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
Rare diseases specialist Swedish Orphan Biovitrum saw its shares fall more than 3% to 204.40 kronor this morning after releasing third-quarter 2022 financial result. 27 October 2022
Generics
The US Food and Drug Administration (FDA) yesterday released its fiscal year (FY) 2023 Generic Drug User Fee Amendments (GDUFA) Science and Research Priority Initiatives. 27 October 2022
Pharmaceutical
In the USA, the Biden-Harris Administration has made expanding access to health insurance and lowering health care costs for America’s families a top priority, and, starting now, consumers can preview their health care coverage options and see the savings available to them in the most competitive Marketplace in history. 27 October 2022
Biotechnology
The questions that were posed to the biopharmaceutical industry in 2020 were more urgent than ever before, as the COVID-19 pandemic brought much of the world to a standstill. 27 October 2022
Biotechnology
A US regulatory submission from microbiome company Seres Therapeutics has been accepted, with an expected decision date of April 26, 2023. 26 October 2022
Biotechnology
Australia’s largest biotech CSL Limited today revealed it has entered into a strategic option and license agreement with Arizona, USA-based Translational Sciences for rights to its enhanced thrombus (blood clot) dissolving drug candidate, TS23. 26 October 2022
Biotechnology
German-born UK resident Volker Hirsch has joined the Medicines Discovery Catapult (MDC) as chief commercial officer. 26 October 2022
Pharmaceutical
Germany’s Merck KGaA has provided new longer-term findings from its research into evobrutinib, an oral Bruton’s tyrosine kinase (BTK) inhibitor. 26 October 2022
Pharmaceutical
According to the Russian pharma trade body the ARPM, the 2nd Annual “Right to Health” Congress was held in Moscow, aimed to highlight the prospects of the domestic healthcare industry, which have become more acute in modern geopolitical conditions, in a wide format. 26 October 2022
Pharmaceutical
Bristol Myers Squibb saw its sales drop by 3% during the third quarter of 2022. 26 October 2022
Pharmaceutical
HIV specialist ViiV Healthcare has announced positive findings from the Phase IIa BANNER proof-of-concept study, looking at its antibody N6LS. 26 October 2022
Biotechnology
The US Food and Drug Administration yesterday granted accelerated approval to Tecvayli (teclistamab-cqyv), the first bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager, for adult patients with relapsed or refractory multiple myeloma. 26 October 2022
Biotechnology
Anglo-Swedish pharma major AstraZeneca’s shares were up as much as 3% this morning, after it announced new clinical data indicating that its capivasertib, a potential first-in-class AKT inhibitor, could become a new option for patients in early and 1L metastatic HR+/ET-sensitive breast cancer, regardless of biomarker status. 26 October 2022
Biotechnology
Boston, USA-based start-up Normunity, which is working on drugs based on a potentially breakthrough biotechnology, yesterday launched out of stealth with a $65 million Series A funding round. 26 October 2022
Biotechnology
British pharma major AstraZeneca has reported mixed top-line results from a trial of its monoclonal antibody Fasenra (benralizumab). 25 October 2022
Biotechnology
The market for spinal muscular atrophy (SMA), a progressive neuromuscular disease that can be fatal, has attracted many of biopharma’s biggest names. 25 October 2022
Biosimilars
Following USA-based JSR Life Sciences’ launch of Similis Bio in May this year as a biosimilar partner, the new unit has signed its first development and license agreement, which is with Brazilian drugmaker Blau Farmacêutica. 25 October 2022
Biotechnology
US biotech major Biogen today reported third quarter 2022 financial results that were better than investors expected, but the stock fell 2.3% to $267.84 in early trading. 25 October 2022
Pharmaceutical
Sales and income were both down at Swiss pharma giant Novartis for the third quarter of 2022, with the company missing analyst estimates on both measures. 25 October 2022
Biotechnology
Japanese pharma major Astellas Pharma has announced a strategic investment to support the advancement of Texas, USA-based Taysha Gene Therapies’ adeno-associated virus (AAV) gene therapy development programs for the treatment of Rett syndrome and giant axonal neuropathy (GAN). 25 October 2022
All news
Pharmaceutical
The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the New Drug Application (NDA) for govorestat, a novel, central nervous system (CNS)-penetrant aldose reductase inhibitor (ARI), for the treatment of classic galactosemia, under development by Applied Therapeutics. 28 November 2024
Biotechnology
Privately-held French drugmaker Servier has announced the inauguration of its first unit dedicated to the production of biological medicines from its R&D pipeline. 28 November 2024
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
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