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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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Biosimilars
Biosimilars are compounds that have demonstrated no clinically meaningful differences in safety, purity and potency from a reference biologic drug. As of September 2022, 38 biosimilars have been approved for use within the USA. 29 September 2022
Biosimilars
Adding to recent market authorizations in the European Union, Japan and the UK, South Korea-based Celltrion Healthcare says its biosimilar of a Roche (ROG: SIX) cancer drug has now gained approval in the USA, sending the firm’s share up 2.7% to 171,100 won. 29 September 2022
Biotechnology
Spanish dermatology specialist Almirall and Simcere Pharmaceutical Group have signed an exclusive licensing agreement for the Chinese firm’s IL-2 mutant fusion protein (IL-2 mu-Fc) autoimmune drug candidate, SIM0278. 29 September 2022
Pharmaceutical
Japanese drug major Sumitomo Pharma has filed an appeal with the US Court of Appeals for the Federal Circuit (CAFC) seeking revocation of the decision of the US Patent and Trademark Office (USPTO) relating to the proprietary atypical antipsychotic agent Latuda (lurasidone HCl tablets). 29 September 2022
Biotechnology
Continuing its impressive rise, Dupixent (dupilumab) has secured US Food and Drug Administration approval for prurigo nodularis, a debilitating skin condition. 29 September 2022
Generics
Private equity firm SK Capital Partners has entered into a deal to acquire Apotex Pharmaceutical Holdings, a Canada-based generic drugmaker with products across all major therapeutic areas for patients around the world. 29 September 2022
Pharmaceutical
Russia plans to accelerate the production of active pharmaceutical ingredients (APIs) for antibiotics, as well as to pay more attention to the development of drugs against chronic infections, as part of a new State Concept for the Development of Pharmaceutical industry in Russia that is designed until 2030, reports The Pharma Letter’s local correspondent. 29 September 2022
Biosimilars
Increasing access to capital has resulted in a surge of Indian biopharmaceutical companies focusing on research and development. A think-tank has advised the government that it is imperative to streamline regulatory approval procedures for the biotechnology industry and eliminate redundant steps so as to expedite the approval process, reports The Pharma Letter’s India correspondent. 28 September 2022
Pharmaceutical
Japanese drugmaker Shionogi closed 1% higher after Tokyo trading on Wednesday after reporting progress with its COVID-19 antiviral. 28 September 2022
Biotechnology
Elranatamab, an investigational B-cell maturation antigen (BCMA) CD3-targeted bispecific antibody in development for the treatment of multiple myeloma (MM) by US pharma giant Pfizer, has been granted an ‘Innovation Passport’ from the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA). 28 September 2022
Biotechnology
AstraZeneca has written to US healthcare professionals to notify them of the company’s volunatary withdrawal of an indication for Lynparza (olaparib). 28 September 2022
Pharmaceutical
Drugmakers in Europe are arguing for a new economic model for reimbursement of antibiotics, paving the way for a breakthrough in the fight against antimicrobial resistance. 28 September 2022
Biotechnology
Shares in Avidity Biosciences were down as much as 26% on the news that the US Food and Drug Administration (FDA) has placed a partial clinical hold on new participant enrollment in the Phase I/II MARINA clinical trial of AOC 1001 - an antibody-oligonucleotide conjugate (AOC) - in adults with myotonic dystrophy type 1 (DM1). 28 September 2022
Pharmaceutical
The Russian Parliament (State Duma) has said it will consider establishing the priority of using domestic reference materials in the pharmaceutical industry. 28 September 2022
Biotechnology
Japanese drugmaker Eisai’s shares gained more than 17% to 6,784 yen today, after it released top-line results from the Clarity AD Phase III clinical trial for lecanemab, an investigational anti-amyloid beta (Aβ) protofibril antibody for the potential treatment of early Alzheimer’s disease. 28 September 2022
Biotechnology
Japan’s Ministry of Health, Labor and Welfare (MHLW )has granted approval of the manufacturing and marketing application for Berinert SC Injection 2000 submitted by CSL Behring KK, a subsidiary of Australia’s CSL Limited. 28 September 2022
Biotechnology
A new UK-based antibody-drug conjugate (ADC) company, Pheon Therapeutics, has launched with $68 million in series A backing. 28 September 2022
Biotechnology
Californian genetic medicine company Scribe Therapeutics has scored a major strategic collaboration with French giant Sanofi. 27 September 2022
Biotechnology
Privately-held Arsenal Biosciences, a programmable cell therapy company engineering advanced CAR T therapies for solid tumors, has announced a multi-year collaboration with the Roche subsidiary Genentech. 27 September 2022
Biotechnology
North Carolina, USA-based 9 Meters Biopharma saw its shares rise nearly 22% to $0.25, after it announced positive final results from the Phase II study of vurolenatide and the outcome from its End-of-Phase II meeting with the US Food and Drug Administration (FDA). 27 September 2022
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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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