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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.

FDA signage at its office in Maryland
FDA
Regeneron Expands Eylea’s Label with High-Dose Approval
Following a prior rejection due to manufacturing problems, Regeneron’s higher-dose Eylea won the FDA’s approval Friday, allowing for more infrequent dosing for the treatment of various eye diseases.
August 21, 2023
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Tristan Manalac
Merck Research Laboratories headquarters in Silicon Valley
Drug Development
Merck’s Welireg Clears Phase III Primary Endpoint in Renal Cell Carcinoma
The company is continuing its renal cell carcinoma push for its oral HIF-2α inhibitor Welireg with promising Phase III data showing significant progression-free survival improvements in patients.
August 18, 2023
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Tristan Manalac
Pictured: Man packing up his office things in a bo
Business
Kodiak CMO Steps Down After Phase III Flops for Eye Therapy
After the company’s investigational eye therapy recently failed two late-stage studies, Kodiak Sciences’ Chief Medical Officer and Chief Development Officer Jason Ehrlich has resigned from his roles.
August 18, 2023
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Tristan Manalac
Pictured: Healthcare worker administering a vaccin
Drug Development
Pfizer, Moderna Target Emerging Variants with Updated COVID-19 Shots
The companies contend that their updated COVID-19 vaccines for the fall vaccination season can elicit strong immune responses against the virus’ currently dominant and emerging subvariants.
August 18, 2023
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Tristan Manalac
Pictured: Exterior of an FDA building
FDA
FDA Approves Ipsen’s Palovarotene for Ultra-Rare Bone Disease
After two prior setbacks, the regulator has finally approved Ipsen’s palovarotene to treat fibrodysplasia ossificans progressiva. It’s the first treatment for the ultra-rare bone disease.
August 17, 2023
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Tristan Manalac
Pictured: The U.S. Supreme Court building in Washi
Policy
Federal Appeals Court Rules for Tighter Restrictions on Abortion Pill
Mifepristone’s legal saga continues as the U.S. 5th Circuit Court of Appeals ruled for steep restrictions on the drug’s access, though its effectivity is pending the Supreme Court’s review.
August 17, 2023
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Tristan Manalac
Pictured: FDA signage at its office in Washington, DC
Policy
Bluebird’s Lovo-Cel Gene Therapy for SCD Will Not Face FDA Adcomm
The regulator informed bluebird bio that it will not convene an advisory committee meeting to discuss the company’s application for the gene therapy being developed for sickle cell disease.
August 16, 2023
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Tristan Manalac
Pictured: Cancer cells growing on the liver/iStock
FDA
Delcath Gets FDA Approval for Cancer Drug-Device Combo 10 Years After Rejection
Following a nearly decade-long effort, Delcath Systems finally won the FDA’s greenlight for its Hepzato Kit for the liver-directed treatment of adult patients with metastatic uveal melanoma.
August 16, 2023
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Tristan Manalac
Pictured: Businessmen shaking hands after closing
Stada CEO Confirms Buyout Rumors, Sale Could Potentially Fetch $11B
Amid strong performance in the first half of 2023, Stada Arzneimittel’s private equity owners are considering a potential sale, though there are still no definite plans, according to CEO Peter Goldschmidt.
August 16, 2023
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Tristan Manalac
Pictured: Air sacs inside the lungs/iStock, Ozgu A
Drug Development
Galecto Drops Idiopathic Pulmonary Fibrosis Hopeful After Phase II Flop
The company is ending its investigational drug GB0139’s run in idiopathic pulmonary fibrosis after the small-molecule inhibitor failed to slow lung function decline in a Phase IIb study.
August 15, 2023
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Tristan Manalac
Pictured: Businessmen shaking hands after closing a deal
Deals
Harmony Makes Rare Disease Play with Potential $200M Zynerba Buyout
Following its Scorpion Capital controversy in March, Harmony Biosciences is seeking to deepen its pipeline with an acquisition of Zynerba Pharmaceuticals’ cannabinoid therapies for neuropsychiatric disorders.
August 15, 2023
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Tristan Manalac
Pictured: Pfizer office at its South San Francisco
FDA
Pfizer Bispecific Drug Wins FDA Accelerated Approval for Multiple Myeloma
On the heels of J&J’s Talvey, Pfizer’s bispecific antibody Elrexfio has secured an accelerated approval as another off-the-shelf treatment option for patients with relapsed or refractory multiple myeloma.
August 15, 2023
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Tristan Manalac
Pictured: FDA signage at its office in Washington, DC
Policy
FDA Delays PDUFA Date for Valneva’s Chikungunya Shot
Valneva’s chikungunya vaccine candidate will have to wait three more months for a decision from the regulator, potentially giving rival Bavarian Nordic additional time to catch up.
August 14, 2023
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Tristan Manalac
Pictured: Janssen headquarters in California/iStoc
FDA
FDA Approves J&J’s Akeega for BRCA-Positive Prostate Cancer
J&J’s Janssen Pharmaceutical got the FDA’s greenlight Friday for its PARP inhibitor Akeega, which is now authorized to treat BRCA-mutated metastatic castration-resistant prostate cancer.
August 14, 2023
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Tristan Manalac
Pictured: Doctor conducts an eye exam on a man/iSt
Drug Development
Regeneron’s High-Dose Eylea Allows for Longer Dosing Intervals in wAMD
Ahead of an FDA decision in the third quarter, Regeneron is touting promising durability data from the Phase III PULSAR trial for higher-dose Eylea in patients with wet age-related macular degeneration.
August 11, 2023
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Tristan Manalac
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