Research & Development

Singapore has granted approval for a Phase I/II trial of Arcturus’s next generation mRNA COVID-19 vaccine candidates, hot on the heels of a similar approval from Vietnam earlier this week. The biotech’s share price duly rocketed, but there may be more at play.

Germany’s Boehringer Ingelheim highlighted its clinical-stage research efforts in neuropsychiatry and COVID-19 when describing its first half financial results as solid, despite the continuing impact of the pandemic.

Novartis aims to double the addressable market for its spinal muscular atrophy gene therapy – and catch up to competitors – with the intrathecal version known as OAV-101.

The upcoming filing of Lilly's Alzheimer's antibody donanemab dominated the company's second quarter call. Lilly is also developing a new blood test to confirm diagnosis and a second-generation antibody. 

Positive Phase III topline results follow the US FDA’s acceptance of the drug in cholangiocarcinoma and encouraging data in low-grade glioma at ASCO 2021.

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Sanofi has transformed the productivity of its R&D pipeline over the past several years, and late-stage clinical data readouts are expected in the second half of this year for new anticancer drugs, a candidate pemphigus therapy and a COVID-19 vaccine.

Artios Pharma rides the wave of DDR enthusiasm following the recent signing of big pharma partnerships with a financing to bring its first-in-class cancer treatments into the clinic.

Ipsen has inked a worldwide collaboration pact with BAKX Therapeutics to research, develop, manufacture and commercialize the biotech’s asset BKX-001 as a potential treatment for leukemia, lymphoma and solid tumors.

AGTC hopes to gain the first approval in X-linked retinitis pigmentosa for its gene therapy AGTC-501, now in a Phase II/III study. It also is advancing development in achromatopsia, another unmet medical need.

Deal Snapshot: The company is looking to expand its pipeline beyond Alzheimer’s, where it hit a speedbump in September with the failure of a tau-targeting drug.

A surprise surge in Roche's R&D spending this year reflects high quality in-house innovation opportunities as well as high prices for external M&A targets, management said.