After the Alzheimer's Crash, Should Biogen Turn to M&A to Bolster Its Pipeline?

Earlier this week, Biogen reported out its first-quarter financial results, showing an 11% increase in revenues, hitting $3.5 billion. But in light of the company’s announcement in late March that it was dropping development of aducanumab for Alzheimer’s, analysts are speculating on what the company needs to do to stay profitable. And the Alzheimer’s pivot wasn’t the only challenge, although that announcement resulted in a stock drop where the company lost $18 billion in value overnight. But one of the company’s top-selling drugs is Spinraza to treat a rare muscular disease called spinal muscular atrophy (SMA). Spinraza came on the market as the first viable treatment, but Novartis is developing its own drug, which in late-stage trials appears to be a one-and-done gene therapy, rather than an ongoing treatment like Spinraza. If Novartis’ Zolgensma is approved, it will likely be the therapy of choice for SMA Type 1 patients, although it is as of now not a treatment for all types of SMA like Spinraza is.

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Replimune's mission is to revolutionize cancer treatment with therapies designed to activate a powerful and durable full-body anti-tumor response. Replimune is pioneering the development of novel tumor-directed oncolytic immunotherapies. We imagine a world where cancer is a curable disease.

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MedTech

Advancement in Genomics Accelerating its Penetration into Precision Health

Article | October 7, 2022

Genomics is an interdisciplinary field of biology emphasizing the structure, editing, evolution, function, and mapping of genomes. It is creating deeper inroads across the precision health domain with the increasing introduction of advanced technologies such as quantum simulation, next-generation sequencing (NGS), and precise genome manipulation. As precision health focuses on providing the proper intervention to the right patient at the right time, genomics increasingly finds applications in human and pathogen genome sequencing in clinical and research spaces. Rising Hereditary Diseases Burden Paving the Way for Genomics in Precision Health In the last few years, a significant surge in the prevalence of diseases and ailments such as diabetes, obesity, baldness, and others has been witnessed across the globe. A history of family members with chronic diseases, such as cancer, diabetes, high blood pressure, hearing issues, and heart disease, can sometimes continue into the next generation. Hence, the study of genes is extensively being conducted for predicting health risks and early treatment of these diseases. It also finds use in CRISPR-based diagnostics and the preparation of precision medication for the individual. In addition, ongoing advancements in genomics are making it possible to identify different genetic traits that persuade people to more widespread diseases and health problems. The Emergence of Genomics Improves Disease Understanding Genomics refers to the study of the complete genetic makeup of a cell or organism. Increasing scientific research in the area substantially contributes to increasing knowledge about the human genome and assists in improving the ability to understand disease etiology, risk, diagnosis, treatment, and prevention. On account of these improvements, innovative genomic technologies and tools are being developed to enable better precision health not only for the individual but for various regional populations as well. The Way Forward With growing preference for personalized medicine and an increasing need for more accurate pathogen detection and diagnostics, genomics is gaining huge popularity across the precision health domain. Also, increasing research activities for developing novel high-precision therapeutics and rising importance of gene study in the prevention, diagnosis, and management of infectious and genetic diseases will further pave the way for genomics in the forthcoming years.

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Medical

Next-Gen Genetics Cancer Therapies Creating Investment Prospects

Article | July 14, 2022

Genetic therapeutics such as genetic engineering and gene therapy are increasingly emerging as one of the most influential and transformed biotechnological solutions around the globe in recent times. These genetic solutions are being assessed across various medical domains, including cancer treatment, neurology, oncology, and ophthalmology. Citing the trend, the genetics industry is estimated to experience a tsunami of approvals, with over 1,000 cell and gene therapy clinical trials currently underway and over 900 companies worldwide focusing on these cutting-edge therapies. Growing Cancer Encourages Advancements in Genetic Technologies With the surging cases of cancers such as leukemias, carcinomas, lymphomas, and others, patients worldwide are increasing their spending on adopting novel therapeutic solutions for non-recurring treatment of the disease, such as gene therapy, genetic engineering, T-cell therapy, and gene editing. As per a study by the Fight Cancer Organization, spending on the treatment of cancer increased to $200.7 billion, and the amount is anticipated to exceed $245 billion by the end of 2030. Growing revenue prospects are encouraging biotechnology and biopharmaceutical companies to develop novel genetic solutions for cancer treatment. For instance, Bristol-Myers Squibb K.K., a Japanese pharmaceutical company, introduced a B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell immunotherapy, Abecma, for the treatment of relapsed or refractory (R/R) multiple myeloma in 2022. Amid a New Market: Genetics Will Attract Massive Investments Despite several developments and technological advancements, genetics is still considered to be in a nascent stage, providing significant prospects for growth to the companies that are already operating in the domain. Genetics solutions such as gene therapies, gene editing, and T-cell immunotherapy are emerging as highly active treatments across various medical fields, resulting in increasing research and development activities across the domain, drawing significant attention from investors. Given the potential of genetic treatments and the focus on finding new ways to treat cancer and other related diseases, it's easy to understand why companies are investing in the domain. For instance, Pfizer has recently announced an investment of around $800 million to construct development facilities supporting gene therapy manufacturing from initial preclinical research through final commercial-scale production. Due to these advancements, cell and gene therapies are forecast to grow from $4 billion annually to more than $45 billion, exhibiting growth at a 63% CAGR. The Future of Genetics Though there is a significant rise in advancement in genetic technologies and developments, the number of approved genetic treatments remains extremely small. However, with gene transfer and CRISPR solutions emerging as new modalities for cancer treatment, the start-up companies will attract a growing amount and proportion of private and public investments. This is expected present a tremendous opportunity for biopharma and biotechnology investors to help fund and benefit from the medical industry's shift from traditional treatments to cutting-edge genetic therapeutics in the coming years.

