PHARMA & MEDICAL UPDATES
Paul Healy
Director @ PHARMeMED | Pharmaceutical & Biotech Publisher, B2B Marketing Specialist, Healthcare Content Driver, Executive Search, Recruitment Specialist
This week, I cover GSK's acquisition of Elsie Biotechnologies, Sanofi's partnership with OpenAI, and the FDA's approval of Bristol Myers Squibb's Breyanzi, along with other key stories. Additionally, I discuss BioNTech's collaboration with NanoTag and spotlight Geron Corporation, including the FDA approval of Rytelo.
LATEST NEWS
AbbVie’s top-selling arthritis drug Humira has held onto more than 80% of patients after facing nine lower-priced rivals in the U.S. in the last year, raising questions about whether the market for prescription biosimilars can survive in its current form, drug pricing experts and analysts say. Humira, which lists for almost $7,000 a month, is the first top-selling drug to compete with a slew of biosimilars, which are close but not exact copies of branded biologic medicines. Read
Scientists identify a positive molecular feedback loop which could explain stroke-induced memory loss: When we learn something new, our brain cells (neurons) communicate with each other through electrical and chemical signals. If the same group of neurons communicate together often, the connections between them get stronger. Read
Serac’s imaging agent marks a breakthrough in endometriosis detection: Early-stage endometriosis now visible through non-invasive imagingIn a significant advancement for endometriosis diagnosis, Serac Healthcare, in collaboration with the University of Oxford, has presented new data showcasing the effectiveness of 99mTc-maraciclatide in imaging the earliest stage of the disease. Read
Boehringer Ingelheim has unveiled promising results from a Phase II trial of survodutide, demonstrating a notable improvement in liver fibrosis among patients.The sub-analysis indicated that up to 64.5% of adults with moderate to advanced scarring (fibrosis stages F2 and F3) experienced an improvement without worsening metabolic dysfunction-associated steatohepatitis (MASH), compared to 25.9% with placebo after 48 weeks of treatment. Read
GSK has announced that it acquired US-based Elsie Biotechnologies and its oligonucleotide discovery platform for $50m. The deal comes just under a year after the companies entered into a research collaboration, which GSK said allowed it to “explore and validate” the technology. Read
The US Food and Drug Administration (FDA) has approved Geron’s Rytelo (imetelstat) to treat adults with lower-risk myelodysplastic syndromes (MDS) who have transfusion-dependent anaemia. Patients eligible for the oligonucleotide telomerase inhibitor will have low- to intermediate-1 risk MDS, have anaemia requiring four or more red blood cell units over eight weeks, and will have not responded to, lost response to, or cannot be treated with erythropoiesis-stimulating agents. Read
Sanofi’s CEO is giving OpenAI access to its data in the hope of developing drugs more quickly: Exciting drug discovery developments! Further movement in the drug discovery field with OpenAI forming a new partnership with Sanofi to build AI-powered software to boost drug development and bring new medicines to patients more efficiently."It costs us 3-4 billion [dollars] to develop a drug, and 80% fail in phase 1 clinical trials," said Paul Hudson, Sanofi CEO. "I’d like to know in advance what will fail". Read
Many mental-health conditions have bodily triggers: Psychiatrists are at long last starting to connect the dots - The tics started when Jessica Huitson was only 12 years old. Over time her condition worsened until she was having whole-body fits and being rushed to hospital. But her local hospital, in Durham, England, was dismissive, suggesting she had anxiety, a mental-health condition, and that she was probably spending too much time watching videos on TikTok. Her mother describes the experience as “belittling”. In fact, Jessica had an autoimmune condition brought on by a bacterial infection with Streptococcus. The condition is known as Paediatric Autoimmune-Neuropsychiatric Disorders Associated with Streptococcus (pandas). When the infection was identified and treated, her symptoms finally began to improve. Read
