Blood Cancer Drug Trials To Resume; Take A Deeper Dive On Antibiotics Use

Reuters: FDA Lifts Partial Clinical Hold On Gilead's Blood Cancer Drug Trials 
Gilead Sciences Inc. said on Monday the U.S. Food and Drug Administration had lifted the partial clinical hold placed on its trials testing a blood cancer drug combination. The FDA removed the hold after a review of the safety data from each trial, the company said. (4/11)

Stat: Trying A Three-Drug Combo To Help Engineered T Cells Fight Cancer 
For years, Kristin Anderson has been trying to push immunotherapy to work in ovarian cancer, only to see immune tool after tool fail to crack the tumors. But now, Anderson has new data from a preliminary approach that some experts called both thought-provoking and a little controversial: a combination of three immune checkpoint inhibitors and a batch of engineered T cells. The work started off with a simple question, said Anderson, a postdoctoral scientist at the Fred Hutchinson Cancer Center: Is it possible to engineer T cells to attack ovarian tumors? Anderson started by modifying T cells to carry a receptor that would recognize mesothelin — a protein common in several cancer types including ovarian. That way, these modified immune cells would be more likely to infiltrate the tumors and, hopefully, start cleaning up the cancer. (Chen, 4/13)

In antibiotics research —

CIDRAP: Study: Medicare Outpatients Frequently Received Antibiotics For COVID-19
A review of data on Medicare beneficiaries during the first year of the COVID-19 pandemic found that nearly a third of outpatient COVID-19 visits were linked to an antibiotic prescription, mainly for azithromycin, Centers for Disease Control and Prevention (CDC) researchers reported late last week in JAMA. (4/11)

CIDRAP: Study Finds Antibiotic Use In Iowa Hospitals Wasn't Affected By COVID-19
A study of hospitals in Iowa that employ three different antibiotic stewardship program (ASP) models found that core stewardship activities were maintained during the COVID-19 pandemic, researchers reported today in Antimicrobial Stewardship & Healthcare Epidemiology. The study, conducted at 12 hospitals that are part of an integrated health system, examined trends in antibiotic days of therapy (DOT) per 1,000 days present in medical-surgical and intensive care units from Jan 1, 2019, to Feb 28, 2021. (4/8)

CIDRAP: Stewardship Linked To Drop In Fluoroquinolones For Urinary Tract Infections
A multifaceted antimicrobial stewardship intervention at a community health system dramatically reduced fluoroquinolone prescribing for urinary tract infections (UTIs), researchers reported today in Infection Control & Hospital Epidemiology. ... Comparison of prescribing data from the 6-month post-intervention period (September 2019 to February 2020) with the pre-intervention period (September 2018 to February 2019) showed that the percentage of fluoroquinolone prescribing for UTIs fell from 17.6% pre-intervention to 3.0% post-intervention in the four urgent care clinics, and from 23.8% to 6.8% in the 19 primary care clinics. Percentages of any primary care clinic visits at which a fluoroquinolone was prescribed fell from 1.3% to 0.5%. (4/11)

CIDRAP: 'Time-Honored' Technique Could Guide Choice Of Pneumonia Antibiotics
The results of a randomized clinical trial conducted in Japan indicate that Gram stain–guided antibiotic therapy could help safely reduce the use of broad-spectrum antibiotics in patients who have ventilator-associated pneumonia (VAP).  The results, published last week in JAMA Network Open, showed that Gram stain–guided antibiotic treatment in VAP patients yielded non-inferior clinical responses to guideline-based treatment, while significantly reducing the use of antipseudomonal and anti-methicillin resistant Staphylococcus aureus (MRSA) antibiotics. (Dall, 4/11)

ScienceDaily: How A Narrow-Spectrum Antibiotic Takes Aim At C. Diff
Most antibiotics are double-edged swords. Besides killing the pathogen they are prescribed for, they also decimate beneficial bacteria and change the composition of the gut microbiome. As a result, patients become more prone to reinfection, and drug-resistant strains are more likely to emerge. (Rockefeller University, 4/6)

In pharmaceutical industry news —

FiercePharma: High-Flying Pfizer May Disappoint On Comirnaty And Paxlovid Sales In Q1, Analyst Warns 
Pfizer’s BioNTech-partnered COVID-19 vaccine Comirnaty and its antiviral pill Paxlovid are destined to reap many billions in 2022, but the company’s first-quarter pandemic haul may come in lighter than previously thought, one group of analysts predicts. Louise Chen’s team at Cantor Fitzgerald has dialed back its first-quarter sales estimate for Pfizer while keeping its full-year predictions for the company “intact,” the analysts said in a note to clients Monday. The team's updated forecast assumes Comirnaty and Paxlovid revenues for the first three months of the year will come in lower-than-expected. (Kansteiner, 4/11)

The Wall Street Journal: Halozyme Therapeutics Nears Deal To Buy Antares Pharma
Halozyme Therapeutics Inc. HALO 0.58% is close to a nearly $1 billion deal to buy specialty pharmaceutical company Antares Pharma Inc., ATRS -0.27% according to people familiar with the matter, in a move that would deepen its focus on drug delivery. Halozyme would pay $5.60 a share in cash in a deal that could be announced Wednesday and value Antares at roughly $960 million, the people said. (Cooper, 4/13)

FiercePharma: Despite TV Ads, Most Asthma Patients Don't Recognize New Biologic Brands, But They're Willing To Try Them, A Survey Finds
There’s no shortage of TV commercials extolling new biologics for asthma, but most patients who could benefit still don’t recognize the brands, a new survey from Phreesia Life Sciences found. Sanofi and Regeneron’s Dupixent led the pack when it came to brand recall among these drugs, according to the survey. That part’s not too surprising given the $288 million the drugmakers shelled out on TV ads for the brand in 2021 (the biggest pharma TV ad spend last year). (Missakian, 4/8)