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
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
Biosimilars
Samsung Bioepis has appointed Kyung-Ah Kim as its new president and chief executive, succeeding Christopher Hansung Ko, who will lead the Samsung Future Business Division. 27 November 2024
Biotechnology
US clinical stage biotech Alector saw its shares tumble 35% to $2.57 by close of trading yesterday, as it announced disappointing results from the INVOKE-2 Phase II clinical trial evaluating the safety and efficacy of AL002 in slowing disease progression in individuals with early Alzheimer’s disease (AD). 27 November 2024
Pharmaceutical
Japanese drugmaker Otsuka has announced the submission of a New Drug Application (NDA) to the Japanese Ministry of Health, Labor and Welfare (MHLW) for the manufacture and sale in Japan of bempedoic acid - trade name Nexletol in Japan - for the treatment of hypercholesterolemia and familial hypercholesterolemia. 27 November 2024
Pharmaceutical
Berlin, Germany-based Eckert & Ziegler Radiopharma has received approval of its proprietary non-carrier added Lutetium-177 chloride, Theralugand, by the European Commission (EC). 27 November 2024
Biotechnology
PTC Therapeutics has announced that its Phase II trial for utreloxastat, aimed at treating amyotrophic lateral sclerosis (ALS), failed to meet its primary endpoint. 27 November 2024
Biotechnology
US companies Arrowhead Pharmaceuticals and Sarepta Therapeutics have announced a global licensing and collaboration agreement. 26 November 2024
All news
Biotechnology
The US Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for Vemlidy (tenofovir alafenamide) 25mg tablets as a once-daily treatment for chronic hepatitis B virus (HBV) infection in pediatric patients 12 years of age and older with compensated liver disease. 2 November 2022
Pharmaceutical
Shares of Danish diabetes care giant Novo Nordisk were up 6.4% at 852.60 kroner by mid-afternoon today, after it released financial results, showing that sales increased by 26% in Danish kroner and by 16% at constant exchange rates (CER) to 128.9 billion kroner ($17.12 billion) in the first nine months of 2022. 2 November 2022
Pharmaceutical
Third quarter 2022 revenues of £7.8 billion ($9 billion) for GSK represent a significant outperform by most analysts’ lights - the consensus ahead of results day was £7.3 billion, according to data from the FT. 2 November 2022
Pharmaceutical
Rigel Pharmaceuticals’ share were up 3.4% at $0.75 yesterday, after it announced encouraging top-line efficacy and safety results from the FOCUS Phase III clinical trial of fostamatinib in hospitalized COVID-19 patients without respiratory failure who have certain high-risk prognostic factors. 2 November 2022
Biotechnology
A landmark approval in infectious diseases could be achieved by the end of the year, after New York pharma giant Pfizer reported fast progress in its respiratory syncytial virus (RSV) vaccine program. 2 November 2022
Biotechnology
Spain's AELIX Therapeutics, a spin-off of the HIVACAT vaccine research consortium, has published in Nature results from the AELIX-002 trial. 2 November 2022
Pharmaceutical
US healthcare giant Johnson & Johnson yesterday revealed it is making its largest acquisition in six years and potentially one of the biggest deals by a pharma this year. 2 November 2022
Biosimilars
Four years after it was established, Syna Therapeutics has just signed an exclusive license agreement with Indian drugmaker Intas Pharmaceuticals and its wholly-owned subsidiary Accord Healthcare for the marketing worldwide of its biosimilar medicine LB-0702 to treat pathologies in the field of hematology. 2 November 2022
Pharmaceutical
Continuing its extraordinary ascent, the world’s largest pharmaceutical firm, Pfizer, reported solid financial results in the third quarter, with revenues of $22.6 billion. 1 November 2022
Biotechnology
Switzerland-headquartered antibody-drug conjugate specialist ADC Therapeutics today announced the appointment of Kristen Harrington-Smith as chief commercial officer, effective November 17, 2022, and Peter Graham as chief legal officer, effective today. 1 November 2022
Pharmaceutical
US pharma major Eli Lilly saw its shares fall more than 4.7% to $344.91, after it released third-quarter 2022 financial results, along with a lowered full-year guidance. 1 November 2022
Pharmaceutical
The share of US pharma giant Pfizer’s erectile dysfunction drug Viagra (sildenafil) in the Russian market is steadily declining, due to the ever-growing competition from local generics and serious interruptions with supplies of the drug from Europe. 1 November 2022
Pharmaceutical
A new prefilled autoinjector pen for diabetics, Ogluo (glucagon) has been launched in Germany by Tetris Pharma, a subsidiary of British firm Arecor Therapeutics. 1 November 2022
Biotechnology
Adding to a string of recent research collaborations, Japanese drugmaker Ono Pharmaceutical has signed a drug discovery agreement for drugs in the immuno-oncology field with Swiss biotech Memo Therapeutics (MTx), an innovator in the field of antibody discovery and development. 1 November 2022
Biotechnology
US pharma major AbbVie communicated during its third-quarter financial results on October 28, that it has decided to stop the development of cedirogant (ABBV-157), an oral RORg inverse agonist jointly discovered by French firm Inventiva and AbbVie for the treatment of autoimmune diseases. 1 November 2022
Pharmaceutical
Trouble recruiting patients has thrown a wrench in the works of efforts to develop a novel prostate cancer treatment, EPI-7386. 1 November 2022
Generics
The Russian capital Moscow is expected to be one of the centers for the production of new vital and essential drugs in the country already in the short term as its pharmaceutical output is steadily growing, according to recent statements by the Moscow city senior state officials and local media, reports The Pharma Letter’s local correspondent. 1 November 2022
Biotechnology
Long available in Europe under an emergency nod, AstraZeneca's COVID-19 vaccine, Vaxzevria, has finally been granted full approval in the region. 1 November 2022
Biotechnology
Having soared as much as 164% earlier in the day, shares of USA-based Coeptis Therapeutics closed down 45% at $6.50 on the Nasdaq, after it announced the completion of its business combination with Bull Horn Holdings, a special purpose acquisition company (SPAC). 1 November 2022
Pharmaceutical
Drug-resistant pathogens have increased over the past few years and no longer respond to available antibiotics. A new study in India has noted that infections that were once easily treatable are now more difficult to treat, reports The Pharma Letter’s India correspondent. 1 November 2022
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