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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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Biotechnology
Founded by Yale professors Akiko Iwasaki and Anna Marie Pyle, RIGImmune has announced its launch, an acquisition and a financing all in a single day. 15 September 2022
Pharmaceutical
The US Food and Drug Administration (FDA) today announced it has approved Terlivaz (terlipressin) injection to improve kidney function in adults with hepatorenal syndrome (HRS) with rapid reduction in kidney function. 15 September 2022
Biotechnology
Privately-held Swiss drug developer Neovii Pharmaceuticals has entered into an agreement with a unit of Shanghai Fosun Pharmaceutical, granting the latter an exclusive license to develop and commercialize Neovii's Grafalon (rabbit anti-human T-lymphocyte globulin, ATLG) in Chinese Mainland, Hong Kong SAR, Macau SAR and Taiwan region. 15 September 2022
Pharmaceutical
The Basel headquarters of pharma giant Novartis were raided at dawn earlier this week by the Swiss Competition Commission (COMCO). 15 September 2022
Biotechnology
French start-up Tridek-One has closed a 16 million euros ($16.1 million) financing round. 15 September 2022
Pharmaceutical
Eloxx Pharmaceuticals (Nasdaq: ELOX) shares traded down around 40% to $0.23 after-hours on Wednesday, after it announced disappointing top-line results from the Phase II clinical trial of ELX-02 in combination with ivacaftor in Class 1 cystic fibrosis (CF) patients with at least one nonsense mutation. 15 September 2022
Pharmaceutical
Coinciding with the 50th anniversary of its Lessines, Belgium, site, Japanese pharma major Takeda said it is investing close to 300 million euros ($304 million) in a new state-of-the-art production facility for the manufacturing of plasma-derived therapies for people with rare and complex chronic diseases. 15 September 2022
Biotechnology
Positive news from the medicines regulator yesterday saw US clinical-stage biotech Larimar Therapeutics’ shares close up 15.5% at $3.64. 15 September 2022
Generics
As global pharma majors exit South America after the coronavirus pandemic, India's Pharmexcil (Pharmaceuticals Export Promotion Council of India) is looking to promote Indian pharmaceutical exports in the Latin American and Caribbean Region. 14 September 2022
Biotechnology
US biotech Ocugen has announced the publication of a comprehensive review of its COVID-19 vaccine, BBV152, in Frontiers in Immunology. 14 September 2022
Biotechnology
India’s Bharat Biotech International, a leading in vaccine innovation and developer of vaccines for infectious diseases, revealed that iNCOVACC (BBV154) intranasal vaccine has now received approval under Restricted Use in Emergency Situation for ages 18 and above. 14 September 2022
Biotechnology
Continuing this year’s trend of new venture capital-backed biotechs springing up, today sees the launch in the USA of Capstan Therapeutics, which says it is dedicated to developing and delivering precise in vivo cell engineering to patients, and has a bicoastal presence with operations in San Diego and Philadelphia. 14 September 2022
Biotechnology
Privately-held US CAR-T company ImmPACT Bio has tasked Jonathan Benjamin with leading its clinical development strategy as the company’s chief medical officer. 14 September 2022
Pharmaceutical
The Medicines Patent Pool and French pharma company MedinCell have signed a license agreement for a candidate long-acting drug formulation that could be used to fight malaria in low- and middle-income countries. 14 September 2022
Biotechnology
Spanish CNS specialist Minoryx Therapeutics said today it has filed a Marketing Authorization Application (MAA) for its lead candidate leriglitazone to the European Medicines Agency (EMA) for the treatment of adult male patients with X-linked adrenoleukodystrophy (X-ALD). 14 September 2022
Pharmaceutical
Privately-held US developer of healthcare therapies Nacuity Pharmaceuticals and Icelandic firm Arctic Therapeutics International have entered into an exclusive licensing agreement and strategic partnership for the development and commercialization of NPI-001 in Iceland for the treatment of hereditary cystatin C amyloid angiopathy (HCCAA). 14 September 2022
Biotechnology
France-based SparingVision, a portfolio company of venture capital firm 4BIO Capital that is focussed on developing vision-saving treatments for ocular diseases, has raised 75 million euros in a Series B financing. 14 September 2022
Pharmaceutical
The size of the North American oncology market is projected to reach a valuation $246.5 billion by 2028, helped by government initiatives. 14 September 2022
Biotechnology
Shares of Massachusetts, USA-based Rubius Therapeutics closed down 13% on Tuesday and fell a further 6% to $0.87 pre-market today, after it announced plans to restructure the company and align resources to advance its next generation red blood cell-based cell conjugation platform. 14 September 2022
Biotechnology
Australian biotech conglomerate CSL Limited has cut the ribbon on a new 150 million-euro ($150 million) research and development site in Marburg, Germany. 14 September 2022
All news
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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