Drug Development

Protocols: Booming Moderna adds staff, new clinical program; Lilly boasts of R&D gains

As promised, fast-growing Moderna has moved its second program into clinical development. The mRNA specialist now has mRNA 1440 and mRNA 1851, infectious disease vaccine candidates, in early stage studies. And there are eight more headed to the clinic later in the year. The busy clinical agenda at Moderna comes as the company reports a cash cache of 1B and the recent addition of 120 staffers, boosting the total to 440.

Emboldened by some blockbuster candidates in late-stage development, Eli Lilly says it’s ready to commit to steady revenue growth in the years to come. That’s not an idle boast, either. The jury may be out on just how big its CDK 4/6 drug and other candidates may be, but the company is aiming high with promising drugs after a long fallow period.

J&J’s daratumumab, in-licensed from GenMab, has now picked up its second breakthrough designation, this time in combination with standard of care for multiple myeloma. BTD announcements from the oncology group at the FDA have become routine.

Waltham, MA-based X-Chem is putting its discovery platform to work for AbbVie.

The auction process is now taking shape at a bankrupt Bind Therapeutics. The struggling company, operating under Chapter 11 protection, says two unidentified bidders have expressed an interest in buying the company after Pfizer set the opening price at 20M with its stalking horse offer.

Italy’s Newron Pharmaceuticals says it’s ready to resubmit its Parkinson’s drug, 4 months after the FDA handed out a CRL.

Bedford, MA-based Ocular Therapeutics was handed a CRL for Dextenza (dexamethasone insert) 0.4 mg, for intracanalicular use in the treatment of ocular pain occurring after ophthalmic surgery.

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RAPS Regulatory Convergence 2017