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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Biotechnology
Japanese drugmaker Takeda has put plenty on the line to acquire NDI-034858 from privately-held US drug discovery company Nimbus Therapeutics. 13 December 2022
Biotechnology
Shares in Moderna were up by nearly a quarter at lunchtime Tuesday. 13 December 2022
Biotechnology
The retiring Paul Perreault is to be replaced by another Paul as chief executive and managing director of Australian biotech CSL Limited. 13 December 2022
Pharmaceutical
Providing further evidence that generics major Viatris is pushing wider beyond copy drugs, the company has entered into an exclusive license agreement with Sweden’s Calliditas Therapeutics to register and commercialize the latter’s Nefecon in Japan. 13 December 2022
Biotechnology
Terms for a strategic collaboration in the area of cell and gene therapies have been agreed between Wave Life Sciences and GSK. 13 December 2022
Biosimilars
Biosimilar medicines deliver access for patients suffering from serious and debilitating conditions such as cancer, auto immune diseases, and diabetes. 13 December 2022
Biotechnology
Troubled US biotech Clovis Oncology has officially filed for bankruptcy in Delaware, hit by a fall in its cancer drug sales and challenges in raising additional capital, and will also seek to sell its assets through a court supervised sales process. 13 December 2022
Biotechnology
German immuno-oncology company Affimed has sought to impress with data on its blood cancer candidates at the ongoing ASH (American Society of Hematology) meeting. 13 December 2022
Biotechnology
US biotech major Regeneron added to its offering at this year’s American Society of Hematology (ASH) meeting with data on linvoseltamab in multiple myeloma. 13 December 2022
Pharmaceutical
Eli Lilly’s (NYSE: LLY) oncology company, Loxo@Lilly, has announced updated clinical data from the global Phase I/II BRUIN trial of pirtobrutinib. 13 December 2022
Biotechnology
A second KRAS blocker has won US approval, opening further a market in oncology based on a target that was once thought undruggable. 13 December 2022
Pharmaceutical
Indian pharmaceutical companies are on an acquisition spree after a decade of caution and organic growth. And their main target appears to be cancer drugs. As patient numbers continue to rise, the country's Parliamentary panel has also called for free cancer treatment to middle-class households through a government-funded health insurance scheme, reports The Pharma Letter’s India correspondent. 13 December 2022
Pharmaceutical
Belgium’s largest pharma company UCB yesterday announces that its board of directors has accepted the resignation of Stefan Oschmann as chairman and board member of the firm. 13 December 2022
Pharmaceutical
Drugmakers Novo Nordisk, Daiichi-Sankyo, Lundbeck, AstraZeneca, UCB and Biogen have been named and shamed by the UK pharma trade group. 12 December 2022
Biotechnology
USA-based Regeneron Pharmaceuticals has announced positive new and updated data from the Phase I ELM-1 and pivotal Phase II ELM-2 trials of its lymphoma candidate odronextamab. 12 December 2022
Pharmaceutical
At its December meeting today, the board of directors of Swiss pharma giant Roche approved to propose some major board changes at the Annual General Meeting, which will take place on March 14, 2023: 12 December 2022
Biotechnology
With Imbruvica (ibrutinib) sales of nearly $10 billion recorded by Janssen and AbbVie combined in 2021, the blood cancer drug has already changed the standard of care for patients in certain settings. 12 December 2022
Biotechnology
Coming as no surprise following rumors for the last couple of weeks, but with a much bigger price tag than had been expected, US biotech giant Amgen today announced that it is to acquire Horizon Therapeutics. 12 December 2022
Biotechnology
Autoimmune diseases specialist argenx has previously referred to Vyvgart (efgartigimod alfa-fcab), an antibody fragment that binds to the neonatal Fc receptor (FcRn), as a ‘pipeline in a product’. 12 December 2022
Biotechnology
Developed by the UK’s AstraZeneca (LSE: AZN) in collaboration with scientists at the University of Oxford, Vaxzevria (ChAdOx1-S [Recombinant]) was one of the first COVID-19 vaccines to come on the market, but it has been far less successful than the mega money-spinners such as Pfizer and BioNTech’s Comirnaty and Moderna’s Spikevax, not to mention that it has been sold at cost and has never been approved in the vast US market. 12 December 2022
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