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Pharmaceutical
US pharma giant Merck & Co and Japanese drugmaker Otsuka’s immuno-oncology therapy Keytruda (pembrolizumab) is projected to be the best-selling drug by annual revenue in 2023, earning an impressive $22.2 billion by 2025, says analyst. 7 October 2019
Pharmaceutical
M&A news last week featured Swedish Orphan Biovitrum (Sobi) revealing its plans to acquire Dova Pharma and its Doptelet in order to expand its hematology platform. On the regulatory front, AstraZeneca had a disappointment with the US Food and Drug Administration issuing a complete response letter on the company’s triple combination chronic obstructive pulmonary disease (COPD) drug Breztri Aerosphere (PT010), while Heron Therapeutics pleased investors with the resubmission of a New Drug Application for its post-operative pain drug HTX-011. Also, Novartis last week presented positive new data for Cosentyx in spondylarthritis, bringing the drug closer to getting a fourth indication approved. 6 October 2019
Biotechnology
The Japanese Intellectual Property High Court has ruled in favor of the Roche majority-owned subsidiary Chugai in relation to allegations that its hemophilia A drug Hemlibra (emicizumab-kxwh) breached another company’s patent. 3 October 2019
Biotechnology
Swiss pharma giant Roche has officially announced localization of two of its innovative drugs in Russia at the facilities of its local partners, reports The Pharma Letter’s local correspondent. 30 September 2019
Pharmaceutical
Swedish Orphan Biovitrum today announced a definitive agreement to acquire USA-based Dova Pharmaceuticals by means of a tender offer. 30 September 2019
Biotechnology
The US Food and Drug Administration has approved Rituxan (rituximab), in combination with glucocorticoids, for the treatment of granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) in pediatric patients two years of age and older. 28 September 2019
Biotechnology
Japanese drugmaker JCR Pharmaceuticals has withdrawn its application with the Ministry of Health, Labor and Welfare of Japan (MHLW) for additional marketing approval of Temcell HS Inj, allogeneic bone marrow-derived mesenchymal stem cells, for the indication of epidermolysis bullosa (EB) (development code: JR-031EB). 20 September 2019
Pharmaceutical
The National Institute for Health and Clinical Excellence (NICE), the health technology appraisal body in England and Wales, has issued its Final Appraisal Determination (FAD) recommending Takhzyro (lanadelumab) subcutaneous injection as an option for preventing recurrent attacks of hereditary angioedema (HAE). 18 September 2019
Biotechnology
A new study shows that the hemophilia A and B market is expected to grow from $7.0 billion in 2018 to $9.3 billion by 2028 across the eight major markets (8MM: USA, France, Germany, Italy, Spain, UK, Japan and China), expanding at a compound annual growth rate (CAGR) of 2.9%. 5 September 2019
Pharmaceutical
Privately-owned Swiss drugmaker Helsinn has signed agreements with companies that will market its pan histone deacetylase inhibitor, pracinostat, in South America. 2 September 2019
Biotechnology
Shares of US biotech firm Alexion Pharmaceuticals crashed 8% in pre-market trading on Friday, reacting to the news that peer Amgen is challenging of three patents covering top seller Soliris (eculizumab). 31 August 2019
Biotechnology
Ono Pharmaceutical is relying on data from a Phase I/II study in 44 patients with its application for manufacturing and marketing approval of tirabrutinib hydrochloride to treat recurrent or refractory primary central nervous system lymphoma (PCNSL) in Japan. 29 August 2019
Biotechnology
The latest approval for Darzalex (daratumumab), a multiple myeloma drug from Danish biotech Genmab and its big pharma partner Janssen, has come in Japan in the frontline setting. 22 August 2019
Biotechnology
The US Food and Drug Administration has accepted the New Drug Application (NDA) for zanubrutinib for priority review for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. 22 August 2019
Biotechnology
Swedish biotech Oncopeptides has poached AstraZeneca's Klaas Bakker to replace Johan Harmenberg as its new chief medical officer. 20 August 2019
Pharmaceutical
The Delhi High Court has allowed Alembic Pharmaceuticals and Natco Pharma to export sorafenib, an active ingredient in German pharma major Bayer’s cancer drug Nexavar, and rivaroxaban, the API in its blood thinner medicine Xarelto, for research and development purposes. 19 August 2019
Biotechnology
Celgene Corp today announced the US Food and Drug Administration has approved Inrebic (fedratinib) for the treatment of adult patients with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis. 16 August 2019
Biotechnology
Australian biotech CSL Limited saw its shares rise 6.6% to A$234.00 today, after it posted revenue of $8,539 million, up 7.9%, for the 12 months ended June 30, 2019. CSL is Australia largest health business specializing in immunotherapies and vaccines for life-threatening diseases. 14 August 2019
Pharmaceutical
A survey of 4,000 patients in the USA and Europe has revealed their attitudes towards the non-profit groups supporting them and pharma companies, as well as how such organizations should work together. 14 August 2019
Biotechnology
The US Food and Drug Administration has granted Breakthrough Therapy designation (BTD) for Calquence (acalabrutinib) as a monotherapy treatment for adult patients with chronic lymphocytic leukemia (CLL), one of the most common types of leukemia in adults. 14 August 2019
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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