Latest Pharma and Biotech News
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27 November 2024 The strain of opioid use disorder (OUD), a chronic neurological disorder characterized by the compulsive, repeated use of opioid drugs, has weighed heavily on many countries in recent years, especially the USA.
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Biotechnology
The European medicines regulator has approved a combo therapy starring PD-1 inhibitor Tevimbra (tislelizumab), from cancer firm BeOne Medicines, formerly BeiGene. 27 November 2024
Biotechnology
After trading closed yesterday, Exelixis revealed that the US Food and Drug Administration (FDA) has notified the company that the supplemental New Drug Application (sNDA) for cabozantinib (Cabometyx) for the treatment of adults with previously treated advanced pancreatic neuroendocrine tumors (pNET) and advanced extra-pancreatic NET (epNET) will be discussed at an Oncologic Drugs Advisory Committee (ODAC) meeting in March 2025. 27 November 2024
Biotechnology
Chengdu-based Kelun-Biotech has received marketing authorization in China for sacituzumab tirumotecan (sac-TMT), a Trop2-directed antibody-drug conjugate (ADC). 27 November 2024
Biotechnology
AI-powered protein engineering company Cradle has raised $73 million in a Series B funding. The European firm, which has now raised more than $100 million in total, calls itself the leading platform for AI-powered protein engineering. 27 November 2024
Biotechnology
US clinical stage biotech Alector saw its shares tumble 35% to $2.57 by close of trading yesterday, as it announced disappointing results from the INVOKE-2 Phase II clinical trial evaluating the safety and efficacy of AL002 in slowing disease progression in individuals with early Alzheimer’s disease (AD). 27 November 2024
Biotechnology
PTC Therapeutics has announced that its Phase II trial for utreloxastat, aimed at treating amyotrophic lateral sclerosis (ALS), failed to meet its primary endpoint. 27 November 2024
Biotechnology
US companies Arrowhead Pharmaceuticals and Sarepta Therapeutics have announced a global licensing and collaboration agreement. 26 November 2024
Biotechnology
Clinical-stage US CAR-T therapies developer Poseida Therapeutics saw its shares skyrocket 227% to $9.36 pre-market today, on the news of a proposed takeover by Swiss pharma giant Roche. 26 November 2024
Biotechnology
Replimune, a clinical-stage biotech focused on oncolytic immunotherapies, has announced plans to raise $125 million through a public offering. 26 November 2024
Biotechnology
Chinese gene therapy firm Kanglin Biotechnology has completed a $20 million series A financing round, with the money earmarked for KL003, an innovative treatment for blood disorders. 26 November 2024
Biotechnology
BRL Medicine, a Shanghai-based biotechnology company specializing in cell and gene therapies, has raised nearly 200 million yuan ($27 million) in a series B+ round led by CSPC Fund. 26 November 2024
Biotechnology
Italian oncology focused biotech Nerviano Medical Sciences yesterday announced that it has successfully negotiated with Germany’s Merck KGaA to buy back the full world-wide rights of NMS 293 (also known as NMS-03305293). 26 November 2024
Biotechnology
South African-Australian private equity firm LeapFrog Investments has announced the close of its fourth fund (Fund IV), with commitments and designated co-investments totalling $1.02 billion. 26 November 2024
Biotechnology
Pyxis Oncology has announced encouraging preliminary data from a Phase I trial of PYX-201, its lead antibody-drug conjugate (ADC), in solid tumors. 26 November 2024
Biotechnology
The Phase III SKYSCRAPER-01 trial has missed its primary endpoint, Swiss cancer giant Roche has reported. 26 November 2024
Biotechnology
US biopharma Biohaven has provided an update regarding the taldefgrobep alfa development programs in spinal muscular atrophy (SMA) and obesity. 25 November 2024
Biotechnology
Cassava Sciences, a US biotech developing a novel, investigational treatment for Alzheimer’s disease (AD) dementia, was trading 83% lower at midday on Thursday. 25 November 2024
Biotechnology
The US Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for belantamab mafodotin in combinations with bortezomib plus dexamethasone (BorDex [BVd]) and pomalidomide plus dexamethasone (PomDex [BPd]) for multiple myeloma patients who have received at least one prior line of therapy. 25 November 2024
Biotechnology
Danish biotech Adcendo today announced the successful closing of an oversubscribed $135 million Series B financing round. 25 November 2024
Biotechnology
StemCyte, a subsidiary of StemCyte International, has secured approval from the US Food and Drug Administration for Regenecyte, a cord blood-derived stem cell therapy. 25 November 2024
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Biotechnology
China’s Sinovac has reported positive Phase III data for its coronavirus vaccine, CoronaVac, with 50.65% overall efficacy after two weeks, following two doses. 8 February 2021
