10 October 2024 Machine learning-enabled drug discovery and development company insitro has announced the execution of three strategic agreements with Eli Lilly.
The stand-off between Vertex Pharmaceuticals and the UK’s cost watchdog for medicines over the cystic fibrosis (CF) drug Orkambi (lumacaftor/ivacaftor) has now gone on for two-and-a-half years. 12 November 2018
Shares in Anglo-Swedish pharma major AstraZeneca were nearly 7% higher than they were a week ago on Monday lunchtime as data on Farxiga (dapagliflozin) bumped up the company’s stock further. 12 November 2018
US clinical stage biotech Provention Bio saw its shares leap 12.4% after it announced a deal with its much larger peer Amgen for the co-development of AMG 714, now re-designated by Provention as PRV-015. 9 November 2018
As far as PARP inhibitors are concerned, AstraZeneca stole the show at the annual congress of ESMO this month, with the SOLO-1 trial of Lynparza (olaparib) showing striking data in the first-line maintenance setting for ovarian cancer patients. 9 November 2018
UK-headquartered commercial-stage biotech firm Orchard Therapeutics today announced two additions to its global commercial leadership team, appointing Robin Kenselaar as senior vice president and general manager, EMEA commercial operations, and Brad Mathis as vice president, US commercial operations. 8 November 2018
China’s BeiGene (Nasdaq: BGNE) has disclosed a delay in plans to file a New Drug Application (NDA) for zanubrutinib in relapsed/refractory (R/R) Waldenstrom's macroglobulinemia (WM) from first-half 2019 to 2019-Early 2020 in light of updated US Food and Drug Administration feedback. 8 November 2018
US biotech firm Immunomedics has announced its current clinical collaboration with AstraZeneca and its MedImmune unit for the development of Imfinzi (durvalumab) and sacituzumab govitecan combination therapy has been broadened to include second-line metastatic non-small cell lung cancer (NSCLC). 8 November 2018
Vaccines Europe, a trade group representing vaccines manufacturers in Europe, warns that vaccines have become “a victim of their own success,” as the absence of severe diseases has created a perception that vaccination is no longer necessary. 8 November 2018
The UK’s Medicines Discovery Catapult is joining forces with the Medical Research Council (MRC) Centre for Drug Safety Science (CDSS) at the University of Liverpool in a new research collaboration based around cell and gene therapy technologies. 7 November 2018
Foamix Pharmaceuticals was up by 20% in pre-market trading on Wednesday after releasing results from Phase III studies of FMX103 1.5% minocycline foam. 7 November 2018
The US Food and Drug Administration has approved Empliciti (elotuzumab) injection for intravenous use in combination with pomalidomide and dexamethasone (EPd) for the treatment of adult patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor.1 7 November 2018
Regeneron Pharmaceuticals has posted upbeat financial results for the third quarter of 2018, with revenues of $1.6 billion, a little under many analysts’ expectations, but still 11% higher than the same period last year. 6 November 2018
Japanese pharma major Daiichi Sankyo says that the European Medicines Agency has validated for review and granted accelerated assessment to the Marketing Authorization Application (MAA) for quizartinib for the treatment of adults with relapsed or refractory acute myeloid leukemia (AML) which is FLT3-ITD positive. 6 November 2018
San Franciscan oncology specialist Nektar Therapeutics has entered into a collaboration with Pfizer to evaluate several combination regimens in multiple cancer settings. 6 November 2018
US gene therapy developer Abeona Therapeutics says that it has been granted new exclusive licenses to develop gene therapies for treatment of four rare lysosomal storage disorders using US biotech Regenxbio’s NAV AAV9 vector platform technology. 6 November 2018
South Korean pharma company Yuhan Corp has licensed out its new clinical-stage lung cancer drug to Janssen Biotech, in a deal potentially valued at up to $1.25 billion. 6 November 2018
The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) to US biopharma Trevena in relation to the opioid painkiller, oliceridine. 5 November 2018
Danish dermatology specialist Leo Pharma has revealed plans to cut 200 jobs, marking the company’s fourth workforce reduction since 2022. 11 October 2024
Booster Therapeutics, a biotechnology company pioneering a new class of proteasome activator medicines to treat neurodegenerative and other diseases, has launched with the support of a $15 million financing. 11 October 2024
German cancer specialist Immatics has announced the pricing of its $150 million public offering, with Jefferies, BofA Securities, and Leerink acting as joint book runners. 11 October 2024
The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has approved Pfizer and BioNTech's latest COVID-19 vaccine, Comirnaty (KP.2). 11 October 2024
In what Astella Pharma calls “a landmark decision for advanced bladder cancer patients,” the Japanese drugmaker gained approval in the UK for its treatment regimen. 10 October 2024
Nanoscope Therapeutics says that, following a productive FDA meeting with the US Food and Drug Administration (FDA) for its clinical program evaluating MCO-010 for the treatment of retinitis pigmentosa (RP), the company will commence with submission of a Biologics License Application (BLA) in the first quarter of 2025. 10 October 2024
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
China’s Quantum Pharmaceuticals has announced a significant licensing agreement between its biologics-focused subsidiary, Ailux Biologics, and Johnson & Johnson. 10 October 2024
USA-based Kezar Life Sciences announced this week that it was pausing its Phase IIb PALIZADE trial evaluating zetomipzomib in lupus nephritis (LN) following the deaths of four patients. 10 October 2024
Advances in gene editing, such as the FDA approval of Vertex Pharmaceuticals’ Casgevy (exagamglogene autotemcel) in December 2023 for the treatment of beta thalassemia and sickle cell disease, have fueled significant interest in innovative epigenetic drugs. 10 October 2024
Gene therapy start-up GEMMA Biotherapeutics (GEMMABio) has announced a significant partnership with Brazil's Fiocruz, a key supplier for the Brazilian Ministry of Health. 10 October 2024
California’s Arda Therapeutics, a biotech focused on targeted cell depletion therapies for chronic diseases, has announced the successful completion of a $43 million Series A financing round. 9 October 2024
Purespring Therapeutics, a gene therapy company focused on transforming the treatment of kidney diseases, has raised £80 million ($105 million) in a Series B financing. 9 October 2024