US pharma giant Merck & Co announced positive overall survival (OS) results from the final analysis of the Phase III KEYNOTE-811 trial. 14 September 2024
Under pressure from certain shareholders, autoimmune diseases specialist Aurinia Pharmaceuticals on Friday said it has restructured its board of directors. 14 September 2024
As the world’s leading cancer research professionals arrived at the European Society for Medical Oncology (ESMO) Congress 2024 in Barcelona on Friday, they were given a reminder of some of the remaining challenges that lie ahead in their field. 13 September 2024
The National Institute for Health and Care Excellence (NICE) has recommended access Vabysmo (faricimab) for the treatment of adults with visual impairment due to macular oedema secondary to branched and central retinal vein occlusion. 13 September 2024
Among the first presentations at the European Society for Medical Oncology (ESMO) meeting that kicked off today, were results from the DESTINY-Breast12 Phase IIIb/IV trial of Enhertu (trastuzumab deruxtecan). 13 September 2024
US biotech Nona Biosciences has entered into a multi-target antibody discovery collaboration with Umoja Biopharma, an immunotherapy company creating off-the-shelf treatments that aim to extend the reach and effectiveness of CAR-T cell therapies in oncology and autoimmunity. 13 September 2024
Women’s health focussed company Organon China today revealed that it has entered into license and supply agreements with Shanghai Bao Pharmaceutical, acquiring the exclusive commercialization rights to its investigational asset, SJ02, in China Mainland. 13 September 2024
On Thursday, the US Food and Drug Administration released a Drug Safety Communication warning that Veozah (fezolinetant), which is used to treat hot flashes due to menopause, can cause rare but serious liver injury. 13 September 2024
US pharma major Eli Lilly has announced a $1 billion expansion of its manufacturing site in Limerick, Ireland, to increase production of biologic active ingredients, including those for its recently approved treatment for early symptomatic Alzheimer's disease. 13 September 2024
Aura Biosciences announced positive Phase II end of study results evaluating belzupacap sarotalocan (bel-sar; AU-011) for the first-line treatment of early-stage choroidal melanoma (CM), a vision and life-threatening ocular cancer. 13 September 2024
Thursday was a wretched day for Fulcrum Therapeutics, a US biopharma company focused on developing small molecules to improve the lives of patients with genetically defined rare diseases. 13 September 2024
The protection of intellectual property (IP) rights of foreign pharmaceutical companies in Russia remains complex situation, according to recent statements by Konstantin Panurovsky, legal director of AstraZeneca’s Russian subsidiary, reports The Pharma Letter’s local correspondent. 13 September 2024
The US Food and Drug Administration (FDA) has approved Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs), the first and only PD-(L)1 inhibitor for subcutaneous (SC) injection for patients in the USA, Swiss pharma giant Roche subsidiary Genentech announced yesterday. 13 September 2024
Gilead Sciences’ shares closed up 2.7% at $83.16 yesterday, after it releases positive results of an interim analysis from a second pivotal Phase III clinical trial investigating the use of the company’s twice-yearly injectable HIV-1 capsid inhibitor, lenacapavir. 13 September 2024
Germany’s Pentixapharm is planning a public offering of new shares as part of its spin-off from Eckert & Ziegler, a leading specialist in radioisotopes for medical, scientific and industrial applications. 12 September 2024
The Russian Ministry of Health wants to speed registration of drugs that are not localized in the Russian Federation at the time of the application submitted by domestic pharmaceutical companies, explaining such changes by "unpredictable geopolitical situation," reports The Pharma Letter’s local correspondent. 12 September 2024
The US Food and Drug Administration (FDA) has approved Tremfya (guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis (UC). 12 September 2024
US pharma giant Merck & Co announced positive overall survival (OS) results from the final analysis of the Phase III KEYNOTE-811 trial. 14 September 2024
Under pressure from certain shareholders, autoimmune diseases specialist Aurinia Pharmaceuticals on Friday said it has restructured its board of directors. 14 September 2024
As the world’s leading cancer research professionals arrived at the European Society for Medical Oncology (ESMO) Congress 2024 in Barcelona on Friday, they were given a reminder of some of the remaining challenges that lie ahead in their field. 13 September 2024
The National Institute for Health and Care Excellence (NICE) has recommended access Vabysmo (faricimab) for the treatment of adults with visual impairment due to macular oedema secondary to branched and central retinal vein occlusion. 13 September 2024
Among the first presentations at the European Society for Medical Oncology (ESMO) meeting that kicked off today, were results from the DESTINY-Breast12 Phase IIIb/IV trial of Enhertu (trastuzumab deruxtecan). 13 September 2024
US biotech Nona Biosciences has entered into a multi-target antibody discovery collaboration with Umoja Biopharma, an immunotherapy company creating off-the-shelf treatments that aim to extend the reach and effectiveness of CAR-T cell therapies in oncology and autoimmunity. 13 September 2024
Women’s health focussed company Organon China today revealed that it has entered into license and supply agreements with Shanghai Bao Pharmaceutical, acquiring the exclusive commercialization rights to its investigational asset, SJ02, in China Mainland. 13 September 2024
On Thursday, the US Food and Drug Administration released a Drug Safety Communication warning that Veozah (fezolinetant), which is used to treat hot flashes due to menopause, can cause rare but serious liver injury. 13 September 2024
US pharma major Eli Lilly has announced a $1 billion expansion of its manufacturing site in Limerick, Ireland, to increase production of biologic active ingredients, including those for its recently approved treatment for early symptomatic Alzheimer's disease. 13 September 2024
Aura Biosciences announced positive Phase II end of study results evaluating belzupacap sarotalocan (bel-sar; AU-011) for the first-line treatment of early-stage choroidal melanoma (CM), a vision and life-threatening ocular cancer. 13 September 2024
Thursday was a wretched day for Fulcrum Therapeutics, a US biopharma company focused on developing small molecules to improve the lives of patients with genetically defined rare diseases. 13 September 2024
The protection of intellectual property (IP) rights of foreign pharmaceutical companies in Russia remains complex situation, according to recent statements by Konstantin Panurovsky, legal director of AstraZeneca’s Russian subsidiary, reports The Pharma Letter’s local correspondent. 13 September 2024
The US Food and Drug Administration (FDA) has approved Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs), the first and only PD-(L)1 inhibitor for subcutaneous (SC) injection for patients in the USA, Swiss pharma giant Roche subsidiary Genentech announced yesterday. 13 September 2024
Gilead Sciences’ shares closed up 2.7% at $83.16 yesterday, after it releases positive results of an interim analysis from a second pivotal Phase III clinical trial investigating the use of the company’s twice-yearly injectable HIV-1 capsid inhibitor, lenacapavir. 13 September 2024
Germany’s Pentixapharm is planning a public offering of new shares as part of its spin-off from Eckert & Ziegler, a leading specialist in radioisotopes for medical, scientific and industrial applications. 12 September 2024
The Russian Ministry of Health wants to speed registration of drugs that are not localized in the Russian Federation at the time of the application submitted by domestic pharmaceutical companies, explaining such changes by "unpredictable geopolitical situation," reports The Pharma Letter’s local correspondent. 12 September 2024
The US Food and Drug Administration (FDA) has approved Tremfya (guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis (UC). 12 September 2024