Bristol-Myers Squibb gets FDA green light for Empliciti
Bristol-Myers Squibb Company has received the Food and Drug Administration’s approval for Empliciti (elotuzumab) injection for intravenous use in combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor.
“Empliciti plus pomalidomide and dexamethasone has been proven to extend the time that certain patients live without disease progression, giving health care professionals an effective new tool to tackle this relentless cancer,” Bristol-Myers Squibb senior vice president and head of medical Joseph Eid said. “Today’s approval reinforces the importance of immuno-oncology in blood cancers and expands the role of Empliciti to address the needs of relapsed or refractory multiple myeloma patients.”
Bristol-Myers Squibb and AbbVie are co-developing Empliciti, with Bristol-Myers Squibb solely responsible for commercial activities.
Coherus BioSciences gets FDA nod for Neulasta biosimilar
Coherus BioSciences has received the FDA’s clearance for Udenyca, which is a biosimilar of Amgen’s Neulasta. It is the first pegfilgrastim biosimilar approved by the FDA and the European Commission for patients with cancer receiving myelosuppressive chemotherapy, the company said.
Udenyca is a PEGylated growth colony-stimulating factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia.
“The list price of Neulasta has nearly tripled since approval in 2002 and now represents a $4 billion annual cost burden in the United States. We believe that competition is essential in controlling burdensome price increases, and Udenyca will play an important role in curbing that spend when launched,” Coherus BioSciences chairman and CEO Denny Lanfear said.“Our in-depth understanding of the market will allow us to deliver significant value to patients, payors and providers in the U.S., including 340 billion hospitals, small clinics and small hospitals.”
CVS Health opens first MinuteClinic in San Francisco
A new MinuteClinic walk-in medical clinic has opened inside the CVS Pharmacy store at 1900 19th Avenue in San Francisco, California, providing the community with convenient access to common health care services.
The clinic is the first MinuteClinic location in the city of San Francisco and will be open seven days a week with no appointment necessary, providing wellness services for patients ages 18 months and older.
“Our new clinic will help increase access to high-quality, affordable health care for people who live and work in San Francisco,” MinuteClinic senior vice president and executive director, Sharon Vitti said.
“We’re excited to bring our unique care model to people in San Francisco and we look forward to being a healthcare resource for residents, when and where they need us.”
MinuteClinic is staffed by nurse practitioners who specialize in family health care and can diagnose, treat and write prescriptions for common illnesses such as strep throat and ear, eye, sinus, bladder and bronchial infections. Minor wounds and abrasions, and sprains, strains and joint pain are treated, and common vaccinations for conditions such as influenza, tetanus, pneumonia and hepatitis A and B are available.
Prevention and wellness services include screening and monitoring for diabetes, high blood pressure and high cholesterol, tuberculosis testing, contraceptive care, motion sickness prevention and smoking cessation. In addition, MinuteClinic nurse practitioners can evaluate and treat such common skin conditions as acne, dermatitis and rosacea.
Patients receive educational material, a prescription (when clinically appropriate) and a visit summary. A copy of the diagnostic record can be sent electronically, or by fax or mail, to a primary care provider with patient permission.
Most major health insurance is accepted at MinuteClinic.The cost for most services is between $89 and $129.
Individuals who visit MinuteClinic and do not have a primary care provider are given a list of physicians in the community who are accepting new patients.
A new digital tool accessible on the MinuteClinic website allows patients to view wait times at all MinuteClinic locations. Patients can also hold a place in line or schedule a future appointment from the convenience of their smartphone, computer or tablet.