Deerfield leads a $75M round for Akari

Deerfield Management is leading a $75 million round for a new biotech startup dubbed Akari Therapeutics, which was created out of Celsus Therapeutics' recent acquisition of Volution Immuno Pharmaceuticals SA.

In Addyi's shadow, Richter walks away from a female libido drug

Hungarian drugmaker Gedeon Richter is no longer developing a treatment for female sexual dysfunction, dissolving a partnership with tiny Palatin Technologies in the middle of late-stage development.

Gilead's new pangenotype hep C combo scores stellar results in PhIII

Gilead has proved once again that it knows how to cure hepatitis C for a heavy concentration of patients, posting some stellar pangenotype data from a slate of four late-stage studies that combined its blockbuster Sovaldi with the experimental NS5A inhibitor velpatasvir. And the Big Biotech says it's ready to step up with new marketing applications with an eye to continuing its domination.

UniQure beats a path to Phase III after a 'promising' gene therapy trial

UniQure is pressing forward with its gene therapy for a rare and deadly disease after charting a positive signal in a small yearlong trial, news that sent the Dutch company's share price soaring.

One win, one loss in Merck's PhIII double header for C. diff

Merck says that it's ready to apply for EU and U.S. marketing approval for the anti-infective bezlotoxumab, flagging a pivotal clinical success which arrived four years after the pharma giant launched its late-stage program. But the pharma giant also sounded taps for a related Phase III effort on actoxumab.

Kinase-focused Deciphera gets marquee backing for a big $75M venture round

A little more than a year after Deciphera CEO Mike Taylor set up an office for the biotech in the Boston area, the cancer drug developer has rounded up a whopping $75 million B round to make a clinical push for its top cancer drug candidates.

Why would Martin Shkreli hike an old drug price by 5000%? Only a 'moron' would ask

Back when Martin Shkreli was CEO of Retrophin, he managed to grab a few headlines by buying an old rare-disease drug, Thiola, and raising the price 2000%. Now that he's on to his next company, Turing Pharmaceuticals, he's done himself one better, by buying another old drug and boosting the price 5000%.

With $1B in VC cash, Intarcia is happy to stay out of the IPO scrum

Intarcia Therapeutics is rolling toward an FDA application with its long-acting diabetes treatment, but despite the ready availability of IPO cash for drug developers, the company is content to stay private for now.

Nabriva pulls off a down-sized IPO, raising $92M for antibiotic R&D

Antibiotics biotech Nabriva Therapeutics executed a $92.3 million IPO, pricing well below its projected range but scraping together the funds it needs to start a Phase III study for its lead drug.

NIH pushes forward in Obama's $215M 'precision medicine' plan

The National Institutes of Health is pressing ahead with plans to gather genetic information on 1 million Americans under President Barack Obama's Precision Medicine Initiative, angling to kick off the ambitious project next year.

President Obama nominates Califf as next FDA commissioner

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...

FierceBiotech Radio on 'amazing' diabetes data, biotech's VC boom, and Severin Schwan's hot mic

FiercePharma's Carly Helfand and FierceBiotech's Damian Garde discuss some surprising trial results for a diabetes drug from Eli Lilly and Boehringer Ingelheim, the continued flow of money into private biotech companies, and the public frankness of Roche CEO Severin Schwan.

RegenX IPO raises $138M, renewing hopes for a big Q4 biotech run

The biotech IPO window is still wide open and ready for new business, especially if it relates to a hot new tech like gene therapy. RegenX Bio proved that point today, raising $138 million from the sale of 6.3 million shares at $22 a pop.

Allergan and Richter win FDA approval for a once-rejected schizophrenia pill

Partners Allergan and Gedeon Richter convinced a once-skeptical FDA to clear the antipsychotic drug cariprazine on a second pass, winning approval to treat schizophrenia and bipolar disorder.

Advaxis gets a whiplash after its upbeat assessment of PhII cancer vaccine data

After rounding up a long lineup of collaborations for its cancer vaccine axalimogene filolisbac (ADXS-HPV), Advaxis says that a small study for cervical cancer produced promising outcomes for a significant number of the 26 patients involved.

Roche-partnered Oryzon plans Madrid IPO as launchpad to Nasdaq

Oryzon Genomics has joined the wave of European biotechs to file for an IPO on their home continent. But the Roche-partnered epigenetics specialist is doing things differently, first by going public in the biotech backwater of the Madrid stock exchange and then by using this listing as a launchpad for a Nasdaq IPO.

Merck's weekly diabetes drug measures up to an old blockbuster in Phase III

Merck's once-a-week omarigliptin proved itself equal to Januvia, stacking up to a daily treatment that brought in about $3.9 billion for the company last year.

Roche partner Oryzon plots Madrid IPO; Serono commits to Germany; Celyad nabs GSK IO vet

In this week's EuroBiotech Report, Acacia Pharma's mooted £150 million ($230 million) fundraising goal meant London won out again in terms of sheer scale. Roche-partnered Oryzon Genomics is set to file to list on the Madrid exchange later this year. But, like many of its peers, the Spanish epigenetics specialist already has one eye on Nasdaq. And more.

Pfizer mulls early-stage site to tap into German research infrastructure

Pfizer is considering setting up a research site in Germany, Frankfurter Allgemeine Zeitung reports. The investment would represent a rare foray by a Big Pharma into basic research in Germany, but Pfizer's chief in the country thinks the ability to work with existing academic and medical institutions means the plan has merits.

Inspired by $220M in BARDA funding, AstraZeneca steps up antibiotics R&D

Close to 18 months after AstraZeneca decided to jettison its early-stage anti-infectives division and the 180 staffers that were then working in the Massachusetts-based group, the pharma giant is stepping back up in the field, with the feds footing up to $220 million in research costs to hunt down new antibiotics.