Advarra

DECEMBER 17, 2024

As we look to 2025, Advarra thought leaders have compiled predictions and perspectives on key topics shaping the industry. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA), will continue to drive harmonization in the clinical research industry. The coming year is expected to be no different.

Clinical Research

Alta Sciences

JULY 18, 2025

Highlights From the 2025 American Society for Mass Spectrometry Conference | By Jean-François Larocque and Benjamin Charron aasimakopoulos Tue, 07/22/2025 - 18:05 We were thrilled to represent Altasciences at this year’s American Society for Mass Spectrometry (ASMS) conference in Baltimore. Curious to see this poster in action?

Assay Development

LifeSciVC

MAY 14, 2025

In recent years, the renaissance in private space has rekindled interest in microgravity and spawned a more radical vision for the future: manufacturing drugs in space. Why Space, Why Drugs, and Why Now? Keytruda, which generates >$25B in annual sales, is among the most important and impactful oncology drugs of all time.

Science

Alta Sciences

JULY 23, 2025

With our deep expertise in regulated cellular analysis, our team ensures that every step—from sample collection and processing to transport and analysis—is optimized for precision and speed. Turcotte is always enthusiastic to share his knowledge and help Altasciences’ partners improve the quality of their drug development programs.

International

Alta Sciences

FEBRUARY 19, 2025

Regulatory Guidance for Oligonucleotide Bioanalysis in Drug Development pmjackson Wed, 02/19/2025 - 21:30 The unique physicochemical properties of oligonucleotides require the use of specialized bioanalytical approaches, with key considerations including selectivity and specificity, sensitivity, stability, and matrix effects.

Drug Development

Broad Institute

MAY 21, 2025

Scientists create next generation of tools in battle against brain disease By Corie Lok May 21, 2025 Breadcrumb Home Scientists create next generation of tools in battle against brain disease The findings contained in eight studies could lead to targeted gene therapies for brain disorders.

Disease

Drug Target Review

JULY 7, 2025

Non-human primates (NHPs), such as macaques and cynomolgus monkeys, have long served as a cornerstone in preclinical drug development due to their close genetic, anatomical and physiological resemblance to humans. 3-5 These layers of regulation, while essential for animal welfare, make NHP-based studies complex, expensive and time-consuming.

Drug Research

The Pharma Data

JUNE 25, 2025

The drug’s mechanism also aims to delay the overall progression of disease severity—an urgent need in a patient population that often progresses to end-stage renal disease. In March 2025 , Regulus announced the successful completion of its Phase 1b multiple-ascending dose clinical trial for farabursen. Eastern Time on June 25, 2025.

RNA

FDA Law Blog: Drug Discovery

JANUARY 30, 2025

As a result of reforms enacted by the Food and Drug Omnibus Reform Act of 2022 (FDORA), FDAs authority to approve as well as withdraw an accelerated approval was given new regulatory teeth to ensure that confirmatory trials are conducted expeditiously.

FDA

FDA Law Blog: Biosimilars

MARCH 18, 2025

Koblitz Integral to the careful balance Congress struck when passing the Hatch-Waxman Amendments, the patent term extension (PTE) is intended to restore patent life that was consumed during regulatory review of an FDA-regulated product. On March 13, 2025, the Federal Circuit ventured into the world of reissued patents and PTE. (

Pharmaceutical Companies

Drug Target Review

JUNE 16, 2025

G protein-coupled receptors (GPCRs) are a highly validated drug target family – accounting for 30-35 percent of all approved drugs. Despite this, the therapeutic potential of targeting most GPCRs remains untapped, as only 10 percent of GPCRs have been drugged.

Disease

The Pharma Data

JUNE 12, 2025

Foundation, explained during the EULAR 2025 presentation: “IgG4-related disease is a progressive, immune-mediated condition with a significant unmet patient need. Fast Track and Orphan Drug Designations from FDA The U.S. John Stone, MD, MPH , Professor of Medicine at Harvard Medical School, the Edward A.

