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,…

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,…

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, 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…

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…

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…

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…

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…

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…

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…

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 (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 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…

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 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…

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…

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.…

LabCentral is a 501(c)3 nonprofit that serves as a springboard for life sciences and biotech startups. The model makes it easier for creative academics to transform an idea into a profitable business by addressing the initial need to invest in lab equipment and space. “Biotech startups have historically had to spend all of this money…

AbbVie (NYSE:ABBV) will work with the gene therapy platform company Capsida Biotherapeutics (Thousand Oaks, California) to develop serious eye diseases with few treatment options. The partnership will unite AbbVie’s development and commercialization capabilities with Capsida’s high-throughput adeno-associated virus (AAV) engineering platform. AbbVie will also help explore therapeutic cargo approaches and provide expertise in ophthalmology disease biology.…

Interest in mRNA therapy has exploded in recent years following the development of mRNA-based COVID-19 vaccines, but can the platform live up to the initial hype that surrounded it? More companies have announced clinical trial data from mRNA trials for conditions ranging from cardiovascular disease to cancer. mRNA, or messenger RNA, is a type of…

Determining the most overpaid CEOs is a controversial topic, but one notable list that has recently surfaced is the one published by the non-profit As You Sow. This list includes several pharmaceutical and life science executives on its 100 most overpaid CEOs ranking. To determine its most recent ranking, As You Sow assessed compensation packages…

The use of oligonucleotides (i.e., “oligos”) was first proposed in the late 1970s, but has not achieved widespread popularity until recently. Developments in delivery method and target specificity for oligos have led to oligos’ resurgence in popularity. These therapies are particularly of interest because their mechanism of action allows for targeting virtually any nucleic acid…

Biogen (Nasdaq:BIIB) and Sage Therapeutics (Nasdaq:SAGE) have announced that the FDA accepted the New Drug Application (NDA) for zuranolone, a neuroactive steroid. The drug candidate could be a novel 14-day oral medication to treat Major Depressive Disorders (MDD) or postpartum depression (PPD). Priority review has been granted and the application is slated to be processed…

Several companies, including GSK, Janssen, Novartis and Pfizer, have announced that they are cutting their pipelines as they release their full-year 2022 financial results. The following are the drugs removed from these companies’ pipelines. Bristol Myers Squibb Anti-CTLA-4 NF: The oncology monoclonal antibody candidate directed against the human T-cell receptor cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) known as BMS-986218 was…

The most common types of drugs in drug development are small molecules and biologics. Small molecules have a long history in the pharmaceutical industry and remain a pillar of modern medicine.  Conversely, biologics are more complex molecules derived from living organisms.  In this article, we provide a brief overview of common drug types, including biologics, small…