WHO is recommending the use of interleukin-6 (IL)-6 receptor blockers in patients with severe and critical COVID-19, adding them to its list of treatments for the virus.
Cell therapy player, Bone Therapeutics, has secured up to €16m (US$18.9m) in a financing loan from the European Investment Bank (EIB) to accelerate ongoing clinical and commercial development of innovative orthopedic treatments.
Eli Lilly and Company will make an equity investment of around $15m in MiNA Therapeutics: a company with a proprietary small activating RNA (saRNA) technology platform.
The committee for human medicines (CHMP) of the European Medicines Agency (EMA) has approved a scale-up of the active substance manufacturing process at a Janssen Biologics BV site in the Netherlands.
German company, CureVac, says it is in ongoing dialogue with the European Medicines Agency (EMA) and is continuing regulatory submissions on its first-generation mRNA COVID-19 vaccine candidate, CVnCoV.
Simcere has announced a partnership with Vivoryon whereby it will leverage the potential of innovative N3pE amyloid-targeting agents to treat Alzheimer’s disease (AD) in Greater China.
The University of Oxford in partnership with AstraZeneca began vaccinations yesterday for a new phase in human trials to test a COVID-19 vaccine ‘AZD2816’ in volunteers against the Beta [South African] variant.
Catalent is to acquire German company, RheinCell Therapeutics, a developer and manufacturer of GMP-grade human induced pluripotent stem cells (iPSCs) for the next generation of cell therapies.
Statisticians at the US Food and Drug Administration (FDA) said there was insufficient evidence to support the agency’s approval of the Alzheimer’s drug produced by Biogen, according to newly released internal memos.
Bio-Thera Solutions recently initiated a Phase 3 trial of its proposed golimumab biosimilar BAT2506 in China and Eastern Europe, making it the first subcutaneous golimumab biosimilar to do so in multiple countries, according to a report from GlobalData.
A judgement has been issued in the legal dispute between the European Commission and AstraZeneca over a shortfall of delivery of the company’s COVID-19 vaccine doses to the EU-27.
These organizations hope to connect with attendees at the event, sharing clinical research ideas and innovations in sessions and the virtual exhibit hall.
Decentralized trials and remote monitoring, long discussed, but never really taking off until COVID-19 disrupted studies last year, will be under the spotlight at the DIA 2021 Annual Meeting at the end of this month.
New analysis by PHE shows for the first time that two doses of the COVID-19 vaccines produced by Pfizer and AstraZeneca offer are highly effective against hospitalization from the Delta variant.
The G7 wants to see a 100-day response to future pandemics, including vaccines ready for deployment at scale in this time. ‘The three best weapons we have are diagnostics, therapeutics and vaccines’ says a report from the summit.
Ocugen will pursue submission of a biologics license application (BLA) in the US for the COVID-19 vaccine candidate, COVAXIN, rather than a EUA application. The company believes that the differentiated vaccine has the potential to address variants, as...
The World Health Organization (WHO), as part of its International Nonproprietary Names (INN) system, has recently made progress in developing and harmonizing the definition paragraphs that support the naming of cell-based substances.
The US Food and Drug Administration (FDA) has approved Biogen’s Aduhelm (aducanumab) for the treatment of Alzheimer’s: making it the first new treatment approved for the disease since 2003.
Moderna has applied to expand use of its COVID-19 vaccine to adolescents in the EU: and also plans to submit an application for emergency use authorization (EUA) for this age group in the US.
The FDA has lifted the clinical holds on bluebird bio’s trials of gene therapies in sickle cell disease (SCD) and transfusion-dependent beta thalassemia (TDT), an inherited blood disorder.
The online pharma event will address the COVID-19 pandemic’s impact on the industry (and vice versa) and innovation in the face of formidable challenges.
The therapeutic has been approved as an adjuvant treatment for varieties of esophageal cancers in patients who have received neoadjuvant chemoradiotherapy.
A robust research and innovation ecosystem makes Italy an attractive life sciences hotspot, according to a post from an Italian trade delegation at Bio Digital 2021.
June 2021 marks the 40th anniversary of the publication of the first reported cases of AIDS in the US. A session at BIO Digital – featuring Dr. Anthony Fauci, Director of NIAID at the NIH – will focus on four decades of innovation as well as the critical...
Corbus Pharmaceuticals announced the expansion of its portfolio into immuno-oncology through licensing deals with the University of California San Francisco and Panorama Research Inc for two new monoclonal antibodies (mAbs).
Moderna has initiated the rolling submission process with the US Food and Drug Administration (FDA) for a Biologics License Application (BLA) to distribute and market its mRNA COVID-19 vaccine in the US for use in individuals aged 18 and older.
The World Health Organization (WHO) is assigning ‘simple, easy to say and remember’ labels to key variants of SARS-CoV-2, using letters of the Greek alphabet.
Eli Lilly and Co received a subpoena late last week from the US Department of Justice (DOJ), requesting certain documents, as part of a probe into its manufacturing site in Branchburg, New Jersey.
The European Medicines Agency’s (EMA) human medicines committee (CHMP) has given the green light for the Pfizer/BioNTech COVID-19 vaccine to be administered to adolescents aged 12-15 years old.
The World Health Organization (WHO) and the Swiss Confederation have launched the first WHO BioHub Facility to enhance the rapid sharing of viruses and other pathogens between laboratories and partners globally.
The European Commission today announced that it has reserved an additional 1.8 billion doses of the coronavirus vaccine developed by Pfizer-BioNTech, on behalf of all 27 EU countries, from the end of 2021 to 2023.
Novartis subsidiary, Sandoz, says the US Supreme Court has denied its petition to review the Federal Circuit’s decision last summer in relation to Erelzi, its biosimilar of the Amgen reference medicine, Enbrel (etanercept), which is used to treat autoimmune...
Many turn to Boston and North Carolina’s Research Triangle to set up life science companies, but Chicago is now also fast becoming a draw in this respect. The city is emerging as a life science and biopharma hub and seems poised for even further growth,...
The Medicines and Healthcare products Regulatory Agency (MHRA) has published final guidance on how the UK will license biosimilar products now it is outside of the European Union.
Moderna has agreed to provide 15m doses of its updated variant COVID-19 vaccine to Australia, providing a boost to its efforts to generate ongoing revenues from its coronavirus work.
RoslinCT is set to collaborate with the Scottish Universities Life Sciences Alliance (SULSA) and additional academic institutions to deliver high impact advanced therapy and vaccine manufacturing GMP training.
The US Food and Drug Administration (FDA) has expanded the emergency use authorization (EUA) for Pfizer and BioNTech’s COVID-19 vaccine: now including adolescents aged 12-15 years old.
The US says it will support the proposed waiver of IP protections on COVID-19 vaccines: but the country’s industry says this sets a ‘dangerous precedent for future pandemics’.
Moderna has reported the first profitable quarter in the company’s history: after 10 years of research and several billion dollars of investment in its mRNA platform. The next step will be to start a rolling submission for a Biologics License Application...
![WHO Director-General, Tedros Adhanom Ghebreyesus and Swiss Federal Councillor, Alain Berset, signed an agreement in relation to the BioHub on the edges of the World Health Assembly yesterday [May 24] © WHO/Christopher Black](/var/wrbm_gb_food_pharma/storage/images/_aliases/news_teaser_medium/publications/pharmaceutical-science/biopharma-reporter.com/article/2021/05/26/new-switzerland-hub-for-pathogen-storage-sharing-and-analysis/12512537-4-eng-GB/New-Switzerland-hub-for-pathogen-storage-sharing-and-analysis.jpg)
