News

Activist investor joins the Amgen breakup crusade, and shareholders are listening

Hedge fund manager Daniel Loeb is lending his voice to the chorus of investors who believe Amgen would do better as two companies. And his firm, Third Point, has upped its stake in the Big Biotech, giving him a bigger stage from which to pressure executives.

Inovio, MedImmune and Penn unite to fight the flu on DARPA's dime

Inovio Pharmaceuticals, AstraZeneca's MedImmune and the University of Pennsylvania have joined forces to study influenza and antibiotic-resistant bacteria, drawing on $12.2 million in federal funds.

Meet Unum, a new immunotherapy biotech with Fidelity, Atlas and Sanofi in its corner

As the promise of harnessing the immune system to fight cancer grabs headlines around the industry, venture stalwarts Fidelity Biosciences and Atlas Venture have teamed up to launch Unum Therapeutics, a Cambridge, MA, startup with a hybrid approach to the field.

Omeros halts a Phase II Huntington's trial over alarming rat results

Following the FDA's advice, Omeros has hit the brakes on a mid-stage human trial of its Huntington's disease treatment in light of data from a separate animal study, news that tanked the biotech's share value.

AbbVie's $55B deal for Shire is officially dead. Now what?

Shire and AbbVie have formally called it quits on a planned $55 billion merger, leaving each company to get by on the merits of its own pipeline and talk up the benefits of life without the other.

Despite a mid-stage miss, Cytokinetics is taking its ALS drug toward Phase III

Earlier this year, Cytokinetics tanked as its lead prospect, a treatment for amyotrophic lateral sclerosis (ALS), missed its primary endpoint and a slew of secondary goals in a mid-stage trial. But the drug did come through on one measure of lung function, and, upon analysis of the results, the biotech believes that could be its ticket to FDA approval.

Novartis clears an FDA hurdle with its pioneering psoriasis treatment

A panel of FDA advisers voted unanimously in favor of approving Novartis' new anti-inflammatory treatment, an expected positive outcome for the company as it races to be first in line among what promises to be a crowded field.

Left at the altar by AbbVie, Shire has cash, options and an M&A pedigree

While its merger with AbbVie is looking dead, Shire is likely in line for a $1.6 billion breakup fee, cash that could fund a major M&A push. And with renowned dealmakers in its executive ranks, Shire may not be lonely for long.

TesoRx licenses oral low-T drug to Aspen amid FDA crackdown

While the testosterone therapy field is under fire from government regulators, Menlo Park, CA-based TesoRx is licensing its oral-testosterone replacement therapy to a subsidiary of South African generics maker Aspen Pharmacare.

Cubist CEO Bonney hands over reins as new buyout rumors circulate

After 11 years at the helm of Cubist Pharmaceuticals, CEO Michael Bonney is stepping down and handing the reins to COO and President Robert Perez.

Celgene's $2.6B deal for Crohn's drug pays off with promising PhII

Celgene bet big on the little-known Irish biotech Nogra Pharma when it partnered on a mid-stage drug for Crohn's disease. And today Celgene spelled out the reasons why it gambled $710 million upfront on a Phase II drug, highlighting data that support a clear case that the therapy can help spur clinical remission in a broad group of patients.

Top 10 Phase III disasters of 2014

Welcome to the hall of shame, where blockbuster drug projections go to die. This list includes some drugs that clearly should never have wound up in Phase III to begin with, a few that were steered back to the clinic in a doomed attempt to mine something positive, and a couple of notable exceptions that may have helped advance the field by exploring the outer limits of new drug technology.

PureTech reels in $55M to fund new biotech bets

Biotech startup machine PureTech has raised a $55 million round to fund the next stage of its evolution, recruiting some big thinkers to help it advance its stable of ventures and develop new technologies.

Genentech pays $150M upfront to partner on NewLink's immuno-oncology drug

Biotech powerhouse Genentech is going all in with Ames, IA-based NewLink Genetics, partnering on an early-stage cancer program which has been billed as an important example of a new class of checkpoint inhibitor. And Genentech says that it plans to build a portfolio of programs pairing this therapeutic with Roche's closely watched PD-L1 drug.

Merck and Roche prep breast cancer data for promising immunotherapy drugs

As fervor surrounding a new class of cancer drugs builds, drug giants Merck and Roche are set to roll out new data for their opposing immunotherapy drugs for breast cancer by the end of the year.

Astellas backs out of a $760M Alzheimer's deal with CoMentis

Astellas and CoMentis are calling it quits on their partnership in Alzheimer's disease, as the Japanese drugmaker walks away from a deal valued at up to $760 million.

Amgen sues to block Sanofi and Regeneron at the PCSK9 goal line

Sanofi and Regeneron have cut to the front of the line in the race to develop a new class of cardio drugs, but now rival Amgen has made a chess move of its own, filing a patent-infringement lawsuit designed to block its rivals from reaching what's expected to be a blockbuster market.

Incyte taps David Gryska to be its new CFO

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 Michael Gibney (email | Twitter)...

Repros plummets as the FDA deals a blow to its low-T hopes

After years of clinical and regulatory setbacks, Repros Therapeutics was finally on the path to submitting its testosterone treatment to the FDA, scheduling a prefiling meeting for November with hopes of handing the drug in by year's end. But the agency has had some second thoughts, changing the agenda for the meeting and indefinitely delaying Repros' plans.

Adaptimmune's novel cancer treatment posts promising early results

Adaptimmune's pioneering approach to cancer immunotherapy has charted some impressive results in a small study. And while the biotech is quick to point out that it's early days yet, the data underscore the potential of a therapy that has convinced GlaxoSmithKline to bet up to $350 million on its future.