Aerami Therapeutics, previously known as Dance Biopharm, is developing a smart inhaler that delivers insulin as a gentle mist, potentially improving the convenience and efficiency of insulin administration for diabetics. Their product, Dance 501, has shown promising results in a Phase I/II clinical trial, demonstrating safety, tolerability, and a faster onset of action compared to injected insulin lispro. Despite the historical market challenges faced by inhaled insulin products like Exubera and Afrezza, Aerami's unique design and liquid formulation aim to overcome these issues. The company is now seeking a partner for a Phase III program and is expanding its focus to include other chronic diseases, rebranding itself to reflect this broader vision.

Hong Kong pro-democracy activists, now living overseas, have been targeted by the Hong Kong Police Force's National Security Department with bounties for their arrest due to alleged violations of the National Security Law. Activists such as Frances Hui, Joey Siu, and Simon Cheng, who have been advocating for human rights and democracy for Hong Kong, are among those named. Hui, now in the U.S., has been involved in promoting the Hong Kong Sanctions Act, which calls for sanctions against Hong Kong officials. Siu, a U.S. citizen, and Cheng, a former British Consulate employee now in the UK, have also been active in lobbying for sanctions and advocating for Hong Kong's independence. Despite the threats, the activists remain undeterred and continue their advocacy work, viewing the bounties and arrest warrants as intimidation tactics and publicity stunts by the Hong Kong government.

The article discusses a study by The Institute of Cancer Research, London, which analyzed cancer drug approvals by the European Medicines Agency (EMA) from 2000 to 2016. The study found that despite an increase in the number of cancer drugs on the market, there is a delay in making them available to patients, particularly for hard-to-treat and pediatric cancers. The study suggests that the EU Clinical Trials Directive may be contributing to this delay. It also highlights that certain cancer types, such as brain and esophageal, have seen no new drug authorizations, and only a small percentage of drugs are approved for pediatric use. The article mentions a need for more incentives for pharmaceutical companies to develop treatments for children and suggests that the EMA consider novel clinical endpoints. The overarching message is the importance of prioritizing drugs with new mechanisms of action to improve patient outcomes in the face of cancer evolution and drug resistance.

The article discusses the importance of selecting the appropriate solid form of an active pharmaceutical ingredient (API) in drug development, focusing on statins as an example. Statins, used to treat lipid disorders, can exist in multiple polymorphic forms, affecting their solubility and bioavailability. The article highlights the challenges of low bioavailability in statins and the need for drugmakers to create stable, bioavailable dosage forms. Dr. Steef Boerrigter, a senior research scientist at AMRI, shares his expertise on the subject, explaining the different types of solid forms, such as neat polymorphs, cocrystals, and amorphous materials, and their impact on drug solubility, stability, and manufacturing. He emphasizes the importance of considering solid form selection early in the drug development process and how it can influence intellectual property strategy and extend the patent lifetime of a drug. The article also touches on the evolution of drug development over the past 20 years, with new screening technologies allowing drugs with low solubility to still be viable candidates.

Cardinal Health, a multinational healthcare and medical device company, is dealing with sterility issues in their surgical gowns, leading to two voluntary field actions for their pre-packaged surgical kits. The US Food and Drug Administration has been aware of the potential contamination since mid-January. The gowns, produced by Chinese supplier Siyang Holymed, were made in unapproved and uncontrolled environments, raising concerns about their sterility. Cardinal Health has ended its relationship with Siyang Holymed following the discovery that 9.1 million gowns are affected, which are also part of nearly 3 million PreSource procedural packs. CEO Mike Kaufmann has issued an apology and the company is taking steps to address the shortage and prevent future occurrences. The recall is expected to cost Cardinal Health $96 million, a figure excluded from their non-GAAP financial results. The company's Q2 earnings call is scheduled for February 6, 2020.

The article discusses the Office of Prescription Drug Promotion's (OPDP) new studies on the impact of third-party endorsements in pharmaceutical advertising. One study examines how celebrity, physician, or patient endorsers affect perceptions of a fictitious acne medication ad, with a focus on payment disclosures. The article references past incidents, such as Robert Jarvik's non-licensed endorsement for Pfizer's Lipitor and Kim Kardashian's FDA warning for promoting Diclegis without proper disclosures. The second OPDP study looks at the effects of payment disclosure explicitness in an Instagram ad for a fictitious endometriosis drug. The research aims to guide industry best practices in leveraging celebrity and expert endorsements in direct-to-consumer advertising.

Biopharma companies including Johnson & Johnson, Gilead, Novavax, Moderna Therapeutics, and Inovio Pharmaceuticals are racing to develop a vaccine for the Wuhan coronavirus (2019-nCoV). The outbreak has caused over 100 deaths and infected thousands, with the virus spreading rapidly. These companies are using various technologies, such as synthetic genetic code and recombinant nanoparticle technology, to create a vaccine. Johnson & Johnson is working on multiple constructs, while Gilead is testing its experimental Ebola vaccine, Remdesivir, against the coronavirus. Vaccine development is a lengthy and expensive process, as illustrated by Merck's Ebola vaccine, which took years to be approved. The urgency for a coronavirus vaccine is high, but it remains uncertain how soon it will be available and whether it can be produced in sufficient quantities to meet demand.

The article discusses the highly regulated process of naming prescription drugs in the US, overseen by the FDA's CDER and OPDP. These organizations aim to prevent medication errors and misleading drug names. The OPDP is conducting a study to understand how drug names influence healthcare providers and the public. The study will examine reactions to ten drug names, including one called 'CureAll'. The article also highlights past issues with drug name confusion, such as the mix-up between Depo-Provera and Depo-Medrol, and emphasizes the importance of drug names in a company's brand, citing Viagra as an example of a successful drug name. The OPDP study aims to improve drug naming practices to prioritize patient safety.

FUSION IV Pharmaceuticals, operating as AXIA Pharmaceutical, has voluntarily recalled 65 unused sterile drug products nationwide due to potential sterility issues. The recall includes drugs like dexamethasone and alprostadil. No adverse events have been reported to the FDA yet. Outsourcing facilities like AXIA are regulated under section 503b of the Federal Food, Drug, and Cosmetics Act and must comply with Good Manufacturing Practices. The recall is a precautionary measure following inconsistencies with federal guidelines. The article also references past safety issues in the industry, including a fungal meningitis outbreak linked to the New England Compounding Center and a warning letter issued to Imprimis NJOF, LLC for various violations. The article highlights ongoing concerns about the safety of drugs produced by outsourcing facilities due to infrequent FDA inspections.

The article discusses the advancements and challenges in the field of liquid biopsies for cancer detection and treatment. Liquid biopsies offer a non-invasive alternative to traditional tissue biopsies by analyzing tumor material in body fluids. Despite the potential, only a few tests have received FDA approval, and the regulatory path is complex. The article highlights the importance of validation studies and FDA Breakthrough Designations in advancing liquid biopsy products. It also outlines the top 10 breakthroughs in liquid biopsy research for 2019, including new assays, clinical trials, and the potential for early cancer detection. The BloodPAC consortium's open-source collaboration is noted as a significant step towards the development and clinical use of liquid biopsy assays. The article suggests that 2020 may see further integration of liquid biopsies into clinical practice, with more validation trials and FDA-approved tests leading to improved cancer care.