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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.

3D illustration of a stomach tumor
Regulatory
FDA Considers Narrowing Label of PD-1 Drugs in Stomach Cancer Ahead of Adcomm Meeting
If approved, the potential restrictions would impact Merck’s Keytruda and Bristol Myers Squibb’s Opdivo, which are marketed for the first-line treatment of several types of stomach cancer regardless of PD-L1 expression.
September 25, 2024
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Tristan Manalac
FDA signage at its headquarters in Maryland
Approvals
IntraBio Wins FDA Nod for Ultra-Rare Neurodegenerative Disease on Heels of Competitor’s Approval
IntraBio’s Aqneursa is the second drug within a week approved by the regulator for treating Niemann-Pick disease type C, just days behind Zevra Therapeutics’ Miplyffa.
September 25, 2024
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Tristan Manalac
External view of the U.S. Capitol building at sunset
Drug pricing
Amgen, Lilly Are Part of Ongoing Senate Probe Into Pharma’s Restrictions on 340B Program
A senior senator has asked the CEOs of both companies to provide information about the limits they are putting on 340B drug pricing for hospitals.
September 24, 2024
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Tristan Manalac
Pictured: Boy in a wheelchair looking out the window
Neurodegenerative disease
Biohaven Sets Stage for Comeback With Pivotal Study Results in Spinocerebellar Ataxia
The FDA previously refused to review Biohaven’s candidate in the indication due to a failed late-stage trial. However, the company is now planning to file an NDA in the fourth quarter of 2024.
September 24, 2024
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Tristan Manalac
Amgen sign at its headquarters in Thousand Oaks, California, USA.
Legal
Amgen Gets Legal Win in Eylea Patent Row With Regeneron
Regeneron’s lawsuit, filed earlier this year, alleged more than 30 counts of patent infringement against Amgen and its biosimilar to the blockbuster eye therapy Eylea.
September 24, 2024
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Tristan Manalac
Biogen’s headquarters in Massachusetts
Immunology and inflammation
Biogen, UCB Score Phase III Lupus Victory After Mid-Stage Stumble
Stifel analyst Paul Matteis called Tuesday’s readout a “positive surprise” that could reinvigorate some investor enthusiasm for Biogen as the company “has essentially become an out-of-favor value stock,” driven by the slow launch of its Alzheimer’s disease therapy Leqembi.
September 24, 2024
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Tristan Manalac
3D illustration of an antibody-drug conjugate
Antibody-drug conjugate (ADC)
AstraZeneca, Daiichi Sankyo’s ADC Flops in Phase III Breast Cancer on Heels of Lung Cancer Stumble
Monday’s failure to improve overall survival in breast cancer “further dents belief” in the companies’ Dato-DXd and “likely complicates regulatory discussions for approval of this indication,” Jefferies analyst Peter Welford wrote in a note to investors.
September 23, 2024
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3 min read
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Tristan Manalac
Photo of a judge's gavel, a balance and a stack of papers
Legal
Appeals Court Breathes New Life Into PhRMA’s Legal Challenge to IRA
A lawsuit filed by the Pharmaceutical Research and Manufacturers of America, which claims the Inflation Reduction Act’s Medicare Drug Price Negotiation Program is unconstitutional, now goes back to a lower Texas court.
September 23, 2024
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Tristan Manalac
Pictured: Blue Sanofi sign on building in Germany at night
Approvals
Sanofi Secures First-Line Nod for Sarclisa in Multiple Myeloma, Tees Up Competition With J&J
With Friday’s approval, Sanofi’s anti-CD38 antibody Sarclisa will go head-to-head with the first such therapy for multiple myeloma, Johnson & Johnson’s Darzalex, which raked in nearly $10 billion last year.
September 23, 2024
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Tristan Manalac
Sanofi's Distribution Center in Quebec, Canada
Multiple sclerosis
Sanofi’s Tolebrutinib Delays MS Progression in Phase III Study Following Earlier Flops
The positive readout in patients with non-relapsing secondary progressive multiple sclerosis comes on the heels of back-to-back failures in which tolebrutinib was unable to improve relapse rates in patients with relapsing MS.
September 20, 2024
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Tristan Manalac
Corporate headquarters of Novo Nordisk. A pharmaceutical company headquartered in Denmark. Copenhagen, Denmark - august 12, 2023.
Regulatory
Novo Secures EU Panel’s Backing for Cardiovascular Use of Wegovy
With Thursday’s positive opinion from the Committee for Medicinal Products for Human Use, the matter now heads to the European Commission which will have the final say on whether Wegovy’s label will be updated.
September 20, 2024
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Tristan Manalac
South side and Dome of the US Capitol in Washington DC, United States
IRA
Senate Bill Seeks to Spare Small Biotechs from IRA’s Drug Price Negotiations
While unlikely to pass this year, given the Democrats’ control over the White House and Senate, the proposed legislation might be a harbinger of the Republicans’ agenda next year for the Inflation Reduction Act should they win the November elections.
September 20, 2024
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Tristan Manalac
3D illustration of a fatty liver
MASH
Aligos Claims Mid-Stage Win in MASH but Investors Are Skeptical
An unusual placebo effect in Aligos Therapeutics’ Phase IIa trial is driving shareholder skepticism for its metabolic dysfunction-associated steatohepatitis candidate, according to Jefferies analyst Michael Yee.
September 20, 2024
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Tristan Manalac
FDA signage at its headquarters in Maryland
Complete response letters
Vanda Contests FDA Rejection of Gastroparesis Drug, Slams ‘Delayed’ Decision
Vanda Pharmaceuticals on Thursday announced that the regulator declined to approve its application, a decision the company says was delayed by more than 185 days and failed to satisfy the requirements of the Federal Drug and Cosmetic Act.
September 19, 2024
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Tristan Manalac
Facade of AstraZeneca's office in Shanghai, China
Approvals
AstraZeneca Wins Rare Autoimmune Indication for Asthma Biologic Fasenra
With the FDA’s approval, Fasenra will compete with GSK’s Nucala, which in December 2017 became the first biologic approved for eosinophilic granulomatosis with polyangiitis.
September 19, 2024
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Tristan Manalac
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