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1 week ago | 
biopharminternational.com | Susan Haigney
FDA Director Martin Makary announced on May 6, 2025 that he has appointed Dr. Vinay Prasad, MD, MPH as the director of FDA’s Center for Biologics Evaluation and Research. Prasad is a hematologist-oncologist and was previously a professor in the department of Epidemiology and Biostatistics at the University of California San Francisco (UCSF).
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1 week ago | 
biopharminternational.com | Susan Haigney
Adeno-associated virus (AAV) vectors are commonly used for gene therapies, according to Noah Kopcho, field application scientist at Gyros Protein Technologies. AAV vectors come with challenges in productions, however. “Namely, compared to other vectors, AAV often has lower titers,” says Kopcho. “This can present problems with scalability. During the production and purification workflow, there are several different contaminants that need to be kept in mind, and purity is often essential.
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1 week ago | 
biopharminternational.com | Susan Haigney
The use of automation in the protein industry is relatively new, according to Lun Xin, associate director at WuXi Biologics, with automated analysis, automated upstream, and automated downstream production becoming more common. “Where this industry is going is automation, particularly coming down to the drug product formulation [and] development,” says Xin. “This [is] because we need to understand the protein’s properties and then screen different types of buffer pH exceptions.
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1 week ago | 
biopharminternational.com | Susan Haigney
Biologic drugs typically have a higher dosage than small-molecule drugs, according to Lun Xin, associate director at WuXi Biologics, and sometimes patients will need to spend hours at an infusion center to receive these treatments.
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2 weeks ago | 
biopharminternational.com | Felicity Thomas |Susan Haigney
Political shifts in the United Kingdom and Europe may have a negative impact on research efforts for gene therapies performed by universities and other research organizations, says Alexander Seyf, CEO and co-founder of Autolomous. However, the impact on the bio/pharmaceutical industry is more likely to be minimal.
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2 weeks ago | 
biopharminternational.com | Susan Haigney
On May 1, 2025, Aviva Capital Partners and mixed-use developer Socius announced plans for a new £1 billion (US$1.33 billion) investment to create a cancer research and treatment center in Sutton, London. The 12-acre site will be located at the London Cancer Hub next to The Institute of Cancer Research, London and The Royal Marsden NHS Foundation Trust’s Sutton site.
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2 weeks ago | 
biopharminternational.com | Susan Haigney
Vesicor Therapeutics, a California-based early development stage biotechnology corporation, announced on April 28, 2025 that it has signed a business combination agreement (BCA) with Black Hawk Acquisition Corp., a special purpose acquisition company. Under the BCA, Black Hawk’s subsidiary, BH Merger Sub, will merge with Vesicor. The transaction, which is valued at $70 million, has been approved by both companies’ board of directors and isexpected to be completed in the fourth quarter of 2025.
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2 weeks ago | 
biopharminternational.com | Susan Haigney
Biohaven Ltd, a clinical-stage biopharmaceutical company, announced on April 28, 2025 that it has entered into an investment agreement with Oberland Capital Management for up to $600 million dollars, with the first installment of $250 million to be funded on or before April 30, 2025. The funding will support the company’s development of treatments and commercialization of products for rare and common diseases, including approval of troriluzole for patients with spinocerebellar ataxia (SCA).
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2 weeks ago | 
biopharminternational.com | Susan Haigney
Emerging modalities for cancer treatment have been advancing, giving patients who have not responded to other treatments hope. Cell and gene therapies, peptides, monoclonal antibodies (mAbs), antibody drug conjugates (ADCs), and vaccines such as messenger RNA, as well as a variety of other treatments have developed in recent years (1). Sarah Hein, co-founder and CEO of March Biosciences, sees immunotherapies as having a significant impact on oncology treatments.
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3 weeks ago | 
biopharminternational.com | Felicity Thomas |Susan Haigney
The European Medicines Agency (EMA) announced in December 2024 that the agency and the Heads of Medicines Agencies (HMA) have revised their guidance on identification of commercially confidential information (CCI) and personal data used in marketing authorization applications. The revision was done as part of the agency’s commitment to transparency in the disclosure of information in response to access-to-document requests and the publication of data for authorized medicines (1).
