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Thursday, June 1, 2023

Arcturus fast tracked for liver enzyme deficiency treatment

 Arcturus Therapeutics, Inc. (the “Company”, “Arcturus”, Nasdaq: ARCT), a global late-stage clinical messenger RNA medicines company focused on the development of infectious disease vaccines and opportunities within liver and respiratory rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to ARCT-810, the Company’s mRNA therapeutic candidate for ornithine transcarbamylase (OTC) deficiency.

Fast Track Designation is designed to facilitate development and expedite review of new therapeutics intended to treat serious or life-threatening conditions that demonstrate the potential to address important unmet medical needs. Programs granted Fast Track Designation may receive important benefits including more frequent interactions with FDA review teams and the ability to obtain rolling review of a Biologics License Application (BLA). In addition, BLA applications may receive a priority review, with the FDA aiming to complete its review within six months, instead of the standard ten months review timeline.

https://www.biospace.com/article/releases/arcturus-therapeutics-receives-u-s-fda-fast-track-designation-for-arct-810-mrna-therapeutic-candidate-for-ornithine-transcarbamylase-deficiency/

More Oath Keepers convicted of sedition in US Capitol attack face sentencing

 Two more members of the far-right Oath Keepers militant group are set to be sentenced on Thursday for seditious conspiracy and other crimes arising from the Jan. 6, 2021, attack on the U.S. Capitol by then-President Donald Trump's supporters.

Federal prosecutors are asking U.S. District Judge Amit Mehta to sentence Roberto Minuta and Edward Vallejo to 17 years in prison each after they were convicted in January alongside two other Oath Keepers members.

If the judge follows that recommendation, those would be the second-longest sentences for any of the 1,000-plus people charged in the Capitol attack that was intended to block Congress from certifying Democrat Joe Biden's November 2020 election victory over the Republican Trump.

Oath Keepers founder Stewart Rhodes, convicted in November of seditious conspiracy and other charges, was sentenced by Mehta last week to 18 years in prison, the longest of any of the sentences. Three co-defendants of Rhodes were given between four and 12 years in prison. Two of those three were acquitted of seditious conspiracy - is a felony charge involving attempting "to overthrow, put down or to destroy by force the government of the United States" - but convicted on other felony counts.

Minuta, who provided a security detail to Trump ally Roger Stone during political rallies on the day of the attack, entered the Capitol with other Oath Keepers and, according to prosecutors, pushed past police officers while screaming obscene language.

In their sentencing memo, prosecutors said Minuta has failed to accept responsibility and has "continued to spread lies and sow distrust in the criminal investigation" by referring to himself and other Jan. 6 defendants as "political prisoners."

Vallejo was not at the Capitol on the day of the attack. Prosecutors said he stayed at a suburban Virginia hotel where the Oath Keepers had staged a "quick reaction force" and stashed firearms to be quickly ferried into Washington if needed.

Attorneys for Minuta and Vallejo are expected to tell the judge on Thursday that the evidence against their clients was thin and did not justify the stiff sentences the prosecution is recommending.

"The government's sentencing statement is a farce," Minuta's attorney William Shipley wrote in his sentencing memo to the judge.

Matthew Peed, Vallejo's attorney, intends to ask the judge to give his client no more time incarcerated beyond the amount he already has served.

Peed sought to shift blame to Trump, who during a speech to supporters shortly before the riot repeated his false claims that the election had been stolen from him through widespread voting fraud and urged them to march on the Capitol and "fight like hell."

"The tragedy of January 6 is that hundreds of lifelong law-abiding people like Edward Vallejo were lied to by the sitting president and told that the certification was an orchestrated assault on our democracy," Peed wrote.

"The people who broke the law that day were not al Qaeda members bombing the World Trade Center or even 'traitors' who consciously chose to attack democracy rather than accept that they validly lost. They were patriotic Americans who believed wrongly - very wrongly - that they were defending democracy against corrupt officials," Peed added.

