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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
Israeli-American company VBL Therapeutics was trading 79% lower in Wednesday’s pre-market activity. 20 July 2022
Biotechnology
California, USA-based precision medicine company Cartography Biosciences launched on Tuesday with $57 million in initial funding. 20 July 2022
Biotechnology
Comirnaty developers Pfizer and BioNTech have submitted to the European Medicines Agency for their Omicron-adapted variant. 20 July 2022
Biosimilars
The Pharmaceutical Research and Manufacturers of America (PhRMA) is to oppose what it calls “flawed price-setting proposals,” arguing instead for changes to the way Medicare covers and pays for medicines, including biosimilars. 20 July 2022
Pharmaceutical
UK-based mental health care company COMPASS Pathways has announced the appointment of Kabir Nath as its chief executive. 20 July 2022
Biotechnology
The US Food and Drug Administration (FDA) has approved Opzelura (ruxolitinib) cream 1.5% for the topical treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older, the drug’s developer, Incyte, announced late Monday, when the firms share closed up 3.2% at $81.36. 20 July 2022
Biotechnology
Cell therapies are among the most researched treatment types for blood cancer and the product pipeline is oversaturated, with over 800 products currently in development for just five major blood cancers. 20 July 2022
Biotechnology
Chinese contract research, development and manufacturing organization (CRDMO) WuXi Biologics has announced a 10-year, $1.4 billion investment plan to expand its research, development, and large-scale drug substance and drug product manufacturing capacity and capabilities in Singapore. 19 July 2022
Biotechnology
USA-based Tiziana Life Sciences has moved fast to strengthen its management team following this week’s announcement of the resignation of Kunwar Shailubhai as chief executive, chief scientific officer and board director, effective as of August 1. 19 July 2022
Pharmaceutical
US healthcare conglomerate Johnson & Johnson beat estimates for sales and earnings figures with its second quarter results. 19 July 2022
Biotechnology
Along with providing a program update on GTX-102 for the treatment of Angelman syndrome (AS), Ultragenyx Pharmaceuticals today announced it will acquire GeneTx Biotherapies, its partner on the candidate. 19 July 2022
Pharmaceutical
US biotech Gilead Sciences and the European Commission today signed a new joint procurement agreement (JPA) that will ensure continued rapid and equitable access to Veklury (remdesivir) for participating member states across the European Union (EU) and European Economic Area (EEA). 19 July 2022
Biotechnology
US biopharma firm Apellis Pharmaceuticals today announced that the US Food and Drug Administration (FDA) has accepted and granted Priority Review designation for the intravitreal pegcetacoplan New Drug Application (NDA). 19 July 2022
Biotechnology
Swedish rare disease specialist Hansa Biopharma has entered into an agreement with USA-based NovaQuest Capital Management, securing $70 million in non-dilutive financing, with the news propelling Hansa’s shares 30% higher to 72.70 kronor. 19 July 2022
Biotechnology
AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has been approved in the European Union (EU) as a monotherapy for the treatment of adults with unresectable or metastatic HER2-positive breast cancer who have received one or more prior anti-HER2-based regimens. 19 July 2022
Generics
Novartis has reported slightly lower than expected revenues for the second quarter, which came in at $12.78 billion, a 1% decline from the same period of last year. 19 July 2022
Biotechnology
Swedish Orphan Biovitrum today released financial results covering the second quarter of 2022, showing that revenues came in at 3,876 million kronor ($369 million), a rise of 21% (+10% at constant exchange rates). 19 July 2022
Biotechnology
Shares of US biotech firm Sesen Bio plunged nearly 32% to $0.62 yesterday, after it announced that it has made the strategic decision to voluntarily pause further development in the USA of its lead asset, Vicineum (oportuzumab monatox-qqrs). 19 July 2022
Biotechnology
Japanese drugmaker Daiichi Sankyo today announced today that the US Patent and Trademark Office (PTO) has granted Seagen’s request for rehearing of the decision to institute post-grant review, and therefore decided not to proceed with the post-grant review process in which Daiichi Sankyo was contesting the patentability of certain claims within Seagen’s US patent 10,808,039 (the ’039 patent). 19 July 2022
Biotechnology
Belgian biotech Bone Therapeutics has announced changes to the statistical analysis and the implementation of an interim analysis for the ongoing Phase IIb trial of its allogeneic bone cell therapy product, ALLOB. 18 July 2022
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