Latest Pharma and Biotech News
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
All news
Biotechnology
Announcing a second collaboration this month, Hong Kong-based Innovent Biologics said yesterday that it has entered into a licensing agreement with Eli Lilly for the development and potential commercialization of oxyntomodulin analog, OXM3, in China, adding to its cooperation with the US pharma major in oncology started in 2015. 22 August 2019
Biotechnology
The US Food and Drug Administration has accepted the New Drug Application (NDA) for zanubrutinib for priority review for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. 22 August 2019
Biotechnology
Eiger BioPharmaceuticals says that the US Food and Drug Administration has granted Breakthrough Therapy designation for peginterferon lambda (Lambda) for the treatment of hepatitis delta virus (HDV) infection. 22 August 2019
Biotechnology
Any questions about how committed Pfizer is to gene therapies were answered on Wednesday. 21 August 2019
Biotechnology
Privately-held biotech Enteris BioPharma has granted to Cara Therapeutics a non-exclusive, royalty-bearing license to Peptelligence technology to develop, manufacture and commercialize oral Korsuva (CR845/difelikefalin) worldwide, excluding Japan and South Korea. 21 August 2019
Biotechnology
Final overall survival (OS) results from the Phase III NEPTUNE trial, a randomized, open-label, multicenter, global trial of Imfinzi (durvalumab) in combination with tremelimumab, an anti-CTLA4 antibody, versus standard-of-care (SoC) platinum-based chemotherapy in previously-untreated Stage IV (metastatic) non-small cell lung cancer (NSCLC) patients once again failed to sow benefit for the combination treatment. 21 August 2019
Biotechnology
Since its European approval in April 2019, Pfizer’s Vizimpro (dacomitinib) has been available for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR)-activating mutations. 21 August 2019
Biotechnology
There was nice news for US biopharma major AbbVie today, as the UK health technology appraiser issued a positive guidance for its Skyrizi (risankizumab). 21 August 2019
Biotechnology
US clinical-stage drug developer Synlogic’s shares plummeted on Tuesday after it said it is discontinuing development of SYNB1020, an early stage clinical product candidate for the treatment of hyperammonemia. 21 August 2019
Biotechnology
The US Food and Drug Administration (FDA) has accepted Vertex Pharmaceuticals’ New Drug Application (NDA) for a triple therapy combination in cystic fibrosis (CF), and granted priority review to the submission. 20 August 2019
Biotechnology
Under a license agreement announced today, Sweden’s Alligator Biosciences has granted Biotheus rights in Greater China (including Republic of China, Hong Kong, Taiwan and Macau) to an antibody from ALLIGATOR-GOLD for the creation of up to three bispecific molecules. 20 August 2019
Biotechnology
The US Food and Drug Administration has seen enough from PharmaMar to accept a filing for an accelerated approval for lurbinectedin monotherapy as a treatment second-line small cell lung cancer. 20 August 2019
Biotechnology
Clinical-stage US biotech Provention Bio today announced the appointment of Sherron Kell as senior vice president of clinical development. 20 August 2019
Biotechnology
Swedish biotech Oncopeptides has poached AstraZeneca's Klaas Bakker to replace Johan Harmenberg as its new chief medical officer. 20 August 2019
Biotechnology
Sarepta Therapeutics revealed that it has received a Complete Response Letter (CRL) from the US Food and Drug Administration regarding the New Drug Application (NDA) for Vyondys 53 (golodirsen) injection for the treatment of Duchenne muscular dystrophy (DMD) in patients with a confirmed mutation amenable to exon 53 skipping. 20 August 2019
Biotechnology
The inclusion and wording of a black box warning for thrombosis and embolism risk in the label for upadacitinib are now likely to be applied across all JAK inhibitors used for autoimmune diseases, according to SVB Leerink Research analyst Pasha Sarraf, referring to last Friday’s approval of AbbVie’s Rinvoq (upadacitinib) by the US Food and Drug Administration. 20 August 2019
Biotechnology
Canada-headquartered Generex Biotechnology saw its shares rise 3.9% to $2.13 by mid-morning today, after it said that it has acquired an additional 38% of Olaregen Therapeutix for a total Generex ownership of approximately 99% after the share exchange at $2.50 a share for GNBT stock, in a cashless transaction. 18 August 2019
Biotechnology
Discovered and developed by AbbVie Rinvoq (upadacitinib) marks the second US Food and Drug Administration approval of a targeted immunomodulator (TIM) therapy for the company this year. 17 August 2019
Biotechnology
Celgene Corp today announced the US Food and Drug Administration has approved Inrebic (fedratinib) for the treatment of adult patients with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis. 16 August 2019
Biotechnology
The Institute for Clinical and Economic Review (ICER) could scarcely have been more damning of two companies behind treatments for Duchenne muscular dystrophy (DMD), the most common fatal genetic disease diagnosed in childhood. 16 August 2019
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