Tag: drug manufacturing

September 29, 2023

Over the past year, PTC has replaced its CEO, fired its CFO and rolled out two restructuring plans. The initial round of layoffs was expected to impact about 8% of its workers, and came after the study failure of an […]

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 26, 2023

On Sept. 21, 2023, FDA released a new guidance on how the agency plans to utilize alternative tools to remotely evaluate drug manufacturing facilities identified in a marketing application. The application may be a new drug application, an abbreviated new […]

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 13, 2023

Drug development is inherently costly and time-intensive, with potential attrition a persistent burden on companies’ finances (1). As companies gain a deeper understanding of cell and molecular biology and seek to develop more complex therapeutics for patient populations, they will […]

September 7, 2023

Seagen is the biotech sector’s leading developer of antibody-drug conjugates, which deliver cell-killing toxins to diseased cells by attaching them to an antibody that seeks out proteins on tumor cells. Its first, Adcetris, is on track to become a blockbuster […]

August 14, 2023

As with other types of cancers, researchers have sought ways to turn the immune system against multiple myeloma. Their efforts have borne fruit with engineered T cell therapies like Bristol Myers Squibb and 2Seventy Bio’s Abecma and J&J and Legend […]

August 11, 2023

On Aug. 4, 2023, FDA released a guidance document, Recommended Acceptable Intake Limits for Nitrosamine Drug Substance-Related Impurities (NDSRIs). The guidance gives both applicants and manufacturers of drugs recommendations for estimating the mutagenic and carcinogenic potential of NDSRIs that could […]

August 1, 2023

The acquisition is a quiet end for EQRx, which was launched three years ago by biotech venture capitalist Alexis Borisy and quickly became one of the sector’s most closely watched startups. EQRx formed with an unusual mission to develop lower-cost […]

July 31, 2023

The FDA’s decision means that RiVive stands as the second non-prescription, OTC naloxone nasal spray product that the agency has approved. FDA commissioner, Robert Califf, said: “We know naloxone is a powerful tool to help quickly reverse the effects of […]

July 24, 2023

Tornado damage to a Pfizer drug-making plant in North Carolina is unlikely to trigger drug shortages across the country, the U.S. Food and Drug Administration says. “We do not expect there to be any immediate significant impacts on supply, given […]

July 21, 2023

The U.S. Food and Drug Administration is working closely with Pfizer to assess the impact of the damage at Pfizer’s Rocky Mount, North Carolina, facility. Over the next few days, we will complete a more extensive assessment of the products […]

July 6, 2023

Initial public offerings in the biotechnology sector have been occuring at a snail’s pace in 2023, prolonging a downturn that’s now lasted nearly two years. Since January, only nine biotech companies have gone public, putting new stock offerings in the […]

June 30, 2023

Vertex Pharmaceuticals and Lonza are partnering in the production of a new facility. Both companies are working together to manufacture and support the production of Vertex’s experimental cell therapy VX-880 for Type 1 diabetes and a second candidate VX-264. The […]

June 21, 2023

The U.S. Food and Drug Administration on Tuesday approved two drugs that have been used in adults with type 2 diabetes for years for use in children aged 10 and up. The approvals of Jardiance (empagliflozin) and Synjardy (empagliflozin and […]

June 12, 2023

Many professionals in the life sciences industry are excited about the benefits decentralized clinical trials (DCTs) bring to the clinical research process and specifically to patients. The use of wearables, electronic consent forms, digital outcomes assessments, and other DCT technologies […]

May 30, 2023

Since biological drugs first became available, their demand has been increasing—with the biologic market being valued at approximately US$302.63 billion in 2020 and expecting to reach US$509.23 billion by 2026 at a compound annual growth rate of 9.06% (1). With […]