Takeda (TSE:4502/NYSE:TAK) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review its New Drug Application (NDA) resubmission for TAK-721 (budesonide oral suspension) which is being investigated for the short-term treatment of eosinophilic esophagitis (EoE), a chronic inflammatory disease that can cause damage to the esophagus.1 The resubmission is intended to address previous FDA feedback to the Company’s original NDA submission.
Wednesday, September 20, 2023
Nutriband: U.S. Patent for Transdermal Abuse Deterrent Tech
Nutriband Inc. (NASDAQ:NTRB)(NASDAQ:NTRBW), a developer of transdermal pharmaceutical products, today announced that the United States Patent and Trademark Office (USPTO) has granted US Patent No. 11,759,431 for Nutriband's proprietary AVERSA™ abuse deterrent technology utilizing taste aversion to address the primary routes of abuse of opioid based transdermal patches.
PDS: Neutralization of Multiple Influenza Strains in Preclinical Studies
- PDS0202 (Infectimune® + COBRA influenza antigens) vaccination also prevented illness/weight loss
- Vaccine protected against replication of the virus in the lungs of ferrets after challenge with the H1N1 virus
- Data from Cleveland Clinic’s Ted Ross Lab presented at the 9th ESWI Influenza Conference
Genentech, PeptiDream Ink Potential $1B Radiopharma Deal
Japanese biopharma PeptiDream on Wednesday announced yet another licensing agreement with Roche’s Genentech, this time worth up to $1 billion.
The latest deal builds on previous partnerships between the two companies starting in December 2015 with licensing in 2016 and an expansion deal in 2018.
PeptiDream will receive $40 million upfront for R&D of its macrocyclic peptide-radioisotope drug conjugates. Going forward, another $1 billion is on the line in milestones plus tiered royalties of product sales to markets outside of Japan. PeptiDream will oversee preclinical activities to develop a peptide-RI drug conjugate and retain rights in Japan for any products developed.
While a particular target was not disclosed, PeptiDream CEO Patrick Reid said in a statement that the company hopes to “bring innovative first-in-class peptide radiopharmaceuticals to patients worldwide.”
The peptide-RI drug conjugates in the deal with Genentech are designed to use radioisotopes to hit a cancer cell directly, minimizing off-target toxicity. The biopharma’s Peptide Discovery Platform System is designed to identify a range of candidates for peptide-based, small molecule-based or peptide drug conjugates-based therapeutics.
Genentech is just one of many big pharma’s to partner with the company. PeptiDream’s pipeline is full of well-known partners including Bristol Myers Squibb, Eli Lilly, Merck and Novartis.
BMS has two oncology assets that are partnered with PeptiDream. One is a PD-L1 inhibitor peptide and the other is a radiopharmaceutical diagnostic agent to evaluate PD-1/PD-L1 expression in patients. Both are currently in Phase I testing.
In March 2023, PeptiDream announced a second targeted peptide radiopharmaceutical candidate has been nominated for clinical development in its partnership with RayzeBio. The first candidate is indicated for liver cancer, a disease with a market size estimated at $5.3 billion by 2029 in the eight major markets, according to PeptiDream.
Aquestive Reaffirms Timeline and Pathway for Anaphylm™ (epinephrine) Sublingual Film
Aquestive Therapeutics, Inc. (NASDAQ:AQST), a pharmaceutical company advancing medicines to solve patients' problems with current standards of care and provide transformative products to improve their lives, today provided an update on the development timeline and pathway for its oral epinephrine product candidate, Anaphylm™.
As previously disclosed, Aquestive submitted its revised protocol for the proposed pivotal PK clinical trial to the Food and Drug Administration (FDA) in August 2023. The Company intends to commence the pivotal trial in the fourth quarter 2023, following alignment with the FDA. In addition, the Company’s current development plan continues to include a standard repeat-dose study of Anaphylm and an already-approved comparator.
Earlier this year, the Company disclosed repeat-dose data of Anaphylm 12mg at 25 minutes post initial dosing from Study AQ109102 including a cross-study comparison to epinephrine manual injection 0.3mg with a repeat dose at 10 minutes post initial dosing. Further information on this comparison is available in the Company’s corporate presentation located on the Investor page of the Company’s website.
https://finance.yahoo.com/news/aquestive-therapeutics-reaffirms-timeline-pathway-130400102.html
Ardern Urges United Nations To 'Crack Down On Free Speech As A Weapon Of War'
Jacinda Ardern may no longer be Prime Minister of New Zealand, but she was back at the United Nations continuing her call for international censorship.
