News

Foundering Aveo strikes a small deal to resurrect its thrice-failed drug

With former collaborator Astellas Pharma long since out the door, Aveo Oncology has found another partner willing to take a shot on the troubled tivozanib, signing a modest deal with Ophthotech to see how the cancer drug fares in eye diseases.

Promising asthma trial prompts Regeneron, Sanofi to push dupilumab into PhIII

Regeneron and its close partner Sanofi have cleared the final mid-stage hurdle for dupilumab in asthma patients, with several doses hitting the trial endpoint both for a subset of patients as well as the broad population. And the ambitious development team at Regeneron now plans to hustle into a pivotal late-stage program as they continue to make swift progress with a drug that promises to tackle a trio of conditions that share a core inflammatory trigger.

Amgen takes another stride in frenzied race toward the PCSK9 finish line

Amgen now has a deadline in place for an FDA decision on its cholesterol-lowering drug evolocumab. The Big Biotech put out the word Monday morning that the FDA has accepted its BLA application on the PCSK9 drug for review, giving regulators until August 27, 2015 to issue their decision on marketing the therapy.

Battered ArQule shares bump up on badly needed positive data for tivantinib

ArQule's badly battered shares managed a quick surge this morning on news that the biotech's lead drug tivantinib scored a positive outcome in a Phase II metastatic prostate cancer study.

Place your bets: Biotechs hustle along new drugs for blockbuster liver diseases

Late last week investors wound up using Intercept Pharmaceuticals as a punching bag after new data on its NASH drug for fatty liver disease raised some troubling questions about its safety and efficacy. Its stock was hit hard, forced down 30% in hours as analysts mulled the implications of potential trouble.

J&J chief hints at unease in China, but plots new buyouts

Johnson & Johnson CEO Alex Gorsky likes to hint at trouble developing its Chinese sales, but don't expect him to come right out and criticize the prickly Chinese government. In an brief interview with The Wall Street Journal, Gorsky said J&J was looking for new acquisitions in China, with new drugs for lung cancer as one of its topic targets.

Fledgling Ziarco grabs a $33M transatlantic round for PhII atopic dermatitis drug

Two years after Michael Yeadon and a close-knit group of Pfizer investigators managed to grab some of the pharma giant's anti-inflammatory assets on the way out the door at Sandwich, they've drummed up a $33 million B round for their biotech from some U.S. and European investors. And now they're set to launch a midstage clinical program to help determine the value of what they took with them when launching Ziarco.

UPDATED: Biotech upstart Sage sees early efficacy for rare brain seizure drug

Sage Therapeutics has successfully resolved a rare seizure disorder among the majority of patients in its small but closely watched Phase I/II study, adding more promising outcomes to the early evidence that helped inspire one of this year's most successful biotech IPOs. In the data update out Monday morning investigators say the 73% overall response rate in their study is also being mirrored among a small group of patients who are receiving the drug on an emergency-use basis.

UPDATED: Merck's hepatitis C cocktail drug fails a 4-week challenge

After sending out signals that it might be running into trouble with a short-duration study of a new triple combination drug for its hepatitis C regimen, Merck investigators hailed the clear success of an 8-week test but confirmed analysts' fears in a batch of 4-week data released at the meeting of the American Association for the Study of Liver Diseases.

Trevi wraps up a $26M round to fund its anti-itching drug

New Haven, CT's Trevi Therapeutics banked another $11 million in venture cash, bringing its B round to $26 million and giving it the cash it needs to complete a pivotal trial for its top prospect.

INC banks $150M in the latest big CRO IPO

INC Research is the latest among Big Pharma's biggest contractors to pull off an IPO, raising $150 million and joining its largest rivals on Wall Street.

Avanir's odds for a timely drug approval aren't looking so good

Avanir Pharmaceuticals, awaiting FDA approval for a new migraine treatment, got a letter from the agency pointing out flaws in submitted data, a regulatory hiccup that could derail the company's plans.

UPDATED: Intercept shares tank as investigators question OCA's safety/efficacy for NASH

After crunching the data on Intercept's clinical study of OCA for nonalcoholic steatohepatitis, investigators say they tracked some distinct improvements for patients suffering from the liver disease. But they also fretted about some troubling safety issues as well as inadequate efficacy endpoints that will have to be carefully considered in follow-up studies, tempering some of the high excitement that has been stoked by some analysts and the biotech's investors ahead of a pivotal Phase III study.

AcelRx CEO Richard King steps down

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)...

Rockwell clears an FDA hurdle with its dialysis drug

A group of FDA advisers voted in favor of approving Rockwell Medical's iron-replacement treatment for dialysis patients, setting aside concerns about the drug's pivotal data and burnishing the company's hopes of finally launching its top prospect.

Shire's tax model under scrutiny, KDEV cozies up to Asian conglomerate, Onxeo heads to PhIII

In this week's EuroBiotech Report, after a brief post-AbbVie deal lull in discussion of Shire's tax rate, the Irish-headquartered drugmaker found its financial structures in the headlines once again when The Guardian made it the centerpiece of an investigation into the role Luxembourg plays in global tax schemes.

FDA advisers spurn Novartis' blood cancer drug, putting approval in doubt

Novartis' new multiple myeloma is treatment too risky to be approved, a group of FDA advisers voted, dealing a blow to the drugmaker and its hopes of launching the cancer drug next year.

Spark snags a 'breakthrough' tag for its Phase III gene therapy

Gene therapy startup Spark Therapeutics has picked up the FDA's coveted breakthrough-therapy designation for its lead candidate, a one-time treatment that promises a permanent solution some rare eye diseases.

GlaxoSmithKline's effort to relaunch cancer R&D faces skepticism

GlaxoSmithKline made a high-profile decision to exit the cancer drug field in its recent deal with Novartis, but as Reuters reports, a band of specialists inside GSK still has ambitious plans for developing next-gen therapies.

Actavis bid looms as Allergan says it's been approached (again) on merger

Allergan today confirmed what much of the industry has been buzzing about for some time now: It's in takeover discussions with another company other than the acquisition-hungry Valeant. And the business news outlets quickly identified Actavis as the interested party.