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29 November 2024 The currently available evidence is not sufficient to establish a causal relationship between the use of the antibiotic doxycycline and the risk of suicidality.
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Pharmaceutical
The world’s hematologists are packing their bags in preparation for a visit to San Diego, California, for the American Society of Hematology (ASH) Annual Meeting and Exposition. Which companies’ data will they be looking out for? And which might take them by surprise? Our guide below offers a preview of some of the major presentations coming up. 1 December 2024
Biotechnology
Among important regulatory news last week, US drugmaker BridgeBio Pharma gained Food and Drug Administration (FDA) approval for its cardiomyopathy drug Attruby (acoramidis). On the research front, Biohaven posted disappointing data for its spinal muscular atrophy (SMA) and obesity candidate taldefgrobep. Also, PTC Therapeutics released new Phase II data on its investigational amyotrophic lateral sclerosis drug utreloxastat that missed its goal. Also of note, Arrowhead Pharmaceutical entered into an agreement, potentially worth $11 billion, granting rights to Sarepta Therapeutics for a multiple clinical program in the area of muscle, CNS and lung disease. 1 December 2024
Biotechnology
Belgium’s largest drugmaker UCB on Friday announced the successful closing of the sale, divestment and license of its mature neurology and allergy portfolio in China to CBC Group, Asia’s largest healthcare-focused asset management group, and Mubadala Investment Company for an enterprise value of $680 million, first announced earlier this year. 30 November 2024
Biotechnology
AstraZeneca and Daiichi Sankyo’s breast cancer med Enhertu (trastuzumab deruxtecan) will be included in China’s state-run health insurance scheme from next year, boosting availability at the cost of reduced pricing. 29 November 2024
Biotechnology
Minghui Pharmaceutical has reported encouraging results from a Phase III trial of MH004 (tofacitinib etocomil) in mild to moderate atopic dermatitis (AD). 29 November 2024
Biotechnology
Allink Biotherapeutics, a Chinese start-up focused on bispecific antibody and antibody-drug conjugates (ADC), has raised $42 million in a financing round led by Lanchi Ventures. 29 November 2024
Biotechnology
China’s Innovent Biologics has announced that the updated 2024 National Reimbursement Drug List (NRDL) now includes Sintbilo (tafolecimab) injection, an anti-PCSK9 monoclonal antibody for the first time. The updated NRDL will be officially effective from January 1, 2025. 29 November 2024
Pharmaceutical
The Danish Ministry of Interior and Health has announced that the political parties have decided to permanently legalize treatment with medical cannabis in Denmark. 29 November 2024
Pharmaceutical
The currently available evidence is not sufficient to establish a causal relationship between the use of the antibiotic doxycycline and the risk of suicidality. 29 November 2024
Pharmaceutical
Taiwan-based Formosa Pharmaceuticals (6838: TW) revealed that it has entered into an exclusive licensing agreement with Medvisis Switzerland, in Switzerland and Liechtenstein, for exclusive rights to the commercialization of clobetasol propionate ophthalmic suspension, 0.05% (APP13007), a marketed innovative treatment of post-operative inflammation and pain following ocular surgery. 29 November 2024
Pharmaceutical
Industry is showing a very high level of readiness for upcoming new packaging and labelling measures impacting the UK market, according to the Medicines and Healthcare products Regulatory Agency (MHRA). 29 November 2024
Pharmaceutical
German family-owned pain focused drugmaker Grünenthal has announced the pricing of 500 million-euro ($527.5 million) aggregate principal amount of 4.625% senior secured notes due 2031. 29 November 2024
Biotechnology
Zug-based Galderma has published positive results from the Phase III OLYMPIA 1 trial in JAMA Dermatology, as the company’s newly-minted shares change hands in record volumes. 29 November 2024
Biotechnology
Indian drugmaker Dr Reddy’s Laboratories has launched its toripalimab in the domestic market, sending the firm’s share up 2%. Toripalimab is a New Biological Entity (NBE), the company noted. 29 November 2024
Pharmaceutical
Germany’s Evotec has said its chief operating officer Craig Johnstone will leave the business at the end of the year. 29 November 2024
Biotechnology
French pharma major Sanofi has added a new plant in Singapore to make vaccines and other medicines, as the company seeks to bolster preparedness for emergencies, including potential pandemics, according to Bloomberg and other media reports. 29 November 2024
Biotechnology
During the Belgian Economic Mission to Brazil, a historic Memorandum of Understanding (MoU) was signed between the Brazilian Oswaldo Cruz Foundation (Fiocruz) through its Institute of Technology on Immunobiologicals (Bio-Manguinhos), and the Belgian companies Quantoom Biosciences and Univercells. 29 November 2024
Pharmaceutical
The waiting time for Latin American patients with cancer, central nervous system disorders or rare diseases can take up to 4.75 years from the time a drug receives approval from global health authorities such as the US Food and Drug Administration (FDA) or the European Medicines Agency (EMA), until it is approved by their local authority and is available on the market, writes The Pharma Letter's local correspondent. 28 November 2024
Biotechnology
PTC Therapeutics is to sell its rare pediatric disease priority review voucher (PRV) for $150 million. 28 November 2024
Biotechnology
