
The company plans to deliver initial doses by mid-2021, and Australia will have the option to purchase up to 10 million additional doses through the agreement.

The company plans to deliver initial doses by mid-2021, and Australia will have the option to purchase up to 10 million additional doses through the agreement.

The vetting and authorizing of important new therapies remained productive in 2020, despite the need to devote considerable resources to dealing with COVID-19 related approvals and policies.

Bayer will support the development and supply of CureVac’s COVID-19 vaccine candidate, CVnCoV.

EMA has chosen Panalgo's Instant Health Data (IHD) platform to enable rapid analyses of real-world data.

Intravacc and Cristal Therapeutics have entered into a strategic collaboration for the development of novel vaccine programs against human diseases.

The European Commission has granted a conditional marketing authorization to Moderna for its COVID-19 vaccine.

Evonik has closed its acquisition of the Lactel Absorbable Polymers product line from DURECT Corporation on Dec. 31, 2020.

Avacta Group has entered into a license agreement with POINT Biopharma, granting access to its pre|CISION technology for the development of tumor-activated radiopharmaceuticals.

The transaction will include operations located at different Novasep sites, including its Pompey, France site and sites in the United States, China, and India.

The collaboration will utilize ViGeneron’s novel engineered AAV capsids, vgAAV, to transduce retinal cells with intravitreal injections for an undisclosed target.

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.