Latest Pharma and Biotech News
Pharmaceutical
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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Pharmaceutical
Following a four to zero vote for the action, the US Federal Trade Commission (FTC) has filed an amicus brief with the US District Court for the District of Delaware in the case of US drugmaker Jazz Pharmaceuticals versus Ireland-incorporated Avadel Pharmaceuticals 12 November 2022
Biosimilars
As with every sector, the biopharmaceutical field has its own lingo—a world of jargon and buzz words that develop alongside industry trends and wider societal changes, some carrying significant meaning and others representing little more than the hype of marketers. 11 November 2022
Biosimilars
Following its November 2022 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended four medicines for approval, one a biosimilar, two generics and the other a coronavirus vaccine. 11 November 2022
Biotechnology
A dose of reality appears to have brought about a change at EQRx. 11 November 2022
Biotechnology
Harbour BioMed saw its shares close up 12% at HK$1.30 today, on the news that its subsidiary Nano Biosciences has entered into a license and collaboration agreement with US biotech Moderna, a pioneer of messenger RNA (mRNA) therapeutics and vaccines. 11 November 2022
Biotechnology
There is a new COVID-19 booster vaccine in town, just in time for Europe’s fall and winter season. 11 November 2022
Biosimilars
The European Commission has granted a marketing authorization for Ximluci (ranibizumab), a biosimilar candidate referencing Lucentis, developed by Germany’s STADA Arzneimittel and Sweden’s Xbrane Biopharma. 11 November 2022
Biotechnology
The US Food and Drug Administration has granted a new approval to a checkpoint inhibitor combo developed by AstraZeneca, Imfinzi (durvalumab) plus Imjudo (tremelimumab), in lung cancer. 11 November 2022
Pharmaceutical
Diabetes giant Novo Nordisk looks set to maintain its dominant position in type 2 diabetes, despite recent supply issues affecting its glucagon-like peptide-1 (GLP-1) franchise. 11 November 2022
Biotechnology
US Biotech Seagen announced that David Epstein has been appointed as a permanent chief executive and board member, replacing interim CEO Roger Dansey. 11 November 2022
Pharmaceutical
UK pharma major GSK has announced the publication of positive end of study results from the B-Clear Phase IIb trial evaluating bepirovirsen in chronic hepatitis B in the New England Journal of Medicine. 10 November 2022
Biotechnology
The game is nearly up for Clovis Oncology. 10 November 2022
Biotechnology
Shares of USA-based Kronos Bio plunged more than 9% to $2.32 in early trading today, after it announced the prioritization of its clinical portfolio to focus on the development of its next generation SYK inhibitor, lanraplenib, and its CDK9 inhibitor, KB-0742. 10 November 2022
Pharmaceutical
Another healthy set of financial results led to a 3% rise in the share price of Anglo-Swedish pharma major AstraZeneca by late-afternoon Thursday. 10 November 2022
Pharmaceutical
R-Pharm Group, one of Russia’s leading pharmaceutical producers, is expanding into the market Southeast Asia, according to the company, reports The Pharma Letter’s local correspondent. 10 November 2022
Biotechnology
News of the planned merger of Norway-based companies Nordic Nanovector and APIM Therapeutics, a privately held, clinical-stage cancer-focused biotechnology firm, saw the former’s shares fall 13.3% to 1.17 Norwegian kroner by late afternoon. 10 November 2022
Pharmaceutical
German drugmaker Merck KGaA has reported net sales in the 2022 third quarter of 5.8 billion euros ($5.8 billion), in line with many analysts’ expectations, with earnings per share coming in at 2.68 euros. 10 November 2022
Biotechnology
After months of searching for a new leader, US biotech major Biogen today announced the appointment of industry veteran Christopher Viehbacher as president and chief executive and a member of its board of directors, effective November 14. 10 November 2022
Pharmaceutical
It has not been an easy year for Spanish skincare specialist Almirall, reflected by a 17% reduction in the company’s share price. 10 November 2022
Pharmaceutical
The US Food and Drug Administration (FDA) yesterday issued an emergency use authorization (EUA)for Kineret (anakinra) injection for the treatment of COVID-19 in hospitalized adults with pneumonia requiring supplemental oxygen (low- or high-flow oxygen) 10 November 2022
All news
Pharmaceutical
The board of Spanish plasma-based medicines producer Grifols has announced the termination of discussions with Brookfield Capital Partners (UK) regarding a potential acquisition of Grifols shares. 28 November 2024
Generics
The US Food and Drug Administration (FDA) yesterday announced its Fiscal Year 2025 Generic Drug User Fee Amendments (GDUFA). 28 November 2024
Biotechnology
Kronos Bio, a biotech with a presence on the east and west coasts of the USA, has unveiled a major restructuring plan. 28 November 2024
Pharmaceutical
UK-based drugmaker Advanz Pharma has announced that following the grant of a temporary suspension, as announced on last month, the General Court of the European Union (General Court) has decided not to further extend the suspension of the European Commission (EC) decision to revoke the conditional marketing authorization (CMA) for Ocaliva (obeticholic acid) in Europe. 28 November 2024
Biotechnology
Johnson & Johnson has made significant strides in multiple myeloma treatment, with breakthroughs in targeted therapies like CAR-T and bispecific antibodies. At the 2024 ASH meeting, J&J aims to showcase progress, with a goal of achieving a functional cure for multiple myeloma. 28 November 2024
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
Pharmaceutical
According to a report from industry analyst DelveInsight, the market for Down syndrome treatments in the USA is now valued at almost $250 million. 27 November 2024
Pharmaceutical
The European Commission (EC) has approved a single-vial, fully liquid presentation of Menveo (meningococcal Group A, C, W-135 and Y conjugate vaccine, MenACWY vaccine) to help protect against invasive meningococcal disease (IMD) caused by bacterial serogroups A, C, W and Y, UK pharma major GSK announced today. 27 November 2024
Pharmaceutical
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. 27 November 2024
Pharmaceutical
Novartis announced today that the European Commission (EC) has approved Kisqali (ribociclib) in combination with an aromatase inhibitor (AI) for the adjuvant treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer (EBC) at high risk of recurrence. 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
Pharmaceutical
The Biden administration has proposed a new rule that could significantly expand Medicare and Medicaid coverage for obesity medications, potentially benefiting millions of Americans. 27 November 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has extended the review period for Soleno Therapeutics’ the New Drug Application (NDA) for DCCR (diazoxide choline) extended-release tablets 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
Pharmaceutical
Swiss drugmaker Idorsia was trading more than 10% higher by lunchtime on Wednesday. Idorsia earlier announced that it has entered into exclusive negotiations with an undisclosed party for the global rights to aprocitentan. 27 November 2024
Biosimilars
Samsung Bioepis has appointed Kyung-Ah Kim as its new president and chief executive, succeeding Christopher Hansung Ko, who will lead the Samsung Future Business Division. 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
Pharmaceutical
Japanese drugmaker Otsuka has announced the submission of a New Drug Application (NDA) to the Japanese Ministry of Health, Labor and Welfare (MHLW) for the manufacture and sale in Japan of bempedoic acid - trade name Nexletol in Japan - for the treatment of hypercholesterolemia and familial hypercholesterolemia. 27 November 2024
Pharmaceutical
Berlin, Germany-based Eckert & Ziegler Radiopharma has received approval of its proprietary non-carrier added Lutetium-177 chloride, Theralugand, by the European Commission (EC). 27 November 2024
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