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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
Ascentage Pharma over the weekend announced a clinical collaboration with Acerta Pharma, the hematology R&D subsidiary of UK pharma major AstraZeneca. 22 June 2020
Biotechnology
Miami, USA-based Ridgeback Biotherapeutics has initiated two Phase II clinical trials to test the efficacy of EIDD-2801 as an anti-viral treatment for COVID-19. 22 June 2020
Biotechnology
The US Food and Drug Administration will convene a meeting of the Oncologic Drugs Advisory Committee (ODAC) to review data supporting the Biologics License Application (BLA) for belantamab mafodotin on July 14. 20 June 2020
Biotechnology
The US Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Tazverik (tazemetostat) in two follicular lymphoma (FL) indications. 19 June 2020
Biotechnology
China’s National Medical Products Administration (NMPA) has approved Dupixent (dupilumab) for moderate-to-severe atopic dermatitis in adults whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. 19 June 2020
Biotechnology
Mixed results for Swiss pharma giant Roche show the Phase III IPATential150 study met one of its co-primary endpoints, while missing the other. 19 June 2020
Biotechnology
The US Food and Drug Administration has approved Crysvita (burosumab-twza) injection to treat patients age two and older with tumor-induced osteomalacia (TIO), a rare disease that is characterized by the development of tumors that cause weakened and softened bones. 19 June 2020
Biotechnology
Two subsidiaries of Japan’s Sumitomo Dainippon Pharma, Urovant Sciences and Sunovion Pharmaceuticals, have teamed up to work on the launch of vibregon. 19 June 2020
Biotechnology
Seattle, USA-based biotech Alpine Immune Sciences saw its shares rocket 170% pre-market after announcing its biggest deal yet, with AbbVie, for an exclusive worldwide option and license agreement for ALPN-101, a first-in-class dual CD28/ICOS co-stimulation antagonist. 18 June 2020
Biotechnology
Chicago-based AbbVie has released positive data from the Phase III MEASURE UP 1 study of Rinvoq (upadacitinib) in moderate to severe atopic dermatitis. 18 June 2020
Biotechnology
The marketing authorization application (MAA) for Brukinsa (zanubrutinib) to treat Waldenström’s macroglobulinemia (WM) patients who have received at least one prior therapy or as first-line treatment for those unsuitable for chemo-immunotherapy has been validated for regulatory review by the European Medicines Agency (EMA). 18 June 2020
Biotechnology
UK respiratory disease focussed biotech firm Synairgen has announced the expansion of the placebo-controlled home setting clinical trial of SNG001 (inhaled formulation of interferon-beta-1a) in patients with COVID-19. 18 June 2020
Biotechnology
Swiss pharma giant Roche has announced positive results from the Phase III IMpassion031 study, evaluating Tecentriq (atezolizumab) plus chemo in triple-negative breast cancer (TNBC). 18 June 2020
Biotechnology
TG Therapeutics has announced the completion of the rolling submission of a New Drug Application (NDA) to the US Food and Drug Administration requesting accelerated approval for umbralisib as a treatment for patients with previously-treated marginal zone lymphoma (MZL) and follicular lymphoma (FL). 18 June 2020
Biotechnology
Californian company Ideaya Biosciences has agreed a strategic partnership with UK pharma major GlaxoSmithKline in synthetic lethality, an emerging field in oncology. 17 June 2020
Biotechnology
US clinical-stage immunotherapy firm PDS Biotechnology saw its shares soar 12% pre-market today, after announcing a co-development agreement with Brazil-based Farmacore Biotechnology for Versamune CoV-2FC, a Versamune -based vaccine aimed at preventing COVID-19 infection. 17 June 2020
Biotechnology
Latest research findings show Emgality (galcanezumab-gnlm), which received regulatory approval in the USA and Europe in 2018, reduces total pain burden in a recent analysis of patients with episodic and chronic migraine. 17 June 2020
Biotechnology
The US Food and Drug Administration granted accelerated approval for an additional indication for Keytruda (pembrolizumab), Merck & Co’s best-selling drug with 2019 sales of $11.08 billion, and already approved for a number of cancer indications. 17 June 2020
Biotechnology
Cosentyx (secukinumab), the only fully-human biologic directly targeting IL-17A, has picked up a new approval for a fourth indication in the USA. 17 June 2020
Biotechnology
Eli Lilly yesterday announced that Verzenio (abemaciclib) in combination with standard adjuvant endocrine therapy (ET) has met the primary endpoint of invasive disease-free survival (IDFS), significantly decreasing the risk of breast cancer recurrence or death compared to standard adjuvant ET alone. 17 June 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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