FDA has published draft guidance to clarify its perspective on including children in clinical trials. The agency notes that it wrote the draft guidance to help industry, sponsors and institutional review boards (IRBs) protect children in clinical studies testing drugs, biological products and medical devices. The draft guidance is titled “Ethical Considerations for Clinical Investigations of Medical…

Startup BioNanoTech has developed a patented platform technology for purifying proteins/antibodies across size ranges. In particular, the company has developed a new class of Immobilization Metal Affinity Chromatography (IMAC) nanoresins. “We are building something new at a new scale, and something that can do chemistry and physics on a scale that is more closely to…

Dr. Susan Galbraith, executive vice president of oncology R&D at AstraZeneca, says her entry into the pharmaceutical industry was serendipitous. “I always wanted to be a doctor, and during medical school, I was fascinated by the science behind how cancer happens and what we can do to better treat it,” she said. After following this…

The computational disease model developer CytoReason has announced that it has entered into a multi-year partnership with Pfizer (NYSE:PFE) that is potentially worth $110 million over the next five years.  In the recent partnership, Pfizer will make a $20 million equity investment in CytoReason. The company will also obtain options to license platform and disease models from…

With top-notch universities, federal research institutes, leading companies from nine major industry sectors, and 14 top-ranked hospital systems, Ohio is a “quiet giant” of innovation in industrial sectors and life science. Ohio has the fifth-highest number of Fortune 500 and Fortune 1000 companies — and is home to more than 120 NYSE/Nasdaq companies with a…

Johnson & Johnson (NYSE:JNJ) has opened an almost 200,000 ft2 science and technology campus in the San Francisco Bay Area. The new facility more than doubles the company’s presence in the Bay Area, which has been a hub for life sciences innovation for decades. Up to 400 employees will work at the facility. “This campus is…

It’s no surprise that developers of COVID-19 vaccines had healthy profits in 2021. Most of the fastest-growing pharma companies in 2021 saw a COVID-19 therapy of some type contribute to their bottom line. Nevertheless, it remains difficult to fathom that BioNTech (Nasdaq:BNTX) reported annual revenue growth of 3,834.4% last year, making it the fastest-growing pharma companies…

Rocket Pharmaceuticals (Nasdaq:RCKT) is a late-stage clinical biotech focusing on developing gene therapies for rare pediatric diseases with high unmet need. In 2016, that focus drew in Kinnari Patel, president and COO, and Jonathan Schwartz, chief medical officer of the company. “My passion has been making rare disease drug development more efficient and having more therapies…

Pfizer (NYSE:PFE) and Morgan State University have unveiled a novel program known as the Doctor of Public Health (DrPH) Fellowship in Vaccines Medical Development. A central aim of the program is to foster diversity in vaccine development.  In particular, the two-year DrPH program aims to increase the number of minority scholar-practitioners involved in vaccine development. In addition,…

The FDA is on the verge of authorizing updated COVID-19 boosters without the benefit of Phase 3 clinical trial data, according to media reports. The bivalent boosters, based on the omicron sublineages BA.4 and BA.5 and the original form of SARS-CoV-2, could be available soon after Labor Day. To authorize the omicron-specific COVID-COVID-19 boosters, FDA…

Moderna (Nasdaq:MRNA) announced today that it is suing Pfizer (NYSE:PFE) and its COVID-19 vaccine partner BioNTech (Nasdaq:BNTX) over patent infringement in U.S. and German courts. Cambridge, Massachusetts–based Moderna said it is in the process of filing the complaints in U.S. District Court in Massachusetts and the Regional Court of Düsseldorf in Germany. The suits could…

Cardinal Health (NYSE: CAH) announced today that its board has elected CFO Jason Hollar to become the pharma and medtech giant’s new chief executive officer, effective Sept. 1. Hollar will succeed Mike Kaufmann, who has been Dublin, Ohio–based Cardinal Health’s CEO for the past five years. The CEO transition comes as Cardinal Health continues efforts…

