Novavax has completed its rolling submission to the World Health Organization for emergency use listing (EUL) of NVX-CoV2373, its COVID-19 vaccine candidate.
bluebird bio has signed a long-term lease for a 61,000 square foot facility at Assembly Row, Greater Boston: saying the new headquarters has been designed to reflect modern ways of working and deliver significant cost savings.
Sphere Fluidics, a UK company that has developed and is commercializing single cell analysis systems underpinned by its picodroplet technology, has just closed a US$40m investment round.
Biomunex Pharmaceuticals, a French company focused on the discovery and development of bi- and multi-specific antibodies, sees its BiXAb5 project receive nearly €3m (US$3.5m) in the form of a grant from the French government.
Clade Therapeutics has raised US$87m in a Series A led by Syncona Ltd with participation from LifeSci Venture Partners, Emerson Collective and Bristol Myers Squibb (BMS).
Lonza has been investing in developing exosome manufacturing and characterization technologies for the past five years, and this week it ramped up its focus on that category by acquiring two sites.
The Biosimilars Forum, in partnership with the Pacific Research Institute (PRI), recently released a report and interactive tool highlighting the significant costs that biosimilars can save US states.
A lot has changed over the last year since IP waiver proposals were first put forward - notably a massive rise in the production of COVID-19 vaccines. Komal Kalha of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA)...
Drug packaging and delivery system company, Gerresheimer, noted the prefillable syringes business is booming as it reported double digit organic revenue growth in Q3 2021.
The World Health Organization is recommending widespread use of the RTS,S/AS01 (RTS,S) vaccine among children in sub-Saharan Africa and other regions with moderate to high malaria transmission.
A probe has identified 'human error’ at the Spanish contract development and manufacturing organization, Rovi, as the reason for the presence of metal contaminants in Moderna COVID-19 vaccine doses, leading to Japanese authorities withdrawing 1.6...
The European Medicine Agency’s human medicines committee (CHMP) says that booster doses of the Pfizer/BioNTech vaccine may be considered in people aged 18+, although decisions on who is offered a booster will be made at a national level.
CEOs at large pharma and biotech companies are upbeat when it comes to their outlook for both their own company and the industry at large; they also have a healthy appetite for M&A, found a KPMG survey.
AstraZeneca’s Alexion has exercised its option to acquire all remaining equity in Caelum Biosciences for CAEL-101, a fibril-reactive monoclonal antibody (mAb) for the treatment of light chain (AL) amyloidosis.
Merck and Pfizer subsidiary, Wyeth LLC, have resolved a patent row related to their competing vaccines for preventing diseases including pneumonia and meningitis.
Takeda has received approval from Japan’s ministry of health to manufacture and market its stem cell therapy, Alofisel, for the treatment of complex perianal fistulas in patients with non-active or mildly active luminal Crohn’s disease (CD).
The US Food and Drug Administration (FDA) has amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine to include a single booster dose in certain populations.
This month sees the launch of a new gene therapy player, Opus Genetics, a company backed and spun out by leading patient group Foundation Fighting Blindness’ venture arm, the Retinal Degeneration Fund (RD Fund).
AstraZeneca has announced a long-term research collaboration with VaxEquity for the discovery, development and commercialization of its self-amplifying RNA (saRNA) therapeutics platform.
Biocair has expanded its pharmaceutical and clinical trial logistics operations with new location in California, near Los Angeles International Airport.
Johnson & Johnson says data published in The Lancet on its Ebola vaccine regimen shows it has a robust and durable immune response in adults and children.
French innovator, TreeFrog Therapeutics, which is focused on developing affordable stem cell-derived cell therapies, has just closed a US$75m (€64M) Series B financing round, bringing its total funding to date to US$83m (€70M).
The US medical research agency plans to offer funding over five years through a newly launched consortium, expected to include 30 sites across the country.
The UK government accuses Valneva of being in breach of its supply agreement obligations - something the company 'strenuously denies' - as it cancels its COVID-19 vaccine contract.
Biosimilar producer, Sandoz, has entered into a commercialization agreement for biosimilar, BAT1706, referencing Avastin (bevacizumab) with Bio-Thera Solutions for the treatment of multiple types of cancers.
Japan’s health ministry is to secure 150 million doses of Novavax’ vaccine candidate that Takeda is producing. The Japanese government's purchasing agreement is subject to regulatory approvals.
Previously a series of unsuccessful clinical trials for treatments, combined with the high costs of R&D in the area, led to declining interest in dementia research but a new publication from the WHO notes a definite uptick in the funding of such work...
Moderna and the nonprofit Institute for Life Changing Medicines (ILCM) are collaborating to develop a new messenger RNA (mRNA) therapeutic (mRNA-3351) for Crigler-Najjar Syndrome Type 1 (CN-1), an ultra-rare disease.
A leader from the home trial services provder says patients’ increasing awareness of clinical research has how trial teams should consider their approach.
Moderna has submitted data for a conditional marketing approval (CMA) with the European Medicines Agency (EMA) for the evaluation of a booster dose of its COVID-19 vaccine.
The European Commission and AstraZeneca have settled their dispute over the supply of COVID-19 vaccine, Vaxzevria, in a move that will see the EU receive 200 million doses of the drug maker’s shot by March 2022.
Moderna has initiated its submission to the US Food and Drug Administration (FDA) to support the authorization of a booster dose of its mRNA COVID-19 vaccine at the 50-microgram (mcg) dose level.
Special Edition: Reviewing the advanced therapy pipeline
As a relatively new player in the field of cell therapy, Santen Pharmaceutical has outlined how it is looking to collaborate with key stakeholders in order to shape relevant policies, forge meaningful partnerships and create an optimal environment for...
