News

Baxalta's first-of-its-kind bleeding drug lines up for FDA approval

Baxalta, recently spun out from Baxter, is charging toward its first drug approvals under a new identity, publishing positive results for a bleeding treatment awaiting word from the FDA.

Bristol-Myers to collaborate on immuno-oncology studies

Bristol-Myers Squibb has signed on Northwestern University to partner on some early-stage immunotherapy trials.

Sorrento buys into biosimilars with a Chinese antibody deal

Sorrento Therapeutics, among many companies in the orbit of billionaire entrepreneur Patrick Soon-Shiong, is looking to take a spot in the growing market for knockoffs of the world's top-selling biotech medicines.

Lexicon rockets up after a positive PhIII study sets up an NDA

Shares of Lexicon Pharmaceuticals soared 35% this morning after The Woodlands, TX-based biotech claimed a win in Phase III for one of its lead drugs. The biotech said that telotristat etiprate proved effective against rare cases of carcinoid syndrome, a condition triggered by neuroendocrine tumor cells that causes severe diarrhea.

UPDATED: Shire chief Ornskov bets $300M on another eye drug bolt-on buyout

Shire CEO Flemming Ornskov is spending $300 million of his cache of cash on a new ophthalmology buyout. Ornskov has pulled the trigger on a deal to snap up Foresight Biotherapeutics, adding a new bolt-on group with plans to take an eye drug into Phase III.

AstraZeneca deepens its Isis ties with a $65M R&D pact

AstraZeneca is widening its long-standing relationship with Isis Pharmaceuticals, betting on the company's proprietary approach to RNA-targeted therapies in hopes of expanding its early-stage pipeline.

EyeGate ekes out a tiny IPO to fund its R&D efforts

Massachusetts' EyeGate Pharmaceuticals picked up $10 million in an IPO do-over, raising cash to support its sole clinical candidate.

GBT lines up for a $124M IPO with a pill for sickle cell

Global Blood Therapeutics, a graduate of Third Rock Ventures' startup academy, set terms for an IPO worth as much as $124 million, looking to raise money for its oral sickle cell disease program.

Merck's Ebola vaccine is 100% successful in interim Phase III results

Merck's Ebola vaccine, in development alongside NewLink Genetics, protected 100% of patients from contracting the virus in interim results from an ongoing study, giving rise to hopes it can help prevent future outbreaks.

125 ex-GSK R&D staffers in RTP face the ax--again

Eight months after the ax dropped late last year, 125 former GlaxoSmithKline staffers in Research Triangle Park found their jobs back on the chopping block Thursday as their new employer at Parexel included them in a lineup of new layoffs.

Amgen lops another 6% off its R&D budget amid wide cost cuts

Amgen, long criticized over its appetite for moonshot R&D projects, scaled back its research budget by more than 10% in the second quarter, part of a companywide effort to cut costs while advancing a make-or-break pipeline.

Aegerion's embattled CEO Beer 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 Eric Sagonowsky (email) or...

AstraZeneca isn't giving up on brodalumab despite its links to suicide

Amgen shocked the industry in May when it cut ties with an AstraZeneca-partnered psoriasis treatment after spotting alarming rates of suicidal thoughts among patients taking the antibody. But its former collaborator is remaining optimistic about the once-promising treatment, tentatively moving toward an FDA filing.

RIP: AstraZeneca clips two pipeline programs in Q2

Every quarter AstraZeneca notes at the end of its financial report which of its new drug programs are being discarded and dropped from the pipeline.

Report: Parexel layoffs include up to 200 ex-GlaxoSmithKline staffers

When GlaxoSmithKline reported last December that it was ripping into its R&D operations in Research Triangle Park, NC, and laying off 900 staffers, the pharma giant softened the blow by noting that some 450 of the workers would be transferring to Parexel, a major CRO with close ties to Glaxo. But today many of those jobs appear to be in danger after all.

FibroGen's anemia drug, not yet approved, is a hit among cheating cyclists

FibroGen's in-development treatment for anemia is still in the midst of Phase III development, but thanks to a legal loophole, the pill has made its way into the world of competitive cycling, where its red blood cell-boosting effects can give athletes an advantage.

Failed Alzheimer's drug wins $117M in vTv's IPO

Highpoint, NC-based vTv raised $117 million after selling 7.8 million shares at $15 a share--the low end of the range. The company had hoped to raise more than $150 million from the IPO. vTv is taking a failed Alzheimer's drug and heading straight into Phase III--and its strategy is raising a few eyebrows.

GlaxoSmithKline CEO's enthusiasm for R&D effort falls flat

GlaxoSmithKline CEO Andrew Witty had some upbeat Q2 revenue numbers to report, but a renewed effort to spur some enthusiasm for its drug pipeline fell flat with analysts.

Synergy Pharma jumps as second PhIII scores a success against constipation

Synergy Pharmaceuticals handed over a fresh set of Phase III data from its second pivotal study of plecanatide, confirming the first round of positive efficacy results for chronic constipation and delivering a slightly improved safety profile that should help as the biotech makes a run at a drug approval and market launch.

FierceBiotech Radio on Allergan's 'transformational' moves, Sanofi's new bet on Regeneron, and the (latest) biggest-ever biotech IPO

FiercePharma's Carly Helfand and FierceBiotech's Damian Garde discuss the week's biggest news in biopharma, including a surprise one-eighty from Allergan, an unsurprising deal involving Sanofi and Regeneron, and the latest biotech IPO stirring fears that there's a bubble soon to burst.