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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
A pharma company created last year with the merger of 10 privately-held biotech companies has cut a second drug program of the summer. 11 August 2022
Biotechnology
Shares of US biopharma company VYNE Therapeutics closed down 22.9% at $0.31 yesterday, having plunged as much as 35%, after it revealed results from the Phase IIa segment of a Phase Ib/IIa clinical trial evaluating FMX114 for the treatment of mild-to-moderate atopic dermatitis (AD) that failed to hit its goal. 11 August 2022
Pharmaceutical
Danish allergy immunotherapy specialist ALK Abello saw its shares rise 8.7% to 153.80 kroner by mid-morning today, as it reported strong financial results for the second quarter of 2022. 11 August 2022
Generics
Indian drugmaker Strides Pharma Science today announced that its formulation facility at Singapore underwent a US Food and Drug Administration (FDA) inspection that ended on August 8, 2022. 11 August 2022
Biotechnology
Positive top-line results from a Phase III trial of the first CAR T-cell therapy in multiple myeloma have been presented by developers Bristol Myers Squibb and 2seventy bio. 10 August 2022
Biotechnology
Gemini Therapeutics and privately-held clinical-stage Disc Medicine today announced a merger agreement to create a NASDAQ-listed, clinical stage biopharma focused on advancing Disc’s pipeline of hematology programs. 10 August 2022
Biotechnology
Boston, USA-based engineered regulatory T cells (Tregs) company GentiBio has entered into a collaboration with US pharma major Bristol Myers Squibb to develop new engineered Treg therapies to re-establish immune tolerance and repair tissue in patients living with inflammatory bowel diseases (IBD). 10 August 2022
Biotechnology
Efforts on the part of Swiss pharma giant Roche to take on AstraZeneca in the treatment of paroxysmal nocturnal hemoglobinuria (PNH) advanced a step this week. 10 August 2022
Pharmaceutical
Japanese pharma major Shionogi today announced that ensitrelvir fumaric acid (S-217622), Shionogi’s orally administered antiviral drug for COVID-19 (caused by infection with the novel coronavirus [SARS-CoV-2]), shows high in vitro antiviral activity against the Omicron subvariant (BA.2.75), with antiviral potency in pre-clinical testing similar to its potency against other existing variants. 10 August 2022
Biotechnology
Belgian cell therapy company Bone Therapeutics is to acquire a majority stake in Medsenic, a privately-held French biopharma specializing in the development of optimized formulations of arsenic salts and their application in inflammatory conditions and other indications. 10 August 2022
Biotechnology
The European Commission (EC) and US biotech Moderna have reached an agreement to address the demand for COVID-19 vaccines for the late summer and winter period. 10 August 2022
Pharmaceutical
US Health and Human Services (HHS) Secretary Xavier Becerra yesterday took action that will allow the US Food and Drug Administration (FDA) Commissioner to grant emergency use authorizations (EUA) for monkeypox vaccines, following the August 4 declaration of a public health emergency for monkeypox. 10 August 2022
Biotechnology
US biotech Novavax, which is dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, has announced its financial results for the second quarter ended June 30, 2022. 10 August 2022
Biotechnology
California, USA-based Appia Bio, a pre-clinical-stage biotechnology company today announced that Jason Damiano has been appointed as its chief scientific officer. 10 August 2022
Pharmaceutical
Catalent announced that it has reached an agreement to acquire Metrics Contract Services (Metrics), a full-service specialty Contract Development and Manufacturing Organization (CDMO) with a facility in Greenville, North Carolina, USA. 10 August 2022
Pharmaceutical
Miami-based Veru has presented Phase III results on sabizabulin in hospitalized COVID-19 patients at high risk for acute respiratory distress syndrome (ARDS) at the International Conference on Emerging Infectious Diseases. 9 August 2022
Pharmaceutical
Cerevance, a British clinical-stage biotech working on new medicines for brain disorders, has inked a deal with Merck & Co, focused on Alzheimer’s disease. 9 August 2022
Pharmaceutical
SIGA Technologies’ shares were up 6.8% at $23.67 mid-morning today, as it announced the exercise of procurement options under its 19C contract with the US Department of Health and Human Services for the delivery to the US government of intravenous (IV) formulation of TPOXX treatment courses valued at around $26 million. 9 August 2022
Biotechnology
Late-breaking post-hoc exploratory results from the POSEIDON Phase III trial suggest a trend for improved overall survival (OS) with a limited course of five cycles of tremelimumab added to AstraZeneca’s Imfinzi (durvalumab) plus platinum chemotherapy, in the first-line treatment of patients with STK11, KEAP1 or KRAS-mutated Stage IV (metastatic) non-small cell lung cancer (mNSCLC). 9 August 2022
Pharmaceutical
A trial testing the use of cyclosporine in the treatment of COVID-19 has been stopped after independent data monitors decided it would likely fail. 9 August 2022
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