As Pfizer and Moderna receive the FDA nod for COVID-19 boosters, their 2023 global sales projections appear to be just a fraction of the previous year’s. In 2022, Pfizer and its partner BioNTech jointly sold $56 billion worth of their Comirnaty COVID-19 vaccine, marking the best-selling drug of the year. Moderna’s Spikevax COVID-19 vaccine wasn’t…
Embedding patient perspectives: Keri Yale’s impact as a change agent at Boehringer Ingelheim
When Keri Yale, the company’s head of patient affairs and engagement at Boehringer Ingelheim (BI), joined more than 25 years ago, she recognized a need to put patients at the center of the pharmaceutical industry. Since then, she has spearheaded a transformation towards greater patient centricity at the company that started with HIV/AIDS community engagement…
Anti-obesity drugs to command a $44 billion market by 2030
As obesity rates continue to soar across the globe, analysts anticipate that the market for anti-obesity drugs will skyrocket in the coming years. Goldman Sachs projects the market to be worth $44 billion by 2030. That’s an almost 16-fold expansion from its valuation of approximately $2.82 billion in 2022. Barclays is even more upbeat on…
Exploring future cancer therapies: Designing linkers to increase ADC efficacy and reduce toxicity
Antibody-drug conjugates (ADCs) represent a significant paradigm shift in cancer treatment, marrying the precise target recognition of monoclonal antibodies with the potent cell-killing capabilities of cytotoxic agents. In contrast to traditional small-molecule therapies, ADCs are multifaceted structures with three distinct components — i.e., antibody, cytotoxic payload and a linker — each playing a crucial role…
Mapping the cancer patient journey with liquid biopsy
According to the American Cancer Society, one in two men and one in three women will be diagnosed with cancer at some point in their lives. Patients seek treatment to shrink their tumors and ideally achieve remission; however, there is no one-size-fits-all approach. At its core, cancer is a genetic disease: Different types of cancer that affect…
Legal dispute precede Pfizer’s latest FDA nod for RSV vaccine
Amid a backdrop of recent RSV vaccine approvals, GSK and Pfizer find themselves locked in a legal spat over alleged patent infringements. Both Big Pharma giants now possess the FDA’s blessing for their respective respiratory syncytial virus (RSV) vaccines. Pfizer’s recent win came with the second approval for its Abrysvo vaccine, which the company now…
Nvidia exec: Generative AI can turn every biologist into a computer scientist — and vice versa
On a recent visit to Nvidia’s headquarters in Santa Clara, I had the chance to speak with Kimberly Powell, the company’s vice president and general manager of healthcare. After asking about the pharma industry’s surging interest in AI, Powell remarked, “Every pharma knows who Nvidia is now.” Curious, I asked her, “How long has that…
Ketabon GmbH eyes KET01’s potential as an at-home option for treatment-resistant depression
A joint venture between HMNC Brain Health and Develco Pharma in Switzerland, Ketabon GmbH recently released top-line results from its phase 2 KET01-02 study of KET01, a slow-release formulation of oral ketamine, for treatment-resistant depression (TRD). KET01 was associated with improvements in depression severity as early as day 1, but the results were not statistically…
Prices of top 25 Medicare Part D drugs more than doubled since market entry; AARP offers new insights in drug pricing report
Medicare Part D drug prices have seen a significant surge in recent years. The price of the arthritis drug Enbrel has soared 701% since its launch in 1998, and the diabetes drug Januvia has jumped 275% since its debut 2006. All in all, the average price increase for the 25 brand-name drugs with the highest…
Key considerations for the FDA approval of zuranolone for postpartum depression treatment
Mixed-bag approval hit Sage hard but spared Biogen Sage Therapeutics recently notched an FDA win for the neuroactive steroid zuranolone (Zurzavae) for postpartum depression (PPD). For major depressive disorder (MDD), however, the agency handed the drug a complete response letter. In the wake of the news, Sage’s stock is down 46% to $19.52, while BIIB,…
Epstein-Barr virus: Trigger and driver of multiple sclerosis?
