Morning Briefing
Summaries of health policy coverage from major news organizations
FDA Grants Accelerated Approval For Breast Cancer Drug
MedPage Today: Breast Cancer Drug Wins Approval Despite Rejection By Agency Advisors
The FDA on Friday granted accelerated approval to camizestrant (Etcamah) for treating hormone receptor-positive/HER2-negative breast cancer at the first sign of ESR1 resistance mutations during first-line treatment. (Bassett, 9/8)
In other pharma and tech news —
Stat: Immunotherapy Sees Striking Response In Some Head And Neck Cancers
Inhibrx said Tuesday that its experimental immunotherapy targeting a protein called OX40 showed responses in patients with head and neck cancer. But the most striking results were in a small subset of patients with HPV-positive tumors, which could significantly limit the drug’s use. (Mast, 9/8)
Fox News: Experimental Lung Disease Drug May Slow Aging By 3-4 Years, Study Suggests
A drug being developed to treat a serious lung disease may also help to slow the aging process, researchers say. In a small clinical study, patients who took rentosertib – developed by Insilico Medicine in Massachusetts – showed changes in blood proteins that made them appear biologically younger. Several tests estimated that after treatment, the patients were biologically about three to four years younger. (Rudy, 9/8)
ABC News: New Drug Shows Promise In Reducing COPD Symptoms In Former And Current Smokers, Clinical Trials Show
A new drug appeared to show promise in reducing rates of chronic obstructive pulmonary disease (COPD) symptoms in former and current smokers, according to results from late-stage clinical trials. The medication, called tozorakimab and developed by AstraZeneca, is the first biologic drug to show efficacy in treating COPD symptoms in a broad population of patients with varying ranges of blood eosinophil counts, according to Dr. Frank Sciurba, professor of pulmonary and critical care medicine at the University of Pittsburgh, in an AstraZeneca press release. (Miao, 9/8)
Stat: Roivant May Have Second Blockbuster Medicine
Roivant said Tuesday an experimental drug for a type of pulmonary hypertension achieved the goals of a mid-stage study — positive results that could open up a new way to treat the serious lung disease and bolster the biotech company’s financial health with a second blockbuster medicine. (Feuerstein, 9/8)
The New York Times: Early Data Indicates An A.I.-Generated Drug Could Slow Aging
Last year, a clinical trial conducted by Insilico Medicine, a company that aims to accelerate drug discovery using artificial intelligence, indicated that one of its drug candidates could help treat patients suffering from a chronic lung disease. Now, the company says that data from the same clinical trial shows a more intriguing possibility: that the drug could also slow the aging process. (Metz, 9/7)
The New York Times: A Newer Kind Of Gene Editing Promises To Edit ‘Nurture’ Over ‘Nature’
It is one of biology’s most ingenious rhythms: Every baby is born young. No matter how much wear and tear their parents’ DNA accumulated over their lifetimes, reproduction erases the molecular scars, handing a clean slate to the next generation. Now, a new frontier in biotechnology aims to harness this natural mechanism to do something once thought impossible: scrub away the biological detritus of our own past. By mimicking Mother Nature’s magic eraser, geneticists are working to open a new avenue for treating or preventing disease later in life — not by editing genes themselves, but by altering when, where and how genes are expressed. (Baumgaertner Nunn, 9/8)
Also —
Stat: FDA Warns Pharma Company On Poor Conditions, Corroded Gear At Its Facility
Residue and stains plastered on production walls, floors, and manufacturing equipment. Corrosion on a product line. An employee wearing open-toed sandals. These were among the unsanitary conditions found last April by a Food and Drug Administration inspector during a visit to Shoolin Pharma in Gujarat, India, where the company makes active pharmaceutical ingredients for more than a dozen medicines, including erectile dysfunction and anti-convulsant pills, that are sold to compounding pharmacies in the U.S., according to the agency. (Silverman, 8/8)
On weight loss drugs —
The Hill: GLP-1 Drug Use Sees Significant Surge In Kids 8-11, Experts Say
Over the last seven years, GLP-1 medication use in children age 8 to 11 has increased by nearly 31,000 percent, according to a new NYU Langone Health study. The Food and Drug Administration (FDA) has not approved any GLP-1 medication for children under 12, but in drastic circumstances, doctors have prescribed it off-label. (Sokol, 9/8)
MedPage Today: Asthma, COPD Attacks Down With GLP-1 Drugs In The Picture
Growing evidence linked GLP-1 drugs to a reduced risk of exacerbations of two types of chronic airways disease: asthma and chronic obstructive pulmonary disease (COPD). (Lou, 9/8)
The Washington Post: The Financial Force Helping Drive America’s Craze For GLP-1 Weight-Loss Drugs
Firms are spending hundreds of millions of dollars to convince doctors to prescribe GLP-1 drugs. (Rowland, Sidhom and Cha, 9/9)
