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
German radiopharmaceutical company ITM Isotope Technologies Munich (ITM) and Swiss biopharma Debiopharm have announced a licensing deal. 12 September 2024
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for Sanofi’s mega blockbuster drug Dupixent (dupilumab) as an add-on maintenance treatment for adults with uncontrolled chronic obstructive pulmonary disease (COPD) characterized by raised blood eosinophils. 12 September 2024
Innovent Biologics has announced positive results from a Phase III trial for mazdutide, a dual agonist targeting GLP-1 and glucagon receptor. 12 September 2024
Intercept Pharmaceuticals’ Ocaliva (obeticholic acid) will come under the microscope when the US Food and Drug Administration’s (FDA) Gastrointestinal Drugs Advisory Committee meets on Friday. 12 September 2024
French pharma major Sanofi is delving into the emerging class of cancer drugs known as radiopharmaceuticals, which use radioactive substances to attack tumor cells in a targeted way. 12 September 2024
EQT Life Sciences revealed that it has led a 93 million-euro ($102.5 million) oversubscribed Series A fundraise in PanTera, a Belgian radioisotope producer. 12 September 2024
Novo Nordisk has announced that its obesity drug Saxenda (liraglutide) has been shown to be safe and effective in treating obesity in children aged 6-12 years, based on results from a Phase IIIa trial. 12 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
German radiopharmaceutical company ITM Isotope Technologies Munich (ITM) and Swiss biopharma Debiopharm have announced a licensing deal. 12 September 2024
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for Sanofi’s mega blockbuster drug Dupixent (dupilumab) as an add-on maintenance treatment for adults with uncontrolled chronic obstructive pulmonary disease (COPD) characterized by raised blood eosinophils. 12 September 2024
Innovent Biologics has announced positive results from a Phase III trial for mazdutide, a dual agonist targeting GLP-1 and glucagon receptor. 12 September 2024
Intercept Pharmaceuticals’ Ocaliva (obeticholic acid) will come under the microscope when the US Food and Drug Administration’s (FDA) Gastrointestinal Drugs Advisory Committee meets on Friday. 12 September 2024
French pharma major Sanofi is delving into the emerging class of cancer drugs known as radiopharmaceuticals, which use radioactive substances to attack tumor cells in a targeted way. 12 September 2024
EQT Life Sciences revealed that it has led a 93 million-euro ($102.5 million) oversubscribed Series A fundraise in PanTera, a Belgian radioisotope producer. 12 September 2024
Novo Nordisk has announced that its obesity drug Saxenda (liraglutide) has been shown to be safe and effective in treating obesity in children aged 6-12 years, based on results from a Phase IIIa trial. 12 September 2024