Okanagan Specialty Fruits plans to launch its nonbrowning biotech Arctic Golden apples in the US this fall after successful completion of a market trial. The apples were packaged in 10-ounce grab-and-go bags for the trial, and the company plans an initial commercial rollout in the Midwest.
Pfizer's biosimilar to Amgen's Epogen, or epoetin alfa, has been recommended by the FDA's Oncologic Drugs Advisory Committee for all indications. Pfizer has an agreement with Vifor Pharma for the marketing of the drug.
Merck has been granted exclusive rights to an undisclosed antibody targeting microtubule-associated protein tau from Teijin Pharma, which Merck intends to develop as an Alzheimer's disease treatment. Teijin has the option to co-promote the antibody in Japan and will get an upfront payment and potential milestones and royalties.
Anika Therapeutics said it anticipates completion of its supplemental late-stage trial of Cingal for osteoarthritis-related knee pain in 2018 and FDA approval in 2019. The company has enrolled its first patient in the trial.
A Series B financing round raised $45 million for Harpoon Therapeutics. The company will use the funds to develop its antibody-based trispecific T-cell-activating construct platform and to launch clinical studies for its two lead candidates based on the technology.
Results from an early-stage study to test the safety of Trovagene's blood cancer candidate PCM-075 showed reversible toxicities including thrombocytopenia and neutropenia. A Phase I/II study is also being planned to test the drug in patients with acute myeloid leukemia.
The European Commission has given orphan drug designation to GlycoMimetics' GMI-1271, which is intended to treat patients with acute myeloid leukemia.
AstraZeneca has received European Commission approval to market an orodispersible tablet form of Brilique, or ticagrelor, in 28 European Union countries, as well as Norway, Liechtenstein and Iceland. The new formulation was developed for patients who are intubated or have trouble swallowing film-coated tablets and need an alternative to ticagrelor 90-mg film-coated tablets.
A nationwide recall was issued by Caverflo.com for its Caverflo Natural Herbal Coffee after a death was reported following consumption of the product, and the FDA found that it contains Sildenafil and Tadalafil, which are active ingredients for erectile dysfunction prescription drugs. The recalled products were sold in 25-gram packets directly to consumers nationwide through online sales from August 2016 to last February.
The FDA does not have to speed up its approval process for medical devices and instead should focus on ensuring the efficiency of the device-development process so that safe products are produced and postmarket recalls are avoided, agency Commissioner Scott Gottlieb said in hearing held by a House Appropriations subpanel on Thursday. Gottlieb added that the FDA lifted its hiring freeze, allowing the agency to increase the number of experts for product reviews.
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