10 October 2024 Machine learning-enabled drug discovery and development company insitro has announced the execution of three strategic agreements with Eli Lilly.
US biotech Adagio Therapeutics today outlined strategic initiatives for its ADG20 program, as well as research efforts to address SARS-CoV-2 and other coronaviruses. 22 February 2022
US rare liver disease-focussed biotech Albireo Pharma said today that the UK’s National Institute for Health and Care Excellence (NICE) has issued guidance that recommends Bylvay (odevixibat) for the treatment of all types of progressive familial intrahepatic cholestasis (PFIC) in people aged six months and older. 22 February 2022
Dutch thrombotic diseases specialist TargED Biopharmaceuticals has raised 39 million euros ($44 million) in a Series A financing to accelerate development of its lead compound, Microlyse. 22 February 2022
Following a December positive opinion from the European Medicines Agency’s advisory committee, the European Commission has granted marketing authorization in the European Union (EU) for Kerendia (finerenone). 22 February 2022
Independent private equity firm dedicated to biotech and biopharma Jeito Capital today announced that it has co-led a $65 million Series A financing round in EyeBiotech Limited (EyeBio), a privately held ophthalmology biotechnology company working to deliver a new generation of therapies for eye diseases. 22 February 2022
German biotech BioNTech, which has earned billions of dollars through its COIVD-19 vaccine development with Pfizer (NYSE: PFE), is looking to expand its business into new areas. 22 February 2022
Binnopharm Group, leading drug producer in Russia via its affiliate Alium, and Indian pharm major Dr Reddy's Laboratories today announced the signing of a deal that will allow Binnopharm Group to acquire anti-bacterial medicines under the Ciprolet (ciprofloxacin) and Levolet (levofloxacin) brands from Dr Reddy’s in Russia, Uzbekistan and Belarus. 21 February 2022
Shares in US genetic medicines company Homology Medicines were set to open 37% lower on Monday following the release of bad news since Friday’s close. 21 February 2022
Positive high-level results from the pivotal DESTINY-Breast04 Phase III trial showed Enhertu (trastuzumab deruxtecan) demonstrated a statistically-significant and clinically-meaningful improvement in both progression-free survival (PFS) and overall survival (OS) in patients with HER2-low unresectable and/or metastatic breast cancer regardless of hormone receptor (HR) status versus physician’s choice of chemotherapy. 21 February 2022
Japanese drugmaker Ono Pharmaceutical says that its Taiwanese subsidiary has received an approval of Velexbru (tirabrutinib hydrochloride) tablet 80mg, a Bruton’s tyrosine kinase (BTK) inhibitor, from the Taiwan Food and Drug Administration (TFDA) for the treatment of adult patients with recurrent or refractory B-cell primary central nervous system lymphoma. 21 February 2022
The bipolar disorder market is expected to grow from $4.1 billion in 2020 to $4.9 billion by 2030 across the eight major markets (8MM: the USA, France, Germany, Italy, Spain, UK, Japan and Canada) at a compound annual growth rate (CAGR) of 1.7%. 21 February 2022
Shares of UK respiratory disease focussed biotech Synairgen plunged more than 85% to 25.04 pence this morning, after it announced that the international Phase III SPRINTER trial of SNG001 in patients hospitalized with COVID-19 did not meet its primary or key secondary efficacy endpoints. 21 February 2022
A Phase III trial (CUPID STUDY B) evaluating Dupixent (dupilumab) in patients with chronic spontaneous urticaria (CSU), who were refractory to omalizumab, will stop due to futility based on a pre-specified interim analysis, marking a rare, albeit minor, set-back for the blockbuster monoclonal antibody (MAb). 21 February 2022
South Korea’s Celltrion Healthcare announced new data sets on the SC formulation of infliximab, Remsima (CT-P13) in IBD, at the European Crohn’s and Colitis Organization (ECCO) virtual congress 2022. 21 February 2022
Danish dermatology specialist LEO Pharma has appointed Brian Hilberdink new executive vice president and president of LEO Pharma Inc in the USA, effective March 14, 2022. 21 February 2022
The US Food and Drug Administration has lifted its clinical hold on the Investigational New Drug (IND) application to evaluate the vaccine candidate, BBV152, known as COVAXIN outside the USA, that was submitted by Ocugen. 21 February 2022
The long-awaited confirmation from the US Senate of Robert Califf’s nomination to become Food and Drug Administration Commissioner was announced last Tuesday, but on a tight vote. On the research front, Sage Therapeutics and Biogen announced confident results for their depressive disorder candidate zuranolone but questioned were raised on its commercial potential. Regulatory developments included the FDA granting accelerated approval for Agios Pharmaceuticals’ Pyrukynd (mitapivat) for a rare form of anemia. But BioMarin had a setback last Thursday when the FDA said it needed more information to lift the clinical hold on the firm’s gene therapy BMN 307 clinical trial. 20 February 2022
German life sciences and pharma company Merck KGaA late on Friday revealed that the European Commission (EC) has approved once-daily oral Tepmetko (tepotinib) as monotherapy for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harboring alterations leading to mesenchymal-epithelial transition factor gene exon 14 (METex14) skipping, who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy. 19 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