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27 November 2024 The strain of opioid use disorder (OUD), a chronic neurological disorder characterized by the compulsive, repeated use of opioid drugs, has weighed heavily on many countries in recent years, especially the USA.
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Biotechnology
Proteostasis Therapeutics has entered into a definitive merger agreement with US neuroscience-focused start-up Yumanity Therapeutics. 24 August 2020
Biotechnology
German pharma major Bayer has strengthened its ties with the USA-based digital health platform Informed Data Systems. 24 August 2020
Biotechnology
Bristol Myers Squibb has entered into a definitive agreement to acquire Forbius, a privately held, clinical-stage protein engineering company that designs and develops biotherapeutics for the treatment of cancer and fibrotic diseases. 24 August 2020
Biotechnology
The Phase III COMBI-i study evaluating the immunotherapy spartalizumab (PDR001), in combination with the targeted therapies Tafinlar (dabrafenib) and Mekinist (trametinib), did not meet its primary endpoint of investigator-assessed progression-free survival. 22 August 2020
Biotechnology
US biotech major Gilead Sciences and co-developer Belgium-based Galapagos received a big shock following the Food and Drug Administration’s complete response letter (CRL) for its rheumatoid arthritis (RA) candidate filgotinib earlier this week. 21 August 2020
Biotechnology
The European Commission has approved Kaftrio (ivacaftor/tezacaftor/elexacaftor) in a combination regimen with ivacaftor for cystic fibrosis (CF) patients aged 12 and older with one F508del mutation and one minimal function mutation (F/MF), or two F508del mutations (F/F) in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. 21 August 2020
Biotechnology
Japan’s Ono Pharmaceutical has received a supplemental approval for Velexbru (tirabrutinib) tablet 80mg, a Bruton’s tyrosine kinase (BTK) inhibitor, in Japan for additional indication of Waldenstrom macroglobulinemia and lymphoplasmacytic lymphoma, for a partial change in approved items of the manufacturing and marketing approval. 21 August 2020
Biotechnology
Shares in German company BioNTech and US pharma giant Pfizer are both set to open Friday’s training with significant gains after the latest update on their COVID-19 vaccine. 21 August 2020
Biotechnology
The US Food and Drug Administration has approved Kesimpta (ofatumumab, formerly OMB157) as an injection for subcutaneous use for the treatment of relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. 21 August 2020
Biotechnology
The US Food and Drug Administration has approved the expansion of the Kyprolis (carfilzomib) US prescribing information to include its use in combination with Darzalex (daratumumab) plus dexamethasone (DKd) in two dosing regimens — once weekly and twice weekly — for the treatment of patients with relapsed or refractory multiple myeloma (R/R MM) who have received one to three previous lines of therapy. 21 August 2020
Biotechnology
UK pharma major AstraZeneca has secured approval in Japan for Imfinzi (durvalumab) as a treatment for extensive-stage small cell lung cancer (ES-SCLC). 21 August 2020
Biotechnology
Tokyo’s Chugai Pharmaceutical has secured a label update for Kadcyla (trastuzumab) from the Japanese Ministry of Health, Labour and Welfare. 21 August 2020
Biotechnology
Clinical-stage German biotech CureVac saw its shares rise 16% on Thursday and a further 6% to $70.00 pre-market today after it was revealed that the company had concluded exploratory talks with the European Commission with respect to the purchase of its investigational vaccine against COVID-19. 21 August 2020
Biotechnology
India’s Stempeutics Research has received regulatory approval by the Drug Controller General of India (DCGI) for the launch of Stempeucel in India, which will be achieved under a partnership with generics major Cipla. 20 August 2020
Biotechnology
Teva Pharmaceutical Industries today announced the availability in Canada of Ajovy (fremanezumab) 225mg solution for subcutaneous injection for the preventive treatment of migraine in adults who have at least four migraine days per month. 20 August 2020
Biotechnology
Germany-based biotech Evotec and Centogene today announced that they have expanded their existing drug discovery partnership related to the protein target glucocerebrosidase (GBA) with a focus on Gaucher disease, a genetic and relatively common lysosomal storage disorder. 20 August 2020
Biotechnology
US biotech Regeneron Pharmaceuticals has enlisted the help if Swiss pharma giant Roche to develop, manufacture and distribute REGN-COV2, Regeneron’s investigational antiviral antibody combination. 19 August 2020
Biotechnology
US biotech BioMarin Pharmaceutical opened 30% lower on Wednesday after a major setback. 19 August 2020
Biotechnology
Switzerland-based Myovant Sciences (NYSE: MYOV) says that its New Drug Application (NDA) for once-daily, oral relugolix combination tablet (relugolix 40mg, estradiol 1.0mg, and norethindrone acetate 0.5mg) for the treatment of women with heavy menstrual bleeding associated with uterine fibroids has been accepted for review by the US Food and Drug Administration. 19 August 2020
Biotechnology
Shares of US biotech Momenta Pharmaceuticals raced up 70% to $52.44 in pre-market trading this morning, after it was revealed that it had agree to be acquired by healthcare giant Johnson & Johnson. 19 August 2020
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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 BeOne Medicines, formerly 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
Biotechnology
Clinical-stage US CAR-T therapies developer Poseida Therapeutics saw its shares skyrocket 227% to $9.36 pre-market today, on the news of a proposed takeover by Swiss pharma giant Roche. 26 November 2024
Biotechnology
Replimune, a clinical-stage biotech focused on oncolytic immunotherapies, has announced plans to raise $125 million through a public offering. 26 November 2024
Biotechnology
Chinese gene therapy firm Kanglin Biotechnology has completed a $20 million series A financing round, with the money earmarked for KL003, an innovative treatment for blood disorders. 26 November 2024
Biotechnology
BRL Medicine, a Shanghai-based biotechnology company specializing in cell and gene therapies, has raised nearly 200 million yuan ($27 million) in a series B+ round led by CSPC Fund. 26 November 2024
Biotechnology
Italian oncology focused biotech Nerviano Medical Sciences yesterday announced that it has successfully negotiated with Germany’s Merck KGaA to buy back the full world-wide rights of NMS 293 (also known as NMS-03305293). 26 November 2024
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