The leaders and ranking members of the House Ways and Means Committee and the Energy and Commerce Committee released the discussion draft of legislation meant to limit beneficiaries' out-of-pocket spending on prescription drugs in Medicare Part D and reduce the government's portion of catastrophic coverage from 80% to 20% over a four-year period. Stakeholders are invited to submit input on the proposals by June 6.
Janssen Pharmaceuticals, a Johnson & Johnson unit, announced the FDA has granted priority review for the supplemental marketing application of diabetes drug Invokana, or canagliflozin. The expanded label would allow the use of Invokana to curtail the risk of end-stage kidney disease in adults who have type 2 diabetes and chronic kidney disease.
The FDA has issued an alert about a Class 1 recall of Beckman Coulter's DxH 600, DxH 800 and DxH 900 blood analyzer devices, which may not produce correct readings for platelet counts. Laboratories using the devices are advised to "use backup analyzers, if available, to confirm platelet results or perform manual platelet estimate/screening and follow the instructions in the Urgent Medical Device Correction letter dated May 20, 2019 before reporting platelet counts out of the laboratory," the alert stated.
The FDA has approved Novocure's NovoTTF-100L System plus pemetrexed and platinum-based chemotherapy as a treatment for patients with unresectable, locally advanced or metastatic malignant pleural mesothelioma. Patients who were treated with tumor treating fields plus chemotherapy achieved 18.2 months median overall survival.
InBios International has gained marketing authorization from the FDA for its ZIKV Detect 2.0 IgM Capture ELISA for routine use to detect Zika virus immunoglobulin antibodies in blood. The product is the first Zika blood test authorized for marketing in the US.
Hologic's Aptima Combo 2 Assay and Cepheid's Xpert CT/NG have been cleared by the FDA for use in Neisseria gonorrhoeae and Chlamydia trachomatis detection via rectum and throat samples. The assays, which were previously granted approval for urine, endocervical and vaginal sample testing, are the first to receive clearance for extragenital testing of those infections with throat and rectum samples.
Confidence USA is facing a US civil complaint that seeks a permanent ban on its sales of allegedly adulterated dietary supplements. The company previously received an FDA warning letter in 2011 and has been subject to product seizures by US Marshals.
Bayer and the World Federation of Hemophilia's Humanitarian Aid Program have partnered for five years to educate and train health care professionals in over 60 countries regarding the disease using the pharma giant's recombinant factor VIII treatment portfolio.
An initial public offering has pulled in $50 million for Ideaya Biosciences, and a separate IPO has raised $60.6 million for Bicycle Therapeutics; the companies plan to use proceeds to fund their experimental cancer drugs trials. Ideaya's IDE196 is being developed to target cancers such as metastatic uveal melanoma, which have GNAQ or GNA11 gene mutations, and Bicycle's BT1718 is in Phase I/IIa study for patients with advanced solid tumors.
Dynavax Technologies CEO Eddie Gray has announced his retirement effective Aug. 1, with his job to be taken over by David Novack and Ryan Spencer, who will be interim co-presidents until a new CEO is named. The company also said it is undergoing restructuring to focus on marketing its hepatitis B vaccine HEPLISAV-B.
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