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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Pharmaceutical
The US Food and Drug Administration (FDA) on Friday announced the approval of the investigational oral selective estrogen receptor degrader (SERD) Orserdu (elacestrant) for postmenopausal women or adult men with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy. 28 January 2023
Biotechnology
On Thursday, the US Food and Drug Administration’s (FDA) Vaccine and Related Biological Products Advisory Committee (VRBPAC) met to discuss future vaccination regimens addressing COVID-19. 27 January 2023
Pharmaceutical
The European Medicines Agency (EMA) has issued an update on ongoing shortages of antibiotic medicines containing amoxicillin—alone and in combination with clavulanic acid. 27 January 2023
Biotechnology
Although there were several positive recommendations for label extensions on already approved medicines, January proved a thin month for novel drug approvals in the European Union, with just one new drug and three for generics. 27 January 2023
Biotechnology
Exkivity (mobocertinib) is the first targeted therapy to be approved for locally-advanced or metastatic epidermal growth factor receptor (EGFR) exon 20 insertions (exon20ins)-positive non-small cell lung cancer (NSCLC) in China. 27 January 2023
Pharmaceutical
Research from the IQVIA Institute for Human Data Science shows that total spending and global demand for medicines could hit $1.9 trillion by 2027. 27 January 2023
Biotechnology
Yesterday the US Food and Drug Administration (FDA) granted yet another approval for Merck & Co’s mega blockbuster checkpoint blocker Keytruda (pembrolizumab, this time for adjuvant treatment following resection and platinum-based chemotherapy for stage IB (T2a ≥4 cm), II, or IIIA non-small cell lung cancer (NSCLC). 27 January 2023
Biotechnology
The US Food and Drug Administration (FDA) has approved the expanded indication for Enjaymo (sutimlimab-jome), the first and only treatment of hemolysis in adults with cold agglutinin disease (CAD), to include patients with or without a history of transfusions. 27 January 2023
Biotechnology
The US Food and Drug Administration yesterday revised the Emergency Use Authorization (EUA) for Evusheld (tixagevimab co-packaged with cilgavimab) to limit its use to when the combined frequency of non-susceptible SARS-CoV-2 variants nationally is less than or equal to 90%. 27 January 2023
Biotechnology
US traded shares of AC Immune were up more than 9% at $2.56 in pre-market activity today, as the Swiss biotech said its ACI-24.060 anti-amyloid beta (Abeta) vaccine for Alzheimer's disease (AD) showed positive initial interim safety and immunogenicity in a Phase Ib/II trial dubbed ABATE. 26 January 2023
Biotechnology
After a career that has seen him lead Exelixis, Biogen and most recently, Vir Biotechnology, George Scangos is to retire in early April. 26 January 2023
Pharmaceutical
An interview reflecting on 2022 and looking forward to the year ahead with Paul O'Donohoe senior director, eCOA Product and Science at Medidata. 26 January 2023
Biotechnology
As global macroeconomic uncertainty hit fundraising across all sectors, investment in UK biotechnology fell from the all-time highs seen in 2021, a new analysis from the industry lobby group UK BioIndustry Association (BIA) and data and insights company Clarivate shows. 26 January 2023
Pharmaceutical
Pharma industry analyst GlobalData has highlighted the strength of data supporting a submission from US biotech Intercept Pharmaceuticals in non-alcoholic steatohepatitis (NASH). 26 January 2023
Pharmaceutical
On December 23 2022, the FDA Modernization Act 2.0 was passed with full support from both the US House of Representatives and the Senate.1 This act aims to improve the process for approving drugs and commits to significantly reducing the use of dogs, primates, and other animals in laboratory testing. 26 January 2023
Biosimilars
The US Food and Drug Administration (FDA) has released the BsUFA III Regulatory Science Pilot Program: Research Roadmap. 26 January 2023
Pharmaceutical
Shares of US retinal eye disorder specialist Ocuphire Pharma slumped more than 29% to $2.66, after it released disappointing top-line efficacy and safety results from its ZETA-1 Phase II trial evaluating oral APX3330 for the treatment of diabetic retinopathy (DR). 26 January 2023
Biotechnology
Already expected to reach blockbuster status with its 2022 sales, AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has won another approval in Europe. 26 January 2023
Biotechnology
Leading checkpoint blocker Keytruda (pembrolizumab) has offered a mixed bag of outcomes for people with two different types of cancer. 26 January 2023
Biotechnology
In the second setback in the space of a little over a month, Magenta Therapeutics saw its shares crash 23.3% to $0.38 pre-market today, after the US biotech revealed that the latest participant dosed at the Cohort 3 level (0.08mg/kg) in the ongoing MGTA-117 Phase I/II dose-escalation clinical trial in relapsed/refractory acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) experienced a Grade 5 serious adverse event (SAE) (respiratory failure and cardiac arrest resulting in death) deemed to be possibly related to MGTA-117. 26 January 2023
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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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