After a follow-up review, the FDA has decided that the adverse events and deaths recorded in CTI BioPharma's pivotal program of the myelofibrosis drug pacritinib are so alarming that they've imposed a full clinical hold on the trial, halting dosing and persuading the biotech to yank its newly completed drug application.
A group of independent FDA advisers voted in favor of OK'ing Pfizer and Celltrion's take on the blockbuster inflammation treatment Remicade for all of the reference drug's approved indications, unswayed by protests from Johnson & Johnson.
Samuel Isaly, co-founder of biotech investment giant OrbiMed Advisors, said biotech's recent dip in valuations will likely start to turn around as Big Pharma--"the guys with cash"--start to swoop in and buy up suddenly affordable assets.
Editas and BeiGene may have made it to Nasdaq, but the IPO window isn't open for everyone. Apellis pulled their attempt at going public.
One of the market themes that emerged in 2015 was that marquee biotech players could get a boost out of a high-profile acquisition--just as Big Pharmas remained aloof to the ever-rising, jaw-dropping price tags tied to drug pipelines after a three-year bull market. Now, though, with industry share prices in a savage spiral, some top execs in the industry voted most likely to ink new deals are adopting a wary attitude as they wait for the dust to settle.
San Diego's Amplyx Pharmaceuticals boosted its Series B fundraise to $49.2 million and expanded its executive ranks, on pace to take its lead antifungal treatment into human trials this year.
Like a lot of biotechs, Juno Therapeutics has seen its share price kicked down to what would have looked like a bargain-basement rate from its highs in 2015 as a bear market mauled industry valuations in recent weeks.
Actelion, the standard bearer in treatments for pulmonary arterial hypertension, is scouting for new disease areas as it rolls out its next potential blockbuster, hoping to keep up its pace of growth by pivoting away from its home base.
AstraZeneca has successfully wrapped a small proof-of-concept study to help demonstrate how two immunotherapy drugs will likely work better than one. The pharma giant is reporting that a combination of the PD-L1 drug durvalumab combined with the CTLA-4 treatment tremelimumab achieved an objective tumor response rate of 23% for metastatic non-small cell lung cancer patients.
Sarepta Therapeutics, hoping to win approval with a treatment for Duchenne muscular dystrophy, will have to endure a three-month FDA delay before getting final word on its drug.
Biogen has signed up with a GlaxoSmithKline-founded effort to better understand the underlying biology of disease, hoping to map out better targets for future therapies by collaborating on early-stage research.
The FDA has slapped a partial clinical hold on CTI BioPharma's late-stage myelofibrosis drug pacritinib after patients in the drug arm of a Phase III study began to die at a higher rate than those in the placebo group. The drug arm also registered a higher number of adverse events, further raising concerns about the safety of the drug.
BioCryst got the biotech week started with a crash. The Research Triangle Park, NC-based company says its midstage study of their lead drug avoralstat for hereditary angioedema flopped, with both doses failing to register a statistically significant improvement for patients compared to a placebo.
A little more than a week after Cambridge, MA-based Akashi Therapeutics suspended its study of a new drug for Duchenne muscular dystrophy after a patient was sent to the hospital, the biotech reports that the trial subject has died.
FDA staff signaled support for Celltrion's biosimilar of Johnson & Johnson's Remicade in documents released ahead of a key panel vote, a positive development for the South Korean company as it works with Pfizer to tap the U.S. market.
Shire's once-rejected treatment for dry eye disease has another date with the FDA, supported by new data the company believes will get the drug on the market and eventually help bring in more than $1 billion in annual revenue.
Bothell, WA-based biotech OncoGenex is laying off nearly a third of its workforce to conserve cash as it holds out hope for its lead cancer program in a move designed to keep the doors open until Phase III results come in.
In this week's Chutes and Ladders, Marc Tessier-Lavigne was named president of Stanford University, Katie Wilson was named EVP of human resources at Gilead, and Osiris CEO Lode Debrabandere stepped down. Plus more hirings and retirings throughout the industry.
Next year at the big J.P. Morgan conference in San Francisco, don't be surprised by the absence of attractive models at the LifeSci Advisors after party--or any party in the area around Union Square.
French Health Minister Marisol Touraine has criticized the CRO behind a botched drug trial that has seen one die and 5 others seriously ill for failing to stop the study.