Music therapy helps stroke survivors regain lost speech by singing: Ray Hart's vocabulary consisted of just one word after his August 2022 stroke."Yep" was all he could say, said Pamela Jenkins, his caregiver and partner of 24 years. Like many survivors, Hart, 62, can understand what's said to him almost as well as he could before the stroke, but it's still hard for him to form complete sentences. Now, though, a year after adding music therapy to his rehabilitation schedule, he can sing them. Read
Amgen has announced positive topline results from a late-stage trial evaluating Uplizna (inebilizumab-cdon) in immunoglobulin G4-related disease (IgG4-RD), a rare and progressive fibroinflammatory disease estimated to affect one to five per 100,000 people.IgG4-RD impacts almost any organ in the body and is characterised by periods of remission and unpredictable disease flares. Read
Cambridge-based Alchemab Therapeutics has been awarded a substantial grant from The Michael J. Fox Foundation to propel its research into Parkinson’s disease (PD).The $595,000 grant will support Alchemab’s exploration of antibodies targeting prostaglandin biology, a novel approach that could transform PD treatment.Alchemab’s research focuses on antibodies derived from individuals who show resilience to PD. The company’s cutting-edge platform, which combines proteomics, bioinformatics, and machine learning, has identified a target believed to contribute to disease resistance. Read
AstraZeneca’s (AZ) Tagrisso (osimertinib) has been recommended by the European Medicines Agency’s human medicines committee as part of a combination treatment for a subset of advanced lung cancer patients. The Committee for Medicinal Products for Human Use (CHMP) has recommended that the epidermal growth factor receptor-mutated (EGFR)-tyrosine kinase inhibitor be authorised for use alongside pemetrexed and platinum-based chemotherapy as a first-line treatment for adults with locally advanced or metastatic EGFR-mutated (EGFRm) non-small cell lung cancer (NSCLC) whose tumours have exon 19 deletions or exon 21 (L858R) mutations. Read
Phase III trial shows lorlatinib highly effective against ALK-positive non–small cell lung cancer: A large team of medical researchers and doctors has found via phase III clinical trial that the ALK inhibitor lorlatinib is highly effective for treating non–small cell lung cancer (NSCLC).In their paper published in the Journal of Clinical Oncology, the group describes the history of the drug and how well it has performed in treating cancer patients over five years of testing. Read
Retina indicates severity of schizophrenia, scientists discover: Researchers have discovered that the retina of schizophrenia patients differs from the retina of healthy participants. These changes could help psychiatrists to recognize who will have a particularly severe course of illness. The findings are published in the journal Biological Psychiatry. Read
Alligator Bioscience released positive data from its Phase Ib/II OPTIMIZE-1 study (NCT04888312) investigating its pancreatic cancer monoclonal antibody therapy, mitazalimab.The Sweden-headquartered company presented the Phase II readout at the American Society of Clinical Oncology Annual Meeting (ASCO 2024), publishing the data in the Lancet Oncology on 3 June. Read
ASCO24 - Sanofi’s Sarclisa looks to gain an edge in multiple myeloma: Soon after Sanofi announced that the US Food and Drug Administration (FDA) accepted its supplemental biologics licence application (sBLA) for priority review, the global pharma company announced positive results for the Phase III study of its Sarclisa (isatuximab) combination therapy for the treatment of multiple myeloma (MM). Read
COVID-19 vaccine makers said data from animals studies showed their 2024-25 shots targeting the JN.1 variant that was dominant earlier this year could neutralize newer subvariants such as KP.2 much better than the older shots. This was disclosed in presentations by the companies ahead of a meeting of the U.S. Food and Drug Administration's advisers on Wednesday. Read