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MedTech

Laboratory Information Management System for Biotech Labs: Significance & Benefits

Article | September 22, 2022

If you have ever visited the testing laboratory of a large biotechnology company, you will be aware that managing the laboratory's operations single-handedly is no easy task. The greater the size of a lab, the more research and testing activities it must accommodate. A variety of diagnostic tests are prescribed for patients in order to detect various diseases. For example, it may include blood glucose testing for diabetics, lipid panel, or liver panel tests for evaluating cardiac risk and liver function, cultures for diagnosing infections, thyroid function tests, and others. Laboratory management solutions such as laboratory information management systems (LIMS) and other software play a significant role in managing various operational data at biotech laboratories. It is one of the important types of software developed to address thedata management and regulatory challenges of laboratories. The software enhances the operational efficiency of biotech labs by streamlining workflows, proper record-keeping, and eradicating the need for manually maintaining data. What Are the Benefits of Laboratory Information Management Software in Biotechnology? As the trends of digitization and technology continue to create deeper inroads into the biotechnology sector, a significant rise in the adoption of innovative medical software solutions, such as LIMS, is being witnessed for managing research data, testing reports, and post-research results globally. Here are a few reasons that are encouraging biotech facilities to adopt LIMS solutions Real-Time Data Collection and Tracking Previously, collecting and transporting samples was a tedious and time-consuming task. However, the adoption of LIMS with innovative tracking modules has made the job easier. The real-time sample tracking feature of LIMS has made it possible for personnel to collect the research data in real-time and manage and control the workflow with a few mouse clicks on the screen. Increase Revenue LIMS makes it possible to test workflows while giving users complete control over the testing process. A laboratory is able to collect data, schedule equipment maintenance or upgrades, enhance operational efficiency, and maintain a lower overhead with the help of the LIMS, thereby increasing revenue. Streamlined Workflow With its completion monitoring, LIMS speeds up laboratory workflows and keeps track of information. It assigns tasks to the specialist along with keeping a real-time track of the status and completion of each task. LIMS is integrated into the laboratory using lab information, which ultimately speeds up internal processes and streamlines the workflow. Automatic Data Exchange LIMS solutions store data in a centralized database. Automated transfer of data between departments and organizations is one of the major features of LIMS. Through its automated information exchange feature, LIMS improves internal operations, decreases the reporting time for data sharing, and assists in faster decision-making. Final Thoughts As the healthcare sector continues to ride the wave of digital transformation, biotech laboratories are emphasizing adopting newer technologies to keep up with the changes. Citing this trend, laboratory information management systems are becoming crucial for biotech and medical organizations for maintaining research data, instant reporting, and managing confidential, inventory, and financial data with centralized data storage.

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Diagnostics

Making Predictions by Digitizing Bioprocessing

Article | April 20, 2021

With advances in data analytics and machine learning, the move from descriptive and diagnostic analytics to predictive and prescriptive analytics and controls—allowing us to better forecast and understand what will happen and thus optimize process outcomes—is not only feasible but inevitable, according to Bonnie Shum, principal engineer, pharma technical innovation, technology & manufacturing sciences and technology at Genentech. “Well-trained artificial intelligence systems can help drive better decision making and how data is analyzed from drug discovery to process development and to manufacturing processes,” she says. Those advances, though, only really matter when they improve the lives of patients. That’s exactly what Shum expects. “The convergence of digital transformation and operational/processing changes will be critical for the facilities of the future and meeting the needs of our patients,” she continues. “Digital solutions may one day provide fully automated bioprocessing, eliminating manual intervention and enabling us to anticipate potential process deviations to prevent process failures, leading to real-time release and thus faster access for patients.” To turn Bioprocessing 4.0 into a production line for precision healthcare, real-time release and quickly manufacturing personalized medicines will be critical. Adding digitization and advanced analytics wherever possible will drive those improvements. In fact, many of these improvements, especially moving from descriptive to predictive bioprocessing, depend on more digitization.

