Drugs typically go through three phases of clinical testing to support an application for FDA approval. It’s easy to overlook Phase 4, which takes place after a drug reaches the market.
Post-marketing studies aim to identify side effects not observed in... Read more »
Eisai is withdrawing weight-loss drug lorcaserin after a post-marketing study found a higher incidence of cancer in patients who took the medicine.
The FDA said Thursday that its request for removal of the product from the market is voluntary, but Eisai... Read more »
Pfizer and Merck are each cutting ties with a smaller clinical-stage biotech after experimental drugs being developed under separate alliances fell short in human testing.
Pfizer (NYSE: PFE) is walking away from a partnership with GlycoMimetics (NASDAQ: GLYC) a... Read more »
Two experimental drugs from Eli Lilly and Roche have failed a clinical trial testing them as treatments for a form of Alzheimer’s disease caused by certain genetic mutations, the companies reported Monday.
The study, sponsored by Washington University, tested the drugs... Read more »
Merck is corralling products representing $6.5 billion in sales and spinning them off into a separate company, a strategic bet that focusing the remaining business on developing innovative new medicines will drive future growth.
The new company will take Merck’s... Read more »
If this week is any indication, the steady march of life science companies to Wall Street will continue in 2020. Black Diamond Therapeutics is leading the way, having raised $201 million from its IPO. In its first day of trading, the... Read more »
Biopharmaceutical companies focused on advanced therapies are changing industry R&D, manufacturing, and supply chain models according to KPMG.
The audit, tax, and advisory services firm shared details of the trend in its Healthcare & Life Sciences Outlook report, explaining that for... Read more »
Cells die all the time in a controlled manner that’s perfectly normal. But the way cells die matters. Sometimes cell death is violent, sparking inflammation believed to contribute to disease.
Quench Bio aims to develop drugs that stop the uncontrolled forms... Read more »
Allergan is selling off an experimental drug and a commercialized product in order to allay antitrust concerns from regulators reviewing the company’s $63 billion acquisition by AbbVie.
The rights to brazikumab, which is currently in testing for Crohn’s disease and... Read more »
Company news slowed somewhat this week, perhaps as some took the federal Martin Luther King Jr. Day holiday away from the office and others recovered from back-to-back meetings and late nights at the JP Morgan Healthcare Conference. However, a new coronavirus... Read more »
MedImmune, AstraZeneca’s biologics division, is no more. The pharmaceutical giant announced last year that the name would be retired as part of a research and development restructuring.
Before MedImmune became an AstraZeneca (NYSE: AZN) business unit, it was a standalone... Read more »
The first treatment for a rare disease that causes eye bulging and double vision received an FDA nod on Tuesday, weeks ahead of the agency’s March 8 deadline to review the drug.
Dublin, Ireland-based Horizon Therapeutics (NASDAQ: HZNP) tested the... Read more »
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 »
Neon Therapeutics closed 2019 by curtailing its cancer vaccine programs and laying off 24 percent of its workforce, part of a corporate restructuring aimed at finding a new path for the company. That new path will now be as a division... 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 »
Two weeks after MorphoSys filed for FDA review of its experimental treatment for a form of lymphoma, the company has struck a deal with Incyte to further develop and commercialize the therapy in the US and around the world.
According to... 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 »
When a group of scientists from Amira Pharmaceuticals wanted to start a new biotech after the company’s 2011 acquisition by Bristol-Myers Squibb, Celgene provided seed funding.
Eventually Celgene kicked in $35 million more for a research collaboration, an equity stake,... 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 »
Cell and gene therapies are becoming more mainstream, but an essential aspect of the drug development process is talking with clinicians about how it would fit into their practice, according to Joe Dupere, CEO of UK-based regenerative medicine company Rexgenero.
Rexgenero... Read more »
Swiss biopharma Roche is betting more than $1 billion that Sarepta Therapeutics, which recently won FDA approval for its second RNA medicine for Duchenne muscular dystrophy, will get its lead gene therapy treatment across the finish line too.
The deal, one... 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 »
