Teva Pharmaceutical Industries

Fremanezumab (Ajovy; Teva) significantly reduced monthly migraine days (MMD) and monthly headache days (MHD) in children aged 6 to 17 years compared to placebo, according to the phase 3 SPACE trial. 47.2% of children reached a 50% response rate to fremanezumab vs 27.0% to placebo over 12 weeks, with a safety profile consistent with adult studies. Fremanezumab's benefits were similar across age groups and sexes, and it resulted in significant reductions in MMD and MHD vs placebo.

Teva Pharmaceutical Industries reported positive outcomes from its Phase III SPACE trial of Ajovy (fremanezumab) for episodic migraine in children aged 6-17, showing significant reduction in migraine frequency and a safety profile consistent with adults.

Fremanezumab (Ajovy) shows significant efficacy in reducing migraine days in children and adolescents aged 6-17 in a phase 3 trial, with a safety profile consistent with adults, marking a significant step forward in pediatric migraine treatment.

Tonix Pharmaceuticals appoints Bradley Raudabaugh as VP of Marketing and Errol Gould as VP of Medical Affairs to support the launch of TNX-102 SL for fibromyalgia. The NDA for TNX-102 SL was submitted to the FDA in October 2024, with an expected decision in 2025, potentially marking the first new drug for fibromyalgia in over 15 years.

The FDA approved Biocon Biologics' ustekinumab biosimilar, YESINTEK, for treating Crohn disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis. Another biosimilar, Accord Biopharma's IMULDOSA, was also approved for the same conditions, with both biosimilars demonstrating similarity to reference ustekinumab in clinical data.

Abingworth seeks to raise up to $1.5 billion for biopharma clinical development in return for royalties, aiming to support up to eight late-stage trials. This follows earlier deals with Gilead and Teva, where Abingworth funded clinical studies in exchange for fixed payments and royalties on sales.

Israeli startup Converge Bio uses AI to accelerate drug and vaccine development, raising $5.5 million in seed funding. Their large language models analyze data to predict and optimize drug candidates, partnering with Teva, Compugen, and BiomX.

Propionic acid deficiency may contribute to multiple sclerosis (MS) pathology. Propionate shows beneficial effects on immune, peripheral, and central nervous systems in MS patients, potentially improving outcomes when used with immune-modulating therapy. Further large clinical trials are necessary to evaluate its efficacy and safety.

Formycon reports nine-month results for 2024, highlighting product approvals for FYB202 in the USA and Europe, the start of clinical development for Keytruda® biosimilar FYB206, and the initiation of FYB210 development. Financial results reflect successful business performance, confirming guidance.

The Federal Circuit debated whether Teva's patents for ProAir HFA inhalers should be listed in the Orange Book, with Amneal arguing they fail to claim the specific drug as required by law. The District Court previously ruled the patents improperly listed, and the Federal Circuit's decision will clarify if pure device patents can be included.