Codon

JULY 28, 2025

The first of these components is the therapeutic genetic payload, or cargo, which is designed to correct or regulate the disease-causing mutation, whether that means offering a healthy copy of a mutated gene or delivering precision-editing tools like CRISPR. Still, AAV’s most obvious limitation remains its packaging capacity (~4.7

Immune Response

Drug Patent Watch

JANUARY 9, 2025

Navigating the complex landscape of drug development and manufacturing can be a daunting task. The Importance of Quality and Reliability In the high-stakes world of drug development, quality isn’t just important it’s everything. Assessing Your Technical Needs Every drug is unique, and so are its manufacturing requirements.

Compliance

Codon

JUNE 5, 2025

pyogenes protein — whose compactness makes them far easier to package into viral vectors and deliver into the human body. For example, one can fuse a deactivated Cas9 protein to so-called “transcriptional regulators” to either activate or repress genes without directly editing the genome at all.

DNA

Chemical Biology and Drug Design

DECEMBER 5, 2024

Natural drugs, including delphinidin, which target the core genes, tripartite motif containing 16 (TRIM16), and protein regulator of cytokinesis 1 (PRC1), were then identified. ABSTRACT Pancreatic cancer (PC) is the leading cause of cancer-related death worldwide, and new biomarkers, therapeutic targets, and candidate drugs are needed.

Packaging

FDA Law Blog: Biosimilars

MAY 4, 2025

Houck Drug Enforcement Administration (DEA) civil monetary settlements involving listed chemicals that do not include pseudoephedrine are rare. DEA seized five packages in Eagle Pass, Texas, identifying IMC Pro as the shipper containing 26.4 IMC Pro did not store or handle the packages nor maintain records about their contents.

Packaging

Codon

NOVEMBER 1, 2024

They engineered genetically-encoded RNA exporters, based on viruses, that package and secrete RNA molecules in protective nanoparticles, allowing non-destructive monitoring of those RNA molecules in real-time. It demands protocols, regulations, and collaborative efforts between human beings. 7 Not to mention scaling things (i.e.

DNA

Drug Patent Watch

FEBRUARY 19, 2025

The Unsung Heroes of Generic Drugs: The Importance of Quality Assurance As we navigate the complex world of pharmaceuticals, it's easy to overlook the behind-the-scenes efforts that ensure the quality and safety of the medications we rely on. So, what can we learn from the importance of Quality Assurance in generic drugs?

Drugs

FDA Law Blog: Drug Discovery

DECEMBER 6, 2024

However, as your high-school literature teacher warned youto ace the test, you need to read the book, ahem, source regulations, guidance, or other policy documents. The draft guidance recommends that no more than 15 questions are included in the briefing package. CBER will not commit to reviewing packages greater than 250 pages.

Therapies

FDA Law Blog: Biosimilars

APRIL 10, 2025

Food and Drug Administration (FDA) is already having ripple effects not just internally, but across the broader regulatory and life sciences communities and the public at large. FOIA is a U.S. In some cases, previously routine postings are delayed or going unpublished altogether.

FDA

Drug Patent Watch

FEBRUARY 17, 2025

Unlocking the Path to Affordable Medications: A Step-by-Step Guide to Generic Drug Approval As a healthcare professional or a patient advocate, you're likely no stranger to the importance of affordable medications. But have you ever wondered what it takes for a generic drug to hit the market?

Packaging

New Drug Approvals

JULY 18, 2025

D-ARABINOFURANOSYL)- 4′-C-Azido-2′-deoxy-2′-fluoro-b-D-arabinocytidine Azvudine is an antiviral drug which acts as a reverse transcriptase inhibitor. [3] In addition to its antiviral activity, concentration of the drug in the thymus has suggested immune-targeting activity; this dual function is unique among RdRp inhibitors.8

RNA

The Premier Consulting Blog

MAY 31, 2023

As a cornerstone of the drug development process, nonclinical investigational new drug (IND)-enabling studies are essential for supporting first-in-human (FIH) dosing for novel therapeutics. Pharmacology A typical IND-enabling package includes information on the primary, secondary, and safety pharmacology of the drug.

