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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.

Entrance of the FTC in Washington, DC
Policy
FTC Investigates Teva Over Refusal to Remove Improperly Listed Patents from Orange Book
The Federal Trade Commission has opened an investigation into Teva Pharmaceuticals after the company allegedly ignored directives to withdraw or amend contentious patent listings on the FDA’s Orange Book.
July 2, 2024
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1 min read
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Tristan Manalac
Business partners discussing the terms of a contract
Patents
Daiichi Sankyo Wins $47M in ADC Patent Arbitration With Seagen, Pfizer Dispute Looms
Daiichi Sankyo has secured a victory in its patent arbitration with Seagen, nabbing a $47 million award for attorneys’ fees and other costs, plus interest. However, a larger patent battle with Pfizer remains.
July 1, 2024
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2 min read
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Tristan Manalac
Merck & Co. headquarters in Silicon Valley; Merck & Co. Inc. is an American multinational pharmaceutical company
Infectious Disease
CDC Backs Merck’s Capvaxive, Tees Up Pneumococcal Competition With Pfizer
In a potential challenge to Pfizer’s Prevnar 20, Merck’s Capvaxive has been recommended by the Centers for Disease Control and Protection for use in preventing invasive pneumococcal disease in adults.
July 1, 2024
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2 min read
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Tristan Manalac
U.S. Supreme Court in Washington, DC
Policy
Supreme Court’s Chevron Doctrine Ruling Could Limit FDA’s Regulatory Authority
The U.S. Supreme Court on Friday overturned the long-standing Chevron doctrine, which required courts to defer to federal agencies and their interpretation of statutes, putting potential limits on the FDA’s regulatory decisions.
July 1, 2024
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2 min read
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Tristan Manalac
Antibody drug conjugates (ADCs) are targeted medicines that deliver chemotherapy agents to cancer cells 3d rendering
Business
Eisai Assumes Sole Responsibility for ADC After Collaboration With BMS Ends
Due to Bristol Myers Squibb’s ongoing portfolio reprioritization, Eisai is taking over the development and commercialization of farletuzumab ecteribulin, an investigational antibody-drug conjugate targeting solid tumors.
July 1, 2024
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2 min read
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Tristan Manalac
The Legal Execution Department makes an appointment with the customer to sign a mediation agreement to pay the debt.
Policy
Daiichi Sankyo Wins $47M in ADC Patent Arbitration With Seagen, Pfizer Dispute Looms
Daiichi Sankyo has secured a victory in its patent arbitration with Seagen, nabbing a $47 million award for attorneys’ fees and other costs, plus interest. However, a larger patent battle with Pfizer remains.
July 1, 2024
 · 
2 min read
 · 
Tristan Manalac
Feb 2, 2020 South San Francisco / CA / USA - Merck & Co. headquarters in Silicon Valley; Merck & Co. Inc. is an American multinational pharmaceutical company
Policy
CDC Backs Merck’s Capvaxive, Tees Up Pneumococcal Competition With Pfizer
In a potential challenge to Pfizer’s Prevnar 20, Merck’s Capvaxive has been recommended by the Centers for Disease Control and Protection for use in preventing invasive pneumococcal disease in adults.
July 1, 2024
 · 
2 min read
 · 
Tristan Manalac
Supreme Court of the United States. Washington DC, USA.
Policy
Supreme Court’s Chevron Doctrine Ruling Could Limit FDA’s Regulatory Authority
The U.S. Supreme Court on Friday overturned the long-standing Chevron doctrine, which required courts to defer to federal agencies and their interpretation of statutes, putting potential limits on the FDA’s regulatory decisions.
July 1, 2024
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2 min read
 · 
Tristan Manalac
Pictured: Nasdaq building in New York City
Deals
Alumis Pushes Through With Smaller IPO, Looks to Raise $250M for Immuno Candidate
Alumis is debuting in an initial public offering Friday on the Nasdaq, though the $250 million IPO is less than its initial targeted raise of $274 million just days ago.
June 28, 2024
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2 min read
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Tristan Manalac
Pictured: AbbVie's headquarters in California
Deals
AbbVie Expands Immuno Portfolio With $250M Celsius Buy as Humira Hits Patent Cliff
AbbVie on Thursday announced it has acquired Celsius Therapeutics to expand its immunology portfolio with a first-in-class TREM1 inhibitor CEL383, following other big players looking to cash in on the hot immuno market.
June 28, 2024
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2 min read
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Tristan Manalac
Pictured: Illumina's sign at its office in California
Business
Illumina Reports $1.47B ‘Goodwill’ Impairment Charge After Grail Spinoff
Following the recently completed spinoff of cancer detection company Grail, sequencing giant Illumina said Thursday it expects to absorb a $1.47 billion goodwill impairment charge.
June 28, 2024
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2 min read
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Tristan Manalac
Pictured: Gloved hand holding a white pill
Drug Development
ICER Doubles Down on Critique of Lykos’ MDMA Therapy, Cites Data Concerns
The Institute for Clinical and Economic Review has again flagged “substantial concerns” with Lykos Therapeutics’ data for its MDMA-based therapy for post-traumatic stress disorder and propensity for bias.
June 28, 2024
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2 min read
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Tristan Manalac
South San Francisco, CA, USA - May 1, 2022: Exterior view of the Merck Researches Laboratories in South San Francisco, California. Merck & Co., Inc. is a global pharmaceutical company headquartered in Rahway, New Jersey. The company does business as Merck Sharp & Dohme (MSD) outside the United States and Canada.
Policy
Merck’s ADC Pact With Daiichi Hits Regulatory Setback in FDA Rejection
The FDA on Thursday rejected Merck and Daiichi Sankyo’s HER3-targeted antibody-drug conjugate patritumab deruxtecan in a Complete Response Letter, citing problems with a third-party manufacturer.
June 27, 2024
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2 min read
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Tristan Manalac
Pictured: Front view of the CDC museum in Georgia
Policy
CDC Narrows RSV Vaccine Recommendations for Seniors
New recommendations from the Centers for Disease Control and Prevention call for the use of respiratory syncytial virus vaccines in adults aged 75 and older, but limited its use in 60- to 74-year-olds.
June 27, 2024
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2 min read
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Tristan Manalac
Washington, D.C., USA- January 13, 2020: FDA Sign at its headquarters in Washington DC. The Food and Drug Administration (FDA or USFDA) is a federal agency of the USA.
FDA
AbbVie, Genmab Secure FDA Label Expansion for Epkinly in Follicular Lymphoma
AbbVie and Genmab on Wednesday announced the FDA has expanded the label of their bispecific antibody Epkinly, allowing it to be used in patients with relapsed or refractory follicular lymphoma.
June 27, 2024
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2 min read
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Tristan Manalac
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