Recent research has indicated a link between Epstein-Barr virus (EBV) and multiple sclerosis (MS), with some researchers going as far as to say that EBV might be a potential trigger of MS. However, it remains unclear whether the virus also drives the progression of the disease. Current treatments focus largely on moderating inflammation. In this…
Biotech bloodbath? Nearly 100 companies announce layoffs in the first half of 2023, but job openings also surge
The first half of 2023 brought job cuts to roughly 100 biotech and pharma companies. But while that may indicate an unstable employment landscape, it is not a universal trend. Since March, appetite for life sciences talent has gathered steam. According to data from real-estate firm JLL, June 2023 had the sixth highest number of…
FDA approves zuranolone for postpartum depression but issues complete response letter for major depressive disorder
FDA’s approval of Zurzuvae for PPD could mark a significant shift in the fight against postpartum depression (PPD). On August 4, the agency gave the green light for the oral medication, although it declined its use for major depressive disorder (MDD), citing insufficient evidence of effectiveness. The former approval represents a milestone as the first ever…
New AI tool InClinico predicts clinical trial outcomes with 79% accuracy: A closer look with InSilico CEO, Alex Zhavoronkov
Roughly nine out of ten clinical trials fail as a result of factors such as lack of efficacy and unmanageable toxicity, as the journal Pharma Excipients has noted. After seven years of development, Insilico Medicine has scored a breakthrough with its generative AI tool, inClinico. In particular, the tool demonstrated 79% accuracy in predicting the…
In data we trust: AI’s growing influence on drug development
The journey to developing a successful drug, theoretically, may appear linear: you discover the right drug, find the suitable patient and administer it at the right time. The reality, however, often deviates from this straightforward path. Aligning these three variables remains notoriously difficult, often leading to elongated timelines strewn with failures, sometimes extending over a…
QuantHealth taking a data-driven predictive approach to simulate clinical trials
In drug discovery, the process of shooting for regulatory approval can feel less like a sprint and more like a marathon, but with no guarantee of crossing the finish line. Despite the hefty investment of time, effort and resources, the success rate for bringing new drugs to market hasn’t improved in recent decades. The American…
Microsoft details how its technology is advancing drug discovery and biomedical research
As cloud technology matures, life-sciences companies are finding new avenues for business value in life sciences, extending beyond the cost efficiencies typically associated with cloud migrations, as McKinsey noted. In an email statement, Microsoft outlined how its own cloud computing, AI and research capabilities are driving similar innovation for biopharma companies. This article explores Microsoft…
Microsoft goes all in on Azure Quantum to accelerate scientific discovery
In the rapidly evolving landscape of quantum computing, Microsoft is pushing the boundaries with its Azure Quantum platform. As Microsoft CEO Satya Nadella recently announced, “Our goal is to compress the next 250 years of chemistry and material science progress into the next 25,” Nadella said. The executive also noted that, thanks to recent advances…
Bridging bioanalytical gaps: Examining validation methods across species
Bioanalytical method validation is the backbone of effective drug discovery and development. Its pivotal role ensures the generation of reliable and reproducible data from diverse species, leading to safe and effective therapeutics. As critical as this process is, scientists face many challenges, particularly regarding validation across different species in preclinical and clinical studies. Accommodating species…
Eli Lilly to acquire cardiometabolic disease treatment maker Versanis for $1.925B
Eli Lilly (NYSE:LLY) announced today that it entered into a definitive agreement to acquire Versanis, a private, clinical stage biopharmaceutical company. Versanis focuses on the development of new medicines for the treatment of cardiometabolic diseases. Its lead asset, bimagumab, is a monoclonal antibody. Bimagumab binds activin type II A and B receptors to block activin…
Take a global tour of 19 major biotech hubs with our interactive map
The international biotech sector clocked in at $1.37 trillion in 2022 despite headwinds such as slow launches, long-term drug pricing shifts and changing consumer behavior. Recent biotech breakthroughs include the development of an Ebola vaccine, progress in genetic testing and drug treatments and advances in artificial tissue growth. This article explores several leading biotech…
Pharma M&A trends in Q2 2023: Strategic acquisitions rise as deal-making holds steady
The pharma industry in 2023 has been marked by an uptick of M&A activity. The year began with a relative frenzy of massive mergers. Pfizer’s $43 billion acquisition of Seagen and Amgen’s $27.8 billion purchase of Horizon Therapeutics earlier in the year were notable examples. But that initial spike of billion-dollar megamergers significantly cooled in…
Raising the efficiency floor and innovation ceiling with generative AI in drug discovery
Large language models (LLMs) such as ChatGPT promise advances that extend beyond capturing public interest. Because transformer models like GPT have an architecture that supports the understanding of language in context, they point to an array of novel possibilities for scientific research. “The transformer architecture is critical,” according to Michael Connell, the chief operating officer…
Pharma 2023 half-year review reveals winners and losers
In many ways, the economic landscape of 2023 has been turbulent. High inflation? Talent shortages? Rising costs of doing business? Volatile currency markets? New regulatory hurdles? Check, check, check. To navigate the choppy waters, a significant number of companies have turned to strategic M&A to drive growth and strengthen product pipelines. Despite these challenges, a…
Finding the right formula for nitrosamine risk mitigation
The pharmaceutical industry is facing many challenges to ensure drug products are free from nitrosamine contaminants and safe for human use. Since the discovery of potentially carcinogenic nitrosamines in some commonly prescribed drug products in 2018, mitigating nitrosamine risk has been a top priority for the pharmaceutical industry and its governing bodies. As such, strict…