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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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Pharmaceutical
Shares of Amylyx Pharmaceuticals rocketed up 74% in pre-market trading today on positive news from a regulatory advisory committee on its amyotrophic lateral sclerosis (ALS) drug candidate, having suffered earlier following the release of downbeat briefing papers from the US Food and Drug Administration’s (FDA) last Friday. 8 September 2022
Generics
Indian drugmaker Dr Reddy’s Laboratories has launched a generic version of Bristol Myers Squibb’s cancer drug Revlimid (lenalidomide). 8 September 2022
Biotechnology
Positive Phase III results have been presented on eplontersen, a ligand-conjugated antisense therapy from US RNA-targeted drug developer Ionis Pharmaceuticals and Anglo-Swedish pharma major AstraZeneca. 8 September 2022
Biotechnology
LifeArc revealed that its portfolio company Ducentis BioTherapeutics, a pre-clinical-stage UK biotechnology company focused on developing novel therapies for inflammation and autoimmune diseases, has been acquired by Arcutis Biotherapeutics. 8 September 2022
Biotechnology
Industry analyst GlobalData has presented context on recently-approved inhalable coronavirus vaccines, indicating that the method of administration could be key to combating the spread of infections. 8 September 2022
Biotechnology
Nodus Oncology has announced the completion of an asset purchase agreement (APA) for Basilea Pharmaceutica's novel poly (ADP-ribose) glycohydrolase (PARG) inhibitor discovery program. 8 September 2022
Biotechnology
Chinese biotech Hutchmed today announces summary results of the 691-patient, multi-regional clinical trial (MRCT) of fruquintinib. 8 September 2022
Pharmaceutical
India's drug regulator has stepped up efforts to stop the sale of unapproved antibiotic cocktail combinations over the counter. The regulator has warned that certain fixed-dose combinations (FDCs) will be banned unless scientific trials are conducted to verify their regularisation before they can be distributed, reports The Pharma Letter’s India correspondent. 8 September 2022
Biotechnology
Danish companies Zealand Pharma and Novo Nordisk have announced a deal. 7 September 2022
Pharmaceutical
It is no secret that last year was a generally a positive one for the world’s largest biopharmaceutical companies, particularly those with COVID-19 vaccines. 7 September 2022
Biotechnology
Health authorities in Europe have urged countries to use newly-authorized adapted COVID-19 vaccines as part of autumn and winter vaccination campaigns. 7 September 2022
Biotechnology
Privately-held Seattle, USA-based drug developer Good Therapeutics says it has entered into a definitive agreement to be acquired by Swiss pharma giant Roche. 7 September 2022
Biotechnology
California’s Arsenal Biosciences, a privately-held programmable cell therapy company engineering advanced CAR-T therapies for solid tumors, has closed a $220 million Series B financing. 7 September 2022
Biotechnology
Based in Cambridge, Massachusetts, USA, Orbital Therapeutics launched today with a vision of enhancing global health by unleashing the full potential of RNA medicines to treat human disease in ways that were not previously possible. 7 September 2022
Biotechnology
US biotech Rhythm Pharmaceuticals yesterday announced that the European Commission (EC) has expanded the marketing authorization for Imcivree (setmelanotide) to include the treatment of obesity and control of hunger associated with genetically confirmed Bardet-Biedl syndrome (BBS) in adult and pediatric patients six years of age and older. 7 September 2022
Biosimilars
Competition for one of the best-selling medicines of all time is gaining traction, with new three-year data for Hadlima (adalimumab-bwwd), a biosimilar of adalimumab developed by Samsung Bioepis. 7 September 2022
Biotechnology
Belgium’s largest pharma company UCB has announced new three-year results from the BE BRIGHT open-label extension study of bimekizumab. 7 September 2022
Biotechnology
The European Commission (EC) has approved CAR-T cell therapy Tecartus (brexucabtagene autoleucel) for the treatment of adult patients 26 years of age and above with relapsed or refractory (r/r) B-cell precursor acute lymphoblastic leukemia (ALL), developed by Kite, a part of Gilead Sciences. 7 September 2022
Biosimilars
Germany-headquartered drugmaker Fresenius Kabi says that the US Food and Drug Administration (FDA) has approved its biosimilar, Stimufend (pegfilgrastim-fpgk), for use in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. 7 September 2022
Biotechnology
Results from the DESTINATION Phase III extension trial showed Tezspire (tezepelumab) demonstrated an overall long-term safety and efficacy profile consistent with the previous PATHWAY Phase II and NAVIGATOR Phase III trials, sustained over 104 weeks in a broad population of patients with severe asthma. 7 September 2022
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