10 October 2024 Machine learning-enabled drug discovery and development company insitro has announced the execution of three strategic agreements with Eli Lilly.
Russia may be faced with a shortage of Convulex (valproic acid) - one of the most popular drugs for the treatment of epilepsy – as its manufacturer, the Canadian firm Bausch Health, has stopped exports of the drug to the Russian market. 17 February 2022
US biotech companies Sage Therapeutics and Biogen have announced that the CORAL study in people with major depressive disorder (MDD) met the trial objectives. 16 February 2022
Third Harmonic Bio, a US clinical-stage company developing a first-in-class, highly selective, oral KIT inhibitor for treatment of severe allergy and inflammation, today launched from stealth, with the closing of a Series B financing that brings the total capital raised to date to $155 million. 16 February 2022
California’s Cytokinetics has announced top-line results from the METEORIC-HF Phase III trial of omecamtiv mecarbil in patients with heart failure with reduced ejection fraction (HFrEF). 16 February 2022
The European Commission (EC) has granted Marketing Authorization for Oxbryta (voxelotor), from Global Blood Therapeutics, for the treatment of hemolytic anemia due to sickle cell disease (SCD) in adult and pediatric patients 12 years of age and older as monotherapy or in combination with hydroxycarbamide (hydroxyurea). 16 February 2022
Privately-held UK biotech Curve Therapeutics today announces a global research collaboration with US pharma giant Merck & Co, known as MSD outside the USA and Canada, to discover and validate modulators of up to five therapeutic targets using its Microcycle technology, initially for oncology and neurology indications. 16 February 2022
The US Food and Drug Administration will have a new leader, after the Senate confirmed Robert Califf in a tight vote, 50 to 46, which exposed political divisions over a range of healthcare issues. 16 February 2022
First-in-class lupus therapy Saphnelo (anifrolumab) has been approved in the European Union as an add-on therapy for people with moderate to severe disease. 16 February 2022
The European Commission has granted marketing authorization for the next-generation long-acting recombinant human growth hormone Ngenla (somatrogon). 16 February 2022
Antibody drug conjugate (ADC) specialist ImmunoGen has entered into a global, multi-year definitive licensing agreement whereby it granted pharma major Eli Lilly exclusive rights to research, develop and commercialize ADCs directed to targets selected by Lilly based on ImmunoGen's novel camptothecin technology. 16 February 2022
The Federal Court of Appeal has dismissed an appeal by Pharmascience from a decision of the Federal Court that found Canadian patent No 2,760,802 (the 802 patent) valid and infringed by Pharmascience's proposed glatiramer acetate product, a generic of Teva Pharmaceutical Industries’ blockbuster multiple sclerosis drug Copaxone and Pharmascience's Glatect. 16 February 2022
US clinical-stage biotech Legend Biotech Corporation managed to close up 2.2% yesterday, despite announcing that, on Friday, February 11, the company was informed by the US Food and Drug Administration (FDA) via email communication that its Phase I clinical trial for LB1901 has been placed on clinical hold. 16 February 2022
Privately-held drug discovery company Aquinnah Pharmaceuticals has announced an agreement with Swiss cancer giant Roche in neurodegenerative diseases. 16 February 2022
The European Federation of Pharmaceutical Industries and Associations (EFPIA) and its specialist group Vaccines Europe have highlighted a series of statistics to show progress being made in vaccinating the world against COVID-19. 16 February 2022
The potential Food and Drug Administration acceptance of US biopharma Anavex Life Sciences’ AVATAR as a pivotal Phase III trial would have an important bearing on the Rett syndrome market, as it could enable blarcamesine to launch at a similar time as Australia-based Neuren Pharmaceuticals’ trofenitide, which is a major future competitor. 16 February 2022
Influential pricing watchdog ICER - the Institute for Clinical and Economic Review - has released a final report into the cost-effectiveness of Eli Lilly’s GLP-1 agonist tirzepatide. 15 February 2022
Danish dermatology specialist Leo Pharma has revealed plans to cut 200 jobs, marking the company’s fourth workforce reduction since 2022. 11 October 2024
Swiss generic and biosimilar medicines major Sandoz today announced that it has launched a generic paclitaxel formulation in the USA, the first generic to its reference medicine to be approved by the US Food and Drug Administration (FDA). 11 October 2024
California-based AI company Suki has raised $70 million in new funding to accelerate the growth of its AI-powered voice solutions in healthcare. 11 October 2024
Pfizer is to present initial findings from its CULTIVATE study of its sphingosine-1-phosphate (S1P) receptor modulator Velsipity (etrasimod) in Crohn’s disease (CD) at United European Gastroenterology Week 2024. 11 October 2024
Two US units of Israel’s Teva Pharmaceutical Industries have agreed to pay $450 million to resolve two matters that allege Teva violated the Anti-Kickback Statute (AKS) and the False Claims Act (FCA), the US Department of Justice (DoJ) announced yesterday. 11 October 2024
Switzerland-based KeyBioscience and US pharma major Eli Lilly have agreed to extend their collaboration on the development of dual amylin calcitonin receptor agonists (DACRA), a new class of potential treatments for obesity and related disorders. 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
South Korea’s Samsung Bioepis has released its Fourth Quarter 2024 Biosimilar Market Report, marking the seventh-edition of the Quarterly Biosimilar Market Report in the United States. 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
Machine learning-enabled drug discovery and development company insitro has announced the execution of three strategic agreements with Eli Lilly. 10 October 2024
Pfizer released positive top line results from the final prespecified overall survival (OS) analysis of the TALAPRO-2 study of Talzenna (talazoparib), an oral poly ADP-ribose polymerase (PARP) inhibitor, in combination with Xtandi (enzalutamide). 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
Cancer start-up Black Diamond Therapeutics has announced a significant restructuring as part of its plan to focus resources on its lead drug, BDTX-1535. 10 October 2024
The European Medicines Agency (EMA) has accepted for review the Marketing Authorization Applications for AVT03, a proposed biosimilar candidate to the Prolia and Xgeva (denosumab), submitted by Germany’s STADA Arzneimittel. 10 October 2024