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
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
Biosimilars
Biosimilars are compounds that have demonstrated no clinically meaningful differences in safety, purity and potency from a reference biologic drug. As of September 2022, 38 biosimilars have been approved for use within the USA. 29 September 2022
Biosimilars
Adding to recent market authorizations in the European Union, Japan and the UK, South Korea-based Celltrion Healthcare says its biosimilar of a Roche (ROG: SIX) cancer drug has now gained approval in the USA, sending the firm’s share up 2.7% to 171,100 won. 29 September 2022
Biotechnology
Spanish dermatology specialist Almirall and Simcere Pharmaceutical Group have signed an exclusive licensing agreement for the Chinese firm’s IL-2 mutant fusion protein (IL-2 mu-Fc) autoimmune drug candidate, SIM0278. 29 September 2022
Pharmaceutical
Japanese drug major Sumitomo Pharma has filed an appeal with the US Court of Appeals for the Federal Circuit (CAFC) seeking revocation of the decision of the US Patent and Trademark Office (USPTO) relating to the proprietary atypical antipsychotic agent Latuda (lurasidone HCl tablets). 29 September 2022
Biotechnology
Continuing its impressive rise, Dupixent (dupilumab) has secured US Food and Drug Administration approval for prurigo nodularis, a debilitating skin condition. 29 September 2022
Generics
Private equity firm SK Capital Partners has entered into a deal to acquire Apotex Pharmaceutical Holdings, a Canada-based generic drugmaker with products across all major therapeutic areas for patients around the world. 29 September 2022
Pharmaceutical
Russia plans to accelerate the production of active pharmaceutical ingredients (APIs) for antibiotics, as well as to pay more attention to the development of drugs against chronic infections, as part of a new State Concept for the Development of Pharmaceutical industry in Russia that is designed until 2030, reports The Pharma Letter’s local correspondent. 29 September 2022
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