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BRIEF—Eisai launches Alzheimer’s drug Leqembi in South Korea

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

BRIEF—Centauri given $1.25m to advance antimicrobials

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

BRIEF—Halozyme withdraws non-binding offer for Evotec

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Evotec says it has taken notice of the statement made by Halozyme Therapeutics on November 22, stating that it has withdrawn its non-binding proposal to acquire Evotec for 11.00 euros per share in cash. 23 November 2024

argenX spinoff secures series A extension to fight blood cancer

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

BRIEF—Brookfield mulls $7.4 billion bid for Grifols

19 November 2024

BRIEF—Eisai updates Leqembi outlook

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

BRIEF—Boehringer drops development of Gubra’s NPY2R in obesity

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

BRIEF—Eisai completes rolling submission to US FDA for Leqembi maintenance dosing

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

$800 million investment planned at GSK Pennsylvania site

GSK has announced its largest US manufacturing investment to date, dedicated to producing medicines and vaccines. 25 October 2024

BRIEF—EMA re-affirms non-renewal of masitinib and Translarna authorizations

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

BRIEF—UMCG and SHINE receive $11 million grant for cancer study

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

BRIEF—Germany becomes first country to launch LEO Pharma’s Anzupgo

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

BRIEF—Sanofi in talks to sell 50% of Opella

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

BRIEF—ABPI reviews first six months of the 2024 Voluntary Scheme

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

BRIEF—Sirnaomics secures $7.5 million in share subscription

Sirnaomics, a firm specializing in RNAi therapeutics, has entered into a subscription agreement with biotech specialist Poon Hung Fai. 4 October 2024

GigaGen wins $135 million BARDA contract for botulinum toxin treatment

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

BRIEF— Enara Bio raises $32.5 million to advance pipeline

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

BRIEF—Mitem Pharma acquires Desferal from Novartis

French drugmaker Mitem Pharmavhas the worldwide acquisition of Desferal (deferoxamine), a major MITM in hematology, from Swiss giant Novartis. 25 September 2024

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BRIEF—Bruno Sepodes elected as EMA’s new CHMP chair

The European Medicines Agency’s (EMA) Committee for Human Medicinal Products (CHMP) has elected Bruno Sepodes as its new chair. 19 September 2024

BRIEF—OeAW and Boeh-Ing Foundation establish new Institute for biomedical AI in Vienna

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

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BrainStorm to press on with NurOwn BLA

USA and Israel-based-BrainStorm Cell Therapeutics is to submit a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for NurOwn (autologous MSC-NTF cells) to treat amyotrophic lateral sclerosis (ALS). 16 August 2022

Indian companies move patent matters out of court

As generic drugmakers are dragged to court by patent holders and the cost of litigation soars for both generic as well as innovative pharma companies, many are settling patent disputes out of court. Generic companies often agree to delay their entry into the market in exchange for certain benefits, such as licenses to other patents, reports The Pharma Letter’s India correspondent. 16 August 2022

ADC restructures debt as Zynlonta struggles to make impact

Deerfield Management is to take a stake in Swiss firm ADC Therapeutics, an antibody-drug conjugate company based in Lausanne, as the company restructures its obligations. 16 August 2022

FDA accepts supplemental BLA for Roche's Polivy combo

Swiss pharma giant Roche has announced that the US Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) for Polivy (polatuzumab vedotin-piiq) in combination with Rituxan (rituximab). 16 August 2022

FDA inspections back up to speed, except those now deemed unnecessary

During much of the last two years, due to the COVID-19 pandemic and the movement restrictions that were imposed, US Food and Drug Administration inspections of manufacturing facilities were seriously limited and resulted in a large number of delays in new drug approvals. 16 August 2022

Chugai's Edirol Tablet approved in Japan as osteoporosis therapy

Japanese pharma major Chugai Pharmaceutical has obtained regulatory approval from the Ministry of Health, Labor andY Welfare (MHLW) for the osteoporosis treatment Edirol (eldecalcitol) Tablet (0.5µg/0.75µg). 16 August 2022

Gilead to acquire remaining worldwide rights of Trodelvy

US biotech major Gilead Sciences has entered into an agreement with China’s Everest Medicines to transfer all development and commercialization rights to Gilead for Trodelvy (sacituzumab govitecan) in Greater China, South Korea, Singapore, Indonesia, Philippines, Vietnam, Thailand, Malaysia and Mongolia. 16 August 2022

