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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
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Biotechnology
Outlook Therapeutics, a biopharmaceutical company working to develop and launch the first approved ophthalmic formulation of bevacizumab for use in retinal indications, has announced it has re-submitted its Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for ONS-5010. 30 August 2022
Biotechnology
Sino-American RNAi therapeutics company Sirnaomics has announced that the cohort receiving the 180μg dose in its Phase II trial of STP705 (cotsiranib) for cutaneous basal cell carcinoma (BCC) achieved a 100% complete response (CR), indicating the promising viability of the treatment. 30 August 2022
Biotechnology
AcuraBio (formerly Luina Bio), an Australian biopharma contract development and manufacturing organization (CDMO), has been acquired by biotech investor Dr Glenn Haifer and Ampersand Capital Partners, a USA-based private equity firm. 30 August 2022
Biotechnology
A biotechnology company aimed at creating a new class of medicines that precisely target disease biology, Vilya, has announced its launch with $50 million in committed Series A financing led by ARCH Venture Partners. 30 August 2022
Pharmaceutical
London listed Jordanian drugmaker Hikma Pharmaceuticals and Indian drugmaker Glenmark Pharmaceuticals’ Glenmark Specialty subsidiary have announced the launch of Ryaltris olopatadine hydrochloride and mometasone furoate nasal spray) in the USA. 30 August 2022
article
US biopharma Chimerix has signed a multi-year contract with the Biomedical Advanced Research and Development Authority (BARDA) for the delivery of up to 1.7 million treatment courses of tablet and suspension formulations of Tembexa (brincidofovir) to the US government. 30 August 2022
Biotechnology
AstraZeneca's (LSE: AZN) Evusheld (tixagevimab and cilgavimab, formerly AZD7442), a long-acting antibody combination, has been approved in Japan for both prevention (pre-exposure prophylaxis) and treatment of symptomatic disease caused by SARS-CoV-2 infection. 30 August 2022
Biotechnology
The European Commission (EC) has approved Scemblix (asciminib) for the treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP), previously treated with two or more tyrosine kinase inhibitors (TKIs). 30 August 2022
Pharmaceutical
The European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) have published the 2022-2026 workplan of the initiative Accelerating Clinical Trials in the EU (ACT EU). 30 August 2022
Biotechnology
Shares of UK-based Diurnal shot up 134% to 26.35 pence this morning, after the company announced it has reached agreement on the terms of a recommended cash acquisition under which US neurology specialist Neurocrine Biosciences will acquire the entire issued and to be issued ordinary share capital of Diurnal. 30 August 2022
Biotechnology
The US Food and Drug Administration (FDA) has accepted for priority review the Biologics License Application (BLA) for efanesoctocog alfa (BIVV001) for the treatment of hemophilia A, a rare and life-threatening bleeding disorder. The target action date for the FDA decision is February 28, 2023. 30 August 2022
Generics
It was not so very long ago that Indian drugmakers were facing headwinds due to the spike in prices of active pharmaceutical ingredients (APIs) and intermediates being imported from China. From being dependent on China for APIs in the past, India has now swung to the opposite end of the spectrum and is imposing anti-dumping duties on several APIs and key starting materials that come from China, reports The Pharma Letter’s India correspondent. 30 August 2022
Biotechnology
French vaccines developer Valneva today reported further positive Phase III results for its inactivated, adjuvanted COVID-19 vaccine VLA2001, despite which the firm’s shares were down 3.4% at 9.28 euros by late afternoon trading. 29 August 2022
Biotechnology
The annual meeting of the European Society of Medical Oncology (ESMO) kicks off in Paris on September 9, and early indications are the event could be full of practice-changing data. In the runup to the event, The Pharma Letter spoke with medical oncologist and ESMO Council member Antonio Passaro for an inside look at some of the leading themes and key presentations at the event. 29 August 2022
Pharmaceutical
Late-breaking data presented today at the European Society of Cardiology Congress 2022 highlight the potential of German pharm major Bayer’s Kerendia (finerenone), compared to placebo, to significantly reduce the incidence of sudden cardiac death across a broad range of patients with early to late-stage chronic kidney disease (CKD) and type 2 diabetes (T2D). 29 August 2022
Biotechnology
US biotech giant Amgen today presented results from the FOURIER-OLE studies – the open-label extension studies of the Repatha FOURIER cardiovascular outcomes trial at the European Society of Cardiology (ESC) Annual Meeting being held in Barcelona, Spain. 29 August 2022
Pharmaceutical
Results from the Phase II AXIOMATIC-SSP dose-ranging study of the investigational oral factor XIa (FXIa) inhibitor, milvexian, were released on Sunday in a Hot Line session at the European Society of Cardiology (ESC) Congress 2022. 29 August 2022
Pharmaceutical
German drug major Bayer has announced the start of a Phase III clinical development program OCEANIC to investigate the efficacy and safety of asundexian, an oral Factor XIa (FXIa) inhibitor, as a potential new treatment in patients with atrial fibrillation and in patients with a non-cardioembolic ischemic stroke or high-risk transient ischemic attack. 29 August 2022
Biotechnology
Australian biotechnology company CSL Limited has announced positive top-line Phase III results for garadacimab (CSL312), the company’s investigational first-in-class monoclonal antibody inhibiting Factor XIIa being developed as a long-term preventive treatment for patients with hereditary angioedema (HAE). 29 August 2022
Biosimilars
Israeli generics giant Teva Pharmaceutical Industries announced that the European Commission (EC) has granted a Marketing Authorization for Ranivisio/FYB201 (ranibizumab), a biosimilar of the ophthalmology treatment Lucentis across all five indications in adults for which Lucentis is authorized. 29 August 2022
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