10 October 2024 Machine learning-enabled drug discovery and development company insitro has announced the execution of three strategic agreements with Eli Lilly.
As the UK’s National Institute for Health and Care Excellence (NICE) looks set to approve changes to the way it evaluates new medicines and health technologies, the Association of the British Pharmaceutical Industry believes that – taken in their entirety - the changes will move the needle in the right direction for NHS patients. 19 January 2022
Belgium biopharma UCB has announced positive top-line interim analysis results showing that the Phase III BE MOBILE 1 study met the primary and all ranked secondary endpoints. 18 January 2022
The US Food and Drug Administration has extended the review period for the biologics licensing applications (BLA) for its lentiviral vector gene therapies – betibeglogene autotemcel (beti-cel) for β-thalassemia and elivaldogene autotemcel (eli-cel) for cerebral adrenoleukodystrophy (CALD), submitted by bluebird bio, whose shares dived more than 11% to $8.27. 18 January 2022
French hearing loss specialist Sensorion saw its share plummet 42% yesterday, when it announced disappointing research results, and a further 13.7% to 0.91 euros today. 18 January 2022
Cell and gene therapy (CGT) manufacturing technology company Ori Biotech has secured more than $100 million in an oversubscribed Series B funding round. 18 January 2022
So-called ‘pharma bro’ Martin Shkreli has been held liable for antitrust claims brought by the US Federal Trade Commission (FTC) and a group of seven state enforcers. 18 January 2022
Spanish dermatology focussed drugmaker Almirall and IRB Barcelona (the Institute for Biomedicine) today announced a research collaboration to identify new oral treatments for immune-inflammatory skin diseases with remaining high unmet medical needs using molecular glue degraders, a novel therapeutic modality. 18 January 2022
The leading developer of vaccines and therapeutics for coronavirus disease, Pfizer, is to build new facilities in France as part of a near-$600 million investment in production of Paxlovid (nirmatrelvir/ritonavir). 18 January 2022
After an early decline, shares of UK-headquartered pharma services and products company Clinigen Group closed unchanged at 898.00 pence yesterday, after the company agreed higher take-private bid from Triton Investment Management, via Triley Bidco. 18 January 2022
German biotech Evotec has entered into a drug discovery collaboration with Eli Lilly in the field of metabolic diseases with a focus on kidney diseases and diabetes. 18 January 2022
In its latest analysis 2021 Review & Outlook for 2022, The Biotech Growth Trust reveals that now is an ideal time to buy small-cap biotech stocks for long-term investors, with many companies now trading at prices lower than the net cash on their balance sheet. 17 January 2022
US biopharma Adagio Therapeutics has summarized recent findings reported in three separate publications that show ADG20, its lead monoclonal antibody (mAb), has neutralization activity against the Omicron variant of SARS-CoV-2, and outlined initiatives to address current and future SARS-CoV-2 variants of concern. 17 January 2022
Even as Pfizer said it is redesigning a COVID-19 vaccine that specifically targets the Omicron coronavirus variant and is ready to launch the same by March, India could soon have its first messenger or mRNA vaccine targetting Omicron. 17 January 2022
London-listed Jordanian drugmaker Hikma Pharmaceuticals has agreed to acquire the Canadian assets of Teligent for $45.75 million. The transaction is expected to be completed before the end of the first quarter of 2022. 17 January 2022
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has today launched a public consultation on a set of far-reaching proposals to improve and strengthen the UK clinical trials legislation to make the UK the best place to research and develop safe and innovative medicines. 17 January 2022
The US Food and Drug Administration has accepted the supplemental Biologics License Application (sBLA) of Enhertu (trastuzumab deruxtecan) for the treatment of adult patients in the US with unresectable or metastatic HER2-positive breast cancer who have received a prior anti-HER2-based regimen. 17 January 2022
Shares of UK drugmaker GlaxoSmithKline were up 4.8% at 1,721.11 pence in early trading today, as the company rejected an unsolicited offer on Saturday for its Consumer Healthcare business, which could have been the biggest pharma M&A deal for several years. 17 January 2022
Newly-formed infectious diseases specialist Poolbeg Pharma has in-licenced a novel, first-in-class RNA-based immunotherapy from the University of Warwick. 17 January 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