SPOTLIGHT -
Trump departs from tradition with likely new FDA commissioner
Health groups had urged Trump to make a different choice.
Express Scripts reveals Medicare savings plans for 2020
PBM’s Medicare plan includes deep discounts
Formulary changes cause problems for asthmatic kids
Researchers find lower lung function after inhaler change.
Blockbuster anticoagulant snags another indication
This is the eighth indication approved for Xarelto.
Top 5 drugs in the pipeline
Here are the most exciting drugs in the pipeline right now.
Asthma drug can now be self-administered via pen
Drug is the only respiratory therapy that can be given at home every 8 weeks.
Gilead snags approval for second HIV-1 prevention drug
New HIV prevention drug not indicated for women.
Drugstore retailers pull Zantac as recalls expand
Drugstore retailers pull ranitidine and Zantac products off the shelves due to cancer concerns.
FDA expands Mavyret for certain hepatitis C patients
Drug is first 8-week treatment approved for this type of HCV.
Pharma exec: New type 2 diabetes treatment competitively priced
How the first oral GLP-1 oral treatment for type 2 diabetes is unique and how it will be priced compared to other GLP-1 medications.
Overdoses on the rise for this antidiarrheal drug
FDA limits packaging for this OTC medication.
Manufacturer recalls several compounded drugs over sterility issues
Fentanyl citrate and ephedrine sulfate are among the medications affected.
Cancer-linked impurity found in heartburn drug
FDA is evaluating risks to patients.
Lung cancer drug receives breakthrough therapy designation
Targeted therapy gives new hope to patients with an aggressive form of lung cancer.
Trump considers next FDA commissioner
Health groups urge Trump to appoint Acting FDA Commissioner Ned Sharpless.
FDA clears Parkinson’s add-on treatment
The new drug is an add-on to levodopa/carbidopa for Parkinson’s patients experiencing “off” episodes.
FDA issues warning for certain hepatitis C drugs
Use of these meds to treat chronic hepatitis C in patients with moderate to severe liver impairment has resulted in liver failure in rare cases.
Generic EpiPen for kids may help with shortage
Teva’s generic EpiPen Jr. helps alleviate allergy drug shortage.
DEA to propose marijuana research regs
DEA scrambles to add qualified marijuana growers.
New drug targets key genetic driver of cancer
FDA approved the third oncology drug in the US that targets a key genetic driver of cancer, rather than a specific tumor.
RA drug could help pharma maker stunt Humira losses
Blockbuster drug could be key to Humira’s successor.
GAO: Generic drug approvals too slow
While FDA’s drug approval time is generally improving, the agency needs to speed up generic drug application reviews, according to a new report.
Novartis defends data on its $2.1 million drug
While FDA recently said Novartis and AveXis did not reveal data on their $2.1 million gene thaerpy for pediatric spinal muscular atrophy until after it was approved, Novartis is defending its actions.
Prostate cancer drug poised to generate big sales
Drug to treat prostate cancer is expected to produce a major windfall for two pharma makers.
Merck’s Keytruda snags another cancer indication
FDA approved yet another indication for pembrolizumab (Keytruda) to treat patients with recurrent, locally advanced or metastatic, squamous cell carcinoma of the esophagus (ESCC).
FDA adds warning to Xeljanz
FDA is adding an important new Boxed Warning on the higher-dose version of this drug.
FDA clears first ready-to-use insulin for IV infusion
FDA approved the first and only ready-to-use insulin for IV infusion in hospitals and acute care settings.
Experts debate drug pricing policies
While some are concerned that President Trump’s proposed “favored nations” policy would harm pharma makers, one analyst is not as concerned.
EpiPen shortage: Pharma maker, retailer offer aid
EpiPens have been in short supply, but stakeholders are trying to fill in the access gap.