Aytu Biopharma Inc. (NASDAQ: AYTU ) (NASDAQ: AYTU)
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The China National Medical Products Administration (NMPA) has approved Zai Lab’s supplemental New Drug Application ((sNDA)) for ZEJULA (niraparib) as a maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy.
Zai Lab in-licensed rights to the drug from GlaxoSmithKline for Mainland China, Hong Kong and Macau.
ZEJULA’s sNDA for the first-line maintenance treatment setting was accepted by the NMPA in March 2020, and was granted priority review status in April 2020.
Earlier in December 2019, Zejula was approved in China as maintenance therapy for adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy.
The FDA has approved a new indication for GlaxoSmithKline (NYSE:GSK) and Innoviva’s (NASDAQ:INVA) Trelegy Ellipta (fluticasone furoate / umeclidinium / vilanterol ‘FF/UMEC/VI’) for the treatment of asthma in patients aged 18 years and older adding to its current license for use in patients with chronic obstructive pulmonary disease (COPD).
The FDA-approved strength for both COPD and asthma is FF/UMEC/VI 100/62.5/25mcg. There is an additional strength for asthma alone which is 200/62.5/25mcg.
The approval means Trelegy is the first single inhaler triple therapy for the maintenance treatment of both asthma and COPD in U.S.
FF/UMEC/VI is a combination of three molecules in a single inhaler that only needs to be taken in a single inhalation, once a day.
The company in-licensed the product from Innoviva (formerly Theravance).
INVA +11% after-hours, trading at $11.72.
Johnson & Johnson’s (NYSE:JNJ) The Janssen Pharmaceutical Companies has filed a supplemental marketing application with the FDA seeking approval to use Darzalex Faspro (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab, to treat patients with light chain amyloidosis, a rare and potentially fatal protein folding disorder that leads to multiple organ failure.
The filing is being reviewed under an FDA initiative called Project Orbis which allows concurrent submission and review of cancer medicine applications among international regulatory agencies.
Darzalex Faspro is currently approved in the U.S. for five indications in multiple myeloma. Subcutaneous administration is enabled by Halozyme Therapeutics’ (NASDAQ:HALO) Enhanze technology.
SA Authors are Bullish on the company.
Canopy Growth (NYSE:CGC) announces the launch of Martha Stewart CBD – a new line of premium quality, hemp-derived wellness supplements, with flavor profiles inspired by some of Martha’s most popular recipes.
The initial product offering will include a range of human wellness supplements, with a gift box and pet line launching later this year.
The new portfolio of natural, gourmet-flavored wellness gummies, softgels and oil drops are specially formulated by Martha Stewart, in collaboration with the cannabinoid scientists at Canopy Growth.
At launch, the Martha Stewart CBD product line includes:
Martha Stewart CBD 10mg Wellness Gummies in Citrus Medley and in Berry Medley for $34.99.
Martha Stewart CBD 25mg Softgels (Unflavored, 30 count) for $44.99.
Martha Stewart CBD 750mg Oil Drops (Blood Orange, Meyer Lemon or Unflavored) for $44.99.
Cowen is out with an interesting update on the state of the cannabis legislation.
“We believe 2020 will be remembered more for symbolic votes on cannabis than for any substantive change in the law. Despite broad House support for various cannabis bills, Senate Majority Leader Mitch McConnell is an obstacle that we do not believe can be overcome in the next several weeks,” writes Vivien Azer.
Azer expects a symbolic win only if the House passes the MORE Act to de-schedule cannabis from the Controlled Substances Act.
“We believe the legal protection for medical cannabis will be included in the spending bill that Congress must enact by Sept. 30. This bars the Justice Department from prosecuting state-legal medical cannabis businesses,” she adds.
In regard to the election, a Democratic majority in the Senate is seen as the only way to get past McConnell with legislation.
Sector watch: Cronos Group (CRON +1.7%), Canopy Growth (CGC +3.7%), Aphria (APHA +4.5%), Aurora Cannabis (ACB -0.5%), Tilray (TLRY +2.4%) and Green Thumb Industries (OTCQX:GTBIF -0.5%).
