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