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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
Roche’s long-delayed $4.3 billion acquisition of Spark Therapeutics, announced in February, moved a step forward to completion, with the news that it has been cleared by the UK’s regulator, though in the USA approval is still awaited,
. 16 December 2019
Biotechnology
A US jury has ordered the Gilead Sciences subsidiary Kite Pharma to pay a total of $752 million to Juno Therapeutics – which has now become part of Bristol-Myers Squibb – and the Memorial Sloan Kettering Cancer Center (MSKCC). 16 December 2019
Biotechnology
There are currently no approved treatments for the increasingly prevalent liver disease non-alcoholic steatohepatitis (NASH), but this looks highly likely to change within the next year. 16 December 2019
Biotechnology
Rare and rheumatic disease specialist Horizon Therapeutics has been boosted by a unanimous vote from a key FDA advisory panel in favor of its ophthalmic candidate teprotumumab. 16 December 2019
Biotechnology
US biotech major Biogen today announced disappointing top-line results from the Phase II PASSPORT study of gosuranemab (BIIB092) for progressive supranuclear palsy (PSP). 13 December 2019
Biotechnology
French oncology-focused biotech company Innate Pharma was down more than 5% during Friday afternoon’s trading after the firm provided an update on its TELLOMAK Phase II trial on lacutamab. 13 December 2019
Biotechnology
The US Food and Drug Administration has granted accelerated approval for its Vyondys 53 (golodirsen) injection to treat Duchenne muscular dystrophy (DMD) patients who have a confirmed mutation of the dystrophin gene that is amenable to exon 53 skipping. 13 December 2019
Biotechnology
Swiss pharma giant Roche has announced positive results from the Phase III IMspire150 study of Tecentriq (atezolizumab). 13 December 2019
Biotechnology
French cancer immunotherapies biotech Transgene announced after European markets closed on Thursday that the primary endpoint (overall response rate) of the Phase II trial evaluating its TG4010 in combination with chemotherapy and Opdivo (nivolumab) was not reached. 13 December 2019
Biotechnology
Switzerland-based biotech Numab have formed a partnership focusing on the development and commercialization of a portfolio of novel multi-specific antibodies for the therapy of cancer based on Numab’s technology platform with 3Sbio subsidiary Sunshine Guojian Pharmaceutical. 12 December 2019
Biotechnology
Danish dermatology specialist LEO Pharma says that tralokinumab – an investigational, fully-human monoclonal antibody that specifically neutralizes the interleukin-13 (IL-13) cytokine – met all primary and secondary endpoints in its three pivotal Phase III studies (ECZTRA 1-3) for the treatment of moderate-to-severe atopic dermatitis (AD) in adults. During the studies, the overall adverse event rate was comparable between tralokinumab and placebo. 12 December 2019
Biotechnology
French start-up GoLiver Therapeutics has signed an agreement with Paul-Brousse Hospital, a specialist center for hepatobiliary diseases in Paris that has already conducted clinical trials of innovative therapies for the liver. 12 December 2019
Biotechnology
California’s Amgen and Belgian biotech UCB have won approval in Europe for Evenity (romosozumab), as an option for severe osteoporosis in postmenopausal women at high risk of fracture. 12 December 2019
Biotechnology
Ireland-incorporated superbug specialist Iterum Therapeutics has announced disappointing top-line results from the pivotal SURE 3 study of the novel antibiotic sulopenem. 12 December 2019
Biotechnology
Gilead Science subsidiary Kite has submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for the investigational chimeric antigen receptor (CAR) T cell therapy, KTE-X19, for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL). 12 December 2019
Biotechnology
Ireland-incorporated biotech Alkermes saw its shares down almost 3% at $20.93 yesterday after it received a sharp rebuke from the US regulator over advertising of its opioid dependence drug. 12 December 2019
Biotechnology
Privately-held US biotech NeoImmuneTech has joined the club of companies testing their therapeutic alongside Merck & Co’s blockbuster immuno-oncology drug Keytruda (pembrolizumab). 11 December 2019
Biotechnology
Japanese drugmaker Kyowa Kirin says that Crysvita (burosumab) was launched in Japan on December 6, 2019. 11 December 2019
Biotechnology
US drugmaker Vertex Pharmaceuticals has announced that the European Commission has granted a label extension for Kalydeco (ivacaftor) to allow treatment of certain cystic fibrosis (CF) patients aged from six to 12 months. 11 December 2019
Biotechnology
The US Food and Drug Administration has accepted the supplemental Biologics License Application (sBLA) for Xolair (omalizumab) for the treatment of nasal polyps in adult patients 18 years of age and older with inadequate response to intranasal corticosteroids. 11 December 2019
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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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