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Biotechnology
Japanese drugmaker Eisai today that the humanized antisoluble aggregated amyloid-beta (Aβ) monoclonal antibody Leqembi (lecanemab) has been launched in South Korea. 28 November 2024
Pharmaceutical
UK-based immunotherapy firm Centauri Therapeutics has secured a £1 million ($1.25 million) grant from PACE (Pathways to Antimicrobial Clinical Efficacy) to further develop its Alphamer technology. 25 November 2024
Biotechnology
Germany’s Evotec says it has taken notice of the statement made by Halozyme Therapeutics on November 22, stating that it has withdrawn its non-binding proposal to acquire Evotec for 11.00 euros per share in cash. 23 November 2024
Biotechnology
Colorado, USA-based OncoVerity announced the closing of a series A extension led by existing investors, argenX and RefinedScience. The value was not disclosed, but this extension follows a $30 million Series A fundraiser in March 2023. 22 November 2024
Biotechnology
Sweden-based BioArctic saw its fall 7.5% to 139.90 kronor on Friday, after its announced that its partner, Japan’s Eisa, has updated its revenue outlook for the Alzheimer’s treatment Leqembi (lecanemab) for the 2024 fiscal year (FY), which runs from April 2024 through March 2025. 11 November 2024
Biotechnology
Danish biotech Gubra announces that Germany’s Boehringer Ingelheim has decided to discontinue the development of the long-acting neuropeptide Y receptor type 2 (NPY2R) agonist BI 1820237 in obesity. 4 November 2024
Biotechnology
Japanese drugmaker Eisai has completed the rolling submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for lecanemab-irmb (US brand name Leqembi) subcutaneous autoinjector for weekly maintenance dosing after it was granted Fast Track designation by the FDA. 1 November 2024
Pharmaceutical
GSK has announced its largest US manufacturing investment to date, dedicated to producing medicines and vaccines. 25 October 2024
Pharmaceutical
Following a re-examination, the European Medicines Agency’s human health committee, CHMP confirmed its initial recommendation to refuse the granting of a conditional marketing authorization for Masitinib AB Science’s masitinib. 18 October 2024
Pharmaceutical
University Medical Center Groningen (UMCG) and SHINE Europe have secured a 10.5 million euro ($11 million) grant to advance European production of terbium isotopes for cancer treatments. 17 October 2024
Pharmaceutical
Danish dermatology focused LEO Pharma has announced the launch of Anzupgo (delgocitinib) cream in Germany for the treatment of adult patients with moderate to severe chronic hand eczema (CHE), for whom topical corticosteroids are inadequate or inappropriate. 15 October 2024
Pharmaceutical
French pharma major Sanofi revealed it has entered into negotiations with private equity firm Clayton Dubilier & Rice (CD&R) for the potential sale of a 50% controlling stake in Opella, its consumer healthcare business. 14 October 2024
Pharmaceutical
The UK’s new 2024 voluntary scheme for branded medicines pricing, access, and growth (VPAG) came into force at the beginning of January this year. 4 October 2024
Biotechnology
Sirnaomics, a firm specializing in RNAi therapeutics, has entered into a subscription agreement with biotech specialist Poon Hung Fai. 4 October 2024
Biotechnology
GigaGen has been awarded a contract by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the US Department of Health and Human Services (HHS). 4 October 2024
Biotechnology
Oxford, UK-based Enara Bio today announces the closing of a $32.5 million Series B financing supported by a strong syndicate of new and existing biotech investors. 3 October 2024
Pharmaceutical
French drugmaker Mitem Pharmavhas the worldwide acquisition of Desferal (deferoxamine), a major MITM in hematology, from Swiss giant Novartis. 25 September 2024
article
The European Medicines Agency’s (EMA) Committee for Human Medicinal Products (CHMP) has elected Bruno Sepodes as its new chair. 19 September 2024
Pharmaceutical
The Austrian Academy of Sciences (OeAW) is further expanding its focus on life sciences by opening an institute for biomedical artificial intelligence (AI) based on a 150 million euros ($166.8 million) funding from the German non-profit Boehringer Ingelheim Foundation (BIS). 18 September 2024
Pharmaceutical
UK-based Verona Pharma pleased investors today, as it announced positive results from its Phase III ENHANCE-2 trial of ensifentrine for the treatment of chronic obstructive pulmonary disease (COPD), news of which sent the firm’s shares up more than 100% to $13.93 in pre-market trading. 9 August 2022
Biotechnology
Chinese biotech BeiGene has announced that the global Phase III RATIONALE 301 trial with tislelizumab met its primary endpoint of non-inferior overall survival (OS) versus sorafenib as a first-line treatment in adults with unresectable hepatocellular carcinoma (HCC). 9 August 2022
