News

AbbVie and Biogen inch toward the FDA with once-a-month MS drug

Partners Biogen Idec and AbbVie are touting late-stage results for their new, monthly multiple sclerosis treatment, preparing to hand in regulatory applications next year and contend in a crowded market.

Oxygen Bio halts work on brain injury drug over enrollment woes

Oxygen Biotherapeutics' rollercoaster development of a brain injury treatment has come to a grinding halt, as the biotech has put an end to a mid-stage trial on the drug and is looking to move on.

Clavis' Hellebø takes the helm at Sir Chris Evans-backed ReNeuron

Welcome to this week's Chutes and Ladders, our roundup of hirings and retirings throughout the industry. Please send the good word--or the bad--from your shop to Michael Gibney (email | Twitter)...

Merck KGaA scraps a controversial PhIII comeback attempt for cancer vaccine

About a year ago Merck KGaA made the controversial decision to revive its late-stage program for the cancer vaccine Stimuvax, trying to start off fresh by renaming it tecemotide and pointing it toward a subpopulation of non-small cell lung cancer patients which appeared to respond in its very big failed Phase III. Today, the program is--once again--officially terminated.

Novartis commits $20M to build a new CAR-T development center at Penn

Novartis is contributing $20 million to build a new, 30,000-square-foot research center at Penn that will concentrate on developing a wave of new immuno-oncology drugs.

FDA panel backs Novo's weight-loss plan with new liraglutide nod

Novo Nordisk convinced a group of FDA advisers that its liraglutide, already a blockbuster diabetes treatment, can effectively combat obesity, clearing the way for a second indication that could add $1 billion to its annual sales.

Google's stealthy Calico inks an R&D deal for new compounds aimed at neurodegeneration

Google's stealthy biotech upstart Calico announced today that it has inked its first licensing pact with UT Southwestern in Dallas to gain development rights to protective P7C3 compounds that appear to guard against Parkinson's disease, amyotrophic lateral sclerosis and depression and set up labs in the Dallas area to support its development program.

Baxalta: Baxter's newly named biopharma spinout has had its ups and downs

First there was AbbVie, the new biopharma company created by the big Abbott split. And now comes Baxalta, the new moniker for Baxter's drug spinoff, which is reportedly plotting a big move to the Boston/Cambridge hub.

Hunt for next Sovaldi leads to $150M deal, Poxel raises €10M, AbbVie backs AM-Pharma round

In this week's EuroBiotech Report, the search for the drug that can do to hepatitis B what Sovaldi does to hepatitis C led OnCure BioPharma to Sweden to strike a $150 million (€116 million) deal with NeuroVive Pharmaceutical. And more.

ACT, ex-CEO hit with $550K in SEC penalties for keeping mum on insider stock sales

Between 2010 and 2012 Gary Rabin, then CEO of the stem cell player Advanced Cell Technology, sold $1.5 million worth of his shares in 27 transactions. But according to the SEC, Rabin never told investors of his stock sales--a strict no-no that is now costing the ex-CEO a $175,000 penalty, with the Marlborough, MA-based biotech company agreeing to fork over $375,000 as it reviews its compliance policy.

Virobay tees up a $50M IPO to get a trio of candidates into Phase II

Menlo Park, CA's Virobay is lining up for a Wall Street debut, filing to bank $50 million in an IPO and accelerate its pipeline of treatments for pain and autoimmune diseases.

Sanofi keeps the faith in MS and eyes a new dawn for Genzyme

Despite an FDA rejection and changing winds in the field of multiple sclerosis, Sanofi believes its Genzyme unit is on an upward trajectory, talking up potential deals and could-be blockbusters for its pricey acquisition.

UPDATED: Orexigen nabs long-awaited FDA approval for obesity drug Contrave

More than three long years after Orexigen was turned back at the FDA and forced to do a costly late-stage safety study of its weight drug Contrave, the agency has come back and given its seal of marketing approval to the drug.

Roche abandons another Fragile X R&D program after PhII trials flunk out

A long, rough patch in Fragile X syndrome drug R&D just got longer and rougher. Roche has notified patient groups that both of its mid-stage studies for RG7090--an mGluR5 therapy--failed to hit the primary and secondary goals, prompting the pharma giant to shut down the program.

Gates Foundation adds $50M to help speed Ebola drug development efforts

As government health agencies and industry players ramp up efforts to bring experimental therapies as quickly as possible to people affected by the Ebola outbreak in West Africa, the Bill and Melinda Gates Foundation said Wednesday that it is putting up $50 million to aid drug development and outbreak response efforts.

Clal, Evotec take a hit after Hyperion claims it was defrauded in diabetes deal

Shares of Israel's Clal Biotechnologies took a nasty hit after Hyperion alleged that it was being forced to drop a diabetes drug obtained in its buyout of Andromeda from Clal.

NPS jumps as FDA reviewers take little issue with orphan drug

NPS Pharma is moving toward FDA approval with its treatment for a rare disease, as agency staff applauded the drug's efficacy ahead of a make-or-break panel vote.

Xenon pitches Genentech, Teva 'extreme genetics' ties as it rolls out a $52M IPO

Xenon Pharmaceuticals has gone 8 long years since its last equity raise, relying on a slate of partnerships with some of the biggest names in the business to fund its work. And now it's set out to test the fall biotech IPO market with a $52 million offering designed to take the company down another stage of its journey through the clinic.

FDA panel spurns Actavis' cardio combo, jeopardizing its potential

A group of FDA advisers voted against recommending approval for a new combination blood-pressure treatment from Actavis, clouding the future of a prospect the company picked up in its $28 billion buyout of Forest Laboratories.

Genmab re-ups with Seattle Genetics on a $211M armed antibody cancer drug pact

Genmab is taking its cancer drug collaboration with Seattle Genetics one more step forward. The Danish biotech is handing over an $11 million upfront and promising up to $200 million more to get the right to use Seattle Genetics' antibody-drug conjugate technology for its HuMax-AXL program.