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Thursday, April 20, 2023

Dermata: Type C Meeting Response from FDA, Submits DMT310 End of Phase 2 Meeting Package

 FDA agrees that Dermata's CMC procedures and controls support the initiation of Phase 3 studies-

- Dermata also submitted an end of phase 2 meeting package to the FDA -

 Dermata Therapeutics, Inc. (NASDAQ:DRMA)(NASDAQ:DRMAW) ("Dermata" or the "Company"), a clinical-stage biotechnology company focusing on the treatment of medical and aesthetic skin conditions, today announced that it has received a response from the U.S. Food and Drug Administration ("FDA") to the Company's Type C Chemistry, Manufacturing, and Controls ("CMC") meeting request. The FDA's response stated that the Company has provided documentation of its CMC procedures and controls sufficient to support the initiation of Phase 3 studies. The Company has also submitted an end of phase 2 meeting package to the FDA to discuss clinical requirements to advance DMT310 into Phase 3 development as a treatment for moderate-to-severe acne. The Company expects to receive written feedback on the end of phase 2 meeting package from the FDA by the end of June 2023. Upon agreement with the FDA, the Company plans to initiate the Phase 3 program for acne in the second half of 2023. If the Company is able to successfully complete the Phase 3 program, it believes the results could support submission of a new drug application for DMT310 for the treatment of moderate-to-severe acne.

https://finance.yahoo.com/news/dermata-announces-receipt-type-c-100000817.html

BeiGene, Novartis: Positive Phase 3 in Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

 BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, today announced the global RATIONALE 305 trial met its primary endpoint of overall survival, with tislelizumab in combination with chemotherapy demonstrating superior overall survival (OS) compared with chemotherapy in patients with advanced unresectable or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma, regardless of PD-L1 status. No new safety signals were identified for tislelizumab.

BeiGene previously announced superior OS for the combination compared with chemotherapy in the PD-L1 high group at a planned interim analysis1 and the trial continued according to pre-specified statistical hierarchy testing. At the final analysis, tislelizumab, in combination with chemotherapy, demonstrated superior OS compared with chemotherapy in the intent-to-treat (ITT) population. Results will be submitted for presentation at an upcoming medical conference.

https://finance.yahoo.com/news/beigene-announces-positive-phase-3-110000423.html

Acadia cut to Sell from Hold by Deutsche Bank

 Target to $63 from $75

https://finviz.com/quote.ashx?t=ACHC&ty=c&ta=1&p=d

Ocean Biomed: Allowance for U.S. Patent Application for Breakthrough Pulmonary Fibrosis Treatments

 Ocean Biomedical, Inc. (NASDAQ: OCEA), a biopharma company working to accelerate the development and commercialization of scientifically compelling assets from research universities and medical centers, announced today that its Scientific Co-founder Dr. Jack A. Elias, received a Notice of Allowance from the United States Patent and Trademark Office (“USPTO”) for his U.S. patent application covering a therapeutic molecule that Ocean Biomedical is working to advance into the clinic for patients suffering from pulmonary fibrosis. Discoveries in recent years by Ocean Biomedical’s Scientific Co-founder, Dr. Jack A. Elias, and his colleagues at Brown University, have revealed a new target and a new pathway for treating pulmonary tissue damage in Idiopathic Pulmonary Fibrosis (IPF). This patent allowance covers pulmonary fibrosis caused by multiple conditions including: idiopathic pulmonary fibrosis (IPF), genetic pulmonary fibrosis such as Hermansky-Pudlak Syndrome (HPS), chemotherapy and radiation-induced pulmonary fibrosis, and exposure-induced interstitial lung diseases including asbestosis and silicosis.

A Notice of Allowance is issued after the USPTO examines a patent application and determines that the applicant should be granted a patent from the application. Ocean Biomedical anticipates that a patent will be issued by the USPTO from Dr. Elias’ application in the coming months.

