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Biotechnology
Privately-held Italian pharma group Mediolanum Farmaceutici has acquired the French immuno-oncology specialist ElsaLys Biotech. 7 May 2020
Biotechnology
Late Wednesday, the US Food and Drug Administration said it has granted accelerated approved for Tabrecta (capmatinib; INC280) for the treatment of adult patients with non-small cell lung cancer (NSCLC) that has spread to other parts of the body. 7 May 2020
Biotechnology
Investors in Regeneron could afford a rare smile in these difficult times, as the company’s first quarter results came in on Tuesday, sending shares 7% higher by midday. 5 May 2020
Biotechnology
Positive top-line data for a pivotal, single-arm, open-label trial of PD-1 inhibitor Libtayo (cemiplimab) in patients with advanced basal cell carcinoma (BCC) who had progressed on or were intolerant to prior hedgehog pathway inhibitor (HHI) therapy were announced today, marking the second non-melanoma skin cancer for which the drug has demonstrated first-in-class data. 5 May 2020
Biotechnology
Privately-held pharma and diagnostics firm Menarini Group has announced a definitive agreement to acquire USA-based Stemline Therapeutics. 5 May 2020
Biotechnology
French drugmaker Ipsen has bought an option on an oncology program from Montreal-based biotech group, IRICoR. 4 May 2020
Pharmaceutical
Deal-making news last week included Japan’s Takeda Pharmaceutical’s collaboration with ProThera Biologics to develop a novel plasma-based IAIP therapy for acute inflammatory conditions. Research news featured a disappointment for Blueprint Medicines with the release of top-line Phase III results for its gastrointestinal stroma tumor (GIST) drug Ayvakit (avapritinib) that failed. Meantime, Sanofi and partner Regeneron Pharmaceuticals presented data on their trial of the repurposed drug Kevzara as a potential therapy for COVID-19, as well as long-awaited positive data for Gilead Sciences’ anti-viral drug remdesivir in the COVID-19 setting and also from the NIAID study of the drug. Elsewhere, news of the US Food and Drug Administration approval for Neurocrine's Parkinson’s disease drug Ongentys was welcome, but the decision to not launch the drug immediately due to the COVID-19 pandemic, while partly expected, was not. 3 May 2020
Biotechnology
On May 1, the US Food and Drug Administration approved Darzalex Faspro (daratumumab and hyaluronidase-fihj) for adult patients with newly diagnosed or relapsed/refractory multiple myeloma. 2 May 2020
Biotechnology
Former Celgene acute myeloid leukemia (AML) candidate CC-486 will be evaluated by the US regulator under its Priority Review scheme. 1 May 2020
Biotechnology
Shares in US biotech Seattle Genetics were 8% higher within minutes of trading starting on Friday, following the announcement of the company’s quarterly financial results. 1 May 2020
Biotechnology
The US Food and Drug Administration has approved the supplemental New Drug Application (sNDA) for Zejula (niraparib), an oral, once-daily poly (ADP-ribose) polymerase (PARP) inhibitor. 30 April 2020
Pharmaceutical
Spanish drugmaker PharmaMar has signed an agreement with Sweden’s Immedica Pharma for the exclusive distribution and marketing, if approved, of the anti-tumor drug lurbinectedin, for territories that include the UK, Ireland, the Nordic countries, some countries within Eastern Europe, the Middle East and North Africa. 29 April 2020
Biotechnology
Blueprint Medicines’ shares dropped 19% in early trade on Tuesday and were still down 17.3% at $58.63 at close, after the rare diseases and cancer immunotherapy company announced that its late-stage trial of already marketed Ayvakit (avapritinib) in an extended indication was a flop. 29 April 2020
Pharmaceutical
Beating analysts’ forecasts for profits in the first quarter of 2020, UK-based drugmaker AstraZeneca reported revenues of $6.3 billion, ban increase of 16% and beating forecasts, yielding a 27% increase in earnings per share (EPS), to $0.59. 29 April 2020
Pharmaceutical
Oslo, Norway-based Photocure has regained sales and marketing rights to Cysview (hexaminolevulinate), known in Europe as Hexvix, from French firm Ipsen. 28 April 2020
Pharmaceutical
In its first quarterly results statement of the year, New York-based pharma giant Pfizer revealed net income of $3.4 billion, better than analysts had expected, based on revenues of $12 billion. 28 April 2020
Biotechnology
US drug giant Merck & Co was trading 3% lower after two hours of trading on Tuesday. 28 April 2020
Biotechnology
The primary endpoint of overall survival (OS) was met in a Phase III trial comparing the PD-1 inhibitor Libtayo (cemiplimab) to platinum doublet chemotherapy in patients with first-line locally advanced or metastatic non-small cell lung cancer (NSCLC) that tested positive for PD-L1 in ≥50% of tumor cells. 27 April 2020
Pharmaceutical
Bayer was trading 5% higher by late Monday after announcing its first quarter financial results. 27 April 2020
Pharmaceutical
