Search This Blog

Thursday, April 15, 2021

West Virginia to see slight increase in vaccine allocation

 West Virginia will see a slight increase in Moderna and Pfizer coronavirus vaccine doses as it continues its pause of Johnson & Johnson’s one-shot vaccine.

An increase of 5,340 combined Moderna and Pfizer doses will be part of the state’s allocation next week, U.S. Sen Joe Manchin’s office said Wednesday. That comes to nearly 98,000 total first and second doses.

“It is very important for you to know there has been nothing but rave reviews about the Pfizer and Moderna vaccines,” Gov. Jim Justice said Wednesday. “We will continue to have those vaccines available to you. We’re not going to slow up on our vaccination events.”

West Virginia health officials say they haven’t received reports of the rare blood clotting condition that led U.S. authorities to recommend a temporary halt on the Johnson & Johnson vaccine usage. So far, there are only six known cases nationwide of the clotting issue out of over 7 million people who have received the Johnson & Johnson shot.

https://apnews.com/article/health-joe-manchin-west-virginia-coronavirus-pandemic-3a2f794379ea035431f7c7b1d6c8438e

Tool behind crackdown on opioids could expire

 The Biden administration has been slow-walking its work on the extension of a legislative order that would keep in place a sweeping tool that’s helped federal agents crack down on drugs chemically similar to fentanyl, three people familiar with the matter told The Associated Press.

In recent weeks, the people said, the White House and Justice Department leaders have, on several occasions, canceled meetings with officials at the Drug Enforcement Administration to discuss the plan around so-called fentanyl analogues, which are generally foreign-made drugs with a very close chemical makeup to the dangerous opioid. The people had direct knowledge of the discussions but were not authorized to speak publicly and spoke to the AP on the condition of anonymity.

The legislation temporarily classifies the synthetic opioids as a Schedule 1 drug under the federal Controlled Substances Act, making it easier for prosecutors to build cases against traffickers. The emergency authority, initially authorized in 2018, is set to expire next month and requires Congress to reauthorize it.

The Biden administration will need to either quickly move forward to lobby Congress to pass another extension, propose a permanent legislative solution that could quickly pass the House and the Senate or put a plan in place to prosecute cases involving the synthetic opioids if the temporary authorization expires.

“The Biden-Harris Administration is committed to avoiding expiration of this legislation, and we have communicated that clearly to both parties in Congress,” White House spokesman Andrew Bates said.

There is growing concern from lawmakers and law enforcement officials, who fear that failing to act could lead to a surge in opioid deaths, and the rapidly approaching deadline makes it nearly impossible to reauthorize it in time. The U.S. is in the midst of an opioid crisis.

But saying a quick yes isn’t quite so simple. The situation is politically thorny and has the potential to anger both Democrats and Republicans. Most of the drugs are coming in from China, and if President Joe Biden were to skip the reauthorization it could create foreign policy issues, but there are concerns from some in the administration over mandatory minimum sentences attached to the order that have the potential to anger reformists.

The law triggers some mandatory penalties for possessing large quantities of fentanyl or fentanyl analogues, and it’s been a hold-up, the people said. For example, possessing 100 grams (3.5 ounces) of a fentanyl analogue triggers a 10-year mandatory minimum penalty; the same penalty would apply for possessing 1 kilogram (2.2 pounds) of heroin.

But in the last three years, only eight prosecutions would have even qualified for mandatory minimum sentences, according to the people.

The rate at which federal law enforcement encounters fentanyl analogues has dropped drastically in the last few years. Law enforcement officials say that’s in part because there is little incentive for drug traffickers to change the chemical compound given that the law had categorized both fentanyl and analogues in the same class. But they worry it will skyrocket if the order isn’t extended.

The analogues are powerful synthetic opioids that can be significantly more potent than morphine or heroin.

The number of deaths from fentanyl-related substances is unknown, but the Centers for Disease Control and Prevention reports that there were more than 50,000 deaths involving all synthetic opioids in the 12-month period ending July 2020.

