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Wednesday, March 1, 2023

CCP government 'intentionally released' COVID-19 'all over the world,' Chinese virologist says

 A Chinese virologist who sounded the alarm in early 2020 about where the coronavirus came from said Monday the U.S. has reached a "milestone achievement" after a classified intelligence report from the Energy Department reportedly found the virus most likely originated in a Chinese lab. 

Dr. Li Meng Yan told "Tucker Carlson Tonight" in September 2020 that the Chinese government intentionally manufactured and released the COVID-19 virus, leading to nationwide shutdowns and deaths. 

Host Tucker Carlson asked Yan on Monday if she still believes the virus was intentionally released nearly three years after the pandemic started. 

"Of course, it was not an accident," she responded. 

"Maybe for people who don't have this kind of biosafety lab 3 or 4 experience on coronavirus, maybe it's easy for them to accept the accident lab leak. However, I'm a scientist, working in [a] research lab using coronavirus. And I can tell you, based on the print protocol and also the other surveillance system, it would be impossible for the lab leak [to] accidentally happen in such [a] lab and cause the Wuhan outbreak and also the pandemic," Yan said. 

"So definitely now we just reached the first step. It was from China's lab, and we need to pursue the truth of origin, and we need to keep going on."

Carlson suggested the Chinese government unleashed COVID to destroy Western economies and elevate their own position globally. 

Yan said based on the evidence she has seen and the source she has spoken to, the virus was "intentionally brought out of this strict lab and released in the community."

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"However, I don't think the outbreak in Wuhan was intentional. I would say it was because [the] CCP government and the military scientists underestimated the transmissibility," she added. "That's why finally it got out of control and the cost [was] a local outbreak. However, we should know that [the] CCP government intentionally let it go all over the world to kill millions of people all over the world later."

Yan was a respected doctor who specialized in virology and immunology at the Hong Kong School of Public Health before fleeing in April 2020 after she began looking into the growing number of cases coming out of mainland China that involved human-to-human transmission. 

Residents wait in line for their routine COVID-19 test at a coronavirus testing site in Beijing, Dec. 7, 2022.

Residents wait in line for their routine COVID-19 test at a coronavirus testing site in Beijing, Dec. 7, 2022. (AP Photo/Andy Wong)

She said she reported her findings to her supervisor on Jan. 16, but that's when he allegedly told her "to keep silent, and be careful."

"As he warned me before, 'Don't touch the red line,'" Yan said referring to the government. "We will get in trouble, and we'll be disappeared." 

https://www.foxnews.com/media/ccp-government-intentionally-released-covid-19-over-world-chinese-virologist

US FDA approval tracker: February 2023

 There were several high-profile approvals last month, including for Apellis’s Syfovre, given a broad label and a flexible dosing regimen in geographic atrophy. However, Apellis might not have the market to itself for long as Iveric Bio’s Zimura has a Pdufa date in August. Reata gained a surprise greenlight for its Friedreich's ataxia therapy Skyclarys, despite a complex regulatory path. However, Cytokinetics received a knockback for its heart failure project omecamtiv after an earlier negative adcom. The company has no plans to run another study, leaving it to focus on aficamten in obstructive hypertrophic cardiomyopathy, with phase 3 data due later this year. Lastly, the outcome of an adcom for Pfizer’s adult respiratory syncytial virus (RSV) vaccine Abrysvo was less clear-cut than might have been expected, with a 7 to 4 vote in favour. Panellists highlighted incidences of Guillain-BarrĂ© Syndrome, and post-marketing studies are expected to evaluate this risk. Stifel analysts note that GSK, whose own vaccine Arexvy is up before a panel today, has agreed with the FDA to monitor the syndrome as part of its pharmacovigilance programme.

Notable first-time US approval decisions in February
ProjectCompanyIndication(s)2028e SBI ($m)Outcome
Syfovre (intravitreal pegcetacoplan)ApellisGeographic atrophy secondary to age-related macular degeneration2,310Approved
Altuviiio (efanesoctocog alfa)SanofiUltra-long-acting FVIII therapy for haemophilia A879Approved
Skyclarys (omaveloxolone)ReataFriedreich's ataxia in patients aged 16 and older838Approved
FezolinetantAstellasModerate to severe vasomotor symptoms associated with menopause699Extended to 22 May (more time to review)
Filspari (sparsentan)TravereIgA nephropathy412Approved (accelerated)
Jesduvroq (Duvroq, daprodustat)GSK/Kyowa KirinAnaemia due to CKD in adults on/not on dialysis355Approved in dialysis patients, CRL in non-dialysis
Omecamtiv mecarbilCytokineticsReduce the risk of CV death and heart failure events in patients with symptomatic chronic HFrEF326CRL (additional trial required)
Lamzede (velmanase alfa)ChiesiAlpha-mannosidosis-Approved
SBI: sales by indication. Source: Evaluate Pharma & company releases.
 
