Alta Sciences

JUNE 6, 2025

For biotechnology and pharmaceutical companies, automation can decrease their drug-to-market development time and remain financially competitive in an evolving market. In 2023, he relocated to Montreal, with the aim to continue automating tasks with the same liquid handling system, which ultimately led him to join Altasciences.

Pharmacokinetics

New Drug Approvals

JULY 25, 2025

10] Vamorolone was approved for medical use in the United States in October 2023, [11] [10] and in the European Union in December 2023. [2] Vamorolone was approved by the FDA in October 2023 for the management of DMD in patients ≥2 years of age. 2] Vamorolone was approved for medical use in the European Union in December 2023.

FDA

Drug Target Review

APRIL 7, 2025

Prior to being validated, the FDA will still consider biomarkers in the marketing approval process as a reasonably likely surrogate endpoint or candidate surrogate endpoint. 2001) Biomarkers Definitions Working Group Biomarkers and surrogate endpoints: preferred definitions and conceptual framework. Clinical Pharmacology and Therapeutics.

Clinical Development

PPD

NOVEMBER 11, 2024

billion in 2023 to 1.2 As a result, biopharma and biotech companies working to bring their drug pipelines to the market require deep expertise from trusted partners to help deliver critical therapies for their patients. billion in 2035.

Drug Development

The Pharma Data

JUNE 9, 2025

This milestone marks a significant step forward in their collaboration, originally initiated in December 2023, and signifies the beginning of domestic manufacturing for VISEN’s flagship product in China.

Therapies

New Drug Approvals

JUNE 11, 2025

2] Gepirone was synthesized by Bristol-Myers Squibb in 1986 and was developed and marketed by Fabre-Kramer Pharmaceuticals. [4] 4] It was approved for the treatment of major depressive disorder in the United States in September 2023. [4] Archived from the original (PDF) on 28 September 2023. Retrieved 28 September 2023.

FDA

The Pharma Data

JUNE 13, 2025

This collaboration, initially forged in 2023, aims to bring forward next-generation CAR T-cell therapies for patients in need, with the exception of the Greater China market, where separate rights apply. formerly Cellular Biomedicine Group, Inc.).

Therapies

Drug Target Review

JULY 7, 2025

The shift is not only ethical but also pragmatic: the agency cited goals such as lowering research and development costs, accelerating time to market and improving translational relevance between preclinical and clinical outcomes. Federal ruling on USDA primate welfare petition, 2023. References Animal Legal Defense Fund v.

Drug Research

New Drug Approvals

JULY 9, 2025

5] In China, it was conditionally approved in 2023 for the treatment of NSCLC and full approval is contingent on results of phase 3 clinical trials. [6] 11 December 2023. Dhillon S (2023). 2] [3] It is an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor. [2] 12 (3): 185–186. doi : 10.1016/S2213-2600(23)00419-8.

FDA

The Premier Consulting Blog

OCTOBER 30, 2024

Innovation can also lead to faster time to market by accelerating drug development timelines, strengthening the supply chain, and providing better responsiveness during a public health emergency. FDA Guidance, Advanced Manufacturing Technologies Designation Program , December 2023, [link] [link]

FDA

SugarCone Biotech

JUNE 19, 2025

Tarlatamab triggered an ORR of ~40% in refractory (second-line or later) SCLC patients in the DeLLphi-301 clinical trial published in 2023. CD3 binding activates the T cells to attack and kill any cell that expresses DLL3, thus killing SCLC cells. The primary endpoint is median OS versus durvalumab maintenance alone.

Therapies

Drug Target Review

APRIL 7, 2025

2 Considering 2530 percent of marketed drugs work by binding to GPCRs, 3 it is vital that these challenges are overcome through innovation and research. 2023) Biochemistry, G protein coupled receptors , StatPearls [Internet]. Jones EM, et al. doi:10.7554/elife.54895. Available at: [link] (Accessed: 23 September 2024).

Fragment Screening

Codon

JULY 28, 2025

Companies weigh market size, reimbursement potential (the likelihood insurers or governments will pay for the therapy), and the level of existing competition before deciding which vector to use for their gene therapy. Some diseases occur so rarely that they face treatment barriers due to unfavorable economics of scale. Join Asimov Press.

