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
US clinical-stage oncology company Revolution Medicines saw its shares fall as much as 7% to $22.81 yesterday, after it announced that French pharma major Sanofi has pulled out their global SHP2 development and commercialization collaboration, which could have earned the American company more than $500 million. 8 December 2022
Pharmaceutical
Swiss pharma major Novartis has announced positive results from the Phase III APPOINT-PNH study. 8 December 2022
Biotechnology
Anjarium Biosciences, a Swiss biotech focused on creating and delivering a new class of non-viral gene therapies, has announced the appointment of Otmane Boussif as chief technology officer (CTO). 8 December 2022
Biotechnology
Japanese drug major Daiichi Sankyo’s shares edged up nearly 2% to 4,426 yen today, after it announced it was giving up Japanese marketing rights to Yescarta (axicabtagene ciloleucel). 8 December 2022
Pharmaceutical
An analysis of how - and why - ophthalmology is increasingly on pharma and investors' radar as a new growth area. 8 December 2022
Biotechnology
Earlier this month, US President Biden told a Carlsbad, Calif. audience that America’s future rests on major breakthroughs in technology and science. “Other countries are closing in fast,” he elaborated. “The CHIPS and Science Act sets us on a path to move up again.” 8 December 2022
Biotechnology
Swedish biotech Oncopeptides saw its shares plunge 36% to 12.00 Swedish kronor yesterday, after it revealed that the US Food and Drug Administration (FDA) has requested a withdrawal of the US marketing authorization for its multiple myeloma drug Pepaxto (melphalan flufenamide). 8 December 2022
Pharmaceutical
The crisis in the Russian pharmaceutical sector is deepening as the country’s Ministry of Health has officially called on the regions to form a four-month reserve of drugs, which is mainly due to the possible interruptions in their supplies from abroad, reports The Pharma Letter’s local correspondent. 8 December 2022
Biotechnology
US biotech Mammoth Biosciences, which is building the next generation of CRISPR products to cure and detect disease, has reinforced its C-suite with the arrival of two industry veterans - Phil Tinmouth as chief business officer, and Siang Chin as general counsel. 8 December 2022
Biotechnology
US biotech Paragon Therapeutics has announced the launch of its first spinout. 7 December 2022
Pharmaceutical
The Office of the US Trade Representative (USTR) yesterday announced support for extending the deadline to decide whether the World Trade Organization’s (WTO) intellectual property (IP) waiver should be expanded to COVID treatments and diagnostics -a sign the 0USTR’s position could be shifting. 7 December 2022
Biotechnology
The marketing authorization application (MAA) for momelotinib, an investigational oral treatment for myelofibrosis, submitted by UK pharma major GSK, has been accepted by the European Medicines Agency (EMA). 7 December 2022
Pharmaceutical
Following a review, the European Medicines Agency’s (EMA) Emergency Task Force (ETF) has concluded that adapted mRNA bivalent vaccines targeting the original strain and Omicron BA.4-5 subvariants of SARS-CoV-2 may be used for initial vaccination. 7 December 2022
Pharmaceutical
A US court has dismissed allegations that the heartburn drug Zantac (ranitidine) causes cancer. 7 December 2022
Pharmaceutical
Developed and marketed by family-owned German Boehringer Ingelheim and the USA’s Eli Lilly, their drug Jardiance (empagliflozin) is the first SGLT2 inhibitor to demonstrate a statistically-significant reduction 0in the primary outcome of HbA1c in children. 7 December 2022
Pharmaceutical
Armed with a huge money pile generated from its COVID-19 anti-viral Paxlovid (nirmatrelvir and ritonavir tablets), not to mention the mammoth success of the Comirnaty vaccine, Pfizer is looking to further expand its offering in the sector. 7 December 2022
Biotechnology
Trodelvy (sacituzumab govitecan-hziy), an antibody-drug conjugate (ADC) developed by California’s Gilead Sciences, has performed well in a post hoc analysis of the Phase III TROPiCS-02 study. 7 December 2022
Biotechnology
Massachusetts, USA-based Entact Bio, co-founded in 2019 by an international group of researchers to develop precision medicines that enhance the function of key proteins, announced it has raised $81 million in Series A financing to advance its proprietary Encompass platform for developing enhancement-targeting chimeric (ENTAC) molecules. 7 December 2022
Biotechnology
Shares of US drugmaker Summit Therapeutics went stratospheric yesterday, rocketing 194% to $2.31 by close, after it announced a licensing deal with a Chinese drug developer that could cost it as much as $5 billion. 7 December 2022
Biotechnology
Australian biotech CSL Limited today unveiled the future of plasma manufacturing in Australia with the opening of its A$900 million ($608 million) plasma fractionation facility in Victoria, which the company claims is the largest of its kind in the Southern Hemisphere. 7 December 2022
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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