Christine Blank

The FDA is postponing its Vaccines and Related Biological Products Advisory Committee meeting originally scheduled for February 15. Pfizer notified the agency about new data from its ongoing clinical trial.

Under the proposed rule, CMS would cover Aduhelm and other monoclonal antibodies for Alzheimer’s disease patients only if they are participating in approved clinical trials.

BioMatrix Specialty Pharmacy is now included as a preferred provider in AscellaHealth’s home infusion pharmacy network.

Drugs works by interfering with the classical complement pathway.

The Biosimilars Forum Board of Directors recently appointed Juliana M. Reed as its new executive director and Formulary Watch got the scoop from Reed first hand.

FDA approved the first generic version of Restasis 0.05% eye drops to increase tear production in patients whose production is suppressed due to dry eye.

German research team finds that 11% of those who quit the drug for pregnancy had “clinically meaningful disability” one-year postpartum. They don’t advise against quitting the drug but say their findings suggest that patients should be informed of the risk.

Results of an AstraZeneca trial presented at a recent ASCO meeting sow hopes for a new treatment for patients diagnosed with unresectable hepatocellular carcinoma, the most common type of liver cancer.

The new therapy treats patients with unresectable or metastatic uveal melanoma.

Regeneron Pharmaceuticals and Sanofi said they are voluntarily withdrawing their supplemental Biologics License Application (sBLA) for Libtayo (cemiplimab-rwlc) as a second-line treatment for patients with advanced cervical cancer.

More than $250 million worth of counterfeit and illegally resold versions of Gilead Sciences’ HIV medications Biktarvy (bictegravir, emtricitabine and tenofovir alafenamide) and Descovy (emtricitabine and tenofovir alafenamide) were distributed to pharmacies and patients.

The company joins the wide array of online pharmacy services, such as Amazon Pharmacy, that have popped up in recent years. Cuban has also launched a namesake PBM.

United States healthcare spending rose 9.7% in 2020, while medication spending is increasing by more than 18%.

The FDA okayed two Janus kinase 1 (JAK1) JAK inhibitors January 14 the for atopic dermatitis: Cibinqo and Rinvoq.

Problems with N-nitrosodimethylamine (NDMA)-contaminated metformin were identified by the FDA in 2020. Viona Pharmaceuticals announced in earlier this month that it was recalling 23 lots of the popular diabetes medication.

CMS has proposed covering the anti-amyloid treatment only if the person taking it is enrolled in a clinical trial.

Lecanemab and donanemab, monoclonal antibodies for Alzheimer’s, are on the list of drugs in late-stage development that Clarivate analysts will have annual sales of a $1 billion or more in the next five years.

But Paxlovid and molnupiravir will be available only at certain Walmart and Sam’s Club locations.

A review of real-world data from Israel didn't show any increase risk of myocardities or pericarditis.

'Just do it' is the takeaway from a review of 19 studies that found no difference between bouts of high-intensity physical activity and more moderate forms of aerobic exercise when it comes reducing liver fat.

The FDA has approved Amgen and AstraZeneca’s Tezspire (tezepelumab-akko) for severe asthma. But the drug may have limited uptake in the near term, according to one analyst.

The FDA has set a Prescription Drug User Fee Act goal date of Sept. 28, 2022.

The broader indication for Zynrelef now covers around 7 million procedures annually and reduces the need for post-surgery opioids.

Blood cancer patients who had at least some antibodies after the first two doses are likely to produce large amounts after the third vaccination.

The FDA in late November authorized the COVID-19 booster for all people 18 years of age and older.

Evusheld is the only monoclonal antibody authorized in the United States for COVID-19 pre-exposure prophylaxis.

Pfizer and BioNTech expect to have an omicron-specific booster ready by March 2022.

Preclinical studies show sotrovimab is active against key mutations of the omicron variant of SARS-CoV-2, which causes COVID-19.