All the elements for a big M&A year are in place, but political uncertainty and interest rates could push more deals into the second half of the year, according to business development experts at BIO CEO & Investor.
Parexel's CEO Peyton Howell and India boss Sanjay Vyas talk to Scrip about the value of clinical trial diversity, AI pilots underway and opportunities for India amid geopolitical rumblings, as well as the need for standardized regulatory approaches to enhance sponsor interest.
Pfizer has been unable to take a big slice of the meningococcal vaccine market with Penbraya and now GSK looks set to consolidate its lead with its new 5-in-1 vaccine.
Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.
Parexel's CEO Peyton Howell and India boss Sanjay Vyas talk to Scrip about the value of clinical trial diversity, AI pilots underway and opportunities for India amid geopolitical rumblings, as well as the need for standardized regulatory approaches to enhance sponsor interest.
The checkpoint inhibitor combo missed a recurrence-free survival endpoint in Phase III in post-surgical melanoma. The LAG-3 inhibitor-containing product continues development in lung cancer, however.
Public Company Edition: Aardvark Therapeutics’ US IPO – the fifth of 2025 – will fund a Phase III trial in Prader-Willi syndrome and other studies. Also, Sarepta closed on a $600m revolving credit facility and Biogen entered into a funding agreement with Royalty Pharma for up to $250m.
The biotech disclosed that its norovirus vaccine program was under US FDA hold due to a case of Guillain-Barré syndrome, but said this would not affect timelines.
Having built its portfolio from university collaborations and targeted in-licensing, the UK firm now hopes to validate its business model with Phase II readouts in 2025.
The Swedish company is celebrating approval for the first treatment for MCT8 deficiency
Public Company Edition: Aardvark Therapeutics’ US IPO – the fifth of 2025 – will fund a Phase III trial in Prader-Willi syndrome and other studies. Also, Sarepta closed on a $600m revolving credit facility and Biogen entered into a funding agreement with Royalty Pharma for up to $250m.
Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.
Private Company Edition: Abcuro’s series C venture capital round will fund its lead drug through pivotal results, filing with the US FDA and launch preparations. Also, AdvanCell completed a $112m series C round, Lutris Pharma raised $30m and Imvax closed a $29m financing.
Restructuring Edition: Third Harmonic cut its workforce by half based on positive Phase I data for THB335. Also, encouraged by early Phase IIa results in alopecia areata, Q32 Bio is focusing on bempikibart. In addition, X4, Turnstone, Fractyl, Cargo and others recently revealed layoffs.
