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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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Pharmaceutical
UK pharma major GSK has announced positive headline results from a Phase III trial of its MenABCWY combination vaccine candidate. 14 March 2023
Pharmaceutical
Japan’s largest drugmaker Takeda has revealed that its dengue vaccine, Qdenga (dengue tetravalent vaccine [live, attenuated]; TAK-003), is now approved by Brazil’s National Health Surveillance Agency (ANVISA) for the prevention of dengue caused by any of the four virus serotypes that can be found in individuals from four to 60 years of age. 14 March 2023
Biotechnology
Given the large market potential and high unmet need for new respiratory syncytial virus (RSV) therapies, drug developers have been focused on new vaccine and monoclonal antibody (MAb) development. 14 March 2023
Pharmaceutical
The Lancet has published detailed results from the Phase III SKYLIGHT 1 study of fezolinetant. 14 March 2023
Pharmaceutical
In June 2021, the US Food and Drug Administration (FDA) approved Novo Nordisk’s (NOV: N) type 2 diabetes drug Wegovy (semaglutide) injection for chronic weight management in overweight or obese adults with at least one weight-related condition.1 This is just one example of the potential for existing drugs to offer new uses – also known as drug repurposing. 14 March 2023
Biotechnology
US biotech Moderna has failed to dodge a patent lawsuit relating to its COVID-19 vaccine. 13 March 2023
Biotechnology
The Phase I trial of XMT-2056 has been placed on clinical hold by the US Food and Drug Administration (FDA), said the drug’s developer, US clinical-stage biotech Mersana Therapeutics, whose shares fell over 2% to $4.6 in pre-market trading today 13 March 2023
Pharmaceutical
Exenatide, a GLP-1 agonist sold under the brand names Byetta and Bydureon by AstraZeneca (LSE: AZN) as a type 2 diabetes drug, could be useful in another indication, a trial has found. 13 March 2023
Pharmaceutical
March is Wilson’s Disease Awareness Month – an opportunity to raise awareness and explore progress within the management and treatment of this rare condition. 13 March 2023
Pharmaceutical
Two American firms have agreed terms for the joint commercialization of the novel attention deficit/hyperactivity disorder (ADHD) candidate CTx-1301 (dexmethylphenidate). 13 March 2023
Pharmaceutical
The Indian Institute of Technology (IIT) Kanpur has licensed a gene therapy technology to Mumbai-based Reliance Life Sciences that could change the landscape of gene therapy, particularly for genetic eye diseases. 13 March 2023
Biotechnology
Provention Bio’s shares skyrocketed 262% to $24.27 in pre-market trading today, on the news that French pharma major Sanofi had made a takeover bid for the US biotech. 13 March 2023
Biotechnology
Representatives from the UK biopharmaceutical industry are calling on the government to provide more support through a specially-designated tax relief program. 13 March 2023
Biotechnology
An analysis of the recent investment activity in antibody–drug conjugates (ADCs) prior to Pfizer's newly-announced $43 billion takeover of Seagen. 13 March 2023
Biotechnology
Given that early merger talks between Pfizer and Seagen had already been reported, the confirmation of the deal was not a surprise, but the price was a great deal more than the around $30 billion previously rumored. 13 March 2023
Pharmaceutical
Swedish rare disease company Calliditas Therapeutics has announced positive Phase III results for Tarpeyo (budesonide) in primary IgA nephropathy (IgAN). 13 March 2023
Biotechnology
After a run on assets, Santa Clara headquartered Silicon Valley Bank (SVB) was closed on Friday by the California Department of Financial Protection and Innovation, which appointed the Federal Deposit Insurance Corporation (FDIC) as receiver. 13 March 2023
Pharmaceutical
Shares of US drug developer Intercept Pharmaceuticals closed almost 14% lower at $16.12 on Friday, after it revealed that the US regulator will hold an advisory committee meeting to review its re-submitted approval request for its investigational non-alcoholic steatohepatitis (NASH) treatment obeticholic acid (OCA). 13 March 2023
Pharmaceutical
On Friday, the US Food and Drug Administration (FDA) issued a notice addressing the agency’s COVID-19-related guidance documents, including which of those guidance documents will no longer be in effect after the expiration of the COVID-19 public health emergency (PHE) declared under the Public Health Service (PHS) Act, and which of those guidance documents the FDA is revising to temporarily continue in effect. 13 March 2023
Pharmaceutical
Fiocruz, Brazil’s scientific institution for R&D, and the Drugs for Neglected Diseases Initiative (DNDi) have signed a strategic alliance agreement, which expands and strengthens the relationship between the two institutions. 13 March 2023
All news
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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