DUBLIN – Merus NV is banking $40 million up front, plus an equity investment of $20 million, under a research collaboration and license agreement with Eli Lilly and Co.’s Loxo Oncology arm to develop up to three CD3-directed bispecific T-cell engager antibodies. Each program also has up to $540 million attached in development and commercialization milestones, taking the total potential value of the deal to $1.68 billion. Merus would also receive tiered royalties on any product sales, ranging, in percentage terms, from mid-single-digits to low-double-digits. Read More
Aclaris Therapeutics Inc. CEO Neal Walker said “a lot of room within rheumatoid arthritis [RA]” remains for new drugs, such as his firm’s orally delivered ATI-450. “We see opportunities given the profile, the relative efficacy and safety that we've already demonstrated, to look at not only potentially monotherapy or earlier treatment of disease but also combo treatment, particularly given the safety profile. I think it's pretty well-known that polypharmacy is the rule in this indication.” Read More
The 39th Annual J.P. Morgan Healthcare Conference was sans Celgene Corp.'s annual tradition of kicking off the conference with preliminary revenue and earnings from the previous year, but plenty of other companies stepped up and offered preliminary results of their own. Unfortunately, some companies continued to face headwinds selling drugs during the pandemic as patients avoided their doctors' offices. Read More
CAJICA, Colombia – Brazil’s health care surveillance agency, Anvisa, granted the first two emergency approvals for COVID-19 vaccines on Sunday, Jan. 17, giving the green light to Sinovac Biotech Ltd.’s Coronavac and to Covishield, developed by Astrazeneca plc and the University of Oxford. Read More
Sekar Kathiresan is building Verve Therapeutics Inc. around the concept of a one-and-done treatment for cardiovascular disease because only half of patients are disciplined enough to take a statin every day. “That’s a huge issue for durable cholesterol lowering after a heart attack,” Verve’s CEO and co-founder told BioWorld. Read More
LONDON – A remodeled Rexgenero Ltd. has launched as an integrated cell and gene therapy specialist, following integration of a French biotech acquired last year and a commitment from the company’s two shareholders to invest £40 million (US$54 million). Read More
Luye Pharma Group Ltd. won marketing approval in China for its risperidone microspheres for injection to treat schizophrenia, which the company said is the first formulation developed by a Chinese company in the space to get a green light. Under the trade name Ruixintuo, the long-acting drug is administered once every two weeks by intramuscular injection. Read More
PERTH, Australia – The majority of medical device and biopharma industry respondents agreed that Australia’s Therapeutic Goods Administration (TGA) responded effectively to COVID-19, but they want to see the agency improve its processes to act faster and with more clarity, according to the TGA’s annual stakeholder survey. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Bioinvent, C4, Dr. Reddy's, Genmab, Gracell, Immunitybio, Khondrion, Metacrine, Molecular Templates, Omeros, Pieris, Precision, Steba, Takeda, Tessa, Tracon, Transgene. Read More
