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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
Pharmaceutical
Sanofi reported 15.7% sales growth for the third quarter of the year, reaching 13.4 billion euros ($14.2 billion), with adjusted earnings per share (EPS) rising by 12.2% to 2.86 euros, surpassing many forecasts. 25 October 2024
Biotechnology
Johnson & Johnson has secured European approval for an expanded indication of Darzalex (daratumumab) in a subcutaneous formulation. 24 October 2024
Biotechnology
Swedish Orphan Biovitrum, the Nordic biotech company also known as Sobi, today announced significantly improved financial results for the third quarter of 2024, sending the firm’s shares up 2.5% to 333.60 kronor in early trading. 24 October 2024
Biotechnology
US clinical-stage biotech AvenCell Therapeutics announced that it has raised $112 million in Series B financing, which was led by global life sciences investor Novo Holdings. 23 October 2024
Pharmaceutical
Swiss pharma giant Roche this morning reported that, in the first nine months of 2024 group sales increased by 6% at CER (2% in francs) to 45.0 billion francs ($52.0 billion). 23 October 2024
Pharmaceutical
UK pharma major AstraZeneca’s Alexion Rare Disease unit has received a positive recommendation for Voydeya (danicopan), from the UK’s National Institute for Health and Care Excellence (NICE). 22 October 2024
Biotechnology
The European Medicines Agency’s (EMA) human health committee, CHMP, announced six positive opinions of novel medicines, as well as two biosimilars, following its October meeting. 18 October 2024
Biotechnology
The US Food and Drug Administration (FDA) on Friday approved US pharma giant Pfizer’s Hympavzi (marstacimab-hncq). 14 October 2024
Biotechnology
US healthcare giant Johnson & Johnson’s Tecvayli (teclistamab) has been recommended by the National Institute for Health and Care Excellence (NICE) as a first-line option to treat myeloma in England and Wales. 10 October 2024
Biotechnology
The US Food and Drug Administration (FDA) has granted the Gilead Sciences subsidiary Kite a Regenerative Medicine Advanced Therapy Designation (RMAT) for Yescarta (axicabtagene ciloleucel) for adults with newly-diagnosed, high-risk large B-cell lymphoma (LBCL). 3 October 2024
Pharmaceutical
AstraZeneca’s supplemental New Drug Application (sNDA) for Calquence (acalabrutinib) has been accepted and granted Priority Review in the USA for the treatment of adults with previously untreated mantle cell lymphoma (MCL). 3 October 2024
Biotechnology
Roche’s long-delayed $4.3 billion acquisition of Spark Therapeutics, announced in February, moved a step forward to completion, with the news that it has been cleared by the UK’s regulator, though in the USA approval is still awaited,
. 16 December 2019
Biotechnology
A US jury has ordered the Gilead Sciences subsidiary Kite Pharma to pay a total of $752 million to Juno Therapeutics – which has now become part of Bristol-Myers Squibb – and the Memorial Sloan Kettering Cancer Center (MSKCC). 16 December 2019
Pharmaceutical
Company acquisitions featured big in the news last week, with two significant M&A deals. First, French pharma major Sanofi announced a $2.5 billion bid for US biotech Synthorx and its cancer drug THOR-707, and US giant Merck & Co is forking out $2.7 billion to buy ArQule and its investigational drug ARQ 531 for the treatment of hematological malignancies. Sanofi was also in the news on Tuesday, when its new chief executive set out plans for refocusing the company’s research priorities. Meantime, the UK parliamentary elections resulted in an overwhelming majority for the Conservatives and Boris Johnson, but still questions remain for the pharmaceutical sector. 15 December 2019
Pharmaceutical
The UK’s National Institute for Health and Care Excellence (NICE) and Scottish Medicines Consortium (SMC) have published positive appraisals recommending the use of Mulpleo (lusutrombopag) by the National Health Service (NHS) in England, Wales and Scotland for the treatment of severe thrombocytopenia in adult patients with chronic liver disease (CLD) undergoing planned invasive procedures, Japanese drug major Shionogi. 12 December 2019
Biotechnology
