News

FDA approves NPS Pharma's drug, burnishing Shire's $5.2B bet

NPS Pharma picked up FDA approval for the rare disease-treating Natpara, capping a lengthy review process and supporting Shire's decision to spend $5.2 billion on the company.

Biotech upstart enGene preps first trial for next-gen 'gene pill' tech

Montreal-based enGene has lined up $11.5 million in venture financing to put its next-gen approach to an inflammatory bowel disease treatment through its first clinical test.

UPDATED: Rockwell's dialysis drug wins an FDA OK, despite lingering doubts

Rockwell Medical has overcome some hard questions and lingering doubts about its iron-replacement drug for dialysis patients, winning a long-sought FDA approval for Triferic and providing the biotech a green light to begin its marketing campaign.

Sanofi, Regeneron capture a shot at first-mover advantage in the PCSK9 market

Amgen just lost a key regulatory race. Armed with a handy FDA shortcut voucher, Regeneron and its Big Pharma partner Sanofi announced today that the agency has accepted their application for the powerful new PCSK9 cholesterol drug alirocumab and set a priority deadline of July 24 for their marketing decision. If they get a quick green light, as many analysts expect, their decision to buy the priority review voucher will be rewarded with first-mover advantage with U.S. payers as Amgen sits out an FDA game clock that ends August 27.

India's GVK Biosciences gets harsh accusations from EMA on fake generic trials

In a no-holds-barred action, the European Medicines Agency has accused India-based CRO GVK Biosciences of systematically faking clinical trials for about 700 generic drugs marketed throughout the world. The products of dozens of generic makers are among the drugs involved, including popular antidepressants.

India's Biocon keeps many irons in the fire, Malaysian plan on schedule

India's Biocon held a busy earnings call on Jan. 23 that highlighted extensive spending on research and keeping several deals rolling, though tight-lipped on a possible license to make Gilead's chronic hepatitis C products and said it will sell a 10% to 15% stake in its research services arm Syngene through an initial public offering.

Osteoarthritis biotech Carbylan swings for a $75M IPO

Palo Alto, CA's Carbylan Therapeutics has set terms for an IPO worth $75 million at its midpoint, working to get a treatment for osteoarthritis pain through late-stage development.

Booming biotechs bank $2.7B in follow-on cash

Much of the focus in biotech's recent boom has been on the ease with which companies are making their way onto Wall Street. And, over the past week, a host of drug developers illustrated the benefits of being a publicly traded company, raising roughly $2.7 billion in follow-on offerings to bankroll R&D and potential acquisitions.

The Medicines Co.'s FDA-rejected cardio drug finds EU success

European regulators are recommending approval for The Medicines Company's cangrelor, setting up an overseas nod for a blood-thinning drug rejected by the FDA last year.

COO Caforio named incoming BMS chief

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)...

GlaxoSmithKline's Ebola vaccine rolls into Phase III as outbreak simmers

GlaxoSmithKline has shipped out the first batch of its in-development Ebola vaccine, expecting to kick off late-stage studies in the coming weeks.

Innovent's $100M deal signals how biotech is ready to explode in China

China biotech Innovent's recent success in raising $100 million in venture capital to help it build a pipeline of biosimilars could be a signal of how the industry may be set to explode in a country about to invest $6.45 billion in startups.

EU IPOs obliterate recent highs, U.K. VC funding tops $700M, Woodford backs microbiome play

In this week's EuroBiotech Report, data arrived to back up what everyone knew: 2014 was financially a much better year for European biotechs. The IPO window finally opened; 15 companies jumped through and €719.8 million ($835.3 million) of public investors' money landed in European biotechs' bank accounts. And more.

Astellas' new antibiotic marches toward FDA approval with panel nod

A group of independent FDA advisers voted in favor of a new anti-infective from Astellas Pharma, setting the stage for a likely approval.

CytRx PhIIb cancer survival data fail to impress

CytRx released some unimpressive overall survival rates from its Phase IIb study of its aldoxorubicin compared with doxorubicin for soft tissue sarcoma.

AstraZeneca's $1.3B gout drug comes under EU scrutiny

The European Medicines Agency has accepted AstraZeneca's application for lesinurad, a gout treatment with a checkered efficacy record, stoking the company's hopes that it can make the drug into a blockbuster.

As PhIII data looms, Nektar sets the stage for a big expansion

This is a big year for South San Francisco-based Nektar Therapeutics. And the company is making some big expansion plans, telling the local San Francisco Business Times that it has lined up a new lease on extra space as it sets the stage for adding up to 150 staffers.

Kite expands its immuno-oncology brain trust in the CAR-T footrace

Kite Pharma, contending with a slew of rivals in the newfangled field of immuno-oncology, has aligned itself with a pioneer in the field, teaming up with an Israeli university to work on treatments that train the body's own defenses on cancerous growth.

The CAR-T brain war: Scientific trailblazer inspires a $45M biotech startup

Martin Pule, who was directly involved in some of the pioneering discovery work being done on engineering T cells into cancer attack vehicles, today takes the role of chief scientific officer behind Autolus, the latest CAR-T upstart to join the ranks of some of the most disruptive players in cancer drug R&D.

China's Innovent banks $100M to cash in on the biosimilar boom

Innovent Biologics has raised $100 million in venture cash in hopes of becoming the premier maker of biotech drugs in its native China, advancing a pipeline of biosimilars and proprietary treatments.