The FDA ruled that Recro Pharma's nonopioid shot IV meloxicam did not meet expectations on pain relief despite the statistically significant outcomes it showed pertaining to its main goals in late-stage trials. The agency also cited issues on the chemistry, manufacturing and controls related to certain data provided by Recro in its application.
Krystal Biotech's KB103 was granted fast-track designation by the FDA. The drug candidate is in a Phase I/II study for the treatment of dystrophic epidermolysis bullosa.
Novartis unit Sandoz's Zessly, or biosimilar infliximab, was approved by the European Commission for all of the same indications for which its reference medicine, Merck and Johnson & Johnson's Remicade, has been cleared -- including Crohn's disease, ankylosing spondylitis, plaque psoriasis, psoriatic arthritis, rheumatoid arthritis and ulcerative colitis.
Cancer company Antengene acquired the rights to develop and market Karyopharm Therapeutics' cancer candidates selinexor and eltanexor in China and Macau in a deal that gives Karyopharm $12 million upfront plus development and sales milestones. Also included in the agreement are Karyopharm's noncancer drug verdinexor and cancer candidate KPT-9274's development and commercial rights in China, Macau, Taiwan, Hong Kong, South Korea and countries in the Association of Southeast Asian Nations.
Follow-on funding pulled in $110 million for anti-infectives firm Melinta Therapeutics, which recently launched acute bacterial skin and skin structure infections treatment Baxdela delafloxacin.
Biotechnology company Oxitec and the Cayman Islands' Mosquito Research and Control Unit agreed to work together in a trial program that will evaluate integrated mosquito management techniques to control Aedes aegypti mosquito populations. The location of the project will be in the same area where Oxitec and the government previously collaborated on releasing nonbiting biotech mosquitoes.
Swedish energy company St1 and forest products firm SCA signed an agreement to develop a facility in Gothenburg that will produce advanced renewable fuels from tall oil with a capacity of 100,000 tons annually.
The National Institute for Health and Care Excellence recommended against the use of Chiesi's Lamzede, or velmanase alfa, in patients with alpha-mannosidosis. The cost regulator ruled that trial evidence showed the nature and size of the clinical benefits are uncertain in the short and long term, and the drug's benefit did not meet cost-effectiveness standards.
A recall was issued by Stop & Shop for its SB Cut Broccoli because it could be contaminated with listeria monocytogenes. The recalled product bears the UPC number 068826700926 and the "best-by date of March 15, 2020, and was distributed to Stop & Shop stores in Connecticut, Massachusetts, New Jersey, New York and Rhode Island.
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