Latest Pharma and Biotech News
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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Biotechnology
Swedish Orphan Biovitrum, also known as Sobi, today announced an executive appointment. 2 February 2023
Pharmaceutical
Roche’s shares dipped 1.4% to 322.60 francs this morning, when the Swiss pharma giant announced that, in full-year 2022, it achieved sales growth of 2% (+1% in Swiss francs) to 63.3 billion francs ($.66.8 billion), but warned that 2023 profits would see a downturn. 2 February 2023
Biotechnology
In the UK, two new marketing authorizations have been granted by the country’s medicines regulator, the Medicines and Healthcare products Regulatory Agency (MHRA). 2 February 2023
Pharmaceutical
As the British pharmaceutical industry gets ready to negotiate the reimbursement regime in the country, representatives have expressed dismay at a move to raise the statutory revenue clawback rate. 2 February 2023
Biotechnology
Canadian mRNA-focussed biotech firm Providence Therapeutics today announced the appointment of Robert Georgantas III as president and chief technology officer (CTO). 1 February 2023
Generics
Mumbai, India-based generic drugmaker Lupin Limited revealed that it has received tentative approval from Food and Drug Administration (FDA), under the US President’s Emergency Plan for AIDS Relief (PEPFAR), for its New Drug Application for dolutegravir, emtricitabine and tenofovir alafenamide (DETAF) tablets. 1 February 2023
Biotechnology
UK-based Orbit Discovery, which calls itself a ‘leader in the discovery of therapeutic peptide hits’, has announced a collaboration. 1 February 2023
Pharmaceutical
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has led on a joint consultation on proposed amendments to the MHRA’s statutory fee, which will come into effect on April 1 this year. 1 February 2023
Pharmaceutical
Swiss pharma giant Novartis presented its financial results for the fourth quarter and 2022 as a whole on Wednesday morning. 1 February 2023
Pharmaceutical
British pharma major GSK outperformed expectations with its annual financial results statement, reporting sales of £29.3 billion ($36.1 billion) for the year, an increase of 19%, driven by revenues of £7.4 billion in the final quarter. 1 February 2023
Pharmaceutical
Danish diabetes care giant Novo Nordisk today reported that sales for full-year 2022 increased by 26% in Danish kroner and by 16% at constant exchange rates to 177.0 billion kroner ($25.6 billion) in 2022, slightly ahead of analysts’ expectations of 176 billion kroner. 1 February 2023
Biotechnology
US biotech giant Amgen released mixed financial results for the fourth quarter and full year 2022 versus comparable periods in 2021, after markets closed on Monday. 1 February 2023
Pharmaceutical
The life sciences industry in Australia has called for better funding for the country’s medicine and technology regulator. 31 January 2023
Pharmaceutical
US drugmaker Pfizer cemented its place at the top of the pile of global pharma companies in delivering its 2022 financial results. 31 January 2023
Pharmaceutical
The UK health technology assessor the National Institute for Health and Care Excellence (NICE) , has been recommended for reimbursement for USA-based Jazz Pharmaceuticals’ Epidyolex (cannabidiol,100mg/mL oral solution), for adjunctive therapy of seizures associated with tuberous sclerosis complex (TSC), for patients two years of age and older. 31 January 2023
Biosimilars
Two decades and more than $200 billion later, AbbVie has finally lost its exclusive hold on the US market for biologics based on Humira (adalimumab). 31 January 2023
Biotechnology
Dutch gene therapy company uniQure and University of Massachusetts Medical School (UMMS) spin-out Apic Bio have entered into a global licensing agreement for APB-102 to treat superoxide dismutase 1 (SOD1) amyotrophic lateral sclerosis (ALS), a rare, genetic form of ALS. 31 January 2023
Pharmaceutical
Pharma companies participating in the 340B drug pricing program in the USA do not have to provide medicines ad nauseam to contract pharmacies. 31 January 2023
Biotechnology
mRNA specialist CureVac has reported positive data from key Phase I programs in COVID-19 and seasonal flu. 31 January 2023
Biosimilars
Biologic products have revolutionized the treatment options for many diseases and typically carry favorable benefit–risk profiles compared with small molecule drugs. 31 January 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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