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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.

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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2 min read
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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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2 min read
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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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2 min read
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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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2 min read
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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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2 min read
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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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2 min read
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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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2 min read
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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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2 min read
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Tristan Manalac
Pictured: Oxycontin bottles on a shelf/iStock, Pur
Policy
SCOTUS Blocks $6B Purdue Pharma Bankruptcy Settlement
The Supreme Court of the United States has granted the Department of Justice’s motion for a stay regarding Purdue’s bankruptcy case and is set to assess the legality of the settlement in December.
August 11, 2023
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2 min read
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Tristan Manalac
Pictured: Illumina headquarters in California/iSto
Deals
SEC Investigating Illumina’s Multi-Billion Dollar Merger with GRAIL
The Securities and Exchange Commission has joined the mounting antitrust scrutiny of Illumina’s acquisition of the cancer diagnostics company, according to an SEC filing by the DNA sequencing giant.
August 11, 2023
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2 min read
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Tristan Manalac
Silver Spring, MD, USA 11/10/2020: Exterior view of the headquarters of US Food and Drug Administration (FDA). This federal agency approves medications, vaccines and food additives for human use.
Drug Development
FDA Action Alert: Ipsen, Revance, Neurocrine and Regeneron
The FDA has four decisions on deck this week, including ones for two rare disease treatments from Ipsen and Regeneron.
August 10, 2023
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5 min read
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Tristan Manalac
Facade of Novo Nordisk's office in Fremont, California
Business
Novo Nordisk Boosts Obesity Business with $1B Inversago Buy
Amid record sales of its obesity treatment Wegovy, as well as diabetes drugs Ozempic and Rybelsus, Novo is buying Canadian biotech Inversago Pharma to further boost its weight-loss pipeline.
August 10, 2023
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2 min read
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Tristan Manalac
Pictured: Illumina signage outside its office in California
Business
Illumina Lowers Outlook as Business Challenges, Exec Departures Continue
The company has lowered its 2023 guidance amid leadership changes and antitrust scrutiny. Illumina now expects a 1% increase in revenue, down from its previous 7% to 10% growth forecast.
August 10, 2023
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2 min read
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Tristan Manalac
Silver Spring, MD, USA 11/10/2020: Exterior view of the headquarters of US Food and Drug Administration (FDA). This federal agency approves medications, vaccines and food additives for human use.
Business
Galera Lays Off 70% of Staff After FDA Rejection in Severe Oral Mucositis
After the regulator rejected avasopasem manganese, its candidate for severe oral mucositis, Galera is implementing a restructuring initiative that involves reducing its headcount by 70%.
August 10, 2023
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2 min read
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Tristan Manalac
Pictured: Man packing up his office things in a bo
Business
Mirati CEO Steps Down After Going Toe-to-Toe with Amgen in KRAS
Following an FDA approval and a Phase III flop, Mirati CEO David Meek has resigned in a “mutually agreed” decision, the company announced late Tuesday as it searches for a permanent replacement.
August 9, 2023
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2 min read
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Tristan Manalac
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