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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
The waiting time for Latin American patients with cancer, central nervous system disorders or rare diseases can take up to 4.75 years from the time a drug receives approval from global health authorities such as the US Food and Drug Administration (FDA) or the European Medicines Agency (EMA), until it is approved by their local authority and is available on the market, writes The Pharma Letter's local correspondent. 28 November 2024
Biotechnology
PTC Therapeutics is to sell its rare pediatric disease priority review voucher (PRV) for $150 million. 28 November 2024
Biotechnology
A report from industry analyst DelveInsight highlights progress in the myotonic dystrophy treatment landscape, with more than 20 companies developing over 22 innovative treatments. 28 November 2024
Pharmaceutical
A new indication for olverembatinib, developed by Suzhou-based Ascentage Pharma will be added to China’s National Reimbursement Drug List (NRDL) from next year. 28 November 2024
Biotechnology
The UK subsidiary of Dutch drugmaker argenx confirmed today that its investigational therapy, subcutaneous efgartigimod alfa has been granted Promising Innovative Medicine (PIM) designation by the UK Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of adults with chronic inflammatory demyelinating polyneuropathy (CIDP). 28 November 2024
Pharmaceutical
The first iteration of the European Shortages Monitoring Platform (ESMP) has gone live. 28 November 2024
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
All news
Biosimilars
Poland-based drugmaker Polpharma Biologics today announced that the European Medicines Agency (EMA) has accepted the first-ever Marketing Authorization Application (MAA) for biosimilar natalizumab, a proposed biosimilar to branded multiple sclerosis treatment Tysabri. 15 July 2022
Generics
Following a public comment period, the USA’s Federal Trade Commission (FTC) has approved a final order settling charges that London-listed Jordanian drugmaker Hikma Pharmaceuticals’ $375 million acquisition of Custopharm likely would have harmed competition in the market for the corticosteroid drug triamcinolone acetonide, or TCA. 15 July 2022
Biotechnology
Chinese vaccine developer Sinovac Biotech announced that its COVID-19 vaccine (CoronaVac) has been approved by the Brazilian Health Regulatory Agency (Anvisa) for emergency use in children from three to five years old on July 13. 15 July 2022
Pharmaceutical
The US Food and Drug Administration yesterday issued a final guidance, “Instructions for Use – Patient Labeling for Human Prescription Drug and Biological Products – Content and Format.” 15 July 2022
Biotechnology
Sino-American biotech firm BeiGene today announced that the US Food and Drug Administration (FDA) has deferred action on the Biologics License Application (BLA) for tislelizumab as a second-line (2L) treatment for patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC). 14 July 2022
Biotechnology
The National Institute for Health and Care Excellence (NICE) has issued a Final Appraisal Document (FAD) recommending the combination of Opdivo (nivolumab) and Yervoy (ipilimumab) for the first-line treatment of adults with unresectable malignant pleural mesothelioma (MPM), in England and Wales. 14 July 2022
Biotechnology
Despite a very tardy authorization in the USA, the Novavax jab has the potential to be much more than just an also-ran in the COVID-19 vaccine market. 14 July 2022
Biotechnology
Swiss pharma giant Roche today announced new two-year data from the TENAYA and LUCERNE studies that reinforce the long-term efficacy, safety and durability of Vabysmo (faricimab) in neovascular or “wet” age-related macular degeneration (nAMD), a leading cause of vision loss. 14 July 2022
Biotechnology
Californian cytokine storm specialist Humanigen lost 80% of its market value on Wednesday based on the results of the National Institute of Allergy and Infectious Diseases’ (NIAID) ACTIV-5/BET-B trial. 14 July 2022
Pharmaceutical
Shares of US drug developer Theravance Biopharma were up more than 17% at $10.14 pre-market, following the announcement late Wednesday that it has entered into a definitive agreement to sell all of its units in Theravance Respiratory Company, representing its 85% economic interest in the sales-based royalty rights on worldwide net sales of UK pharma major GSK's (LSE: GSK) Trelegy (fluticasone furoate/ umeclidinium/vilanterol) Ellipta to Royalty Pharma. 14 July 2022
Biotechnology
A possible new indication for Sanofi’s IL-13 and IL-4 blocking antibody Dupixent (dupilumab) is on the cards, after a successful Phase III trial. 14 July 2022
Pharmaceutical
Family-owned drugmaker Grünenthal today announced an agreement with fellow Germany-based Bayer to acquire Nebido, a long-acting depot preparation of testosterone undecanoate and a well-known brand for the treatment of male hypogonadism, and its associated brands. 14 July 2022
Generics
India's Department for Promotion of Industry and Internal Trade (DPIIT) has been instructed by the Kerala High Court to consider compulsory licensing for the breast cancer drug ribociclib, marketed by Swiss pharma giant Novartis under the brand names Kisqali and Kryxana, reports The Pharma Letter’s local correspondent. 14 July 2022
Biotechnology
UK health technology assessor the National Institute for Health and Care Excellence (NICE) has recommended the use of Piqray (alpelisib) for use in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2), locally advanced or metastatic breast cancer with a PIK3CA mutation after disease progression following endocrine-based therapy. 14 July 2022
Biotechnology
US biotech Gilead Sciences has announced that the National Institute for Health and Care Excellence (NICE) has recommended the use of Trodelvy (sacituzumab govitecan) in England within its marketing authorization. 14 July 2022
Pharmaceutical
SIGA Technologies saw its shares gain almost 8% to $14.05 today, after it announced around $28 million of procurement orders for oral TPOXX (tecovirimat). 13 July 2022
Pharmaceutical
South Korean firm SK bioscience has announced that SKYCovione, the Asian country’s first COVID-19 vaccine candidate adjuvanted with GSK’s pandemic adjuvant, has been authorized by the Korean Ministry of Food and Drug Safety. 13 July 2022
Biotechnology
Belgian biotech Agomab Therapeutics has extended its series B financing round with an additional close of $40.5 million, bringing the total to $114 million. 13 July 2022
Biotechnology
An expert review of data from 79 real-world studies showed that AstraZeneca’s COVID-19 vaccine, Vaxzevria (ChAdOx1-S [recombinant]) and the available mRNA COVID-19 vaccines provide equally effective protection against hospitalization and death from COVID-19 following two doses. 13 July 2022
Biotechnology
US biopharma company Greenwich LifeSciences , which is focused on the development of GLSI-100, announced that the Food and Drug Administration (FDA) has removed the clinical hold permitting the Flamingo-01 Phase III clinical trial to proceed. 13 July 2022
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