May 15, 2020 - Fierce Pharma
Gilead Sciences had barely rushed its COVID-19 drug remdesivir into mass production when it started touting the potential benefits of alternate formulations of the IV drug, including an inhaler that moderately ill patients could use at home. The company says it’s already working on developing inhaled remdesivir as well as a version that could be injected under the skin.
But for those easy-to-administer renditions of remdesivir to contribute to Gilead’s top line, the company will first have to demonstrate the drug makes a meaningful impact on moderately ill patients—and that won’t be easy, JPMorgan analyst Cory Kasimov warned investors in a note earlier this week.
In fact, Kasimov said, “remdesivir is unlikely to result in tangible long-term cash flows,” and the expected $5 billion short-term boost to sales from the drug will have a “marginal impact” on the company’s valuation going forward, Kasimov added.
May 13, 2020 - BioPharma Dive
Instruments maker Thermo Fisher plans to spend $180 million to build a 290,000-square-foot site that will double capacity to make viral vectors, the inactivated viruses used to convey gene therapies into human cells. The contract development and manufacturing organization plans to complete work on the facility in Plainville, Massachusetts, in 2022 and add more than 200 jobs.
Thermo's investment is the latest in a series of expansions designed to meet growing demand for gene therapies and vaccines, the company said in a May 11 statement.
May 12, 2020 - Fierce Biotech
In what will be of little surprise to anyone, the FDA has hitched its fast-track tag to Moderna’s speedy attempt at an mRNA COVID-19 vaccine.
The
label
, which aims to help speed up the time a new drug or vaccine takes to hurdle the normal regulatory barriers, is specifically for mRNA-1273, which is hoping for a phase 3 summer trial to assess whether it can protect people from COVID-19.
“Fast Track designation underscores the urgent need for a vaccine against the novel coronavirus,” said Tal Zaks, M.D., Ph.D., chief medical officer at Moderna. “As we await the full set of clinical data from the NIAID-led phase 1 study, we are actively preparing for our phase 2 and phase 3 clinical studies to continue learning about the potential of mRNA-1273 to protect against SARS-CoV-2.”
May 11, 2020 - Fierce Pharma
After winning a small grant for early vaccine work in March, Novavax just won the largest-ever investment from CEPI, a global coalition aiding COVID-19 vaccine development.
The grant of up to $384 million from the Coalition for Epidemic Preparedness Innovations will fund Novavax’s COVID-19 vaccine testing through phase 2, plus early work to scale-up manufacturing. The funding follows a $4 million award back in March.
The Maryland biotech will use the funds to conduct a phase 1/2 trial on its candidate, NVX-COV2373, starting with the phase 1 portion in Australia this month. After phase 1 results—expected in July—the phase 2 portion is slated for multiple countries, Novavax said.
May 11, 2020 - Fierce Pharma
Pfizer has dedicated enormous resources to churning out hundreds of millions of doses of a possible COVID-19 vaccine. But that massive effort requires a trade-off: Pfizer will have a hard time meeting production goals for its existing meds and will look to its contractor network to help keep up.
Pfizer plans to outsource production of some of its drug portfolio to make way for a rapidly growing vaccine manufacturing effort, the company said Monday.
The drugmaker will lean on its 200-strong network of contractors as part of a plan to "build a robust U.S.-based supply chain as well as one based in Europe," a Pfizer spokesperson said.