A report from industry analyst DelveInsight highlights progress in the myotonic dystrophy treatment landscape, with more than 20 companies developing over 22 innovative treatments. 28 November 2024
All news
Pharmaceutical
The world’s hematologists are packing their bags in preparation for a visit to San Diego, California, for the American Society of Hematology (ASH) Annual Meeting and Exposition. Which companies’ data will they be looking out for? And which might take them by surprise? Our guide below offers a preview of some of the major presentations coming up. 1 December 2024
Biotechnology
Among important regulatory news last week, US drugmaker BridgeBio Pharma gained Food and Drug Administration (FDA) approval for its cardiomyopathy drug Attruby (acoramidis). On the research front, Biohaven posted disappointing data for its spinal muscular atrophy (SMA) and obesity candidate taldefgrobep. Also, PTC Therapeutics released new Phase II data on its investigational amyotrophic lateral sclerosis drug utreloxastat that missed its goal. Also of note, Arrowhead Pharmaceutical entered into an agreement, potentially worth $11 billion, granting rights to Sarepta Therapeutics for a multiple clinical program in the area of muscle, CNS and lung disease. 1 December 2024
Biotechnology
Belgium’s largest drugmaker UCB on Friday announced the successful closing of the sale, divestment and license of its mature neurology and allergy portfolio in China to CBC Group, Asia’s largest healthcare-focused asset management group, and Mubadala Investment Company for an enterprise value of $680 million, first announced earlier this year. 30 November 2024
Biotechnology
AstraZeneca and Daiichi Sankyo’s breast cancer med Enhertu (trastuzumab deruxtecan) will be included in China’s state-run health insurance scheme from next year, boosting availability at the cost of reduced pricing. 29 November 2024
Biotechnology
Minghui Pharmaceutical has reported encouraging results from a Phase III trial of MH004 (tofacitinib etocomil) in mild to moderate atopic dermatitis (AD). 29 November 2024
Biotechnology
Allink Biotherapeutics, a Chinese start-up focused on bispecific antibody and antibody-drug conjugates (ADC), has raised $42 million in a financing round led by Lanchi Ventures. 29 November 2024
Biotechnology
China’s Innovent Biologics has announced that the updated 2024 National Reimbursement Drug List (NRDL) now includes Sintbilo (tafolecimab) injection, an anti-PCSK9 monoclonal antibody for the first time. The updated NRDL will be officially effective from January 1, 2025. 29 November 2024
Pharmaceutical
The Danish Ministry of Interior and Health has announced that the political parties have decided to permanently legalize treatment with medical cannabis in Denmark. 29 November 2024
Pharmaceutical
The currently available evidence is not sufficient to establish a causal relationship between the use of the antibiotic doxycycline and the risk of suicidality. 29 November 2024
Pharmaceutical
Taiwan-based Formosa Pharmaceuticals (6838: TW) revealed that it has entered into an exclusive licensing agreement with Medvisis Switzerland, in Switzerland and Liechtenstein, for exclusive rights to the commercialization of clobetasol propionate ophthalmic suspension, 0.05% (APP13007), a marketed innovative treatment of post-operative inflammation and pain following ocular surgery. 29 November 2024
Pharmaceutical
Industry is showing a very high level of readiness for upcoming new packaging and labelling measures impacting the UK market, according to the Medicines and Healthcare products Regulatory Agency (MHRA). 29 November 2024
Pharmaceutical
German family-owned pain focused drugmaker Grünenthal has announced the pricing of 500 million-euro ($527.5 million) aggregate principal amount of 4.625% senior secured notes due 2031. 29 November 2024
Biotechnology
Zug-based Galderma has published positive results from the Phase III OLYMPIA 1 trial in JAMA Dermatology, as the company’s newly-minted shares change hands in record volumes. 29 November 2024
Biotechnology
Indian drugmaker Dr Reddy’s Laboratories has launched its toripalimab in the domestic market, sending the firm’s share up 2%. Toripalimab is a New Biological Entity (NBE), the company noted. 29 November 2024
Pharmaceutical
Germany’s Evotec has said its chief operating officer Craig Johnstone will leave the business at the end of the year. 29 November 2024
Biotechnology
French pharma major Sanofi has added a new plant in Singapore to make vaccines and other medicines, as the company seeks to bolster preparedness for emergencies, including potential pandemics, according to Bloomberg and other media reports. 29 November 2024
Biotechnology
During the Belgian Economic Mission to Brazil, a historic Memorandum of Understanding (MoU) was signed between the Brazilian Oswaldo Cruz Foundation (Fiocruz) through its Institute of Technology on Immunobiologicals (Bio-Manguinhos), and the Belgian companies Quantoom Biosciences and Univercells. 29 November 2024
Pharmaceutical
The waiting time for Latin American patients with cancer, central nervous system disorders or rare diseases can take up to 4.75 years from the time a drug receives approval from global health authorities such as the US Food and Drug Administration (FDA) or the European Medicines Agency (EMA), until it is approved by their local authority and is available on the market, writes The Pharma Letter's local correspondent. 28 November 2024
Biotechnology
PTC Therapeutics is to sell its rare pediatric disease priority review voucher (PRV) for $150 million. 28 November 2024
Biotechnology
A report from industry analyst DelveInsight highlights progress in the myotonic dystrophy treatment landscape, with more than 20 companies developing over 22 innovative treatments. 28 November 2024
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