Roche's long-dead drug dalcetrapib may be revived in new study

Scientists in Canada say they have drilled down into the massive data files from the development effort for cholesterol drug dalcetrapib and found that a subset of patients with the right genetic profile benefited greatly from the drug. And now they plan to follow up with a new study in an effort to revive the long-dead drug.

An inside look at the FDA's approach to speeding new drug approvals

The FDA enjoyed some industry kudos at the end of 2014 after handing out a record number of new drug approvals for the past decade. And now it's crunched the numbers for the year to underscore the kind of trends regulators see in the biopharma world.

Ex-employees say Soon-Shiong's Big Data venture is a fraud

NantHealth, an arm of billionaire physician and biotech entrepreneur Patrick Soon-Shiong's empire, promises to improve cancer diagnostics through a marriage of genomics and high-speed computing. But behind its sleek marketing campaign and Soon-Shiong's bravura, the company is misleading customers and putting patients at risk, according to a lawsuit filed by two former employees.

The 2015 biotech takeover target list includes some hot new players

With the big multinationals like Merck, Roche, Pfizer and J&J joining some of the most aggressive biotechs (think Shire) in roaming the planet in search of the right biotech targets to acquire, you can expect to see a steady stream of fresh speculation among analysts over which companies figure as the most likely buyout--and the next place to score some quick cash by investors.

Enanta plots a future in NASH, chasing another blockbuster

Enanta Pharmaceuticals, perhaps best known as AbbVie's partner in hepatitis C, has blueprinted its next big solo step, joining the race to develop treatments for a pervasive liver disease with blockbuster potential.

The JP Morgan mood: Damn the biotech valuations and full speed ahead in 2015

SAN FRANCISCO--Waiting for an elevator at the Westin St. Francis in San Francisco, Celgene CEO Bob Hugin and I were chatting about the frenzied pace of deals that were announced in the lead-up to the annual JP Morgan confab. "The whole industry is on fire," he said with a happy smile.

NeuroPhage wraps a $27M round to advance its Alzheimer's drug

Cambridge, MA's NeuroPhage banked an additional $10 million in Series D cash, bringing its latest round to $27 million and filling out the biotech's war chest as it marches toward the clinic with a treatment for neurodegenerative disease.

Intrexon and Ziopharm buy into CAR-T in $100M deal

Partners Intrexon and Ziopharm are cutting in on the fervor over a new class of immunotherapies for cancer, striking a deal with the University of Texas' MD Anderson Cancer Center.

Top biotech investor NEA outlines plans for another $2.5B-plus venture fund

In a sign of the times, leading life sciences venture maven David Mott and his colleagues at New Enterprise Associates have begun raising a whopping $2.5 billion venture fund--less than three years after rolling out its latest fund with $2.6 billion.

Soon-Shiong's new biotech pairs up with Amgen on a cancer immunotherapy

Billionaire physician and biotech entrepreneur Patrick Soon-Shiong has launched a company devoted to immuno-oncology, licensing a treatment from Amgen to get rolling in the field.

Tobira eyes Wall Street with Regado merger, targeting NASH

Tobira Therapeutics, moving on from a failed IPO of its own, is plotting a merger with the struggling Regado Biosciences, a deal that would get it on the public market as it develops a treatment for liver disease.

Pfizer's cooking up a PCSK9-blocking pill

SAN FRANCISCO--Keeping up the rear in a three-way race to commercialize the first of a new class of anticholesterol antibodies, Pfizer is at work on a pill that attacks the same target, planning to build a franchise in what is expected to be a blockbuster new therapeutic area.

FierceBiotech Executive Event: Is there more room to boom in biotech in 2015?

January 13, 2015, San Francisco Moderated by FierceBiotech Senior Editor Stacy Lawrence and featuring Ken Drazan, the head of Johnson & Johnson Innovation in California; Dennis Aisling, founder...

Lilly cuts in on immuno-oncology with Merck, Bristol-Myers

Eli Lilly is buying big into the idea that the latest and greatest cancer therapies can work even better in combination, inking agreements to study its drugs alongside immunotherapies from Merck and Bristol-Myers Squibb.

Cortendo lines up $27.5M to get its orphan drug through Phase III

Swedish-American biotech Cortendo has signed up to raise as much as $27.5 million in private placement cash, funds that will help push its rare disease treatment through late-stage trials.

FDA steps in after a patient on Antares' 'low-T' drug breaks out in hives

The FDA wants more safety data on Antares Pharma's testosterone treatment after noting a case of hives in a clinical trial, presenting a costly delay for the company's plans to hit the market.

Merck bets $100M on Moderna and its pioneering RNA tech

Pharma giant Merck is buying into the allure of Moderna Therapeutics and its radical promise to transform patients' cells into drug factories, committing $100 million and joining a host of collaborators and investors betting the early-stage biotech is sitting on transformational technology.

J&J takes another leap into microbiome R&D with $241M Vedanta pact

J&J subsidiary Janssen Biotech has inked a deal to collaborate with Boston-based Vedanta on a new bacterial treatment for inflammatory bowel disease, or IBD. And it handed over an undisclosed upfront payment and promises of up to $241 million in milestones if their partnership can blaze a path to the market eventually.

Roche inks a $750M antibiotics deal as it re-embraces the field

Following through on its sweeping return to antibiotics R&D, Roche has agreed to pay up to $750 million to get its hands on an early-stage drug that helps existing treatments battle drug-resistant infections.

Mersana lines up for $300M in an R&D deal with Takeda

Oncology biotech Mersana Therapeutics has expanded its relationship with Takeda, forging an agreement to develop targeted cancer drugs with as much as $300 million on the line.