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In an interview with BioPharm International®, Ian Lafferty from Upperton discusses the trends and challenges facing sterile manufacturing and how partnering with CDMOs can help innovators progress to the market.

Lonza will develop a GMP-compliant process for Exogenus’ exosome-based lead candidate, Exo-101, at its Sienna, Italy site.

Omlyclo (omalizumab-igec) was approved to treat moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps, and certain food allergies.

The Therapeutic Goods Administration (TGA) of Australia confirmed its initial decision to decline approval of the mAb for treating early Alzheimer’s disease.

The committee’s recommendation is based on results from a Phase III trial in which Imfinzi demonstrated a reduced risk of recurrence, progression, or death by 32% compared to neoadjuvant chemotherapy alone.

Gender diversity and equality in leadership positions have been shown to improve profitability and return on equity through greater innovation and more creative solutions.

In an interview with BioPharm International®, Sheryl Johnson from Orbia Fluor & Energy Materials chats about gender diversity, how women are helping to advance innovation, sustainability challenges, and progress in the field of inhaled drugs.

The investment, led by Foresight Group and secured alongside funding from PARP, will be used to further commercialize uFraction8’s microfiltration technology.

Takeda’s TAKHZYRO (lanadelumab) is now approved in Europe as a subcutaneous injection treatment for hereditary angioedema in patients 12 years old and above and in adults.

The inspection focused on fill/finish of ongoing commercial supplies of an adeno-associated virus viral vector biologics product for a major pharmaceutical client in the United States.

BioPharm International® spoke with Jason Bock, founder and CEO of CTMC, to find out about the newest cancer treatments, specifically developments in tumor-infiltrating lymphocytes.

The partnership will advance the accessibility, scalability, and affordability of RNA-based vaccines.

EMA’s CHMP recommended conditional marketing authorization for linvoseltamab to treat adults with relapsed and refractory multiple myeloma.

FDA has accepted Sanofi’s sBLA for the mAb and granted it priority review status for the targeted treatment of bullous pemphigoid.

The approval provides greater access to insulin treatment options.

Regulatory clearances and approvals continue as agencies work to disseminate literature, raise awareness, redouble research efforts, and improve the efficacy of clinical trials.

BioPharm International® chatted with Preeya Beczek, managing director and co-founder of Beczek.COM, about industry trends from 2024 and which of those might impact the industry in 2025, including the big trend of AI.

The report from Boston Consulting Group and Innovative Pharmaceutical Services Organization said the market in India is currently expanding at a 15% compound annual growth rate.

More than 6000 rare diseases—those which affect fewer than one in 2000 people each—are acknowledged in the medical community, with 72% of them being genetic.

Previous domestic capital expansion commitments since 2020 had been made in Research Triangle Park and Concord, both in North Carolina; Kenosha County, Wisconsin; Lebanon, Indiana; and Lilly’s home city of Indianapolis.

Single-use solutions are the company’s focus this year, including tubing and custom-molded parts.

Avtozma references Roche’s tocilizumab offering and has also shown promise as a treatment for CAR-T cell-induced cytokine release syndrome as well as COVID-19.

The European Commission has approved Biocon Biologics’ YESINTEK, a biosimilar referencing Janssen Biotech’s Stelara (ustekinumab).

BioPharm International® sat down with Kate Coleman from Arriello to run through the major trends from 2024, including the importance of technological advances, and how these may progress in 2025.

Co-led by Andera Partners and Bpifrance, the Series B financing will go toward an ongoing Phase Ib/IIa clinical study for EG 427’s lead candidate and to advance the company’s genetic medicines platform.

Vector Bioscience Cambridge is developing highly porous nanomaterials that can help reduce toxicities due to the small amount of vehicle material.

The new AI co-scientist is a multi-agent AI system that acts as a virtual scientific collaborator to aid scientific research.

In this episode of the Ask the Expert video series, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Siegfried Schmitt, PhD, vice president, Technical at Parexel, discuss the implications of FDA’s new draft guidance on complying with 21 CFR 211.110.

Vimkunya was granted approval under priority review based on positive results from two Phase III trials.

Ospomyv, or Obodence in the EU, and Xbryk were approved for all indications referencing Prolia and Xgeva, respectively.