Hematology
Refine Search
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
Pharmaceutical
Japanese drugmaker Otsuka and its US subsidiary Astex Pharmaceuticals have announce top-line results from the ASCERTAIN Phase III study evaluating cedazuridine and decitabine fixed-dose combination (ASTX727) versus decitabine IV in adults with intermediate and high-risk myelodysplastic syndromes (MDS) or chronic myelomonocytic leukemia (CMML). 7 June 2019
Biotechnology
AstraZeneca today announced positive results from the Phase III ELEVATE-TN trial of Calquence (acalabrutinib) in patients with previously-untreated chronic lymphocytic leukemia (CLL), the most common type of leukemia in adults. 6 June 2019
Pharmaceutical
Japanese drugmaker Takeda has abandoned its Phase III TOURMALINE-AL1 trial in relapsed or refractory systemic light-chain (AL) amyloidosis. 6 June 2019
Biotechnology
Celgene has provided cause for celebration for Bristol-Myers Squibb, which is set to take over the US biotech company, and its partner Acceleron Pharma. 5 June 2019
Biotechnology
Japanese drug major Astellas Pharma today announced that the US Food and Drug Administration approved a supplemental New Drug Application (sNDA) to update the US product labeling for Xospata (gilteritinib) to include final analysis data from the ADMIRAL trial. 31 May 2019
Biotechnology
Phase III findings on BioMarin Pharmaceutical’s valoctocogene roxaparvovec were announced on Tuesday, leading the US biotech’s share value to fall by 5% by the close. 29 May 2019
Pharmaceutical
Spanish pharma and chemical manufacturer Grifols has announced an optimistic strategy up until 2022 that will see some 1.4 billion euros ($1.6 billion) invested in the search for further growth. 28 May 2019
Biotechnology
The Province of Ontario has become Canada’s first to reimburse Venclexta (venetoclax) monotherapy under its Drugs and Devices Division's (DDD) Exceptional Access Program. 23 May 2019
Biotechnology
When it comes to long-term investment in pharma stocks, looking at pipeline assets at a pre-clinical or early clinical stage gives as good a clue as any as to where the value lies. 17 May 2019
Biotechnology
USA-based Celgene has won European approval for two new triplet regimens based on Revlimid (lenalidomide) and Imnovid (pomalidomide). 17 May 2019
Pharmaceutical
The US Food and Drug Administration said on Thursday it has approved Fragmin (dalteparin sodium) injection, for subcutaneous use, to reduce the recurrence of symptomatic venous thromboembolism (VTE) in pediatric patients one month of age and older. 17 May 2019
Biotechnology
After a slow start, there have been better recent sales of Yescarta (axicabtagene ciloleucel), the CAR-T therapy that Gilead Sciences picked up in its $11.9 billion acquisition of Kite Pharma in 2017. 16 May 2019
Biotechnology
The Roche and AbbVie partnered asset Venclexta (venetoclax) has won US approval in combination with Gazyva (obinutuzumab) as a first-line, chemo-free option in chronic lymphocytic leukemia (CLL). 16 May 2019
Pharmaceutical
The US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee has voted in favor of approving one cancer drug from Japanese drugmaker Daiichi Sankyo but voted against another one. 15 May 2019
Biotechnology
Swedish Orphan Biovitrum, the Nordic biotech company that is known as Sobi, has bumped its share price up by 5% at its Capital Markets Day 2019. 14 May 2019
Pharmaceutical
In 2018, the FDA set a new record in the number of new drug approvals, with a total of 59 new drugs approved by its Center for Drug Evaluation and Research (CDER).1 So far in 2019, the CDER has approved 8 drugs, with 6 of these approvals happening in the first quarter of the year,2 exactly the same number that was approved in the first quarter of 2018.3 10 May 2019
Biotechnology
Sobi and Sanofi have presented further data to show that their drugs can provide perioperative hemostatic control across a wide spectrum of major and minor surgeries in patients of all ages with both severe hemophilia A and B. 10 May 2019
Biotechnology
AstraZeneca today announced positive results from the Phase III ASCEND trial of Calquence (acalabrutinib) in previously-treated patients with chronic lymphocytic leukemia (CLL). Because of the good results, the trial will now be stopped early, the company stated. 7 May 2019
Pharmaceutical
Among last week’s research news of note was Denmark’s diabetes care giant Novo Nordisk presentation of new data on its already blockbuster drug Victoza, clearing the path for regulatory approval in children with type 2 diabetes. Also, GlaxoSmithKline released positive new data on its triple therapy Trelegy Ellipta in asthma. On the regulatory front, Portola Pharmaceuticals gained European Union approval for its bleeding reversal agent Ondexxya. Negative news included two Complete Response Letters (CRLs) from the US Food and Drug Administration, one for Heron Therapeutics’ postoperative pain drug HTX-011 and one for Nabriva Therapeutics regarding its urinary tract infection candidate Contepo. 4 May 2019
Biotechnology
The US Food and Drug Administration has approved Agios Pharmaceuticals’ supplemental New Drug Application (sNDA) for Tibsovo (ivosidenib) for newly-diagnosed acute myeloid leukemia (AML) with a susceptible IDH1 mutation. 3 May 2019
Sign up to receive email updates
Join industry leaders for a daily roundup of biotech & pharma news
Today's issue
Company Spotlight
A US biotech company dedicated to creating oral drugs with an emphasis on indications in virology and immunology.
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze