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Biotechnology
26 November 2024 US companies Arrowhead Pharmaceuticals and Sarepta Therapeutics have announced a global licensing and collaboration agreement.
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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
Shares of Denmark’s Lundbeck were up more than 9% this morning, after the CNS specialist released its 2022 financial results, showing that growth of its strategic brands accelerated further with an increase of 31% (+20% in local currencies) in 2022, reaching 12.1 billion kroner ($1.76 billion), and representing 67% of overall revenue. 7 February 2023
Biotechnology
US pharma major Bristol Myers Squibb has pulled put of a license and collaboration deal with privately-held USA-based biotech Dragonfly Therapeutics. 7 February 2023
Biosimilars
The American business of South Korea's Celltrion Healthcare has appointed Thomas Nusbickel as chief commercial officer. 7 February 2023
Biotechnology
When Johnson & Johnson’s Janssen unit acquired nipocalimab in its $6.5 billion buy of Momenta Pharmaceuticals in 2020, the opportunity in myasthenia gravis appeared most compelling.
But the importance of another indication is becoming clear after Janssen’s presentation of positive Phase II results from the UNITY trial for the treatment of pregnant adults at high risk for severe hemolytic disease of the fetus and newborn (HDFN). 7 February 2023
Biotechnology
Roche’s (ROG: SIX) ambition to muscle in on the paroxysmal nocturnal hemoglobinuria (PNH) sector has received another boost, as the Swiss pharma giant today announced positive results from the global Phase III COMMODORE 2 study, evaluating the efficacy and safety of crovalimab in people with PNH who have not been previously treated with complement inhibitors. 7 February 2023
Pharmaceutical
Pharma lobby group the European Federation of Pharmaceutical Industries and Associations (EFPIA) says it welcomes the opportunity to provide feedback on the European Commission proposal for a revised European Medicines Agency (EMA) Fees regulation. 7 February 2023
Biotechnology
US pairing Biogen and Sage Therapeutics have announced that the US Food and Drug Administration (FDA) has accepted the filing of a New Drug Application (NDA) for zuranolone in the treatment of major depressive disorder (MDD) and postpartum depression (PPD). 6 February 2023
Biotechnology
Genetic medicines company 4D Molecular Therapeutics has announced that its Fabry disease gene therapy program has been placed on clinical hold by the US Food and Drug Administration (FDA). 6 February 2023
Biotechnology
US pharma giant Merck & Co has announced the results of its Phase III NRG-GY018 trial evaluating Keytruda (pembrolizumab) alongside standard-of-care chemotherapy (carboplatin and paclitaxel). 6 February 2023
Biotechnology
The US Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) to expand the use of Takhzyro (lanadelumab-flyo) for prophylaxis to prevent attacks of hereditary angioedema (HAE) in pediatric patients aged two to 6 February 2023
Biosimilars
Privately-held Advanz Pharma has announced that it has entered into an exclusive agreement with Alvotech, an Icelandic biosimilars company, for the exclusive license and supply rights for a proposed copy of Xolair (omalizumab). 6 February 2023
Biotechnology
A steady rise in the number of agents approved to treat inflammatory bowel diseases (IBD) has provided physicians with an increasing number of options to treat Crohn’s disease (CD). 6 February 2023
Pharmaceutical
Japanese drug major Astellas Pharma says it has been working on its Corporate Strategic Plan 2018 and Corporate Strategic Plan 2021 (CSP2021) since fiscal year 2018, when Kenji Yasukawa was appointed as president and chief executive, to realize its VISION “On the forefront of healthcare change to turn innovative science into VALUE for patients. 6 February 2023
Pharmaceutical
Shares of US drug developer Context Therapeutics were up more than 7% at $0.97 pre-market, after it announced that two patients enrolled in the Phase II OATH trial of ONA-XR plus anastrozole in advanced endometrial cancer) have achieved partial response (tumor shrinkage) to the treatment. 6 February 2023
Biosimilars
Sandoz, the generics and biosimilars business unit of Swiss pharma giant Novartis that is soon to be spun out, today announced that the US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for proposed biosimilar denosumab. 6 February 2023
Pharmaceutical
Swiss pharma company Idorsia was trading 10% lower at lunchtime on Monday. 6 February 2023
Biotechnology
In order to spur research and innovation in the pharmaceutical industry, the Narendra Modi government in India is developing a new policy that will cater to a range of therapies - from gene therapy to precision medicine. 6 February 2023
Pharmaceutical
Hyderabad, India-based vaccine manufacturer Indian Immunologicals Limited (IIL) is all ready to launch vaccines for hepatitis A (Hep A) and for measles and rubella (MR) in 2023. 6 February 2023
Pharmaceutical
Pinder Sahota, who is the UK country manager of Danish diabetes care giant Novo Nordisk (NOV: N), has made the decision to resign as president of the trade body Association of British Pharmaceutical Industries (ABPI). 6 February 2023
Pharmaceutical
The European Medicines Agency (EMA), along with the Heads of Medicines Agencies (HMA) and the European Commission (EC) announced on Friday that they are launching a public consultation on the establishment of a multi-stakeholder platform to improve clinical trials in the European Union (EU). 6 February 2023
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