Shares of Regado Biosciences took a nasty beating Thursday evening after the company put out the word that enrollment in its big, self-funded Phase III study of a new anticoagulant had to be put on hold so that a safety monitoring committee could check out "serious adverse events related to allergic reactions."
Marc Blaustein never said it would be easy to develop a new drug for Duchenne muscular dystrophy. But even though he doesn't have the biggest organization, the most money or a full set of human data on key endpoints, he has been making some steady, early progress on his quest.
The FDA is guaranteeing a priority review for Boehringer Ingelheim's much-watched treatment for a rare lung disease, likely speeding up the drug's path to market as the German pharma races with biotech InterMune.
Welcome to the latest edition of our weekly EuroBiotech Report. With the battle for investor support in the AbbVie-Shire takeover tug of war heating up, the Ireland-headquartered biopharma has played up its European roots and rare position in the region as a mid-sized company. And more.
In a deal designed to beef up its pipeline of ophthalmology drugs, France's Nicox has snapped up Boston-based Aciex for $65 million in newly issued shares and up to $55 million in contingent value rights. Those CVRs are structured to pay off Aciex's investors in large part based on the success of Aciex's drug AC-170, which has been in Phase III studies for allergic conjunctivitis.
Christophe Weber is next in line for the throne at Takeda, and the former GlaxoSmithKline exec has a mind to grow the Japanese pharma through dealmaking, hoping to refill the in-transition company's pipeline and expand in emerging markets.
The biotech is also planning to launch studies for SNC-102 in Tourette syndrome and post-traumatic stress syndrome. Accellient seeded Synchroneuron up to its $6 million Series A from Morningside.
After two consecutive quarters of mostly bullish biotech debuts, two drugmakers are lining up IPOs in hopes the market stays drug-friendly, seeking a combined $126.5 million to bankroll treatments for cancer and metabolic disease.
When Jazz Pharmaceuticals bought out the rare-disease drug developer Gentium for a billion dollars late last year, the company picked up a new therapy for severe veno-occlusive disease that it went on to launch in Europe last April. Now it's buying back the U.S. rights to the drug--which Gentium had bargained away to Sigma-Tau--for $75 million in cash and up to $175 million in milestones. And that extra cash will be staked entirely on its ability to shove the long-delayed drug through the FDA approval process.
Just a year after J&J swooped in to buy up Aragon's game-changing work on prostate cancer in a billion-dollar deal, Roche's Genentech has followed up to buy what remained: a closely-related breast cancer program that promises to change the way that disease is treated.
Agenus' vaccine for a deadly form of brain cancer helped extend patients' lives in a single-arm study, the company said, news that sent its shares up as much as 20% on hopes it can find a partner to help it into Phase III.
Sanofi CEO Chris Viehbacher is often pressed to answer why he doesn't just buy Regeneron, a biotech outfit closely bonded with Big Pharma on several important development initiatives.
Long since shelving an attempt to go public, antibiotics developer Paratek Pharmaceuticals has signed a deal that will give it a Wall Street debut after all, planning a reverse merger with the struggling Transcept Pharmaceuticals and picking up a $93 million investment along the way.
Amgen has scored boasting rights to a breakthrough drug designation from the FDA for its promising mid-stage leukemia drug blinatumomab.
It takes a scorecard to keep up with the biotech IPO action these days. Four of the 8 companies planning to go public in the U.S. this week are biotechs, including Minerva and Syndax, and the crush of companies at the Nasdaq gate is making it increasingly hard for all of them to find a large enough group of investors to back their play.
The gene therapy pioneer bluebird bio has snapped up a biotech outfit skilled in gene-editing and cell-signaling tech in a deal valued at up to $156 million, including about $16 million worth of its stock.
Merck is racing to be first on the market among contenders in the PD-1 field of cancer therapy, and the European Medicines Agency has agreed to review its pembrolizumab as a treatment for advanced melanoma.
The FDA has handed out its third rejection of a new, inhalable migraine therapy Allergan had hoped could be used to help fend off Valeant's buyout bid. The big biotech did get some good news, though, announcing that the agency approved Ozurdex for diabetic macular degeneration.
This year's explosion of pharma deals, both real and rumored, has put a spotlight on the U.K.'s complicated, far-reaching rules on corporate takeovers, and AbbVie's $46 billion pursuit of Shire has teased out a new wrinkle. Under local law, the Irish-headquartered Shire is unable to make any big buyouts of its own until AbbVie's pitching period expires, a provision that has hamstrung the company's deal-friendly ethos, CEO Flemming Ornskov said.
Cidara Therapeutics has emerged from stealth mode with a crew of experienced biotech execs, a $32 million bankroll from a slate of top-shelf venture investors and a plan to make a difference in developing frontline antifungal drugs.