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Pharmaceutical
Rare diseases specialist Swedish Orphan Biovitrum saw its shares fall more than 3% to 204.40 kronor this morning after releasing third-quarter 2022 financial result. 27 October 2022
Pharmaceutical
Bristol Myers Squibb saw its sales drop by 3% during the third quarter of 2022. 26 October 2022
Biotechnology
The US Food and Drug Administration yesterday granted accelerated approval to Tecvayli (teclistamab-cqyv), the first bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager, for adult patients with relapsed or refractory multiple myeloma. 26 October 2022
Biosimilars
Following USA-based JSR Life Sciences’ launch of Similis Bio in May this year as a biosimilar partner, the new unit has signed its first development and license agreement, which is with Brazilian drugmaker Blau Farmacêutica. 25 October 2022
Biotechnology
Novartis saw its shares edge up 1% to 77.33 francs this morning, after the Swiss pharma giant released top-line clinical trial results showing the its hemoglobinuria treatment candidate iptacopan showed superiority over Alexion and AstraZeneca’s blockbuster drugs Soliris (eculizumab) and Ultomiris (ravulizumab), the current standard of care treatments for the condition. 24 October 2022
Biotechnology
Licensing and M&A deals featured in last week’s news. First up, MacroGenics signed a collaboration with US biotech major Gilead Sciences last Monday relating to its antibody MGD024 for indications including myeloid leukemia that could earn the company as much as $1.7 billion. Jazz Pharmaceuticals entered a deal with Zymeworks that could cost it over $1.7 billion for rights to the latter’s zanidatamab, an HER2-targeting antibody. Swiss pharma giant Roche signed a license agreement with Austria’s Hookipa Pharma for HB-7001, an arenaviral immunotherapy for KRAS-mutated cancers. Also, Eli Lilly on Tuesday announced it is acquiring US precision medicines company Akouos for up to $610 million, along with its hearing loss treatment candidate AK-OTOF. And AbbVie announced an agreement to acquire UK biotech DJS Antibodies for around $255 million 23 October 2022
Generics
Swiss pharma giant Novartis has entered into a voluntary licensing agreement for its chronic myeloid leukemia (CML) drug with the Medicines Patent Pool (MPP), agreeing to the production of generics in low-and-middle income countries. 20 October 2022
Biotechnology
Spanish plasma-derived medicines company Grifols ( today announced that its drug Tavlesse (fostamatinib) has a been recommended by UK health technology assessor the National Institute for Health and Care Excellence (NICE) to treat chronic immune thrombocytopenia (ITP) in adult patients refractory to other treatments. 19 October 2022
Pharmaceutical
Swiss pharma giant Roche today reported that third-quarter 2022 revenues fell 6% to 14.74 billion Swiss francs ($14.84 billion), below market expectations of about 15.5 billion francs. 18 October 2022
Pharmaceutical
Some of the most exciting medical breakthroughs in development have been picked out by the European Federation of Pharmaceutical Industries and Associations (EFPIA) as evidence of the sector’s progress. 17 October 2022
Biotechnology
Biotech major Gilead Sciences has entered an exclusive option and collaboration agreement with fellow USA-based Macrogenics to develop MGD024, an investigational, bispecific antibody that binds CD123 and CD3 using MacroGenics’ DART platform, and two additional bispecific research programs. 17 October 2022
Biotechnology
Among important research news last week, US pharma giant Merck & Co released positive Phase III results for the pulmonary arterial hypertension (PAH) candidate sotatercept, validating its $11.5 billion acquisition of Acceleron last year. Also, Sino-American biotech BeiGene announced new Phase III showing that its blood cancers drug Brukinsa scored superiority to Johnson & Johnson’s Imbruvica in chronic lymphocytic leukemia (CLL). After several delays, the US Food and Drug Administration (FDA) has at last approved scPharmaceuticals at-home heart failure treatment Furosix. Last week Merck & Co also excercised its option to jointly develop Moderna’s personalized cancer vaccine mRNA-4157. 17 October 2022