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Replimune

Replimune's mission is to revolutionize cancer treatment with therapies designed to activate a powerful and durable full-body anti-tumor response. Replimune is pioneering the development of novel tumor-directed oncolytic immunotherapies. We imagine a world where cancer is a curable disease.

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Biogen’s Experimental Drug Shows Promise for Genetic Form of ALS

biospace | May 15, 2019

Amyotrophic lateral sclerosis (ALS) is a devastating disease with no approved treatments. Diagnosis is tantamount to a death sentence and researchers are desperately searching for some kind of therapy. Although there have been numerous failed treatments, Biogen believes it might be on the right track. “ALS is a disease you really want to make a difference in,” Toby Ferguson, M.D., Ph.D, Senior Medical Director for Neuromuscular Research and Early Development at Biogen told BioSpace. Earlier this month, Biogen announced interim results from a Phase I/II study of tofersen, an antisense oligonucleotide the company licensed from Ionis Pharmaceuticals that is being studied as a potential treatment of ALS patients who have a confirmed superoxide dismutase 1 (SOD1) mutation. The interim results showed both a proof-of-biology and proof-of-concept, which supported the start of a Phase III clinical trial to confirm the efficacy and safety of tofersen in that patient population, Ferguson said. Ferguson said this was exciting news as it showed the potential of tofersen to target the genetic driver of this form of ALS.

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Biogen and Ionis Pharmaceuticals Announce SPINRAZA (nusinersen) Meets Primary Endpoint at Interim Analysis of Phase 3

Biogen | November 07, 2016

Biogen (NASDAQ:BIIB) and Ionis Pharmaceuticals (NASDAQ:IONS) announced that SPINRAZATM (nusinersen), an investigational treatment for spinal muscular atrophy (SMA), met the primary endpoint at the interim analysis of CHERISH, the Phase 3 study evaluating SPINRAZA in later-onset (consistent with Type 2) SMA. The analysis found that children receiving SPINRAZA experienced a highly statistically significant improvement in motor function compared to those who did not receive treatment. SPINRAZA demonstrated a favorable safety profile in the study.

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Nature Publishes Results from Pre-Clinical Research and Phase 1b Study of Biogen’s Investigational Alzheimer’s Disease Treatment Aducanumab

Biogen | August 31, 2016

Results from pre-clinical research and PRIME, the Phase 1b study of Biogen’s (NASDAQ: BIIB) investigational treatment for early Alzheimer’s disease (AD), aducanumab, were published today in Nature. The full manuscript titled, “The Antibody Aducanumab Reduces Aβ Plaques in Alzheimer’s Disease,” can be found in the 1 September, 2016 issue of Nature

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Biogen’s Experimental Drug Shows Promise for Genetic Form of ALS

biospace | May 15, 2019

Amyotrophic lateral sclerosis (ALS) is a devastating disease with no approved treatments. Diagnosis is tantamount to a death sentence and researchers are desperately searching for some kind of therapy. Although there have been numerous failed treatments, Biogen believes it might be on the right track. “ALS is a disease you really want to make a difference in,” Toby Ferguson, M.D., Ph.D, Senior Medical Director for Neuromuscular Research and Early Development at Biogen told BioSpace. Earlier this month, Biogen announced interim results from a Phase I/II study of tofersen, an antisense oligonucleotide the company licensed from Ionis Pharmaceuticals that is being studied as a potential treatment of ALS patients who have a confirmed superoxide dismutase 1 (SOD1) mutation. The interim results showed both a proof-of-biology and proof-of-concept, which supported the start of a Phase III clinical trial to confirm the efficacy and safety of tofersen in that patient population, Ferguson said. Ferguson said this was exciting news as it showed the potential of tofersen to target the genetic driver of this form of ALS.

Read More

Biogen and Ionis Pharmaceuticals Announce SPINRAZA (nusinersen) Meets Primary Endpoint at Interim Analysis of Phase 3

Biogen | November 07, 2016

Biogen (NASDAQ:BIIB) and Ionis Pharmaceuticals (NASDAQ:IONS) announced that SPINRAZATM (nusinersen), an investigational treatment for spinal muscular atrophy (SMA), met the primary endpoint at the interim analysis of CHERISH, the Phase 3 study evaluating SPINRAZA in later-onset (consistent with Type 2) SMA. The analysis found that children receiving SPINRAZA experienced a highly statistically significant improvement in motor function compared to those who did not receive treatment. SPINRAZA demonstrated a favorable safety profile in the study.

Read More

Nature Publishes Results from Pre-Clinical Research and Phase 1b Study of Biogen’s Investigational Alzheimer’s Disease Treatment Aducanumab

Biogen | August 31, 2016

Results from pre-clinical research and PRIME, the Phase 1b study of Biogen’s (NASDAQ: BIIB) investigational treatment for early Alzheimer’s disease (AD), aducanumab, were published today in Nature. The full manuscript titled, “The Antibody Aducanumab Reduces Aβ Plaques in Alzheimer’s Disease,” can be found in the 1 September, 2016 issue of Nature

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