Latest Pharma and Biotech News
Biotechnology
26 November 2024 US companies Arrowhead Pharmaceuticals and Sarepta Therapeutics have announced a global licensing and collaboration agreement.
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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
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
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
All news
Biotechnology
An antibody-drug conjugate (ADC) from AstraZeneca and Daiichi Sankyo has secured approval in China. 24 February 2023
Biotechnology
At its February meeting, the European Medicines Agency’s human medicines committee CHMP recommended approval of eight novel medicines, one of which is a biosimilar. 24 February 2023
Biotechnology
The US Food and Drug Administration (FDA) has approved Altuviiio (efanesoctocog alfa), a high-sustained factor VIII replacement therapy. 24 February 2023
Pharmaceutical
Germany’s Merck KGaA has announced updated long-term efficacy and safety data for its investigational small molecule evobrutinib. 24 February 2023
Biotechnology
Shares of Nektar Therapeutics sank more than 40% to $1.78 in pre-market activity today after the company reported that a study of rezpegaldesleukin (rezpeg) did not achieve its goals and that partner Eli Lilly has decided not to proceed with Phase III development of the investigational treatment for systemic lupus erythematosus (SLE). 24 February 2023
Pharmaceutical
US precision oncology company Enliven Therapeutics today announced that, concurrent with the completion of its previously announced merger with Imara, it has completed a $165 million private placement. 24 February 2023
Biotechnology
Two and half years after the Swiss pharma giant paid $775 million up front to in-license the RET inhibitor, as part of a $1.7 billion deal with US biotech Blueprint Medicines, Roche is pulling out of the deal to develop Gavreto (pralsetinib), citing “strategic reasons”. 24 February 2023
Biotechnology
Pfizer has already reported eye-watering annual revenue of $100.3 billion for 2022 driven by its products related to the COVID-19 pandemic, notably the Comirnaty vaccine, which witnessed a record demand last year with forecast sales of $37 billion. 24 February 2023
Biotechnology
California, USA-based precision medicine company Cartography Biosciences, which launched in July last year with $57 million financing, has appointed Chester Wong as vice president, head of business development. 24 February 2023
Pharmaceutical
An Expert View from David Bleakman, president, Drug Discovery and Development at PsychoGenics. 24 February 2023
Biotechnology
US pharma major AbbVie and privately-held gene therapy company Capsida Biotherapeutics have expanded their strategic collaboration on the development of genetic medicines for eye diseases with high unmet need. 23 February 2023
Biotechnology
Today, Dutch gene therapy company uniQure announced that the prestigious New England Journal of Medicine (NEJM) has published data from the pivotal Phase III HOPE-B study evaluating the efficacy, durability and safety of Hemgenix (etranacogene dezaparvovec-drlb), the first gene therapy approved for the treatment of adults with hemophilia B. 23 February 2023
Biotechnology
US mRNA specialist biotech Moderna today reported financial results for the fourth quarter and fiscal year 2022 that disappointed and sent its shares down 7.5% at $146.63 in mid-morning in trading. 23 February 2023
Biotechnology
UK pharma major AstraZeneca (LSE: AZN) saw its shares dip 1.2% after it announced an exclusive global license deal with KYM Biosciences. 23 February 2023
Biotechnology
Struggling to finance further development of its immunotherapy candidates alone, Jounce Therapeutics has announced plans to merge with British firm Redx Pharma. 23 February 2023
Biotechnology
Two more American biotech companies have been forced to announce plans to restructure, including mandatory redundancies, to avoid looming financial trouble. 23 February 2023
Pharmaceutical
HIV specialist company ViiV Healthcare has announced positive 12-month findings from the SOLAR study. 23 February 2023
Biotechnology
Rare Disease Day is honored globally on February 28 each year. For a long time, the number of known rare diseases in the world was pegged between 6,000 and 8,000. 23 February 2023
Biotechnology
French clinical-stage biotech Abivax yesterday announced the successful pricing of an oversubscribed 130 million-euro ($139 million) financing with high-quality US and European biotech specialist investors, adding to the 49 million-euro fundraising in September last year. 23 February 2023
Generics
Four applicants have received the first tranche of incentives under India's Production Linked Incentive (PLI) scheme released by the Department of Pharmaceuticals (DoP), which awarded the Indian drugmakers $20 million. 23 February 2023
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