Joseph Hackett and David Moerschel, co-defendants in the trial in which Minuta and Vallejo were convicted - are due to be sentenced on Friday. They too were convicted of seditious conspiracy and other crimes. The prosecution has recommended a sentence of 12 years in prison for Hackett and 10 for Moerschel.

https://sports.yahoo.com/more-oath-keepers-convicted-sedition-102243131.html

Anavex gets patent for therapy for CNS conditions

Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders including Alzheimer’s disease, Parkinson’s disease, Rett syndrome and other central nervous system (CNS) disorders, announced today it was awarded new U.S. Patent No. 11,661,405 entitled “CRYSTAL FORMS OF TETRAHYDRO-N,N-DIMETHYL-2,2-DIPHENYL-3-FURANMETHANAMINE HYDROCHLORIDE, PROCESSES OF MAKING SUCH FORMS, AND THEIR PHARMACEUTICAL COMPOSITIONS” from the United States Patent and Trademark Office (USPTO), expanding Anavex’s patent coverage of certain crystal forms of ANAVEX®2-73 (blarcamesine) compositions, processes of preparation, and uses thereof.

Anavex’s newest patent will be expected to remain in force at least until October 2036, not including any patent term extensions. The new patent will expand the coverage of certain ANAVEX®2-73 (blarcamesine) crystals covered by U.S. Patent No. 10,413,519, to methods of their making. The ANAVEX®2-73 (blarcamesine) compound in one of its crystal forms has been used in various preclinical and clinical trials, for a broad range of CNS disorders, including but not limited to, Alzheimer’s disease, Parkinson’s disease, Parkinson’s disease dementia, Rett syndrome, Fragile X syndrome, Infantile spasms, Angelman syndrome

https://finance.yahoo.com/news/anavex-announces-issuance-u-intellectual-113000380.html

AstraZeneca to stop developing Crohn's disease drug

 British drugmaker AstraZeneca said on Thursday it would stop developing its drug brazikumab to treat inflammatory bowel diseases, including Crohn's disease and ulcerative colitis.

The company said the discontinuation was due to a delay in the drug's development timeline, affected by global events and "the context of a competitive landscape".

AstraZeneca regained the rights to brazikumab from Allergan in 2020 following U.S. drugmaker AbbVie's $63 billion tie-up with Allergan.

AbbVie will stop funding the drug's development, AstraZeneca said.

AbbVie's Skyrizi also treats Crohn's disease.

https://finance.yahoo.com/news/1-astrazeneca-stop-developing-crohns-063625904.html

Amarin Partner Approval for Vascepa® (Icosapent Ethyl) in Mainland China

 - VASCEPA Approved by the National Medical Products Administration (NMPA) as an Adjunct to Diet to Reduce Triglyceride Levels in Adult Patients with Severe Hypertriglyceridemia (≥ 500 mg/dL) --

-- EddingPharm Now Working Towards Preparing for Commercial Launch of VASCEPA Across Mainland China Expected by Year-End --

https://finance.yahoo.com/news/amarin-partner-eddingpharm-receives-regulatory-100000116.html

All Three Farallon Nominees to Exelixis’ Board

 Based on Preliminary Results, Farallon Director Candidates Tom Heyman, Dave Johnson and Bob Oliver Have Each Been Elected

Expects Exelixis' Board to Welcome the New Directors and Embrace Fresh Perspectives to Help Improve Lagging Performance

https://finance.yahoo.com/news/farallon-capital-management-comments-election-163000700.html

Reunion: $13.1 Million Take-Private Transaction with MPM BioImpact

 Reunion Common Shareholders to Receive Consideration of US$1.12 Per Share in Cash

Represents a 43.1% Premium to the 30-Day Volume Weighted Average Price

Reunion Presents Encouraging Phase 1 Final Analysis at American Society of Clinical Psychopharmacology Annual Meeting, Enabling Advancement into Phase 2 in 2H 2023

https://finance.yahoo.com/news/reunion-neuroscience-announces-us-13-113000384.html