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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: 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
Pictured: Analyst pointing to stock chart / iStock
Business
Bluebird Pins Hopes on Zynteglo Uptake, FDA Verdict Amid Cash Constraints
The biotech company is looking to forge a path to profitability by scaling up the commercial uptake of Zynteglo and winning the FDA’s approval for its lovo-cel gene therapy for sickle cell disease.
August 9, 2023
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2 min read
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Tristan Manalac
Facade of Novo Nordisk's office in Fremont, California
Drug Development
Novo’s Wegovy Protects Heart Health in Overweight, Obese Adults
Data from a Phase III study released Tuesday found that Novo Nordisk’s Wegovy lowered the risk of cardiovascular complications and death by 20% versus placebo in overweight and obese adults.
August 8, 2023
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2 min read
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Tristan Manalac
Pictured: Man feeling anxious while in a group/iSt
Drug Development
VistaGen Stock Soars 1,000% After Phase III Social Anxiety Win
Despite failing a previous late-stage study, VistaGen’s fasedienol finally scored a win by meeting its primary endpoint and strongly easing distress among patients with social anxiety disorder.
August 8, 2023
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2 min read
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Tristan Manalac
Pictured: Sign at FibroGen's headquarters in Calif
Business
FibroGen Looks to Regroup After Rocky Q2 Results, Ongoing Challenges
Following a handful of clinical failures and changes to its leadership, FibroGen is trying to chart a more positive path forward by focusing on four strategic areas.
August 8, 2023
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3 min read
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Tristan Manalac
Pictured: Astellas' Americas headquarters in Illin
FDA
Iveric Gets FDA Approval in Geographic Atrophy After Being Acquired by Astellas
Friday, Iveric Bio scored a regulatory win for its geographic atrophy eye injection Izervay, just three months after the New Jersey biotech was bought by Astellas Pharma for $5.9 billion.
August 7, 2023
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2 min read
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Tristan Manalac
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