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Biotechnology
US biotech major Celgene is reportedly looking at what could be its second big acquisition for 2018, and is said to be discussions to purchase US CAR-T cell therapy company Juno Therapeutics. 17 January 2018
Pharmaceutical
After a quiet year of M&A activity in 2017, 2018 has already kicked off with two deals exceeding a billion dollars. Novo Nordisk’s rejected $3.1 billion bid for Belgium’s Ablynx – along with its lead candidate caplacizumab -attracted attention, and expectations of a higher offer, as did Celgene’s proposed $1.1 billion acquisition of Impact Biomedicines and its fedratinib. Among deal-making news, there was Chinese biotech firm BeiGene’s interesting accord with Mirati Therapeutics for lung cancer candidate sitravatinib. Also, AstraZeneca’s US Food and Drug Administration approval of its Lynparza, making it the first drug to be cleared for BRAC-positive breast cancer, has resulted in speculation about competitors. 14 January 2018
Pharmaceutical
At its January 8-11, 2018 meeting, the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) recommended the suspension of the marketing authorizations for hydroxyethyl-starch (HES) solutions for infusion across the European Union. 12 January 2018
Biotechnology
Following this morning’s confirmation that it had made that Novo Nordisk has made an increase, unsolicited bid to acquire Belgian biotech firm Ablynx, the latter responded in the afternoon saying the offer fundamentally under-values the company. 8 January 2018
Biotechnology
US biotech Celgene became the first drugmaker of 2018 to announce an acquisition worth more than $1 billion on Sunday with news that it is to buy Impact Biomedicines. 8 January 2018
Biotechnology
Alnylam Pharmaceuticals and French pharma major Sanofi today announced a strategic restructuring of their RNAi therapeutics alliance to streamline and optimize development and commercialization of certain products for the treatment of rare genetic diseases. 8 January 2018
Biotechnology
Pfizer today announced that its appeal has been upheld against the National Institute for Health and Care Excellence’s (NICE) decision not to recommend Besponsa (inotuzumab ozogamicin) as a treatment for adults with relapsed or refractory (R/R) CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL). 28 December 2017
Biotechnology
Japan’s Ministry of Health, Labor and Welfare (MHLW) has approved Soliris (eculizumab) as a treatment for patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody-positive and whose symptoms are difficult to control with high-dose intravenous immunoglobulin (IVIG) therapy or plasmapheresis (PLEX). 27 December 2017
Biotechnology
Pfizer has received US Food and Drug Administration approved of its supplemental New Drug Application (sNDA) to expand the indication for Bosulif (bosutinib) to include adult patients with newly-diagnosed chronic phase Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML). 20 December 2017
Pharmaceutical
Major news last week included new Teva Pharmaceutical Industries’ chief executive Kåre Schultz bringing out the hatchet with a vengeance, with the market reacting positively to the massive restructuring announcement. Elsewhere, the annual American Society of Hematology (ASH) was still bringing out important results, including on: bluebird bio and Celgene’s myeloma candidate bb2121 and AbbVie’s Venclexta/Rituxan combination. Other clinical trials results of note was the latest on Roche’s Tecentriq in lung cancer and Regeneron and Sanofi’s new checkpoint inhibitor cemiplimab. Also attracting comment was Ionis’ $45 million deal with Roche for its Huntington’s disease candidate IONIS-HTTrx. 17 December 2017
Biotechnology
The US Food and Drug Administration has lifted the hold on clinical studies with fitusiran, including the Phase II open-label extension (OLE) study and the ATLAS Phase III program. 15 December 2017
Biotechnology
Striking results from hemophilia A trials carried out at research institutes in London have been described as potentially “groundbreaking” by the lead investigator. 15 December 2017
Biotechnology
In a reversal of a previous guidance, the UK’s National Institute for Health and Care Excellence (NICE) has issued draft guidance recommending ibrutinib (or routine National Health Service (NHS) use to treat mantle cell lymphoma in people who have had only one prior line of therapy. 14 December 2017
Biotechnology
The pressure to show progress in blood cancers at this year’s American Society of Hematology (ASH) Annual Meeting has been intense, and Janssen has not missed out with its data on Imbruvica (ibrutinib), and now on Darzalex (daratumumab) in particular. 12 December 2017
Biotechnology
Californian biotech Amgen has revealed new positive positive overall survival (OS) data from the Phase III ASPIRE trial in an oral presentation at the ongoing American Society of Hematology (ASH) meeting. 12 December 2017
Biotechnology
Madrid-headquartered PharmaMar has presented positive results at the American Society of Hematology (ASH) annual meeting in Atlanta, Georgia. 11 December 2017
Biotechnology
In the race to be the frontrunner in the CAR-T therapy field, the two companies currently in the lead position look to be mirroring each other’s progress. 11 December 2017
Biotechnology
Six-month follow-up data on Kymriah (tisagenlecleucel) will bring relief at Swiss pharma giant Novartis and at other drugmakers developing CAR-T therapies. 11 December 2017
Biotechnology
The US branch of Taiwan’s PharmaEssentia has presented follow-up results from a trial of its orphan drug candidate Ropeginterferon alfa-2b at the ongoing American Society of Hematology (ASH) meeting in Atlanta, Georgia. 11 December 2017
Biotechnology
Both Celgene and bluebird bio looked set to open up on Monday morning after they presented updated results from the ongoing CRB-401 Phase I study of bb2121, an investigational anti-B-cell maturation antigen (BCMA) CAR-T cell therapy. 11 December 2017
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
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