Packaging

BioPharma Drive: Drug Pricing

JUNE 23, 2025

Originally developed in the 1970s to treat diabetes, these drugs—such as Ozempic, Wegovy, and Mounjaro—have become headline-makers for their ability to induce significant weight loss. Understanding GLP-1 drugs GLP-1, or glucagon-like peptide-1 receptor modulators, mimic natural hormones that regulate insulin and appetite.

Treatment

FDA Law Blog: Biosimilars

JUNE 25, 2025

FDA notes that it has, in the past, required single-unit or unit-dose containers for approved new drugs in ODT and film dosage form due to concerns about such products being more palatable than capsules or tablets. The suitable reference product must be a capsule or tablet that is swallowed.

FDA

Agency IQ

JUNE 9, 2023

What will the orphan drug market exclusivity haircut mean for industry? Just over a month ago, the European Commission released its proposal for the new pharmaceutical directive and regulation. Fill out the form to read the full article.

Marketing

Agency IQ

MARCH 15, 2024

California publishes draft regulations for landmark plastic pollution reduction act CalRecycle has launched the formal rulemaking process for Senate Bill 54, which will implement a sweeping plan to reduce plastic waste in the state by 2032. By 2028, the state will require the recycling of 30% of single-use packaging and food service ware.

Regulations

FDA Law Blog: Biosimilars

JUNE 12, 2023

By Riëtte van Laack — FDA regulates pet food similar to other animal foods. The Federal Food, Drug, and Cosmetic Act (FDC Act) requires that all animal foods, like human foods, be safe to eat, produced under sanitary conditions, contain no harmful substances, and be truthfully labeled.

Regulations

Drug Target Review

JULY 18, 2023

Artificial Intelligence (AI) is poised to transform the field of target discovery in drug development, offering immense potential to enhance efficacy, personalised medicine, and accelerate the development of innovative compounds. Cavlan notes that underpinning this use of AI in early discovery is the need to better understand biology.

Drug Development

Drug Target Review

AUGUST 7, 2024

This continued innovation highlights the complexity of the drug development process, particularly as the field is highly regulated by health authorities around the world. While it may not seem like a priority at first glance, the success of a drug can hinge on early decisions around artwork.

Drug Development

FDA Law Blog: Biosimilars

MARCH 3, 2024

The Act is intended to address national security concerns by prohibiting certain conduct by regulated industry. In this regard we note that Medicaid is described in federal regulations as “Federal grants to States for medical assistance.” See, e.g., 42 CFR § 430.0.

Government

The Premier Consulting Blog

MAY 4, 2023

The global ophthalmic drugs market size was valued at $33.81 Food and Drug Administration (FDA) published in March of 2022 pertaining to ophthalmic drugs and devices, titled Certain Ophthalmic Products: Policy Regarding Compliance With 21 CFR Part 4. Now, these companies are required to comply with new guidance from the U.S.

FDA

FDA Law Blog: Drug Discovery

DECEMBER 7, 2022

Of course, neither “cure” nor permanency are the bar for FDA to find that a new drug is effective; simply because there is the potential for something to be a “cure” or offer permanent/near-permanent effects does not mean it should be required to be such. That brings us to the product’s approval.

Therapies

FDA Law Blog: Biosimilars

FEBRUARY 21, 2024

By Véronique Li, Senior Medical Device Regulation Expert & Ana Loloei & Allyson B. Mullen — More than five years after FDA first announced its plan to harmonize 21 CFR Part 820 with ISO 13485, on February 2, 2024, FDA finally issued the Quality Management System Regulation (QMSR) Final Rule. Revised § 820.3

FDA

The Premier Consulting Blog

NOVEMBER 8, 2022

Determining if you have a combination product The high-level definition of combination product seems straightforward: a product with at least two constituent parts, such as: Drug/biologic (e.g., therapeutic drug/monoclonal antibody) Drug/device (e.g., insulin injector pen) Multiple drugs/device (e.g.,

Production

Agency IQ

MAY 3, 2024

What we expect European regulators to do in May 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

Regulations

The Pharma Data

MAY 17, 2021

The authority to change drug labels outside of considerations for new safety information “could encourage third parties, such as academic investigators, insurance companies, and cooperative trial groups, to initiate such changes,” they wrote. .

