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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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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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Biosimilars
India’s largest biotech firm Biocon today announced that Shreehas Tambe, currently deputy chief executive of its Biocon Biologics (BBL) subsidiary, has been appointed as managing director of the company, with effect from December 5, 2022. Mr Tambe will lead BBL in realizing its goal of being a global biosimilars leader. 5 December 2022
Pharmaceutical
Additional data from the Phase III EMERALD study (NCT03778931) of elacestrant, an investigational oral selective estrogen receptor degrader (SERD), are being presented during the San Antonio Breast Cancer Symposium (SABCS) being held from December 6-10. 5 December 2022
Biotechnology
US clinical-stage targeted oncology company Mirati Therapeutics saw its shares close up 5.2% at $96.25 on Friday, after it announced that, based on the results of an interim analysis on overall survival (OS), the registrational Phase III study evaluating sitravatinib in combination with nivolumab (Bristol Myers Squibb’s blockbuster drug Opdivo) in patients with second or third line non-squamous non-small cell lung cancer (NSQ-NSCLC) who have acquired resistance to prior therapy with chemotherapy and immune checkpoint inhibitor therapy (SAPPHIRE) will continue to the study's final analysis. 5 December 2022
Biotechnology
The Australian state of Queensland will become a global mRNA vaccine hub with French pharma major Sanofi partnering with the Palaszczuk government to establish a world-first research center in Brisbane. 5 December 2022
Biotechnology
Important regulatory news last week included US rare diseases specialist Sarepta Therapeutics last Monday revealing that the US Food and Drug Administration (FDA) has accepted for priority review its Duchenne muscular dystrophy (DMD) candidate SRP-9001. On the M&A front, UK pharma major AstraZeneca last Tuesday announced it is to acquire Dutch biotech firm Neogene Therapeutics to help accelerate its advance into oncology cell therapy. Also, Switzerland-based Roivant Sciences has established a new “Vant” company in partnership with Pfizer, to develop the US pharma giant’s ulcerative colitis and Crohn’s disease candidate RVT-3101. Clinical trial news included Eisai and Biogen last Wednesday releasing much awaited new data on their Alzheimer’s disease candidate lecanemab that attracted a lot of attention. 4 December 2022
Biotechnology
Having invented the concept, it is odd that China should have been so behind in making medicine for so long. That has changed: the Chinese pharmaceutical market is now the second biggest in the world, and for many years the Chinese state has been driving towards the enormous opportunities that a firmer grip on this drug development could bring, according to a report from McKinsey & Co. 3 December 2022
Biotechnology
US immunotherapeutic vaccines company Vaxxinity has announced positive Phase III topline data for its COVID-19 booster vaccine, UB-612. 2 December 2022
Biotechnology
Data has been cited by the US Food and Drug Administration (FDA) in support of its latest stance on bebtelovimab, Eli Lilly’s antibody treatment for COVID-19. 2 December 2022
Biotechnology
The European Medicines Agency (EMA) has accepted for review the marketing authorization application (MAA) for aumolertinib, a third-generation epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitor (TKI). 2 December 2022
Biotechnology
Shares of UK-based biotech Immunocore Holdings edged up 2.2% to $61.29 pre-market, as the company announced a collaboration with Netherlands-based Gadeta on the first γδ ImmTAC for solid tumors, including colorectal cancer. 2 December 2022
Biotechnology
Unsurprisingly given a negative advisory committee vote a few weeks ago, the US Food and Drug Administration (FDA) has issued a complete response letter (CRL) for the Biologics License Application (BLA) for the investigational medicine 131I-omburtamab in the treatment of CNS/leptomeningeal metastasis from neuroblastoma, submitted by US biotech Y-mAbs Therapeutics. 2 December 2022
Biotechnology
Franco-American pairing Valneva and Pfizer have reported new data on their Lyme disease vaccine candidate, VLA15. 2 December 2022
Biotechnology
It has been a week when Biogen and Eisai prompted fresh hope in Alzheimer’s by sharing full data on lecanemab, the successor to their failed drug Aduhelm (aducanumab). 2 December 2022
Biotechnology
A late comer to the PD-/PD-Li inhibitors sector, UK pharma major GSK has had a fair number of disappointments with its new cancer drugs. Just a few days ago, the company withdrew the US marketing authorization for multiple myeloma drug Blenrep (belantamab mafodotin-blmf). 2 December 2022
Pharmaceutical
Well ahead of expectations, on December 1, the US Food and Drug Administration (FDA) approved Rezlidhia (olutasidenib) capsules for adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by an FDA-approved test. 2 December 2022
Pharmaceutical
Today, the Pediatric Praziquantel Consortium announced that the European Medicines Agency (EMA) has validated for review the application for arpraziquantel for the treatment of schistosomiasis in preschool-aged children (three months to six years of age), submitted by its partner, German pharma and life sciences firm Merck KGaA. 2 December 2022
Biotechnology
Canada’s AbCellera and US biotech Rallybio Corporation have agreed a strategic alliance to discover, develop, and commercialize antibody-based therapeutics for rare diseases. 1 December 2022
Biotechnology
Switzerland-headquartered Roivant Sciences, a serial creator of new research-targeted start-ups, saw its share rise 7% to $5.74 by late-morning, after revealing a collaboration with US pharm giant Pfizer to establish a new “Vant” company. 1 December 2022
Pharmaceutical
US health technology assessor the Institute for Clinical and Economic Review (ICER) today posted its revised Evidence Report assessing the comparative clinical effectiveness and value of Japanese pharma major Astellas’ fezolinetant for the vasomotor symptoms (VMS) associated with menopause, finding the evidence for drug promising but inconclusive. 1 December 2022
Pharmaceutical
The US Food and Drug Administration (FDA) has approved its first fecal microbiota product in the shape of Rebyota (fecal microbiota, live-jslm). 1 December 2022
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