The Justice Department during President Donald Trump’s administration lobbied to make the ban permanent, putting fentanyl analogues in the same legal category as heroin and cocaine forever. But Congress only voted to extend the temporary ban.

Justice officials said they were seeking a seven-month extension while working on a more permanent solution and were taking the May 6 deadline seriously. But no one has submitted legislation sponsoring that extension in Congress.

“We will work with Congress to seek a clean, seven-month extension to prevent this important law enforcement tool from lapsing while we address legitimate concerns related to mandatory minimums and researcher access to these substances,” the Justice Department said in a statement.

The U.S. topped 50,000 opioid-related overdose deaths for the first time in 2019, and several states last year reported a record pace of overdose deaths due to all drugs. Nearly 74,000 overdose deaths were counted from April 2019 to March 2020, up from the 68,000 reported for the comparable period one year earlier.

The Justice Department took the unusual step of suing Walmart over the opioid crisis, accusing it of fueling the crisis by pressuring its pharmacies to fill even potentially suspicious prescriptions for the powerful painkillers. Walmart Inc., which is based in Bentonville, Arkansas, and operates more than 5,000 pharmacies around the country, said the lawsuit “invents a legal theory that unlawfully forces pharmacists to come between patients and their doctors, and is riddled with factual inaccuracies and cherry-picked documents taken out of context.”

https://apnews.com/article/politics-opioids-synthetic-opioids-legislation-only-on-ap-53bd1eb68f77c1b3d6e0c5af0ed2b783

EMA starts review of Vir-GSK monoclonal antibody to treat COVID-19 patients

 The European Medicines Agency said on Thursday it is reviewing available data on the use of GlaxoSmithKline's monoclonal antibody to treat COVID-19 patients.

The agency said its review of VIR-7831, which GSK is developing with Vir Biotechnology Inc, will include data from a study comparing its effect with that of a placebo in patients with mild to moderate COVID-19 who were at high risk of progressing to a more severe condition. (https://bit.ly/3n0spGx)

While a more comprehensive rolling review is expected to start at a later time, the agency said the current review will provide European Union-wide recommendations for national authorities who may take decisions on early use of the medicine.

The companies reported in March that VIR-7831 reduced the risk of hospitalisation and deaths among patients by 85%, based on interim data from a study.

In late March, the companies filed an application to U.S. regulators for emergency use authorization of VIR-7831 to treat early-stage COVID-19 infections.

The United States has already recommended similar therapies from Eli Lilly and Co and Regeneron Pharmaceuticals Inc .

European health regulators are reviewing treatments from this class of medicines called monoclonal antibodies, which are synthetically manufactured copies of the human body’s natural infection-fighting proteins and are already being used to treat some types of cancers.

GSK and Vir announced a partnership in 2020 to research COVID-19 treatments, and earlier this year said they will expand that partnership to develop monoclonal antibody treatments for influenza and other respiratory illnesses.

https://news.yahoo.com/ema-starts-review-gsks-monoclonal-130407618.html

CureVac Q4 2020 results and business update

 - COVID-19 vaccine candidate: CVnCoV in final stage of clinical development and believed to be well on track to provide data for conditional approval based on EMA rolling submission

- Pivotal Phase 2b/3 in Europe and Latin America fully recruited with over 40,000 participants. Interim analysis for vaccine efficacy expected in Q2 2021

- Phase 2a trial in Peru and Panama amended for addition of secondary endpoint for vaccine efficacy in total population with a focus on participants over the age of 60

- CVnCoV demonstrates, in preclinical challenge study, full protection from infections with Variant of Concern B.1.351 (South Africa variant)

- Expanding COVID-19 vaccine program: Three new CVnCoV studies in specific populations expected to be initiated soon

- Advancing the commercial organization and preparing access to commercial territories

- Expanded manufacturing network with European partners expected to manufacture up to 300 million doses of CVnCoV by end of 2021 and up to one billion doses in 2022

