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28 February 2025 Japanese biopharma Nxera Pharma has announced two deals in a single day with partners that will commercialize its products in parts of Asia.
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Pharmaceutical
The Critical Medicines Alliance Strategic Report has been published in a bid to develop a coordinated, European industrial framework to prevent and mitigate shortages of crucial medical products. 3 March 2025
Pharmaceutical
The Irish Pharmaceutical Healthcare Association (IPHA) has published a position paper on the 2025 Programme for Government Commitments calling for faster and fairer access to medicines. 3 March 2025
Pharmaceutical
In a partnership marking AbbVie’s entrance into the weight management field, the US pharma major has signed a licensing deal with Denmark’s Gubra to develop GUB014295, a potential best-in-class, long-acting amylin analog for the treatment of obesity. 3 March 2025
Pharmaceutical
BridgeBio Oncology Therapeutics (BBOT), a company advancing small molecule therapeutics targeting RAS and PI3Ka malignancies, and Helix Acquisition Corp II , a special purpose acquisition company (SPAC) sponsored by affiliates of Cormorant Asset Management, have agreed to merge. 3 March 2025
Pharmaceutical
US oncology-focused Nuvation Bio today announced non-dilutive financings of up to $250 million with Sagard Healthcare Partners (Sagard), with the news pushing its shares up 6.6% to $2.10 in pre-market activity. 3 March 2025
Pharmaceutical
USA/China-based SciClone Pharmaceuticals has entered into a license agreement with Japan’s Eisai for the latter’s fibroblast growth factor (FGF) receptor selective tyrosine kinase inhibitor tasurgratinib succinate (code named E7090). 3 March 2025
Biotechnology
Boston, USA-based biotech Praxis Precision Medicines has provided an update on the interim analysis for Study 1 of the Essential3 program of ulixacaltamide in essential tremor (ET), sending the firm’s shares tumbling more than 40% to $38.60 on Friday. 3 March 2025
Biotechnology
Amgen and AstraZeneca have announced full results from the Phase III, registrational WAYPOINT trial showing that Tezspire (tezepelumab-ekko) significantly reduced nasal polyp severity, the need for surgery and systemic corticosteroid use in patients with chronic rhinosinusitis with nasal polyps (CRSwNP [nasal polyps]). 3 March 2025
Biotechnology
The Therapeutic Goods Administration (TGA) of Australia has declined the approval of Leqembi (lecanemab) as a treatment for early Alzheimer’s disease (AD). 3 March 2025
Biotechnology
New positive data from Stage 2 and Stage 3 of the National Institutes of Health (NIH)-sponsored Phase III OUtMATCH study, which provide further evidence supporting the role of Xolair (omalizumab) for the treatment of one or more food allergies, have been released by Swiss pharma giant Roche. 3 March 2025
Generics
Even as the spectre of tariffs looms over the pharmaceutical trade between India and the USA, presenting a complex scenario with potential repercussions for both regions, its implementation would necessitate a rapid recalibration of supply chains and pricing strategies, reports The Pharma Letter’s India correspondent. 3 March 2025
Biotechnology
The US Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation for Anktiva (nogapendekin alfa inbakicept-pmln) and CAR-NK (PD-L1 t-haNK) for the reversal of lymphopenia in patients receiving standard-of-care chemotherapy/radiotherapy and in multiply relapsed locally advanced or metastatic pancreatic cancer. 3 March 2025
Pharmaceutical
UK-based specialty drugmaker Kelso Pharma has appointed experienced pharma executive, Giovanni Mauri, as general manager at Velit Biopharma, the Italian-based pharma business that was acquired by Kelso in November 2023. 3 March 2025
Pharmaceutical
Among significant research news last week, US CNS specialist Axsome Therapeutics released new Phase III data on its recently US Food and Drug Administration (FDA)-approved migraine drug Symbravo, and the UK’s AstraZeneca announced positive Phase III trial results for its breast cancer candidate camizestrant. US biotech giant Amgen revealed it is pressing ahead with its $200 million investment in Indian technology center. US pharma major Eli Lilly attracted attention with its licensing deal for Organovo’s FXR program and announcing the release of new dosages and prices for its blockbuster obesity drug Zepbound. 2 March 2025
Pharmaceutical
Massachusetts, USA-based start-up Magnet Biomedicine, which is advancing molecular glue discovery with rational selection and design, has announced a collaboration and license agreement with pharma major Eli Lilly & Co to discover, develop, and commercialize molecular glue therapeutics in oncology. 1 March 2025
Biotechnology
The US President Donald Trump began his second term with a series of directives targeting the US National Institutes of Health (NIH), creating uncertainty around NIH grant funding for biopharmaceutical drug development. 1 March 2025
Pharmaceutical
The European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended three novel medicines for approval at its February 2025 meeting. The European Commission is expected to announce a final decision on approval in the coming months. 1 March 2025
Pharmaceutical
Medicare Part D spending for 10 selected diabetes drugs in the USA totaled $35.8 billion in 2023, an increase of 364% from 2019. 28 February 2025
Biotechnology
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved an mRNA respiratory syncytial virus (RSV) vaccine (brand name mRESVIA) to protect patients aged 60 and over against lower respiratory tract disease caused by RSV. 28 February 2025
Pharmaceutical
