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Tristan Manalac

Tristan Manalac

Contributing Writer | News

Tristan is an independent science writer based in Metro Manila, with 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.

Novartis' office building in Marburg, Germany
Policy
EU Pulls Authorization of Novartis’ Sickle Cell Disease Drug
The Phase III STAND trial found no significant therapeutic benefit to Novartis’ Adakveo, pushing the European Commission to revoke its conditional authorization of the SCD treatment.
August 7, 2023
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2 min read
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Tristan Manalac
Pictured: Rejected stamp/iStock, Pavel Muravev
Policy
FDA Blocks Mesoblast Cell Therapy Again, Asks for More Data
For the second time, the regulator has blocked Mesoblast’s attempt to have remestemcel-L approved for pediatric steroid-refractory acute graft versus host disease, citing the need for adult data.
August 4, 2023
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2 min read
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Tristan Manalac
Pictured: CDC signage at its headquarters in Georg
Policy
AstraZeneca, Sanofi Win CDC Support for Preventive RSV Antibody for Infants
Following the FDA’s approval last month, a Centers for Disease Control and Prevention panel has recommended AstraZeneca’s and Sanofi’s Beyfortus for immunizing infants and high-risk young children.
August 4, 2023
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2 min read
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Tristan Manalac
Amgen sign at its headquarters in Thousand Oaks, California, USA.
Drug Development
Amgen Clinches Clinical Wins in SCLC and Colorectal Cancer
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.
August 4, 2023
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Tristan Manalac
Pictured: Financial graph overlaid on stacks of co
Business
Regeneron Eyes Earlier FDA Decision on Higher-Dose Eylea
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.
August 3, 2023
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3 min read
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Tristan Manalac
FDA signage at its office in Maryland
FDA
FDA Clears Taiho’s Lonsurf in Metastatic Colorectal Cancer Ahead of Takeda, Hutchmed
The regulator Wednesday approved expanding Lonsurf’s label for previously treated metastatic colorectal cancer, authorizing a combination regimen with Roche’s bevacizumab.
August 3, 2023
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Tristan Manalac
Pictured: Entrance to the U.S. Department of Healt
Policy
IRA’s Drug Price Negotiation Program Could Save Medicare $1.8B in First Year
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.
August 3, 2023
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Tristan Manalac
FDA sign outside its office in Maryland
Policy
Cancer Drug Manufacturer Intas Slapped with FDA Warning Letter
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.
August 2, 2023
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Tristan Manalac
Pictured: Businessmen shaking hands after closing a deal
Deals
Revolution to Buy EQRx in All-Stock Deal, Add $1B in Cash to Balance Sheet
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.
August 1, 2023
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2 min read
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Tristan Manalac
Pictured: Quest Diagnostics headquarters in New Je
Drug Development
Quest Launches Alzheimer’s Beta-Amyloid Blood Test for Consumers
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.
August 1, 2023
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Tristan Manalac
Pictured: GSK laboratories in Dresden, Germany
FDA
GSK’s Jemperli Beats Merck’s Keytruda for Frontline Endometrial Cancer Approval
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.
August 1, 2023
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Tristan Manalac
Pictured: Healthcare worker conducting an eye exam
Apellis Eye Injection Treatment Flagged for Safety Issues
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.
July 31, 2023
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Tristan Manalac
Pictured: U.S. Capitol Building, Washington DC
Policy
House Republicans Propose Drug Shortage Legislation After Gutting Democrats’ Bill
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.
July 31, 2023
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Tristan Manalac
Pictured: HSBC headquarters in London/iStock, Will
Early-Stage Biopharma Funding to Drop 40% This Year: Report
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.
July 31, 2023
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2 min read
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Tristan Manalac
John Tlumacki/The Boston Globe via Getty Images
Deals
Biogen Boosts Neuro Pipeline with $7.3B Reata Buy Amid Layoffs
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.
July 28, 2023
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2 min read
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Tristan Manalac
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