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Cellevate's nanofiber microcarriers are the first on the market for use in manufacturing viral vectors used in gene therapy production, according to the company.

The agency is working with the European medicines regulatory network to improve the assessment and approval process for new medications.

This Behind the Headlines news roundup panel discussion on recent news items includes updates regarding sickle cell therapies (e.g,, Pfizer’s withdrawal of Oxbryta and Vertex’s choosing of Lonza as the commercial manufacturer of Casgevy); Emergent BioSolutions $400 million BARDA contract for an mpox vaccine; and the first in a generation novel schizophrenia drug, Cobenfy (xanomeline and trospium chloride). The panel also examines investment revival with ARCH Ventures $3 billion biotech fund raise and the $3.6 billion for Flagship Pioneering. Rounding things out is a discussion on COVID-19-associated childhood myopia and patent thickets artificially keep the price of drugs high.

SGD Pharma plans to showcase its siliconized molded glass vials at CPHI Milan as part of its range of sustainable products and services.

Results from the CPHI annual survey show that 49% of industry respondents are “highly positive” on the contract services sector seeing growth over the next 18 months.

FDA’s Darby Kozak provided commentary on the anniversary of the Drug Price Competition and Patent Term Restoration Act of 1984.

The two companies are partnering to provide logistics and manufacturing services to biotechnology and pharma companies.

Under the long-term supply agreement, Lonza will manufacture CASGEVY (exagamglogene autotemcel) for Vertex at its facility in Geleen, the Netherlands, and plans to expand manufacturing to Portsmouth, NH, in the United States.

The next-generation IRO platform was found to significantly outperform the legacy Prodigy system, showing improvements in cell growth, CAR+ cell yield, and overall efficiency.

Approvals were recommended for treatments of ovarian cancer, lung cancer, bleeding disorders, respiratory disease, and more.

The agency is recommending the extension of the smallpox and mpox vaccine, Imvanex, to adolescents aged 12 to 17.

By approving EBGLYSS (lebrikizumab-lbkz), FDA has made available a new biologic treatment for moderate-to-severe atopic dermatitis that is not well controlled with topical treatments.

Ecolab's Hayley Crowe, executive vice-president and general manager Global Life Sciences sat down at BIO 2024 to discuss technology innovations and how they have enhanced downstream bioprocessing.

Vectura’s expertise in the field includes formulation and device development for dry powder inhalers and pressurized metered dose inhalers, among other products and services.

Lilly has increased its manufacturing investment for biologics in Limerick, Ireland, by $1 billion while launching its new $800 million facility in Kinsale.

The company said this new commitment to its facility in Germany goes hand in hand with its recently announced ReciPredict, an initiative intended to streamline the product development cycle.

Novo Nordisk will use Korro Bio’s OPERA platform to develop RNA editing candidates for two targets to treat cardiometabolic diseases.

The critical APIs that this funding will contribute to are used in the treatment of asthma, diabetes, and anxiety disorders.

During a presentation at the PDA/FDA Joint Regulatory Conference, Nicholas Violand of Johnson & Johnson and Paul Palmer of Paul R. Palmer Limited discussed how aging facilities can impact the quality of pharmaceutical products.

The new Vivaflow SU tangential flow filtration cassette is designed to be more flexible and user-friendly and offers enhanced ultrafiltration and diafiltration efficiency.

The finalists for the 2024 CPHI Pharma Awards are spread across 14 categories, which include future leaders, women of the year, and an “at the heart of pharma” category.

CDER’s Jonathan Chapman, senior policy advisor, and Takeda’s Paulien Groll, head of Compliance Excellence, discussed how companies can be proactive with their CAPA strategies instead of reactive, at the 2024 PDA/FDA Joint Regulatory Conference.

Rentschler Biopharma now offers a new lentiviral vector manufacturing toolbox at its site in Stevenage, UK.

This is the company’s largest single investment in the Sweden Biomanufacturing Center, in Södertälje, which opened in 2021.

A coordinated and international response is needed to help control the latest mpox outbreak in Africa.

FDA’s latest approval of Imfinzi (durvalumab) in combination with chemotherapy for treating resectable non-small cell lung cancer before and after surgery is based on Phase III trial results showing that the regimen reduced the risk of recurrence, progression, or death by 32%.

PiaSky (crovalimab) has previously been approved in countries such as the United States and Japan for monthly, subcutaneous use that may be self-administered with adequate training.

With the completion of its acquisition of Morphic, Lilly expands its immunology pipeline to include Morphic's oral integrin therapies to address inflammatory bowel disease.

Opaganib was given orphan drug designation for the treatment of neuroblastoma in children, which is rare, but the most common infancy malignancy.

In a 24-week study of patients with PAH, six-minute walking distance improved by an average of 40.8 meters, and risk of death or clinical worsening was reduced by 82%.