The FDA has issued a third set of guidance documents this year, this time focused on generic drug development. The 53 product-specific directives consist of new and revised guidance on products lacking generic competition, as well as guidance for complex products.
Oscar Health, with Chandelier Creative and Franklyn, has launched a new campaign that includes TV ads in English and Spanish that show how the brand helps consumers fit getting health care advice into their busy lives with the line, "Talk to a doctor anywhere, anytime, for free." The push also includes a brand refresh with playful illustrations featured across out-of-home and digital content.
Officials at the Eitan Group want to disrupt the infusion pump market by selling devices that are more connected and software-based -- able to be used not only in hospitals but in the home. Eitan is probably best known for its Q Core Medical company that makes Sapphire infusion pumps, which have been around for more than a decade. But Netanya, Israel-based Eitan also has its Avoset Medical business, marketing what it describes as simple, easy-to-use pumps for home healthcare settings. Sorrel Medical, Eitan's third subsidiary, makes a wearable injector device that delivers biological drugs for chronic diseases. Read this story.
Customer data platforms take marketing segmentation to a new level by enabling brands to customize campaigns to the individual level in real-time, writes James McDermott. He explains the differences between CDPs and offers advice on selecting the best fit, noting "Done right, CDPs should transform the way you interact with customers, optimize workflows to realize greater levels of efficiency, and deliver on the promise of data-driven decision-making."
AbbVie led in TV ad spend for August with 10 spots for its anti-inflammatory drug Humira. Gilead took the No. 2 spot with advertising for Truvada, an HIV and pre-exposure prophylaxis drug.
Bellerophon Therapeutics' treatment for idiopathic pulmonary fibrosis was granted Orphan Drug Designation from the FDA. A Phase II/III trial is currently underway evaluating nitric oxide, including the INOpulse system, in patients with IPF and other pulmonary fibrotic diseases.
The FDA has designated for Fast Track review Wave Life Sciences' suvodirsen as a treatment for patients with Duchenne muscular dystrophy who are amenable to exon 51 skipping. Orphan Drug-tagged suvodirsen is currently under assessment in a Phase II/III study.
Janssen has filed a supplemental Biologics License Application with the FDA for its candidate guselkumab, indicated as a treatment for active psoriatic arthritis in adults. Submission of the sBLA is supported by data from its late-stage trials that tested the subcutaneous drug's safety and efficacy compared to a placebo in this patient group.
Results from a preclinical study indicate that designing chimeric antigen receptor T cells to target the protein GPRC5D specifically could be a safe and effective strategy in treating multiple myeloma. Data from the study reported in the journal Science Translational Medicine showed the treatment was safely tested in mice and monkeys, which did not exhibit any clinical signs of toxicity.
Lundbeck of Denmark will acquire Alder BioPharmaceuticals in a $1.95 billion deal that will improve the former's biologics capabilities and late-stage pipeline. This is the second major acquisition by Lundbeck CEO Deborah Dunsire, who is searching for new growth drivers that will offset the loss of its US patent exclusivity in 2018 for Onfi, or clobazam, its best-selling epilepsy treatment.
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