Biotechnology
Troubled Boston, USA-based rare disease specialist Imara saw its shares rise 4.4% yesterday and a further 17% to $3.01 pre-market today, after a planned merger with fellow USA-based Enliven Therapeutics was revealed. 14 October 2022
Biotechnology
Russia has been faced with a shortage of Oncaspar (pegaspargase), a drug from French independent pharma major Servier, which is designed for the treatment of leukemia in children. 14 October 2022
Biotechnology
Sino-American biotech BeiGene shot up on Wednesday, after the company's chronic lymphocytic leukemia (CLL) treatment was shown to beat out a blockbuster drug from Johnson & Johnson. 13 October 2022
Biotechnology
In a sign that special purpose acquisition company (SPAC) deals may be back in favor, Estrella Biopharma and TradeUP Acquisition Corp, a publicly-traded SPAC, have entered into a definitive business combination agreement that will result in Estrella becoming a publicly listed company. 10 October 2022
Biotechnology
Elranatamab, an investigational B-cell maturation antigen (BCMA) CD3-targeted bispecific antibody in development for the treatment of multiple myeloma (MM) by US pharma giant Pfizer, has been granted an ‘Innovation Passport’ from the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA). 28 September 2022
Pharmaceutical
There was a tepid market reaction to news that Japan’s Daiichi Sankyo had secured its first regulatory approval for Ezharmia (valemetostat tosilate), in a disease area where there is a severe lack of effective treatments. 26 September 2022
Biotechnology
US pharma giant Pfizer and biotech company Sangamo Therapeutics have re-opened recruitment for the AFFINE study. 26 September 2022
Pharmaceutical
As with any big pharma company, Swiss giant Novartis periodically holds events to inform shareholders and other interested parties on its updated strategy and optimism for future drug sales. 22 September 2022
Biotechnology
San Diego-based Kura Oncology and Japan’s Kyowa Kirin have entered into a global strategic collaboration to develop and commercialize ziftomenib. 21 November 2024
Biotechnology
The European Commission (EC) has granted marketing authorization for Hympavzi (marstacimab), from US pharma giant Pfizer. 20 November 2024
Pharmaceutical
Ascentage Pharma will see its investigational BCL-2 selective inhibitor, lisaftoclax, assessed under China’s Priority Review scheme. 20 November 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has approved Syndax Pharmaceuticals’ Revuforj (revumenib). 18 November 2024
Biotechnology
UK drugmaker GSK might be trading lower following Thursday’s nomination of vaccine sceptic Robert F Kennedy Jr as the USA’s next health secretary, but the day brought good news for the group elsewhere in the business. 15 November 2024
Biotechnology
Adaptimmune Therapeutics reported promising data Wednesday from its pivotal Phase II trial of lete-cel in certain solid tumors with few effective treatments. 14 November 2024
Biotechnology
Sanofi has announced that the UK's health technology assessor will conduct a new review of its Sarclisa (isatuximab) combo therapy for relapsed or refractory multiple myeloma. 13 November 2024
Biotechnology
Syndax Pharmaceuticals has announced that its Phase II AUGMENT-101 trial of experimental drug revumenib achieved its primary endpoint. 13 November 2024
Biotechnology
VarmX, a Dutch biotech developing innovative approaches for the bypass of direct oral anticoagulants targeting activated factor Xa (FXa DOACs) and inherited coagulation disorders, has appointed industry veteran John Glasspool (pictured, above) as chief executive. 12 November 2024
Biotechnology
On November 8, the US Food and Drug Administration approved Aucatzyl (obecabtagene autoleucel; obe-cel) from US biopharma Autolus Therapeutics' 11 November 2024
Biotechnology
Geron Corporation, a biopharma company focused on telomerase inhibition therapies, has announced a $375 million financing agreement aimed at supporting the commercial rollout of Rytelo (imetelstat). 11 November 2024
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
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