Roche's much-hyped multiple sclerosis treatment ocrelizumab kept up its momentum with the release of detailed late-stage data, burnishing hopes the injected drug is a blockbuster in the making.
Boehringer Ingelheim's in-development injection for psoriasis outpaced Johnson & Johnson's blockbuster Stelara in a Phase II trial, setting the table for late-stage development.
Switzerland's Octapharma AG is paying €80 million to bag the exclusive worldwide license to certain IP behind Glycotope's recombinant technology as well as a minority stake in the German biotech.
Harvard's Wyss Institute is spinning out another biotech. The cutting-edge research group has launched Opsonix with $8 million from Baxter Ventures and Hansjörg Wyss, the Swiss billionaire who founded the institute.
In this week's EuroBiotech Report, after four weeks in which drug pricing emerged as the go-to political football in the U.S. and economic issues rocked markets, Shield Therapeutics' confidence in its ability to pull off a smooth IPO has waned, prompting the specialty pharma to hit pause on its plans. The big question now is how quickly the situation will settle down. And more.
Eli Lilly's would-be rival to Pfizer's Ibrance (palbociclib) just gained an inside track at the FDA. Regulators handed Lilly the coveted "breakthrough therapy" designation for abemaciclib, another CDK 4/6 inhibitor with big plans for carving out a niche among patients with advanced breast cancer.
Evgen Pharma has rebooted its IPO plans months after abandoning an attempt to raise £20 million ($30 million) on the London Stock Exchange. The aim now is to tap investors for £5 million, a sum that will support Phase II trials of Evgen's vegetable-inspired drug in breast cancer and stroke.
He's been described as the most hated man in America. He's been kicked out of BIO, condemned by every biotech executive who's been queried by the media, lampooned on Saturday Night Live and subjected to the taunts of an online mob. But Martin Shkreli, the CEO of newborn Turing Pharmaceuticals, is still confident that he can turn it all around in his favor.
Neurocrine Biosciences says its experimental drug for tardive dyskinesia hit the primary endpoint in a Phase III study, setting up a near-term application with the FDA and spurring a 28% spike in the biotech's share price in premarket trading.
Shield Therapeutics picked a bad time to try to go public. Since it unveiled its plans on September 7, the NASDAQ Biotechnology Index has slumped 10% and confidence on the London Stock Exchange has seesawed as well. Faced with such conditions, Shield has decided to postpone its listing in London.
The biotech IPO window may not be closed, but it's also not wide open--at least for now. You can add CytomX to the list of biotechs that have now stumbled their way into an IPO.
FierceBiotech Radio on biotech's Wall Street malaise, Valeant's Washington woes, and immuno-oncology's primetime slot
FiercePharma's Carly Helfand and FierceBiotech's Damian Garde discuss another rough week for biotech stocks, Valeant Pharmaceuticals' doggedness in the face of congressional inquiry, and a curious new trend in pharma advertising.
French drugmaker Servier has outlicensed some early-stage cancer treatments to Horizon Discovery, holding on to the rights to buy them back if they come through in preclinical development.
The European Medicines Agency has put Cell Therapy's Heartcel on its conditional approval pathway, raising the possibility that the allogeneic stem cell therapy could come to market in 2017. And with the drug now nearing the market, Cell Therapy has begun to sound out investors about an IPO.
Euroscreen has topped up its bank balance to support the globalization of its clinical trial program. The €16 million ($18 million) round will allow the G-protein coupled receptor specialist to file an IND and advance ongoing Phase II trials of its lead candidate in women's health diseases.
Shares in DBV Technologies traded up as much as 13% in Paris following the publication of long-term data from a trial of its peanut allergy treatment. The open-label extension to a Phase IIb trial found that the extra year of taking Viaskin Peanut was associated with a rise in the proportion of kids who responded to the treatment.
Merck KGaA and Pfizer, playing catch-up among drug companies using the immune system to fight cancer, picked up the FDA's fast-track designation for their in-development therapy, designed to expedite its eventual review.
Big Pharma has been willing to pay hundreds of millions of dollars for a shortcut to FDA approval, buying up priority review vouchers created to incentivize new drugs for neglected diseases. But the agency seems less than enthusiastic about honoring its end of the bargain, with one top official expressing concerns about how the voucher program might harm the FDA's core mission.
Dermatology drug developer Aclaris Therapeutics priced its IPO well below its expected range, raising $55 million as a prolonged bear turn has dampened Wall Street's appetite for biotech debuts.
Atlas Venture startup Quartet Medicine added $6.25 million to its Series A fundraise, closing the round at $23.25 million as it moves toward clinical trials with a newfangled way of treating chronic pain.