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Single-temperature incubation has been discussed for a long time in the pharmaceutical industry but only a few sites have implemented this system. Here, Guillaume Pinon, Head of the Microbiology Lab at Servier, discusses the use of single-temperature incubation in an aseptic production facility, outlining the regulatory considerations, strategic approach, challenges…
Botanical drugs, also known as traditional herbal therapies, have long been used, but obtaining regulatory approval for these medicines, or therapies, is convoluted. Often manufacturers will market their botanical drugs as dietary supplements or traditional therapies, designations that require far less regulatory approval than marketisation as a drug. In this…
FDA’s new draft guidance follows the new requirement for clinical study sponsors to submit Diversity Action Plans, eg, when submitting their investigational new drug (IND) application.
This article highlights some of the key regulatory approvals granted in May and June in the EU and US so far this year, including for oligonucleotide and biologic therapies.
The FDA’s regulatory approval of the telomerase inhibitor is welcome, considering the high unmet need for many lower-risk myelodysplastic syndromes (LR-MDS) patients, according to Geron.
The first omalizumab biosimilar in allergic diseases is approved by the European Commission and the US Food and Drug Administration (FDA) has authorised the fifty third biosimilar in the US.
Expansion of the WLA framework means that the largest number of regulatory agencies for medical products are approved as WHO Listed Authorities.
Amgen’s Imdelltra™, previously known as tarlatamab, is approved for the treatment of adult patients with advanced small cell lung cancer.
In this Q&A, Dr Michael Wechsler, Professor of Medicine, Director of the National Jewish Health (NJH)/Cohen Family Asthma Institute, reveals details of the data from the MANDARA Phase III trial, showing remission is achievable in EGPA with Fasenra.
In formulating the current Coordinated Framework for the Regulation of Biotechnology, the US Food and Drug Administration (FDA), US Environmental Protection Agency (EPA) and the US Department of Agriculture (USDA) utilised horizon scanning for novel biotechnology products.
In this interview, Vikas Gupta, President of CDMO ReciBioPharm, outlines several key trends shaping the biopharma manufacturing landscape, including the rise of nucleic acid-based therapeutics, and the quest for continuous manufacturing.
Pfizer has attained its first approval for a gene therapy from the US Food and Drug Administration (FDA), which is indicated to treat the rare blood disorder haemophilia B.
The novel approval provides a dedicated therapy option for patients with ALK-positive early-stage lung cancer.
Approval of the cell therapy by the US FDA could provide a treatment-free respite as early as first relapse for patients with multiple myeloma.
In this interview, Mindy Leffler, Managing Director of Qualitative Research and Psychometrics at Emmes Endpoint Solutions, discusses the nuances of designing clinical trials for rare diseases including specific challenges related to traditional endpoints.
