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Biotechnology
Germany’s MorphoSys shares were up 7.5% at 25..69 euros, after along with partner USA-based Incyte, announced that the Swiss agency for therapeutic products (Swissmedic), has granted temporary approval for Minjuvi (tafasitamab) in combination with lenalidomide. 24 March 2022
Generics
Indian generic players may soon have access to a blockbuster cancer drug. The loss of exclusivity in the USA for Bristol Myers Squibb's Revlimid (lenalidomide) is helping several generic players to seek huge gains, with some in India entering unique settlements, reports The Pharma Letter’s India correspondent. 21 March 2022
Pharmaceutical
Boston, USA-based pricing watchdog The Institute for Clinical and Economic Review (ICER) has published a revised assessment of the relative merits of two possible competitors in hematology. 17 March 2022
Biotechnology
Metagenomi, a California, USA-based genetic medicines company with a versatile portfolio of next-generation gene editing tools, today announced the appointment of Christine Foster, as chief business officer and Alan Cohen, as chief medical officer and senior vice president of Monogenic Diseases. 15 March 2022
Biotechnology
UK health technology assessor the National Institute for Health and Care Excellence (NICE) has recommended the use of Darzalex (daratumumab) monotherapy for adult patients with relapsed and refractory multiple myeloma that has previously been treated with three therapies, including a proteasome inhibitor and an immunomodulator, and who have demonstrated disease progression on the last therapy. 15 March 2022
Biotechnology
French pharma major Sanofi and Blackstone have entered into a strategic, risk-sharing collaboration under which funds managed by Blackstone Life Sciences (BXLS) will contribute up to 300 million euros ($330 million) to accelerate the global pivotal studies and the clinical development program for the subcutaneous formulation and delivery of the anti-CD38 antibody Sarclisa (isatuximab-irfc), to treat patients with multiple myeloma (MM). 15 March 2022
Biotechnology
Research developments were significant among last week’s news, with US biotech Gilead Sciences presenting a bullish view on the TROPICS-02 Phase III trial of its cancer drug Trodelvy, but analysts were not that convinced. French drug major Sanofi and its partner Swedish Orphan Biovitrum released strong new Phase III results for their hemophilia A candidate efanesoctocog alfa. And US drug developer Venatorx came out with positive Phase III results for its urinary tract infection combination – cefepime-taniborbactam. Also of note, Voyager Therapeutics has signed a licensing and research deal that could be worth $1.5 billion with Novartis, for the Swiss pharma giant to get rights to its novel capsids focussed on CNS diseases. 13 March 2022
Biotechnology
Newly-approved Vonjo promising for patients with both low and moderate platelet counts, says analyst
Not only has CTI BioPharma’s drug Vonjo (pacritinib) already broken new ground by being the first treatment approved for intermediate and high-risk myelofibrosis patients with low platelet counts (below 50x109 per liter of blood), key opinion leaders interviewed by GlobalData note that the drug has promise as a treatment for patients with moderate platelet counts (between 50x109 and 100x109 per liter). 11 March 2022
Pharmaceutical
Germany’s MorphoSys said yesterday that it will account for a non-cash impairment charge on goodwill in the amount of approximately 231 million euros ($255 million). 11 March 2022
Biotechnology
Barcelona-based plasma-derived medicine specialist Grifols has secured approval in several European countries for Xembify (immune globulin subcutaneous human–klhw). 10 March 2022
Biotechnology
French pharma major Sanofi and Swedish Orphan Biovitrum have announced positive top-line results from the pivotal XTEND-1 Phase III study evaluating the safety, efficacy and pharmacokinetics of efanesoctocog alfa (BIVV001) in previously treated patients ≥12 years of age with severe hemophilia A. 9 March 2022
Generics
The US subsidiary of Israeli generic giant Teva Pharmaceutical Industries has announced the launch of a first generic version of Revlimid (lenalidomide capsules), in 5mg, 10mg, 15mg, and 25mg strengths, in the USA. 8 March 2022
Biotechnology
Japanese drug major Chugai Pharmaceutical Chugai has filed a regulatory application with the Ministry of Health, Labor and Welfare (MHLW), for approval of an anti-cancer agent/humanized anti-CD20 monoclonal antibody Gazyva (obinutuzumab), intravenous infusion 1000mg (genetical recombination)] for the treatment of chronic lymphocytic leukemia (CLL). 7 March 2022
Pharmaceutical
Seattle, USA-based hematology company CTI BioPharma has won approval in the USA for Vonjo (pacritinib) in myelofibrosis. 2 March 2022
Generics
Taiwanese generics and biosimilar drugmaker Lotus Pharmaceutical has received approval for its abbreviated new drug application (ANDA) in the Philippines for its generic versions of Bristol Myers Squibb’s Revlimid (lenalidomide) and AstraZeneca’s lung cancer drug Iressa (gefitinib). 2 March 2022
Biotechnology
Legend Biotech, a clinical stage CAR-T immuno-oncology biotech spun out of Hong Kong-listed GenScript Biotech, says that the US Food and Drug Administration has approved its first product, Carvykti (ciltacabtagene autoleucel; cilta-cel). 1 March 2022
Biotechnology
US precision therapy company Blueprint Medicines’ shares dipped more than 2% to $61.62 early today, after it announced a strategic collaboration with Proteovant Therapeutics to advance novel targeted protein degrader therapies to address important areas of medical need. 28 February 2022
Biotechnology
GlobalData has taken a look at the acute myeloid leukemia (AML) treatment landscape in China. 25 February 2022
Biotechnology
Shares in US genetic medicines company Homology Medicines were set to open 37% lower on Monday following the release of bad news since Friday’s close. 21 February 2022
Biotechnology
Japanese drugmaker Ono Pharmaceutical says that its Taiwanese subsidiary has received an approval of Velexbru (tirabrutinib hydrochloride) tablet 80mg, a Bruton’s tyrosine kinase (BTK) inhibitor, from the Taiwan Food and Drug Administration (TFDA) for the treatment of adult patients with recurrent or refractory B-cell primary central nervous system lymphoma. 21 February 2022
Biotechnology
British pharma major AstraZeneca is facing challenges in its bid to secure full approval for its anticoagulant reversal therapy, Andexxa (andexanet alfa), in the USA. 22 November 2024
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
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