Pharma Manufacturing

JULY 21, 2025

Magazine ENEWS SUBSCRIBE WEBINARS PODCASTS EBOOKS ABOUT US Edit submissions Media kit Innovation Awards Articles CDMO sector to remain largely unaffected by US tariffs, finds Morningstar DBRS July 21, 2025 While supply chain disruptions may arise, contract development and manufacturing organizations are resilient, contends the credit ratings agency.

Therapies

Codon

JULY 28, 2025

The gene therapy is designed to protect this infant from the neurological disorders that otherwise would have resulted from this rare, and often fatal, condition. And while matching a gene therapy to its targeted mutation is an intricate and nuanced process, much boils down to two core elements: a vector and its cargo.

Immune Response

New Drug Approvals

JULY 25, 2025

Corticosteroid therapy is the current standard of care for DMD despite relatively high rates of adverse effects. 2025, 68, 2147−2182 Vamorolone (Agamree). “Drug Approval Package: Agamree” U.S. Retrieved 11 February 2025. Nagaraju, J.M. Damsker, J.M. 21 (2013) 2241–2249. 77 Readily available steroid 9.1

FDA

Codon

JUNE 5, 2025

The treatment, now known as Casgevy, became the first CRISPR-based therapy to gain FDA approval, in 2023. pyogenes protein — whose compactness makes them far easier to package into viral vectors and deliver into the human body. Researchers have also discovered a slew of small Cas9s — some less than half the size of the S.

DNA

BioPharma Drive: Drug Pricing

JUNE 24, 2025

Daily Dive M-F Commercialization Weekly Every Wednesday Gene Therapy Weekly Every Thursday Emerging Biotech Weekly Every Tuesday By signing up to receive our newsletter, you agree to our Terms of Use and Privacy Policy. You can unsubscribe at anytime.

RNA

BioPharma Drive: Drug Pricing

JULY 14, 2025

Daily Dive M-F Commercialization Weekly Every Wednesday Gene Therapy Weekly Every Thursday Emerging Biotech Weekly Every Tuesday By signing up to receive our newsletter, you agree to our Terms of Use and Privacy Policy. PCI helps biopharmaceutical companies manufacture and package drug products used in clinical trials as well as commercially.

Production

Codon

JULY 14, 2025

Eichengrün noted that it wasn’t just that aspirin was effective with limited side effects, but also that it came packaged as tablets rather than as a powder in a paper bag. NSAIDs may likewise play some as yet undetermined role in neurodegenerative diseases, diabetes, and cancer disease therapy. ” Asimov Press (2025).

Treatment

BioPharma Drive: Drug Pricing

JUNE 23, 2025

Daily Dive M-F Commercialization Weekly Every Wednesday Gene Therapy Weekly Every Thursday Emerging Biotech Weekly Every Tuesday By signing up to receive our newsletter, you agree to our Terms of Use and Privacy Policy. You can unsubscribe at anytime. Thus, these drugs best complement, rather than replace, healthy lifestyle interventions.

Treatment

Fierce BioTech

JANUARY 3, 2025

This joint webinar presentation by West and Groninger, explores the unique challenges of Cell and Gene Therapies, mRNA LNP therapeutics particularly regarding cold storage requirements and their impact on packaging solutions. On Demand Start Date Wed, 02/12/2025 - 11:00 Listing Image WestPharma_ListingLogo_250x190.png

Packaging

Fierce BioTech

JANUARY 3, 2025

Innovations in aseptic processing for container closure systems dwunderlin Fri, 01/03/2025 - 14:26 Wed, 02/12/2025 - 10:00 Resource Type Webinar Jim Thompson Julian Petersen Duration 60 Minutes The pharmaceutical landscape is shifting from blockbuster drugs to personalized treatments, driving the need for innovative container closure systems.

Packaging

Broad Institute

MAY 14, 2025

Cas9 ancestor engineered into a compact genome editing tool By Tom Ulrich May 14, 2025 Breadcrumb Home Cas9 ancestor engineered into a compact genome editing tool Researchers adapt a compact RNA-guided enzyme from bacteria for a variety of DNA editing tasks in human cells. Online May 7, 2025. Nature Biotechnology.

