Perhaps the most talked-about news at the JP Morgan Healthcare Conference this week was a new startup that launched with $200 million and an ambitious claim that its first drug would be approved within five years, and 10 in total within... Read more »
[Updated 1/15/2020, 8:51 a.m. See below.] As the nation grapples with the ongoing opioid crisis, an FDA advisory panel on Tuesday unanimously voted against recommending approval of a Nektar Therapeutics painkiller that would add a new compound to the... Read more »
A letter signed by 215 people involved in the biopharma industry, including CEOs and investors, published Wednesday promised to put the “interests of patients first.”
Six CEOs, including five who run public companies, co-authored the letter. Signatories agreed to what they... Read more »
In the week leading up to Christmas, six drugs won FDA approvals. The decisions covered insomnia, migraine, and several different forms of cancer.
The FDA’s final tally for the year totaled 48 new drug approvals. If you’re keeping score, that compares... Read more »
As national politics dominates the news in the final days of the decade, we at Xconomy are wrapping up the year with some big moves by the FDA, including an approval of the first drug OK’d reduce heart risk in patients... Read more »
If you’re keeping track, FDA drug approvals have been on a tear in the past month with several decisions coming well ahead of their targeted dates. And then there’s Sarepta Therapeutics.
Late Thursday, the FDA announced approval of the Cambridge,... Read more »
Iterum Therapeutics’ bid to bring patients a new antibiotic that’s safer than currently available drugs has fallen short of the main efficacy goal of a late-stage clinical trial. But the company is pinning its hopes on another Phase 3 study that... Read more »
It’s been a roller-coaster year for those hoping for new drugs to treat Alzheimer’s disease, a leading cause of death with rising treatment costs and no clear answer yet as to its cause.
Clearing proteins, such as amyloid and tau, was... Read more »
[Updated 12/4/19, 4:01 p.m. ET. See below.] Veracyte, a company whose tests help physicians make treatment decisions, is adding technology from NanoString to the fold to expand its diagnostic capabilities.
South San Francisco-based Veracyte (NASDAQ: VCYT) announced Tuesday... Read more »
Cyrus Biotechnology and the Broad Institute of MIT and Harvard have teamed up to make gene editing with the CRISPR-Cas9 technology safer.
The multi-target collaboration, specific details of which are not being disclosed, aims to address longstanding concerns surrounding gene editing:... Read more »
Bristol-Myers Squibb this week completed its acquisition of Celgene, a $74 billion deal that creates a pharmaceutical juggernaut. And all it took was the largest asset sale ever required by federal antitrust regulators.
As the Federal Trade Commission reviewed Bristol’s (NYSE:... Read more »
Drug pricing debates and uncertainty associated with Brexit are the issues most likely to keep biopharmaceutical executives awake at night. Nevertheless, senior figures remain optimistic about the industry’s prospects in 2020. These are among the major findings of a survey of... Read more »
Lung injuries connected to the use of electronic cigarettes have topped 2,000 and killed 40 people, according to the Centers for Disease Control and Prevention.
It’s still unclear whether the cases are tied to legally sold products or devices modified by... Read more »