 
Advisory committee meetings in February
ProjectCompanyIndication2028e SBI ($m)Outcome
Abrysvo (RSVpreF)PfizerPrevention of acute respiratory disease and lower respiratory tract disease caused by RSV in adults ≥60 years1,2167 to 4 in favour (note GSK's vaccine Arexvy has an adcom on March 1)
Narcan nasal spray (4mg/0.1ml)Emergent BiosolutionsNonprescription treatment of known or suspected opioid overdose175Unanimously in favour
JemperliGSKMonotherapy in early treatment of MMRd/MSI-high rectal cancer-8 to 5 in favour of data from two single-arm trials being sufficient to characterise benefits and risks (Jemperli moves towards adjuvant rectal cancer at last)
RSV: respiratory syncytial virus. Source: Evaluate Pharma, company releases & FDA adcom calendar.

 

Supplementary and other notable approval decisions in February
ProductCompanyIndication (clinical trial)Outcome
EmpaveliApellisPNH, treatment-naive patients, and long-term safety and efficacy data (PrincePegasus)Approved
TrodelvyGileadPretreated HR+/Her2-metastatic breast cancer (Tropics-02)Approved
EyleaRegeneron/ SanofiRetinopathy of prematurity in preterm infants (FirefleyeButterfleye)Approved
TezspireAstrazeneca/ AmgenSelf-admin in a pre-filled, single-use pen for patients ≥12 years with severe asthma (Path-HomePath-Bridge)Approved
KevzaraSanofi/ RegeneronPolymyalgia rheumatica (Saphyr)Approved
TakhzyroTakedaHereditary angioedema attacks in children 2 to <6 years (HelpSpring)Approved
JemperliGSKMMRd endometrial cancer, progressed on or following a prior platinum-containing regimen (long-term outcomes from Garnet)Full approval
CibinqoPfizerAdolescents with refractory, moderate-to-severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products (Jade Teen)Approved
Austedo XRTevaOnce-daily formulation for tardive dyskinesia and chorea associated with Huntington’s diseaseApproved
Voquezna (Vonaprazan, Takecab)PhathomErosive oesophagitis (Phalcon-ee) and H pyloriCRLs, stability data requested owing to impurity previously found in product, launch of Voquezna Dual and Triple Pak on hold (H pylori indication)
Krabeva/MYL-1402O
(Avastin biosimilar)
BioconCertain oncology indicationsCRL (facility inspection issues)
Source: Evaluate Pharma & company releases.

https://www.evaluate.com/vantage/articles/insights/nme-approvals-snippets/us-fda-approval-tracker-february-2023

Organogenesis: Positive Interim Phase 3 Clinical Trial of ReNu for Knee Osteoarthritis

 Organogenesis Holdings Inc. (Nasdaq: ORGO), a leading regenerative medicine company focused on the development, manufacture, and commercialization of product solutions for the Advanced Wound Care and Surgical and Sports Medicine markets, today reported the favorable outcome of the interim analysis of its Phase 3 clinical trial for the management of symptoms associated with knee osteoarthritis.

The pre-specified interim analysis on 50% of the 474 required patients with moderate to severe knee osteoarthritis (Kellgren-Lawrence [KL] severity grade 2 to grade 4) focused on the 6-month primary endpoint for potential sample size re-estimation. The Independent Data Monitoring Committee (DMC) for the trial provided directional guidance on the results of the interim analysis, while rigorously maintaining all aspects of study blinding. The DMC recommended that the trial proceed without modification and without increase to sample size. Additionally, the DMC found the safety data to be consistent with the known safety profile for ReNu.

https://finance.yahoo.com/news/organogenesis-reports-positive-interim-analysis-210100687.html

Pivotal Phase 3 Study of Ambrx Treatment of HER2 Positive Metastatic Breast Cancer Achieves Positive Results

 Interim analysis of the ACE-Breast-02 study being conducted by Ambrx’s partner, NovoCodex Biopharmaceuticals, was completed by the Independent Data Monitoring Committee (IDMC)

The pivotal Phase 3 ACE-Breast-02 study met its pre-specified interim primary efficacy endpoint with statistical significance, demonstrating a greater progression free survival benefit compared to the control

Ambrx Biopharma Inc., or Ambrx, (NYSE: AMAM) announced today that it has been informed by its partner, NovoCodex Biopharmaceuticals, Inc. (NovoCodex), that an interim analysis for ACE-Breast-02, a randomized Phase 3 breast cancer clinical trial investigating Ambrx’s ARX788, an anti-HER2 antibody drug conjugate (ADC), has met its pre-specified interim primary efficacy endpoint with statistical significance, demonstrating a greater progression free survival (PFS) benefit compared to the active control.

