News

Baxalta sets sail with blockbuster ambitions for its growing pipeline

More than a year after announcing plans to spin out its drug business, Baxter has begotten Baxalta, a $6 billion standalone company with plans to elbow its way into the upper ranks of biopharma.

Roche forced to concede another flop for Alzheimer's program

You can score another setback for Roche's star-crossed attempt to develop a new drug for Alzheimer's. Roche partner Evotec reported that their drug sembragiline failed a Phase IIB study.

Xenon's Teva-partnered pain drug flunks a test in osteoarthritis

Xenon Pharmaceuticals' Teva-partnered treatment for osteoarthritis pain missed its goals in a Phase IIb trial, a failure the biotech believes won't derail the drug's development in other indications.

FierceBiotech Radio on the cost of CAR-T, the future of Zoetis, and gentrification in Kendall Square

FiercePharma's Carly Helfand and FierceBiotech's Damian Garde discuss the week's biggest news in biopharma, including Celgene's big-money partnership with Juno Therapeutics, buyout rumors surrounding Zoetis, and the latest Big Pharma to move into Cambridge, MA.

Purdue pulls out of FDA panel on abuse-deterrent OxyContin just days before meeting

Purdue Pharma has canceled an all-important discussion with FDA advisers about its latest spin on OxyContin less than a week ahead of the scheduled meeting, an uncommon move the company said will ultimately improve its odds of success.

Whittled down to biotech size, AstraZeneca's antibiotics crew starts over as Entasis

AstraZeneca CEO Pascal Soriot made it clear back in early 2014 that he planned to spin off a big chunk of the company's anti-infectives pipeline along with the neurosciences side of R&D. And now more than a year later the pharma company has completed the task, hatcheting down a once large group of researchers and birthing a small biotech with its own pipeline of antibiotics and a core group of investigators.

Intercept files its 'breakthrough' liver drug for rare disease approval

Intercept Pharmaceuticals has submitted its top candidate to the FDA for approval in primary biliary cirrhosis, a rare disease that results in serious liver damage.

Transgene is shedding 120 jobs to save cash and get its pipeline moving

French biotech Transgene is planning to slash its payroll and redouble its focus on clinical development, moving on from a costly snub at the hands of Novartis.

Biotech billionaire Soon-Shiong plots a second IPO--this time for NantHealth

Biotech billionaire Patrick Soon-Shiong has already laid the foundation for a big IPO to help finance his low-profile oncology R&D player Conkwest. Now he's moving closer to getting his high-profile personalized drug-finding company NantHealth on the market as well.

Waksal's post-prison startup runs into more fraud allegations

Sam Waksal, the once-jailed former CEO of ImClone, is again the subject of fraud accusations as a former associate says he bailed on an investment deal designed to circumvent his punishment and defaulted on a $15 million promise.

Is Celgene killing the traditional biotech partnering formula?

Celgene's $1 billion front-loaded deal to buy into Juno's CAR-T and TCR programs--$150 million upfront and $850 million for 10% of the company's stock at more than double the going share price--instantly and predictably spurred a backlash among some of the top analysts in the industry over the frothy figures in play.

UPDATED: Roche heralds PhIII successes for MS, but some tough rivals lie in wait

Roche heralded the late-stage success of two big trials for its multiple sclerosis drug ocrelizumab today, which they say puts them on a straight road to regulatory filings for the injectable in early 2016. But even under the best-case scenario for the future, the Big Pharma player will face a tough task squaring off against the new oral drugs that have been divvying up this big market recently.

Actelion creates vaccine startup with €30M investment and Max Planck assets

Actelion has got into startup creation. The Swiss biotech has committed €30 million ($33 million) to set up Vaxxilon, a synthetic carbohydrate vaccine-focused startup with a mission to push a program licensed from the Max Planck Society into the clinic within the next three years.

Adocia climbs 10% after Lilly-partnered insulin clears PhIb

Shares in Adocia rose 10% after its Eli Lilly-partnered fast-acting insulin impressed in a small early-phase study. The data position Adocia to push ahead with development of a product that could surpass Lilly's blockbuster fast-acting insulin Humalog in terms of speed and effectiveness.

UPDATED: Celgene pays $1B in landmark deal to buy into Juno's pipeline of CAR-T drugs

Celgene is paying about $1 billion to move to the front of the hectic race to build new CAR-T cancer therapies. The Big Biotech is shelling out $150 million upfront and paying $93 a share--a huge premium--to snap up 9.1 million shares of Juno Therapeutics, inking a collaboration to develop and commercialize new oncology therapies.

Egalet's pain pill is tougher to abuse than Purdue's morphine tablet, study shows

Egalet's in-development pain pill met its goals in a study designed to prove its abuse-deterrence, beating out a rival treatment from Purdue Pharma as it heads toward an FDA filing.

AMAG snags Cord Blood Registry for $700M

AMAG Pharmaceuticals has stepped in to buy Cord Blood Registry for $700 million, capturing about half of the privately stored cord blood units and taking a prominent position as supplier of stem cells to R&D groups.

Samsung and Biogen plot an IPO for their biosimilars JV

Samsung Bioepis, a joint venture between the South Korean conglomerate and Biogen, is planning a jump to the Nasdaq with eyes on raising cash to market cheaper copies of blockbuster biologics.

Facing off rivals, Merck looks to expand CINV label on positive PhIII Emend study

Merck posted another batch of promising Phase III data for Emend, its antivomiting drug for chemo patients. The pharma giant noted that in the study its NK1 receptor agonist scored a statistically significant complete response rate among patients getting a moderately emetogenic (or vomit-inducing) chemotherapy. Merck will now look to broaden its label for the drug for chemotherapy-induced nausea and vomiting (CINV) as it squares off against prospective competitors.

Sarepta submits its DMD drug for FDA scrutiny, on the heels of BioMarin

Sarepta, ending a protracted process that may have cost its last CEO his job, submitted its treatment for Duchenne muscular dystrophy to the FDA, setting the stage for a possible approval early next year.