Last month, Madrigal Pharmaceuticals (NSDQ:MDGL) announced promising preliminary results from an open-label Phase 3 trial from its MAESTRO-NAFLD-1 study focused on Resmetirom. The drug, also known as MGL-3196, appeared to support reducing fat and fibrosis within the liver while also curbing biomarkers associated with inflammation. The data also suggest that the drug reduces LDL cholesterol.…
FDA links J&J vaccine to rare cases of Guillain–Barré
The Food and Drug Administration has concluded that the COVID-19 vaccine from Johnson & Johnson’s (NYSE:JNJ) could rarely cause Guillain–Barré syndrome in which the immune system attacks the nervous system. A warning is forthcoming, according to media reports. Researchers have also linked prior vaccines, including a swine flu vaccine introduced in the 1970s, with the syndrome, which destroys…
Private equity and SPACs in the biopharma and biotech landscape
During the past few years, the biopharma and biotech markets have seen rapid growth. The global biotechnology market was worth $266 billion in 2019 is projected to reach $505 billion by 2026.1 In those strategic and important markets, what roles do private equity and Special Purpose Acquisition Companies (SPACs) play? An overview of the biotech…
FDA asks for an independent federal review of its aducanumab approval
Acting FDA Commissioner Dr. Janet Woodcock is responding to criticism about the agency’s controversial decision a month ago to approve aducanumab, Biogen’s and Eisai’s Alzheimer’s drug. In a letter to Principal Deputy Inspector General Christi Grimm, Woodcock called for an independent investigation into the contacts between Biogen and FDA during the approval process. Biden has…
Why Bioclinica tapped AI in immunotherapy trials early in the pandemic
An AI-based system proved its mettle in screening patients in immunotherapy trials, according to Dan Gebow, chief innovation officer at Bioclinica. Early in the COVID-19 pandemic, developers of cancer immunotherapies worried that the novel coronavirus would interfere with their clinical trial results. In previous years, the scientific community established that immunotherapy can rarely cause interstitial…
Johnson & Johnson launches research partnerships network
Johnson & Johnson (NYSE:JNJ) announced today that it has launched the J&J Centers for Global Health Discovery, a global network of research partnerships to address the world’s health challenges. The first J&J Satellite Center for Global Health Discovery is at the London School of Hygiene & Tropical Medicine. The pharma and medtech giant plans to…
Several companies could vie for next-gen COVID-19 vaccine market share
A couple of years ago, mRNA vaccines remained at the research stage. Now, they are among the best-selling pharmaceutical products with Pfizer (NYSE:PFE), BioNTech (NSDQ:BNTX) and Moderna (NSDQ:MRNA) dominating the market. However, that could change in the long run as a growing number of companies develop next-generation mRNA COVID-19 vaccines, which promise to be more effective…
Biosimilars adoption growing, but the market remains nascent
While biosimilar adoption remains at an early stage in the U.S., biosimilar adoption is ticking up. Biosimilar penetration for Roche’s Avastin (bevacizumab) is especially high at 69%. In addition, biosimilars for Genentech’s Herceptin and Amgen’s Neupogen have also achieved a market penetration of 57% and 62%, respectively, according to IQVIA data based on late June sales data.…
Tryp Therapeutics announces research alliance with the University of Michigan
La Jolla, Calif.–based Tryp (CSE: TRYP) is tapping the University of Michigan to test its TRP-8803 drug formulation against traditional oral formulations of synthetic psilocybin. The psilocybin-based drug developer will also work with the university to compare TRP-8803 with conventional formulations of synthetic psilocybin. In particular, the university will perform pharmacokinetic analysis for blood samples…
APC debuts ‘medicine accelerator’ in collaboration with Enterprise Ireland
The Dublin-based pharmaceutical R&D firm APC Ltd has launched a ‘Global Centre of Excellence for Vaccine and Advanced Therapeutic Research and Manufacturing.’ The result of a €25 million investment, the new facility will staff 120 new employees. The facility will have the capacity to produce hundreds of millions of doses of vaccines (including for COVID-19)…
Thermo Fisher Scientific expands corporate leadership team
Thermo Fisher Scientific (NYSE:TMO) announced today that it appointed Alan Sachs to chief medical officer and Karen E. Nelson to chief scientific officer. Sachs served as Waltham, Mass.-based Thermo Fisher’s CSO since 2016 and will be succeeded by Nelson as he assumes the newly established CMO position at the company. Both will join the company’s leadership…
NVIDIA debuts supercomputer for healthcare and AI research
Santa Clara, Calif.–based NVIDIA has launched the Cambridge-1, which it hails as “the United Kingdom’s most powerful supercomputer.” Developed with healthcare applications in mind, NVIDIA invested some $100 million in the supercomputer. Initial applications of the Cambridge-1 include using AI to improve drug development, explore the causes of dementia and identify genomic-based disease risk factors.…
Novartis refiles paperwork to FDA for novel cholesterol drug inclisiran
Novartis (NYSE: NVS) has resubmitted paperwork to the FDA for inclisiran, a subcutaneously-delivered drug candidate for treating hyperlipidemia in adults whose low-density lipoprotein cholesterol (LDL-C) remains elevated after taking a maximum tolerated dose of statin therapy. In Dec. 2020, FDA issued a complete response letter (CRL) for inclisiran. A CRL indicates that the agency has decided…
