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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.

External view of Novartis' office in Canada
Drug Development
Novartis Clears Phase III in IgAN, Eyes Regulatory Path for Complement Inhibitor
The Swiss pharma will seek accelerated approval for iptacopan in IgA nephropathy next year after the complement blocker demonstrated promising efficacy in the Phase III APPLAUSE-IgAN study.
October 3, 2023
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2 min read
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Tristan Manalac
Pictured: Boehringer Ingelheim's office in California
Boehringer Offers Unbranded Biosimilar at 81% Discount to AbbVie’s Humira
German biopharma Boehringer Ingelheim is now offering an unbranded version of its interchangeable biosimilar to the AbbVie blockbuster arthritis drug at a deep discount.
October 3, 2023
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2 min read
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Tristan Manalac
Pictured: Eli Lilly's headquarters in Indianapolis
Policy
FDA Rejects Lilly’s Eczema Treatment Over Third-Party Manufacturing Issues
Eli Lilly’s Biologic License Application for its monoclonal antibody lebrikizumab was denied by the regulator after issues were found at a third-party contract manufacturing organization.
October 2, 2023
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2 min read
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Tristan Manalac
Pictured: A wooden gavel on a table with a book in
Policy
Federal Judge Denies Request to Block Medicare Drug Price Negotiation Program
Judge Michael Newman of the Southern District of Ohio issued a ruling Friday denying the U.S. Chamber of Commerce’s request for a preliminary injunction against the Inflation Reduction Act provisions.
October 2, 2023
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2 min read
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Tristan Manalac
Pictured: IPO concept art showing stacks of coins
Deals
Lexeo, Abivax File for IPOs on Nasdaq Amid Industry-Wide Drought
Despite a sharp downturn in initial public offering activity, New York-based gene therapy company Lexeo Therapeutics and French biotech Abivax are seeking funding for their lead candidate programs.
October 2, 2023
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2 min read
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Tristan Manalac
Pictured: 3D illustration of a damaged liver/iStoc
Madrigal Pursues $500M Public Offering with NASH Market Up for Grabs
With Intercept’s failure to emerge as the nonalcoholic steatohepatitis market leader, Madrigal Pharmaceuticals is seeking to take leadership of the space fueled by a half-a-billion-dollar public offering.
September 29, 2023
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3 min read
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Tristan Manalac
Pictured: Bar and line graphs showing increasing t
Drug Development
Bionomics’ PTSD Candidate Clears Phase IIb Study, Stock Jumps 415%
Following disappointing results in a mid-stage social anxiety disorder study, the Australian biotech’s investigational ion channel modulator demonstrated promising effects in patients with post-traumatic stress disorder.
September 29, 2023
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2 min read
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Tristan Manalac
Pictured: A silhouette of a woman sitting on the f
FDA
Fabre-Kramer Finally Gets FDA Approval for MDD Drug After Decades-Long Quest
After several rejections over 20-plus years, Fabre-Kramer Pharmaceuticals has secured the FDA’s approval for its major depressive disorder drug gepirone hydrochloride, now marketed under the brand name Exxua.
September 29, 2023
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2 min read
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Tristan Manalac
Pictured: FDA sign at Washington D.C. headquarters
Policy
FDA Action Alert: Amgen, Alnylam and BMS
The FDA will kick off October with an advisory committee meeting for Amgen’s Lumakras and target action dates for Alnylam’s patisiran and Bristol Myers Squibb’s Opdivo.
September 28, 2023
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4 min read
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Tristan Manalac
Pictured: J&J sign and office in Ontario/i
Drug Development
J&J’s Rybrevant in Combo with Lazertinib Clears Phase III in NSCLC
Non-small cell lung cancer patients treated with the drug combination saw a statistically significant and clinically meaningful improvement in progression-free survival compared to AstraZeneca’s osimertinib.
September 28, 2023
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2 min read
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Tristan Manalac
Pictured: Person applies eye drops/iStock, megaflo
FDA
FDA Approves Viatris, Ocuphire’s Eye Drops to Reverse Pupil Dilation
The companies on Wednesday secured the regulator’s approval for their eye drop Ryzvumi for the reversal of pharmacologically-induced mydriasis, as Viatris looks to add $1 billion in sales by 2028.
September 28, 2023
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2 min read
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Tristan Manalac
CRISPR-Cas9 genome editing enzyme, 3d illustration
Patient Death Likely from Virus Used to Deliver Gene-Editing Therapy: NEJM Study
The New England Journal of Medicine study suggests that the 2022 death of a Duchenne muscular dystrophy patient was due to an adverse effect of recombinant AAV used to deliver the gene therapy.
September 28, 2023
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2 min read
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Tristan Manalac
Pictured: AbbVie Corporate Office/iStock, vzphotos
Business
AbbVie Terminates Caribou CAR-T Contract in Culling of Cancer Pipeline
Soon after cancelling its contract with I-Mab, AbbVie has now also turned its back on a partnership with Berkeley-based Caribou Biosciences that was focused on advancing allogeneic CAR-T therapeutics.
September 27, 2023
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2 min read
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Tristan Manalac
Pictured: Concept art showing a broken head figure
Drug Development
Alto Reports Positive Phase II PTSD Data After Mid-Stage MDD Win
Following promising results in major depressive disorder, Alto Neuroscience on Tuesday reported positive data for its investigational drug ALTO-100 in post-traumatic stress disorder.
September 27, 2023
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2 min read
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Tristan Manalac
Pictured: Entrance to the U.S. Department of Healt
Policy
AstraZeneca, BMS Reluctantly Agree to Medicare Drug Price Negotiation Program
Despite filing respective lawsuits challenging the program, AstraZeneca and Bristol Myers Squibb have decided to participate in the first round of price negotiations under the Inflation Reduction Act.
September 27, 2023
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2 min read
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Tristan Manalac
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