In Brief
Refine Search
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Evotec says it has taken notice of the statement made by Halozyme Therapeutics on November 22, stating that it has withdrawn its non-binding proposal to acquire Evotec for 11.00 euros per share in cash. 23 November 2024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
Biotechnology
Zenas BioPharma announced the pricing of its upsized initial public offering of 13,235,294 shares of its common stock at an initial public offering price of $17.00 per share. 13 September 2024
Pharmaceutical
The US Food and Drug Administration (FDA) on Friday announced the approval of the investigational oral selective estrogen receptor degrader (SERD) Orserdu (elacestrant) for postmenopausal women or adult men with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy. 28 January 2023
Biotechnology
On Thursday, the US Food and Drug Administration’s (FDA) Vaccine and Related Biological Products Advisory Committee (VRBPAC) met to discuss future vaccination regimens addressing COVID-19. 27 January 2023
Pharmaceutical
The European Medicines Agency (EMA) has issued an update on ongoing shortages of antibiotic medicines containing amoxicillin—alone and in combination with clavulanic acid. 27 January 2023
Biotechnology
Although there were several positive recommendations for label extensions on already approved medicines, January proved a thin month for novel drug approvals in the European Union, with just one new drug and three for generics. 27 January 2023
Biotechnology
Exkivity (mobocertinib) is the first targeted therapy to be approved for locally-advanced or metastatic epidermal growth factor receptor (EGFR) exon 20 insertions (exon20ins)-positive non-small cell lung cancer (NSCLC) in China. 27 January 2023
Pharmaceutical
Research from the IQVIA Institute for Human Data Science shows that total spending and global demand for medicines could hit $1.9 trillion by 2027. 27 January 2023
Biotechnology
Yesterday the US Food and Drug Administration (FDA) granted yet another approval for Merck & Co’s mega blockbuster checkpoint blocker Keytruda (pembrolizumab, this time for adjuvant treatment following resection and platinum-based chemotherapy for stage IB (T2a ≥4 cm), II, or IIIA non-small cell lung cancer (NSCLC). 27 January 2023
Biotechnology
The US Food and Drug Administration (FDA) has approved the expanded indication for Enjaymo (sutimlimab-jome), the first and only treatment of hemolysis in adults with cold agglutinin disease (CAD), to include patients with or without a history of transfusions. 27 January 2023
Biotechnology
The US Food and Drug Administration yesterday revised the Emergency Use Authorization (EUA) for Evusheld (tixagevimab co-packaged with cilgavimab) to limit its use to when the combined frequency of non-susceptible SARS-CoV-2 variants nationally is less than or equal to 90%. 27 January 2023
Biotechnology
US traded shares of AC Immune were up more than 9% at $2.56 in pre-market activity today, as the Swiss biotech said its ACI-24.060 anti-amyloid beta (Abeta) vaccine for Alzheimer's disease (AD) showed positive initial interim safety and immunogenicity in a Phase Ib/II trial dubbed ABATE. 26 January 2023
Biotechnology
After a career that has seen him lead Exelixis, Biogen and most recently, Vir Biotechnology, George Scangos is to retire in early April. 26 January 2023
Pharmaceutical
An interview reflecting on 2022 and looking forward to the year ahead with Paul O'Donohoe senior director, eCOA Product and Science at Medidata. 26 January 2023
Biotechnology
As global macroeconomic uncertainty hit fundraising across all sectors, investment in UK biotechnology fell from the all-time highs seen in 2021, a new analysis from the industry lobby group UK BioIndustry Association (BIA) and data and insights company Clarivate shows. 26 January 2023
Pharmaceutical
Pharma industry analyst GlobalData has highlighted the strength of data supporting a submission from US biotech Intercept Pharmaceuticals in non-alcoholic steatohepatitis (NASH). 26 January 2023
Pharmaceutical
On December 23 2022, the FDA Modernization Act 2.0 was passed with full support from both the US House of Representatives and the Senate.1 This act aims to improve the process for approving drugs and commits to significantly reducing the use of dogs, primates, and other animals in laboratory testing. 26 January 2023
Biosimilars
The US Food and Drug Administration (FDA) has released the BsUFA III Regulatory Science Pilot Program: Research Roadmap. 26 January 2023
Pharmaceutical
Shares of US retinal eye disorder specialist Ocuphire Pharma slumped more than 29% to $2.66, after it released disappointing top-line efficacy and safety results from its ZETA-1 Phase II trial evaluating oral APX3330 for the treatment of diabetic retinopathy (DR). 26 January 2023
Biotechnology
Already expected to reach blockbuster status with its 2022 sales, AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has won another approval in Europe. 26 January 2023
Biotechnology
Leading checkpoint blocker Keytruda (pembrolizumab) has offered a mixed bag of outcomes for people with two different types of cancer. 26 January 2023
Biotechnology
In the second setback in the space of a little over a month, Magenta Therapeutics saw its shares crash 23.3% to $0.38 pre-market today, after the US biotech revealed that the latest participant dosed at the Cohort 3 level (0.08mg/kg) in the ongoing MGTA-117 Phase I/II dose-escalation clinical trial in relapsed/refractory acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) experienced a Grade 5 serious adverse event (SAE) (respiratory failure and cardiac arrest resulting in death) deemed to be possibly related to MGTA-117. 26 January 2023
Sign up to receive email updates
Join industry leaders for a daily roundup of biotech & pharma news
Today's issue
Company Spotlight
A US biotech company dedicated to creating oral drugs with an emphasis on indications in virology and immunology.
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze