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
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
Pharmaceutical
Bharat Biotech has recently completed the Phase III trials of its COVID-19 intranasal vaccine BBV154 and submitted the data to the Drug Controller General of India (DCGI) for approval both as a primary two-dose vaccine, and a heterologous booster dose. However, the company has not yet made clinical trial results publicly available. 25 August 2022
Biotechnology
Zelluna Immunotherapy, a Norwegian company developing allogeneic T Cell Receptor Natural Killer (TCR-NK) cells for the treatment of cancer, has announced an investment from Takeda Ventures. 25 August 2022
Biotechnology
On August 24, the US Food and Drug Administration announced it has approved Pharmacyclics application for Imbruvica (ibrutinib) for pediatric patients ≥ 1 year of age with chronic graft versus host disease (cGVHD) after failure of 1 or more lines of systemic therapy. Formulations include capsules, tablets, and oral suspension. 25 August 2022
Pharmaceutical
AstriVax, a start-up working to develop novel vaccines, has raised the largest amount of seed capital in the history of Belgium-based university KU Leuven spin-offs, totalling $30 million. 25 August 2022
Biotechnology
August is spinal muscular atrophy (SMA) awareness month – an opportunity to reflect on the current and future treatment landscape. 25 August 2022
Biotechnology
When it comes to lung diseases, asthma, chronic obstructive pulmonary disease (COPD), and cystic fibrosis might come to mind. 25 August 2022
Biotechnology
UK pharma major AstraZeneca this morning announced that it has received marketing approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) for three of its pharmaceutical products, sending the firm’s shares edging up 1.3% to 11,497.12 pence. 25 August 2022
Biosimilars
Competition for AstraZeneca’s Soliris (eculizumab) is stepping closer to the market, with developer Amgen, a Californian biotech giant, announcing positive trial results. 24 August 2022
Biotechnology
US healthcare giant Johnson & Johnson subsidiary Janssen today revealed that the European Commission (EC) has granted conditional marketing authorization (CMA) of Tecvayli (teclistamab) as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma (RRMM). 24 August 2022
Biotechnology
Very young children can benefit from a high level of immunity to the novel coronavirus after receiving the Comirnaty vaccine, new research shows. 24 August 2022
Biotechnology
Privately-held Gensaic, a company that seeks to reimagine gene therapy, announced today that it has entered into a strategic collaboration agreement with US neurological diseases specialist Ovid Therapeutics. 24 August 2022
Generics
AMPAC Fine Chemicals (AFC), an SK pharmteco company, has opened its new Complex Molecule Chemistry & Engineering Center in Rancho Cordova, California. 24 August 2022
Pharmaceutical
The passing of the $740 billion Inflation Reduction Act, which aims to control and lower prescription drug costs, will be welcome news for patients feeling the repercussions of rising inflation and a cost-of-living crunch in the US. However, GlobalData predicts that few pharma companies will be left unaffected by its provisions, with its full effects only being felt in 2026. 24 August 2022
Biotechnology
US cancer-focused biotech Foghorn Therapeutics saw its shares plummet 25% to $11.00 by close of trading yesterday, after it announced that the US Food and Drug Administration (FDA) has placed a full clinical hold on the Phase I dose escalation study of FHD-286. 24 August 2022
Pharmaceutical
Based on an interim futility analysis of its global Phase III trial, REALM-DCM, US pharma giant Pfizer recently ceased clinical trial development of its therapy emprumapimod (PF-07265803). 24 August 2022
Pharmaceutical
US Department of Health and Human Services (HHS) Secretary Xavier Becerra has announced more than $20 million in funding to expand HIV prevention, testing, and treatment services at health centers nationwide. 24 August 2022
Biotechnology
US mRNA specialist biotech Moderna says that it has completed its submission to the US Food and Drug Administration (FDA) for emergency use authorization for its BA.4/BA.5 Omicron-targeting bivalent COVID-19 booster vaccine, mRNA-1273.222. 24 August 2022
Biotechnology
Japanese drugmaker Chugai Pharmaceutical today announced receipt of approval from the Ministry of Health, Labor and Welfare (MHLW) for the anticancer agent/antimicrotubule binding anti-CD79b monoclonal antibody Polivy intravenous infusion (polatuzumab vedotin (genetical recombination) for an additional indication of treatment of patients with previously untreated diffuse large B-cell lymphoma (DLBCL). 24 August 2022
Pharmaceutical
The face of the USA’s response to the coronavirus pandemic, Anthony Fauci, has announced he will step down from his role as Director of the National Institute of Allergy and Infectious Diseases (NIAID). 23 August 2022
Biotechnology
British biotech Mereo BioPharma has revealed its largest shareholder is agitating to purge certain board members as part of a plan to change the firm’s strategic direction. 23 August 2022
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