Christopher Haqq joins Elicio to hunt father’s RAS cancer; Kronos expands top team with Gilead, Baylor vets

October 25, 2019 10:34 AM EDTUpdated 03:03 PM

Endpoints Staff

Christopher Haqq joins Elicio to hunt father's RAS cancer; Kronos expands top team with Gilead, Baylor vets

Christopher Haqq’s father taught him how to build volcanoes in their backyard. He was a beloved chemistry teacher for 30 years who inspired many students, Haqq says, and sent him down a path through volcanoes and up into oncology.

Christopher Haqq

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Communicating the value of precision medicine

By Natasha Cowan, Content Marketing Manager at Blue Latitude Health.
Many stakeholders are confused by novel precision medicines, including patients and healthcare professionals. So, how can industry help them to navigate this complexity?

Precision medicine represents a new paradigm in healthcare. It embodies the shift from treating many patients with the same therapy, to having the tools to identify the best treatment for every patient.

November 11, 2019 06:00 AM ESTUpdated 11:53 AM

Endpoints Staff

People

R&D

Special report: Twenty extraordinary women in biopharma R&D who worked their way to the top

What differentiates a woman leader in biopharma R&D from a man?

Not much, except there are fewer of them in senior posts. Data suggest women are not more risk-averse, family-oriented or less confident than their male counterparts — indeed the differences between the two sexes are negligible. But a glance at the top R&D positions in Big Pharma leaves little doubt that upward migration in the executive ranks of biopharma R&D is tough.

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November 12, 2019 10:44 AM EST

Jason Mast

R&D

Editas and Celgene sub Juno are tackling hottest immunotherapy cells

As the first CRISPR-edited cancer patients watch their treatments unfold, one of the first CRISPR companies is rejigging a major oncology deal.

Editas Medicine is amending its long-running collaboration with Celgene and their subsidiary Juno Therapeutics. The new deal will expand the focus of their work to cover a subset of immune cells that have become an increasingly hot target for immunotherapy: gamma-delta cells.

ENDPOINTS CAREERS

Associate Medical Director/ Medical Director

Cold Genesys, Inc.

Irvine, CA

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November 12, 2019 08:47 AM ESTUpdated 10:47 AM

John Carroll

R&D

FDA Vascepa review spotlights new safety signals, possible mineral oil spoiler as Amarin hunts a blockbuster approval

An in-house FDA review of Amarin’s Vascepa raises a set of hurdles the biotech will have to clear if the biotech expects to get the long-awaited FDA approval that could set it on a path to superstar status. But it appears that Amarin has survived another potential setback without introducing a major new threat to its prospects.
The stakes don’t get much higher, with analysts saying a win this week for Amarin could lead to billions in new sales — provided the agency stamps it with an OK. And investors liked what they say in the FDA review this morning, bumping the stock $AMRN 17%.
The insider take at the agency includes a note on two new safety signals seen in the big cardio outcomes study of the omega-3 fatty acid drug that shocked many analysts with a solid set of efficacy data. There’s a key concern over whether the use of mineral oil in the placebo skewed LDL levels in such a way that tilted the data in Amarin’s favor.
The FDA overview was written by John Sharretts, the acting deputy director in the Division of Metabolism and Endocrinology Products.
On the safety side, the internal review focused on a 3.1% versus 2.1% rate of adjudicated events of atrial fibrillation or atrial flutter requiring hospitalization. But they also say a-fib shouldn’t confound the benefit-safety of the drug — given the improvement on MACE — or prevent its use. And then there was also a higher rate of bleeding events in the drug arm.

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Prakash Raman. Flagship

November 12, 2019 10:13 AM ESTUpdated 11:22 AM

Amber Tong

People

Venture

Flagship woos Novartis top dealmaker Prakash Raman in move to get the BD ball rolling early

Flagship Pioneering likes to be ahead of its times — so far ahead, perhaps, that it is often challenging to find partners for their startups while the scientific scaffolding is underway. But Prakash Raman is here to change that.

Raman, who most recently headed up business development at the Novartis Institutes for BioMedical Research, became Flagship’s first chief business development officer two weeks ago. By acting as a “central resource” for the 100 companies in the venture fund’s portfolio, he hopes to help entrepreneurs and management teams strategize about dealmaking to capture value beyond the near-term validation of their platform technologies, Raman told Endpoints News.

November 12, 2019 07:15 AM ESTUpdated 07:35 AM

John Carroll

R&D

FDA puts Solid Bio’s lead gene therapy program on hold — again — after another patient is hurt by SGT-001

Solid Biosciences continues to be plagued by safety issues.

Close to 18 months after the gene therapy biotech was able to quickly shed an FDA hold on their lead Duchenne muscular dystrophy program for SGT-001, regulators have stepped back in to force another halt after another patient was hit hard by a set of serious adverse events remarkably similar to the first set.

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Bill Haney, Skyhawk

November 12, 2019 09:04 AM EST

John Carroll

R&D

Celgene execs shell out $92M cash for a pair of R&D deals that will fit perfectly in their new home at Bristol-Myers

With Bristol-Myers Squibb’s Celgene buyout all but complete, the BD teams are working in perfect synchrony now. The Celgene side is going back to Skyhawk, a darling of the crowd that set out to drug RNA, and they’re adding a suite of new programs that mesh perfectly with the new regime in charge.

Celgene is shelling out $80 million in a cash upfront to add oncology, immuno-oncology and autoimmune diseases to the initial roundup of neurological targets mapped early in Skyhawk’s existence.

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ENDPOINTS CAREERS

Director, Safety Assignment

Battelle Memorial Institute

Columbus, OH

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November 12, 2019 09:02 AM EST

Natalie Grover

R&D

Reata's bardoxolone offers promise in patients with rare kidney disorder

After surprising Wall Street with positive data on its drug, omaveloxolone, in patients suffering from a notoriously hard-to-treat degenerative neuromuscular disorder last month, Reata Pharma on Monday unveiled pivotal results from a trial testing another drug, bardoxolone, in patients with a rare, genetic form of chronic kidney disease for which there exist no approved therapies.

Bardoxolone, like Reata’s other lead drug — omaveloxolone — is a small molecule engineered to bind to a gene called Keap1 to enhance the activity of the protein Nrf2 in order to defuse inflammation.

November 12, 2019 07:31 AM ESTUpdated 07:42 AM

Jason Mast

R&D

Kadmon waxes rhapsodic on cGVHD results as race with Jakafi heats up

A year ago, Kadmon piqued cautious interest and sent its stock up 20% when it announced positive results from a tiny proof-of-concept study on a new, chronic graft-versus-host-disease treatment. Now interim results are out on the pivotal, and not just the biotech’s executives are gushing about it.

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