Pfizer to seek to expand COVID-19 vaccine EUA to children aged 5 to 11
Pfizer (NYSE:PFE) and its partner BioNTech (NSDQ:BNTX) aim to expand the U.S. emergency use authorization (EUA) for their COVID-19 vaccine to include children aged five to 11. The companies plan on filing paperwork for the expanded EUA over the coming months. “We are planning for emergency use authorization submission for [children aged five to 11] in…
Lilly’s donanemab may outclass aducanumab, but questions remain
FDA’s approval of Biogen’s (NSDQ:BIIB) and Eisai’s (TYO:4523) Alzheimer’s drug aducanumab has resulted in significant gains in those companies’ shares. But Lilly’s (NYSE:LLY) donanemab could be “perhaps better and cheaper,” concluded a recent investor note from Truist. Lilly recently announced that it plans to file for accelerated approval for donanemab in the second half of 2021…
J&J COVID-19 vaccine protects against Delta variant
Johnson & Johnson (NYSE:JNJ) has announced that a single shot of its COVID-19 vaccine offers significant protection against the transmissible Delta variant. The vaccine also provides an immune response lasting at least eight months. The announcement coincides with the company filing two preprint studies to bioRxiv. The first analyzes blood samples from eight patients in…
Lupin wins FDA approval for Solosec as treatment of trichomoniasis
Mumbai, India–headquartered Lupin Pharmaceuticals (NYSE:LUPIN) has received an expanded indication for Solosec (secnidazole) to cover the treatment of trichomoniasis in adult patients and their partners. The drug scored an initial FDA approval in 2017 for bacterial vaginosis (BV) in adult women. Solosec is now the only single-dose oral drug that has an FDA indication for both…
Regeneron uncovers genetic mutations that guard against obesity
Regeneron Pharmaceuticals (NSDQ:REGN) has announced that its Regeneron Genetics Center (RGC) has discovered rare genetic mutations associated with protection against obesity. RGC researchers learned that people with at least one inactive copy of the GPR75 gene tend to weigh about 12 pounds less than those without that mutation. In addition, those individuals faced a 54%…
Carlyle to invest nearly $70M in Inova
Investment firm Carlyle and Inova today announced a long-term funding partnership to accelerate growth, product innovation and M&A activities. Lyon, France-based Inova develops software platforms dedicated to life sciences to enable pharmaceutical and biotech companies to collaborate on workstreams across organizations. Inova touts its flagship product, “Inova Enterprise,” as a collaborative tool used to manage…
CureVac aims to rebound after announcing disappointing COVID-19 results
Some two week after announcing that its COVID-19 vaccine had an interim efficacy of 47% in a Phase 2b/3 trial, CureVac (NSDQ:CVAC) appeared to be regaining its footing. After announcing the final results of the trial, however, its stock fell approximately 12% on July 1 in mid-day trading. In the trial, the final vaccine efficacy…
Zuranolone shows promise in treating postpartum depression
Sage Therapeutics’ (NSDQ:SAGE) and Biogen’s (NSDQ:BIIB) experimental depression drug zuranolone fared well in a Phase 3 clinical trial comparing it to placebo in the treatment of postpartum depression. The investigational drug demonstrated meaningful improvements in terms of the baseline 17-item Hamilton Rating Scale for Depression (HAMD-17) score, the most common clinician-administered depression assessment scoring system.…
Biliary cancer drug candidate wins orphan drug designation from FDA
Cranbury, N.J.–based Rafael Pharmaceuticals has announced that its lead pipeline drug CPI-613 (devimistat) now has orphan drug status for biliary cancer. The orphan designation extends the orphan drug status for devimistat, including pancreatic cancer, acute myeloid leukemia, myelodysplastic syndrome, Burkitt’s lymphoma, peripheral T-cell lymphomas, and soft tissue sarcoma. The Europe Medicines Agency has granted orphan…
Moderna’s COVID-19 vaccine holds its own against Delta variant in study
A small study indicated that Moderna’s messenger RNA COVID-19 vaccine was effective against the Delta variant. Using serum samples from eight Phase 1 participants drawn one week after administering the second dose of the vaccine, the analysis found a 2.1-fold reduction in neutralizing titers against the Delta (B.1.617.2) variant relative to the ancestral strain of…
Charles River Laboratories completes $292.5M Vigene acquisition
Charles River Laboratories (NYSE:CRL) announced that it completed a $292.5 million acquisition of Vigene Biosciences. Rockville, Md.-based Vigene, a gene therapy contract development and manufacturing organization (CDMO), develops viral vector-based gene delivery systems, with a primary area of expertise in CGMP viral vector manufacturing for gene therapies and gene-modified cell therapies. Get the full story…
Boston Children’s Hospital, ElevateBio enter 5-year cell, gene therapy collaboration
Boston Children’s Hospital announced today that it partnered with ElevateBio for a five-year cell and gene therapy advancement program. The collaborative agreement will seek to advance cell and gene therapy programs originating out of Boston Children’s Hospital with an introduction to Boston Children’s translational research capabilities. Get the full story at our sister site, Drug Delivery Business…