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Shares of US biotech firm Kura Oncology slumped nearly 23% to $16.60 premarket today, after it announced that the US Food and Drug Administration has placed the KOMET-001 Phase Ib study of KO-539 in patients with relapsed or refractory acute myeloid leukemia (AML) on a partial clinical hold. 24 November 2021
Biotechnology
The European Commission (EC) has approved Brukinsa (zanubrutinib) for the treatment of adult patients with Waldenström’s macroglobulinemia (WM) who have received at least one prior therapy or for the first-line treatment of patients unsuitable for chemo-immunotherapy, says Chinese biotech BeiGene. 24 November 2021
Biotechnology
Japanese drugmaker Daiichi Sankyo today announced positive top-line results from the global pivotal QuANTUMFirst Phase III trial evaluating quizartinib, a highly potent and selective FLT3 inhibitor, in patients with newly diagnosed FLT3-ITD positive acute myeloid leukemia (AML). 19 November 2021
Biotechnology
Biotech start-up Ribonexus (previously called Aglaia Therapeutics) and fellow France-based drugmaker Pierre Fabre today announced an exclusive license agreement on a series of Pierre Fabre patented small molecules targeting the Eukaryotic translation initiation factor 4A (eIF4A). 18 November 2021
Pharmaceutical
Significant news last week including UK Pharma major GlaxoSmithKline releasing positive new data on its daprodustat as a new option for anemia in kidney disease. Deal-making developments featured Pfizer entering an agreement that could cost it up to $1.2 billion to gain certain rights to Biohaven Pharma’s migraine drug Nurtec. Also, Roche subsidiary Genentech inked a license and research collaboration with US start-up Novome Biotechnologies on inflammatory bowel disease (IBD). Meantime, Japan’s Kyowa Kirin gained a positive recommendation for its rare blood cancer drug Poteligeo from the UK’ health technology assessor the NICE. Additionally, health care giant Johnson & Johnson surprised markets, with the announcement that it is splitting out its Consumer Health business into a separate publicly-traded company. 14 November 2021
Biotechnology
The US Food and Drug Administration on Friday approved Besremi (ropeginterferon alfa-2b-njft) injection to treat adults with polycythemia vera, a blood disease that causes the overproduction of red blood cells. 13 November 2021
Biotechnology
The UK’s health technology assessor the National Institute for Health and Care Excellence (NICE) has published positive guidance, in the form of a Final Appraisal Determination (FAD), confirming that Poteligeo (mogamulizumab) is recommended as a treatment option for adults in England and Wales with the ultra-rare blood cancers mycosis fungoides (MF) and Sézary syndrome (SS), two forms of cutaneous T-cell lymphoma (CTCL). 12 November 2021
Biotechnology
Coming out of stealth, US developer of predictive precision medicines Notable Labs is acquiring worldwide development and commercial rights to volasertib, a PLK-1 inhibitor in acute myeloid leukemia (AML) from Oncoheroes, which gained rights to the investigational compound from Germany’s Boehringer Ingelheim in 2019. 11 November 2021
Biotechnology
Japanese pharma major Chugai Pharmaceutical says it has filed an application with the Ministry of Health, Labor and Welfare (MHLW) for approval of additional indication for the anti-coagulation factor IXa/X humanized bispecific monoclonal antibody/coagulation factor VIII substitute Hemlibra (emicizumab [genetical recombination]) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in people with acquired blood coagulation factor VIII deficiency. 11 November 2021
Biotechnology
UK-headquartered cancer immunotherapy company Autolus Therapeutics and Blackstone Life Sciences today announced that they have entered into a strategic collaboration and financing agreement. 8 November 2021
Biotechnology
Japanese drugmaker Ono Pharmaceutical has announced its South Korean subsidiary has received a marketing approval for Velexbru (tirabrutinib hydrochloride) tablet 80mg, a Bruton’s tyrosine kinase (BTK) inhibitor, from the Ministry of Food and Drug Safety (MFDS) in South Korea for the treatment of recurrent or refractory B-cell primary central nervous system lymphoma. 8 November 2021
Biotechnology
Cardiopulmonary diseases focussed US firm PhaseBio Pharmaceuticals saw its shares close down nearly 6% and fall a further 2.9% to $3.93 after-hours yesterday, despite positive mid-stage results for its bentracimab. 4 November 2021
Biotechnology
California’s Amgen has reported third-quarter financial results showing total revenues increased 4% to $6.71 billion, driven by higher demand. 3 November 2021
Pharmaceutical
Shares of Otsuka Holdings were up 2.8% at 4,620 yen today, as the Japanese drugmaker announced that its Dutch subsidiary has submitted an initial marketing authorization application (MAA) to the European Medicines Agency for vadadustat. 1 November 2021
Pharmaceutical
The US Food and Drug Administration has approved Scemblix (asciminib) for the treatment of chronic myeloid leukemia (CML) in two distinct indications. 1 November 2021
Biotechnology
The European Medicines Agency’s (EMA) safety committee (PRAC) is assessing further data on the risk of myocarditis and pericarditis following vaccination with mRNA COVID-19 vaccines. 29 October 2021
Biotechnology
US drugmaker AbbVie has announced better than expected financial results for the third quarter of 2021, pushing the firm’s shares up 2.9% to $112.60 before the opening bell this morning. 29 October 2021
Pharmaceutical