Research

Advarra

SEPTEMBER 8, 2022

One way to do so is to ensure the software platforms you are using to conduct research are in line with federal regulations. Computer systems used for clinical trials fall under Food and Drug Administration (FDA) 21 CFR Part 11. In 1997, FDA released regulations providing guidance on the use of electronic systems.

Compliance

The Premier Consulting Blog

MAY 11, 2023

In this second of our two-part series, we continue our discussion about significant recent developments regarding the regulation of ophthalmic products and discuss what to expect in the months ahead. Food and Drug Administration’s (FDA) released updated guidance following the landmark Genus Medical Technologies LLC v. injectables).

FDA

Agency IQ

AUGUST 25, 2023

Cannabis groups to Congress: FDA should regulate CBD as a dietary supplement U.S. legislators have asked for help to reimagine how the FDA should regulate cannabidiol (CBD) following the agency’s determination that it could not make use of its existing legislative or regulatory authorities to do so.

Regulations

FDA Law Blog: Biosimilars

JULY 15, 2025

Kirschenbaum — The Calendar Year 2026 Medicare Physician Fee Schedule (PFS) proposed rule ( here ), which was issued yesterday by CMS, contained important amendments to the regulations on Medicare Part B average sales price (ASP) reporting. The payment limit for most Part B drugs is ASP plus 6 percent. with certain exceptions.

Regulations

Agency IQ

NOVEMBER 3, 2023

Jan Schakwosky has introduced the No Toxics in Food Packaging Act of 2023, which seeks to ban the use of ortho-phthalates, per- and polyfluoroalkyl substances, bisphenol compounds, styrene, and antimony trioxide as food contact substances. No Toxics in Food Packaging Act of 2023 On October 26, 2023, Reps. Key Documents and Dates H.R.

Packaging

Advarra

JULY 19, 2022

If the sponsor wants their drug approved, they need to complete all clinical studies and submit an application. Q: Please discuss the transfer of investigational new drug (IND) sponsorship from one sponsor to another and that process. Q: Can you ship a drug from another country to the U.S. A: Yes, the EUA is just temporary.

Packaging

FDA Law Blog: Biosimilars

MARCH 27, 2023

Baumhardt, Senior Medical Device Regulation Expert — The Unique Device Identification (UDI) System final rule requires all medical devices to bear a unique numeric or alphanumeric code in easily readable plain-text and machine-readable form. Devices can have both a UPC code and a UDI on their label and package.

Packaging

PPD

OCTOBER 18, 2023

However, an effective CRO doesn’t just perform assays; it provides comprehensive project planning, and also compiles, analyzes and packages data into an actionable and appropriate format for each individual client. Access to a laboratory partner that already possesses the equipment, knowledge and personnel can save time and money.

Laboratories

NIH Director's Blog: Drug Development

MARCH 11, 2014

That’s terrific news for researchers looking for new ways to treat and prevent T2D, because it’s generally much easier to develop drugs that inhibit proteins than ones that boost their activity. ZnT8 is responsible for packaging zinc ions with insulin crystals, which are then secreted from the beta cells in the pancreas. 2014 Mar 2. [2]

DNA

Agency IQ

AUGUST 4, 2023

government was put in place on February 27, 2023 and includes a number of proposed regulations to address trade relations between the E.U. First: all medicines for Northern Ireland must be approved by the MHRA The new regulation (EU) 2023/1182 applies to medicines that require marketing authorization. and the U.K.

Packaging

Agency IQ

JUNE 9, 2023

What will the orphan drug market exclusivity haircut mean for industry? Just over a month ago, the European Commission released its proposal for the new pharmaceutical directive and regulation. Orphan designation in the E.U. provides a 10-year market exclusivity period. However, medical needs of patients are not sufficiently met.

Marketing