10 October 2024 Machine learning-enabled drug discovery and development company insitro has announced the execution of three strategic agreements with Eli Lilly.
Mergers and acquisitions among pharmaceutical and biotechnology companies announced in full year 2021 dropped to their lowest level in more than a decade, which may have been partly influenced by tougher regulations with competition authorities calling for significant divestments to green light deals. 4 January 2022
Adrian Tombling, partner and life sciences sector specialist at European intellectual property firm, Withers & Rogers, offers an Expert View on why patents are not the real barrier and why we need them to guard the human race against the risks posed by COVID-19 mutations or future pandemics. 4 January 2022
Denmark’s Genmab and privately-held Dutch biotech Synaffix have signed a license agreement providing Genmab broad access to Synaffix’ ADC technologies. 4 January 2022
Shares of PTC Therapeutics were up 6.9% to $42.58 by close of trading on Monday, ahead of formally announcing that Waylivra (volanesorsen) has successfully received Category 1 classification from Câmara de Regulação do Mercado de Medicamentos - CMED (Drug Market Regulation Chamber) in Brazil. 4 January 2022
Privately-held Oncoheroes Biosciences is to acquire certain development rights to Allarity Therapeutics’ candidates dovitinib, a pan-targeted kinase inhibitor (pan-TKI), and stenoparib, a PARP inhibitor. 4 January 2022
Advicenne, a French firm specializing in rare renal diseases, has signed an exclusive distribution agreement with Swedish pharma company FrostPharma for the commercialization of Sibnayal (potassium citrate/potassium hydrogen carbonate). 4 January 2022
Shares of Swiss biotech Santhera Pharmaceuticals were up 15.4% at 1.50 Swiss francs by early afternoon, after it revealed an exclusive license agreement with China-based rare diseases specialist Sperogenix Therapeutics. 4 January 2022
Shares in New York-based rare disease firm Applied Therapeutics have fallen by a third, after the company said it would put a US regulatory bid on hold. 4 January 2022
The US Court of Appeals for the Federal Circuit (CAFC) issued its decision upholding the validity of US Patent No 9,187,405 covering a dosing regimen for Gilenya (fingolimod). 4 January 2022
US autoimmune drug developer Kyverna Therapeutics has entered into exclusive, worldwide licenses with the National Institutes of Health (NIH) for intellectual property related to a novel clinical-stage anti-CD19 chimeric antigen receptor T-cell (CAR T) construct with properties uniquely suited for use in autoimmune diseases. 4 January 2022
South Korean Celltrion Group’s shares edged up 1.8% to 200,000 Korean won in early trading on Monday, after it released results for its COVID-19 cocktail therapy candidates including neutralization data against the Omicron variant. 4 January 2022
As another wave of coronavirus infections swamp India, the country has stepped up its efforts to fight the disease and has cleared two new vaccines and one anti-COVID drug for restricted use. 2 January 2022
Novavax closed down 7.6% at $143.07 on Friday, despite announcing that it has completed submission of the final data package, including the complete chemistry, manufacturing and controls module, to fulfill the prerequisites for emergency use authorization (EUA) application request to the US Food and Drug Administration for NVX-CoV2373, the company’s recombinant nanoparticle protein-based COVID-19 vaccine with Matrix-M adjuvant. 1 January 2022
US specialty pharma company Xeris Biopharma saw its share leap nearly 30% to $3.15 post-market on Thursday, after it announced that the US Food and Drug Administration had approved its Recorlev (levoketoconazole) for the treatment of endogenous hypercortisolemia in adult patients with Cushing’s syndrome for whom surgery is not an option or has not been curative. 31 December 2021
The UK subsidiary of US pharma giant Pfizer today announced today that the Medicines and Healthcare products Regulatory Agency (MHRA) has granted a conditional marketing authorization for Great Britain for the supply and use of PF-07321332/ritonavir for the treatment of COVID-19 in adults who do not require supplemental oxygen and who are at increased risk for progression to severe disease. 31 December 2021
Bermuda-based Kiniksa Pharmaceuticals saw its shares drop more than 15% after it announced that the Phase III portion of the Phase II/III trial of mavrilimumab in COVID-19-related acute respiratory syndrome (ARDS) did not meet the primary efficacy endpoint. 31 December 2021
In the USA, a New York jury on Thursday found that Israel-based Teva Pharmaceutical Industries’ US subsidiary contributed to a crisis of opioid abuse in the Empire State, but also placed a small portion of the blame for the epidemic on the state. 31 December 2021
US CNS-focussed biotech Amylyx Pharmaceuticals yesterday revealed that the US Food and Drug Administration has accepted for review its New Drug Application (NDA) for AMX0035 (sodium phenylbutyrate (PB) and taurursodiol [TURSO; also known as ursodoxicoltaurine]) for the treatment of amyotrophic lateral sclerosis (ALS). 30 December 2021
USA-based Viatris announced that it is pleased with decisions issued that affirm the US Patent and Trademark Appeal Board's prior rulings that found the challenged claims of Sanofi's Lantus (insulin glargine) SoloSTAR device patents, US Patent Nos 9,603,044, 8,992,486, 9,526,844, 9,604,008, and 8,679,069, unpatentable. 30 December 2021
Ever increasing investments are being made in artificial intelligence, as drugmakers spy an opportunity to drive efficiencies and spur innovation. In this episode, we discuss an exciting new collaboration between pharmaceutical majors in the field of AI. 30 December 2021
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