Immune Response

Drug Patent Watch

DECEMBER 11, 2024

Addressing Competition and Market Dynamics The lack of competition in the generic drug market contributes to price hikes and shortages. As the industry moves forward, it is crucial to address competition and market dynamics, invest in sustainable practices, and prioritize patient health and safety. Retrieved from [link] KPMG.

Drug Development

Drug Target Review

JUNE 5, 2025

Dr Aaron Haubner, Senior Manager of North America Medical Affairs and Market Access at Terumo Blood and Cell Technologies , reveals that while promising new treatments emerge, urgent partnerships are needed to ensure this essential blood therapy reaches the patients who need it most. Updated 2023 Sep 4]. 2023 Jul 11;7(13):3276-3283.

Disease

The Pharma Data

JUNE 6, 2025

Rilzabrutinib is currently under regulatory review in major markets including the United States, European Union, and China for the treatment of ITP. In the U.S., the therapy has been granted Fast Track Designation , and the Food and Drug Administration (FDA) is expected to make a regulatory decision by August 29, 2025.

Disease

The Premier Consulting Blog

APRIL 13, 2025

All of this information will then need to be integrated into comprehensive Weight-of-Evidence (WOE) assessments to justify initially the safety of the drug to enter the clinic and then the overall benefit:risk of the drug for formal marketing approval. link] [7] H.R.2565

Animal Testing

Drug Target Review

JUNE 2, 2025

With a deep understanding of the industry’s complexities and the evolving market needs, he has been instrumental in providing innovative solutions for both biotech startups and large pharmaceutical companies. The complexity of ADC development ADCs are powerful therapeutics, but they are notoriously complex to develop and manufacture.

Small Molecule

New Drug Approvals

MAY 8, 2025

7] Pirtobrutinib was approved for medical use in the United States in January 2023, [4] [8] [9] [10] and in the European Union in November 2023. [2] 7] Pirtobrutinib was approved for medical use in the United States in January 2023, [4] [8] [9] [10] and in the European Union in November 2023. [2] 27 January 2023.

FDA Approval

The Pharma Data

JUNE 9, 2025

Since its launch in 2023, the product has quickly gained recognition for its high and sustained efficacy throughout the RSV season and is supported by a comprehensive body of real-world evidence involving hundreds of thousands of infants.

Virus

Alta Sciences

JULY 23, 2025

BD Biosciences showcased their FACSDiscover A8 TM as the first provider on the market to combine live-cell imaging with spectral flow cytometry—a useful analytical tool for any institution performing innovative science. INSIGHTFUL CYTOMETRY WORKSHOPS Spectral cytometry continues to evolve.

International

FDA Law Blog: Drug Discovery

JANUARY 30, 2025

Similarly, the December 2024 draft guidance reiterates prior positions that confirmatory trials should generally be underway at the time the marketing application is submitted but also states that this recommendation becomes a requirement by the time of approval except in limited circumstances.

FDA

BioPharma Drive: Drug Pricing

JUNE 11, 2025

In a research note on Wednesday, RBC Capital Markets analyst Leonid Timashev estimated peak yearly sales of the drug could reach nearly $640 million. billion buyout of Blueprint Medicines is the sector’s second-largest M&A deal this year and represents the highest value paid for an immune drug developer since April 2023.

FDA

SugarCone Biotech

JULY 6, 2025

Of course the larger markets would be in non-NRG1 fusion cancers where HER3 is overrexpressed but Partner Therapeutics does not appear to be supporting additional clinical trials. On this basis, and to drive use of the RNA sequencing technology that identifies NRG1 fusions, the drug was purchased by Partner Therapeutics.

Drug Development

PPD

JANUARY 2, 2025

And in a recent survey from the PPD clinical research business of Thermo Fisher Scientific , 34% of participants say they prefer hybrid FSP/FSO outsourcing for clinical development (up from 22% in 2023).

