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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
Biotechnology
Swedish Orphan Biovitrum, also known as Sobi, has reached an agreement to acquire CTI BioPharma, a US biopharma company focused on blood related cancers and rare diseases, by means of a tender offer. 10 May 2023
Biotechnology
US healthcare giant Johnson & Johnson’s Janssen Biotech subsidiary has entered into a worldwide collaboration and license agreement with China-based Cellular Biomedicine Group to develop, manufacture and commercialize next-generation chimeric antigen receptor (CAR) T-cell therapies for the treatment of B-cell malignancies. 2 May 2023
Generics
Two Indian pharma companies have reached a mutual settlement with Bristol Myers Squibb in connection with a patent dispute over BMS' oral anticoagulant drug apixaban, even as the Delhi High Court has dismissed BMS' another request for an injunction against Zee Laboratories. 2 May 2023
Pharmaceutical
The European medicines Agency’s (EMA) human medicines committee (CHMP) recommended six novel medicines for approval at its April 2023 meeting. 28 April 2023
Biotechnology
Californian biopharmaceutical firm Amgen as reported a 2% drop in revenues in the first quarter, to $6.1 billion, a reflection of falling sales from COVID-19 therapeutics. 28 April 2023
Pharmaceutical
Swedish Orphan Biovitrum, also known as Sobi, today released financial results for the first quarter of 2023, showing that total revenues were up 6% year-on-year at 5,239 million Swedish kronor ($508.6 million), but down 2% at constant exchange rates (CER). 27 April 2023
Biotechnology
In a first, more adult patients living with certain forms of blood cancer will now be able to access CAR T-cell therapy on the UK’s National Health Service (NHS). 27 April 2023
Biotechnology
With another set of strong data under its belt, Swiss pharma giant Novartis is now looking to filing regulatory applications for its investigational oral monotherapy iptacopan. 26 April 2023
Pharmaceutical
Swiss pharma giant Roche says that, in the first three months of 2023, group sales declined by 3% (-7% in Swiss franc term) to 15.3 billion francs ($17.2 billion). 26 April 2023
Biotechnology
Gilead Sciences subsidiary company Kite has announced the publication of a new European analysis of commercial manufacturing experience of Yescarta (axicabtagene ciloleucel). 24 April 2023
Pharmaceutical
Japanese pharmaceutical giant Takeda is considering selling its Russian plant that produces, Ninlaro (ixazomib), a treatment for patients with multiple myeloma as well as other drugs, according to some local market analysts and Russian media, The Pharma Letters local correspondent reports. 21 April 2023
Biotechnology
Danish biotech Genmab today announced an award in the second arbitration relating to its license agreement with Janssen Biotech. 21 April 2023
Biotechnology
The US Food and Drug Administration yesterday approved Omisirge (omidubicel-onlv), a substantially modified allogeneic (donor) cord blood-based cell therapy to quicken the recovery of neutrophils (a subset of white blood cells) in the body and reduce the risk of infection. 18 April 2023
Biotechnology
Sino-American biotech BeiGene today announced the first major step in the company’s expansion in Latin America (LATAM) with the formal opening of its office in São Paulo, Brazil. 13 April 2023
Biotechnology
A draft evidence report from Boston, USA-based watchdog The Institute for Clinical and Economic Review (ICER) suggests a cost-effective price of up to $1.9 million for new sickle cell disease (SCD) therapies. 13 April 2023
Biotechnology
South Korean biotech Genexine saw its shares gain more than 9% to 13,850 won, after, along with partner KG Bio, it released interim results of the Phase III clinical trial of GX-E4 (efepoetin alfa), a candidate for chronic kidney disease (CKD)-induced anemia. 12 April 2023
Biotechnology
French drugmaker Sanofi has announced the publication of data from studies on its hemophilia candidate fitusiran in two medical journals. 4 April 2023
Biotechnology
German life science group Sartorius saw its shares fall 4.9% to 310.00 euros today, after it announced an M&A deal. 31 March 2023
Biotechnology
Adding to a string of such deals, US biotech XOMA Corporation has now acquired the commercial payment and a portion of the milestone rights to Ixinity [coagulation factor IX (recombinant)], which is marketed by Canada’s Medexus Pharmaceuticals for the control and prevention of bleeding episodes and postoperative management in people with hemophilia B, from Aptevo Therapeutics. 31 March 2023
Biotechnology
The progress quietly made by Sino-American biotech company BeiGene with its oral Bruton tyrosine kinase inhibitor (BTKi) Brukinsa (zanubrutinib) since 2019 has been nothing short of remarkable. 30 March 2023
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