Gene Therapy in 2025: How Cell Therapy Technology Is Redefining Treatment
Dr. Charlotte Meyer · Nov 3, 2026Gene therapy treats disease at its source — the DNA itself — and cell-based manufacturing is changing how those treatments reach patients.
Tech News
What a Biotech Platform Company Actually Is — and When the Model Fails
Ravi Iyer · Oct 29, 2026Platform biotechs sell a repeatable method, not a single drug. …
Tech News
Theranos Foundations: Why the Elizabeth Holmes Fraud Still Matters
Oliver Strnad · Oct 24, 2026A new documentary reopens the case, and the underlying lesson …
Tech News
Biotech Funding — How Biotech Startups Get Funded: Seed, Series A and the Valley of Death
Oliver Strnad · Oct 23, 2026Biotech financing runs on staged proof: seed capital buys discovery …
Biotech News
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 …
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 …
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 children in the sickle cell cohort remained free of vaso-occlusive crises for up to two years after…
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 commercial and scientific interest sits in the platforms that read those changes at scale: sequencing-…
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 instruments in the US and EU: FDA classification and premarket review in America, and the dedicated European Regulation 2017/746 in Europe. The US boundary moved in 2025, when a federal court vacated the FDA's…
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 data," per FDA — and all such evaluations, unless exempt, "must have an approved IDE before the…
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 sponsor that has screened a molecule for "pharmacological activity and acute toxicity potential in…
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 reproducibility: as the Nextflow authors wrote in Nature Biotechnology, the main source of…
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 than one. The claim is cheap; the validation is not. It arrives as published methods, reference…
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, 2026. The approval, covering use after contact with an individual who has COVID-19, came ahead of…
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 company's announcement. A December 2025 decision to spend more than $6 billion on an Alabama API…
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 on July 15, 2026. The company raised full-year guidance to reported sales of $101.1 billion and…
What Recent Point-of-Care Molecular Diagnostics Launches Mean for Decentralized Testing
Molecular testing is moving to the point of care. Roche said on December 2, 2025 that its cobas liat Bordetella test received FDA 510(k) clearance and a CLIA waiver, with results in about 15 minutes, per the company. On August 6, 2026, Co-Diagnostics announced a dual 510(k) with a concurrent…
All of Us Release Makes the Genomics Platform the Largest Integrated Health Database
NIH's All of Us Research Program became the world's largest integrated genomic and electronic health record database with its June 30, 2026 release, which per the agency's announcement makes data from more than 747,000 participants available to scientists and includes more than 535,000 whole…
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 perfusion production by 68% while holding viable cell density at or above 95%, per a September 23, 2026…