10 October 2024 Machine learning-enabled drug discovery and development company insitro has announced the execution of three strategic agreements with Eli Lilly.
French pharma major Sanofi and US partner Regeneron Pharmaceuticals announced late Tuesday that the European Commission (EC) has approved a new indication for Dupixent (dupilumab) in asthma. 8 May 2019
US biotech Regeneron missed the expectations of Wall Street analysts in both its first-quarter sales and earnings, sending its share price tumbling on Tuesday. 7 May 2019
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
US biotech Cytokinetics has announced that its Phase II FORTITUDE-ALS trial of reldesemtiv in amyotrophic lateral sclerosis (ALS) failed to meet its primary endpoint. 7 May 2019
UK-based Acacia Pharma appears to have made a costly error with its choice of contract manufacturer for Barhemsys (amisulpride injection), a candidate for post-operative nausea and vomiting. 7 May 2019
In a third collaboration with a pharma major within less than a year, US privately-held biotech Skyhawk Therapeutics has entered into a strategic collaboration with Japanese giant Takeda Pharmaceutical. 7 May 2019
Danish CNS specialist Lundbeck on Monday announced the signing of a definitive agreement into acquire La Jolla, USA-based Abide Therapeutics. 7 May 2019
US pharma major Eli Lilly has released positive results from pooled subgroup analyses of efficacy data from the Phase III EVOLVE-1 and EVOLVE-2 studies. 7 May 2019
The US Food and Drug Administration has approved Kadcyla (ado-trastuzumab emtansine) for adjuvant (after surgery) treatment of people with HER2-positive early breast cancer (EBC) who have residual invasive disease after neoadjuvant (before surgery) taxane and Herceptin (trastuzumab)-based treatment. 4 May 2019
An Evidence Report assessing the comparative clinical effectiveness and value of Swiss pharma giant Novartis’ Mayzent (siponimod) for the treatment of secondary progressive multiple sclerosis (SPMS) was released on Thursday by the USA’s Institute for Clinical and Economic Review (ICER). 3 May 2019
Boosted by a strong sales result from its HIV treatments and from novel cancer med Yescarta (axicabtagene ciloleucel), California’s Gilead Sciences beat analysts’ expectations to take in $5.3 billion in the first quarter of the year. 3 May 2019
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
Shares of Clovis Oncology closed up 4.12% at $18.44 yesterday, after the US biotech firm revealed an agreement for up to $175 million in non-dilutive clinical trial financing with certain affiliates of TPG Sixth Street Partners to reimburse Clovis’ costs and expenses related to the ATHENA clinical trial. 3 May 2019
Cambridge, UK-based AstraZeneca has been granted approval to market its once-daily SGLT-2 inhibitor Qternmet XR (dapagliflozin/saxagliptin/metformin hydrochloride) in the USA. 3 May 2019
East Coast, USA-based biotech BioXcel Therapeutics says it has finalized formulation development for its candidate BXCL501, with the aim of supporting a Phase III trial later in the year. 3 May 2019
Geneva, Switzerland-based biotech Amal Therapeutics has entered into a collaborative agreement with German family-owned pharma major Boehringer Ingelheim. 2 May 2019
Thankfully, the growing anti-microbial resistance (AMR) crisis is now getting some major headlines and airtime, so that even many lay people are getting a good grasp of the issues at the heart of this global priority. 2 May 2019
US biotech firm bluebird bio has appointed Joanne Smith-Farrell to chief business officer. In this role, she will lead corporate development and strategy, and she will also continue to serve as our oncology franchise leader. 2 May 2019
Antibiotics specialist Nabriva Therapeutics has been hit by a Complete Response Letter (CRL) from the US regulator, sending its share price down by almost a third. 2 May 2019
Strasbourg, France-based biotech firm Transgene has entered into a research, option and license deal with AstraZeneca to co-develop five armed oncolytic vaccinia virus candidates. 2 May 2019
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
German family-owned pharma major Boehringer Ingelheim and USA-based Circle Pharma (have entered into a research collaboration and license agreement with the shared goal to develop a first-in-class cyclin inhibitor that can halt the growth of cancer cells potentially offering hope to those living with hard-to-treat cancers. 9 October 2024