Category: Research and Development

June 17, 2022

The company says it plans to use a “flexible” model, drawing on both decentralised trial (DCT) and conventional site-based models via its Health Corner and Village Medical outlets at various Walgreens locations across the US. The move follows in the […]

June 16, 2022

The result isn’t a big surprise – Roche terminated two phase 3 trials of crenezumab in people with prodromal to mild sporadic Alzheimer’s in early 2019 after interim analyses found it would be futile to continue – but is another […]

June 15, 2022

When vaccines became available earlier in the COVID-19 pandemic, countries vied for supply contracts. However, as the need for vaccines begins to slow in Europe, some countries want to amend their contracts to reduce spending and to prevent receiving more […]

June 14, 2022

Alnylam, a pioneer in the drugmaking method known as RNA interference, has climbed the biotech industry ranks over the last two decades. After solving challenges associated with delivering these treatments into the body, Alnylam has become one of the sector’s […]

June 14, 2022

China’s emergence as an R&D powerhouse means that the country is quickly adding a number of drug candidates to the global pipeline. Despite more treatment options being a positive, Ben Hargreaves finds that this has raised issues over single-region clinical […]

June 9, 2022

While recent years have seen scientists make major advances in cutting-edge treatments such as gene and cell therapies, manufacturing remains a significant hurdle. The complex, multi-step processes required are beyond the capabilities of a traditional pharmaceutical plant. That’s where Resilience […]

June 9, 2022

Regenxbio recently celebrated the opening of its new Manufacturing Innovation Center gene therapy manufacturing facility. “Launching operations at our Manufacturing Innovation Center is an important milestone in the evolution of REGENXBIO,” said Kenneth T. Mills, president and CEO of REGENXBIO. […]

June 2, 2022

Sana Biotechnology, which raised a whopping $588 million in its initial public offering last year, has inked a deal for new manufacturing space. The preclinical-stage biotech is ditching plans to run its manufacturing operations in Fremont, California, and instead plans […]

June 1, 2022

Sanofi’s effort to switch erectile dysfunction pill Cialis to over-the-counter (OTC) availability from its original prescription status has been slowed to a grinding halt with the FDA’s decision to put a trial on hold. The FDA halted an “actual use […]

May 26, 2022

Moleculin Biotech, Inc., (“Moleculin” or the “Company”), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, today announced the commencement of dosing in its first-in-human Phase 1a study to evaluate the […]

May 23, 2022

Six weeks after slapping a clinical hold on a trial of Ocugen’s COVID-19 vaccine, the FDA has lifted it. That’s the good news for the Malvern, Pa. company, which has partnered with India’s Bharat Biotech on the shot known commercially […]

May 20, 2022

The FDA has sounded a warning about Foghorn Therapeutics’ blood cancer candidate FHD-286, putting a phase 1 clinical trial on a partial hold in response to the death of a patient with potential differentiation syndrome. FHD-286 is an enzymatic inhibitor […]