Japanese biopharma Nxera Pharma has announced two deals in a single day with partners that will commercialize its products in parts of Asia. 28 February 2025
All news
Pharmaceutical
The Critical Medicines Alliance Strategic Report has been published in a bid to develop a coordinated, European industrial framework to prevent and mitigate shortages of crucial medical products. 3 March 2025
Pharmaceutical
The Irish Pharmaceutical Healthcare Association (IPHA) has published a position paper on the 2025 Programme for Government Commitments calling for faster and fairer access to medicines. 3 March 2025
Pharmaceutical
In a partnership marking AbbVie’s entrance into the weight management field, the US pharma major has signed a licensing deal with Denmark’s Gubra to develop GUB014295, a potential best-in-class, long-acting amylin analog for the treatment of obesity. 3 March 2025
Pharmaceutical
BridgeBio Oncology Therapeutics (BBOT), a company advancing small molecule therapeutics targeting RAS and PI3Ka malignancies, and Helix Acquisition Corp II , a special purpose acquisition company (SPAC) sponsored by affiliates of Cormorant Asset Management, have agreed to merge. 3 March 2025
Pharmaceutical
US oncology-focused Nuvation Bio today announced non-dilutive financings of up to $250 million with Sagard Healthcare Partners (Sagard), with the news pushing its shares up 6.6% to $2.10 in pre-market activity. 3 March 2025
Pharmaceutical
USA/China-based SciClone Pharmaceuticals has entered into a license agreement with Japan’s Eisai for the latter’s fibroblast growth factor (FGF) receptor selective tyrosine kinase inhibitor tasurgratinib succinate (code named E7090). 3 March 2025
Biotechnology
Boston, USA-based biotech Praxis Precision Medicines has provided an update on the interim analysis for Study 1 of the Essential3 program of ulixacaltamide in essential tremor (ET), sending the firm’s shares tumbling more than 40% to $38.60 on Friday. 3 March 2025
Biotechnology
Amgen and AstraZeneca have announced full results from the Phase III, registrational WAYPOINT trial showing that Tezspire (tezepelumab-ekko) significantly reduced nasal polyp severity, the need for surgery and systemic corticosteroid use in patients with chronic rhinosinusitis with nasal polyps (CRSwNP [nasal polyps]). 3 March 2025
Biotechnology
The Therapeutic Goods Administration (TGA) of Australia has declined the approval of Leqembi (lecanemab) as a treatment for early Alzheimer’s disease (AD). 3 March 2025
Biotechnology
New positive data from Stage 2 and Stage 3 of the National Institutes of Health (NIH)-sponsored Phase III OUtMATCH study, which provide further evidence supporting the role of Xolair (omalizumab) for the treatment of one or more food allergies, have been released by Swiss pharma giant Roche. 3 March 2025
Generics
Even as the spectre of tariffs looms over the pharmaceutical trade between India and the USA, presenting a complex scenario with potential repercussions for both regions, its implementation would necessitate a rapid recalibration of supply chains and pricing strategies, reports The Pharma Letter’s India correspondent. 3 March 2025
Biotechnology
The US Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation for Anktiva (nogapendekin alfa inbakicept-pmln) and CAR-NK (PD-L1 t-haNK) for the reversal of lymphopenia in patients receiving standard-of-care chemotherapy/radiotherapy and in multiply relapsed locally advanced or metastatic pancreatic cancer. 3 March 2025
Pharmaceutical
UK-based specialty drugmaker Kelso Pharma has appointed experienced pharma executive, Giovanni Mauri, as general manager at Velit Biopharma, the Italian-based pharma business that was acquired by Kelso in November 2023. 3 March 2025
Pharmaceutical
Among significant research news last week, US CNS specialist Axsome Therapeutics released new Phase III data on its recently US Food and Drug Administration (FDA)-approved migraine drug Symbravo, and the UK’s AstraZeneca announced positive Phase III trial results for its breast cancer candidate camizestrant. US biotech giant Amgen revealed it is pressing ahead with its $200 million investment in Indian technology center. US pharma major Eli Lilly attracted attention with its licensing deal for Organovo’s FXR program and announcing the release of new dosages and prices for its blockbuster obesity drug Zepbound. 2 March 2025
Pharmaceutical
Massachusetts, USA-based start-up Magnet Biomedicine, which is advancing molecular glue discovery with rational selection and design, has announced a collaboration and license agreement with pharma major Eli Lilly & Co to discover, develop, and commercialize molecular glue therapeutics in oncology. 1 March 2025
Biotechnology
The US President Donald Trump began his second term with a series of directives targeting the US National Institutes of Health (NIH), creating uncertainty around NIH grant funding for biopharmaceutical drug development. 1 March 2025
Pharmaceutical
The European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended three novel medicines for approval at its February 2025 meeting. The European Commission is expected to announce a final decision on approval in the coming months. 1 March 2025
Pharmaceutical
Medicare Part D spending for 10 selected diabetes drugs in the USA totaled $35.8 billion in 2023, an increase of 364% from 2019. 28 February 2025
Biotechnology
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved an mRNA respiratory syncytial virus (RSV) vaccine (brand name mRESVIA) to protect patients aged 60 and over against lower respiratory tract disease caused by RSV. 28 February 2025
Pharmaceutical
Japanese biopharma Nxera Pharma has announced two deals in a single day with partners that will commercialize its products in parts of Asia. 28 February 2025
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