News

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.

Merck KGaA R&D chief exits, Sobi drug flops in PhIII, Adaptimmune gets full-time CEO

Welcome to our first edition of the weekly EuroBiotech Report, where FierceBiotech will go deeper into the news and events happening in Europe.

FDA panel throws dirt on Novartis' would-be cardio blockbuster serelaxin

After a daylong session heavy on scathing criticism, a panel of FDA advisers voted unanimously against approving Novartis' in-development heart drug serelaxin, casting serious doubts on the treatment's potential.

Genmab banks $22M from J&J as myeloma drug ticks forward

Denmark's Genmab is rolling right along with breakthrough-designated daratumumab for double refractory multiple myeloma, hitting a milestone in Phase II development and triggering a $22 million payout from collaborator Johnson & Johnson.

Pfizer says PCSK9 study was a winner, boosting its chances in hectic R&D race

Pfizer says the Phase IIb study for its closely-watched PCSK9 cholesterol drug bococizumab (RN316) scored the primary endpoint on all doses, which should help steer a massive Phase III program that started out last fall with 22,000 patients.

UPDATED: Baxter breaks in two, creating a $6B biotech business

Baxter International is the latest life sciences player to see better living through mitosis, unveiling a plan to separate its drug development arm from its sprawling med tech business in hopes of helping each grow faster.

RuiYi banks $15M from A-list backers to amp up Chinese R&D

As more and more drugmakers set sights on China through partnerships and acquisitions, Sino-American biotech RuiYi is taking a more direct approach, raising $15 million in venture cash to develop novel drugs in the country, for the country.

Novartis fuels drive for fast OK of LDK378 with new lung cancer data

Novartis has taken another step forward in its quest to win a fast approval for its lung cancer drug LDK378. The pharma giant says the ALK inhibitor demonstrated clear signs of activity in a majority of the non-small cell lung cancer patients enrolled in an early study, including a group already treated by the ALK inhibitor Xalkori (crizotinib).

GlaxoSmithKline joins a biotech brain trust to make R&D more efficient

Translating all the information from the genomics revolution into verifiable drug targets has proven to be no easy task. Now, in an effort to bend the curve toward R&D success, GlaxoSmithKline is teaming up with external experts, putting up money and brainpower to launch a collaborative research effort.

Exelixis' shares flogged after lead drug disappoints at interim PhIII point

Hell hath no fury as a disappointed investor who bet wrong on a biotech catalyst. The execs at Exelixis got a three-course serving of that anger this morning as its stock went into a 35% nose dive--after the biotech announced that its interim analysis was complete and the Phase III prostate cancer study for cabozantinib would go to its conclusion.