Industry news

• Long COVID study expanded across Europe

  30 November 2023 Catherine Eckford / European Pharmaceutical Review

  If biotech Berlin Cures’ larger Phase III study of its Long COVID drug candidate goes ahead, the findings will support the treatment’s potential future regulatory approval.

• Ethical, Regulatory, and Operational Considerations for Cell and Gene Therapy Research in Children

  30 November 2023 FiercePharma

  Cell and Gene Therapy (CGT) has the potential to transform the life trajectory of children with genetic conditions amendable to gene modification with advances in treatment and possible cures. Many of these conditions are rare, debilitating, serious or life-threatening, and do not exist in adults, and consequently, first-in-human trials may need to be initiated in children. Nonclinical in vitro data and nonclinical in vivo studies in relevant animal models are often the only information available to support trials in children.¹ Because of the small number of children with some of these conditions, it may not be possible to conduct multiple trials. Clinical trials in children should be carefully designed to support a marketing application, if necessary.

• Prevention, Treatment for Migraine Rapidly Evolves, Calling for Development of Novel Drugs

  29 November 2023 Ashley Gallagher / Pharmacy Times

  Migraine are recurrent headaches occurring with moderate to severe throbbing and pulsating pain on 1 side of the head, according to the National Institute of Neurological Disorders and Stroke.¹ Untreated attacks can last from 4 to 72 hours, usually accompanied with sensitivity to light and/or noise, nausea, and vomiting. Although non-steroidal anti-inflammatory drugs (NASAIDs) are often used to treat migraine, there have been many preventative medications approved to reduce the severity and frequency of migraine, including FDA-approved drugs like enenmab (Aimovig; Amgen), galcanezumab-gnlm (Emgality, Eli Lilly), and rimegepand (Nurtec; Pfizer).¹ The treatment landscape for treating and preventing migraine has been rapidly evolving.

• Imaging AI hogs the spotlight at RSNA, with debuts from GE, Siemens, Philips

  29 November 2023 Conor Hale / FiercePharma

  Artificial intelligence once again took the spotlight at the annual meeting of the Radiological Society of North America, where the biggest names in digital imaging demonstrated their cutting-edge tech.

• Pharmacy Technician Roles Are Growing and Expanding

  28 November 2023 Ned Milenkovich, PharmD / Pharmacy Times

  Pharmacy technicians’ roles continue to change. Previously, technicians were engaged in basic supportive tasks to the pharmacist. Although this is still the case, technicians are contributing to patient care in a much more expansive role. In recent years, largely because of excessive workflow burdens and technological advances, technicians have increasingly taken on a more essential role within the pharmacy and its daily activities.

• Researchers Create Growth Chart from AI-Based Tool to Measure Muscle Mass

  27 November 2023 Kennedy Ferruggia / Pharmacy Times

  Researchers have developed a growth chart to track muscle mass in growing children, according to research conducted by investigators from Brigham and Women’s Hospital. The researchers created an artificial intelligence

• CRISPR Therapeutics laid off employees on heels of positive FDA AdComm: sources

  27 November 2023 Max Bayer / FiercePharma

  CRISPR Therapeutics laid off a number of employees a week after FDA advisers all but greenlighted the company’s Vertex-partnered, CRISPR-edited sickle cell therapy, sources told Fierce Biotech. 

• EC approves first-line ovarian cancer treatment

  24 November 2023 Catherine Eckford / European Pharmaceutical Review

  A Phase III trial evaluating rucaparib demonstrated that it significantly improved progression-free survival in women with advanced ovarian cancer, regardless of their BRCA mutation status.

• From desperation to innovation: A patient’s battle with antimicrobial resistance

  24 November 2023 Bio.News

  Modern medicine wouldn’t be what we know today if it weren’t for the discovery of antibiotics and antimicrobials. But as we approach World Antimicrobial Resistance (AMR) Awareness Week, we’re reminded that too much of a good thing can turn into a global health threat.

• Europe Publishes Electronic Product Information for Selected Medicines

  23 November 2023 BioPharm International

  Electronic product information for selected human medicines that have been harmonized across the European Union have been published for the first time.