Biosimilars vs. Generics: Why the Two Are Not Interchangeable
Dr. Nathan Pryce · Oct 20, 2026A generic copies a small-molecule drug exactly. A biosimilar only comes close, because biology will not allow a perfect copy.
Tech News
What Recent Point-of-Care Molecular Diagnostics Launches Mean for Decentralized Testing
Oliver Strnad · Sep 25, 2026Molecular testing is moving to the point of care. Roche …
Tech News
All of Us Release Makes the Genomics Platform the Largest Integrated Health Database
Oliver Strnad · Sep 21, 2026NIH's All of Us Research Program became the world's largest …
Devices
How In Vitro Diagnostics Are Regulated in the US and EU
Oliver Strnad · Sep 13, 2026In vitro diagnostics are regulated as medical devices under different …
Biotech
How Orphan Drug Designation Actually Works: Criteria, Incentives and Exclusivity
Ravi Iyer · Sep 7, 2026Orphan drug designation is a formal FDA status for drugs …
FDA Issues Complete Response Letter for Alvotech's Golimumab Biosimilar AVT05
Dr. Nathan Pryce · Jun 16, 2026The FDA has issued a complete response letter for Alvotech's …
Moderna Doses First Patient in Phase 1/2 Trial of mRNA-2808 in Myeloma
Ravi Iyer · May 10, 2026Moderna has dosed the first patient in a Phase 1/2 …
Genetics
Vertex Presents First Casgevy Data in Children Ages Five to 11 at ASH
Yuki Tanaka · Jul 22, 2026Vertex Pharmaceuticals has presented the first clinical data for Casgevy in children ages 5-11 at the American Society of Hematology annual meeting, on December 6, 2025, in Orlando. All evaluated…
Epigenetics Platforms Explained: Reading the Marks That Sit Above the Genome
Dr. Charlotte Meyer · Jun 28, 2026Epigenetics is the field of study focused on changes in DNA that do not involve alterations to the underlying sequence, per NHGRI's Talking Glossary, which also calls the field epigenomics. The…
Devices
How Medical Device Trials Are Designed Differently From Drug Trials
Oliver Strnad · Aug 15, 2026Medical device trials run on an Investigational Device Exemption, the instrument that "allows the investigational device to be used in a clinical study in order to collect safety and effectiveness…
How Are AI-Enabled Medical Imaging Platforms Regulated by the FDA?
Oliver Strnad · Jul 15, 2026AI-enabled medical imaging devices are regulated as medical devices whose software uses artificial intelligence, authorized through FDA's existing premarket pathways and tracked on the public…
From Bench to First-In-Human: How a Drug Candidate Reaches the Clinic
A drug candidate reaches the clinic through an Investigational New Drug application, the exemption that lets a sponsor ship an unapproved drug to investigators. Per FDA, an IND is needed once a…
How Bioinformatics Pipelines Turn Raw Sequencing Data Into Usable Biology
A bioinformatics pipeline is a chained, software-defined series of steps that converts raw sequencing output into analyzed results, recording every tool version and parameter used. It exists to solve…
How Early-Stage Platform Science Actually Gets Validated in Biotech
Platform science in early-stage biotech is engineered, reusable biology — a delivery vector, an engineered binding domain, a data architecture — that one company claims can yield many programs rather…
FDA Approves Shionogi's Xocova as First Oral COVID-19 Post-Exposure Prophylaxis
The FDA has approved Shionogi's Xocova (ensitrelvir) as the first oral post-exposure prophylaxis for COVID-19 in adults and adolescents 12 years of age and older, the company announced on June 1,…
Why Biotech Manufacturing Capacity Announcements Are Reshaping U.S. Drug Supply
Eli Lilly said in May 2026 that it will invest an additional $4.5 billion at two of its three Lebanon, Indiana sites, lifting Indiana capital commitments above $21 billion over six years, per the…
Johnson & Johnson Lifts 2026 Outlook After $25.3 Billion Second Quarter
Johnson & Johnson reported second-quarter 2026 sales of $25.31 billion, up 6.6% year over year, with Innovative Medicine sales of $16.384 billion, up 7.8% — per the earnings release filed with the SEC…
Where Lab Automation Actually Stands in Biotech Right Now
Lab automation in biotech has moved from liquid-handling convenience to process control: a nonlinear model predictive control system developed by Sartorius researchers increased continuous CHO…
PacBio Raises Vega HiFi Output 50 Percent With SPRQ-Nx Chemistry
PacBio (NASDAQ: PACB) announced on August 5, 2026 that SPRQ-Nx chemistry will raise per-run HiFi output on its Vega benchtop sequencer from 60 Gb to 90 Gb, per the company's press release. The U.S.…
GenScript and Tamarind Bio Partner to Connect AI Molecular Design With Validation
GenScript Biotech Corporation and Tamarind Bio announced a strategic partnership on August 5, 2026, connecting Tamarind's AI-powered molecular design platform with GenScript's wet-lab validation…