SUBSCRIBE
SUBSCRIBE
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 DaVita's headquarters in Col
DaVita Casts Doubt on Novo’s Chronic Kidney Disease Results for Ozempic
Dialysis giant DaVita on Thursday raised concerns over Novo Nordisk’s interim analysis of a kidney outcomes study of semaglutide, pointing to the potentially limited applicability of the findings.
October 13, 2023
 · 
2 min read
 · 
Tristan Manalac
Pictured: FDA sign at its office in Washington, DC/iStock, JHVEPhoto
Drug Development
FDA Action Alert: Merck, Ardelyx, BioMarin and More
The FDA is gearing up for six decisions in the next two weeks, two of which involve highly anticipated medicines for rare diseases.
October 12, 2023
 · 
6 min read
 · 
Tristan Manalac
Pictured: FDA sign at its office in Washington, DC/iStock, JHVEPhoto
Policy
FDA Rejects Alvotech’s Stelara Biosimilar as Manufacturing Problems Continue
The regulator issued a Complete Response Letter citing “deficiencies” at the company’s Reykjavik plant, this time for its Stelara biosimilar AVT04. It’s the fourth FDA rejection for Alvotech since last year.
October 12, 2023
 · 
2 min read
 · 
Tristan Manalac
Pictured: Blue upward trendline showing rising sto
Drug Development
Tempest’s Stock Skyrockets 4,000% on Early Data for Hepatocellular Carcinoma
In a Phase Ib/II study, Tempest Therapeutics’ investigational PPAR⍺ antagonist—combined with Roche’s Avastin and Tecentriq—showed strong signs of survival benefits in liver cancer patients.
October 12, 2023
 · 
2 min read
 · 
Tristan Manalac
John Tlumacki/The Boston Globe via Getty Images
Business
Biogen Lays Off 113 Reata Employees Weeks After Completing $7B Acquisition
The layoffs, set to take effect in late November, will impact about a third of Reata’s headcount. The workforce reduction comes just weeks after Biogen completed its $7.3 billion Reata buy.
October 12, 2023
 · 
2 min read
 · 
Tristan Manalac
Pictured: Illustration depicting large layoffs/iSt
Business
Sana Downsizes Staff by 29%, Refocuses on Ex Vivo Cell Therapy Platform
The biotech is laying off about 29% of its employees and will focus its resources on the company’s hypoimmune platform. The latest downsizing follows a previous round of layoffs in August 2023.
October 11, 2023
 · 
2 min read
 · 
Tristan Manalac
Pictured: Illumina signage outside its office in California
Policy
EU Orders Illumina to Divest Grail After Years of Regulatory Challenges
The European Commission on Thursday ordered Illumina to divest Grail, opening the next chapter in the years-long regulatory saga. Illumina is reviewing the order, Reuters reported.
October 11, 2023
 · 
3 min read
 · 
Tristan Manalac
Facade of Novo Nordisk's office in Fremont, California
Drug Development
Novo Ends Semaglutide Kidney Study Early Due to Strong Efficacy Signals
Following the recommendations of an independent Data Monitoring Committee, Novo Nordisk has halted a Phase III kidney outcomes study of semaglutide ahead of schedule due to strong efficacy signals.
October 11, 2023
 · 
2 min read
 · 
Tristan Manalac
Pictured: Illustration of a damaged liver/iStock,
Drug Development
Akero’s Phase IIb NASH Data Disappoints, Sends Stock Plummeting
Both low and high doses of Akero Therapeutics’ lead candidate efruxifermin failed to significantly outperform placebo at improving liver fibrosis without worsening non-alcoholic steatohepatitis.
October 10, 2023
 · 
3 min read
 · 
Tristan Manalac
Pictured: Magnetic resonance imaging scans of the brain
Drug Development
Xenon’s Add-On Epilepsy Treatment Shows Promising Phase IIb Efficacy, Safety
Patients treated with Xenon Pharmaceuticals’ investigational potassium channel opener XEN1101 experienced a significant and dose-dependent reduction in seizure frequency.
October 10, 2023
 · 
2 min read
 · 
Tristan Manalac
Pictured: Artistic rendition of schizophrenia/iSto
Drug Development
Newron’s Schizophrenia Candidate Scores Mid-Stage Win, Moves to Phase III
At the six-month follow-up, about 40% of patients treated with Newron Pharmaceuticals’ evenamide improved so much that they no longer meet the Phase II study’s original eligibility criteria.
October 10, 2023
 · 
2 min read
 · 
Tristan Manalac
Pictured: Alnylam headquarters in Cambridge, Massa
Policy
FDA Blocks Alnylam’s Bid to Expand Onpattro Label
Despite winning the backing of an FDA advisory committee, the regulator in a Complete Response Letter declined Alnylam’s bid to expand Onpattro’s label to cardiomyopathy in ATTR amyloidosis.
October 9, 2023
 · 
2 min read
 · 
Tristan Manalac
Pictured: Novartis' logo outside its building in S
FDA
Novartis Wins FDA Approval for Intravenous Cosentyx Formulation
The Swiss pharma continues its winning streak with the FDA’s approval of the intravenous formulation of Cosentyx for ankylosing spondylitis, axial spondyloarthritis and psoriatic arthritis.
October 9, 2023
 · 
2 min read
 · 
Tristan Manalac
Pictured: Bristol Myers Squibb office in California
Deals
BMS Buys Mirati for $4.8B to Boost Cancer Business
Following rumors last week of a potential acquisition by Sanofi, Bristol Myers Squibb on Sunday announced that it paid $4.8 billion to gain access to Mirati Therapeutics’ oncology-focused portfolio.
October 9, 2023
 · 
2 min read
 · 
Tristan Manalac
Pictured: Facade of Sanofi's headquarters in Franc
Deals
Sanofi Mulls Mirati Buy as KRAS Battle Heats Up: Bloomberg
Following a Phase III failure and the departure of its CEO, Mirati Therapeutics is rumored to be engaged in acquisition discussions with French pharma giant Sanofi, according to Bloomberg.
October 6, 2023
 · 
2 min read
 · 
Tristan Manalac
Load More