The agency’s action date is February 18, 2020.
Tuesday, July 9, 2019
FDA accepts Merck supplemental BLAs to update Keytruda dosing frequency
The FDA accepts for review six supplemental marketing applications from Merck (NYSE:MRK) to update the dosing frequency for Keytruda (pembrolizumab) to include a 400 mg dose infused over 30 minutes once every six weeks, double the time of the currently approved regimen.
Altimmune up on acquisition of Spitfire Pharma
Thinly traded nano cap Altimmune (NASDAQ:ALT) is up 10% premarket on modest volume on the heels of its announcement that it has agreed to acquire Spitfire Pharma for up to $93M.
Under the terms of the deal, Spitfire shareholders will receive $5M in ALT common stock upfront, up to $8M in regulatory and clinical milestones (either cash or ALT stock) and up to $80M in sales-based milestones.
The top prize is pipeline candidate SP-1373 (to be renamed ALT-801), a GLP-1/Glucagon receptor co-agonist for the treatment of nonalcoholic steatohepatitis (NASH).
ALT hosted a conference call this morning at 8:30 am ET to discuss the transaction.
Dr. Reddy’s launches Guaifenesin and Pseudoephedrine HCl generics in US
Dr. Reddy’s Laboratories (NYSE:RDY) has launched an OTC store-brand equivalent of Mucinex D Extended Release Tablets in two strengths – Guaifenesin 600 and 1200 mg, and Pseudoephedrine HCl 60 and 120 mg, in U.S.
Dr. Reddy’s OTC Guaifenesin and Pseudoephedrine HCl is used to help loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways; relieve nasal congestion due to common cold, hay fever, and upper respiratory allergies; promote nasal and/or sinus drainage; and temporarily relieve sinus congestion and pressure.
The Mucinex D had U.S. sales of ~$71M for year ended May 2019, according to IRI.
Mucinex is a trademark of RB HEALTH LLC
Check-Cap’s C-Scan beats reference test in study
Results from Check-Cap’s (NASDAQ:CHEK) post-CE approval study evaluating the screening performance of C-Scan to detect precancerous polyps in the colon showed much better performance compared to the fecal immunochemical test (FIT).
The data were generated from 90 patients who either had known polyps or were considered to be at average risk. Each ingested a C-Scan capsule in additional to undergoing a FIT test and colonoscopy.
In patients with polyps at least 10 mm in size, the sensitivity (correctly identifying true positives) of C-Scan was 76% compared to 29% for FIT. C-Scan’s specificity (correctly identifying true negatives) was 82% versus 96% for FIT in these patients.
In all patients, C-Scan’s sensitivity was 66% compared to 23% for FIT.
A U.S. pilot study is in process with an estimated completion date in September. A pivotal trial should launch in mid-2020.
Update: Shares are up 20% premarket on average volume.
Dialysis firms hit on Trump plan to shake up kidney care market
Dialysis services providers DaVita (NYSE:DVA) and Fresenius Medical Care (NYSE:FMS) are down 1% and 3%, respectively, premarket (both on light volume) on the heels of a report from Politico that the Trump administration is planning to announce initiatives aimed at encouraging more kidney transplants and home-based treatment. The President is scheduled to unveil the strategy in a Wednesday morning speech. He is also mulling additional actions via executive order.
Concurrently, the U.S. Department of Health and Human Services (HHS) will announce new reimbursement models to incentivize a shift away from standalone clinics to the home, in addition to an agency-wide initiative to encourage home dialysis and better prevention and screening for kidney disease.
U.S. dialysis clinics generated $24B in revenue last year, mostly by DVA and FMS. Medicare spends more than $114B per year on kidney care.
Related ticker: American Renal Associates (NYSE:ARA)
Bausch + Lomb launches Ocuvite Eye Performance vitamins in U.S.
Bausch + Lomb, a wholly owned subsidiary of Bausch Health (NYSE:BHC) has launched Ocuvite Eye Performance vitamins in the U.S.
Ocuvite Eye Performance eye vitamins were formulated with seven vital nutrients that help strengthen the macula, which protects the eye from stressors such as sun light and blue light emitted from digital devices.
AbbVie selects second target under CytomX collaboration
CytomX Therapeutics (NASDAQ:CTMX) announces that collaboration partner AbbVie (NYSE:ABBV) has selected a second target under their 2016 agreement aimed at discovering and developing ProBody drug conjugates.
The action triggers a $10M milestone payment to CTMX.
The companies are also advancing a clinical-stage candidate, CX-2029, a Probody drug conjugate against a cell surface protein called CD71.
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