Ardern is now one of the leading anti-free speech figures in the world and continues to draw support from political and academic establishments.
In her latest attack on free speech, Ardern declared free speech as a virtual weapon of war.
She is demanding that the world join her in battling free speech as part of its own war against “misinformation” and “disinformation.”
Her views, of course, were not only enthusiastically embraced by authoritarian countries, but the government and academic elite.
In her speech, she notes that we cannot allow free speech to get into the way of fighting things like climate change. She notes that they cannot win the war on climate change if people do not believe them about the underlying problem. The solution is to silence those with opposing views. It is that simple.
While some of us have denounced her views as an attack on free expression, Harvard rushed to give her not one but two fellowships.
While the free speech community denounced her for unrelenting attacks on this human right, Harvard praised her for “strong and empathetic political leadership” and specifically enlisted her to help “improve content standards and platform accountability for extremist content online.”
I actually have no objection to the inclusion of Ardern as a Harvard fellow. She is a former world leader who is leading the movement against free speech. It is a view that students should consider in looking at these controversies.
However, Harvard has heralded her views with no acknowledgment of her extreme antagonism toward free speech principles.
There is also little countervailing balance at the school with fellows supporting free speech as a human right. Rather, Harvard (which ranks dead last on the recent free speech survey) has become a virtual clearinghouse for anti-free speech academics and advocates.
Free speech is now commonly treated on campuses as harmful.
Rather than the right that defines us, it is treated as an existential threat.
What is so chilling is to hear Ardern express her fealty to free speech as she calls on the nations of the world to severely curtail it to prevent people from undermining their policies and priorities.
She remains the “empathetic” face of raw censorship and intolerance. She is now the virtual ambassador-at-large for global speech criminalization.
"Could Be Largest Healthcare Strike In US History": Kaiser Workers In DC, Va., Md. Authorize Strike
By Kelly Gooch of Beckers Hospital Review
Kaiser Permanente workers in the District of Columbia, Virginia and Maryland have joined workers in other states in voting to authorize a strike.
The Office and Professional Employees International Union Local 2 said in a news release that members at Kaiser voted to authorize a strike by a margin of 98 percent if no agreement is reached by Sept. 30. This comes after Service Employees International Union members in Colorado, California, Oregon and Southwest Washington voted to authorize a strike at Kaiser in the past two weeks.
Some unionized workers at Kaiser facilities are still voting on possible strike authorization, with voting by additional union members in California concluding on Sept. 20, according to the release. Oakland, Calif.-based Kaiser is currently bargaining with the Coalition of Kaiser Permanente Unions, which represents more than 85,000 workers at Kaiser facilities in California, Colorado, Oregon, the District of Columbia, Hawaii, Maryland, Virginia and Washington.
If Kaiser workers end up striking, it could be the largest healthcare strike in U.S. history, union representatives estimate.
Union members contend that Kaiser is not properly addressing their priorities, including staffing and patient care. They also expressed concerns about workers' ability to keep up with the cost of living, said management proposals related to pay and workforce development would make the staffing crisis worse, and argued that Kaiser has not bargained in good faith.
"We've been raising the alarm about patient safety, but Kaiser isn't hearing us. Kaiser executives keep refusing to listen to frontline healthcare workers on the issues that impact the care of our patients, and they're violating the law by failing to bargain in good faith," Katrina Schaetz, OB-GYN clinical assistant, said in the OPEIU release. "We are standing up for more staff and better patient care. If Kaiser doesn't stop committing unfair labor practices, healthcare workers are prepared to go on strike."
Becker's has reached out to Kaiser and will update this story if additional information becomes available.
Kaiser said in a statement shared with Becker's last week that it "is a leader in employee wages and benefits in every market we are in. In bargaining this year, we are offering across-the-board wage increases, an enterprise wide minimum wage starting at $21 an hour, continuing our existing excellent health benefits and retirement income plans, and much more. These and our other operational proposals reflect our deep commitment to the economic well-being of our employees."
Kaiser refuted some of union members' claims in its statement, noting that the pay increases it has offered during bargaining sessions will put all Kaiser union members above market rates in their respective regions. The health system also pointed to the recruitment and workforce development efforts it has made, including investment in several education and training programs, tuition reimbursement programs, and coaching services for employees.
Kaiser also said it is committed to reaching an agreement "that ensures we can continue to provide market-competitive pay and outstanding benefits," and is confident an agreement will be reached by the contract expiration date.
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