News

G1 banks $33M to cut in on a blockbuster oncology race

North Carolina's G1 Therapeutics hauled in $33 million to advance a headline-grabbing approach to cancer treatment, helping the biotech hit the gas in a space otherwise dominated by Big Pharma.

U.K. panel calls for innovation fund to break antibiotic discovery dam

A panel set up by the United Kingdom government to review antimicrobial resistance has called for the creation of a global innovation fund to spur the discovery of new drugs. The idea is to counter years of underinvestment by public and private players in basic to mid-stage scientific research.

Valeant said to weigh a Salix buy; Ironwood's GERD drug moves into Phase IIb;

@FierceBiotech: Third Rock starts a $45M Revolution to soup up natural remedies. News | Follow @FierceBiotech @JohnCFierce: That Merck BTD on HCV--not looking so revolutionary after $GILD and $ABBV...

Report: GlaxoSmithKline moves toward an IPO for its HIV business

GlaxoSmithKline has hired a trio of banks to help it orchestrate a spinoff for the HIV-focused venture it majority-owns, Reuters reports, part of a companywide reorganization effort.

Medicines Co. snaps up an Atlas seedling and a promising anesthetic

The Medicines Company bought out the shares of Annovation Biopharma it didn't already own, getting exclusive rights to a new anesthetic and scooping up a tiny biotech incubated by Atlas Venture.

FDA yanking 'breakthrough' bragging rights to Merck's hep C combo

Now that AbbVie has followed up on Gilead's game-changing combo with its own directly competitive hep C cocktail, Merck's late-stage player in the field doesn't look quite as revolutionary as it once did. With a new drug application being prepped for a near-term filing, the FDA has decided to drop its breakthrough therapy designation for Merck, possibly slowing the Big Pharma's marketing timeline a bit.

MicroConstants leverages Chinese Academy of Sciences antibody rights in license deal

MicroConstants China has signed a licensing agreement to gain the global rights for the development of AA98 antibody drug candidates from the Institute of Biophysics of the Chinese Academy of Sciences in a unique deal between academia and local industry.

Mixed M&A figures a rare low in Europe's upbeat 2014

Analysts have identified an area of European biopharma in which 2014 was a middling year: M&A. The data show that while deals involving U.S. biotechs hit new highs, the renewed optimism in Europe has yet to translate into the signing of checks.

UPDATED: Genmab stock jumps after PhII cancer data raise hopes of speedy approval

Phase II data from Genmab have ratcheted up expectations for a fast-track approval of its Johnson & Johnson-partnered treatment for double refractory multiple myeloma. Analysts see the data as strong enough to bring the CD38 monoclonal antibody to market in the first half of 2016.

Third Rock starts a $45M Revolution to soup up natural remedies

Revolution Medicines is developing technology it believes can do evolution one better, improving on naturally occurring compounds to transform promising but raw molecules into discrete drug candidates. And, with the help of $45 million from Third Rock Ventures, the biotech is first setting its sites on a pedigreed antifungal therapy.

Amgen clears PhIII hurdle in crowded biosimilar race to topple Humira

Amgen wrapped up a second successful Phase III study of its Humira knockoff, ABP501, flagging its head-to-head success in a brief thumb's up announcing that the biosimilar hit its primary and key secondary endpoints. And barring any nasty surprises the positive readout on rheumatoid arthritis should give Amgen the ammunition needed to gun for an approval in a crowded field of late-stage contenders.

Pfizer wins early FDA approval for a potential cancer blockbuster

Pfizer picked up a speedy FDA nod for palbociclib, a breast cancer treatment with blockbuster potential, barreling toward the market as it works to carve out a bigger share of the oncology space.

FDA wants to go on a hiring spree to fulfill 'precision' promise

The FDA is asking for $4.9 billion in the next fiscal year, a 9% annual hike that would help fund a broad expansion of the agency as it works to modernize.

AstraZeneca stares down protesters' last-ditch effort to derail new HQ

A small army of protesters united by a diverse set of causes has mobilized in a last-ditch effort to throw up a roadblock to AstraZeneca's ambitious plans to build a sprawling new corporate headquarters and research center in Cambridge, U.K. But the angry backlash against its plans appears to have little chance of delaying the centerpiece project in the pharma giant's big comeback effort.

Onconova tanks as Baxter backs away from its oncology drug

Baxter is scaling back its support of Onconova's lead candidate, nixing plans to pay for European trials and paring down the potential of what could have been a $565 million deal for the biotech.

J&J teams with U.K. to probe molecular causes of RA drug failures

The United Kingdom's National Institute for Health Research has teamed up with Johnson & Johnson's Janssen to figure out why anti-TNF drugs are ineffective in some rheumatoid arthritis patients. J&J is funding the collaboration, which is indicative of how the U.K. wants to embed its healthcare infrastructure in drug development.

Famed investor Mellon plans £100M fund for small biotechs

Jim Mellon wants to put his theory that British and European biotechs are undervalued to the test. The famed investor is trying to raise up to £100 million ($150 million) for a new fund dedicated to small biotechs in the United Kingdom and the rest of Europe.

Isis hails a Phase II diabetes victory, with caveats

Isis Pharmaceuticals is touting positive mid-stage results for its in-development Type 2 diabetes treatment, which significantly improved blood sugar levels and body weight. But the company didn't disclose how the drug did against the study's primary goals, clouding its promise and spurring investor doubts.

Sanofi, Roche and Lilly help bankroll a $20M round for Parkinson's player LTI

Kees Been has banked the $20 million round needed to move a bold new development program for delaying or preventing Parkinson's toward the clinic. And the veteran biotech CEO at the helm of Lysosomal Therapeutics Inc. is moving forward with a group of high-profile backers in his corner.

Troubled KaloBios axes CMO, staffers as setbacks mount up

Just weeks after KaloBios' second antibody program ended in an embarrassing failure and CEO David Pritchard quickly exited the company soon after, the biotech has now seen off its chief medical officer and more than 20% of its staff in a restructuring designed to reflect its dwindling pipeline prospects.