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Recent items include:
- <![CDATA[The Evolving Relationship Between FDA and Biotech]]>
- Biotech Insights - Spring 2026
- Three-year biotech policy drafted
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Biotech Insights - Spring 2026
Regulatory Overview: Post-Approval Changes to Marketed Drugs - The popularity of GLP-1s have brought post-approval changes to New Drug Applications (NDAs) to centerstage. Recently...
Three-year biotech policy drafted
Policy designed to enhance agricultural output, adopt global farming practices
Seeds of Change: How Biotechnology is Reshaping Agriculture
Agricultural biotechnology is advancing quickly – but the regulatory path to market can be anything but straightforward. In this episode, hosts Lauren Petrin and Dr. Alex Stanton e...
This Startup Aims to Upend Biologic Drug Production With Implantable ‘Cell Factories’
Duracyte’s implants employ cells engineered to produce therapeutic protein, bypassing the complexities of traditional biologics manufacturing. The startup’s marriage of biotechnolo...
EU Biotech Act: The European Commission’s landmark proposal to strengthen biotechnology in Europe
In December 2025, the European Commission published its proposal for the European Biotech Act. The proposal is a centerpiece of the Commission's broader strategy to position the EU...
USDA Seeks Input on Future Biotechnology Regulation as Agricultural Biologicals Policy Continues to Evolve
On May 15, 2026, the U.S. Department of Agriculture (USDA) published a Request for Information (RFI) seeking public input on the future regulation of genetically engineered (GE) or...
CPC Biotech Launched to Offer a Fluid Management Component Portfolio
CPC Biotech’s solutions support a range of applications in bioprocessing operations, spanning the upstream and downstream biologic drug manufacturing process, as well as cell and g...
Light-Controlled Gene Expression Platform Reportedly Doubles Standard Fed-Batch Manufacturing Performance
The real opportunity lies in next generation complex biologics such as multispecifics, cytokines, and fusion proteins. These molecules represent more than 50% of today's early pipe...
<![CDATA[Lessons Learned in the Current Biotech Funding Environment]]>
Toxin Free USA Campaigns to Prevent Products of Genetic Engineering to Be Labeled “Natural”
April 03, 2026 | Source: Toxin Free USA New Fairfield, CT, April 3, 2026 — Public interest nonprofit GMO/Toxin Free USA (TFUSA) succeeded in delaying a U.S. Food and Drug Adminis...
Plant Molecular Farming Comes of Age
The convergence of advances in biology and digital manufacturing is catapulting plant molecular farming to a scalable, cost-effective position relative to microbial, mammalian, and...
<![CDATA[FDA Extends Priority Review of Leqembi Iqlik Subcutaneous Injection ]]>
Redefining Bioprocessing Using Reservoirs of Biochemical Diversity
Scientists exploring Saudi Arabia’s desert soils have discovered resilient microbial enzymes that could transform drug manufacturing. These glycosyltransferases, shaped by extreme...
Initial Tests Show Promise for Novel Protein-Based Biopesticide
In a partnership with Syngenta, early laboratory testing demonstrated the activity of novel bioactive ingredients, developed with Biotalys’ AGROBODY technology, against a specific...
FDA tests out ‘real-time’ clinical trials; AbbVie closes in on a KRAS biotech
Through two pioneering studies, Amgen and AstraZeneca will share study data with FDA scientists as it’s accrued. Elsewhere, Lilly inked a gene editing deal and Pfizer reported succ...
<![CDATA[The Relationship Between the Capital Markets and Biotech?]]>
<![CDATA[The Biotech Industry’s Relationship with Real-Time Data: Q&A with Dr. Richard Graham]]>
Lilly’s obesity pill off to a strong start; OpenAI debuts new drug discovery tool
Some 1,390 Foundayo prescriptions were written in two days, according to analysts. Elsewhere, multiple biotechs are using OpenAI’s “GPT-Rosalind” and Janux debuted a “double-masked...
<![CDATA[Modern Communication Between FDA, Biotech, and Investors: Q&A with David Crean]]>
Executing Biologics Technology Transfer through Integrated Operating Models
As biologics modalities diversify and processes grow complex, the success of tech transfer depends on integrated execution rather than each procedural completion. The post Executin...
FDA floats new clinical trial reforms; Takeda punts Denali brain drug
In its budget request, the agency proposed a way to speed up early drug testing and help smaller biotech firms. Elsewhere, two startups raised megarounds.
Coalition of Biotechnology Companies Launch American Biotech Innovation Alliance
On May 5, 2025, a coalition of U.S. biotechnology companies announced the launch of the American Biotech Innovation Alliance (ABIA). ABIA states that it will “focus on a shared obj...
Biotech Firm Says It Can Cut Gene Therapy Production Time To One Day
A key claim by the company MedTherapy is a major reduction in production timelines. While gene therapies typically take weeks or months to manufacture, MedTherapy says it has signi...
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