It is in with the new and out with the old today as the first session of the 119^th U.S. Congress is called to order. Although Republicans will control both the House and Senate for the next two years, their narrow majority could prove a challenge to passing some of President-elect Donald Trump’s agenda, including his proposal to cut the corporate tax rate to 15% for companies that manufacture their products in the U.S. If Congress goes along with Trump’s tax plan, it could be a boon to the biopharma and med-tech industries and encourage more domestic drug and device manufacturing.

UK legislation seeks to revamp clinical trial regulations

The U.K. is embarking on the biggest overhaul of clinical trials regulations in 20 years in a bid to retake ground that was lost following Brexit, when the Medicines and Healthcare products Agency was excised from the EMA’s regulatory system. After much discussion, a lengthy public consultation and an independent review, new legislation was laid before parliament in December.

Newco news: Australia’s Celosia heads toward clinic with gene therapy for ALS

After raising AU$16.75 million (US$10.4 million) in a series A round, Celosia Therapeutics Pty Ltd. is heading toward the clinic with its novel gene therapy that targets TDP-43, a protein directly linked to amyotrophic lateral sclerosis (ALS) pathology. In February 2024, researchers Lars Ittner and Yazi Ke from Macquarie University’s Dementia Research Center discovered an unrecognized disease pathway of TDP-43, a novel protein interactor (14-3-3θ) that interacts exclusively with only toxic forms of TDP-43, a protein that is normally found in neurons in the brain and spinal cord, and in diseases such as ALS.

Credibility gap closing for psychedelics

Psychedelic drugs continued to make regulatory and clinical headway, as non-believers converted to believers in the category once regarded with skepticism, to say the least. Psilocybin, one of the more talked-about drugs in the class, scored a win in oral form during the summer when Tryptamine Therapeutics Ltd. reported an improvement in fibromyalgia pain severity, sleep and pain interference. There was bad news in the space, too, as the U.S. FDA delivered a complete response letter to Lykos Therapeutics Inc. for midomafetamine capsules, for use in combination with psychological intervention to treat post-traumatic stress disorder.

The struggle to fund women’s health startups

Companies working in the field of women’s health have long struggled for funding, but as the number of these companies increase and new dedicated venture capital (VC) funds emerge, the conversation is changing. BioWorld delved into the subject in 2024, finding that, while things have improved from a decade ago, women’s health dealmaking is done primarily by large biopharma companies with the finances to fail, and just 15% of all VC funding in 2023 went to companies that have at least one women’s health program. A report by Silicon Valley Bank also showed that VC deal activity dropped by 12% in 2023 from the previous year, but the volume was up by 314% since 2018 – indicating an overall move in the right direction

Scientists deliver the latest advances in pregnancy health

Around the end of every year, the media reports on pregnancy and women who give birth on the last and first days of the new year. They tell their stories, the names of their babies and the cities where they were born. While 2024 was coming to an end, gynecologists and other researchers finalized their publications to improve the health of women and their babies. The formation of the placenta or the study of preeclampsia are some of the first and last stories that greet and say goodbye to 2024.

December's $4.69B in biopharma financings caps a $102.15B year

Biopharma companies secured $102.15 billion in funding in 2024, a 44% increase from $70.97 billion in the full-year 2023 and significantly higher than the $60.81 billion raised in 2022. December financings reached $4.69 billion, marking an increase from $3.6 billion in November.

Also in the news

Atavistik, Capricor, Cel-Sci, Galera, Hookipa, Hutchmed, Innocan, Micurx, Neumora, Nova, Os Therapies, Pfizer, Pharmanovia, Poolbeg, Radius, Siga, Xgene