News

EMA board agrees to approve revised trial data policy

The management board of the European Medicines Agency (EMA) agreed on June 12 to approve a new policy that would require drug companies to share certain clinical trial data with the public. It says it has added "more user-friendly amendments," including one that will allow patients to "download, save and print the trial data for academic and noncommercial research purposes."

Could the cunning use of CVRs save a Pfizer-AstraZeneca merger?

With AstraZeneca's CFO telling investors that Pfizer's colossal takeover bid failed purely because it was too cheap, creative dealmakers are looking at new ways to get the two parties shaking hands.

OncoMed hits the brakes on cancer studies after troubling safety signs

Cancer biotech OncoMed Pharmaceuticals voluntarily halted dosing and enrollment in two early studies after patients experienced bone damage, sending its shares down roughly 20%.

CEO John Johnson jumps ship as Dendreon sinks lower

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

Analyst: Amgen's moonshot R&D spending is bad for business

Amgen is hardly gun shy about high-risk, high-reward R&D bets, but the Big Biotech's swing-for-the-fences approach to research is bad for the bottom line, according to Bernstein analyst Geoffrey Porges. 

UPDATED: With early data looming, Celgene grabs rights to Agios' leukemia drug

Not long after Agios was established, Celgene leaned in early to grab options on the preclinical cancer drug programs in the biotech's pipeline, paying $130 million upfront to land the deal and extending their option arrangement last year with another $20 million offering. This morning, with Phase I data on a lead program due for public review this weekend, Celgene pounced, agreeing to exercise its option and provide a package of milestones worth up to $120 million to obtain the rights on AG-221.

Merck keeps the checkbook open after its $3.9B Idenix deal

Fresh off signing a blockbuster deal for hepatitis C drug developer Idenix Pharmaceuticals, Merck R&D chief Roger Perlmutter said his company won't shy away from buying big into biotech, provided there are promising medicines at stake.

EC probes patent box tax breaks, VBL plans $75M IPO, Selvita bags cash for PhI

In this week's edition of the EuroBiotech Report, the European Commission is investigating the United Kingdom's patent box--which partly motivated Pfizer's pursuit of AstraZeneca--and other tax laws in the region. And more.

Sanofi, Regeneron add positive PhIII data on key RA drug

Sanofi and its close development partner Regeneron added some positive year-long results to the promising Phase III rheumatoid arthritis data that they've been gathering on sarilumab, an antibody that is billed as one of the pharma giant's top late-stage drug prospects.

J&J teams with Glaxo's ViiV on an HIV combo treatment

Johnson & Johnson has signed a deal with ViiV Healthcare, the HIV-focused venture majority-owned by GlaxoSmithKline, to spin their two antivirals into a single tablet, potentially sparing patients from some harsh side effects associated with current therapies and challenging Gilead Sciences' dominance in the field.

Is the biotech bubble back?

The biotech sector proved to be last year's darling of irrational exuberance, seeing a whole slate of small-cap companies surge in value. Over the last few months, though, swelling hopes gave way to a painful correction, especially after a series of clinical-stage disasters.

Merck KGaA tackles hot immuno-oncology field in partnership with MorphoSys

MorphoSys has notched another high-profile pharma partnership on its belt of antibody deals, and it's set its sights on immune checkpoint inhibitors. With this pact, Merck KGaA is also staking out a position on the growing roster of companies scrambling to find a profitable place for itself in immuno-oncology.

J&J helps bankroll a $55M gamble on partner Aduro's PhIIb cancer drug study

With the ink still drying on a $365 million deal to in-license rights to a therapeutic cancer vaccine and immunotherapy tech at Aduro BioTech, J&J is back with the news that it is also helping to bankroll the company's research work, jumping into a syndicate which has pledged $55 million to fuel an advanced drug study.

Geron's cancer drug shakes off one FDA hold but remains on pause

The FDA has loosened its grip on imetelstat, Geron's in-development blood cancer treatment, lifting a partial clinical hold on a Mayo Clinic-sponsored study of the drug. However, a separate agency hold on the company's own Phase II trials remains in effect, tying Geron's hands with its one and only candidate.

AstraZeneca extends global shopping spree with $232M asthma drug deal

AstraZeneca's executive crew extended one of the biggest shopping sprees in the industry with a pact, in-licensing rights to a drug from Synairgen that targets the viral infections that afflict the respiratory tracts of asthma patients. And the little biotech's shares soared on the news.

Billionaire Thiel backs biotech startups with eyes on Alzheimer's, GI disease

Breakout Labs, a science investing venture from PayPal billionaire Peter Thiel, is staking three biotechs at work on early-stage therapies for Alzheimer's disease, gastrointestinal disorders and bone surgery.

Old Roche R&D campus in NJ faces the wrecking ball

Developers are razing most of the 40 buildings in the complex, prepping for a sale of the campus either as one parcel or building-by-remaining-building.

Hostile Allergan bid is part of Valeant's war on 'value-destroying' R&D

As Valeant mounts a $53 billion hostile bid for Allergan, rivals, analysts and investors are wondering whether the model of buying up a company with promising assets, carving up its R&D operation and moving on can survive.

Eli Lilly's key franchise drug ramucirumab flops in PhIII liver cancer study

Lilly has hit another setback in its effort to expand the market range for its key cancer drug ramucirumab, recently approved as Cyramza for stomach cancer.

Rebel AstraZeneca investors push plan to tie exec pay to rosy R&D projections

AstraZeneca's executive team under CEO Pascal Soriot confidently batted down Pfizer's $120 billion takeover bid by putting an extraordinary valuation on its pipeline, often far exceeding the most optimistic forecasts by industry analysts. And now there appears to be a growing movement among a group of disenchanted investors at the U.K. company to hold management's incentive packages hostage to the sky-high expectations they've created.