News

Merck KGaA teams up with Pfizer to spotlight new lupus therapies

Rival drugmakers Merck KGaA and Pfizer are putting their cash and expertise into a new effort to better understand lupus, tapping the Broad Institute for a Big Data approach to help map out the disease and light the way for future drug candidates.

Foresite banks $300M to bet on late-stage biotechs

San Francisco biotech bankroller Foresite Capital has closed a $300 million second fund, setting out to invest in drugmakers with a clear path to market amid some renewed optimism in life sciences venture capital.

Investors pump $200M into Intarcia's PhIII for once-yearly diabetes therapy

For most biotechs, the huge cost of a late-stage diabetes drug program is enough to shut down any discussion about pushing through alone to an approval. Intarcia, though, says it now has the money needed to do just that for new technology billed as a prospective game-changer for one of the world's most prevalent diseases.

Celgene doubles down on Forma with a $600M discovery deal tied to a buyout option

Close to a year after Forma Therapeutics' executive team hammered out a partnership with Celgene packed with $200 million in early-stage payouts, the big biotech outfit has come back with a $600 million discovery deal that might eventually lead the pair to the M&A altar.

Cubist's superbug drug clears FDA panel, lines up for Pfizer showdown

Cubist's latest antibiotic won praise from a panel of FDA advisers, setting the stage for a likely approval and head-to-head competition with Pfizer's blockbuster Zyvox.

AstraZeneca cozies up to MRC scientists amid an R&D rethink

AstraZeneca isn't due to move into its new Cambridge, U.K., headquarters for another two years, but the British giant is already laying the groundwork for open collaboration in the biomedical hub, signing a deep-seated deal with the government-run Medical Research Council to work on drug discovery.

FDA lifts a partial hold on Curis cancer drug

Lexington, MA-based Curis says the FDA has lifted the partial clinical hold on CUDC-427, which was instituted after the death of a patient in a Phase I study of solid tumors and lymphoma.

Glaxo scraps the ovarian cancer app for Votrient

The drug giant is pulling its application in Europe after concluding that the data didn't paint a sufficiently positive portrait of overall survival benefits for patients--despite an improvement seen in progress-free survival.

Shares of Prana collapse after long-shot Alzheimer's study flops

Small-cap Australian biotech Prana Biotechnology set out to vanquish a biomarker for Alzheimer's disease in a Phase II study of a lead drug pursuing an odd avenue in fighting the disease. This morning, when it acknowledged that the study was a bust, the rout of investors popped its stock price, pumped up in a speculative bubble in the lead-up to the results.

Tomorrow's cardio blockbusters: Inside 'the next big leap' in controlling cholesterol

Thanks to genomic sequencing, some heart-healthy mutants and billions of dollars spent on R&D, rival drug developers are bearing down on a promising new way of treating the scourge of high cholesterol. And with the first FDA applications likely coming in the next year, the nascent field's trailblazers are vying for the top spot with blockbuster aspirations.

On the ropes, Novartis' cardiology team declares a blockbuster PhIII knockout

The pharma giant announced that the data monitoring committee has hit the green light for any early close to the pivotal study for its new blood pressure treatment LCZ696 after investigators tracked delays in cardiovascular deaths and fewer hospitalizations resulting from heart failure in comparison to Vasotec, a generic blood pressure medicine that has been around for years.

UPDATED: GlaxoSmithKline's darapladib team finds hope in a PhIII bomb

No matter how badly a drug fails in Phase III, investigators and the companies that employ them often bend over backward to highlight any positive sign of efficacy, no matter how weak the signal. And GlaxoSmithKline's team at the American College of Cardiology meeting over the weekend was in full spin mode with their heart drug darapladib.

Amgen's PCSK9 drug slashes 'bad' cholesterol in PhIII, stoking blockbuster hopes

Amgen widened its lead among competing drugmakers in a promising new field of cardio treatments on the strength of late-stage results in which its in-development drug lowered LDL cholesterol by as much as 75%.

Biogen wins FDA OK for long-acting hemophilia drug Alprolix

Late on Friday the FDA announced that it had approved Biogen Idec's long-acting hemophilia B drug Alprolix, setting the stage for a rough-and-tumble showdown among the new and old generations of drugs competing for the blockbuster market.

AstraZeneca looks to China for kidney disease R&D

AstraZeneca has struck up a partnership with the Shenzhen University Health Science Center in Shanghai to collaborate on preclinical work for chronic kidney disease treatments, a growing problem among China's aging population. 

Ebola still a tough target due to Big Pharma disinterest and few outbreaks

In the nearly 40 years since scientists first nailed down the Ebola virus, drug researchers have yet to commercialize an effective therapy for the deadly disease, a problem made worse by a lack of commercial promise and the relative rarity of outbreaks.

MannKind faces stiff skepticism in its third go at FDA approval

After two FDA rejections, MannKind has returned with more data on its long-delayed inhaled diabetes drug, but regulators see Afrezza as anything but a slam-dunk case, raising questions over the treatment's safety and efficacy before a scheduled review.

Merck appoints Baxter exec to fill chief financial officer role

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)...

Idera spikes as its up-and-down TLR program comes through in PhII

After setbacks in cancer and respiratory disease, Idera Pharmaceuticals has finally found some success with its toll-like receptor program, touting encouraging results from a Phase II trial on autoimmune disease that sent its share price soaring.

Syndax swings for a $69M IPO with 'breakthrough' drug in tow

Waltham, MA's Syndax Pharmaceuticals is setting out to raise $69 million in an IPO, planning to take its promising cancer therapy through Phase III and into the hands of regulators.