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Biotechnology
28 November 2024 Johnson & Johnson has made significant strides in multiple myeloma treatment, with breakthroughs in targeted therapies like CAR-T and bispecific antibodies. At the 2024 ASH meeting, J&J aims to showcase progress, with a goal of achieving a functional cure for multiple myeloma.
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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
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
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
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
Biotechnology
The UK subsidiary of Dutch drugmaker argenx confirmed today that its investigational therapy, subcutaneous efgartigimod alfa has been granted Promising Innovative Medicine (PIM) designation by the UK Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of adults with chronic inflammatory demyelinating polyneuropathy (CIDP). 28 November 2024
Biotechnology
Privately-held French drugmaker Servier has announced the inauguration of its first unit dedicated to the production of biological medicines from its R&D pipeline. 28 November 2024
Biotechnology
The US Food and Drug Administration has received new reports of hematologic malignancies, including life-threatening cases of myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML), following treatment of early, active cerebral adrenoleukodystrophy (CALD) patients with Skysona (elivaldogene autotemcel). 28 November 2024
Biotechnology
San Diago, USA-based Acadia Pharmaceuticals yesterday announced it has entered into an exclusive worldwide license agreement with Denmark’s Saniona for the development and commercialization of SAN711, a first-in-class, highly selective GABAA-α3 positive allosteric modulator. 28 November 2024
Biotechnology
Kronos Bio, a biotech with a presence on the east and west coasts of the USA, has unveiled a major restructuring plan. 28 November 2024
Biotechnology
Johnson & Johnson has made significant strides in multiple myeloma treatment, with breakthroughs in targeted therapies like CAR-T and bispecific antibodies. At the 2024 ASH meeting, J&J aims to showcase progress, with a goal of achieving a functional cure for multiple myeloma. 28 November 2024
Biotechnology
The European medicines regulator has approved a combo therapy starring PD-1 inhibitor Tevimbra (tislelizumab), from cancer firm BeiGene. 27 November 2024
Biotechnology
After trading closed yesterday, Exelixis revealed that the US Food and Drug Administration (FDA) has notified the company that the supplemental New Drug Application (sNDA) for cabozantinib (Cabometyx) for the treatment of adults with previously treated advanced pancreatic neuroendocrine tumors (pNET) and advanced extra-pancreatic NET (epNET) will be discussed at an Oncologic Drugs Advisory Committee (ODAC) meeting in March 2025. 27 November 2024
Biotechnology
Chengdu-based Kelun-Biotech has received marketing authorization in China for sacituzumab tirumotecan (sac-TMT), a Trop2-directed antibody-drug conjugate (ADC). 27 November 2024
Biotechnology
AI-powered protein engineering company Cradle has raised $73 million in a Series B funding. The European firm, which has now raised more than $100 million in total, calls itself the leading platform for AI-powered protein engineering. 27 November 2024
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Biotechnology
Heron Therapeutics has resubmitted its New Drug Application (NDA) to the US Food and Drug Administration for HTX-011, an investigational agent for the management of postoperative pain. 1 October 2019
Biotechnology
Canada’s ImmunoPrecise Antibodies, a provider of best-in-class therapeutic antibody discovery capabilities for the global industry, today announced the appointment of industry professional Dr Stefan Lang as chief business officer (CBO). 1 October 2019
Biotechnology
Stockholm’s Calliditas Therapeutics has moved one step closer to securing European Medicines Agency (EMA) approval for its lead compound nefecon, the firm said in a statement on Monday. 1 October 2019
Biotechnology
US biotech major Biogen today announced an update to its senior leadership team. 1 October 2019
Biotechnology
Switzerland-based biotech firm Numab Therapeutics and Japan’s Eisai have initiated a partnership, under a research and option agreement, to discover and develop novel multi-specific antibody immunotherapies for cancer, using Numab’s proprietary MATCH platform. 1 October 2019
Biotechnology
Independent French company Servier has acquired Pixuvri (pixantrone), a drug approved in the European Union as monotherapy for multiply relapsed or refractory aggressive non-Hodgkin B-cell lymphoma, from USA-based CTI BioPharma. 1 October 2019
Biotechnology
The Institute for Clinical and Economic Review (ICER) has posted a draft scoping document on its planned review of the cost-effectiveness offered by Vertex Pharmaceuticals’ (Nasdaq: VRTX) cystic fibrosis (CF) drugs in the USA. 1 October 2019
Biotechnology
South Korean company Celltrion, which is best known as a biosimilars manufacturer, is about to launch its first innovative product in the USA. 1 October 2019
Biotechnology
Sweden’s Moberg Pharma has entered into a license agreement granting Japan’s Taisho Pharmaceutical exclusive Japanese rights to MOB-015, a new topical treatment of onychomycosis based on Moberg's patented proprietary formulation of terbinafine. 1 October 2019
Biotechnology
Analysts and crystal ball gazers in pharma love nothing more than a battle for dominance in a major market. 30 September 2019
Biotechnology
Swiss pharma giant Roche has officially announced localization of two of its innovative drugs in Russia at the facilities of its local partners, reports The Pharma Letter’s local correspondent. 30 September 2019
Biotechnology
Positive top-line results from a second Phase III pivotal study evaluating the efficacy and safety of its investigational oral Janus kinase 1 (JAK1) inhibitor, abrocitinib, in patients aged 12 and older with moderate to severe atopic dermatitis (AD), were released on Friday by US pharma giant Pfizer. 30 September 2019
Biotechnology
Hutchison China MediTech, also known as Chi-Med, has presented the results of the Phase III study of surufatinib in advanced neuroendocrine tumors – extra-pancreatic (SANET-ep) at the 2019 ESMO congress, which met the pre-defined primary endpoint of progression free survival (PFS) early. 30 September 2019
Biotechnology
The US Food and Drug Administration has approved Rituxan (rituximab), in combination with glucocorticoids, for the treatment of granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) in pediatric patients two years of age and older. 28 September 2019
Biotechnology
US biotech G1 Therapeutics has presented preliminary overall survival (OS) data from its Phase II trial of trilaciclib in combination with chemotherapy for the treatment of metastatic triple-negative breast cancer. 28 September 2019
Biotechnology
AbbVie’s Mavyret (glecaprevir/pibrentasvir) tablets have received a further approval from the US Food and Drug Administration (FDA). 27 September 2019
Biotechnology
Californian biotech XOMA Corporation has acquired a royalty interest in six clinical-stage assets targeting the adenosine pathway for $10 million from privately-held Spanish firm Palobiofarma. 27 September 2019
Biotechnology
German pharma and sciences firm Merck KGaA says that Erbitux (cetuximab) has been granted approval by China’s National Medical Products Administration (NMPA) for the first-line treatment for patients with RAS wild-type (wt) metastatic colorectal cancer (mCRC) in combination with FOLFOX or FOLFIRI, or in combination with irinotecan in patients who are refractory to irinotecan-based chemotherapy. 27 September 2019
Biotechnology
Following the publication of new Phase II data for Japanese pharma major Takeda’s TAK-620 (maribavir) as a treatment for cytomegalovirus (CMV) infections in recipients of hematopoietic cell or solid organ transplant, GlobalData’s senior pharma analyst Paul Jeng has offered his perspective on the candidate. 27 September 2019
Biotechnology
The UK government-backed Cell and Gene Therapy Catapult (CGT Catapult) has announced that its chief executive, Keith Thompson, is to retire from April 2020. 26 September 2019
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