The pharma and biotech sectors continue to face rapid change. On one hand, top pharma employers have continued to face talent shortages as demand increases for experienced workers. But on the other, the pharma sector has not been immune to layoffs. One factor driving the trend is the increased clip of mergers and acquisitions (M&A)…
Pharma M&A resurgence: An overview of recent deal-making trends
After something of a slow year in 2022, mergers and acquisition (M&A) activity is ramping back up in the pharma and biotech sector. There have been several especially large M&A deals in the past few months. Examples include Pfizer’s (NYSE:PFE) $43 billion acquisition of Seagen, and Merck’s (NYSE:MRK) $11 billion purchase of Prometheus Biosciences. In December…
Unraveling the impact of FDORA and PREVENT Pandemics Acts on the life sciences
As the world continues to grapple with global health challenges, the role of science and biotech law has taken center stage in shaping public health policy and innovation. The FDORA and PREVENT Pandemics Acts are poised to help shape the landscape. In a recent interview, life sciences attorney Barbara Binzak Blumenfeld offers insights into significant…
Brain breakthroughs: Aprinoia Therapeutics’ harnesses AI and strategic partnerships to propel neurodegenerative disease research
Neurodegenerative disease research is witnessing significant advances. To that end, Hong Kong-headquartered Aprinoia Therapeutics is embracing a ‘precision neuroscience’ approach to neurodegeneration diagnostics. The company’s lead program, APN-1607, represents a new generation of advanced tau positron emission tomography (PET) tracers, which play a crucial role in effective and efficient diagnosis of patients suffering from neurodegenerative…
The 50 best-selling pharmaceuticals of 2022: COVID-19 vaccines poised to take a step back
The COVID-19 pandemic has had a profound impact on the best-selling pharmaceuticals, leading to shifts in the list with Pfizer and BioNTech’s Comirnaty surpassing AbbVie’s Humira for the No. 1 spot in 2021. That momentum continued in 2022, with Pfizer and BioNTech jointly raking in $59.1 billion in revenue from the sales of the COVID-19…
HELIOS trial Q&A: Amylyx Pharmaceuticals’ AMX0035 as a potential treatment for Wolfram syndrome
The recently launched phase 2 HELIOS clinical trial from Amylyx Pharmaceuticals, aims to explore the potential of AMX0035 (sodium phenylbutyrate and taurursodiol) in treating Wolfram syndrome, a rare and complex genetic disorder. In a recent interview, Drs. Lahar Mehta and Fumihiko Urano discussed the AMX0035 Wolfram syndrome trial design, objectives and implications for future research…
Using AlphaFold, Insilico Medicine produces AI drug discovery in record time
An international group of researchers employed DeepMind’s deep learning-driven AlphaFold protein structure database to design and synthesize a potential hepatocellular carcinoma (HCC) drug in only 30 days. The AI drug discovery project consisted of Insilico Medicine, the University of Toronto’s Acceleration Consortium and researchers including Nobel laureate Michael Levitt. The team applied AlphaFold to Insilico’s…
Lonza and ABL Bio partner on bispecific antibody development for immuno-oncology and neurodegenerative diseases
Lonza (LON:0QNO) and South Korea-based ABL Bio (KOSDAQ:298380) have joined forces to accelerate bispecific antibody development for immuno-oncology and neurodegenerative diseases. Over email, Basel, Switzerland–headquartered Lonza noted that its experience with novel molecular formats enables the company to handle ABL Bio’s unique challenges. In the partnership, Lonza will provide submission-ready chemistry, manufacturing and controls (CMC) data…
Science 37, Crinetics and Gritstone Bio announce inducement grants to boost talent acquisition
Science 37 Holdings (Nasdaq:SNCE), Crinetics Pharmaceuticals (Nasdaq: CRNX) and Gritstone Bio (Nasdaq:GRTS) have announced recent inducement grants to attract new non-executive employees under Nasdaq Listing Rule 5635(c)(4). This move showcases the companies’ focus on talent acquisition and retention in the competitive pharmaceutical and biotechnology markets. A clinical trial research organization based in Durham, North Carolina,…
Three strikes in pharma: Exploring recent drug withdrawals and clinical trial challenges
Pharmaceutical companies face a long list of regulatory challenges ranging from patent expiry to bioequivalence and international harmonization. It’s not uncommon for drug makers to withdraw or discontinue drugs after failing to meet clinical requirements or endpoints, resulting in drug withdrawals. On average, life science companies pull roughly 4,500 drugs and devices from the market,…
Verana Health launches Qdata anti-VEGF market tracker for in-depth market analysis
Digital health company Verana Health (San Francisco) has unveiled the Qdata anti-VEGF market tracker. It is their first market tracking Data as a Service (DaaS) product. Excessive amounts of vascular endothelial growth factor (VEGF) can cause abnormal blood vessel growth in the eyes, which, when untreated, can result in vision loss in patients with retinal diseases.…
BioTheryX’s Prodegy platform takes center stage in cancer research partnership with Incyte
BioTheryX, a privately-held company, and Incyte (Nasdaq:INCY) have formed a research collaboration and license agreement. Their focus is on discovering and developing molecular glue targeted protein degraders for oncology targets. Several other privately-held companies also focus on protein degradation. Examples include Kymera Therapeutics (Cambridge, Massachusetts), Arvinas (New Haven, Connecticut), Nurix Therapeutics (San Francisco), Cullgen (San…
Incorporating real-world evidence into the life cycle of drug development
