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.

FDA
Despite concerns regarding neffy’s lack of clinical evidence, the panel of experts voted in favor of the nasal spray’s approval for the emergency treatment of type 1 allergic reactions.
Lawmakers on Thursday voted 18–3 to increase oversight of pharmacy benefit managers and limit their practice of spread pricing, when PBMs charge payers for drugs more than they pay pharmacies.
The FDA has four events lined up this week, including a target action date for Krystal Biotech’s gene therapy for a rare skin disease and an adcomm meeting for Pfizer’s RSV vaccine candidate.
The Chapter 11 bankruptcy was driven by increasing generic competition, declining profits and the unrelenting legal woes of its head Martin Shkreli, dubbed “Pharma Bro” in the media.
FDA
The joint committee of external experts voted unanimously in favor of Perrigo, finding that the benefits of allowing non-prescription use of the birth control tablet Opill outweigh its risks.
FDA
Elfabrio’s label contains a boxed warning for hypersensitivity reactions, such as anaphylaxis, and recommends that medical support measures should be on standby when administering the treatment.
The biotech company shuffled deals around Tuesday, dropping a four-year collaboration with Israel’s Entera Bio and picking a new partner in Massachusetts-based TScan Therapeutics.
The biopharma company scored two major wins on Tuesday: a court victory over HIV patent claims and an acquisition deal to expand its pipeline in cancer and inflammatory diseases.
The layoffs come as the company posts nearly $300 million in net losses and just over $80 million in revenue during the first quarter of 2023.
The pharma company will lay off 170 employees and drop all candidates but one, as it seeks to rebuild its business.
The delay and guidance downgrade follow a spate of operational issues that have affected three of Catalent’s major manufacturing sites.
The German biotech is trying to deepen its pipeline in cancer and other infectious diseases as COVID-19 markets contract and the international public health emergency comes to an end.
As competition eats away at profits for the wet age-related macular degeneration drug, Regeneron is diversifying its portfolio and pumping more money into research and development.
The FDA’s agenda includes an advisory committee meeting for Sarepta’s delandistrogene moxeparvovec, which, if approved, would become the first gene therapy for Duchenne muscular dystrophy.
During a first-quarter earnings call, Novo revealed its hemophilia candidate had been blocked by the FDA, and that the company is reducing the U.S. supply of lower doses of weight-loss drug Wegovy.