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
US drug developer Ionis Pharmaceuticals saw its shares close down 8.5% at $40.98 on Friday, after it revealed that its licensing partner, Germany’s Bayer, had pulled out of a deal for the development of fesomersen. 5 November 2022
Biotechnology
The US Food and Drug Administration (FDA) on Friday updated the Health Care Provider Fact Sheet for bebtelovimab with specific information regarding expected reduced activity against certain emerging Omicron subvariants of SARS-CoV-2. This information shows that bebtelovimab is not expected to neutralize Omicron subvariants BQ.1 and BQ.1.1. 5 November 2022
Biotechnology
An Expert View from RJ Tesi, co-founder and chief executive of INmune Bio. 4 November 2022
Biotechnology
The European Commission (EC) has approved Beyfortus (nirsevimab) for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants during their first RSV season. 4 November 2022
Pharmaceutical
Further adding to the wealth of support for their blockbuster diabetes drug Jardiance (empagliflozin), German family-owned Boehringer Ingelheim and US partner Eli Lilly today released new data supporting its benefits in chronic kidney disease during the American Society of Nephrology (ASN)’s Kidney Week 2022. 4 November 2022
Biotechnology
mRNA-based vaccine specialist BioNTech and its partner Pfizer have released strong new data for its Omicron-adapted bivalent booster. 4 November 2022
Pharmaceutical
Privately-held German drugmaker Boehringer Ingelheim has appointed a new chief medical officer, Lykke Hinsch Gylvin. 4 November 2022
Pharmaceutical
Japanese drugmaker Kissei Pharmaceutical has entered into a license agreement with Synmosa Biopharma for the development and commercialization rights in Taiwan for the GnRH antagonist linzagolix that was discovered by Kissei. 4 November 2022
Biotechnology
US biotech major Amgen reported its quarterly financial results late Thursday. 4 November 2022
Pharmaceutical
Shares of Swiss biopharma Kinarus Therapeutics Holding ( were down 13% by midday after it confirmed plans to focus on clinical trials of its lead candidate KIN001 in ophthalmic and pulmonary fibrosis indications, and to refocus its capital resources and financing efforts to drive these programs. 4 November 2022
Biotechnology
Struggling in the wake of the discontinuation of ziritaxestat, Belgian biotech Galapagos is to undertake a radical restructuring aimed at jump-starting the business. 4 November 2022
Biotechnology
Shares of US gene and cell therapy company Abeona Therapeutics hit a high of $4.80 yesterday but closed 13% lower at $3.87, after it announced positive top-line data from its pivotal Phase III VIITAL study assessing the safety and efficacy of EB-101 for the treatment of patients with recessive dystrophic epidermolysis bullosa (RDEB), as well as a $35 million financing. 4 November 2022
Biotechnology
Shares of US mRNA-focussed biotech Moderna slid more than 11% pre-market yesterday, before recovering to close down 0.76% at $147.50, as it reported financial results. 4 November 2022
Pharmaceutical
Special purpose acquisition company (SPAC) deals were October's order of the month in the pharmaceutical M&A market. 3 November 2022
Generics
Israeli generics company Teva Pharmaceutical Industries was trading more than 2% lower late on Thursday, following the firm’s presentation of its third quarter 2022 financial results. 3 November 2022
Biotechnology
Germany’s Affimed saw its shares leap more than 17% to $1.98 today, after it revealed a collaboration with privately held US biotech Artiva Biotherapeutics. 3 November 2022
Biotechnology
Revenues at Regeneron came in at $2.9 billion in the third quarter of 022, slightly higher than most analysts’ were expecting, but still 15% lower than the same period of 2021. 3 November 2022
Pharmaceutical
A monkeypox vaccine may soon be available from India, as six companies have been identified by The Indian Council of Medical Research (ICMR) and given the go-ahead to make the vaccine, reports The Pharma Letter’s local correspondent. 3 November 2022
Generics
According to the charity Médecins Sans Frontières (MSF), negotiations between the UK and India on a Free Trade Agreement (FTA) were formally launched in January 2022 and are currently accelerating, with high-level meetings between the two governments scheduled this November on the side-lines of the G20 Summit in Indonesia, according to reports. 3 November 2022
Biotechnology
Australia’s CSL Limited has sought to shed light on the promise of its pipeline at its annual R&D investor briefing. 3 November 2022
All news
Biotechnology
The US Food and Drug Administration has received new reports of hematologic malignancies, including life-threatening cases of myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML), following treatment of early, active cerebral adrenoleukodystrophy (CALD) patients with Skysona (elivaldogene autotemcel). 28 November 2024
Biotechnology
San Diago, USA-based Acadia Pharmaceuticals yesterday announced it has entered into an exclusive worldwide license agreement with Denmark’s Saniona for the development and commercialization of SAN711, a first-in-class, highly selective GABAA-α3 positive allosteric modulator. 28 November 2024
Pharmaceutical
Munich, Germany headquartered contract development and manufacturing organization (CDMO) Adragos Pharma has acquired Baccinex, a Swiss-based expert in aseptic fill-finish manufacturing. 28 November 2024
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
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