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.

Novo Nordisk’s partnerships with Flagship Pioneering-backed Omega and Cellarity, each worth up to $532 million, will explore novel treatment approaches to obesity and metabolic dysfunction-associated steatohepatitis.
With a PDUFA date in the second quarter of 2024, Pfizer is poised to compete with CSL Behring, whose Hemgenix became the first FDA-approved gene therapy for hemophilia B in November 2022.
The pharmacy benefit management subsidiary of CVS Health is favoring Humira’s biosimilars for its major formularies, with AbbVie’s branded product to be nixed on April 1, 2024.
In a collaboration agreement announced Wednesday, Boehringer Ingelheim will gain access to Ribo’s platform to target hepatocytes with investigational siRNA therapies for nonalcoholic or metabolic dysfunction-associated steatohepatitis.
FDA
The regulator greenlit 55 new drugs last year, seven of which belonged to Pfizer, including an ulcerative colitis treatment and a migraine nasal spray—both acquired in multibillion-dollar buys.
Patients treated with Longboard Pharmaceuticals’ bexicaserin saw a 32.5% drop in the frequency of countable motor seizures relative to placebo in a Phase 1b/IIa study. The company’s shares soared 316% Tuesday on the news.
The Swiss pharma is looking to leverage Voyager Therapeutics’ capsid technology for gene therapies aimed at treating Huntington’s disease and spinal muscular atrophy.
All three companies closed out the year, which saw significant growth in mergers and acquisitions, with high-value deals that could potentially set the tone for M&A in 2024.
Amid the Biden administration’s efforts to reduce drug prices, Reuters reported in an exclusive that several pharmaceutical companies will raise pharma prices in January 2024.
The acquisition announced on Friday will give Bristol Myers Squibb ownership of Karuna Therapeutics’ investigational antipsychotic KarXT, which is being tested for schizophrenia and Alzheimer’s disease psychosis.
In a Phase II study, Jazz Pharmaceuticals’ investigational fatty acid amide hydrolase inhibitor JZP150 did not significantly improve post-traumatic stress disorder symptoms compared to placebo.
FDA
Wainua, which is jointly developed and commercialized by AstraZeneca and Ionis Pharmaceuticals, was given the FDA’s green light on Thursday and will now compete with Alnylam’s two approved hATTR-PN therapies.
The regulator’s Complete Response Letter on Wednesday said Merck’s data package for gefapixant “did not meet substantial evidence of effectiveness.” The FDA also rejected the drug in 2022 due to a lack of efficacy evidence.
FDA
The oral formulation of budesonide, marketed as Tarpeyo, is the only FDA-approved therapy that significantly reduces the loss of kidney function in immunoglobulin A nephropathy patients.
Argenx’s subcutaneous Fc receptor blocker efgartigimod was unable to induce a significantly higher rate of complete remission than placebo in the skin autoimmune disease. The company’s stock plummeted in response to the news.