Pfizer’s Durveqtix (fidanacogene elaparvovec) has been recommended by the European Medicines Agency’s (EMA) human medicines committee to treat adults with severe and moderately severe haemophilia B. The Committee for Medicinal Products for Human Use (CHMP) has specifically recommended that the one-time gene therapy be granted conditional marketing authorisation for use in patients who do not have both factor IX (FIX) inhibitors and detectable antibodies to variant adeno-associated virus serotype Rh74. Read
Eli Lilly has entered into an exclusive licence agreement worth over $620m to gain rights to QurAlis’ investigational precision therapy for neurodegenerative diseases including amyotrophic lateral sclerosis (ALS) and frontotemporal dementia (FTD). The deal gives Lilly global rights to develop and commercialise QRL-204, a splice-switching antisense oligonucleotide (ASO) designed to restore the function of the UNC13A gene, and other UNC13A-targeting compounds. Read
BioNTech to Evaluate NanoTag’s Target Labeling System in Different Therapeutic Areas: BioNTech, an immunotherapy company pioneering novel therapies for cancer and other serious diseases, and NanoTag, a biotechnology company developing single-domain antibodies, have announced Research Collaboration and exclusive License Agreement aimed at evaluating NanoTag’s target labeling system ALFA across indications in oncology and infectious diseases, in both preclinical and clinical settings. The ALFA System, featured in Nature Communications in 2019, employs high-affinity single-domain antibodies (nanobodies) that recognize a rationally designed 14 amino acid epitope tag, ALFA. Read
Bristol Myers Squibb’s (BMS) Breyanzi (lisocabtagene maraleucel) has been approved by the US Food and Drug Administration (FDA) to treat adult patients with relapsed or refractory mantle cell lymphoma (MCL). Representing around 3% of all non-Hodgkin lymphoma (NHL) cases, MCL is a rare form of NHL that originates from cells in the mantle zone of the lymph node. For most patients, relapse after initial treatment is common and the disease eventually progresses or returns. Read
Pfizer has shared positive longer-term follow-up results from a late-stage study of its anaplastic lymphoma kinase (ALK) inhibitor Lorbrena (lorlatinib) in advanced non-small cell lung cancer (NSCLC).The phase 3 CROWN trial has been comparing the drug to Pfizer’s tyrosine kinase inhibitor Xalkori (crizotinib) in patients with previously untreated ALK-positive disease. Read
Moderna’s respiratory syncytial virus (RSV) vaccine has been approved by the US Food and Drug Administration (FDA) to protect adults aged 60 years and older against lower respiratory tract disease (LRTD) caused by RSV infection. RSV is a common contagious virus characterised by several mild, cold-like symptoms. Although most people can recover within a week or two, RSV can cause severe illness in certain groups, including older adults, young infants and immunocompromised individuals. Read
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COMPANY SPOTLIGHT: GERON
Geron Corporation is a biopharmaceutical company that focuses on the development and commercialisation of innovative therapeutics for cancer. Founded in 1990 and headquartered in Menlo Park, California, Geron has been a pioneer in the field of telomerase research and therapy.
Geron was founded by Dr. Michael D. West with the initial aim to understand and intervene in the aging process. The company's focus later shifted towards telomerase research and its implications in cancer therapy.
Geron's most notable scientific contribution is its work on telomerase inhibitors. Telomerase is an enzyme that allows cancer cells to maintain their telomeres and continue dividing indefinitely. Geron developed imetelstat (GRN163L), a first-in-class telomerase inhibitor, which has shown potential in treating various types of cancers, particularly hematologic malignancies. This week I reported on the FDA's approval of Geron's Rytelo to treat adults with lower-risk myelodysplastic syndromes (MDS) who have tranfusion-dependent anaemia. Their shares were up over 20% today.
Careers at Geron: Jobs
Life Scientist ǀ Value Driven ǀ Passionately Curious ǀ Bridging Science & Customer-Centric Marketing at NanoTag
6moLooking forward to the innovative progress the ALFA System technology will bring to healthcare solutions.
SENIOR CHEMIST at ESDEE PAINTS LTD
6moThanks for sharing