Gilead Science subsidiary Kite has submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for the investigational chimeric antigen receptor (CAR) T cell therapy, KTE-X19, for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL). 12 December 2019
Pharmaceutical
At the annual meeting of the American Society of Hematology (ASH), French drugmaker Sanofi presented positive data for ex-Bioverativ asset sutimlimab. 11 December 2019
Biotechnology
US pharma major Bristol-Myers Squibb presented data from multiple studies evaluating Reblozyl (luspatercept-aamt) in patients with anemia associated with multiple serious blood diseases at the 2019 American Society of Hematology (ASH) Annual Meeting in Orlando, Florida. 10 December 2019
Pharmaceutical
Shares of US biotech firm ArQule spiked 102% to $19.60 in Monday pre-market trading, after it was revealed that it has received a takeover offer from US pharma giant Merck & Co. 9 December 2019
Biotechnology
US pharma major Bristol-Myers Squibb announced over the weekend that its Phase I study of lisocabtagene maraleucel (liso-cel) met its primary and secondary endpoints while demonstrating durable responses. 9 December 2019
Biotechnology
US biotech bluebird bio has presented new data from its Phase I/II HGB-206 study of its LentiGlobin gene therapy for sickle cell disease (SCD) at ASH. 9 December 2019
Biotechnology
Genomic medicine company Sangamo Therapeutics and its pharma partner Pfizer have announced updated follow-up results from the Phase I/II Alta study on the SB-525 gene therapy in patients with severe hemophilia A. 9 December 2019
Biotechnology
Sales of the multiple myeloma drug Darzalex (daratumumab) have hit $2.5 billion in a calendar year, which is good news not just for Janssen, the exclusive global license holder. 5 December 2019
Pharmaceutical
Even after the approval of five new molecular entities (NME) in 2019, the drug launches and pipeline progress at Novartis show no sign of letting up. 5 December 2019
Pharmaceutical
Global drugmakers will continue to the use the policy of dumping in the Russian pharmaceutical market in years to come, in an attempt to get a better access to public procurements in Russia, according to recent statements by some local analysts in the field of pharmaceuticals and senior officials of the Russian Ministry of Health, reports The Pharma Letter’s local correspondent. 3 December 2019
Pharmaceutical
Swiss pharma giant Novartis set the scene in M&A news, announcing a $9.7 billion acquisition of US biotech firm The Medicines Company and its cholesterol-lowerer inclisiran. Clinical trials news featured ChemoCentryx, which saw its shares triple on Tuesday after reporting strong Phase III results with its ANCA vasculitis drug candidate avacopan. Last week also saw a second sickle cell disease drug approval from the US Food and Drug Administration, this time Global Blood Therapeutics’ Oxbryta (voxelotor). Meanwhile, Hutchison China MediTech, also known as Chi-Med, gained approval and price listing for its Elunate for advanced colorectal cancer in China. 1 December 2019
Biosimilars
Biosimilar development partners Biocon and Mylan have been granted approval for a facility to manufacture Fulphila (pegfilgrastim) for the US market. 27 November 2019
Biotechnology
The US Food and Drug Administration (FDA) has granted accelerated approval to Oxbryta (voxelotor) tablets for the treatment of sickle cell disease (SCD) in adults and children 12 years of age and older. 26 November 2019
Generics
Abu Dhabi-based company YAS Holding has agreed a license and distribution deal to commercialize the portfolio of privately-held US generics company Alvogen in the Middle East and North Africa (MENA) region. 25 November 2019
Biotechnology
Californian biotech BioMarin Pharmaceutical has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for its gene therapy, valoctocogene roxaparvovec, for adults with severe hemophilia A. 22 November 2019
Biotechnology
After a many-months saga of anti-trust regulatory delays and a requirement for a substantial divestment, US pharma major Bristol-Myers Squibb late Wednesday announced that it has at last completed its $74 billion acquisition of biotech firm Celgene Corp following the receipt of regulatory approval from all government authorities required by the merger agreement announced on April 12 this year. 21 November 2019
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