Research & Development News

The new small molecule drug ataciguat is garnering attention for its potential to manage aortic valve stenosis, which may prevent the need for surgery and significantly improve patient experience.

In their national budget announced by the UK Labour Party, biopharmaceutical production and manufacturing are set to receive a significant boost in capital grants through the Life Sciences Innovative Manufacturing Fund (LSIMF). 

In the latest episode of the CPHI Podcast Series, Lucy Chard is joined by Thomas Cornell from Abzena to discuss protein engineering for drug design and development. 

Samsung Bioepis, the biologics unit of Samsung, has been issued a lawsuit brought forth by Amgen over proposed biosimilars of Amgen’s bone drugs Prolia and Xgeva. 

The latest episode of the CPHI Podcast Series with Lucy Chard covers women's health, specifically women's representation in clinical trials, the associated bias, and the impacts on health for this population. 

Global pharmaceutical companies Novartis and Viatris are the latest hit with a lawsuit claim pertaining to alleged misuse of the ‘HeLa’ cell line from the estate of woman whose cancerous tissue cells were taken without consent. 

French pharmaceutical company Sanofi have announced an investment of EUR1.3 billion at their existing BioCampus site in Frankfurt am Main for the expansion of insulin production. 

A University of Alabama at Birmingham startup has gained FDA clearance for Investigational New Drug clinical trials for an oral Type 1 diabetes drug, a milestone for diabetes treatment. 

Following from its purchase of Carmot Therapeutics, Roche have announced positive early-stage trial success for its second obesity drug candidate acquired from Carmot Therapeutics.  

A recent study published in Science Advances has identified a set of microproteins produced exclusively in liver tumours, which may provide a clear target for the development of a cancer vaccine. 

American pharmaceutical giant Pfizer have continued with a reworked version of their weight-loss pill danuglipron, progressing with a once-daily version of the pill. 

Researchers have created a new approach to the designing of eco-friendly nanofibres extracted from rice husks, addressing the critical need for sustainable packaging materials in food and biopharmaceutical products.  

German biotechnology company BioNTech has stated their intentions to begin production at their mRNA vaccine factory in Rwanda by 2025, which will mark the first foreign mRNA vaccine manufacturing site on the continent of Africa.

A University of Manchester spin-out pharmaceutical company, PharmaKure, has reported successful study results for the quantification of Alzheimer’s Disease biomarker proteins with a whole blood test.

To address vaccine inequality and accessibility issues, the Bill & Melinda Gates Foundation aims to deliver USD $40m to various biotech companies and vaccine manufacturers in support of mRNA vaccine development.

The next episode of the CPHI Podcast Series delves into the science and background behind some recent developments in the field of Alzheimer's disease and neurological disorders. 

Pfizer gains accelerated approval from the US FDA for their new bispecific antibody therapy for multiple myeloma, set to address an unmet need for patients.

Results from the TRAILBLAZER-ALZ 2 Randomised Clinical Trial into the use of donanemab to treat early symptoms of Alzheimer’s disease have been analysed. 

A quarterly series of articles about responsible supply chain management from the PSCI. 

Listen to the CPHI Podcast Series this June to hear Gil Roth of the PBOA speak with Digital Editor Lucy Chard about the biggest trends and topics to watch in pharma outsourcing and manufacturing at the minute. 

Novavax, developers behind the Matrix-M adjuvant, have entered into an agreement with the Bill and Melinda Gates Medical Research Institute to provide the adjuvant in preclinical vaccine research.

NextPharma has completed their acquisition of a Norway-based manufacturing site, specialising in chewable tablet technologies for calcium/vitamin D3 from pharmaceutical giant Takeda.

Vaccines for RSV from GSK and Pfizer to be analysed by a panel of experts with a view to informing a decision from the US FDA on their approval. 

In this podcast Digital Editor Lucy Chard is joined by Rachel Smith of Parexel to discuss the challenges surrounding the development of medicines for rare disease patients. 

The US FDA are hoping to lead the way in addressing the lack of diversity and representation in clinical trials when developing medicines through new legislation. 

The WHO are proposing a new set of pandemic guidelines to set out how future global health crises should be handled. 

A compound found in magic mushrooms, psilocybin, could be used to treat mental health conditions and help patients suffering with severe depression, as shown by the results of the largest study of its kind to date.

UK-based CRO Quanticate is set to partner with Cancer Research UK for the launch of the DETERMINE study focused on testing a range of existing and approved drugs and therapies on rare cancers.

Both tests have been approved by the US regulator for in vitro diagnostic use  

The test can distinguish between monkeypox and other diseases that cause similar symptoms. 

As concern over the monkeypox outbreak continues to rise, we take a look at major developments from the first week of August.   

Researchers in South Korea have developed an electronic tattoo that automatically signals potential health issues. 

The latest episode in the CPHI Podcast Series dives into the world of novel excipients and explores their importance for innovative drug development. 

Researchers develop method to produce organoid materials for disease and drug development research.

Serious concerns have been raised about the quality of landmark Alzheimer’s research, undermining commonly held beliefs about the disease

Fred Hutchinson is sponsoring the Phase 1 trial, while Amazon are contributing scientific and machine learning expertise

Several countries are stepping up vaccination and testing as monkeypox cases continue to climb

The vaccines have been adapted to target the Omicron variant, which has been the dominant variant globally since the beginning of the year 

Evotec and Janssen Pharmaceutica team up to discover novel therapeutic candidates 

The Rwanda site will be the first piece of the company’s African manufacturing network  

Engaging an integrated services partner could reduce risk and speed-up the process for drug sponsors.

The Consortium aims to increase the scale of cell therapy manufacturing to a level impossible with current manual processes. 

The contract development and manufacturing organisation (CDMO) has completed the first phase of its multi-million-pound development. 

The war in Ukraine has forced companies to suspend or delay clinical trials in the region.

What if unpacking medication could be as engaging as unboxing a new iPhone? Could design cues reassure the patient of drug integrity? Step-by-step opening signal ease of use, or empathetic design reduce patient anxiety? 

The expansion will increase production capacity for synthetic pharmaceutical products

Data showed that continuous treatment with Kesimpta was associated with fewer relapses and reduced risk of disability worsening 

The FDA also granted paediatric exclusivity to the oral solution, branded Fintepla.  

Many clinical trials have been put on hold or cancelled due to the war in Ukraine 

Bristol Myers Squibb to leverage Volastra’s CINtech platform to discover and develop oncology drug candidates.  

A redeveloped R&D facility will enhance Seqens' capabilities in developing and producing APIs and active delivery systems development

CellCarta and physIQ announce collaboration on study that could “revolutionise vaccine development.”  

A diverse range of sectors and industries come together in partnership to address infection management, advocating a whole system approach

The agreement marks the second cell line development collaboration between the two companies

The expansion close to company's Martinsried headquarters includes a lyophilisation development centre for advanced therapy medicinal products

The French CDMO is also creating a new global resource for drug developers of ATMPs

How is the pharmaceutical industry tackling the issue of ensuring minority populations are properly represented in clinical trials?

New facility will be research partnering company’s sixth global site and will be dedicated to mammalian biologics

The US facility in Rockville is expected to accelerate the company’s commercial-scale manufacturing timelines of gavo-cel

AI is helping pharma find the drug candidates with the greatest chance of success, according to experts who say therapeutic efficacy and cost reduction are the key dynamics

Adaptive clinical trials have accelerated COVID-19 vaccine development and could make drug R&D more efficient but running such studies is complex and challenging and sponsors need to prepare, say experts

European Commission pressures pharma firm over reduced shipments amid criticism for slow vaccine rollout across block