Tristan Manalac

Tristan Manalac

Senior Staff Writer

Tristan is BioSpace‘s senior staff writer. Based in Metro Manila, Tristan has more than eight years of experience writing about medicine, biotech and science. Being formally trained in molecular biology, he once dreamed of collecting degrees and starting his own lab. But these days, he finds his greatest joy in a bottle of beer and a beautiful sentence. He can be reached at tristan.manalac@biospace.com, tristan@tristanmanalac.com or on LinkedIn.

The company reported mid-stage and late-stage trial victories, one in small-cell lung cancer and another in colorectal cancer, as part of its second-quarter earnings on Thursday. No specific data was provided.
During Regeneron’s second-quarter earnings call Thursday, the company said that the regulator could make its decision on 8-mg Eylea in the third quarter—much earlier than market expectations.
FDA
The regulator Wednesday approved expanding Lonsurf’s label for previously treated metastatic colorectal cancer, authorizing a combination regimen with Roche’s bevacizumab.
Savings from just four of 10 drugs covered by the Inflation Reduction Act’s Drug Negotiation Program could reach $1.8 billion during the first year of implementation, according to research.
Following reports of destroyed and discarded data, the U.S. regulator issued a warning letter to India’s Intas Pharmaceuticals regarding violations of current good manufacturing practice.
Following difficult recent months for EQRx, the biotech is being bought by Revolution Medicines in an all-stock transaction that secures $1 billion in additional capital for the oncology company.
Amid a re-energized Alzheimer’s disease space, Quest Diagnostics offers what the company contends is the first direct-to-consumer blood-based biomarker test to assess disease risk.
FDA
The FDA has approved Jemperli as an add-on to chemotherapy for patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient or microsatellite instability-high.
Syfovre has been linked to rare cases of eye inflammation that could lead to blinding, though Apellis’ review so far has found no connection between the treatment and the complications.
Amid U.S. shortages in crucial drugs, House Republicans have filed their own draft bill that seeks to increase the accountability of the FDA and provide more flexibility for generics manufacturers.
Seed and Series A funding are set to drop this year as investors are looking for more advanced, less risky deals, according to an industry analysis from HSBC.
Following a sweeping cost-cutting plan announced earlier this week, including an 11% workforce reduction, Biogen is acquiring Reata Pharmaceuticals to bolster its neurological and rare disease pipeline.
Despite beating analyst expectations, Takeda sustains a mid-stage defeat in a rare genetic disorder, leaving the fate of an investigational enzyme replacement therapy uncertain.
Two late-stage trial wins for Merck’s V116 investigational pneumococcal vaccine could make it a serious challenger to Pfizer’s Prevnar 20 in the space.
The FDA has three upcoming action dates in the next two weeks, including a highly anticipated decision regarding Biogen and Sage’s depression drug zuranolone.