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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.

Facade of the FDA's office in Maryland
Policy
FDA Reveals More Details on 22 CAR-T Secondary Cancer Cases
The FDA’s Peter Marks and Nicole Verdun in the NEJM Wednesday disclosed that more than 27,000 CAR-T doses have been administered in the U.S. as of the end of 2023, of which there are 22 cases of T-cell cancers.
January 25, 2024
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2 min read
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Tristan Manalac
FDA signage at its office in Maryland
Policy
Theratechnologies Gets FDA Rejection for Concentrated Formulation of Tesamorelin
The regulator’s Complete Response Letter flagged issues with the new formulation of tesamorelin’s chemistry, manufacturing and controls and sought more information about its immunogenicity risk.
January 24, 2024
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2 min read
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Tristan Manalac
Pictured: J&J's office in Madrid, Spain
Policy
J&J, Legend to Face Adcomm for Carvykti’s Push as Earlier Line MM Treatment
An FDA advisory committee will meet to review J&J and Legend Biotech’s supplemental BLA for Carvykti for the treatment of relapsed or refractory multiple myeloma patients who have undergone at least one prior line of therapy.
January 24, 2024
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2 min read
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Tristan Manalac
Pictured: Eli Lilly's headquarters in Indianapolis
Drug Development
Lilly’s Investigational Gene Therapy Restores Hearing in First Treated Patient
In a Phase I/II trial, an 11-year-old boy gradually regained hearing—eventually reaching normal range for some frequencies at 30 days—following treatment with Eli Lilly’s dual adeno-associated viral vector-delivered gene therapy.
January 24, 2024
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2 min read
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Tristan Manalac
Pictured: FDA sign at its office in Washington, DC/iStock, JHVEPhoto
Policy
FDA Calls for Boxed Warnings on CAR-T Therapies Regarding Secondary Cancer Risks
Although the FDA did not outright say there is a causal secondary malignancy relationship, it asked BMS, Gilead, J&J and Novartis to add warnings to the labels of six CAR-T therapies noting the potential risks.
January 23, 2024
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Tristan Manalac
Pictured: Illustration showing sickle cells in the
Sickle Cell Gene Therapies Seen as Cost Effective Below $2M Threshold: Study
While gene therapies for treating sickle cell disease are promising, they will only be cost effective in the U.S. if priced below $2 million, according to a new modeling analysis.
January 23, 2024
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2 min read
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Tristan Manalac
Pictured: Businessmen shaking hands after closing a deal
Business
Coherus Offloads Lucentis Biosimilar to Sandoz for $170M in Pivot to Oncology
Novartis spin-off Sandoz will make an upfront cash payment for the entire Cimerli ophthalmology franchise, including inventories, software and sales and reimbursement teams.
January 23, 2024
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Tristan Manalac
Pictured: Bristol Myers Squibb office in California
Drug Development
BMS Builds First-Line Case for Opdivo-Yervoy Combo in mCRC with Phase III Data
The immunotherapy combination reduced the risk of disease progression or death by 79% versus chemotherapy in certain metastatic colorectal cancer patients, according to Bristol Myers Squibb.
January 22, 2024
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Tristan Manalac
Pictured: J&J's building in Switzerland
FDA
J&J Secures Full FDA Approval for Bladder Cancer Drug Balversa
Johnson & Johnson’s small molecule FGFR kinase inhibitor is now indicated for patients with susceptible FGFR3 mutations who progressed after at least one line of systemic therapy.
January 22, 2024
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2 min read
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Tristan Manalac
Pictured: Amgen's office in Tampa, Florida
Policy
Amgen’s Osteoporosis Drug Gets FDA Boxed Warning for Hypocalcemia Risk
The regulator concluded that Prolia (denosumab) increases the risk of severe hypocalcemia, which may result in hospitalization and could trigger life-threatening events or even lead to death.
January 22, 2024
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Tristan Manalac
External view of the U.S. Capitol building
Policy
Senator Sanders Warns J&J, Merck CEOs Could Be Subpoenaed on Drug Pricing
The pharma execs may be served with subpoenas to appear before the Senate health committee to explain why their products are much more expensive in the U.S. than in other countries, according to chairman Sen. Bernie Sanders.
January 19, 2024
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2 min read
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Tristan Manalac
Pictured: Businessmen shaking hands after closing a deal
Deals
Sun Finally Buys Remaining Taro Shares in $348M Takeover
Nearly two decades in the making, the companies expect to close the deal in the first half of 2024, after which Taro Pharmaceutical will become a privately held entity and will no longer trade on the New York Stock Exchange.
January 19, 2024
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2 min read
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Tristan Manalac
Pictured: Medicines on dollar bills/iStock, Julia_
Policy
Proposed IRA Expansion Would Cripple Biopharma, Lead to Fewer Drugs: Report
A legislative proposal, if passed into law, could cost the United States up to 1.2 million jobs and lead to more than 130 fewer FDA approvals over a 10-year period, according to a new report.
January 19, 2024
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3 min read
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Tristan Manalac
Pictured: FDA signage at its office in Washington, DC
Policy
Satsuma Fails to Secure FDA Approval for Nasal Powder Migraine Drug
The FDA’s Complete Response Letter identified problems with the drug candidate’s chemistry, manufacturing and controls, parent company Shin Nippon Biomedical Laboratories announced Thursday.
January 18, 2024
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Tristan Manalac
Pictured: AbbVie Corporate Office/iStock, vzphotos
AbbVie’s Humira Maintains Market Dominance Amid Biosimilar Launches: Report
Despite offering discounts that reach as high as 85%, Humira biosimilars are finding it difficult to take market share away from the AbbVie blockbuster, according to a new report from Samsung Bioepis.
January 18, 2024
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3 min read
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Tristan Manalac
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