Ocean Biomedical’s novel approach to treating pulmonary fibrosis – a condition with no disease modifying agents currently available – is focused on inhibiting Chitinase 1 (Chit1) with patented “OCF-203.” Chit1 is also a critical biomarker in Scleroderma-associated interstitial lung disease (SSc-ILD) and plays a role in bleomycin- and IL-13-induced pulmonary fibrosis. In four pulmonary fibrosis animal models, Ocean Biomedical’s OCF-203 has shown an 85% – 90% reduction in collagen accumulation. The results of this antifibrotic (termed molecule X: SMX) in the bleomycin model can be seen in the diagram below. Results also showed efficacy in the pale-ear mouse model of HPS, including impressive reductions in fibrosis. As a result, efforts are now moving towards IND-enabling studies.

GE HealthCare started at Overweight by Piper

 Target $95

https://finviz.com/quote.ashx?t=GEHC&ty=c&ta=1&p=d

Novavax cut to Market Perform from Outperform by TD Cowen

 Target to $10 from $55

https://finviz.com/quote.ashx?t=NVAX&p=d

UN, Globalists Seek To Decriminalise Sex With Minors

 by Steve Wastson via Summit News,

In tandem with another globalist organisation, two UN bodies have published a report that outlines an agenda to decriminalise all ‘consensual’ sexual activity, even between adults and minors.

While it is couched in ‘human rights’ and ‘trans rights’, the report outlines a strategy that would effectively make Pedophilia legal.

Fox News reports that “international legal experts” working for the Geneva-based International Commission of Jurists (ICJ), along with UNAIDS and the Office of the United Nations High Commissioner for Human Rights (OHCHR), made the suggestions in a recent report titled “The 8 March Principles for a Human Rights-Based Approach to Criminal Law Proscribing Conduct Associated with Sex, Reproduction, Drug Use, HIV, Homelessness and Poverty.”

The report calls for offenses pertaining to “sex, drug use, HIV, sexual and reproductive health, homelessness and poverty” to be decriminalized.

The document does not offer a suggested age of sexual consent, but states that “Sexual conduct involving persons below the domestically prescribed minimum age of consent to sex may be consensual in fact, if not in law.”

The report further suggests that lawyers, judges, and law enforcement should take into account “the rights and capacity of persons under 18 years of age to make decisions about engaging in consensual sexual conduct and their right to be heard in matters concerning them.”

“Pursuant to their evolving capacities and progressive autonomy, persons under 18 years of age should participate in decisions affecting them, with due regard to their age, maturity and best interests, and with specific attention to non-discrimination guarantees,” it further states.

The report was published on International Women’s Day:

In an accompanying press release, Ian Seiderman, Law and Policy Director at ICJ noted that “Criminal law is among the harshest of tools at the disposal of the State to exert control over individuals … as such, it ought to be a measure of last resort however, globally, there has been a growing trend towards overcriminalization,” adding “We must acknowledge that these laws not only violate human rights, but the fundamental principles of criminal law themselves.”

Having sex with minors is “overcriminalized” is it?

They lumped it in there with everything else, including abortion, which the report argues “must be taken entirely out of the purview of the criminal law,” along with making punishments less harsh for pregnant women who consume drugs or alcohol when they know they are expecting a child.

A spokesperson for the bodies who produced the report told Fox News that “The process of elaboration… included expert jurists, academics, legal practitioners, human rights defenders and various civil society organizations working in diverse legal traditions,” and that the report was “developed over a five-year consultative process.”

So ‘Trust the experts,’ right?

Believe it or not, there is a growing academic driven movement to ‘destigmatize’ pedophilia:

‘Queer Ethics Professor’ Calls For Pedophilia To Be Destigmatised And Taught In Schools

SUNY Professor: “It’s a Mistake” to Think Pedophilia is Wrong

USA Today Hastily Deletes Tweets About “Science” Proving Pedophilia is “Determined in the Womb”

“Non-Binary” Assistant Professor Calls For ‘Stigma’ of Pedophilia to be ‘Delegitimized’

San Diego State University Normalizes Pedophilia as a “Sexual Orientation”

https://www.zerohedge.com/geopolitical/un-globalists-seek-decriminalise-sex-minors