News

French immuno-oncology biotech OSE eyes an EU IPO

The U.S. boom in biotech IPOs has largely failed to drift across the Atlantic and galvanize many floats in Europe, but France's OSE Pharma is looking to buck that trend in hopes of bankrolling late-stage studies for its immuno-oncology candidate.

Cubist makes Euro landfall with a $400M purse for antibiotics R&D

The antibiotics-focused Cubist Pharmaceuticals has opened up shop in Europe with a Swiss international headquarters, part of its plan to spend $400 million on infectious disease R&D this year and spotlight new treatments for global scourges.

Antibiotics R&D to get critical lift by executive order, Obama advisory group

Antibiotics development is about to get a much-need boost with the release of new federal proposals aimed at curbing rising antimicrobial resistance infections caused by so-called superbugs.

Novo Nordisk wins EU approval for a diabetes combo with billion-dollar potential

Novo Nordisk picked up European approval for a combination of a long-acting insulin and its own Victoza, pioneering a once-a-day approach to Type 2 diabetes that could bring in blockbuster sales.

Merck KGaA rearranges its executive board amid biosimilar surge

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)...

Dutch VC opens €65M cancer fund, Affimed IPO falls short, Evotec begins legal action

In this week's EuroBiotech Report, cash-starved European cancer startups had reason to cheer when Aglaia Biomedical Ventures revealed a new, €65 million ($84 million) oncology fund. The Dutch VC shop plans to invest the cash pool--which could rise to €100 million--in up to 15 early-stage biotechs. And more.

UPDATED: FDA hands Eli Lilly a big win, OKs dulaglutide for diabetes

An embattled Eli Lilly won a major battle today, gaining the FDA's approval to market dulaglutide for Type 2 diabetes. It will be sold as Trulicity.

FDA advisers shoot down Clarus' pitch for a new low-T drug

Amid widespread safety concerns surrounding testosterone drugs, an FDA panel has recommended against Clarus Therapeutics' oral treatment, dimming the future for the company's sole product.

Evotec calls in the lawyers in wake of Andromeda scandal

The German biotech says it will take legal action against Andromeda for the damages that have resulted. And this dust-up has only just begun. More litigation is all but guaranteed.

Struggling Merck KGaA plans blockbuster R&D campaign for biosimilars, pact for PD-L1

Fresh from writing off one of its top late-stage programs, Merck KGaA stepped up with a revised comeback plan today, detailing plans to invest about $500 million in a late-stage effort to develop new biosimilars while scouting for a major-league partner to come in on its PD-L1 immuno-oncology program. And the company pointed to its current lineup of three star players in the pipeline, including one that has already posted a clinical failure.

Biotech IPOs: ProQR soars and Foamix thuds amid a volatile market

For evidence of Wall Street's ongoing hesitance to embrace biotech startups, look no further than ProQR Therapeutics and Foamix Pharmaceuticals, two IPO debutantes with diametric fortunes on the market.

Merck's weekly diabetes drug stacks up to blockbuster Januvia in Phase III

Merck's new, once-a-week treatment for diabetes measured up to the company's top-selling Januvia in its first Phase III test, setting the stage for a Japanese regulatory application and stoking the drugmaker's hopes of another blockbuster in the space.

UPDATED: Oral low-T drugs in the pipeline face a showdown with the FDA

An expert panel assembled by the FDA has taken a big step toward blunting the fast-growing market for low-testosterone drugs, raising a thorny issue not just for the companies that sell such remedies, but also for two biotechs trying to gain approvals for new ones.

Boehringer pairs its lung cancer drug with a vaccine in $600M tie-up with CureVac

A little more than two months after inking a licensing deal with Sanofi, CureVac has completed another tie-up, banking a $45 million upfront from Boehringer Ingelheim and partnering its therapeutic vaccine aimed at lung cancer. The deal also includes up to about $556 million in prospective milestones for the German biotech.

Flexion tanks as FDA clamps a hold on its lead osteoarthritis drug

Just months after pulling off a successful IPO, Flexion Therapeutics is left watching its shares plummet after the FDA forced it to halt a trial on its top prospect.

Proteon joins long IPO line with $69M offering

Another day, another biotech IPO. Waltham, MA-based Proteon Therapeutics has joined the queue of biotechs looking to make the leap into Nasdaq, looking to raise some $69 million.

Tokai pockets $97M in IPO cash to get its cancer drug into Phase III

Cambridge, MA, biotech Tokai Pharmaceuticals pulled off a $97.2 million Wall Street debut, raising the money it needs to get its three-in-one treatment for prostate cancer into late-stage development.

The 2014 Fierce 15 is about to debut in Boston

The 12th annual Fierce 15 report will be rolling out at the BioPharm America meeting in Boston on Monday just before we go live with the report on the website.

Novo Nordisk takes the plunge on obesity, eyeing Seattle for a huge R&D bet

In the midst of its first major foray into treating obesity, Novo Nordisk is liking what it sees in the space, and now the Danish giant plans to hire hundreds of researchers in a gambit to develop new treatments for the global scourge.

Sutro adds Merck KGaA to its roster of marquee 'armed antibody' partners

Sutro Biopharma has landed another marquee name for its list of development partners for antibody-drug conjugates. Merck KGaA, which has been struggling in the clinic for years, has signed on with the San Francisco-based biotech, offering a $300 million package of milestones along with some unspecified research support.