Regulatory news last week included two important decisions from the US Food and Drug Administration. First up, Seattle Genetics gained FDA approval for its breast cancer candidate Tukysa (tucatinib). The other was FDA clearance for Incyte’s Pemazyre (pemigatinib) as a treatment for metastatic cholangiocarcinoma. Clinical trial news of note included Switzerland-based Idorsia scoring a goal with positive Phase III results with its investigational insomnia treatment daridorexant, and AstraZeneca on Friday presented new data on its Lynparza in the treatment of prostate cancer. 26 April 2020
Pharmaceutical
UK pharma major AstraZeneca today released positive high-level results from the CAPItello-281 Phase III trial showing that its Truqap (capivasertib) in combination with abiraterone and androgen deprivation therapy (ADT). 25 November 2024
Biotechnology
Research news last week included US biotech releasing early data for its FT819 in the treatment of systemic lupus erythematosus (SLE), which sent the firm’s shares leaping as much as 70%. Also, Netherlands-based NewAmsterdam Pharma announced positive data on its obicetrapib and ezetimibe combination in cardiovascular disease. On the regulatory front, Dutch firm argenX and China’s Zai Lab gained approval from the Chinese medicines regulator for their Vyvgart Hytrulo in chronic inflammatory demyelinating polyneuropathy (CIDP) care. Meantime, USA-based Kura Oncology signed a collaboration with Japan’s Kyowa Kirin on the development of ziftomenib for myeloid leukemia (ALS). 24 November 2024
Pharmaceutical
Japanese mid-size drugmaker Otsuka Pharmaceutical announced that it has entered into an exclusive worldwide licensing agreement with Ionis Pharmaceuticals for rights to manufacture and market Ionis' ulefnersen (ION363), a drug candidate under development for the treatment of patients with amyotrophic lateral sclerosis (ALS) caused by mutation of the fused in sarcoma (FUS) gene. 23 November 2024
Biotechnology
Japanese drugmaker Takeda has launched Fruzaqla (fruquintinib) in its home country. 22 November 2024
Biotechnology
Chinese biopharma CStone Pharmaceuticals has announced a strategic commercial collaboration with Pharmalink Store, a prominent pharmaceutical company based in the United Arab Emirates (UAE). 22 November 2024
Biotechnology
Privately-held US biotech Alloy Therapeutics has announced a strategic collaboration and license agreement with Takeda Pharmaceutical. 21 November 2024
Pharmaceutical
Japanese drugmaker Eisai has announced that the amyotrophic lateral sclerosis (ALS) treatment Rozebalamin for Injection (mecobalamin) has been launched in Japan as a treatment for slowing progression of functional impairment in amyotrophic lateral sclerosis. 21 November 2024
Biotechnology
The US Food and Drug Administration (FDA) has granted accelerated approval of Ziihera (zanidatamab-hrii) 50mg/mL for injection for intravenous use, say the drug’s developer, Jazz Pharmaceuticals. 21 November 2024
Biotechnology
San Diego-based Kura Oncology and Japan’s Kyowa Kirin have entered into a global strategic collaboration to develop and commercialize ziftomenib. 21 November 2024
Pharmaceutical
Shanghai-based Leading Tac Pharmaceutical has announced the successful completion of a series A financing round, raising over 100 million yuan ($14 million). 21 November 2024
Biotechnology
US biotech major Amgen has announced that Dr Howard Chang will join the company as senior vice president of research, effective December 16, 2024. 21 November 2024
Biotechnology
Bioplatform company builder Flagship Pioneering has announced its companies Ampersand Biomedicines and Montai Therapeutics have entered into agreements to identify targeted molecules that could potentially be further developed as treatments for obesity and lung cancer. 20 November 2024
Pharmaceutical
Ascentage Pharma will see its investigational BCL-2 selective inhibitor, lisaftoclax, assessed under China’s Priority Review scheme. 20 November 2024
Biosimilars
Sweden-based Xbrane Biopharma and Intas Pharmaceuticals have announced an exclusive global licensing and co-development agreement for the former company’s Opdivo (nivolumab) biosimilar candidate. 20 November 2024
Biotechnology
A pair of industry veterans have teamed up to create Jupiter Bioventures, a San Francisco-based biotech venture foundry promised to build bold, science-driven therapeutics companies. 20 November 2024
Biotechnology
The UK’s health technology assessor the Institute for Health and Clinical Excellence (NICE) says that talks with the makers of Enhertu have ended without agreement, meaning guidance that does not recommend Enhertu for advanced breast cancer will remain unchanged. 20 November 2024
Biotechnology
German biotech CatalYm has followed up a groundbreaking 2023 with an impressive 2024. 19 November 2024
Biotechnology
US pharma giant Merck & Co today announced positive top-line results from the pivotal Phase III MK-3475A-D77 trial for its mega blockbuster drug Keytruda (pembrolizumab) in subcutaneous form. 19 November 2024
Biotechnology
Privately-held US biotech Georgiamune has announced the appointment of Mark Avagliano as chief business officer (CBO). 19 November 2024
Biotechnology
Germany’s Lindis Biotech, a specialist in multi-specific antibody platforms, has announced an exclusive licensing agreement with Pharmanovia, for the commercialization of Korjuny (catumaxomab). 19 November 2024
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