News

Cobra Biologics has signed a supply agreement to provide GMP manufacturing for AstraZeneca’s AZD1222 COVID-19 vaccine candidate.

Corning will use BARDA funding to expand US manufacturing capacity for pharmaceutical tubing and vials made from Valor glass.

The guidance provides recommendations on statistical considerations to address the impact of COVID-19 on meeting trial objectives for clinical trials conducted during the pandemic.

The International Coalition of Medicines Regulatory Authorities met again on June 12 to discuss policy approaches to the COVID-19 pandemic.

The report highlights agency’s accomplishments in 2019, including its relocation to Amsterdam.

The company has been selected to produce the active pharmaceutical ingredient for clinical trial supplies of RBT-9, an investigational therapy for the treatment of COVID-19 in patients at high risk of declining health due to age or comorbid conditions.

Valneva will manufacture the Sabin vaccine strains for clinical trials in its manufacturing facility in Solna, Sweden, using Batavia’s process.

The company is planning on adding up to 1.5 million sq. ft. of cGMP distribution space for COVID-19 shipments.

Citing clinical trial data that hydroxychloroquine did not show benefits for COVID-19 patients, FDA removes emergency use authorization for the drug as a treatment for the novel coronavirus.

Catalent will provide vial filling and packaging capacity to AstraZeneca at its manufacturing facility in Anagni, Italy, for the large-scale commercial manufacturing of the University of Oxford’s adenovirus vector-based COVID-19 vaccine candidate.

Oxford Biomedica, has signed a collaboration agreement with the not-for-profit organization, the Vaccines Manufacturing and Innovation Centre, to provide the UK with its first strategic vaccine development and advanced manufacturing capability.

Leo Pharma, medical dermatology specialist, has announced that the European Medicines Agency (EMA) has validated its marketing authorization application (MAA) for tralokinumab.

According to a report from commercial law firm, Hill Dickinson, there is general support by the public of the United Kingdom that vaccine regulations should be relaxed in light of the current COVID-19 pandemic.

The Biomedical Catalyst has been relaunched, meaning that innovative biotech companies will have the opportunity to access a share of £30 million (US$38 million) in grant funding.

The companies have entered into a collaboration agreement to develop and commercialize three of Genmab's early-stage investigational bispecific antibody product candidates.

Will efforts to limit all returns on investment drive biopharma companies away from developing much-needed interventions for COVID-19.

The candidates will be used by the Vaccine Research Center, part of the National Institute of Allergy and Infectious Diseases at the National Institutes of Health.

The companies have entered into a development and manufacturing agreement for Anthos Therapeutics’ abelacimab for treating thrombotic disorders.

Catalent will use its GPEx cell line development technology to create a cell line expressing the recombinant VLP at its Madison, WI facility.

The news comes after the company received its FDA registered ISO 13485 as a CDMO.

The investment will increase production lines for bulk drug substance and will add a fill/finish production line to the site.

The 120-day pilot program was set up to help reduce the availability of unapproved opioids illegally offered for sale online.

The agency published guidance to clarify its enforcement of distribution of drug samples for drug marketing during COVID-19.

The agency has added a COVID-19 innovation resource page and an education resources page to its website.

Siemens and Exyte partner for fast-track construction of modular, automated, digitalized biopharmaceutical facilities.

Novavax announces DoD contract to produce 10 million doses of COVID-19 vaccine candidate.

The European Commission is pledging EUR 300 million (US$339 million) to Gavi for vaccines for infectious diseases, in addition to an earlier pledge of more than EUR 1.5 billion (US$1.7 billion) made on May 4, 2020.

SiO2 Materials Science has received $143 million from the US government to accelerate capacity scale-up of its advanced primary packaging platform.

CPhI Worldwide have announced that the 2020 event will be organized in accordance with new global biosafety measures, Informa’s AllSecure health and safety standard, to ensure hygiene and safety of event attendees.

The protocol on Northern Ireland (NI) once Brexit has been completed has received mixed opinions in industry, according to various press releases.