Mike Hollan While the industry as a whole still faces challenges, there are positive trends appearing for pharmaceutical and medical device companies. Anyone hoping for good news for the financial state of the healthcare industry may have to wait until mid-2024. S&P Global released its annual healthcare industry outlook, providing a thorough analysis of the state of the industry. The last few years have been a rollercoaster for the industry, with it seeing unbelievable highs during the pandemic, only to watch most of that enthusiasm (and the money that came with it) fade in 2023. According to S&P Global’s report, its ratings outlook for the pharmaceutical and medical device subsectors is stable. However, it notes that the ratings outlook for the industry remains negative. This is due to lower end companies, which are typically sponsor-owned, struggling to maintain positive cash flow. There are a variety of factors that play into ...
• Pfizer’s PARP inhibitor Talzenna has gained European approval when used in combination with Pfizer and Astellas’ Xtandi to treat adult patients with metastatic castration-resistant prostate cancer (mCRPC) in whom chemotherapy is not clinically indicated. This approval makes Talzenna the first PARP inhibitor in Europe to be licensed in combination with Xtandi in mCRPC, Pfizer said in a release. The European Commission approved Pfizer’s application based on data from the phase 3 TALAPRO-2 trial, which showed that the combo cut the risk of disease progression or death in patients with mCRPC compared with placebo and Xtandi. Last June, the FDA approved the combination to treat adults with HRR gene-mutated mCRPC. • In another regulatory win for Pfizer, the FDA is reviewing the company’s full approval application on Genmab-partnered Tivdak. Under its priority review timeline, the FDA is assessing whether to convert Tivdak’s accelerated approval into a full nod to treat ...
Novartis is paying Voyager Therapeutics $100 million up front to collaborate on gene therapies for Huntington’s disease and spinal muscular atrophy. The deal builds on a relationship the companies started in 2022. By FRANK VINLUAN Novartis is committing $100 million to Voyager Therapeutics to see if the biotech’s technology can lead to new gene therapies for Huntington’s disease and spinal muscular atrophy. According to deal terms announced Tuesday, the sum is an upfront payment that includes a $20 million equity investment in Voyager. Milestone payments could bring the Lexington, Massachusetts-based biotech up to $1.2 billion more. If the partnership leads to commercialized therapies, Voyager would also receive royalties from sales. Gene therapies reach their bodily destinations carried aboard an engineered virus. The therapy’s genetic cargo is enveloped by a protein shell called a capsid. Voyager’s TRACER technology platform discovers capsids that can target particular types of tissue. In addition to ...
In 2022, fueled by its powerhouse COVID products, Pfizer became the first company in the history of the biopharma industry to top $100 billion in annual revenue. What would the New York drugmaker do for an encore? In 2023, Pfizer went from generating the most sales in the industry to gaining the most approvals. With seven FDA nods in 2023, Pfizer had more than double that of any other company. It’s also more than twice as many as every drugmaker over each of the last three years. You need to go back to 2019, when Novartis scored six approvals, to find a company that approached what Pfizer accomplished in 2023. Pfizer’s splurge included four approvals in a dizzying five weeks in May and June. And all but one of the seven products has been pegged by analysts as a potential blockbuster. Two of the newly approved Pfizer treatments were acquired ...
Bristol Myers Squibb (BMS) has signed a definitive agreement for the acquisition of all outstanding shares of common stock of biopharmaceutical company Karuna Therapeutics for an equity value totalling $14bn in cash. The new strategic merger deal is part of BMS’ strategy to bolster its neuroscience portfolio. Karuna focuses on the discovery and development of therapies for psychiatric and neurological ailments. Through the transaction, BMS will gain access to Karuna’s lead asset KarXT (xanomeline-trospium). It is a potential antipsychotic therapy for patients with schizophrenia and Alzheimer’s disease psychosis. KarXT possesses a new mechanism of action with varied distinguished efficacy and safety profiles. The US Food and Drug Administration (FDA) recently has accepted Karuna’s new drug application (NDA) for KarXT to treat adult patients with an approval decision anticipated on 26 September next year under the Prescription Drug User Fee Act (PDUFA). The antipsychotic is currently being analysed in registrational clinical ...
