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
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
Biotechnology
US clinical stage biotech Alector saw its shares tumble 35% to $2.57 by close of trading yesterday, as it announced disappointing results from the INVOKE-2 Phase II clinical trial evaluating the safety and efficacy of AL002 in slowing disease progression in individuals with early Alzheimer’s disease (AD). 27 November 2024
Biotechnology
PTC Therapeutics has announced that its Phase II trial for utreloxastat, aimed at treating amyotrophic lateral sclerosis (ALS), failed to meet its primary endpoint. 27 November 2024
Biotechnology
US companies Arrowhead Pharmaceuticals and Sarepta Therapeutics have announced a global licensing and collaboration agreement. 26 November 2024
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Biotechnology
US immuno-oncology company OncoSec Medical Incorporated has snubbed an attempted takeover by Korea’s Alpha Holdings. 17 January 2020
Biotechnology
The BioMarin hemophilia A gene therapy Valrox (valoctocogene roxaparvovec) could become the world’s priciest drug, it is being reported. 17 January 2020
Biotechnology
A coveted Rare Pediatric Disease (RPD) designation has been issued to Fortress Biotech’s partner for its investigational Menkes disease candidate CUTX-101. 17 January 2020
Biotechnology
China-based WuXi Biologics is to take over the operations of one of Bayer's final drug product manufacturing plants. 16 January 2020
Biotechnology
German immunotherapeutics specialist BioNTech has entered into a definitive merger agreement to acquire USA-based Neon Therapeutics in an all-stock transaction valued at around $67.0 million 16 January 2020
Biotechnology
Chinese biotech start-up Antengene recently hired two former high-profile managers from its funding partner Celgene, now a Bristol-Myers Squibb (NYSE: BMY) company. In a recent meeting in Shanghai, where Antengene is based, founder and chief executive Jay Mei spoke with The Pharma Letter about the hires and his vision for his company. 16 January 2020
Biotechnology
Having just announced the first launch of its new gene therapy Zynteglo (autologous CD34+ cells encoding βA-T87Q-globin gene), in Germany, US gene therapy company bluebird bio has appointed former Celgene executive Nicola Heffron to head up its European operations, based in Zug, Switzerland. 16 January 2020
Biotechnology
A document from the National Institute for Health and Care Excellent (NICE) has not recommended Keytruda (pembrolizumab) for untreated metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) in adults whose tumors express PD-L1 with a combined positive score of one or more. 15 January 2020
Biotechnology
US drugmaker AbbVie’s Skyrizi (risankizumab) has met both primary and all ranked secondary endpoints, including superiority at week 52, in a comparison with Cosentyx (secukinumab) in moderate to severe plaque psoriasis. 15 January 2020
Biotechnology
The US Food and Drug Administration (FDA) has issued an alert over the results from a clinical trial showing a possible increased risk of cancer with the weight management drug Belviq/Belviq XR (lorcaserin). 15 January 2020
Biotechnology
Dermavant Sciences, a dermatology-focused subsidiary of Switzerland-based Roivant Sciences, has entered into a collaboration and license agreement with Japan Tobacco for exclusive rights to develop, register and market tapinarof in Japan for the treatment of dermatological diseases and conditions, including psoriasis and atopic dermatitis.
Along with 15 January 2020
Biotechnology
When Dr Edward Squibb rented space in a Brooklyn brownstone in 1858, nobody could have predicted what his new pharma venture would evolve into. 15 January 2020
Biotechnology
Tuesday’s meeting of the Food and Drug Administration's (FDA's) Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) and Drug Safety and Risk Management Advisory Committee (DSaRM) to discuss the New Drug Application (NDA) for oxycodegol (formerly NKTR-181) did not recommend approval of oxycodegol, by a vote of 27 to 0. 15 January 2020
Biotechnology
Crysvita (burosumab) co-developers Ultragenyx and Kyowa Kirin have submitted to the US regulator for an expanded label. 15 January 2020
Biotechnology
US biotech firm Celgene, now a subsidiary of Bristol-Myers Squibb, plans to pursue a New Drug Application (NDA) in first-quarter 2020 for its formulation of oral azacitidine (CC-486) after data from the Phase III QUAZAR AML-001 trial showed that maintenance therapy can prolong the overall survival (OS) of acute myeloid leukemia (AML) patients compared with placebo 15 January 2020
Biotechnology
An Expert View column on the need for bosses in the life sciences to understand financing trends from David Diamond, managing director of CBIZ MHM, an accounting and
professional services provider, 14 January 2020
Biotechnology
French oncology-focussed Innate Pharma late yesterday announced that the French National Agency for Medicines and Health Product Safety (ANSM) has agreed that the lacutamab (IPH4102) TELLOMAK Phase II trial can resume recruitment of new patients with relapsed/refractory Sézary syndrome and mycosis fungoides (MF) who have received at least two lines of prior systemic therapy. 14 January 2020
Biotechnology
T-cell therapy company Adaptimmune Therapeutics saw its shares close up 200% at $3.99 on Monday, having rocketed nearly 300%, on encouraging research results and the news that it has entered into a co-development and co-commercialization agreement with Japanese pharma major Astellas Pharma to bring new stem-cell derived allogeneic T-cell therapies to people with cancer that could be worth nearly $900 million. 14 January 2020
Biotechnology
Swiss pharma giant Novartis has announced a deal with the National Health Service (NHS) that will bring English patients with atherosclerotic cardiovascular disease (ASCVD) access to inclisiran. 14 January 2020
Biotechnology
UK-based drugmaker EUSA Pharma and China’s BeiGene have entered into an exclusive development and commercialization agreement for the orphan biologic products Sylvant (siltuximab) and Qarziba (dinutuximab beta). 13 January 2020
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