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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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Pharmaceutical
A strategic licensing deal has been agreed between Barcelona, Spain-based rare disease company Minoryx Therapeutics and German central nervous system (CNS) specialist Neuraxpharm. 10 November 2022
Biotechnology
The entry of new treatments for atypical hemolytic uremic syndrome (aHUS) such as Swiss pharmaceutical giants Novartis and Roche that have strong digital experience can alter the aHUS digital landscape dynamics in Japan, says data and analytics company GlobalData. 10 November 2022
Biotechnology
Shares of Sino-American biotech BeiGene rose as much as 3.8% to 133.97 renminbi when trading started this morning, as the company released third-quarter 2022 financial results that beat consensus forecasts. 10 November 2022
Biotechnology
The growing US-China tension, a chilled market and a weakened China economy had Chinese biotechs re-think their strategies. However, most of them agreed that, despite all the challenges, going global is a must, said speakers at the DJSeedin innovation partnering conference held in Shanghai earlier this month. 9 November 2022
Pharmaceutical
Artificial intelligence (AI)-driven drug discovery company Insilico Medicine has announced a multi-year, multi-target strategic research collaboration with French pharma major Sanofi. 9 November 2022
Biotechnology
The checkpoint blocker Libtayo (cemiplimab-rwlc) has secured US approval for the first-line treatment of certain adults with advanced non-small cell lung cancer (NSCLC). 9 November 2022
Biotechnology
Shares of Novavax were up as much as 3% in pre-market trading, after the US biotech released top-line results from a Phase III boosting trial for COVID-19, showing that its BA.1 vaccine candidate (NVX-CoV2373) met the primary strain-change endpoint. 9 November 2022
Pharmaceutical
San Diego, USA-based Vividion Therapeutics has hired Jenna Goldberg to take the position of chief medical officer. 9 November 2022
Pharmaceutical
French drugmaker Ipsen has announced that Onivyde (irinotecan liposome injection) has met the goals of the Phase III NAPOLI 3 trial. 9 November 2022
Biotechnology
Hopes that the novel antibody-drug conjugate (ADC) camidanlumab tesirine (Cami) might soon secure a review under the Accelerated Approval scheme have been dashed. 9 November 2022
Pharmaceutical
Denmark-based CNS specialist Lundbeck saw its shares rise nearly 4% to 28.48 Danish kroner in early trading, after the company released financial results for the first nine months of 2022. 9 November 2022
Pharmaceutical
UK pharma major AstraZeneca today reported that the US Food and Drug Administration’s (FDA) Pulmonary-Allergy Drugs Advisory Committee has voted overwhelmingly to recommend approval of PT027 (albuterol/budesonide) as a new rescue treatment in the USA for people 18 years of age and older, but was not so supportive for younger age groups. 9 November 2022
Generics
The US Food and Drug Administration (FDA) yesterday published a new draft guidance for industry, titled “Sameness Evaluations in an ANDA – Active Ingredients.” 9 November 2022
Biotechnology
Blue Earth Therapeutics’ investigational therapeutic radiopharmaceutical, 177Lu-rhPSMA-10.2, has been awarded an Innovation Passport by the UK Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of metastatic castrate-resistant prostate cancer. 9 November 2022
Biotechnology
VectorY Therapeutics, a Dutch biotech developing vectorized antibody approaches for neurodegenerative diseases, has named Sander van Deventer, co-founder and formerly chief technology officer, as chief executive. 8 November 2022
Biotechnology
Novartis has presented new data on Leqvio (inclisiran), an siRNA product approved in primary hyperlipidemia as an adjunct to diet and maximally tolerated statin therapy to reduce low-density lipoprotein cholesterol (LDL-C). 8 November 2022
Biotechnology
Sino-American drug developer Zenas BioPharma today announced proceeds of $118 million in connection with the issuance of Series B preferred shares. 8 November 2022
Pharmaceutical
Italian drugmaker Recordati today presented its annual financial results for the first nine months of 2022, edging its shares up 1.6% to 38.48 euros. 8 November 2022
Biotechnology
Japan’s Ono Pharmaceutical has exercised its option to an iPS cell-derived chimeric antigen receptor (CAR)-T cell therapy targeting human epidermal growth factor receptor 2 (HER2)-expressing solid tumors, under its collaboration with Fate Therapeutics. 8 November 2022
Pharmaceutical
Ocuphire Pharma’s leapt nearly 27% to $2.65 in pre-market activity this morning, in reaction to its conclusion of an exclusive license agreement with FamyGen Life Sciences (Famy) for the development and commercialization of Nyxol (phentolamine mesylate) across three indications in USA, Europe, Japan, India, China and other global markets. 8 November 2022
All news
Generics
The US Food and Drug Administration (FDA) yesterday announced its Fiscal Year 2025 Generic Drug User Fee Amendments (GDUFA). 28 November 2024
Biotechnology
Kronos Bio, a biotech with a presence on the east and west coasts of the USA, has unveiled a major restructuring plan. 28 November 2024
Pharmaceutical
UK-based drugmaker Advanz Pharma has announced that following the grant of a temporary suspension, as announced on last month, the General Court of the European Union (General Court) has decided not to further extend the suspension of the European Commission (EC) decision to revoke the conditional marketing authorization (CMA) for Ocaliva (obeticholic acid) in Europe. 28 November 2024
Biotechnology
Johnson & Johnson has made significant strides in multiple myeloma treatment, with breakthroughs in targeted therapies like CAR-T and bispecific antibodies. At the 2024 ASH meeting, J&J aims to showcase progress, with a goal of achieving a functional cure for multiple myeloma. 28 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
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
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