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
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
Pharmaceutical
The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) today announced that Dr Thomas Schinecker, chief executive (CEO) of Swiss pharma giant Roche (ROG: SIX), will take up the post as president of the trade association effective January 1, 2025. 26 November 2024
Pharmaceutical
US central nervous system (CNS) disorders specialist Axsome Therapeutics today released encouraging late-stage results for its narcolepsy candidate AXS-12 (reboxetine), sending its shares edging up 2.6% to $100.00 in pre-market activity. 26 November 2024
Biotechnology
Clinical-stage US CAR-T therapies developer Poseida Therapeutics saw its shares skyrocket 227% to $9.36 pre-market today, on the news of a proposed takeover by Swiss pharma giant Roche. 26 November 2024
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Pharmaceutical
The Medicines for Malaria Venture (MMV) and Shin Poong Pharm have welcomed the formal inclusion of Pyramax (pyronaridine-artesunate), developed by the South Korean company, in the World Health Organization’s (WHO) Guidelines for Malaria following an extensive review process. 25 November 2022
Biotechnology
Privately-held Italian drugmaker Chiesi announced that its new center of excellence for the development and production of biologic drugs, currently under construction, will be built in Parma in the area of the production plant where the company is headquartered. 24 November 2022
Pharmaceutical
Privately-held German drugmaker Grünenthal and Japanese speciality pharma company Kyowa Kirin have announced an agreement. 24 November 2022
Pharmaceutical
The European Organization for Research and Treatment of Cancer (EORTC) has entered into a collaboration aimed at bringing treatment and research in the oncology sector to patients in the Middle East. 24 November 2022
Pharmaceutical
Johnson & Johnson’s subsidiary Janssen has presented further findings on its approved depression drug Spravato (esketamine). 24 November 2022
Biotechnology
In another boost for AbbVie (NYSE: ABBV), the European Commission (EC) has granted a third approval of Skyrizi (risankizumab, 600mg intravenous [IV] induction and 360mg subcutaneous [SC] for maintenance therapy). 24 November 2022
Biotechnology
California, USA-based BioMarin Pharmaceutical saw its shares leap 10.7% to $98.49 yesterday, after it announced that the US Food and Drug Administration (FDA) review of the Biologics License Application (BLA) of Roctavian (valoctocogene roxaparvovec AAV gene therapy) for adults with severe hemophilia A would not, after all, be submitted for review by the agency’s advisory panel. 24 November 2022
Pharmaceutical
New UK Health Security Agency (HAS) evidence indicates that a single MVA-BN vaccine dose provides around 78% protection against monkeypox 14 days after being vaccinated. 23 November 2022
Generics
STADA Arzneimittel has replaced the departing Carsten Cron with Stéphane Jacqmin as head of emerging markets at the German firm. 23 November 2022
Pharmaceutical
Japanese drugmaker Shionogi (TYO: 4507) said yesterday that its Xocova (ensitrelvir fumaric acid, Code No.: S-217622), a novel anti-SARS-CoV-2 drug for COVID-19 obtained emergency regulatory approval from the Ministry of Health, Labor and Welfare (MHLW) in Japan for the indication of SARS-CoV-2 infection. 23 November 2022
Biotechnology
US biotech Arvinas closed 16% lower after Monday’s trading. 23 November 2022
Biotechnology
In a landmark regulatory first, Dutch gene therapy company uniQure (Nasdaq: QURE) has secured US approval for its one-time hemophilia B treatment, Hemgenix (etranacogene dezaparvovec-drlb). 23 November 2022
Biotechnology
A new dengue vaccine, first approved in Indonesia, is to be evaluated by the US Food and Drug Administration under its Priority Review scheme. 23 November 2022
Pharmaceutical
As US federal funding for COVID-19 vaccines and treatments dwindles and cases decline, the Biden administration is planning to stop paying for these products and transition to a more standard purchasing process through different health care system channels, including commercial insurers and pharmacy benefit managers (PBMs) next year. 23 November 2022
Biotechnology
Belgium’s largest drugmaker UCB said yesterday it has resubmitted the Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for bimekizumab for the treatment of adults with moderate to severe plaque psoriasis. 23 November 2022
Generics
Leading Indian and Chinese drugmakers are considering accelerating their expansion into the Russian market – in a move to fill vacant niches that appeared after the reduction of presence of Western pharmaceutical companies in recent months following the invasion of Ukraine. 23 November 2022
Biotechnology
UK pharma major GSK has started the process of withdrawing the US marketing authorization for multiple myeloma drug Blenrep (belantamab mafodotin-blmf). 22 November 2022
Biotechnology
The US Food and Drug Administration (FDA) today revealed it is investigating the risk of severe hypocalcemia with serious outcomes, including hospitalization and death, in patients with advanced kidney disease on dialysis treated with the osteoporosis medicine Prolia (denosumab). 22 November 2022
Pharmaceutical
Novo Nordisk has announced plans to spend 5.4 billion Danish kroner ($750 million) on the expansion of existing facilities and the addition of a new plant in Bagsværd, Denmark. 22 November 2022
Pharmaceutical
Representatives of the Russian patient community have warned about the shortage of the antiretroviral drug Eviplera (rilpivirine/tenofovir/emtricitabine), the most popular and most expensive combination drug for the treatment of HIV on the domestic market, reports The Pharma Letter’s local correspondent. 22 November 2022
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