News

The new facility, to be located in Boston, MA, will contain experimental and analytical equipment for viral vector and advanced therapy process development and will expand the CDMO’s manufacturing capacity.

Amid pressure to get more vaccines administered faster, FDA pushes back against changes in dosing regimens.

Angelini will obtain an exclusive license to commercialize Arvelle’s investigational anti-seizure medication, cenobamate, in the European Union and other countries in the European Economic Area.

Using rDNA technology to synthesize production of proteins and peptide hormones, the biotech startup has achieved synthetic production of insulin, potentially lowering insulin cost by 30%.

The companies have entered into an agreement to support the formulation and fill/finish of Moderna’s COVID-19 vaccine supply outside of the United States.

Honeywell will use Sparta’s expertise to introduce new QMS solutions for life sciences to its customer base.

Part of Operation Warp Speed, the trial will enroll 30,000 people ages 18 to 64 and 65 and older at 115 sites.

Biopharma looks to deliver on COVID-19 vaccines and other promising therapies.

Despite the COVID-19 pandemic disruptions, with continued support and industry resilience, the European bio/pharma outlook for 2021 is positive.

FDA approval rate speeds up despite COVID-19 complications.

The recently published European pharmaceutical strategy is being seen as an opportunity to strengthen medicines regulation in the region.

The outlook for the European pharma industry is appearing to be favourable overall.

Shutting down the COVID-19 pandemic requires a global, selfless effort.

Boreas from Telstar are -86 ºC ultra-low-temperature freezers developed to house COVID-19 vaccines.

Cytiva’s new facility in Shrewsbury, MA will make equipment such as single-use bioreactors.

Commissioner Stephen Hahn evaluates the agency’s response to COVID-19 and how it affected non-COVID related initiatives in 2020.

FDA sent a warning letter to Clientele for CGMP violations at the company’s Sunrise, FL facility that included a lack of an adequate quality unit.

Administration of the COVID-19 vaccination from Oxford University and AstraZeneca is expected to begin in the UK in early 2021.

A report in the New England Journal of Medicine states preliminary results from a Phase III clinical trial shows the vaccine is 94.1% effective.

Sunstar Americas is expanding its voluntary recall of Paroex Chlorhexidine Gluconate Oral Rinse USP, 0.12% products because of Burkholderia lata contamination.

President Trump signed the COVID-19 package, which appropriates $2.3 trillion to finance the federal government through September 2021 and provides support for individuals and entities suffering from the economic crisis wrought by the pandemic.

The agency is targeting websites that market untested CBD products as medical treatments.

Customceutical Compounding was sent a warning letter by FDA after investigators found deficiencies in the production of sterile drug products.

The agency is organizing a second public meeting on January 8, 2021 to discuss the assessment, approval, and roll-out of new COVID-19 vaccines.

The virtual manufacturer and distributor of specialty materials acquired the NY-based company, adding analytical and manufacturing expertise.

The UK company is investing £3 million in new instrumentation and equipment to strengthen its high-throughput screening and translational oncology service offerings.

Moderna’s mRNA vaccine to prevent COVID-19 disease is granted FDA Emergency Use Authorization and CDC recommendation.

The guidance provides information on review timelines during the COVID-19 pandemic.

A decision by the European Commission on conditional marketing authorization for the European Union’s first COVID-19 vaccine is expected soon.

The new guidance provides information on how sponsors should interact with the agency regarding complex innovative trial design proposals.