SUBSCRIBE
SUBSCRIBE
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: Novartis' logo outside its building in S
FDA
Novartis Wins FDA Approval for Oral Monotherapy for Rare Blood Disorder
The Swiss pharma’s Fabhalta, a Factor B inhibitor, is the first FDA-approved oral monotherapy for adults with the rare blood disorder paroxysmal nocturnal hemoglobinuria.
December 6, 2023
 · 
2 min read
 · 
Tristan Manalac
External view of the U.S. Capitol building
Policy
Sen. Bill Cassidy Eyes Legislation to Improve Access to Gene Therapies
With the biopharma industry’s looming wave of gene therapy submissions and potential approvals, the senior senator is laying the groundwork for a legislative initiative to improve access to these expensive treatments.
December 6, 2023
 · 
2 min read
 · 
Tristan Manalac
Pictured: Merck KGaA signage at its headquarters in Darmstadt, Germany
Drug Development
Merck KGaA’s BTK Inhibitor Fails Phase III Multiple Sclerosis Studies
In two late-stage trials, the experimental oral drug evobrutinib was unable to significantly reduce annualized relapse rates in MS patients compared with Sanofi’s Aubagio tablets.
December 6, 2023
 · 
2 min read
 · 
Tristan Manalac
3D illustration of a T cell killing a cancer cell
CRISPR Reorganizes CAR-T Pipeline Ahead of FDA’s Landmark Decision
The gene editing company is dropping two programs and favoring its next-generation assets CTX112 and CTX131, which it will continue to develop in oncology but will also test in autoimmune diseases.
December 5, 2023
 · 
2 min read
 · 
Tristan Manalac
Pictured: Illustration of an electroencephalogram
Drug Development
Alto’s Neuropsychiatric Platform Scores Third Mid-Stage Win
ALTO-300 was significantly more effective in major depressive disorder patients with a specific EEG biomarker than in those without, according to results from an Alto Neuroscience Phase IIa study.
December 5, 2023
 · 
2 min read
 · 
Tristan Manalac
Roche's tower in Shanghai, China
Policy
FDA Puts Clinical Hold on Roche BTK Inhibitor Multiple Sclerosis Program
The regulator placed a partial clinical hold on Roche’s fenebrutinib—being developed for relapsing MS—after two patients experienced elevated hepatic transaminase and bilirubin levels indicative of liver injury.
December 5, 2023
 · 
2 min read
 · 
Tristan Manalac
Pictured: Roche Diagnostics building in California
Deals
Roche Jumps into Lucrative Weight-Loss Space with $2.7B Carmot Buy
The acquisition will give Roche access to Carmot’s clinical portfolio of three GLP-1 receptor agonists, placing it squarely in the middle of the competition to treat overweight and obesity.
December 4, 2023
 · 
2 min read
 · 
Tristan Manalac
Pictured: Eli Lilly's biotechnology center in San Diego, California
FDA
Lilly Wins Second Accelerated Approval for Reversible BTK Inhibitor
Lilly’s Jaypirca (pirtobrutinib) can now be used to treat chronic lymphocytic leukemia or small lymphocytic leukemia that had progressed from at least two prior lines of therapy, in addition to its previously-approved indications.
December 4, 2023
 · 
2 min read
 · 
Tristan Manalac
Pictured: J&J's office in Madrid, Spain
Drug Development
J&J Hires Thousands, Invests Millions in AI-Powered Drug Discovery
Johnson & Johnson’s AI investments include a research facility in San Francisco and a data science workforce of approximately 6,000 employees.
December 4, 2023
 · 
2 min read
 · 
Tristan Manalac
Pictured: FDA sign at Washington D.C. headquarters
Drug Development
FDA Action Alert: Vertex/CRISPR, Arcutis and Optinose
This week, the FDA could approve the first CRISPR-edited therapy in the U.S., while two other companies await decisions on topical drugs.
December 1, 2023
 · 
4 min read
 · 
Tristan Manalac
Pictured: GSK's office in Poznan, Poland/iStock, W
GSK Pulls Ahead of Pfizer in RSV Vaccine Market as Arexvy Nears Blockbuster Status
CEO Emma Walmsley projects that the British biopharma’s Arexvy sales will exceed £1 billion in its first year on the market, leaving Pfizer’s Abrysvo respiratory syncytial virus vaccine far behind in the race.
December 1, 2023
 · 
2 min read
 · 
Tristan Manalac
Pictured: Woman stepping on a weighing scale/iStoc
Drug Development
Altimmune Joins Weight-Loss Race with Phase II Win, Stock Jumps on News
Patients treated with Altimmune’s investigational GLP-1/glucagon dual receptor agonist saw up to 15.6% weight loss, and nearly a third of those taking the highest dose lost at least 20% of their body weight.
December 1, 2023
 · 
2 min read
 · 
Tristan Manalac
Pictured: Image of an MRI brain scan/iStock, sudok
Policy
Karuna Secures FDA Decision Date for Schizophrenia Candidate KarXT
The regulator accepted Karuna Therapeutics’ NDA and set a PDUFA date of September 26, 2024. If approved, it would be the first new mechanism of action to treat schizophrenia in decades, the company contends.
November 30, 2023
 · 
2 min read
 · 
Tristan Manalac
FDA signage at its office in Maryland
Policy
Intas Pharmaceuticals Hit with Another FDA Warning Letter, Put on Import Alert
The troubled Indian pharma company received its second FDA warning letter in months, which this time cited quality control and data integrity lapses at its manufacturing facility in Gujarat, India.
November 30, 2023
 · 
2 min read
 · 
Tristan Manalac
Pictured: Eli Lilly Campus in San Diego
Business
Lilly Puts Potential $660M on the Line for Protein-Protein Interaction Blockers
In a deal with Tokyo-based PRISM BioLab, Eli Lilly will gain access to the Japanese biotech’s proprietary platform to develop small molecule inhibitors of protein-protein interactions.
November 29, 2023
 · 
2 min read
 · 
Tristan Manalac
Load More