foods and tobacco products will be added in May.
Medtech Insight - March 11, 2026

UCB’s BOLD Plans For Pipeline-In-A-Product Bimzelx Are Paying Off
As the Belgian firm's blockbuster beats AbbVie's Skyrizi in a head-to-head psoriatic arthritis study.
Scrip - March 11, 2026

Founders’ Exit Adds Uncertainty To BioNTech’s Pivotal Year
Six late-stage data readouts are expected from BioNTech this year, with a potential first US oncology approval by 2027 – but before that, it needs to find a new CEO and chief medical officer.
Scrip - March 11, 2026

Galenica Grows Despite Weak Cold & Flu Season
Distribution deals helped Galenica grow its OTC sales in 2025 despite lower demand for cold and flu products.
HBW Insight - March 11, 2026

Industry Hails ‘Common Sense’ FDA Rethink On Non-US Comparators For Biosimilars
The latest biosimilars guidance from the FDA – which promises to further streamline applications by making it easier for developers to rely on non-US comparator products – has been warmly received by the off-patent industry.
Generics Bulletin - March 11, 2026

Agilent Pays $950M for Biocare Medical To Expand Pathology Reach
The acquisition adds an immunohistochemistry antibody, reagent and instrument portfolio to Agilent's pathology offering, expanding its clinical and research lab client groups.
Medtech Insight - March 11, 2026

Genentech Targets Biocon In USITC Case Over Perjeta Biosimilar Imports
Genentech has asked the US International Trade Commission to investigate Biocon and related entities over alleged infringement tied to pertuzumab biosimilars, seeking remedies that could block imports into the US.
Generics Bulletin - March 11, 2026

The Game Of Balancing Green Regulations While Keeping Off-Patent Drug Investment In Europe
In the second part of our exclusive interview with Medicines for Europe leaders, Generics Bulletin delves into medicinal product regulation by environmental and chemical agencies, and the need to maintain the historical off-patent drug heritage in Europe.
Generics Bulletin - March 11, 2026

EU Notified Bodies Warn MDR/IVDR Amendments Will Deliver Lower Levels Of Patient Safety
The public consultation on the European Commission’s proposed revision of the MDR and IVDR has been extended to accommodate late delivery of translated texts. EU notified bodies’ group TEAM-NB says the proposals need more balance to ensure the resulting regulations do not do more harm than good.
Medtech Insight - March 11, 2026

Excited About AI, Skeptical Of The Price Tag: Seed Investors Sound Off
Seed investors are enthusiastic about AI in drug discovery but skeptical of the valuations it is used to justify. At a recent panel, they drew a sharp line between real capability and an “AI veneer.”
In Vivo - March 11, 2026

Biocon And Cipla Build On Teva’s First Generic Saxenda Launch
Biocon’s FDA approval and Cipla’s US launch – via partner Orbicular – add momentum to the early generic market for Novo Nordisk’s Saxenda.
Generics Bulletin - March 11, 2026

In Brief: Jacobio/AZ’s JAB-23E73 Reports First Clinical Results For Pan-KRAS Inhibitors
Clinical Data Readout: Jacobio Pharmaceuticals and AstraZeneca's JAB-23E73, a pan-KRAS inhibitor, stands out among its peers as the first to report preliminary Phase I results after completing the dose escalation phase of a China-based clinical study.
Scrip - March 11, 2026

As Refund Claims Mount, Interest On IEEPA Tariff Payments Equals $650M A Month, $10Bn For 2026
US Court of International Trade expects by March 12 to receive from Customs and Border Protection a “short report describing the progress” it “has made toward the development of a process to issue refunds of IEEPA duties paid with interest.”
HBW Insight - March 11, 2026

Henkel Buys Not Your Mother’s, Aveeno Collaborates With Mayo Clinic; Beauty Deals Roundup
Henkel Corp. plans to purchase DeMert Brands, owner of Not Your Mother’s hair care brand, from Main Post Partners for an undisclosed price, while KYT Group is purchasing Glo Skin Beauty and Aveeno has entered into a three-year collaboration with the Mayo Clinic; Beauty Deals Roundup
HBW Insight - March 11, 2026