Five things for pharma marketers to know: Thursday, January 8
Sandoz is close to having the first FDA approved biosimilar on the market with an FDA committee's unanimous vote to recommend approval of its Neupogen knockoff Wednesday.The panel endorsed the drug —to be known as Zarxio in the US, but sold abroad under the name Zarzio since 2009—for the same five indications as those of Amgen's Neupogen: cancer patients receiving myelosuppressive chemo, patients with acute myeloid leukemia, bone marrow transplant cancer patients, patients undergoing peripheral blood progenitor cell collection and therapy, and patients with severe chronic neutropenia.
A new technique for growing bacteria has created 25 new antibiotics, according to a study published in Nature Wednesday. The team of researchers developed a “subterrean hotel” within soil for bacteria to grow—a method which allowed researchers to capture a single robust microbe for study, BBC reported. One antibiotic from that yield, teixobactin proved effective in treating the deadly bacteria, MRSA (methicillin-resistant Staphylococcus aureus), through a unique mechanism of binding to the bacteria's cellular walls. The study's authors hope that its unique mechanism will hinder bacterial resistance to the drug.
Support for using HPV screenings over Pap smears for cervical cancer detection has hit a roadblock: professional disagreement. NPR reports that while the American Society for Colopscopy and Cervical Pathology and the Society of Gynecologic Oncology support using the test for women ages 25 and up, but the American Congress of Obstetricians and Gynecologists say it is too soon to replace the Pap smear. “So many women get HPV who will never, ever get cancer,” advocacy group, the National Center for Health Research, told NPR. The broadcaster also noted that although HPV causes many cervical cancers, a few are not associated with the virus.
Novartis is sending two Phase-III chronic obstructive pulmonary disease drugs to the FDA for review. Variations of these twice-a-day drugs QVA149 (indaceterol/glycopyrronium bromide) and NVA237 (glycoyrronium bromide) are already marketed abroad: QVA149's 110/50g dose is a daily medication known as Ultibro Breezehaler – Novartis is seeking a 27.5/12.5g combo here. NVA237 is a daily dose elsewhere, known as the Seebri Breezhaler at a 50mcg dose. Novartis is submitting a 12.5mcg dose for US approval.
A study published in JAMA Internal Medicine on Monday concludes that a popular generic oral medication for type 2 diabetes, metformin, may be underutilized due to inappropriate FDA restrictions. Researchers surmised that the FDA's label—which cautions patients with kidney damaging from using it—may be “overly conservative” due to how the FDA measures renal function. If FDA used the American Diabetes Association's recommendations, more than 1 million diabetic patients with kidney impairment could use metformin, according to Drug Discovery and Development magazine.