Latest Pharma and Biotech News
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.
Today's issue
Refine Search
Biotechnology
Aiming to add to its vitiligo arsenal, US biopharma firm Incyte today announced that it has entered into an agreement to acquire Villaris Therapeutics, in a deal that could cost it as much as $1.4 billion. 3 October 2022
Biotechnology
The latest in a series of Industry Leader pieces from biological reagent supplier and service provider Sino Biological. 3 October 2022
Biotechnology
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization (MA) for Olumiant (baricitinib) for the treatment of severe alopecia areata (AA) in adult patients. 3 October 2022
Biotechnology
In a transaction aimed at creating a precision genetic medicine company focused on neuromuscular and cardiac rare diseases, Boston, USA-based biotech Solid Biosciences on Friday announced that it has entered into a definitive merger agreement to acquire fellow gene therapy biotech AavantiBio. 3 October 2022
Biotechnology
The US Food and Drug Administration (FDA) has approved Lytgobi (futibatinib) for the treatment of adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma (iCCA) harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements. 3 October 2022
Biotechnology
Among last week’s significant news, US biotechs Seagen and LAVA Therapeutics said they had entered into a licensing deal aimed at the development of the latter’s LAVA-1223 for solid tumors. Japan’s Eisai and US biotech Biogen touted positive new clinical data on their newest Alzheimer’s candidate lecanemab. On the regulatory front, CRISPR Therapeutics and Vertex were granted US Food and Drug Administration (FDA) rolling review for their exa-cel, a gene-edited therapy for sickle cell disease and beta thalassemia. Also, US drug developer Amylyx Pharmaceuticals last Thursday gained FDA approval for its amyotrophic lateral sclerosis (ALS) candidate Relyvrio. 2 October 2022
Biosimilars
The US health care system, including patients, employers, and taxpayers, saved $373 billion in 2021 by using Food and Drug Administration-approved generic and biosimilar drugs. 1 October 2022
Pharmaceutical
Charcot-Marie-Tooth Disease (CMT) is a group of hereditary disorders characterized by sensory loss, muscle weakness and atrophy. As a result of damage to peripheral nerve axons and the myelin surrounding them, nerve cells of individuals with CMT are unable to properly send electrical signals to motor nerves and sensory peripheral nerves. 1 October 2022
Biotechnology
US biotech Gilead Sciences has filed an anti-counterfeiting lawsuit against pharmaceutical suppliers and distributors for selling what it describes as ‘fake’ versions of its HIV medications. 30 September 2022
Pharmaceutical
The European Medicines Agency (EMA) has accepted the marketing authorization application (MAA) for Japanese drugmaker Astellas Pharma’s fezolinetant. 30 September 2022
Pharmaceutical
Lifecycle management company Pharmanovia has entered into an exclusive license and supply agreement with USA-based Aquestive Therapeutics. 30 September 2022
Pharmaceutical
Danish peptide specialist Zealand Pharma has unveiled positive top-line results from the Phase III EASE 1 study of its GLP-2 analog, glepaglutide. 30 September 2022
Pharmaceutical
Swiss biopharma Kinarus Therapeutics Holding was trading more than 20% lower at lunchtime on Friday. 30 September 2022
Pharmaceutical
Disappointing results from a late-stage trial in amyotrophic lateral sclerosis (ALS) have dealt a blow to Biohaven Pharmaceuticals. 30 September 2022
Biotechnology
News that Eisai and Biogen’s anti-amyloid beta (Aβ) monoclonal antibody (MAb) lecanemab was effective in reducing cognitive clinical decline among patients with early Alzheimer’s disease (AD) in the Phase III Clarity AD trial (NCT03887455), resulted in a positive market reaction. 30 September 2022
Pharmaceutical
The US Food and Drug Administration yesterday approved Relyvrio (sodium phenylbutyrate/taurursodiol) to treat patients with amyotrophic lateral sclerosis (ALS), commonly referred to as Lou Gehrig’s disease. 30 September 2022
Pharmaceutical
In the USA, the Biden-Harris Administration announced yesterday that it has made expanding access to health insurance and lowering health care costs for America’s families a top priority. 30 September 2022
Pharmaceutical
Massachusetts-based biotech Ventus Therapeutics has entered into an exclusive global licensing deal with Danish diabetes giant Novo Nordisk. 30 September 2022
Biotechnology
Shares of Axcella Therapeutics were up almost 20% at $2.07 pre-market, after the US biotech said its experimental treatment for the challenging disease area of non-alcoholic steatohepatitis (NASH) showed statistically-significant improvement in liver stiffness. 29 September 2022
Pharmaceutical
Merck & Co and the China National Pharmaceutical Group - known as Sinopharm - have signed a cooperation framework agreement. 29 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
Sign up to receive email updates
Join industry leaders for a daily roundup of biotech & pharma news
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze