United Therapeutics (UTHR) announced approval by the FDA of a new drug application, or NDA, for the use of Remodulin injection in the Implantable System for Remodulin, or ISR. The ISR has been developed under a collaboration with Medtronic (MDT). In December 2017, Medtronic received FDA approval of a premarket application, or PMA, for a proprietary intravascular infusion catheter to be used with its SynchroMed II implantable infusion pump and related infusion system components in order to deliver Remodulin for the treatment of pulmonary arterial hypertension, or PAH. Remodulin was originally approved by the FDA to treat PAH by continuous subcutaneous and intravenous routes of administration in 2002 and 2004, respectively, using external pumps. In the case of intravenous users, the therapy can be very burdensome and brings a risk of sepsis due to the use of a central indwelling catheter. The ISR provides patients a new option for delivery of intravenous Remodulin, where the entire delivery system is implanted into the body and will be refilled by healthcare professionals at intervals of up to 16 weeks depending on the patient’s dose, using a syringe needle through the patient’s skin.
Tuesday, July 31, 2018
Bristol-Myers: EC approves Opdivo for treatment of adults with melanoma
Bristol-Myers Squibb announced that the European Commission has approved Opdivo for the adjuvant treatment of adult patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection. This indication is for both BRAF mutant and wild-type melanoma patients. With this decision, Opdivo becomes the first and only PD-1 therapy to receive an EC approval in the adjuvant setting and has gained its eighth indication across six distinct tumor types in the European Union.
Illumina price target raised to $330 from $280 at Deutsche Bank
Deutsche Bank analyst Dan Leonard raised his price target for Illumina to $330 saying the “strong beat” in Q2 on stronger NovaSeq demand supports his thesis. The analyst sees upside for estimates over the next 6-12 months and reiterates a Buy rating on the shares.
Novocure announces published results of Phase 2 ovarian cancer med trial
Novocure announced that the results of its INNOVATE phase 2 pilot trial have been published in Gynecologic Oncology. The INNOVATE trial was a prospective, single-arm study testing the feasibility, safety and preliminary efficacy of Tumor Treating Fields combined with weekly paclitaxel in recurrent ovarian cancer. Tumor Treating Fields is a cancer therapy that uses electric fields tuned to specific frequencies to disrupt cell division, inhibiting tumor growth and causing affected cancer cells to die. Progression free survival of recurrent ovarian cancer patients treated with Tumor Treating Fields plus weekly paclitaxel was more than double that of weekly paclitaxel-treated historical controls. Median progression free survival in the Tumor Treating Fields-treated group was 8.9 months and median overall survival was not yet reached. Median one-year survival in the Tumor Treating Fields-treated group was 61%. The median compliance of patients with Tumor Treating Fields in the first three months of treatment was 77%. Two cases of severe skin irritation due to Tumor Treating Fields were reported. No other serious device-related adverse events were reported.
NewLink Genetics announces organizational changes
The company has completed an organizational realignment that will support these clinical development efforts within its current financial capacity, substantially cut future expenses, and extend its cash runway into the second half of 2021.The organizational changes include a reduction in headcount of approximately 30%, and include the following changes to senior leadership, effective immediately:Jack Henneman has been appointed Chief Administrative Officer for a transition period to end with his retirement from NewLink in November 2018;Carl Langren has been promoted to Chief Financial Officer; Lori Lawley has been promoted to Vice President, Finance and Controller; Brad Powers has been promoted to General Counsel.
Universal Health acquires The Danshell Group, terms not disclosed
Universal Health Services announced that, through its UK subsidiary Cygnet Health Care, it has acquired The Danshell Group. Danshell owns and operates 25 facilities with a total of 288 beds in the United Kingdom. Cygnet Health Care will operate and manage these new facilities. The Danshell facilities support and care for adults living with learning disabilities, who may also have a diagnosis of autism, in specialist supported living, residential services and hospitals. Through this acquisition, the company expands into new service lines and new geographical areas, complementary to the existing UK portfolio.
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