Fourteen months after the FDA rejected the new antipsychotic cariprazine, the developers say they have gathered together a new batch of late-stage data to demonstrate its effectiveness for schizophrenia, but the statement has done little to dispel the lingering doubts about this one-time blockbuster hopeful.
Shares of CytRx bounced up 10% this morning as investors responded to the news that the FDA had lifted its partial hold on its late-stage cancer drug aldoxorubicin.
Back in January of 2012, Third Rock's upstart epigenetics play Constellation Pharmaceuticals landed a three-year deal with a marquee development partner. Genentech agreed to step in, provided a cash commitment of $95 million to cover part of the Cambridge, MA-based biotech's R&D overhead, and added an option to buy the company. Now the collaboration part of the deal is complete, and on Friday the biotech quietly laid off 23 staffers as it sketched out a path that would allow it to go it alone--if Genentech doesn't acquire the company by its deadline later this year.
The National Cancer Centre Singapore will brief on the status of a first-in-human clinical trial using an adenovirus under a protocol endorsed by the U.S. Food and Drug Administration and Singapore's Health Sciences Authority, highlighting the wealthy city-state's push to be a leader in early stage clinical trials in Asia.
Months after announcing plans to pursue an IPO for its HIV-focused joint venture, GlaxoSmithKline says it may take a similar tack with some of its other businesses.
Pfizer is well behind its rival titans in the race to cash in on a new class of cancer treatments. But instead of playing catch-up in skin cancer, the industry first immuno-oncology target, the drugmaker is skipping ahead to the next wave of malignancies.
Just days after Johnson & Johnson began a Phase I study of its new Ebola vaccine the pharma giant has organized an alliance to help accelerate its work and picked up a $116 million-plus grant to add to its $200 million commitment to get the job done as quickly as possible.
Belgian drugmaker UCB has inked a $480 million deal to team up with Neuropore Therapies on some early-stage treatments for Parkinson's disease.
Roche has signed a deal to trade up to €470 million ($545 million) for Trophos, a company at work on a mid-stage treatment for the rare and debilitating spinal muscular atrophy.
With a big assist from Moderna's recent monster round, the biotech industry came within a rounding error of breaking the record for new venture investing in 2014, racking up $5.96 billion in total investments in a frenzied year of deals, data and buyouts, according to The MoneyTree Report by PricewaterhouseCoopers and the National Venture Capital Association based on data from Thomson Reuters.
In this week's EuroBiotech Report, having unveiled plans for an £80 million ($121 million) listing on AIM this week, the AstraZeneca-partnered Redx is set to be among the first biotechs of the year to test the United Kingdom market. And more.
CTI Life Sciences, a Montreal-headquartered biotech backer, has put together a $112 million new purse, scouting for promising startups in Canada and abroad.
Scientists in Canada say they have drilled down into the massive data files from the development effort for cholesterol drug dalcetrapib and found that a subset of patients with the right genetic profile benefited greatly from the drug. And now they plan to follow up with a new study in an effort to revive the long-dead drug.
The FDA enjoyed some industry kudos at the end of 2014 after handing out a record number of new drug approvals for the past decade. And now it's crunched the numbers for the year to underscore the kind of trends regulators see in the biopharma world.
NantHealth, an arm of billionaire physician and biotech entrepreneur Patrick Soon-Shiong's empire, promises to improve cancer diagnostics through a marriage of genomics and high-speed computing. But behind its sleek marketing campaign and Soon-Shiong's bravura, the company is misleading customers and putting patients at risk, according to a lawsuit filed by two former employees.
With the big multinationals like Merck, Roche, Pfizer and J&J joining some of the most aggressive biotechs (think Shire) in roaming the planet in search of the right biotech targets to acquire, you can expect to see a steady stream of fresh speculation among analysts over which companies figure as the most likely buyout--and the next place to score some quick cash by investors.
Enanta Pharmaceuticals, perhaps best known as AbbVie's partner in hepatitis C, has blueprinted its next big solo step, joining the race to develop treatments for a pervasive liver disease with blockbuster potential.
SAN FRANCISCO--Waiting for an elevator at the Westin St. Francis in San Francisco, Celgene CEO Bob Hugin and I were chatting about the frenzied pace of deals that were announced in the lead-up to the annual JP Morgan confab. "The whole industry is on fire," he said with a happy smile.
Cambridge, MA's NeuroPhage banked an additional $10 million in Series D cash, bringing its latest round to $27 million and filling out the biotech's war chest as it marches toward the clinic with a treatment for neurodegenerative disease.