Biotechnology
On Friday, the US Food and Drug Administration granted accelerated approval for Ukoniq (umbralisib), a kinase inhibitor including PI3K-delta and casein kinase CK1-epsilon. 8 February 2021
Biotechnology
The US Food and Drug Administration on Friday at last approved Breyanzi (lisocabtagene maraleucel – liso-cel), a cell-based gene therapy to treat adult patients with certain types of large B-cell lymphoma who have not responded to, or who have relapsed after, at least two other types of systemic treatment. 8 February 2021
Biotechnology
Regeneron Pharmaceuticals' shares gained 3.9% in pre-market trading on Friday, after announced financial results for the fourth quarter and full year 2020. 6 February 2021
Biotechnology
German mRNA company CureVac has entered a collaboration with the UK government to develop and manufacture potential vaccine candidates against SARS-CoV-2 variants. 5 February 2021
Biotechnology
Anglo-Swedish drugmaker AstraZeneca closed 1.5% lower on Friday following disappointing news on its Imfinzi (durvalumab) immunotherapy. 5 February 2021
Biotechnology
Japanese drugmaker Daiichi Sankyo announced today that it recently entered into an outsourcing agreement with the local subsidiary of UK pharma majora AstraZeneca to manufacture the AstraZeneca/Oxford University-developed COVID-19 vaccine, AZD1222, in Japan. 5 February 2021
Biotechnology
French pharma major Sanofi has reported final quarter sales of 9.4 billion euros ($11.3 billion), bringing the year’s total to 36 billion euros. 5 February 2021
Biotechnology
US biotech Gilead Sciences yesterday posted a strong set of 2020 fourth-quarter and full-year financial results, which saw its shares close up 2%, and a rise a further 2% to $67.15 pre-market today. 5 February 2021
Biotechnology
Belgium’s largest drugmaker UCB today announced that The Lancet has published positive results from BE VIVID and BE READY, two Phase III studies evaluating the efficacy and safety profile of bimekizumab, its investigational interleukin (IL)-17A and IL-17F inhibitor, in the treatment of adults with moderate to severe plaque psoriasis. 5 February 2021
Biotechnology
Janssen Biotech has submitted an application to the US Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) for its investigational single-dose Janssen COVID-19 vaccine candidate. 5 February 2021
Biotechnology
Japanese drugmaker Astellas Pharma has boosted its senior management team, creating two new positions which will report directly to chief executive Kenji Yasukawa. 5 February 2021
Biotechnology
The US Food and Drug Administration is again alerting the public that preliminary results from a safety clinical trial show an increased risk of serious heart-related problems and cancer with the arthritis and ulcerative colitis medicine Xeljanz, Xeljanz XR (tofacitinib) compared to another type of medicine called tumor necrosis factor (TNF) inhibitors. 5 February 2021
Biotechnology
Beating many analysts’ expectations for the final quarter, Bristol Myers Squibb reported sales of $11.1 billion in its annual results statement, yielding full-year revenues of $42.5 billion. 4 February 2021
Biotechnology
The China National Medical Products Administration (NMPA) has granted conditional approval to Xospata (gilteritinib) for the treatment of adult patients who have relapsed (disease that has returned) or refractory (resistant to treatment) acute myeloid leukemia (AML) with a FLT3 mutation (FLT3mut+) detected by a fully validated test. 4 February 2021
Biotechnology
A scientific panel of the European Medicines Agency has kicked off a rolling review of NVX-CoV2373, a COVID‑19 vaccine being developed by US biotech Novavax. 4 February 2021
Biotechnology
Swiss pharma giant Roche this morning announced 2020 financial results, showing that group sales increased 1% to 58.32 billion Swiss francs ($65.43 billion) at constant exchange rates (CER), but a 5% decline in Swiss francs, as a result of continued appreciation of the Swiss franc against most currencies, as well as biosimilars competition. 4 February 2021
Biotechnology
The US Food and Drug Administration late yesterday granted accelerated approval to Tepmetko (tepotinib), from EMD Serono, the US healthcare business of Germany’s Merck KGaA for adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations. 4 February 2021
Biotechnology
Setting the scene for an active M&A year for the biopharma sector, US biotech firm Jazz Pharmaceuticals today announced the biggest takeover deal so far this year. 3 February 2021
Biotechnology
AbbVie, which has recently completed its $63 billion acquisition of Allergan, today announced financial results for the fourth quarter and full year ended December 31, 2020, that beat Wall Street forecasts, and pushing the firm’s shares 1.8% higher to $105.33 by mid-morning. 3 February 2021
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