Disease

FDA Law Blog: Biosimilars

JULY 27, 2025

In those orders, Chief Judge Mulrooney announced that he was retiring from the bench effective August 1, 2025, and that, in the absence of any other DEA ALJs, all proceedings and hearing dates are postponed indefinitely. Where does this leave DEA and all of the DEA registrants with pending or contemplated administrative actions? See 21 U.S.C.

Regulations

FDA Law Blog: Biosimilars

FEBRUARY 26, 2025

Claud The ongoing DOGE-led reductions to the federal workforce and recent sweeping policy changes have spawned many questions for compliance officers and quality managers in FDA-regulated companies. How will the imposition of tariffs and a burgeoning trade war affect domestic drug production and companies supply chain demands?

Compliance

SugarCone Biotech

JUNE 27, 2025

A post-ASCO update on tumor targets DLL3, B7H3 and Her3 June 2025 Paul D Rennert, SugarCone Biotech LLC Introduction: DLL3, B7H3 and Her3 are compelling tumor antigens to target with cancer therapeutics. As we’ll see, ASCO 2025 was a breakout conference for B7-H3-targeted therapies. That trial is in second-line NSCLC.

Therapies

The Pharma Data

JUNE 26, 2025

Food and Drug Administration (FDA) has approved critical label updates for its two chimeric antigen receptor (CAR) T cell therapies— Breyanzi® (lisocabtagene maraleucel; liso-cel) and Abecma® (idecabtagene vicleucel; ide-cel).

FDA Approval

Advarra

MAY 21, 2025

The release of ICH E6(R3) in January 2025 marks the most significant evolution in Good Clinical Practice (GCP) guidelines in over a decade. Final Version, January 6, 2025. Food & Drug Administration. The goal is not more complexity, but smarter, leaner operations grounded in relevance and accountability. link] MHRA UK.

Pharma Companies

Common Sense for Drug Policy Blog

AUGUST 1, 2025

The Drug User Liberation Front and BC's Overdose Crisis "As highlighted during the programʼs inception, the DULF CC&FC model significantly magnified the potential impact of drug checking as a harm reduction service by strategically testing substances at a higher point in the distribution chain ( Lysyshyn, 2021 ). Int J Drug Policy.

Drugs

The Pharma Data

AUGUST 1, 2025

The deal is one of the more notable regional licensing transactions involving an RNAi therapeutic in 2025 and aligns with Sanofi’s ongoing efforts to build out its cardiometabolic portfolio, particularly in markets with high unmet medical need and a growing burden of metabolic disease. The application was formally accepted in January 2025.

Licensing

The Premier Consulting Blog

APRIL 13, 2025

On April 10, 2025, the US FDA announced that it has a long-term plan to eliminate conventional animal testing in drug development, starting with monoclonal antibodies (mAbs).[ One great example is the FDAs 505(b)(2) New Drug Application (NDA) pathway. Legislation with delayed implementation In 2021, the FDA Modernization Act 2.0

Animal Testing

Broad Institute

JUNE 24, 2025

By Broad Communications June 24, 2025 Credit: Casey Atkins David Liu is a core member at the Broad Institute where he is the Richard Merkin Professor and director of the Merkin Institute for Transformative Technologies in Healthcare. To achieve that goal, we need a new framework for developing and approving drugs.

Treatment

The Pharma Data

JUNE 25, 2025

Additionally, the tablet form supports flexible dosing and simplifies dose reductions, which may be required due to drug interactions or adverse events, as guided by the product’s label. Food and Drug Administration (FDA) granted approval to the tablet formulation of BRUKINSA for all five of its approved indications.

Packaging

New Drug Approvals

APRIL 25, 2025

12] However, absorption, metabolism, and excretion data of taselisib , a molecule with a related chemical scaffold, suggest moderately slow absorption into the systemic circulation, metabolism to play a minor role in drug clearance, and biliary excretion to be the main route of excretion. [13] Retrieved 17 April 2025. 3 November 2006.

FDA

Drug Target Review

AUGUST 8, 2025

While monoclonal antibodies and antibody-drug conjugates continue to drive therapeutic pipelines, bispecific T-cell engagers (TCEs) are gaining momentum as a versatile and scalable class of immunotherapies. Regulators are also providing clearer pathways for bispecifics, further fuelling TCE development. Global News Wire; 2025 Mar 17.

