Forge Therapeutics Inc. spinout Blacksmith Medicines Inc. said Eli Lilly and Co. has committed up to $300 million in milestone payments to back its creation of five new immuno-oncology and inflammation-focused medicines targeting human metalloenzymes.
The U.S. Department of Health and Human Services (HHS) released an advisory opinion last week saying that drug manufacturers are obligated to provide 340B pricing for outpatient drugs dispensed by contract pharmacies on behalf of hospitals and clinics that qualify for the discounts. But the opinion said nothing about enforcement action or assessing civil penalties against manufacturers who refuse to do so.
Although it held off on a proposed rule change addressing yet another gaming opportunity for drug manufacturers in the U.S., the Centers for Medicare & Medicaid Services (CMS) still is pressing its policy for including more 505(b)(2) drugs in multiple source reimbursement codes, which could force them to compete with generics on price.
Prevail Therapeutics Inc. won't be prevailing on its own. Eli Lilly and Co. is acquiring the gene therapy company for $880 million up front plus an earn-out of up to $160 million if Lilly can gain regulatory approval for at least one of Prevail's drugs.
The latest global regulatory news, changes and updates affecting biopharma, including: Canada moves to make some COVID-19 flexibilities permanent; Industry group forms to advance subcutaneous technology.
In what the FDA calls “an incremental step” in treating hospitalized COVID-19 patients, the agency has issued an emergency use authorization (EUA) for Eli Lilly and Co.’s baricitinib in combination with remdesivir.
Precision Biosciences Inc. CEO Matthew Kane said the company is in “active discussions around additional partnerships in vivo and in other areas across our organization,” after scoring a deal with Eli Lilly and Co. centered on the firm’s Arcus genome-editing platform. “There’s no conceivable way in the near term that we’re going to advance all of the possibilities of Arcus on our own,” he said.
If the FDA’s opening meeting Nov. 19 on the reauthorization of BsUFA is anything to go by, interchangeability could be a key part of the next round of U.S. biosimilar user fee negotiations.
Seed Therapeutics Inc. signed a massive deal with Eli Lilly and Co. on Nov. 12, a date that resonated deeply with Seed’s CEO, Lan Huang. Twenty-one years earlier to the day she published a pioneering paper on cancer signaling pathways involving p53 degradation in Science. “It’s a magical coincidence that exactly 21 years later we have this deal with Lilly,” she told BioWorld, a deal with protein degradation at its core. In the new research collaboration and license agreement, Seed will receive $10 million cash up front to fund research along with a $10 million equity investment from Lilly.
Now that the FDA has granted emergency use authorization to Eli Lilly and Co.’s bamlanivimab, the company plans to manufacture up to 1 million doses of the therapy by year-end with worldwide distribution to mild to moderate COVID-19 patients ages 12 and older in early 2021.
