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.

While the exact settlement details are confidential, the deal will allow Amgen to launch its Stelara biosimilar no later than January 1, 2025.
The Massachusetts-based company has claimed the year’s largest fundraise so far and secured a powerhouse R&D partner in Novo Nordisk to develop gene editing medicines.
The Massachusetts-based startup’s goal is to develop RNA medicines that can treat diseases anywhere in the body using an “all-in-one” platform.
FDA
With the FDA’s approval on Monday, Ayvakit is the first and only treatment for adults with indolent systemic mastocytosis, a rare hematologic disorder, according to Blueprint Medicines.
FDA
Indivior’s Opvee is an emergency nasal spray medication to reverse opioid overdose approved for patients aged 12 years and above with signs of respiratory or central nervous system depression.
FDA
The topical treatment Vyjuvek got the FDA’s greenlight, making it the first redosable gene therapy and the first therapeutic for the rare skin disease dystrophic epidermolysis bullosa.
FDA
With Friday’s approval, Epkinly edges out Roche’s bi-specific antibody glofitamab, which is also being proposed for diffuse large B-cell lymphoma.
FDA
Crohn’s disease is Rinvoq’s seventh approved indication and could potentially help AbbVie weather declining sales for its blockbuster biologic Humira.
Blueprint Medicines, Indivior PLC and Lexicon Pharmaceuticals are all awaiting FDA decisions this week.
FDA
The regulator’s approval makes Miebo the first DED treatment that directly addresses tear evaporation. The drug is expected to hit U.S. markets in the second half of 2023.
Under a non-exclusive agreement, AstraZeneca is licensing biotech Revvity’s base editing technology to help create cell therapies for the treatment of cancer and immune-mediated diseases.
FDA
An advisory committee of outside experts voted unanimously Thursday that Pfizer’s vaccine was effective in preventing severe disease, but some had questions regarding its safety.
The $75 million deal will leverage Scribe’s CRISPR technologies to develop gene therapies for neurological and neuromuscular disorders. Scribe previously struck deals with Biogen and Sanofi.
Results from Phase IIb VOYAGE study showed Viking’s oral thyroid beta receptor agonist cut liver fat content by up to 51% in confirmed non-alcoholic steatohepatitis patients.
The U.S. Supreme Court’s denial of Teva Pharmaceuticals’ appeal could have broad ramifications for the wider generics industry, for which “skinny labeling” is a common and accepted practice.