Utilizing real-world data (RWD) to generate real-world evidence (RWE) is not new and pharmacoepidemiologists have long-standing experience designing and implementing studies utilizing RWE to satisfy regulatory post-marketing safety commitments and to evaluate the effectiveness of drugs. However, RWD and RWE can be used more largely to support the full life cycle of drug development, during…
Pharmacovigilance in personalized medicine: Adapting to a new era of drug development
One of the ways that the COVID-19 pandemic had a profound impact on the pharma industry was how it highlighted the importance of pharmacovigilance. As personalized medicine gained traction, drug developers had to evolve their strategies to ensure safety and efficacy. In their report, “The Future of Pharmacovigilance,” Dr. Sabine Jeck-Thole and Ben Enejo, partners…
Big Pharma, it’s time to talk: Investors demand transparency on patent thickets
Pharmaceutical companies are running into pushback for their “patent thicket” tactics, designed to maintain exclusive rights and delay cheaper generics. The Financial Times reported that an ethical investor coalition is pushing for greater transparency and urging major drug makers to disclose their patent strategies. Unraveling the patent thicket mystery Patent thickets are a common intellectual property…
This RNA sensor could trigger cells to turn on a synthetic gene
Engineers at MIT designed a new way to trigger cells that could lead to targeted therapies for cancer and other diseases. Using an RNA sensor for the trigger, the researchers ensure that synthetic genes activate only in specific cells. They demonstrated that the sensor could accurately identify cells expressing a mutated version of the p53…
Non-hallucinogenic LSD derivative reduces depression symptoms in preclinical studies
Vancouver-based biotech firm BetterLife Pharma (OTCM:BETRF) is working on a non-hallucinogenic LSD derivative for treating neuropsychiatric and neurological disorders. Known as BETR-001 (2-bromo-LSD), the compound is also not controlled. Conversely, LSD, like other serotonergic hallucinogens, is a Schedule I compound. That status makes it difficult and expensive to research for potential medical uses. BetterLife announced…
Sandoz’s Hyrimoz to challenge AbbVie’s Humira dominance
The generic and biosimilar company Sandoz, a Novartis (NYSE:SIX) subsidiary, has received FDA approval for its Humira biosimilar Hyrimoz (adalimumab-adaz) injection. AbbVie’s (NYSE:ABBV) megablockbuster Humira is a biologic medication with indications for an array of autoimmune conditions, including rheumatoid arthritis, Crohn’s disease and psoriasis. Sandoz’s biosimilar will likely be priced significantly lower than Humira’s. This…
Harnessing the untapped potential of legacy data in pharma R&D
Clinical trials for a new therapy cost a median of $41,117 per patient. Costs like this are no surprise to pharma leaders. But during an age of increasing budgetary pressures, drug developers are under pressure to do more with less money and staff. While there are no “simple” answers to this challenge, there is one strategy that offers…
Vericel’s unique biopharma focus: Tackling unmet needs in sports medicine and burn treatment
Vericel (Nasdaq:VCEL), a biopharma focused on sports medicine and severe burn care therapies, has a portfolio including the cartilage repair treatment MACI and the burn treatments Epicel and NexoBrid. Focal cartilage defects, which occur in approximately 60% of arthroscopies, can lead to debilitating osteoarthritis if left untreated. Vericel’s flagship product, MACI, tackles this medical challenge…
Emory and Pfizer partner to develop new COVID-19 treatments
Emory University has partnered with Pfizer (NYSE:PFE) to create new drugs and therapies aimed at stopping serious disease from COVID-19. The Emory and Pfizer collaboration will take place in Emory University’s Schinazi Laboratory, led by scientist Raymond Schinazi, with the goal of producing novel antiviral compounds to combat COVID, according to The Atlanta Journal-Constitution. Although…
Prominent pharma M&A deals to watch in Q1 2023: Pfizer, Sanofi and others on the hunt
After a relatively quiet 2022, 2023 is anticipated to be a more robust year for pharma M&A activity. In recent months, players such as Pfizer (NYSE:PFE), Sanofi (NYSE:SNY), Chiesi, AstraZeneca (LON:AZN) and Amgen (Nasdaq:AMGN) have unveiled acquisition plans that could reshape the landscape of the sector. This article delves into the details of prominent recent…
PathAI launches AISight digital pathology platform and NSCLC algorithm
PathAI has launched a new digital pathology platform, AISight. Supporting AI-driven research, the digital pathology platform was trained on a real-world dataset of over 5,000 samples with inputs from more than 350,000 cell and tissue-level annotations from more than 50 pathologists. The company has also released its AIM-PD-L1 NSCLC RUO algorithm, which calculates the percentage…
How automation is changing the face of pharmacovigilance
The ever-growing volume of data from clinical trials, drug use and other sources presents both opportunities and challenges for pharmacovigilance. COVID-19 has presented an array of possibilities for pharmacovigilance service providers. Detecting and evaluating potential safety signals is essential to maintain the safety of drugs and other therapeutic products. Companies are constantly challenged to keep…
An executive’s journey from clinical trial manager to marketing director at Biomerica
The in vitro diagnostics company Biomerica has a diversified portfolio, including tests for lab, point-of-care and at-home settings. The company has a particular focus on addressing the treatment of gastrointestinal and inflammatory diseases. We recently spoke with Hamburg, Germany–based Astrid Starke, Biomerica’s marketing director, to learn more about her experience in the life sciences industry.…