Lynparza combo accepted by FDA for priority review

UK pharma major AstraZeneca’s supplemental New Drug Application (sNDA) for Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone has been accepted and granted Priority Review in the USA for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC). 16 August 2022

CinCor raises $258 million following Phase II hypertension data

US clinical-stage biotech CinCor Pharma, which is developing its lead clinical candidate, baxdrostat, for the treatment of hypertension and other cardio-renal diseases, yesterday announced the closing of its upsized underwritten public offering consisting of an aggregate of 8,625,000 shares of common stock and pre-funded warrants. 16 August 2022

Opthea secures up to $170 million

Australia's Opthea, a clinical-stage biopharmaceutical company developing novel therapies to treat highly prevalent and progressive retinal diseases, has announced a non-dilutive financing transaction for up to $170 million. 15 August 2022

Trodelvy first TROP-2 directed ADC to show significant OS improvement in HR+/HER2- breast cancer

US biotech major Gilead Sciences’ shares were up 4% at $65.48 in early trading today, as it announced statistically-significant and clinically-meaningful results from the second interim analysis of the key secondary endpoint of overall survival (OS) in the Phase III TROPiCS-02 study evaluating Trodelvy (sacituzumab govitecan-hziy) in patients with HR+/HER2- metastatic breast cancer who received prior endocrine therapy, CDK4/6 inhibitors and two to four lines of chemotherapy. 15 August 2022

Aptinyx loses a third of its value on fibromyalgia failure

Chicago-based Aptinyx, a clinical-stage biopharmaceutical company developing therapies for the treatment of brain and nervous system disorders, has announced disappointing results from a Phase IIb study evaluating the effects of NYX-2925 in patients with fibromyalgia. 15 August 2022

First global nod for Moderna's Omicron-containing bivalent Covid-19 vaccine

US mRNA biotech Moderna edged up less than 1% pre-market this morning, despite announcing the first-ever approval worldwide for its next-generation bivalent COVID-19 vaccine. 15 August 2022

Novartis' canakinumab fails again

Swiss pharma giant Novartis has announced that the Phase III CANOPY-A study evaluating adjuvant treatment with canakinumab, an inhibitor of interleukin-1beta did not meet its primary endpoint of disease-free survival versus placebo. 15 August 2022

We need a new Prozac: The demand for brain drug innovation

An Expert View from Emer Leahy, chief executive, and Dani Brunner, chief innovation officer, of PsychoGenics, on the challenges involved in tackling mental disorders. 15 August 2022

Santen launches new drug for post-cataract-surgery care

UK-based subsidiary of Japanese ophthalmology firm Santen Pharmaceutical has announced the launch of Ducressa in the UK and Ireland, a fixed dose combination (FDC) of levofloxacin and dexamethasone for use after cataract surgery that also offers a modern and convenient seven-day therapeutic strategy to optimize post-surgery care. 15 August 2022

Terns Pharma leaps on $65 million public offering to advance pipeline

Terns Pharmaceuticals saw it shares fly up more than 25% to $3.02 on Friday, after it announced a $65 million underwritten public offering, which is expected to close on August 16, 2022, subject to customary closing conditions. 15 August 2022

Addex and Indivior extend GABAB research collaboration

Switzerland-headquartered biotech Addex Therapeutics today announced that its collaboration agreement with UK-based Indivior for discovering and developing novel oral gamma-aminobutyric acid subtype B (GABAB) positive allosteric modulator (PAM) drug candidates has been extended until March 31, 2023. 15 August 2022

Nanoparticle therapy may help patients hospitalized with severe COVID-19 infections

Researchers at the USA’s Johns Hopkins Medicine say that an experimental dendrimer nanoparticle treatment called OP-101 substantially reduced the risk of death and need for a ventilator in a study of 24 severely ill adults hospitalized with COVID-19. 15 August 2022

More success in oncology lifts AstraZeneca stock

Investments in research and development continue to pay dividends for British drugmaker AstraZeneca, with the firm’s antibody-drug conjugate (ADC) Enhertu (trastuzumab deruxtecan) passing an important test in breast cancer. 15 August 2022

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