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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.

Pictured: Sign of U.S. Department of Health & Huma
Policy
Medicare to Cover Novo’s Weight-Loss Drug Wegovy for Patients with Heart Disease
Following its label expansion earlier this month, Medicare on Thursday said it will now cover the use of Novo Nordisk’s Wegovy in patients with overweight or obesity who have preexisting cardiovascular disease.
March 22, 2024
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2 min read
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Tristan Manalac
Merck Research Laboratories in South San Francisco, California
Drug Development
Merck’s Keytruda Continues NSCLC Losing Streak with Phase III Flop
Keytruda, when used with AstraZeneca’s Lynparza, did not significantly improve overall and progression-free survival in specific patients with metastatic non-squamous non-small cell lung cancer.
March 21, 2024
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2 min read
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Tristan Manalac
Pictured: Idorsia's office in Switzerland/iStock,
FDA
Idorsia Wins FDA Approval in Hypertension Months After J&J Returned Rights to Drug
Months after Johnson & Johnson turned its back on the hypertension treatment Tryvio, Idorsia has secured the FDA’s nod for the endothelin receptor blocker.
March 21, 2024
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2 min read
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Tristan Manalac
Pictured: Bayer's office in Berlin, Germany/iStock
Business
Bayer Eliminates Nearly Half of Its Executive Positions in Major Overhaul
As part of a sweeping reorganization, Bayer Pharmaceuticals on Wednesday shuffled its leadership roster, which included the creation of a new unit and role changes for its executives.
March 21, 2024
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2 min read
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Tristan Manalac
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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2 min read
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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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2 min read
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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
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