- Partnerships with Bayer, GSK and the UK government (partnership under final discussions) to rapidly advance first-generation vaccines and expand into second-generation vaccines in our COVID-19 program

- Oncology lead asset CV8102: Phase 1 expansion cohort initiated with preferred dose in patients with advanced melanoma

- Financials:

- Cash position of €1.32 billion as of December 31, 2020

- Additional $517.5 million in gross proceeds based on issuance of 5,750,000 common shares from February 2021 capital raise

https://finance.yahoo.com/news/curevac-announces-financial-results-business-114500783.html

Becton Dickinson Backing Vicarious Surgical’s D8 SPAC Deal

 Medical technology giant Becton Dickinson & Co., billionaire Bill Gates and Khosla Ventures are among investors backing robotics startup Vicarious Surgical Inc.’s merger with special purpose acquisition company D8 Holdings Corp.

The transaction gives the combined entity an enterprise value of about $1.1 billion, the companies said, confirming an earlier Bloomberg News report.

In addition to Becton Dickinson, Gates and Khosla, other investors set to participate in the deal’s $115 million private investment in public equity, or PIPE, include former Google CEO Eric Schmidt’s Innovation Endeavors and E15 VC, a venture firm. Bloomberg last month reported that Vicarious and D8 were in merger talks.

Charlestown, Massachusetts-based Vicarious, led by Chief Executive Officer Adam Sachs, develops robotics technology with the aim of improving patient outcomes and the efficiency of surgical procedures, while reducing overall health-care costs. Sachs founded the company with Sam Khalifa, its chief technology officer, and Barry Greene, a bariatric and general surgeon, and management will remain in place following the D8 deal.

Vicarious, whose technology has been granted “breakthrough device” designation by the U.S. Food and Drug Administration, is expected to have more than $425 million in cash following the transaction, and estimated 2025 revenues of $355 million.

Hong Kong-based D8’s president Donald Tang will join Vicarious’ board, alongside AIDS researcher David Da-I Ho. The deal is expected to close in the third quarter. Once it is complete, Vicarious is set to trade on the New York Stock Exchange under the symbol RBOT.

Surgical Robots

D8 was “blown away” by Vicarious’s technology, Tang said in an interview. “After doing due diligence, we were floored by what’s possible in terms of stabilizing surgical procedures,” he said, adding that D8 will seek to leverage its relationships in Asia and elsewhere to help Vicarious expand outside the U.S.

A SPAC merger is the “right path” for Vicarious, Sachs said, as the deal bolsters its cash balance by as much as $345 million without the company having to raise multiple private rounds of funding. “As we move to commercialize our product, being public gives us a level of credibility we may not have had as a private company,” he said.

The company is expected to produce its first year of revenue in 2023 and Sachs said its low cost basis will help its products gain traction. He estimates that Vicarious’ technology, which can be inserted into a patient’s body through a 1.5 centimeter incision, is five to ten times cheaper than legacy surgical robots.

https://finance.yahoo.com/news/becton-dickinson-backing-vicarious-surgical-223042991.html

Biden expands list of potential FDA nominees as pressure mounts to choose

 Despite facing mounting pressure to pick a permanent FDA commissioner amid the ongoing COVID-19 pandemic, it appears President Joe Biden’s pool of potential candidates is only growing larger.

The Biden administration has expanded its shortlist of candidates to lead the FDA, which now includes several women of color, The Wall Street Journal reported Wednesday, citing a person familiar with the process.

While Janet Woodcock, M.D., the interim commissioner since Biden took office in January, remains in the running for the permanent job, some politicians and advocacy groups have pushed back on her potential nomination over concerns about past opioid approvals under her watch.

Challengers for the job now include Katherine Luzuriaga, M.D., a Filipina-American who is the director of the University of Massachusetts Center for Clinical and Translational Science; Florence Houn, M.D., a Chinese-American who has served in leadership positions with the FDA and Celgene Corporation; and Michelle McMurry-Heath, M.D., Ph.D., a Black doctor and former Johnson & Johnson executive, according to the WSJ’s report.

