Category: Research and Development

November 17, 2023

Plasmid DNA is a critical raw material that is required for the manufacturing of virus-based gene therapy and gene-modified cell therapies. The current challenges with the supply of plasmid DNA varies depending on its end use, but usually production capacity, […]

November 15, 2023

The two companies say their partnership could unlock access to millions of customers across a network of more than 550 Chemist Warehouse retail locations in Australia and other countries including New Zealand, Ireland and China, as well as its online […]

November 14, 2023

Netherlands-based biotechnology company VectorY Therapeutics has raised 129 million euros, or $138 million, to fund development of brain disease drugs. The Series A financing, announced Monday, was co-led by venture capital firm Forbion and European investor EQT Life Sciences, alongside […]

November 13, 2023

Pandemic-era changes may have permanently altered the clinical trial landscape as decentralized clinical trials gain broader acceptance. During COVID-19, more than three-quarters (76%) of pharmaceutical companies, device manufacturers and contract research organizations conducted off-site clinical trials. These types of trials […]

November 2, 2023

On Oct. 30, 2023, Aragen, a contract research development and manufacturing organization (CRDMO), announced that it was setting up a new biologics manufacturing facility in Bangalore, India as part of a $30 million investment. The new 160,000 m2 facility will […]

October 16, 2023

Pharmaceutical companies can spend 10 to 15 years and more than $2.3 billion to bring new drugs to market. Despite these significant investments in drug development, 90% of clinical trials fail. For a greater chance of success, pharmaceutical companies must […]

October 12, 2023

The notification scheme stems from the agency’s overhaul of rules announced in March, with the aim of making it “faster and easier” to gain approval and to run clinical trials in the UK – and elevate the country’s position in […]

September 29, 2023

In 2022, the number of newly approved biologic drugs outpaced that of small molecules for the first time (1). Notably, almost a third of the new approvals comprised novel modalities, such as cell and gene therapies, antibody–drug conjugates, and bispecific […]

September 29, 2023

The recent resurgence in microbial fermentation for biologics production can be attributed to many factors. Advances in biochemistry and a growing understanding of when glycosylation is not needed, improved capabilities for modification of naked proteins, the emergence of new protein […]

September 29, 2023

This survey conducted by the authors examined factors of Roger’s diffusion of innovation theory related to adopting machine learning (ML) and artificial intelligence (AI) in the bio/pharmaceutical manufacturing industry. The sample included industry leaders and bio/pharmaceutical professionals with experience in […]

September 15, 2023

A recent publishing of the first part of the CPHI Annual Report predicts substantial progress ahead for artificial intelligence (AI)’s use in pharma, despite the uproar surrounding ChatGPT and other AI programs. According to a press release, the implications go […]

September 15, 2023

The US is currently experiencing a shortage of 15 cancer drugs as a result of manufacturing and supply chain issues. Three of these drugs – cisplatin, carboplatin and methotrexate – have been staples of cancer treatment for decades, but their […]

September 1, 2023

Clinical trials are essential for establishing the efficacy of new drugs, observing patients’ reactions to treatments, and representing populations of people that may not always be discussed in everyday conversation. Although there are many diseases and disorders that are waiting […]

August 21, 2023

On Aug. 21, 2023, Gilead Sciences announced that FDA has placed a partial clinical hold on the company initiating new patients into US studies for magrolimab, an investigational anti-CD47 immunotherapy, to treat acute myeloid leukemia (AML). FDA’s decision follows a […]

August 9, 2023

The biopharmaceutical industry has seen a lot of change in recent years, between new collaborations with supplier and contract development and manufacturing organizations (CDMOs) and accelerated drug delivery times. According to recent research, biopharmaceutical figures are already using digital and […]

August 7, 2023

Although diseases such as Ehlers-Danlos syndrome, Sanfilippo syndrome and Hemophilia are considered rare, their impact looms large. Rare diseases, defined as occurring in fewer than one in 2,000 individuals, affect more than 300 million people across the globe, and most […]

July 26, 2023

The report presents EU-level actions to address the challenges that were experienced during the COVID-19 pandemic and the outbreak of mpox disease in setting up adequately sized clinical trials across multiple member states. Organised in June 2023, with participation from […]

July 17, 2023

An experimental medicine benefited patients with a deadly heart condition in a closely watched Phase 3 trial, lifting the fortunes of its developer, BridgeBio Pharma, and clearing the way for the biotechnology company to seek U.S. approval. Trial results showed […]

July 14, 2023

Caribou Biosciences – a company focused on genome-editing – has announced follow-up data from the dose escalation element of its ongoing ANTLER phase 1 trial. This new data set includes all 16 patients treated in dose escalation with the CB-010 […]

July 11, 2023

FDA recently granted full, or traditional, approval to Eisai Pharmaceutical’s Alzheimer’s treatment Leqembi, converting an earlier conditional approval status with further data from a multi-regional study of nearly 1800 patients. Results indicated that the drug slows the rate of cognitive […]