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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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Biotechnology
A final evidence report from the Institute for Clinical and Economic Review (ICER) on the affordability of multiple sclerosis (MS) drugs in the USA has found that monoclonal antibodies (MAbs) do not offer value for money at current prices. 22 February 2023
Biotechnology
Ono Pharmaceutical’s shares closed down 2.3% at 2,784 yen today, after the Japanese drugmaker revealed it has signed a collaboration and option agreement with Boston, USA-based biotech Cue Biopharma (Nasdaq: CUE) for CUE-401. 22 February 2023
Pharmaceutical
An analysis of three real-world studies shows the positive impact of early use of Gilead Sciences’ COVID-19 antiviral Veklury (remdesivir). 22 February 2023
Biotechnology
The US Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for Pfizer’s respiratory syncytial virus (RSV) vaccine candidate. 22 February 2023
Biotechnology
UK pharma major AstraZeneca today revealed that Imfinzi (durvalumab) and Imjudo (tremelimumab) immunotherapy combinations have been approved in the European Union (EU) for the treatment of advanced liver and lung cancers. 22 February 2023
Biotechnology
Shanghai Junshi Biosciences has announced positive results from a randomized, double-blind, placebo-controlled, multicenter Phase III clinical study (TORCHLIGHT Study, NCT04085276) examining the company’s product toripalimab in combination with paclitaxel for injection (albumin-bound) in patients with an initial diagnosis of stage IV or recurrent/metastatic triple-negative breast cancer. 22 February 2023
Pharmaceutical
Global specialist HIV company ViiV Healthcare, which is majority owned by GSK, has been granted marketing authorization by the European Medicines Agency (EMA) for Triumeq PD. 22 February 2023
Pharmaceutical
Belgian drug major UCB outpaced revenue expectations for 2022, taking in 5.52 billion euros ($5.9 billion), well ahead of the FT consensus forecast of 5.34 billion euros. 22 February 2023
Pharmaceutical
USA-based Akebia Therapeutics said yesterday that it has received a second interim response from the US Food and Drug Administration (FDA) to its formal dispute resolution request regarding the Complete Response Letter (CRL) for vadadustat received in March 2022, with the news sending the firm’s plunging 25.5% to $0.65. 22 February 2023
Biotechnology
US biotech Actinium Pharmaceuticals saw its shares rise as much as 21%, after it announced positive results for the primary and secondary endpoints from its pivotal Phase III SIERRA trial of Iomab-B in patients age 55 and above with active relapsed or refractory acute myeloid leukemia (r/r AML). 22 February 2023
Biotechnology
Authorization has been granted by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for a new version of the Moderna’s ‘bivalent’ COVID-19 vaccine. 21 February 2023
Biosimilars
Indian generic injectables manufacturer Gland Pharma is to invest $48 million to expand its existing facility in Genome Valley in Telangana, Hyderabad, to manufacture biologicals, biosimilars, antibodies, and recombinant insulin. 21 February 2023
Pharmaceutical
Japanese drugmaker Astellas closed Monday’s trading 2% lower following some news on fezolinetant, its investigational agent for the treatment of moderate to severe vasomotor symptoms (VMS) due to menopause. 21 February 2023
Pharmaceutical
Karyopharm Therapeutics and privately-held Italian drugmaker Menarini Group today announced that the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has granted full Marketing Authorization for Nexpovio (selinexor) in combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. 21 February 2023
Biotechnology
The European Commission has granted conditional marketing authorization (CMA) for Hemgenix (etranacogene dezaparvovec), the first and only one-time gene therapy for the treatment of severe and moderately severe hemophilia B (congenital Factor IX deficiency) in adults without a history of Factor IX inhibitors. 21 February 2023
Pharmaceutical
Hidden among the detail of Spanish drugmaker Almirall’s financial results on Monday was news about the leadership of the Barcelona-based company. 21 February 2023
Biotechnology
HealthCap VIII portfolio company Hemab Therapeutics has closed an oversubscribed $135 million Series B financing. 21 February 2023
Pharmaceutical
Danish diabetes care giant Novo Nordisk’s has been impacted by supply chain issues, for the production of semaglutide, the active ingredient of its obesity drug Wegovy, as well as diabetes drugs Ozempic and Rybelsus. 21 February 2023
Pharmaceutical
Drug regulators in China are focusing on approving homegrown antiviral therapies with the ability to tackle new COVID-19 variants, according to analysis from a data and analytics provider. 20 February 2023
Pharmaceutical
The IQVIA Institute has released its Global Trends in R&D 2023 report. 20 February 2023
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