The latest batch of names comes after Democratic Sens. Tammy Duckworth of Illinois and Mazie Hirono of Hawaii said they would block Biden’s nominees if he didn’t appoint more Asian-Americans into leadership roles. The senators have since backed down on that threat.


Gayatri Rao, M.D., an Indian-American who previously worked for the FDA and is currently an executive at Rocket Pharmaceuticals, was also named as a potential nominee in the report. Joshua Sharfstein, M.D., and Luciana Borio, M.D., two former FDA officials, are also said to be in the running.

A White House spokesperson declined to comment to Fierce Pharma’s inquiry regarding the WSJ’s report or the status of Biden’s decision.

Some prominent voices on social media previously speculated that Biden would announce his FDA nominee once his pick for Department of Health and Human Services Secretary, Xavier Becerra, was confirmed. However, it’s been nearly a month since Becerra passed through his Senate confirmation.


The wait has frustrated a handful of former FDA leaders, who penned a March letter to the White House urging the president to make his pick. Robert Califf, M.D.; Scott Gottlieb, M.D.; Margaret Hamburg, M.D.; Jane Henney, M.D.; Mark McClellan, M.D., Ph.D.; and Andrew von Eschenbach, M.D., The Washington Post reported at the time.

Amid the pandemic, the FDA commissioner post is even more important than normal times, the former commissioners wrote. Vaccine, drug and testing issues are playing out in real time, and the agency still needs to issue tobacco regulations, they added.

While the former commissioners didn’t support a specific candidate, they did praise acting chief Woodcock. Her future at the agency, however, was thrown into question Monday when Patrizia Cavazzoni, M.D., was named the permanent director of the FDA’s Center for Drug Evaluation and Research. Woodcock previously held that position before moving under the Trump administration’s Operation Warp Speed and then into her post as interim commissioner.

https://www.fiercepharma.com/pharma/biden-expands-list-potential-nominees-for-fda-chief-even-as-pressure-mounts-to-make-pick

Inovio: Covid vax candidate give broad immunity across variants of concern

 INOVIO (NASDAQ:INO), a biotechnology company focused on rapidly bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases, and cancer, today announced the results of a study focusing on the human immune responses induced by INOVIO's DNA vaccine candidate for COVID-19, INO-4800, against variants of concern. The results showed that INO-4800 induced a robust T cell response against all spike protein variants tested, which the company believes will be key in providing protection against SARS-CoV-2 variants, in addition to providing similar levels of neutralizing activity against both the UK and Brazilian variants as those against the original strain. The study, entitled "INO-4800 DNA Vaccine Induces Neutralizing Antibodies and T cell Activity Against Global SARS-CoV-2 Variants," has been submitted for peer review and can be viewed at https://www.biorxiv.org/content/10.1101/2021.04.14.439719v1.

Dr. J. Joseph Kim, INOVIO's President & CEO, said, "These results are consistent with our expectation that INO-4800, which was found to be well-tolerated and able to produce a balanced immune response in our Phase 1 trial, is able to generate both neutralizing antibodies and robust T cell responses – both of which will be essential to protect against the emerging variants of concern."

Regarding INO-4800 development Dr. Kim said, "We will report Phase 2 results in 2Q, and, with FDA concurrence, expect to move into Phase 3 in the second quarter of this year. Our COVID vaccine's projected safety profile, its stability at room temperature for more than a year, and likely ability to safely boost numerous times positions INOVIO's COVID-19 vaccine as an important factor in addressing the virus in its pandemic and endemic states."

https://www.tiogapublishing.com/news/state/inovios-covid-19-vaccine-candidate-ino-4800-provides-broad-cross-reactive-immune-responses-in-humans/article_38ff98ac-05b2-515f-a195-dd23eb2dc951.html