Biotechnology
US clinical-stage biotech Mersana Therapeutics saw its shares trading up 14.1% at $5.99 pre-market this morning, after it announced a global collaboration that provides UK pharma major GSK with an exclusive option to co-develop and commercialize XMT-2056, an Immunosynthen ADC that targets a novel epitope of HER2. 9 August 2022
Biotechnology
French drugmaker Sanofi has paused recruitment for its global tolebrutinib Phase III trials following guidance from the independent data monitoring committee (iDMC), resulting in an almost 2% drop in its share price. 9 August 2022
Biotechnology
Danish biotech Genmab says it is improving its 2022 financial guidance that was published on May 11 this year. 9 August 2022
Generics
Japanese drug major Chugai Pharmaceutical announced that, along with majority owner Roche and its biotech subsidiary Genentech (collectively “the companies”) have entered into a settlement agreement with Fresenius Kabi USA, on August 5, 2022 relating to the patent lawsuit filed by the companies on March 19, 2020. 9 August 2022
Biotechnology
The outlook for a much-anticipated innovative treatment for Huntington’s disease has been muddied by a surprise serious side effect in a Phase I/II trial. 9 August 2022
Biotechnology
German biotech company BioNTech was trading more than 10% lower on Monday afternoon in New York after announcing its latest financial results. 8 August 2022
Pharmaceutical
The outbreak of coronavirus disease (COVID-19) has brought the issue of localization to the forefront, which necessitated the need for localization of pharmaceutical manufacturing to achieve self-sufficiency and self-reliance, writes The Pharma Letter's local correspondent. 8 August 2022
Biotechnology
Following positive results in a Phase III study of fruquintinib, Hutchmed's shares were on the way up on Monday. 8 August 2022
Biotechnology
Preliminary results from the Savannah Phase II trial showed that Tagrisso (osimertinib) plus savolitinib demonstrated an objective response rate of almost 50% in patients. 8 August 2022
Biotechnology
US clinical-stage biotech firm Karuna Therapeutics saw its shares leap more than 40% to $197.50 pre-market today, as it announced positive top-line results from its Phase III EMERGENT-2 trial evaluating the efficacy, safety, and tolerability of KarXT (xanomeline-trospium), an oral investigational M1/M4-preferring muscarinic agonist, in adults with schizophrenia. 8 August 2022
Pharmaceutical
Big M&A rumors continue to swirl round the pharma world this summer, with talk of a Pfizer bid for Global Blood Therapeutics in the offing. 8 August 2022
Pharmaceutical
US President Joe Biden looks set to secure a major legislative win that would affect drug pricing in the country, as the Inflation Reduction Act narrowly won Senate approval on Sunday. 8 August 2022
Biotechnology
Cash-rich pharma giant Pfizer is continuing its spending spree, with the $5.4 billion acquisition of rare blood disease specialist Global Blood Therapeutics. 8 August 2022
Pharmaceutical
Spanish drugmaker PharmaMar has announced that Zepzelca (lurbinectedin) has received the Innovation Passport (Innovative Medicine Designation) by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). 8 August 2022
Pharmaceutical
Myovant Sciences and Pfizer have received US Food and Drug Administration (FDA) approval for Myfembree (relugolix 40mg, estradiol 1mg, and norethindrone acetate 0.5mg) as a one-pill, once-a-day therapy for the management of moderate to severe pain associated with endometriosis in pre-menopausal women, with a treatment duration of up to 24 months as per the attachment. 8 August 2022
Biotechnology
USA-based biotech EQRx on Sunday announced a late-breaking oral presentation of updated data from the Phase III GEMSTONE-301 trial of sugemalimab in non-small cell lung cancer (NSCLC) at the International Association for the Study of Lung Cancer (IASLC) 2022 World Conference on Lung Cancer (WCLC), taking place August 6 through August 9, 2022. 8 August 2022
Biotechnology
Sino-American biotech BeiGene saw its shares close up more than 12% at 112.05 renminbi on Friday, after it reported financial results for the second quarter of 2022, recent business highlights, and anticipated upcoming milestones. 8 August 2022
Biotechnology
Japanese drugmaker Maruho has launched the anti-interleukin (IL)-31 receptor A humanized monoclonal antibody Mitchga (nemolizumab [genetical recombination]) subcutaneous Injection 60mg syringes for the treatment of itching associated with atopic dermatitis (only when existing treatment is insufficiently effective). 8 August 2022
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