Jan 2, 2025 · Shares of US drugmaker Vertex Pharmaceuticals jumped 8.4% to $475.00 in after-hours trading yesterday after it announced that the US Food and Drug Administration (FDA) has approved Journavx (suzetrigine), an oral, non-opioid, highly selective NaV1.8 pain signal inhibitor for the treatment of adults with moderate-to-severe acute pain.

5 days ago · The two day event offers a variety of means for networking and collaboration: Hackathons offering a hyper-interactive session where attendees work as a team to hack strategic issues.

Dec 30, 2024 · The life sciences industry experienced volatility in 2024, marked by pipeline growth, biologics breakthroughs, and evolving GLP-1 therapies. Challenges in trials, manufacturing, and commercialization persisted, driving adoption of AI and innovative pricing models as the sector prepares for further innovation in 2025.

Jan 10, 2025 · Mountainfield Venture Partners and Keymed Biosciences launch Timberlyne Therapeutics with $180 million in series A funding. The company will develop CM313, a monoclonal antibody for autoimmune disorders and cancers, leveraging Keymed's expertise while holding global rights outside China.

Jan 9, 2025 · Sanofi reports positive Phase III results for a subcutaneous version of Sarclisa in relapsed or refractory multiple myeloma. Delivered via an on-body device, the treatment offers convenience and non-inferiority to the IV formulation. Regulatory submissions in the USA and EU are planned for mid-2025.

Dec 24, 2024 · Viatris faces US FDA regulatory action on its Indore, India facility, with a warning letter and import alert restricting 11 products while exempting four for shortages. The company is implementing corrective measures and engaging with the FDA to address compliance issues.

Dec 2, 1996 · In the USA, the Food and Drug Administration has approved Merck & Co's Stromectil (ivermectin) for its first non-veterinary use, the chemotherapy of two parasitic infections, strongyloidiasis and onchocerciasis, in humans.

Sep 22, 2024 · In the 2024 US presidential election, health policy will remain a key issue for pharma. Both Donald Trump and Kamala Harris have criticized high drug prices, raising uncertainty for the industry. While Trump targeted generics, biosimilars, and international price comparisons during his term, Harris has been associated with pricing transparency and the Inflation Reduction Act (IRA), which ...

Jan 30, 2025 · US pharma giant Merck & Co today revealed an early stop to the Phase III HYPERION study evaluating Winrevair (sotatercept-csrk) versus placebo (both in combination with background therapy) in recently diagnosed adults with pulmonary arterial hypertension (PAH, WHO Group 1) functional class (FC) II or III at intermediate or high risk of disease progression.

Feb 4, 2025 · A Feature on M&A, VC investment licensing and partnerships focusing on novel targets in autoimmune diseases. The global market for autoimmune disease therapeutics is forecast to generate $185 billion by 2029, growing at a CAGR’23-‘29 of 3.7%, driven by the increasing prevalence of autoimmune diseases and immune-related secondary disorders, multiple new product launches, and rising cost for ...