Thanks to some risk-accepting venture capitalists, optimistic public investors and compromising regulators, 2013 was a banner year for the drug development business. But while much of the industry's optimism has rolled on into the new year, early signs suggest 2014 may struggle to keep the pace.
Bayer is gambling $700 million on the ultimate success of its new hemophilia drugs now in Phase III testing. That's about how much Bayer's growing healthcare division plans to spend as it boosts its manufacturing capacity at two sites in Germany.
San Diego biotech Lumena Pharmaceuticals has nailed down a $45 million B round with plans to move forward with treatments for two liver diseases, one a painful orphan condition and the other a fast-spreading cause célèbre in the biotech world.
The careful, buttoned-down style favored by Novartis' top execs in Basel has been getting a makeover--at least on the architectural front.
Anyone in the industry who knows Ken Moch, the CEO of a little biotech in Durham, NC, named Chimerix, is likely to describe him as personable, chronically cheerful and an outspoken champion of all things Chimerix.
It turns out that Bayer doesn't want to be in the chin-fat busting business after all. Bayer's consumer care arm handed back its ex-U.S. rights in Kythera Biopharmaceuticals' lead treatment ATX-101, aimed at eliminating the double chin. And in return Bayer gets a $33 million chunk of Kythera's stock, a $51 million note payable by 2024 and some potential longterm sales milestones.
La Jolla Pharmaceutical's chronic kidney disease drug hit its primary endpoint of improving organ function in a Phase II trial, the company said, and while the results sent the biotech's shares skyward by 75%, a quirk in dosing gave some analysts pause.
Sanofi is joining forces with UCB to study new small-molecule approaches to treating inflammatory conditions like arthritis, looking for an easier form of administration to some of the blockbuster injected biologics that dominate the field. The pharma giant is ready to spend more than $138 million for a package of milestones and an upfront payment to UCB in exchange for the partnering arrangement with its NewMedicines research arm.
After a big mid-stage failure cast doubt on its lead drug, biotech Cerulean Pharma is betting the nano treatment can succeed in other cancers, pitching a $75 million IPO bankroll further development.
Regado Biosciences earned a pop in its stock price this morning after it put out word that the FDA has granted fast-track status to its anticoagulant REG1. The Basking Ridge, NJ-based biotech's share price is up more than 20% on Monday morning.
Eventual winner Johnson & Johnson wasn't Pharmacyclics' first choice to partner with on ibrutinib, CEO Robert Duggan told FierceBiotech in January, but, as The Wall Street Journal lays out, J&J and its expansive approach to dealmaking won out in the end.
A little biotech startup with an impressive lineup of biotech veterans among its backers has won over pharma giant Johnson & Johnson as an early partner on its plan to develop a new drug for Alzheimer's, currently one of the toughest targets in the drug business.
Northwest Biotherapeutics announced that German health regulators have OK'd a special hospital exemption that allows the sale of its controversial--and unproven--dendritic vaccine for brain cancer for all glioma brain cancers.
Some of the leaders in the frenzied late-stage race to develop a PCSK9 drug watched their stock prices stumble on Friday afternoon as word of the FDA's concern about potential neurocognitive side effects in the cholesterol drug class ripped through Twitter.
Fresh off positive results for its late-stage lung drug, InterMune has attracted some M&A interest from a flock of pharmaceutical companies, according to Reuters, sending the biotech's shares up roughly 12% on Friday.
In contrast to NewLink Genetics, Northwest Biotherapeutics' interim analysis was a boon to the company's investors, as word that its Phase III trial of a personalized cancer vaccine was going according to plan sent its shares up as much as 10%.
In the midst of rethinking its approach to R&D, AstraZeneca has dabbled in the virtual model of drug development, matching a small in-house staff with collaborators on contractors around the globe to make the process more efficient. Now, after some early success in neuroscience, the pharma giant is amping up its virtual efforts in oncology, signing a deal with a South Korean institution to hunt for new targets in the field.
Reaping the benefits of deep-seated R&D reorganization, GlaxoSmithKline had the industry's best 6-year run of FDA nods for new drugs, according to EvaluatePharma, leading its competitors by a wide margin and leaving approval-starved outfits like Eli Lilly and Merck in the dust.
Recro Pharma had to dial down its asking price and amp up its offering, but the Malvern, PA, biotech managed to go public at last, grossing $30 million to fund its pipeline of pain treatments.