Clinical Development

The Premier Consulting Blog

DECEMBER 16, 2024

The need for difficult decisions The latest estimates on the median cost of bringing a new drug to market is now $2.3 Competition from more effective or safer drugs on the market can necessitate competitive analyses to solidify the drugs market position.

Pharmacokinetics

Codon

NOVEMBER 1, 2024

bioRxiv (2023). In the pursuit of truth, science needs no market; technology, on the other hand, has no reality beyond its application and exists only in relation to the marketplace. Rather than increase the resolution of microscopy, in other words, expansion microscopy enables researchers to increase the size of the actual specimen.

DNA

BioPharma Drive: Drug Pricing

JULY 18, 2025

Alamy The Food and Drug Administration will ask Sarepta Therapeutics to halt all shipments of its marketed gene therapy for Duchenne muscular dystrophy, a source familiar with the matter confirmed to BioPharma Dive. Food and Drug Administration headquarters in Silver Spring, Md., Reuters first reported news of the FDA’s request.

Therapies

New Drug Approvals

APRIL 18, 2025

18 October 2023). 2023 Oct 30;70(10):945-957. Epub 2023 Jun 29. “Crinecerfont Lowers Elevated Hormone Markers in Adults With 21-Hydroxylase Deficiency Congenital Adrenal Hyperplasia” The Journal of Clinical Endocrinology & Metabolism. 107 (3): 801812. doi : 10.1210/clinem/dgab749. PMC 8851935. PMID 34653252.

FDA

Advarra

DECEMBER 17, 2024

Prediction Area: Increased Site Consolidation Advarra Thought Leader: Christine Senn, SVP Site/Sponsor Innovation After a year of site consolidation slowing down due to difficult times for most independent sites from Q3 2023 to present, 2025 will see an upsurge in consolidation.

Clinical Research

BioPharma Drive: Drug Pricing

JUNE 26, 2025

Meury, whose appointment is effective immediately, previously ran Anthos Therapeutics, which he sold this year to Novartis for nearly $1 billion, and Karuna Therapeutics, which Bristol Myers Squibb bought for $14 billion in 2023. and sold [Karuna],” wrote RBC Capital Markets analyst Brian Abrahams, in a note to clients.

Therapies

Drug Patent Watch

DECEMBER 10, 2024

Their collaborative approach and access to specialized equipment and facilities make them an invaluable partner for companies seeking to bring new products to market. 2023, November 17). 2023, October 12). 2023, June 23). References: Ellis, J. CDMOs and How They Support Business Development. link] Societal CDMO.

Compliance

Perficient: Drug Development

NOVEMBER 6, 2024

SEC The Securities and Exchange Commission (SEC) issued a proposed rule in July 2023 to address conflicts of interest associated with broker-dealers’ and investment advisers’ use of predictive data analytics (“PDA”) and similar technologies, including AI.

Regulations

FDA Law Blog: Biosimilars

NOVEMBER 18, 2024

Referencing an interview with Kennedy from 2023, the Post says that his views on health “were a head-scratching spaghetti of what we can only call warped conspiracy theories, and not just on vaccines.” Substantially weakening the data standards would likely cause significant erosion in public trust.

FDA

Perficient: Drug Development

NOVEMBER 15, 2024

Healthcare Trend #1: AI Disruption and Enablement Healthcare has seen a surge of interest in AI, with the market set to soar to $187.95 Only then can data be richly woven into a reliable 360-degree view of the consumer that spans and supports better care management care management, marketing engagement, and support services.

Regulations

Perficient: Drug Development

NOVEMBER 1, 2024

In November 2022, the Treasury Department explored opportunities and risks related to the use of AI in its report assessing the impact of new entrant non-bank firms on competition in consumer finance markets, for which the department conducted extensive outreach.

Regulations

Perficient: Drug Development

NOVEMBER 15, 2024

Healthcare Trend #1: AI Disruption and Enablement Healthcare has seen a surge of interest in AI, with the market set to soar to $187.95 Only then can data be richly woven into a reliable 360-degree view of the consumer that spans and supports better care management, marketing engagement, and support services. billion by 2030.

Regulations