Engineering

The Pharma Data

JUNE 9, 2025

These attributes have earned the compound Breakthrough Therapy Designation (BTD) from China’s NMPA—recognition reserved for drugs that show substantial clinical improvement over existing therapies in serious conditions. In parallel, we are working to file a New Drug Application (NDA) to the U.S. A New Drug Application (NDA) to the U.S.

Treatment

Codon

APRIL 17, 2025

Such vascular differences are governed by auxin, a plant hormone that regulates leaf venation and shape. Martin Bourdev is an engineer at Amgen Thousand Oaks supporting antibody drug production. ” Asimov Press (2025). He is from Palo Alto and is currently based in Los Angeles. Cite: Bourdev M.

Research

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. Equally vital is the delivery vector, which carries this payload to specific cells.

Immune Response

The Pharma Data

JUNE 27, 2025

This decision has significant implications for millions of patients worldwide who use these drugs to manage chronic metabolic conditions, as well as for physicians tasked with balancing their benefits and risks. While rare, the seriousness of the outcome—irreversible vision loss—prompted regulators to take decisive action.

Therapies

Drug Channels

JULY 21, 2025

Informa Connect’s Medicaid Drug Rebate Program Summit September 15-17, 2025 | Chicago, IL Drug Channels readers save 10% with code 25DRCH10* The Medicaid Drug Rebate Program Summit returns to Chicago this September! Drug Channels readers will save 10% off when they use code 25DRCH10 and register prior to August 22, 2025.*

Government

ACTO

DECEMBER 17, 2024

A survey of healthcare and life science companies found that 93% of these companies expect to increase their spend in 2025. Such cross-functional collaboration ensures consistent implementation from drug development through commercialization. a walled garden of sorts), ensures data sovereignty and compliance with regional regulations.

Government

Codon

JUNE 5, 2025

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. In May 2025, however, Prime Medicine announced that they would shift their priorities to other diseases instead, including cystic fibrosis.

DNA

The Pharma Data

JULY 2, 2025

Food and Drug Administration (FDA) has accepted for review a new supplemental Biologics License Application (sBLA) and granted it priority review status, seeking to update the U.S. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of October 25, 2025.

Trials

The Pharma Data

JUNE 13, 2025

Food and Drug Administration (FDA) has approved KEYTRUDA® (pembrolizumab), its flagship anti-PD-1 therapy, for the treatment of adult patients with resectable, locally advanced head and neck squamous cell carcinoma (HNSCC) whose tumors express PD-L1 (Combined Positive Score [CPS] of 1 or greater) as determined by an FDA-approved test.

FDA Approval

BioPharma Drive: Drug Pricing

JULY 18, 2025

Published July 18, 2025 • Updated 3 hours ago Ned Pagliarulo Lead Editor post share post print email license The U.S. Published July 18, 2025 • Updated 3 hours ago Ned Pagliarulo Lead Editor post share post print email license The U.S. Food and Drug Administration headquarters in Silver Spring, Md.,

Therapies

Drug Patent Watch

JANUARY 13, 2025

The Rise of Biosimilars: A Healthcare Revolution Biosimilars, often referred to as the “generic equivalents” of biologic drugs, have been making waves in the pharmaceutical industry for over a decade. billion by 2025, growing at a CAGR of 34.2% from 2020 to 2025[1]. . billion by 2025, growing at a CAGR of 34.2%

Biosimilars

BioPharma Drive: Drug Pricing

JULY 9, 2025

Deep Dive Library Events Press Releases Topics Sign up Search Sign up Search Pharma Biotech FDA Clinical Trials Deals Drug Pricing Gene Therapy An article from Merck to buy Verona and its lung drug in $10B deal The New Jersey-based pharma has inked one of the biggest deals of the year in pursuit of a promising new way to treat COPD.

Clinical Trials

FDA Law Blog: Drug Discovery

FEBRUARY 27, 2025

Livornese As anticipated, the International Council for Harmonization (ICH) published the Good Clinical Practice (GCP) guideline E6(R3) Principles and Annex 1 on January 6, 2025. How regulators will interpret and enforce its provisions may not become clear for some time.

Clinical Trials