Engineering

LifeSciVC

AUGUST 21, 2024

At this point of the year, the JPMorgan conference seems like ancient history and you are looking into flights for JPM 2025. Instead, it was based on the large unmet need, the advantages of a unique ADC-based delivery platform, and a strong preclinical data package that supported this strategy. Was that only six months ago?

Clinical Trials

BioPharma Drive: Drug Pricing

JULY 21, 2025

Daily Dive M-F Commercialization Weekly Every Wednesday Gene Therapy Weekly Every Thursday Emerging Biotech Weekly Every Tuesday By signing up to receive our newsletter, you agree to our Terms of Use and Privacy Policy. Targeting larger patient populations expands the potential for AAV-therapies to transform patients lives.

Therapies

Agency IQ

MAY 3, 2024

Two consultations on clinical trial considerations, one on advanced therapies and the other addressing non-inferiority and equivalence comparisons, are closing at the end of May. The pharma reform package remains in E.U. leaders’ eyesight as the Parliament winds down ahead of its June elections. On April 10, the E.U.

Regulations

Agency IQ

JULY 8, 2024

Date What’s Happening Explanation Source June 29 GGP Report FDA expected to finalize report on Good Guidance Practices AgencyIQ June 30 User Fee Payments Industry required to confirm NDA prescription drug products in Orange Book for purposes of PDUFA payments in FY 2025 FDA July 1 Anniversary Anniversary of the signing of the Public Health Service (..)

FDA

Agency IQ

JULY 22, 2024

As such, it doesn’t review things like vaccines, blood products or gene therapies – those products are instead reviewed by CBER. AgencyIQ compiles these data using information in approval letters, labeling and review packages posted to the Drugs@FDA database.

Clinical Trials

The Pharma Data

JANUARY 6, 2021

End-to-End Single-Site Solution from Drug Substances to Fill-Finish & Packaging. In addition to drug substance manufacture, the facility will also provide commercial scale, automated fill-finish and assembly, packaging and labeling services. Packaging line?. Spring 2025. TOKYO , Jan.

Packaging

Agency IQ

OCTOBER 27, 2023

WUSF / AgencyIQ November 1 Initial deadline for NDSRIs Under a 2023 guidance document, the FDA has recommended that pharmaceutical companies assess Nitrosamine Drug-Related Substance Impurities for their products by November 1, 2023, with confirmatory testing due by August 1, 2025.

FDA

Agency IQ

OCTOBER 27, 2023

11/9/2023: Enters into force 11/9/2025: Date of application To contact the authors of this resource, please email Sierra Milam ( smilam@agencyiq.com ). policy, such as public registers, drafts, reflection papers, concept papers, and guidance documents expected through Q1 2024.

Regulations

BioPharma Drive: Drug Pricing

JUNE 23, 2025

Daily Dive M-F Commercialization Weekly Every Wednesday Gene Therapy Weekly Every Thursday Emerging Biotech Weekly Every Tuesday By signing up to receive our newsletter, you agree to our Terms of Use and Privacy Policy. You can unsubscribe at anytime. Influenza A virus" [Micrograph]. Retrieved from Flickr. His research, writing offer clues.

Drugs

The Pharma Data

JUNE 18, 2021

The objective of this Phase 3 study is to evaluate the efficacy and safety of risankizumab 180 mg and 360 mg as maintenance therapy versus withdrawal from risankizumab treatment (control) in patients with moderate to severe Crohn’s disease who responded to risankizumab IV induction treatment in the ADVANCE and MOTIVATE studies.

Disease

The Pharma Data

JUNE 18, 2021

The ADVANCE study included patients with past intolerance or inadequate response to conventional therapy (non-bio-IR) and/or biologic therapy (bio-IR). The ADVANCE study included a mixed population of patients who had responded inadequately or are intolerant to conventional and/or biologic therapy. NORTH CHICAGO, Ill. ,

Disease

BioPharma Drive: Drug Pricing

JUNE 23, 2025

Daily Dive M-F Commercialization Weekly Every Wednesday Gene Therapy Weekly Every Thursday Emerging Biotech Weekly Every Tuesday By signing up to receive our newsletter, you agree to our Terms of Use and Privacy Policy. You can unsubscribe at anytime. You can unsubscribe at anytime. Track funding rounds here.

