Tony Coles (Credit: Yumanity)

Tony Coles sets sail on new neu­ro pur­suit at Cerev­el, steer­ing Pfiz­er spin­out as CEO

For nine months, Tony Coles has been watching closely as Adam Koppel and Bain’s life sciences team built Cerevel from the ground up, offering insights into its neuroscience pursuit as executive chairman while staying at the helm of his own biotech. But now that he has passed the reins at Yumanity to Richard Peters, Coles is completing the flip — and the top team puzzle — by taking the chief executive role at Cerevel.

“I’m excited because I get double the opportunity to play a role in two important companies,” Coles noted in an interview with Endpoints News.

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5AM Ven­tures: Fu­el­ing the Next Gen­er­a­tion of In­no­va­tors

By RBC Capital Markets
With Andy Schwab, Co-Founder and Managing Partner at 5AM Ventures

Key Points

Prescription Digital Therapeutics, cell therapy technologies, and in silico medicines will be a vital part of future treatment modalities.
Unlocking the potential of the microbiome could be the missing link to better disease diagnosis.
Growing links between academia, industry, and venture capital are spinning out more innovative biotech companies.
Biotech is now seen by investors as a growth space as well as a safe haven, fuelling the recent IPO boom.

Biohaven CEO Vlad Coric (Photo Credit: Andrew Venditti)

Pssst: That big Bio­haven Alzheimer's study? It was a bust. Even the sub­group analy­sis ex­ecs tout­ed was a flop

You know it’s bad when a biopharma player plucks out a subgroup analysis for a positive take — even though it was way off the statistical mark for success, like everything else.

So it was for Biohaven $BHVN on MLK Monday, as the biotech reported on the holiday that their Phase II/III Alzheimer’s study for troriluzole flunked both co-primary endpoints as well as a key biomarker analysis.

The drug — a revised version of the ALS drug riluzole designed to regulate glutamate — did not “statistically differentiate” from placebo on the Alzheimer’s Disease Assessment Scale-Cognitive Subscale 11 (ADAS-cog) and the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB).  The “hippocampal volume” assessment by MRI also failed to distinguish itself from placebo for all patients fitting the mild-to-moderate disease profile they had established for the study.

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Janet Woodcock and Joshua Sharfstein (AP, Images)

Poll: Should Joshua Sharf­stein or Janet Wood­cock lead the FDA from here?

It’s time for a new FDA commissioner to come on board, a rite of passage for Joe Biden’s administration that should help seal the new president’s rep on seeking out the experts to lead the government over the next 4 years.

As of now, the competition for the top job appears to have narrowed down to 2 people: The longtime CDER chief Janet Woodcock and Joshua Sharfstein, the former principal deputy at the FDA under Peggy Hamburg. Both were appointed by Barack Obama.

Janet Woodcock (AP Images)

Janet Wood­cock is in the run­ning for FDA com­mis­sion­er — what does that mean for the agen­cy's fu­ture?

Just a day after reports emerged that Janet Woodcock will serve as interim chief of the FDA, word has gotten out that she is also in the running for the permanent job.

The decision, as the initial wave of reactions suggest, could have dramatic implications for where the agency is headed in the next four years — if not beyond.

Woodcock, the longtime CDER director, is being vetted alongside former FDA principal deputy commissioner Joshua Sharfstein, Bloomberg reported. Already tapped as acting head of the agency, she’s set to take over from Stephen Hahn right after Biden’s inauguration next week.

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Dan Skovronsky, Eli Lilly CSO (Lilly via Facebook)

Eli Lil­ly tees up dis­cov­ery pact worth more than $1.6B with Merus for T cell-fo­cused bis­pe­cif­ic an­ti­bod­ies

Under science chief Dan Skovronsky, Eli Lilly has taken some big swings at next-gen therapies, including trying to find the next big thing in oncology. Now, after one early failure in the field, Lilly is going back to the bispecific antibody well with a new deal with a Dutch biotech.

Lilly will pay $40 million upfront with an additional $20 million equity stake in Merus NV to identify and develop three bispecific antibodies looking to engage the CD3 antigen on T cells and redirect immune cells, the Indianapolis pharma giant said Tuesday.

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Francesco Marincola (Kite)

Gilead­'s Kite re­cruits an Ab­b­Vie/NIH vet­er­an to head up cell ther­a­py R&D. And he's tak­ing aim at AML in a fe­ro­cious­ly com­pet­i­tive field

Four months after Kite R&D exec Peter Emtage jumped ship to sign on with Versant as a CEO-in-waiting, the big Gilead sub has recruited immuno-oncology expert Francesco Marincola to take his place as head of cell therapy research — putting him in a prominent position in a booming field.

Marincola has been making the rounds to a certain extent as cell therapy took hold as one of the hottest fields in drug R&D. He made his rep at the NIH — where he spent 23 years, 15 as head of the Infectious Disease and Immunogenetics Section at the NIH Clinical Center — and then jumped to AbbVie, where he guided I/O discovery strategy. The research exec spent close to 3 years in his last post as CSO at Refuge Biotechnologies.

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Eric Lander, Office of Science and Technology Policy nominee (Matt Slocum/AP Images)

Biden el­e­vates White House sci­ence of­fice to Cab­i­net-lev­el, with ge­neti­cist Er­ic Lan­der put for­ward to lead pol­i­cy

As incoming President-elect Joe Biden fills out his administration, he has plans to elevate a longtime White House office to a Cabinet-level agency — and has tapped a prominent geneticist to lead its efforts.

Biden will nominate Eric Lander to head up the Office of Science and Technology Policy, his transition team announced last Friday, in a move the President-elect said will emphasize the focus of science in his government. In addition to being a mathematician, Lander was a key leader of the team that mapped the human genome in 2003 and founded the Broad Institute at MIT, which is famous for its work with CRISPR-Cas9 technology.

Andrew Allen (Gritstone)

As coro­n­avirus vari­ants trig­ger new alarms, the NIH is putting an un­der-the-radar ‘next-gen’ vac­cine in­to PhI

Over the past year, the world has been transfixed by the development of new vaccines to fight SARS-CoV-2. In a frenzy of activity, the new mRNA approach has delivered pioneering emergency approvals in record time. And with some setbacks, the more traditional big players are coming along with added jabs as the most affluent nations in the world begin to vaccinate large portions of their populations.

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Janet Woodcock (AP Images)

Janet Wood­cock to be act­ing FDA com­mis­sion­er while Biden team fi­nal­izes nom­i­nee — re­ports

Janet Woodcock is set to be the most powerful person at the FDA in less than a week.

The veteran regulator and longtime director of the Center for Drug Evaluation and Research has been tapped as acting commissioner of the FDA, according to reports by BioCentury’s Steve Usdin and Pink Sheet’s Sarah Karlin-Smith.

The appointment was requested by the incoming Biden team, Karlin-Smith added, as they sort out the nomination of a permanent successor to Stephen Hahn — whose one-year tenure has been defined by Covid-19.

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