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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
Biotechnology
Bad news sent shares in Catalyst Biosciences cratering on Monday, as the Californian hematology specialist revealed that two patients in the ongoing FIX trial developed a neutralizing antibody after treatment with the Factor IX candidate CB-2679d. 19 June 2018
Pharmaceutical
Daiichi Sankyo is confident that its agent quizartinib could be the answer for relapsed/refractory acute myeloid leukemia (AML) patients with FLT3-ITD mutations. 18 June 2018
Biotechnology
In the next five years, Swiss pharma giant Roche is likely to be hit hard by emerging competition to three of its big-selling biologics. 15 June 2018
Biotechnology
Alexion Pharmaceuticals today announced that positive results from one of the two large Phase III studies of ALXN1210, the company’s investigational long-acting C5 complement inhibitor, in patients with paroxysmal nocturnal hemoglobinuria (PNH) were selected for presentation during the late-breaking oral session on June 17, 2018 at the Annual Conference of the European Hematology Association (EHA) in Stockholm, Sweden. 15 June 2018
Pharmaceutical
Shares of Spanish drugmaker PharmaMar were up 6.67% at 1.60 euros ahead of market close today, after the company announced a major licensing agreement for it second most advanced anticancer drug, which is currently under development for the treatment of multiple myeloma and angioimmunoblastic T-cell lymphoma. 11 June 2018
Biotechnology
On June 8, 2018, the Food and Drug Administration granted regular approval to Venclexta (venetoclax) in combination with Rituxan (rituximab) for the treatment of people with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy. 11 June 2018
Biotechnology
The US Food and Drug Administration has accepted the supplemental Biologics License Application (sBLA) and granted Priority Review for Hemlibra (emicizumab-kxwh) for adults and children with hemophilia A without factor VIII inhibitors, an indication that would attract a much wider patient population than currently available. 6 June 2018
Pharmaceutical
Data revealed at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting on Saturday offered a promising signal for AstraZeneca’s antibody drug conjugates (ADC) platform. 4 June 2018
Pharmaceutical
The US Food and Drug Administration has granted Novartis Priority Review designation for a new use of Promacta (eltrombopag), an oral thrombopoietin receptor agonist marketed outside the USA as Revolade. 30 May 2018
Pharmaceutical
The US Food and Drug Administration has accepted and granted Priority Review for the New Drug Application (NDA) for gilteritinib. 29 May 2018
Pharmaceutical
Among last week’s important news, three sets of clinical trial results attracted attention. First, three were positive trial results for Swiss pharma giant Roche’s Hemlibra in hemophilia prophylaxis. Then we heard of another success for Merck & Co’s Keytruda in lung cancer, and there was also good news for AbbVie with a Phase III study of Imbruvica in combination with Roche’s Gazyva. On the regulatory front, Dova Pharmaceuticals gained US Food and Drug approval for its Doptelet in liver disease, and the agency also cleared BioMarin’s Palynziq for phenylketonuria (PKU). 26 May 2018
Biotechnology
Imbruvica is already approved as a monotherapy for first-line chronic lymphocytic leukemia (CLL), but new data is strengthening the case for the drug to also be used in this setting along with Gazyva (obinutuzumab). 25 May 2018
Biotechnology
US clinical and commercial manufacturing of therapeutic proteins company AGC Biologics, says that it will supply bulk drug substance for the launch of AndexXa (coagulation factor Xa [recombinant], inactivated-zhzo), the first and only antidote indicated for patients treated with rivaroxaban and apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding. 25 May 2018
Biotechnology
New evidence from real-life clinical practice in the UK, presented today at the World Federation of Hemophilia (WFH) 2018 World Congress in Glasgow, Scotland, shows that people with hemophilia A treated with an extended half-life (EHL) clotting factor have fewer bleeds than with previously available treatments. 23 May 2018
Biotechnology
Australian plasma products and vaccines producer CSL Limited today announced a revised profit outlook for fiscal 2018. 23 May 2018
Pharmaceutical
The US Food and Drug Administration on Monday approved Doptelet (avatrombopag) tablets to treat low blood platelet count, or thrombocytopenia, in adults with chronic liver disease who are scheduled to undergo a medical or dental procedure. 22 May 2018
Pharmaceutical
Adults with hemophilia B who received a single dose Refixia (nonacog beta pegol; N9-GP) achieved greater total factor IX exposure than those treated with rFIXFc (recombinant factor IX-Fc fusion protein). 21 May 2018
Biotechnology
Switzerland’s Roche and its majority-owned Japanese subsidiary Chugai Pharmaceutical have released full data from Phase III studies testing Hemlibra (emicizumab) as a treatment for haemophilia A. 21 May 2018
Biotechnology
A long-term study has shown that NovoEight (turoctocog alfa) remains effective after three months of storage at a temperature of 40°c (104°f), according to findings presented on Monday at the World Federation of Hemophelia. 21 May 2018
Pharmaceutical
Research from the University of Warwick, UK, indicates that taking a tablet a day can help treat cancer patients to avoid a potentially deadly condition. 11 May 2018
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