FDA

BioPharma Drive: Drug Pricing

JUNE 12, 2025

Daily Dive M-F Commercialization Weekly Every Wednesday Gene Therapy Weekly Every Thursday Emerging Biotech Weekly Every Tuesday By signing up to receive our newsletter, you agree to our Terms of Use and Privacy Policy. You can unsubscribe at anytime. PBMs would no longer be able to pocket the difference as profit if the bill passes.

Small Molecule

Alta Sciences

JANUARY 21, 2025

Highlights From the 2024 American College of Toxicology 45th Annual Meeting pmjackson Tue, 01/21/2025 - 21:59 The ACT 2024 meeting took place at JW Marriott in Austin, TX My fellow Altasciences colleagues and I recently attended the 2024 annual American College of Toxicology (ACT) meeting in Austin, Texas.

Science

New Drug Approvals

MAY 14, 2025

Albanell-Fernndez M (January 2025). Grasselli Kmet N, Luzzati R, Monticelli J, Babich S, Conti J, Bella SD (March 2025). “Salvage therapy of complicated Candida albicans spondylodiscitis with Rezafungin” European Journal of Clinical Microbiology & Infectious Diseases. New Drug Therapy Approvals 2023 (PDF).

Pharmacokinetics

New Drug Approvals

APRIL 27, 2025

This article incorporates text from this source, which is in the public domain. ^ “Drug Approval Package: Flyrcado Injection” U.S. Retrieved 21 January 2025. ^ “Novel Drug Approvals for 2024” U.S. New Drug Therapy Approvals 2024 (PDF). January 2025. Archived from the original on 21 January 2025.

FDA

LifeSciVC

MAY 28, 2025

As illustrated in LEKs May 2025 report Is Biopharma Doing Enough to Advance Novel Targets ? Think about how many CART CD-19 companies got started or gene editing and gene therapy plays literally, dozens and dozens of them emerged, all chasing similar indications. the scale of the current crowding challenge is staggering.

Production

The Open Targets Blog

MARCH 19, 2025

All of our data is up to date as of Q1 2025. The pipelines underpinning our genetic analyses have been completely rewritten as a Python package for post-GWAS analysis: Gentropy. Studies with and without summary statistics are processed and flagged accordingly. Colocalisation is now based on credible set overlaps.

Pharmacogenetics

Drug Target Review

MAY 8, 2025

This combination of single-dose treatment with allele selectivity represents a unique approach among investigational HD therapies in development. This fundamentally different approach combining the durability of a single-dose therapy with the precision of allele-selective editing addresses a critical unmet need in HD treatment.

Disease

SugarCone Biotech

APRIL 8, 2025

Astra Zenecas purchase of Esobiotec with a $425M upfront has rekindled interest in CAR-T cell therapy technologies, and in particular, the in vivo cell therapy companies. In vivo CAR-T cell therapy requires that genetic material be delivered to the desired immune cells while those cells are still inside the patient.

Therapies

Codon

JANUARY 2, 2025

That DNA was then shipped to France, where Imagene , a company specializing in robust and room-temperature storage solutions, packaged the molecules into laser-sealed, stainless steel capsules. Xander Balwit & Niko McCarty The Editors Join Asimov Press in 2025!

DNA

Codon

FEBRUARY 9, 2025

To achieve this, E11 Bio synthesizes protein barcodes (short peptides with unique amino acid sequences), packages them into AAV vectors (engineered, non-harmful viruses for drug delivery), and delivers these into the brain tissue. ” Asimov Press (2025). ” Xander Balwit is editor-in-chief of Asimov Press. Cite: Balwit X.

Research

Codon

FEBRUARY 23, 2025

After decades of research into therapies and preventive measures, though, global AIDS deaths have now fallen to about 600,000 annually. In January 2025, the incoming Trump administration issued a 90-day freeze on PEPFAR while it conducts a “programmatic efficiencies” review. ” Asimov Press (2025).

Clinical Trials