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 European Commission (EC) has approved Xofluza (baloxavir marboxil) in children aged one year and older. 12 January 2023
Pharmaceutical
French pharma major Sanofi has announced an additional multi-year commitment into its evergreen venture fund, with an increase in capital to more than $750 million. 12 January 2023
Biotechnology
Administrators at the US Department of Health and Human Services (HHS) have announced key dates in its planned negotiation of certain prescription drug prices available through Medicare. 12 January 2023
Biotechnology
US neuromuscular and cardiac diseases specialist Solid Biosciences and privately-held Dutch biotech Phlox Therapeutics have announced a strategic collaboration focused on genetic cardiac diseases. 12 January 2023
Biotechnology
Pittsburgh, USA-based clinical-stage biotech Lipella Pharmaceuticals’ shares rose as much as 76% to $5.48, after it announced positive trial results with its bladder disease candidate. 12 January 2023
Biotechnology
Singapore-based Novotech, the leading Asia-Pacific centered biotech contract research organization (CRO), has acquired EastHORN, a European CRO with clinical, medical and regulatory expertise in multiple strategically important locations across the continent. 12 January 2023
Pharmaceutical
Research from industry analyst GlobalData finds that western companies are likely to play an important role in providing new cardiovascular disease (CVD) management options in China. 12 January 2023
Pharmaceutical
The Kerela High Court in India has directed the Department for Promotion of Industry and Internal Trade to consider compulsory licensing of breast cancer drug ribociclib. 11 January 2023
Pharmaceutical
British biotech Pheno Therapeutics has announced a licensing deal with Belgium’s largest drugmaker UCB, focusing on the science of remyelination. 11 January 2023
Biotechnology
Nkarta, a US biopharma developing engineered natural killer (NK) cell therapies to treat cancer, has announced the appointment of a chief medical officer (CMO). 11 January 2023
Pharmaceutical
Global life sciences mergers and acquisitions (M&A) investment totaled $105 billion in the first 11 months of 2022, with total deal value well down on 2021, according to the 11th edition of the annual EY M&A Firepower report published this week. 11 January 2023
Biotechnology
Californian biotech Jasper Therapeutics has announced that it will focus on the development of its lead product candidate, briquilimab, in chronic diseases and stem cell transplant for rare diseases. 11 January 2023
Biotechnology
Privately-held USA-based small-molecule mRNA translation specialist Anima Biotech has entered into other major collaboration, this time with US pharma major AbbVie, which is potentially worth more than $580 million and is aimed at discovering and developing drugs that modulate mRNA biology for three targets in cancer or immune disorders. 11 January 2023
Pharmaceutical
Presentations from German group Bayer at the JP Morgan Healthcare Conference have rallied investors’ confidence in the company’s mid-term prospects. 11 January 2023
Biotechnology
The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) has published its report on new drug approvals in 2022, Advancing Health Through Innovation: New Drug Therapy Approvals. 11 January 2023
Biosimilars
California, USA-based Coherus BioSciences’ shares closed up almost 10% at $9.85 yesterday, when it announced the execution of a binding term sheet with Germany’s Klinge Biopharma for the exclusive US commercialization rights to FYB203, a biosimilar candidate to Eylea (aflibercept). 11 January 2023
Biotechnology
Asklepios BioPharmaceutical, the wholly-owned but independently operated subsidiary of Bayer, has signed a multi-year research collaboration and option agreement with ReCode Therapeutics. 10 January 2023
Biotechnology
US precision immuno-oncology biotech NextPoint Therapeutics has raised $80 million in a Series B financing co-led by Leaps by Bayer, the impact investment arm of Germany’s Bayer, and Sanofi Ventures, the strategic venture capital arm for French drugmaker Sanofi. 10 January 2023
Biotechnology
Massachusetts, USA-based biotech Selecta Biosciences’ shares were up 11% at $1.37, after it announced an exclusive licensing and development agreement with Japan’s Astellas Pharma for IdeXork (Xork). 10 January 2023
Biotechnology
UK-based artificial intelligence (AI) firm InstaDeep is to be acquired by immunotherapy specialist BioNTech for $440 million plus up to $243 million in milestone payments. 10 January 2023
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