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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: Entrance to the U.S. Department of Healt
Policy
Medicare Likely to Negotiate Prices for Obesity Drugs in Next Few Years: CBO
A new analysis from the Congressional Budget Office predicts that Novo Nordisk’s semaglutide will likely be subjected to Medicare’s Drug Price Negotiation Program under the Inflation Reduction Act.
March 21, 2024
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2 min read
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Tristan Manalac
Pictured: Gene therapy illustration showing an inj
Drug Delivery
Orchard Sets $4.25M US Price for Gene Therapy Lenmeldy on Heels of Approval
Two days after winning FDA approval, Orchard Therapeutics on Wednesday provided its U.S. launch plans for metachromatic leukodystrophy gene therapy Lenmeldy, which has a wholesale acquisition cost of $4.25 million for the one-time treatment.
March 20, 2024
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2 min read
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Tristan Manalac
Pictured: European flags flap in the wind outside
Policy
EU Parliament Endorses New Pharma Legislation, Provides More Market Protection for Companies
Under the European Union’s proposed regulations, companies will have data protection for at least seven-and-a-half years preventing competitors from accessing their product data.
March 20, 2024
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2 min read
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Tristan Manalac
Novo Nordisk's corporate headquarters in Denmark
Drug Development
Novo Invests $556M in China Operations to Boost Manufacturing Capacity
Novo Nordisk’s investment of more than half a billion dollars is meant to expand its production capabilities in China and help it meet the global drug demand.
March 20, 2024
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2 min read
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Tristan Manalac
Pictured: A sign in front of a Takeda building/iSt
FDA
Takeda Reaps Rewards of $5.2B Ariad Bet as FDA Expands Iclusig’s Label
Takeda on Tuesday secured another label expansion for the kinase inhibitor, this time in the first-line setting for the treatment of Philadelphia chromosome-positive acute lymphoblastic leukemia.
March 20, 2024
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2 min read
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Tristan Manalac
AstraZeneca's sign on its office in California
Deals
AstraZeneca Buys Fusion in Potential $2B Deal, Joins Radiopharma Buying Spree
Following in the footsteps of Bristol Myers Squibb and Eli Lilly, AstraZeneca on Tuesday jumped into the radiopharmaceuticals space by acquiring Fusion Pharmaceuticals in a deal worth $2.4 billion.
March 19, 2024
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3 min read
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Tristan Manalac
Pictured: bluebird bio logo on wall/device, courtesy of Pavlo Gonchar
Drug Development
Bluebird Extends Cash Runway with $175M Financing to Support Gene Therapy Launch
To help support the launch of Lyfgenia, bluebird bio on Monday entered into a five-year term loan deal with Hercules Capital that will extend the biotech’s cash runway through the first quarter of 2026.
March 19, 2024
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Tristan Manalac
Pictured: Sign above the entrance to a U.S. courthouse
Policy
Regeneron Wins Appeal in Eylea-Lucentis Antitrust Case Against Novartis
An appellate court sided with Regeneron versus Novartis on Monday, agreeing that anti-VEGF pre-filled syringes constitute a distinct market than those sold in vials. The case involves Regeneron’s Eylea and Novartis’ Lucentis eye treatments.
March 19, 2024
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2 min read
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Tristan Manalac
FDA signage at its office in Maryland
FDA
Orchard Wins FDA Approval for First Gene Therapy for Rare Pediatric Disease
Orchard Therapeutics on Monday secured the FDA’s first approval for an autologous gene therapy to treat the rare metabolic disease metachromatic leukodystrophy in children.
March 19, 2024
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2 min read
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Tristan Manalac
Pictured: GSK's headquarters in London
Drug Development
GSK Builds Case for Broader Jemperli Label in Endometrial Cancer with Phase III Data
New late-stage trial results for GSK’s Jemperli show improved overall and progression-free survival in a broader range of endometrial cancer patients, which could lead to a potential label expansion.
March 18, 2024
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Tristan Manalac
Pictured: Nasdaq headquarters in New York/iStock,
Deals
J&J-Backed Contineum Unveils IPO Plans to Advance MS Pipeline
Contineum Therapeutics joined the 2024 initial public offering class on Friday with an SEC filing. The biotech will use the IPO proceeds to complete a Phase II trial for its most mature candidate targeting multiple sclerosis.
March 18, 2024
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2 min read
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Tristan Manalac
Pictured: 3D illustration of a damaged liver/iStoc
FDA
Madrigal’s Rezdiffra Energizes MASH Space, Sets Bar for Future Therapies
With its FDA approval last week and first-to-market advantage, Madrigal Pharmaceuticals’ Rezdiffra will set the standard for other metabolic dysfunction-associated steatohepatitis candidates in development.
March 18, 2024
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3 min read
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Tristan Manalac
Pictured: Merck office building in Canada
Drug Development
Merck’s Keytruda Pushes Towards Earlier Stages of Cervical Cancer with Phase III Data
The PD-1 inhibitor Keytruda significantly improved overall survival in a late-stage trial when used with chemoradiotherapy to treat patients with newly diagnosed advanced cervical cancer.
March 15, 2024
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2 min read
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Tristan Manalac
3D illustration of blood cells being produced in the bone marrow
Policy
FDA Adcomm Backs Geron’s Anemia Drug for Blood Cancer
Despite skepticism from FDA reviewers, the Oncologic Drugs Advisory Committee on Thursday strongly supported Geron’s imetelstat for the treatment of anemia in patients with lower-risk myelodysplastic syndromes.
March 15, 2024
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2 min read
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Tristan Manalac
Facade of the FDA's office in Maryland
FDA
BeiGene’s Tevimbra Wins First US Approval Following Tough Regulatory Path
After several delays, BeiGene on Thursday finally secured the FDA’s approval for its PD-1 inhibitor Tevimbra for the treatment of unresectable or metastatic esophageal squamous cell carcinoma.
March 15, 2024
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2 min read
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Tristan Manalac
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