​​​​​​​Synlogic backs onto Nasdaq by merging with Mirna

​​​​​​​Synlogic has landed a Nasdaq listing and an $82 million cash pile by simultaneously pulling off a reverse merger with Mirna Therapeutics and a series C round. The activity tees up the Jose Carlos Gutierrez-Ramos, Ph.D.-helmed synthetic biology startup to push its lead candidate into the clinic in the coming months.

Cambridge, Massachusetts-based Synlogic turned to a mix of new and existing investors including Arctic Aurora LifeScience, Atlas Venture, CLI Ventures, New Enterprise Associates (NEA) and OrbiMed for the $42 million series C. That round comes 15 months after Synlogic pulled in $40 million in a series B. And, when combined with the cash Mirna has left from its failed tilt at drug development, gives the company $82 million to fuel its move into the clinic.

READ MORE Synlogic backs onto Nasdaq by merging with Mirna

G1 pitches IPO to advance lung and breast cancer candidates

G1 Therapeutics thinks it has a winner on its hands with CDK4/6 inhibitor trilaciclib and is embarking on an initial public offering to give it the resources it needs to bring it to market.

The Research Triangle Park biotech says it is hoping to raise around $115 million from the IPO, which comes a little over a year after G1 raised $47 million in a venture round on the strength of some early-stage data for its lead drug.

Going public signals G1's increasing confidence  in trilaciclib (G1T28), which is in the same class as Pfizer's Ibrance (palbociclib)—the first drug of this type to reach the market in 2015 and already a $2 billion-a-year blockbuster—and Novartis' new entrant Kisqali (ribociclib). Eli Lilly is also nipping at the CDK4/6leaders' heels with its abemaciclib prospect, due to report late-stage data shortly.

READ MORE G1 pitches IPO to advance lung and breast cancer candidates

Bayer cancer drug boards path to speedy approval at FDA

The FDA has granted priority review status to Bayer’s copanlisib, setting the PI3K inhibitor up to speed through the regulatory process in 6 months or less. Bayer secured the privileged position on the strength of data from a midphase trial in patients with non-Hodgkin lymphoma (NHL).

Landing the regulatory status means Bayer will learn whether the FDA shares its enthusiasm for copanlisib within 6 months, rather than the 10 months the agency typically takes to review drugs. The precedent set by other cancer drugs with priority review status suggests the FDA may make a decision about copanlisib in less than 6 months if it is particularly bowled over by the data.

READ FULL STORY HERE- Bayer cancer drug boards path to speedy approval at FDA

Gottlieb tells staffers FDA can help—indirectly—to cut medicine prices

New FDA Commissioner Scott Gottlieb delivered his first address to agency workers yesterday, and tackling high drug prices featured prominently in the speech.

The speech trod some territory that will be familiar to those paying attention to President Trump's pronouncements on the future of the FDA, with efforts to reduce medicine pricing and improve the efficiency at the agency sitting alongside pledges to reduce smoking rates and tackle the greatest immediate challenge" of rampant opioid abuse.

Read more here Gottlieb tells staffers FDA can help—indirectly—to cut medicine prices