Susan Haigney

Managing Editor at Pharmaceutical Technology

Managing Editor at BioPharm International

Managing Editor at MJH Life Sciences

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Articles

Industry Outlook 2025: Talent Up for Grabs

1 week ago | biopharminternational.com | Felicity Thomas |Susan Haigney

The post-COVID-19 era has seen the consequences of ambitious programs launched during the pandemic, according to Erik Wiklund, CEO of Circio, such as a lack of capital for small biotech and employee layoffs, and Wiklund sees this impacting the industry during 2025. “Many companies launch great ambitions, large valuations.
FDA Approves Treatment for Unresectable or Metastatic Hepatocellular Carcinoma

1 week ago | biopharminternational.com | Susan Haigney

Bristol Myers Squibb (BMS) announced on April 11, 2025 that FDA has approved Opdivo (nivolumab) plus Yervoy (ipilimumab) as a first-line treatment for unresectable or metastatic hepatocellular carcinoma (HCC). According to BMS, HCC is the most common primary liver cancer. The approval was based on results from the global Phase III randomized, open-label CheckMate-9DW trial.
Industry Outlook 2025: Cell Therapy Advancement

1 week ago | biopharminternational.com | Felicity Thomas |Susan Haigney

Edwin Stone, CEO of Cellular Origins, sees two themes having the biggest impact to the bio/pharma industry: the expansion of glucagon-like peptide-1 (GLP-1) and the growth of cell therapies from fourth- and third-line treatments to second-line treatments. “It really opens up that question of, when do we start to see first line treatments? And of course, part of that comes down to not just the safety and efficacy profiles, but the cost of goods, which still no one has a good answer to,” Stone says.
INTERPHEX 2025: The Challenge of Developing Ultra-Rare Disease Treatments

1 week ago | biopharminternational.com | Susan Haigney

Editor's note: this interview was originallypublished on PharmTech.com. Joe Katakowski, director of Research at the RTW Foundation, and Deanna Portero vice-president, Partnerships & Innovation, Orphan Therapeutics Accelerator, gave a presentation titled, “A Novel Pathway for Ultra-Rare Disease Treatment Development, Commercialization and Access”, at INTERPHEX 2025, which was held in New York City from April 1–3.
Novel Oncology Biotherapeutics: Gene Therapies

2 weeks ago | biopharminternational.com | Susan Haigney

Speaking from the perspective of a contract development and manufacturing organization (CDMO), Andrew Moreo, head of Process Development and Pre-clinical Manufacturing, Andelyn Biosciences, sat down with BioPharm International® to discuss new modalities in the treatment of cancer, specifically in the field of gene therapies.
Martin A. Makary Becomes New FDA Commissioner

3 weeks ago | biopharminternational.com | Susan Haigney

FDA announced on April 1, 2025 that Martin A. Makary, MD, has been sworn in as the agency’s new commission after a bipartisan confirmation by the US Senate. Makary, a graduate of Bucknell University, Thomas Jefferson University, and the Harvard School of Public Health, completed his residency at Georgetown University and surgical oncology fellowship at Johns Hopkins.
FDA CBER Director Peter Marks Resigns

3 weeks ago | biopharminternational.com | Susan Haigney

In a letter to Sara Brenner, FDA’s acting commissioner of Food and Drugs, Peter Marks, the director of FDA’s Center for Biologics Evaluation and Research (CBER), resigned his post. Marks pointed to an “unprecedented assault on scientific truth” that “adversely impacted public health” and the current administration’s concerns over vaccine safety (1) in his resignation.
Novel Oncology Biotherapeutics: CAR-T Cell Therapy

4 weeks ago | biopharminternational.com | Susan Haigney

The market for novel modalities has increased in demand and innovation. Sarah Hein, co-founder and CEO of March Biosciences, sees this as an exciting time for oncology drug development, including novel therapies and retargeting classic modalities. “But where I've really been excited, both for this company and my prior company, is really around the emergence and impact of immunotherapies.
HHS Announces Restructuring

4 weeks ago | biopharminternational.com | Susan Haigney

The US Department of Health and Human Services (HHS) announced on March 27, 2025 that it is restructuring the organization in response to a Trump Administration Executive Order. HHS states the restructuring will include the reduction of its workforce by 10,000 full-time employees; however, the total amount of workforce reduction will be closer to 20,000 when combined with other agency efforts such as early retirement and Fork in the Road (1).
DCAT Week 2025: Optimizing Drug Development

1 month ago | biopharminternational.com | Susan Haigney

Using a fully integrated service provider can help optimize drug development, says Helen Baker, director of Formulation Design at Quotient Sciences. Having clinical, late-stage, and regulatory processes under one umbrella can also help secure the supply chain. “A huge advantage of [having services under one umbrella] is that you cut out the white space that you often see between services as you move between them, as you go through the development process,” Baker says. “And this reduces the risk.