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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
All news
Pharmaceutical
Italian drugmaker Alfasigma has signed an agreement to acquire the entire share capital of Sofar, a company with over half a century of operational history in the research, production and marketing of drugs, medical devices and food supplements. 18 August 2022
Biotechnology
US clinical-stage biotech firm Karuna Therapeutics recently announced positive top-line results from the Phase III EMERGENT-2 trial of KarXT (xanomeline + trospium chloride) in acutely psychotic hospitalized adult patients with schizophrenia. 18 August 2022
Biotechnology
Shares of China-based immuno-oncology-focussed biotech I-Mab plunged more than 13% to $6.90 yesterday, after the company revealed in a filing with the Securities and Exchange Commissions that AbbVie has discontinued a Phase I trial of I-Mab's anti-CD47 monoclonal antibody lemzoparlimab, which the US pharma major in-licensed for an upfront $180 million 2020. 18 August 2022
Biotechnology
The US Food and Drug Administration approved Zynteglo (betibeglogene autotemcel), also known as beti-cel, from bluebird bio the first cell-based gene therapy for the treatment of adult and pediatric patients with beta-thalassemia who require regular red blood cell transfusions. 18 August 2022
Pharmaceutical
Medicines Australia's national medicines policy (NMP) review, which was put on hold before the May federal election, has restarted. 18 August 2022
Pharmaceutical
Privately-held North Carolina, USA-based contract research organization BioAgilytix has named Linda Robbie its new chief operating officer. 17 August 2022
Biotechnology
Blueprint Medicines has announced positive top-line results from the registrational Part 2 of the PIONEER clinical trial of Ayvakit (avapritinib). 17 August 2022
Biotechnology
UK pharma major GSK announced today that the US Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for momelotinib for the potential treatment of myelofibrosis patients. 17 August 2022
Biotechnology
The contract development and manufacturing organization (CDMO) AGC Biologics and RoosterBio, a supplier of human mesenchymal stem/stromal cells (hMSCs), highly engineered media and bioprocess development services, have announced a strategic partnership. 17 August 2022
Pharmaceutical
The Project to Accelerate New Treatments for Tuberculosis (PAN-TB) collaboration today announced the execution of a joint development agreement (JDA) — among Johnson & Johnson unit Janssen Pharmaceutica, Japan’s Otsuka, TB Alliance and the Bill & Melinda Gates Medical Research Institute — supporting the progression of two investigational tuberculosis (TB) combination treatment regimens into Phase II clinical development. 17 August 2022
Pharmaceutical
In the UK, the National Institute for Health and Care Excellence (NICE) has given a positive reimbursement decision for AbbVie’s Rinvoq (upadacitinib). 17 August 2022
Biosimilars
The US Food and Drug Administration (FDA) has approved the citrate-free, high-concentration (100mg/mL) formulation of Hadlima (adalimumab-bwwd), a biosimilar referencing AbbVie’s mega-blockbuster Humira (adalimumab). 17 August 2022
Pharmaceutical
CNS specialist Lundbeck was trading 12% lower by mid-afternoon Wednesday after presenting its financial results for the first half of the year. 17 August 2022
Pharmaceutical
The UK government has initiated formal consultations with the European Union, with the aim of finalizing UK participation in EU science and research programs. This follows persistent delays by the EU in implementing the agreement reached under the Trade and Cooperation Agreement (TCA). 17 August 2022
Biotechnology
The European Investment Bank (EIB) is providing 22 million euros ($22.4 million; above 100 million polish zlotys) in financing to Ryvu Therapeutics, Poland’s largest biotech firm that is focusing on novel small molecule therapies that address unmet medical needs in oncology. 17 August 2022
Biotechnology
Ideaya Biosciences has announced its financials for second-quarter 2022, saying it has a strong balance sheet of ~$324 million cash, cash equivalents and marketable securities as of June 30, 2022, which is anticipated to fund planned operations into 2025. 17 August 2022
Pharmaceutical
Shares of French pharma major Sanofi were down 4.8% at 82.42 euros this morning, after it announced the discontinuation of the global clinical development program of amcenestrant, an investigational oral selective estrogen receptor degrader (SERD). 17 August 2022
Pharmaceutical
As President Joe Biden signs the Inflation Reduction Act into law, drugmakers in the USA are poring over the likely impact on drug prices, and how best to respond to its enactment. In this episode, we take a quick look at the Act’s provisions, and the likely impact on drugmakers, with Stephanie Kennan from political consultancy McGuireWoods. 17 August 2022
Biotechnology
US biotech Viridian Therapeutics has commenced an underwritten public offering of $175 million of shares of its common stock and series B preferred stock. 16 August 2022
Biotechnology
Big pharma has come knocking at the door of Orna Therapeutics, a biotech launched a few years ago by MIT alumni with the goal of developing a new kind of RNA therapeutic. 16 August 2022
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