Get Smarter on Biotech in 5 Minutes a Day.
Focused insights — expertly curated, clearly delivered, ready for action.
Get the Daily Brief
What’s in Today’s Brief? (November 30th Preview)
-
FDA plan to speed biosimilars: patent office tightening could stall rollout
The FDA announced a proposal to streamline biosimilar regulation to mirror generic drug pathways, aiming to cut development time and cost for copycat biologics. Industry leaders including Stefan Glombitza of Formycon applauded potential savings up to $100 million per drug. However, stakeholders warn the U.S. Patent and Trademark Office’s recent narrowing of inter partes review (IPR) and denials of IPR petitions could leave biosimilar makers unable to challenge extensive patent portfolios filed by originator companies. Analysts say the regulatory gains from FDA guidance may be undermined if patent challenges become more difficult, slowing competition and preserving high biologic prices.
-
ACE2 decoy receptor... neutralizes mutant SARS‑CoV‑2 variants
Researchers led by Lin et al. designed an ACE2 decoy receptor that neutralizes multiple SARS‑CoV‑2 variants, demonstrating activity against mutant spike proteins in preclinical assays. Published in the Journal of Biomedical Science, the work shows engineered soluble ACE2 can retain binding to diverse receptor‑binding domain (RBD) mutations and block viral entry in vitro. The lead finding positions ACE2 decoys as a complementary antiviral strategy to antibodies and vaccines, with potential relevance for rapidly evolving variants that escape neutralizing antibodies.
-
Single 2‑ml mirikizumab injection matches two 1‑ml doses — administration simplified
A pharmacokinetic study led by Otani, Payne and Loftus demonstrated that a single 2‑ml subcutaneous injection of mirikizumab is bioequivalent to two 1‑ml injections in healthy participants. The trial measured systemic exposure and safety endpoints to support switching to a single‑shot regimen. The result could simplify dosing logistics for clinics and patients and reduce injection time and packaging complexity for biologic supply chains, pending regulatory acceptance.
-
Sibiriline halts two cell‑death programs — a dual inhibitor emerges
Scientists reported a novel small molecule, Sibiriline, that simultaneously inhibits necroptosis and ferroptosis in preclinical models. The study describes Sibiriline’s biochemical activity against key mediators of both programmed necrotic pathways and shows protective effects in cellular assays of inflammation and degenerative injury. Blocking both pathways with a single agent could open new therapeutic avenues for diseases where overlapping cell‑death modalities drive pathology, although translational steps toward safety and in vivo efficacy remain to be completed.
-
mTORC1 in ILC2s links nerves to allergic lung inflammation
Wang, Hu, Chen and colleagues published a Nature Communications paper demonstrating that mTORC1 signaling in group 2 innate lymphoid cells (ILC2s) couples neuro‑immune inputs to allergic lung inflammation. The team showed that mTORC1 activity modulates ILC2 effector function and the neuro‑immune axis that amplifies type 2 airway responses. ILC2s are innate immune cells that rapidly produce type 2 cytokines; the study clarifies a molecular node—mTORC1—that could be targeted to blunt neuro‑immune amplification in asthma and allergic disease.
...and 5 more selected Biotech stories in today’s full edition.
Why BioBriefs?
- Expertly curated. We scan 200+ sources daily to deliver only what matters.
- Smart context. Each brief explains why it matters and who it impacts.
- Made for pros. Trusted by founders, scientists, investors, and strategists.
Who Reads BioBriefs?
- Biotech founders & execs
- R&D and Clinical leads
- Life sciences investors
- Regulators and BD pros
- Translational scientists and tech scouts
Stay sharp. Be first to what’s next.
About BioBriefs
We’re a team of biotech analysts, technical writers, and founders who know what it’s like to scan 40 tabs and still miss what matters. BioBriefs was built to solve that. We track the signals, condense the insights, and get them to you before your day starts.