Politics and Policy

Lynparza reduced the risk of death by 32% versus placebo. It is the first targeted treatment for patients with early breast cancer to be used after surgery or prior treatment.

The FDA has granted first approval for cartridges for use with Apokyn for Parkinson’s. Other approvals include: a generic of anticancer therapy Vidaza, the antibacterial Erythrocin, and the anti-epilepsy therapy Lamictal.

The company will distribute nalmefene for no profit, which is part of the company’s bankruptcy filing and settlement with states.

Supplemental applications have been submitted for the cancer therapies Nubeqa and Tibsovo, the gout treatment Krystexxa, and Oxlumo, which treats a rare disease.

With a PDUFA date of Aug. 4, 2022, the FDA plans to hold an advisory committee meeting on resubmitted data for Nuplazid in patients with Alzheimer's disease who have psychosis.

The FDA cited issues related to the compatibility of lenacapavir and the vial used. The agency has not requested new clinical studies.

Amneal Pharmaceuticals received approval for Releuko to decrease incidence of infection after chemotherapy.

Vonjo is the first treatment first approved therapy that specifically addresses the needs of patients with cytopenic myelofibrosis.

Ideally, value-based and technology programs combine to produce better outcomes. But researchers at University of California, San Francisco, found little evidence of synergy in the meaningful use, patient-centered medical home and Medicare Shared Savings Program ACO program.

The new indication for reducing the risk of cardiovascular death and hospitalization for heart failure is expected to boost Jardiance’s sales further. Revenue for the drug jumped 38% in 2021 to reach nearly $432 million globally.

This guidance discusses that individuals 12 years and older can receive the second dose of the Pfizer-BioNTech vaccine 3-8 weeks after the first. Additionally, the interval for those 18 years and older for Moderna is 4-8 weeks.

Sanofi and GSK today announce will try to get approval from the FDA and the European Medicines Agency (EMA) for their COVID-19 vaccine, entering a crowded market.

Pyrukynd, developed by Agios Pharmaceuticals, is a PK activator and the first in this drug class. The company is also awaiting approval by the European Medicines Agency, and a decision is expected by the end of 2022.

During the state of the industry webinar, AHIP experts reviewed policies and solutions to improve affordable access to care and shape healthcare in the post-pandemic world.

The FDA’s authorization would depend on ongoing studies establishing that a fourth dose would shore up people’s molecular defenses that waned after their first booster shot.

Asundexian is an oral factor XIa inhibitor currently under phase 2 trials for potential secondary thrombosis prevention in patients with non-cardioembolic ischemic stroke, atrial fibrillation, or recent myocardial infarction.

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.

The oral formulation of the muscle relaxant was also approved as a treatment for spasticity associated with spinal cord injuries.

Patients who are immunocompromised are advised to get a three-dose series and then a fourth dose.

The conclusion of the pre-print meta-analysis is that small effect of "nonpharmaceutical interventions" on COVID-19 mortality rates did not outweigh the effects of lockdowns.

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.

Biden is reviving the program he headed as vice president with the goal of reducing the cancer mortality rate and improving the experience of patients and their loved ones.

Pfizer and BioNTech initiated an application yesterday (Feb. 1) for emergency use authorization (EUA) of their COVID-19 vaccine for children ages 6 months through 4 years.

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.

The Janssen drug is the only DOAC available in an oral suspension, which facilitates pediatric weight-based dosing.