A new takeover bid for Baxalta is reportedly being prepared by Shire. A source said the potential cash-and-share takeover plan is not yet final and could fail. The acquisition would make Shire a leading rare disease specialist with sales revenue of about $20 billion in 2020.
The CMS said it will reprocess ICD-10 claims with National Coverage Determination and Local Coverage Determination errors automatically and at no cost to providers. The agency also said that it is waiting to reprocess some claims with errors resulting from LCDs until Medicare Administrative Contractors have updated criteria needed to process the claims.
Placental membranes are powerful tools in wound care, and wound care providers should have an understanding of the basic scientific principles on which various placental membrane products are based, writes podiatrist Sarah Abshier. She describes placental membrane graft technology, commercial processing techniques and mesenchymal stem cells, and reviews studies of amniotic membrane grafts and diabetic foot ulcers. She also lists key questions to answer when choosing a placental membrane product.
Eli Lilly and Co.'s Portrazza, or necitumumab, has been approved by the FDA for use in previously untreated advanced squamous nonsmall cell lung cancer patients. The drug is intended to be used along with chemotherapy. The approval was supported by data from a 1,093-patient study that showed those who took the combination regimen had an average survival of 11.5 months, compared with 9.9 months for those treated with chemotherapy alone.
Indivior confirmed Tuesday that its application to market its naloxone-based opioid overdose nasal spray in the US has been denied by the FDA. Details were not given for the rejection, and the firm said it is reviewing the FDA's response. A similar treatment developed by Adapt Pharma was approved by the agency last week.
BioMarin Pharmaceutical's drisapersen for treating patients with Duchenne muscular dystrophy did not get support from an FDA advisory panel reviewing it. The panel, which did not vote, found that clinical trial data submitted by the company lacked statistical significance to prove the drug's effectiveness. The FDA, which has expressed concerns about the drug's side effects, is set to make a final decision on Dec. 27.
The European Commission has granted conditional approval to Amgen's Blincyto, or blinatumomab, for use in patients with Philadelphia chromosome-negative relapsed or refractory B-precursor acute lymphoblastic leukemia. The approval was based on two midstage studies, including one that showed the drug induced complete remission or complete remission with partial hematological recovery in 42.9% of patients.
Novartis has received approval from the European Commission for Entresto, a combination of sacubitril and valsartan, as a treatment for heart failure patients who have reduced ejection fraction. The decision was backed by data from an 8,442-patient study demonstrating that the drug lowered the risk for cardiovascular mortality, death from any cause and hospitalization for heart failure.
The CDC reported Tuesday that the number of people infected with E. coli after eating Costco Wholesale's rotisserie chicken salad has reached at least 19. Five people were hospitalized, and infections have been reported in seven states. Costco has halted sales of the chicken salad.
The XprESS, a multi-sinus dilation device from Entellus Medical, now has additional clearance from the FDA. The system, which uses balloon sinus dilation to open obstructed or narrowed sinus drainage pathways, can now be used to treat sphenoid and frontal sinuses in patients age 12 and older, and maxillary sinuses in patients age 2 and up.
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