ACE-Breast-02 is a randomized, controlled pivotal Phase 3 clinical trial of humanized anti-HER2 monoclonal antibody-AS269 conjugate (ARX788) in the treatment of HER2 positive patients with locally advanced or metastatic breast cancers in China.

The trial enrolled 441 HER2 positive breast cancer patients who have been previously treated with taxane and trastuzumab. Eligible subjects were randomly assigned in a 1:1 ratio to receive ARX788 or the control drugs, lapatinib combined with capecitabine. The primary endpoint was PFS based on Blinded Independent Review Committee (BIRC) assessment. An interim analysis was conducted by an Independent Data Monitoring Committee (IDMC) when two thirds (2/3) of the PFS events occurred.

After reviewing the interim results, the IDMC informed NovoCodex that the ACE-Breast-02 study met its pre-specified interim primary efficacy endpoint with statistical significance, demonstrating a greater PFS benefit compared to the control.

Based on the results from the interim analysis, NovoCodex plans to submit a communication application to seek marketing approval in China pending discussion with National Medical Products Administration (NMPA).

https://finance.yahoo.com/news/ace-breast-02-pivotal-phase-130000772.html

Lilly Cuts Insulin Prices by 70% and Caps Patient Insulin Out-of-Pocket Costs at $35 Per Month

 Eli Lilly and Company (NYSE: LLY) today announced price reductions of 70% for its most commonly prescribed insulins and an expansion of its Insulin Value Program that caps patient out-of-pocket costs at $35 or less per month. Lilly is taking these actions to make it easier to access Lilly insulin and help Americans who may have difficulty navigating a complex healthcare system that may keep them from getting affordable insulin.

Today, Lilly is reducing the list price of insulins by:

  • Cutting the list price of its non-branded insulin, Insulin Lispro Injection 100 units/mL, to $25 a vial. Effective May 1, 2023, it will be the lowest list-priced mealtime insulin available, and less than the price of a Humalog® vial in 1999.
  • Cutting the list price of Humalog® (insulin lispro injection) 100 units/mL1, Lilly's most commonly prescribed insulin, and Humulin® (insulin human) injection 100 units/mL2 by 70%, effective in Q4 2023.
  • Launching RezvoglarTM (insulin glargine-aglr) injection, a basal insulin that is biosimilar to, and interchangeable with, Lantus® (insulin glargine) injection, for $92 per five pack of KwikPens®, a 78% discount to Lantus, effective April 1, 2023.

"While the current healthcare system provides access to insulin for most people with diabetes, it still does not provide affordable insulin for everyone and that needs to change," said David A. Ricks, Lilly's Chair and CEO. "The aggressive price cuts we're announcing today should make a real difference for Americans with diabetes. Because these price cuts will take time for the insurance and pharmacy system to implement, we are taking the additional step to immediately cap out-of-pocket costs for patients who use Lilly insulin and are not covered by the recent Medicare Part D cap."

In addition to reducing the list price of its insulins, Lilly is making it easier for more people with diabetes to get Lilly insulins:   

  • Effective immediately, Lilly will automatically cap out-of-pocket costs at $35 at participating retail pharmacies for people with commercial insurance using Lilly insulin.3
  • People who don't have insurance can continue to go to InsulinAffordability.com and immediately download the Lilly Insulin Value Program savings card to receive Lilly insulins for $35 per month.

"We are driving for change in repricing older insulins, but we know that 7 out of 10 Americans don't use Lilly insulin. We are calling on policymakers, employers and others to join us in making insulin more affordable," continued Ricks. "For the past century, Lilly has focused on inventing new and improved insulins and other medicines that address the impact of diabetes and improve patient outcomes. Our work to discover new and better treatments is far from over. We won't stop until all people with diabetes are in control of their disease and can get the insulin they need."

Today's announcement builds on years of efforts by Lilly to close the gaps in the U.S. healthcare system that keep some people with diabetes from accessing affordable insulin. In recent years, Lilly has introduced multiple insulin affordability solutions that have made a real impact, including launching low-list-price, non-branded insulins in 2019, implementing the Lilly Insulin Value Program in 2020 and committing all of our insulins to the Medicare Part D Senior Savings Model in 2021. Because of these efforts, the average out-of-pocket cost for Lilly insulins has dropped to $21.80 over the last five years.

In the coming weeks, Lilly will launch a nationwide public awareness campaign to help ensure all Lilly insulin users understand how to access the company's industry-leading affordability solutions. For more information, go to Lilly.com/insulin.

https://www.morningstar.com/news/pr-newswire/20230301de28143/lilly-cuts-insulin-prices-by-70-and-caps-patient-insulin-out-of-pocket-costs-at-35-per-month

Ocugen upped to Buy from Neutral by Chardan

 Target $3.50

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

ANI started at Buy by Guggenheim

 Target $55

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