DaHee Han

The FDA has accepted for Priority Review the NDA for intravenous and oral lefamulin for the treatment of CABP.

Nuzyra, an aminomethylcycline (related to tetracycline antibiotics), is designed to overcome tetracycline resistance and has broad-spectrum activity against Gram-positive, Gram-negative and atypical bacteria, and other drug-resistant strains.

Alyq should not be used with concomitant organic nitrates or guanylate cyclase (GC) stimulators (eg, riociguat), and in patients with a known serious hypersensitivity to tadalafil.

Mylan plans to make Wixela Inhub available in 3 strengths: 100mcg/50mcg, 250mcg/50mcg, and 500mcg/50mcg.

The approval was based on findings from a Phase 4 safety and immunogenicity study that included ~2000 children.

The uEXPLORER combines positron emission tomography (PET) with X-ray computed tomography (CT) allowing for imaging of the entire body at the same time.

The product will be made available first in institutions followed by a launch in the retail setting.

To investigate the incidence of anaphylaxis after vaccination, study authors reviewed data submitted to the Vaccine Adverse Event Reporting System (VAERS) between 1990 and 2016.

Vecuronium Bromide, a neuromuscular blocker, is indicated as adjunct to general anesthesia, to facilitate endotracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation.

Tivic Health Systems announced that ClearUP Sinus Pain Relief has been cleared by the Food and Drug Administration (FDA) for the treatment of sinus pain due to allergic rhinitis, or hay fever, in adults aged ≥18 years.

ProAir Digihaler is the first digital inhaler with built-in sensors that connects to a mobile application and provides data on inhaler use to patients with asthma and chronic obstructive pulmonary disease (COPD).

Nabriva Therapeutics announced the submission of 2 NDAs to the FDA for the oral and IV formulations of lefamulin for the treatment of community-acquired bacterial pneumonia.

A study published in Circulation has found a reduced risk of cardiovascular (CV) death in heart failure patients when they are given routine influenza vaccinations.

Currently, same-day delivery is available only in Dallas, Chicago, New York City, Gainesville, Miami, Tampa, and Fort Lauderdale; this program will be expanded in 2019.

The approval was based on data from the IMpower 150 trial, an open-label study involving 1202 patients with stage IV metastatic NSq NSCLC who had not received prior chemotherapy for metastatic disease, but could have received prior EGFR or ALK kinase inhibitor if appropriate, regardless of PD-L1 or T-effector gene status and ECOG performance status 0 or 1.

A meta-analysis of anti-inflammatory agents for the treatment of pediatric OSA found that montelukast plus intranasal steroids or montelukast alone may benefit patients with mild OSA.

The generic version of the EpiPen Jr (epinephrine injection, USP) 0.15mg as well as additional supply of the generic version of the EpiPen Auto-Injector 0.3mg will be made available in 2019.

More than 67% of patients who received AR101 were able to ingest a dose of 600 mg or more of peanut protein at the exit food challenge, without dose-limiting symptoms

Several asthma and allergy groups expressed “deep concern” over the recent FDA approval of Primatene MIST.

The US Department of Health and Human Services has released the second edition of the Physical Activity Guidelines for Americans at the American Heart Association’s Scientific Sessions meeting.

The FDA has approved Yupelri inhalation solution for the maintenance treatment of patients with COPD.

The new inhalation delivery system no longer includes CFC. It contains hydrofluroalkane (HFA) propellants and also features a built-in spray indicator and metal canister, replacing the glass container seen with the original Primatene Mist.

The FDA has approved Lorbrena (lorlatinib) for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic NSCLC.

The 23andMe Personal Genome Service Pharmacogenetic Reports test can detect 33 variants for multiple genes, corresponding to more than 50 commonly prescribed medications and over-the-counter products.

The FDA has approved Keytruda in combination with carboplatin and either paclitaxel or nab-paclitaxel for the first-line treatment of patients with metastatic squamous NSCLC.

Results from the extension trial showed a similar safety and tolerability profile for Fasenra as that seen in SIROCCO and CALIMA.

The primary objective was to characterize the long-term safety and tolerability of Ofev in patients with IPF; efficacy endpoints included annual rate of decline in forced vital capacity (FVC) calculated over 192 weeks.

The designation was based on data from the Phase 2b PATHWAY trial that evaluated 3 doses of tezepelumab as add-on therapy in patients with a history of asthma exacerbations and uncontrolled asthma receiving inhaled corticosteroids/long-acting β-agonist with or without oral corticosteroids and additional asthma controllers vs placebo.

LOXO-292 is being evaluated in the ongoing Phase 1/2 LIBRETTO-001 clinical trial.

The Smart Case includes electronics and sensors to monitor the proximity, temperature, presence and removal, and expiration of auto-injectors.