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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.

A piggy bank crammed with $100 bills on a background of American cash
Drug pricing
Novo’s Ozempic, Wegovy Targeted in Second Round of IRA Drug Price Negotiations
Drugmakers will have until the end of February to decide whether they want to participate in the second round of Medicare negotiations or not. CMS has until June 1 to send an initial offer for the adjusted prices.
January 17, 2025
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3 min read
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Tristan Manalac
Amgen sign at its headquarters in Thousand Oaks, California, USA.
Approvals
Looking Beyond Obesity, Amgen Wins Colorectal Cancer Expansion for Lumakras
The Phase III CodeBreaK 300 study returned disappointing overall survival data for Lumakras plus Vectibix in metastatic colorectal cancer, but in its approval announcement, the FDA pointed to significant improvements in progression-free survival, calling it the “major efficacy outcome” of the trial.
January 17, 2025
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2 min read
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Tristan Manalac
Novartis' office building in Marburg, Germany
Patents
Novartis Scrambles to Squelch Copycats as Generics Gain Ground
Novartis is locked in a legal back-and-forth with MSN Pharma over alleged patent infringement of its heart failure drug Entresto.
January 17, 2025
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2 min read
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Tristan Manalac
Pictured: Boehringer Ingelheim sign on a building/
Schizophrenia
Boehringer Suffers Phase III Schizophrenia Fail, Legal Parry by HHS
Boehringer Ingelheim’s trio of late-stage schizophrenia failures on Thursday came a day after the Department of Health and Human Services hit back on the pharma’s legal challenge to the IRA’s drug price negotiation program.
January 17, 2025
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2 min read
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Tristan Manalac
FDA signage at its headquarters in Maryland
Regulatory
After Letter to Commissioner, FDA Finally Gives Vanda Reason for Rejection, Chance for Hearing
After a series of strongly worded letters—one of which was addressed directly to Commissioner Robert Califf—the FDA has publicly laid out its reasoning for rejecting Vanda Pharmaceuticals’ gastroparesis drug candidate tradipitant.
January 16, 2025
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2 min read
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Tristan Manalac
San Francisco, USA - May 20, 2022: historic Cable Car Powell Hyde Line on turntable at Powell Street terminal at Market Street in downtown San Francisco, California CA, USA.
Pipeline
JPM25 Day 3: AbbVie, Gilead, GSK and Dyne
AbbVie and Gilead are going back to their roots and leaning on their established areas of expertise to set themselves up for sustainable success in 2025.
January 16, 2025
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3 min read
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Tristan Manalac
Eli Lilly's biotechnology center in California
Immunology and inflammation
Lilly’s I&I Push Gains Momentum With Omvoh Expansion
Omvoh’s label expansion is important progress for Eli Lilly as it works to diversify its portfolio beyond obesity, according to analysts from BMO Capital Markets.
January 16, 2025
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2 min read
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Tristan Manalac
Art collage, hands and scales of justice. The concept of the law of the judge.
Legal
HHS Says Vertex is ‘Grasping at Straws’ With Casgevy Fertility Suit
Along with its gene editing therapy Casgevy, Vertex is offering fertility preservation support for its patients—a program that the HHS claims violates anti-kickback statutes.
January 16, 2025
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2 min read
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Tristan Manalac
Businessman jump careful on cracked or broken graph. Job opportunity and career. concept of under pressure. risk, financial, and tax
Pipeline
New Safety Signals Force Keros to Fully Terminate Mid-Stage PAH Study
Taken together with Keros’ recent pivot away from obesity, the termination of its pulmonary arterial hypertension study could lead to a “difficult path ahead” for Keros, according to Guggenheim analysts.
January 15, 2025
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2 min read
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Tristan Manalac
Psychedelic Brain
People
Lykos Loses Five Board Directors After FDA Rejection
Lykos Therapeutics is currently working out ways to fund an additional Phase III study for its MDMA-assisted PTSD therapy following an FDA setback last year.
January 15, 2025
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2 min read
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Tristan Manalac
Entrance to the U.S. Department of Health and Human Services in Washington, DC
Accelerated approval
Inspector General Questions FDA’s Accelerated Approval for Biogen, Sarepta Drugs
An OIG report zeroed in on what it said were three particularly problematic accelerated approvals: Biogen’s Aduhelm, Sarepta’s Exondys and Covis’ Makena.
January 15, 2025
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2 min read
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Tristan Manalac
Pictured: Aerial view of the San Francisco skyline
Pipeline
JPM25 Day Two: Roche, Amgen, Merck, Lilly and Biogen
JPM25 is in full swing as several pharma powerhouses—including Merck, Lilly and Amgen—detail their strategies for growth in the coming year.
January 15, 2025
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4 min read
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Tristan Manalac
Trendy halftone collage. Concept of contracting, negotiation, contracting, favorable terms. Trendy modern retro illustration on business theme. Concept of teamwork. Vector illustration
Gene therapy
Regenxbio Jumps on Potential $800M Rare Disease Deal With Nippon Shinyaku
In exchange for its investigational gene therapies, Regenxbio will receive $110 million upfront and up to $700 million in milestones. After hitting an all-time low of $6.95 at close of business yesterday, the stock surged on the news by nearly 20% before markets opened Tuesday.
January 14, 2025
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2 min read
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Tristan Manalac
A contemporary artistic collage featuring a hand holding a trophy. The concept of victory and achievement.
Cancer
Where Keytruda Failed, Regeneron Touts Phase III Skin Cancer Win for Libtayo
The positive trial results could help Regeneron cushion the blow of its disappointing fourth-quarter sales for Eylea, which exceeded the consensus by a modest 1% and are bogged down by the slow conversion of patients to the high-dose formulation.
January 14, 2025
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2 min read
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Tristan Manalac
Weigh scales on pink background, top view with space for text. Overweight concept
GLP-1
Pfizer Cautiously Optimistic on Obesity Pill as Kailera Challenges Lilly’s Zepbound With Strong Phase II Data
Obesity continues to grab attention at the J.P. Morgan Healthcare Conference in San Francisco, with both Pfizer and Kailera Therapeutics outlining their plans in the space moving forward.
January 14, 2025
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2 min read
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Tristan Manalac
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