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.
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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
Pharmaceutical
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. 27 November 2024
Pharmaceutical
Novartis announced today that the European Commission (EC) has approved Kisqali (ribociclib) in combination with an aromatase inhibitor (AI) for the adjuvant treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer (EBC) at high risk of recurrence. 27 November 2024
Biotechnology
Chengdu-based Kelun-Biotech has received marketing authorization in China for sacituzumab tirumotecan (sac-TMT), a Trop2-directed antibody-drug conjugate (ADC). 27 November 2024
Pharmaceutical
The Biden administration has proposed a new rule that could significantly expand Medicare and Medicaid coverage for obesity medications, potentially benefiting millions of Americans. 27 November 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has extended the review period for Soleno Therapeutics’ the New Drug Application (NDA) for DCCR (diazoxide choline) extended-release tablets 27 November 2024
Biotechnology
AI-powered protein engineering company Cradle has raised $73 million in a Series B funding. The European firm, which has now raised more than $100 million in total, calls itself the leading platform for AI-powered protein engineering. 27 November 2024
Pharmaceutical
Swiss drugmaker Idorsia was trading more than 10% higher by lunchtime on Wednesday. Idorsia earlier announced that it has entered into exclusive negotiations with an undisclosed party for the global rights to aprocitentan. 27 November 2024
All news
Biosimilars
The US Department of Health and Human Services (HHS) said yesterday that it is implementing Medicare Part B payment changes for certain biosimilars, one of the first Medicare provisions of the Inflation Reduction Act to go into effect. 4 October 2022
Biotechnology
The US Food and Drug Administration (FDA) has added important information to the authorized Fact Sheets for Evusheld (tixagevimab co-packaged with cilgavimab) to inform health care providers and individuals receiving the drug of the increased risk for developing COVID-19 when exposed to variants of SARS-CoV-2 that are not neutralized by Evusheld, which is marketed by UK pharma major AstraZeneca. 4 October 2022
Pharmaceutical
Melatonin, a natural hormone that is produced by the pineal gland and used by many long-haul airline travellers to mitigate their jet-lag symptoms, has gained its first approval in the UK, but as a treatment for sleep onset insomnia in children and adolescents aged six-17 years with attention-deficit hyperactivity disorder (ADHD), where sleep hygiene measures have been inadequate. 4 October 2022
Biotechnology
Positive top-line data for Clovis Oncology’s PARP blocker Rubraca (rucaparib) could help the firm compete with more successful options in this class, but the benefit appears limited. 4 October 2022
Pharmaceutical
Japanese pharma major Shionogi gained 1% to 7,035 yen today, after it announced a voluntary license agreement for its oral COVID-19 antiviral candidate ensitrelvir fumaric acid (S-217622) with the United Nations-backed Medicines Patent Pool (MPP), which aims to increase access to life-saving medicines for low- and middle-income countries (LMICs). 4 October 2022
Biotechnology
Dutch neurology-focused genetic medicine company Vico Therapeutics has appointed Scott Schobel as its chief medical officer (CMO). 4 October 2022
Biotechnology
Urica Therapeutics, a Fortress Biotech company focused on the development and commercialization of products for gout and chronic kidney disease, has announced the appointments of Jay Kranzler as chairman and chief executive, and Vibeke Strand to its board of directors. 3 October 2022
Biotechnology
Apellis Pharmaceuticals has again failed to impress investors as the company keeps its fingers crossed on a potential approval for pegcetacoplan, an investigational targeted C3 therapy. 3 October 2022
Biotechnology
Shares of USA-based LogicBio Therapeutics leapt a staggering 641% to $2.02 in early trading today, as it revealed it is being acquired by Alexion, AstraZeneca’s rare disease business. 3 October 2022
Generics
Indian generics major Zydus Lifesciences has received final approval from the US Food and Drug Administration (FDA) to market mirabegron extended-release tablets USP 25mg and 50mg. 3 October 2022
Pharmaceutical
US biopharma Intercept Pharmaceuticals has had a rocky few years, and has just ploughed into the rocks again. 3 October 2022
Generics
In a blog post, the leading trade group for the US pharmaceutical industry has slammed a recent report from the Initiative for Medicines, Access & Knowledge (I-MAK). 3 October 2022
Biotechnology
The Japanese business of Swiss biotech company Idorsia can boast positive top-line results from a Phase III trial of daridorexant. 3 October 2022
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
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