Shares in Rafael Holdings closed down 73% at $8.09 yesterday, after its majority-owned affiliate Rafael Pharmaceuticals revealed that a Phase III study of its leading candidate devimistat in first-line patients with pancreatic cancer failed to meet its primary endpoint of overall survival (OS). 29 October 2021
Biotechnology
Japan’s leading drugmaker Takeda Pharmaceutical today said it is exercising its option to acquire UK-based GammaDelta Therapeutics, an Abingworth portfolio company, focused on exploiting the unique properties of gamma delta (γδ) T cells for immunotherapy. 27 October 2021
Biotechnology
Rare diseases specialist Swedish Orphan Biovitrum, also known as Sobi, today posted financial results for the third quarter of 2021, with total revenue of 3,761 million Swedish kronor ($437 million), an increase of 27% compared with the same period a year ago and 29% at constant exchange rates (CER). 22 October 2021
Biotechnology
US healthcare giant Johnson & Johnson today revealed it has submitted applications with the US Food and drug Administration (FDA) and European Medicines Agency (EMA) to expand the approved indications for its Darzalex (daratumumab) subcutaneous (SC) formulation for the treatment of high-risk smouldering multiple myeloma (SMM). 8 November 2024
Biotechnology
UK health technology assessor the National Institute for Health and Care Excellence (NICE) issued final guidance recommending reimbursement of Ayvakyt (avapritinib) from USA-based Blueprint Medicines. 6 November 2024
Biotechnology
French drugmaker Sanofi has revealed the results from the Phase III LUNA 3 trial of rilzabrutinib, an oral bruton tyrosine kinase (BTK) inhibitor, in persistent or chronic immune thrombocytopenia (ITP). 6 November 2024
Biotechnology
Beam Therapeutics will detail new clinical and preclinical data on its sickle cell disease (SCD) therapies at the upcoming American Society of Hematology (ASH) meeting. 6 November 2024
Pharmaceutical
An impressive set of quarterly financial results and an improved outlook for the rest of the year were announced by Bristol Myers Squibb on Thursday. 31 October 2024
Biotechnology
Maryland, USA–based glycobiology specialist GlycoMimetics has entered into an acquisition agreement with Crescent Biopharma, a privately held biotechnology company advancing a pipeline of oncology therapeutics designed to treat solid tumors. 30 October 2024
Pharmaceutical
Novartis late yesterday revealed that Scemblix (asciminib) was granted accelerated approval by the US Food and Drug Administration (FDA) for adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP). 30 October 2024
Biotechnology
Last week Vertex Pharmaceuticals released positive Phase III results for its suzetrigine for moderate-to-severed pain. Belgium’s UCB revealed that Swiss pharma giant Roche was terminating its collaboration on the Alzheimer’s candidate bepranemab. The UK’s health technology assessor the Institute for Health and Clinical Excellence (NICE) declined to recommend a second Alzheimer’s treatment, this time Eli Lilly’s Kisunla. Also of note, Lyell Immunopharma announced its planned acquisition of ImmPACT Bio and reprioritization of its own clinical pipeline. 27 October 2024
Biotechnology
California, USA-based Lyell Immunopharma (Nasdaq: LYEL) has entered into a definitive agreement to acquire privately-held US CAR-T company ImmPACT Bio. 26 October 2024
Pharmaceutical
Sanofi reported 15.7% sales growth for the third quarter of the year, reaching 13.4 billion euros ($14.2 billion), with adjusted earnings per share (EPS) rising by 12.2% to 2.86 euros, surpassing many forecasts. 25 October 2024
Biotechnology
Johnson & Johnson has secured European approval for an expanded indication of Darzalex (daratumumab) in a subcutaneous formulation. 24 October 2024
Biotechnology
Swedish Orphan Biovitrum, the Nordic biotech company also known as Sobi, today announced significantly improved financial results for the third quarter of 2024, sending the firm’s shares up 2.5% to 333.60 kronor in early trading. 24 October 2024
Biotechnology
US clinical-stage biotech AvenCell Therapeutics announced that it has raised $112 million in Series B financing, which was led by global life sciences investor Novo Holdings. 23 October 2024
Pharmaceutical
Swiss pharma giant Roche this morning reported that, in the first nine months of 2024 group sales increased by 6% at CER (2% in francs) to 45.0 billion francs ($52.0 billion). 23 October 2024
Pharmaceutical
UK pharma major AstraZeneca’s Alexion Rare Disease unit has received a positive recommendation for Voydeya (danicopan), from the UK’s National Institute for Health and Care Excellence (NICE). 22 October 2024
Biotechnology
The European Medicines Agency’s (EMA) human health committee, CHMP, announced six positive opinions of novel medicines, as well as two biosimilars, following its October meeting. 18 October 2024
Biotechnology
The US Food and Drug Administration (FDA) on Friday approved US pharma giant Pfizer’s Hympavzi (marstacimab-hncq). 14 October 2024
Biotechnology
US healthcare giant Johnson & Johnson’s Tecvayli (teclistamab) has been recommended by the National Institute for Health and Care Excellence (NICE) as a first-line option to treat myeloma in England and Wales. 10 October 2024
Biotechnology
The US Food and Drug Administration (FDA) has granted the Gilead Sciences subsidiary Kite a Regenerative Medicine Advanced Therapy Designation (RMAT) for Yescarta (axicabtagene ciloleucel) for adults with newly-diagnosed, high-risk large B-cell lymphoma (LBCL). 3 October 2024
Pharmaceutical
AstraZeneca’s supplemental New Drug Application (sNDA) for Calquence (acalabrutinib) has been accepted and granted Priority Review in the USA for the treatment of adults with previously untreated mantle cell lymphoma (MCL). 3 October 2024
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