A last-ditch effort by Eleven Biotherapeutics to mine positive late-stage data from its only clinical asset has ended in failure, sending its shares crashing back downward and leaving company execs to ponder how to survive a cash crunch.
In this week's Chutes and Ladders, Celgene named Mark Alles as CEO, Baxalta CEO Ludwig Hantson will leave following the Shire merger, and MannKind appointed Matthew Pfeffer as CEO. Plus more hirings and retirings throughout the industry.
Marlborough, MA's Theracos raised $25 million to support its work on a safer version of a common treatment for Type 2 diabetes.
Amgen, at work on a biosimilar of AbbVie's best-selling treatment, got an unfavorable decision from U.S. regulators that could delay the launch of its take on Humira.
Syros Pharmaceuticals raised $40 million in equity to push forward with its pipeline of genetically targeted drugs, securing the cash it needs to take its top prospect into Phase II.
Heron Therapeutics, pushing to finally win approval for a long-delayed treatment for chemotherapy-induced nausea, will have to wait another month or so as the FDA has put off its plans to weigh in this week.
Sarepta's quest to gain an accelerated approval for eteplirsen was subjected to some harsh scrutiny by regulators at the FDA. And the insiders concluded that much of the data submitted for an approval was a mess, with weak, inconsistent data raising serious questions about the efficacy of the drug.
A botched Phase I trial has left 6 patients in serious condition with one effectively "brain-dead," according to the French government, which has opened an investigation.
The two most commonly watched indexes of biotech stocks have each fallen more than 35% from their July peaks, battered down by a pervasive sense that the frothy days of the biotech boom, when becoming "the Amgen of" anything seemed at least glancingly possible, have passed. And that sentiment permeated this year's J.P. Morgan Healthcare Conference.
Our top stories in this week's EuroBiotech Report involve the transfer of more than $100 million (€92 million) from the wallets of investors to the bank accounts of biotechs. Cardiorentis led the way with a $60 million round. And more.
Swedish drug developer NeuroVive Pharmaceutical is cozying up to R&D partner Isomerase Therapeutics, buying a stake in the company as the two move together on a CNS project.
Indian drugmaker Cipla said it currently has 200 drugs in development and that the top 50 of those drugs have the potential to earn the company more than $30 billion.
Pfizer, breaking into the field of re-engineered T cells for cancer, believes its work with partner Cellectis could eventually top the efforts of more advanced rivals including Novartis.
SAN FRANCISCO--During a luncheon meeting with reporters at a hotel near a bustling Union Square, Celgene CEO Bob Hugin--soon to be the executive chairman as Mark Alles moves into the CEO suite--was asked where he was interested in taking the company.
The anecdotes simply highlight a discomforting truth that women in the industry are only too familiar with. Women make up about 40% of the qualified workforce in the industry, and take around 1 in 10 of the board seats.
After outlining its objections to BioMarin's application for its experimental Duchenne muscular dystrophy drug drisapersen in an internal review and hearing clear objections from outside experts, the FDA has rejected the biotech's marketing application, saying it has yet to see real evidence of efficacy.
SAN FRANCISCO--Four months after Biogen swiftly slashed 880 jobs in a wrenching restructuring, the biotech trendsetter is back on a new hiring spree in research aimed at luring in a wave of top talent in neuroscience R&D.
BioLineRx has become the latest company to stake its claim for a spot on the burgeoning roster of immuno-oncology combinations. The small biotech is aiming to muscle into the sector by showing its CXCR4 antagonist BL-8040 can boost the effectiveness of Merck's Keytruda in metastatic pancreatic adenocarcinoma.
Spark Therapeutics, at work on gene therapies for rare diseases, laid out an ambitious three-year plan that would see its top candidate win FDA approval and 9 others enter clinical trials.
Vice President Joe Biden fleshed out his plans to take the lead on a global effort to bolster cancer research, hoping to unite industry and academia to push new therapies forward.