The late 1980s and the 1990s were something of a gold rush for pharmaceutical companies focused on CNS drug development — especially those developing psychiatric drugs. In 1988, Eli Lilly introduced the blockbuster SSRI Prozac (fluoxetine), then a new type of antidepressant. Big Pharma companies launched several SSRIs in the years that followed.  By the…

Alphabet subsidiary DeepMind has announced that its AI system AlphaFold has predicted the structure of more than 200 million proteins, representing almost every known cataloged protein. In addition, AlphaFold and its partner, the EMBL‘s European Bioinformatics Institute, announced that the recent release expanded the database by more than 200 fold, from almost 1 million to…

The accepted definition of a biomarker is a “defined characteristic that is measured as an indicator of normal biological processes, pathogenic processes, or responses to an exposure or intervention, including therapeutic interventions.” This definition was derived from a 2016 partnership between the U.S. FDA and the National Institutes of Health (NIH). Biomarkers are not diagnostic…

To deal with a worsening mental health crisis in the U.S., the FDA is reportedly considering approving 3,4-methylenedioxymethamphetamine (MDMA) and psilocybin within the next two years, according to a letter from a Substance Abuse and Mental Health Services Administration (SAMHSA) published by The Intercept.  MDMA could be authorized as a treatment for post-traumatic stress disorder, while…

The federal government continues to work closely with notable COVID-19 manufacturers, including Moderna and Pfizer, hosting a summit today focused on the future COVID-19 vaccines. “We need a vaccine that can stand up to multiple variants,” said White House Covid-19 Response Coordinator Ashish Jha. While White House officials called for developing inexpensive novel vaccines that…

Sanofi today announced a collaboration with Howard University College of Pharmacy for a two-year post-professional Doctorate in Pharmacy fellowship program. The collaboration is a part of the Cambridge, Massachusetts-based company’s ongoing efforts to address disparities in underrepresented communities. The goal is to hire fellows into permanent full-time positions at Sanofi. The program will begin in…

EEG data can bolster rare disease drug research and trials. An epilepsy drug trial, for instance, could ask patients to log the number of seizures they experience in a day. “If you look at a seizure diary, there might be 10 seizures a day. But if you look at EEG, there could be 150,” said Dr.…

Clinical trials form the cornerstone of evidence-based medicine and are essential to establishing the safety and efficacy of new drugs. However, only some of the information in clinical trial reports is well-structured and searchable via keywords; much of the information is buried in unstructured text. In the past, uncovering actionable insights from this unstructured text…

Biopharma companies are grasping the key role an integrated product development strategy can play in the drug development process. A recent industry survey found growing uptake of this multidisciplinary approach to improving efficiency and reducing costs and timelines, though the barriers to successful implementation were similar across the board. The potential savings a strong integrated…

Amgen (Nasdaq:AMGN) is sharpening its focus on generative biology, an emerging discipline that can accelerate protein drug discovery. The company describes generative biology as “a revolutionary approach to drug discovery and development” that enlists the help of AI and machine learning to design novel protein therapeutics. Although the term generative biology may be new, Amgen has…

Codexis (Nasdaq:CDXS) has announced that its board of directors has appointed Dr. Stephen Dilly, former CEO of Sierra Oncology, to be its president and CEO. Dilly will assume the role on August 9, 2022. Former CEO John Nicols will retire to spend more time with his family. Nichols will continue to serve on the Codexis…

Founded in 2017, the proteomics company Seer (Nasdaq:SEER) is building up a growing roster of customers, including pharma and biotech companies, translational and academic labs and CROs. Applications of its technology include biomarker discovery, target identification and multiomics research for cancer or other complex disease detection. Recently, Weill Cornell Medicine and privately-held SpaceX used Seer’s…

R&D scientific software company Dotmatics recently debuted Chemistry Solution for Small Molecule Drug Discovery, a software package including applications, workflows and data management capabilities. “Supporting collaboration is a central theme of the solution,” said Andrew LeBeau, vice president, product integrations at Dotmatics. “Drug discovery is a team-effort, spanning internally within organizations and, often, externally as…