Science has named the development of glucagon like peptide-1 (GLP-1) agonists and this year’s discovery that these drugs can blunt obesity-associated health problems as its 2023 Breakthrough of The Year. Although obesity’s causes span genetic, physiological, environmental, and social factors, as a medical problem, obesity’s risks can be life-threatening – including heart disease, diabetes, arthritis, liver disease, and certain cancers. Drug treatments for obesity have had “a sorry past, one often intertwined with social pressure to lose weight and the widespread belief that excess weight reflects weak willpower,” writes Jennifer Couzin-Frankel in the Breakthrough news feature. However, a new class of drug therapies for weight loss has emerged and is showing promising results. Originally developed to treat diabetes nearly 20 years ago, the excitement surrounding GLP-1 drugs to treat obesity has recently exploded. And this year, two landmark clinical trials that showed in large numbers that GLP-1 agonists produced meaningful ...
Neurodegenerative disorders are often marked by the buildup of amyloid filament inclusions of specific proteins in the brain. These proteins are critical in diagnosing and treating the associated diseases. Frontotemporal lobar degeneration (FTLD) is one such disorder, leading to frontotemporal dementia, which ranks just behind Alzheimer’s disease in prevalence. In about 10% of FTLD cases, the identity of the filament-forming protein was previously unknown. The protein FUS was the suspected culprit, given its presence in brain inclusions and its known genetic role in some instances of amyotrophic lateral sclerosis, another neurodegenerative condition. Now, researchers using electron cryo-microscopy have unexpectedly found that the filaments are instead formed by the protein TAF15. The research team from MRC Laboratory of Molecular Biology (Cambridge, UK) extracted amyloid filaments from the brains of four individuals affected by this type of FTLD. They carried out neuropathological examinations on the brain tissues obtained. Employing electron cryo-microscopy, they ...
A new study led by the Medical Research Council’s (MRC) Laboratory of Molecular Biology (LMB) has identified a new protein as a potential therapeutic target for frontotemporal dementia, a type of early-onset dementia. Dementia is a progressive neurodegenerative disorder that affects more than 944,000 people in the UK. Frontotemporal dementia occurs from the degeneration of the frontal and temporal lobes of the brain, which control emotions, personality and behaviour, along with speech. Most neurodegenerative diseases involve proteins aggregating into filaments known as amyloids. When identified, researchers can target these proteins for diagnostic tests and treatments. However, in around 10% of frontotemporal dementia cases, researchers had to identify the TAF15 protein. Published in Nature, MRC LMB researchers successfully pinpointed the aggregated structures of the protein using cutting-edge cryo-electron microscopy to study the brains of four patients who had this type of early-onset dementia. The FUS protein is already known to be ...
Americans can’t afford their medications. About 25% leave prescriptions unfilled, split pills, or skip doses. Seniors face challenges covering non-Medicare services, including prescriptions. Even those with commercial health insurance are not immune. One-third of insured adults worry about affording their premiums, and 44% must meet increasingly high deductibles before insurance even kicks in. As a result, 41% of adults carry substantial medical debt. At the same time, FDA approvals for therapeutics targeting rare diseases are on the rise, including those for cancer, Alzheimer’s, and many previously untreatable diseases. In fact, 54% of 2022’s novel drug approvals targeted rare diseases. They encompass groundbreaking therapies like the first acid sphingomyelinase deficiency treatment, a prurigo nodularis remedy, and an obstructive hypertrophic cardiomyopathy therapy. In 2023, the first enzyme replacement therapy for non-neurological alpha-mannosidosis effects gained early approval. Breakthroughs, though welcome, are staggeringly expensive. In fact, Hemgenix, a new treatment for hemophilia, is officially ...
Pharmaceutical Executive Editorial Staff KarXT (xanomeline-trospium) is currently in development to treat schizophrenia and psychosis related to Alzheimer disease. The FDA has accepted a New Drug Application (NDA) for Karuna Therapeutics, Inc’s KarXT (xanomeline-trospium) treatment for schizophrenia in adult patients. The novel muscarinic antipsychotic is currently in development to treat schizophrenia and psychosis related to Alzheimer disease. “There is a significant need for new treatment options for serious mental illness. If approved, KarXT could be one of the more important new product introductions in neuropsychiatry by providing a novel pharmacological approach for the treatment of schizophrenia,” said Bill Meury, Karuna Therapeutics president and chief executive officer, said in a press release.1 Schizophrenia can be a disabling condition, potentially causing a combination of hallucinations, delusions, and extremely disordered thinking and behavior that has a negative impact on the ability to function in daily life. As such, patients with schizophrenia require lifelong ...
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