Advaxis offers a tardy defense after FDA puts cancer vaccine on hold

Two weeks after reporting that its cancer vaccine spurred a positive response among a group of cervical cancer patients in a small clinical trial, Advaxis waited until after the market closed today to reveal that the FDA has placed the same cancer vaccine--axalimogene filolisbac (ADXS-HPV)--on a clinical hold, slamming the brakes on four studies.

After a $191M IPO, Adaptimmune buys a new cancer R&D outpost

U.K. biotech Adaptimmune Therapeutics is expanding its ranks as it moves forward with a pipeline of cancer immunotherapies, leasing a big R&D facility near its native Oxford.

Rodin taps Adam Rosenberg for top post

Cambridge, MA-based Rodin Therapeutics has recruited biotech vet Adam Rosenberg as its new CEO.

Take the poll: Has the biotech boom come to an end?

Is the long-running bull market for biotech dead? Or will it rebound later this year? Take the poll.

Axovant rolls into Phase III with a risky Alzheimer's gambit

Axovant Sciences, rolling the dice on a once-failed Alzheimer's disease treatment, kicked off its big Phase III trial, a make-or-break effort that could spawn a blockbuster drug or liquidate the company's value.

Genentech, Exelixis score another PhIII success for cobimetinib

Genentech has added another piece of the trial puzzle for its MEK inhibitor cobimetinib. The big Roche subsidiary's partner Exelixis announced early Tuesday that the drug combined with Zelboraf hit the mark in a Phase III study, offering a statistically significant overall survival benefit among advanced melanoma patients carrying a BRAF V600 mutation.

Alkermes wins an FDA nod for its monthly schizophrenia drug

Alkermes picked up FDA approval for a long-acting version of Otsuka's now-generic Abilify, planning to launch its injection as a treatment for schizophrenia.

Hub-building MD Anderson partners with Theraclone on $9.5M biotech startup

Seattle-based Theraclone is launching a new biotech focused on the burgeoning field of cancer immunotherapies--OncoResponse--that will operate in Houston in partnership with the entrepreneurial researchers at MD Anderson, setting out with a $9.5 million Series A.

Otonomy heads to the clinic with a tinnitus drug

Otonomy, developing treatments for ear disorders, got FDA clearance to start a clinical trial of its therapy for tinnitus.

Beset by controversy, Turing unveils its first in-house drug candidate

Turing Pharmaceuticals has revealed its first post-Daraprim R&D project: an early-stage therapy for rare and severe brain disorders. Called TUR-004, Turing's candidate is designed to serve as an add-on treatment for easing seizures tied to epileptic encephalopathies, a group of syndromes that crop up in early childhood and are often fatal.

Fidelity Bio thinks global with a new partner and a new name: F-Prime

Fidelity Biosciences, a big venture backer of dozens of global biotech companies, is tying up with Devonshire Capital--which once was called Fidelity Capital--and changing its name to F-Prime Capital.

Trans-Pacific trade pact compromises on drug exclusivity with 5- to 8-year haven

U.S. trade officials have finally delivered a Pacific Rim accord designed to forge closer business ties with eastern Asia and knit together Pacific commerce. But to complete the Trans-Pacific trade deal, the U.S. reportedly had to step far back from a hotly sought-after provision that would have guaranteed market exclusivity for new biologics by 12 years throughout the vast region.

Baxalta and Momenta target Humira with a Phase III biosimilar trial

Partners Baxalta and Momenta Pharmaceuticals are setting sights on the world's top-selling drug with a biosimilar of their own, moving into Phase III with a copy of AbbVie's cornerstone medicine.

NY, London and San Fran: Come see me on FierceBiotech's mini-global October tour

We're coming down to the wire for FierceBiotech's half-day executive conference in London next Monday, October 12, where I'll be moderating discussions on biotech financing, the IPO market (that should be interesting) and clinical trial design in an age of widespread collaborations between biotechs and Big Pharma.

Spark soars on success of gene therapy study, shot at groundbreaking approval

After repeatedly batting back doubts about its lead gene therapy, Spark Therapeutics says its pivotal study for SPK-RPE65, an FDA-designated "breakthrough" for sight-blighting inherited retinal dystrophies, came through with positive data. The biotech says that the treatment hit the primary and two of three secondary endpoints in the late-stage study, setting up a biologics license application at the FDA next year.

After a big IPO, Aduro splurges on a Berkeley R&D hub

Aduro Biotech, months removed from a $119 million IPO, is looking to settle down in Berkeley, leasing a four-story R&D complex as it presses forward with a pipeline of cancer treatments.

Regeneron inks a $325M deal, selling Asian rights to a pain treatment

Regeneron is handing off the Asian rights to its in-development musculoskeletal pain treatment for up to $325 million, handing the antibody over to a subsidiary of Japanese giant Mitsubishi.

XenoPort hits reset after a psoriasis setback, cutting jobs and bailing on R&D

XenoPort has changed its tune on an investigational psoriasis therapy, no longer insisting that the drug's middling efficacy and alarming safety profile merit late-stage development. Instead, the biotech is dumping the drug, cutting payroll and waving away its co-founder and CEO.

Sanofi steps deeper into RNAi work, opts in on Alnylam hemophilia drug

Sanofi cautiously waded deeper into RNAi development waters this week, following up on last year's big $700 million buy-in at Alnylam. The pharma giant's Boston subsidiary, Genzyme Sanofi, has picked up some regional rights to the hemophilia treatment ALN-AT3, setting up a complicated set of next steps as Sanofi juggles just what it will opt into and where it wants to leap into commercialization.

On second thought, Amicus won't be filing its lead drug this year

Amicus Therapeutics, a biotech comeback story, is walking back plans to submit its rare disease treatment for FDA approval this year, rethinking its whole regulatory strategy after follow-up conversations with the agency.