Emergent BioSolutions’ NARCAN® Nasal Spray Launches Over the Counter

 

• Emergent has officially shipped its over the counter, original prescription strength NARCAN^® Naloxone HCl Nasal Spray 4 mg to leading mass, drug/pharmacy and grocery stores, as well as online retailers
• NARCAN^® Nasal Spray will be the first, life-saving emergency medicine for opioid overdose available on shelves beginning this September with a Manufacturer’s Suggested Retail Price of $44.99
• Emergent remains committed to ensuring broad access, awareness and strong supply for essential public interest groups leading naloxone distribution efforts across the country

https://www.biospace.com/article/releases/emergent-biosolutions-narcan-nasal-spray-launches-over-the-counter-making-it-possible-for-everyone-to-help-save-a-life-from-an-opioid-overdose-emergency/

J&J Updated Financials and 2023 Guidance After Kenvue Separation

 

• Company expects increased 2023 Reported Sales Growth of 7.0% - 8.0%, Operational Sales Growth of 7.5% - 8.5%, and Adjusted Operational Sales Growth of 6.2% - 7.2%; Figures exclude the COVID-19 Vaccine
• Company expects 2023 Adjusted Reported Earnings Per Share (EPS) of $10.00 - $10.10, reflecting increased growth of 12.5% at the mid-point and Adjusted Operational EPS of $9.90 - $10.00, reflecting increased growth of 11.5% at the mid-point
• Company reduced outstanding share count by approximately 191 million; 2023 guidance reflects only a partial-year benefit of approximately 73.5 million shares or $0.28 benefit to EPS
• Company secured $13.2 billion in cash proceeds from the Kenvue debt offering and initial public offering and maintains 9.5% of equity stake in Kenvue

https://www.biospace.com/article/releases/johnson-and-johnson-announces-updated-financials-and-2023-guidance-following-completion-of-the-kenvue-separation/

Alzamend Applies for Phase IIA Clinical Trial of AL001, a Next-Gen Lithium

 

• Safety aspects of AL001 development may qualify for (505)(b)(2) pathway for FDA approval

• Alzamend’s recently completed a Phase IIA Study of AL001 in Alzheimer’s and healthy patients that identified a candidate dose that is unlikely to require therapeutic drug monitoring

https://www.biospace.com/article/releases/alzamend-neuro-submits-ind-application-for-phase-iia-clinical-trial-of-al001-a-next-generation-lithium-therapeutic-drug-candidate-in-bipolar-disorder-patients/

Novo Buys Embark Biotech to Find New Avenues for Weight Loss

 Novo Nordisk A/S agreed to buy Embark Biotech, a Danish company working on appetite suppression, for up to €471 million ($512 million) as it seeks to retain its edge in the booming field of weight loss.

Shareholders of the closely held Embark Biotech will receive €15 million upfront and stand to gain as much as €456 million in potential milestone payments if a product advances through clinical trials and makes it to market, Novo said in a statement. The announcement also includes a three-year research and development collaboration agreement.

Novo has helped power the Danish economy as its medicines revolutionize the obesity market.

Last week, a study showed Wegovy, Novo’s blockbuster weight-loss medication, alleviated heart failure symptoms in patients with obesity.

Embark was formed in 2017 when it was spun out of the University of Copenhagen. Three scientists discovered a new target that suppresses appetite, increases energy expenditure and enhances sensitivity to insulin, the hormone that regulates how the body transforms sugar into energy.

https://finance.yahoo.com/news/novo-buys-embark-biotech-avenues-093310441.html

FDA declines to approve Outlook Therapeutics' eye disease drug

 Outlook Therapeutics said on Wednesday the U.S. Food and Drug Administration declined to approve its experimental eye disease drug, in part due to manufacturing issues observed during pre-approval inspections.

The company's shares were down about 78% at 30 cents in premarket trading.

The health regulator's decision marks the latest roadblock for the drug to enter the market, after Outlook Therapeutics last year withdrew its application following an FDA request for additional information.

Outlook Therapeutics said on Wednesday that although the trial for the drug met the goals of safety and efficacy, the FDA cited the need for further confirmatory clinical evidence.

The drug ONS-5010 is under development as an injection for the treatment of wet age-related macular degeneration (AMD) and other retinal diseases.

Wet AMD is a chronic eye disorder that causes blurred vision or a blind spot in the patient's visual field, and is the leading cause of blindness among the elderly.

Outlook Therapeutics had been pinning its hopes on the approval of the drug as the first eye-disease focused version of Roche's cancer drug Avastin.

Outlook Therapeutics will request a meeting with the FDA to address the issues. The European Medicines Agency is set to begin its review process for the drug, with a decision date expected early next year.

The company's application to the FDA was based on a late-stage trial, which showed the drug improved vision in 41.7% patients who were able to read at least 3 lines or 15 letters, when tested in their ability to distinguish shapes and the details.

https://news.yahoo.com/us-fda-declines-approve-outlook-103534479.html

Beating Biden’s Drug Plan

 

Voters worry about the government interfering in doctor-patient decisions and pulling money out of Medicare to spend on other priorities.

“The doctor is closer to the patient…I have family members who work in the medical community, so they live it firsthand where a doctor’s opinion…is overruled by an administrator who has little to no medical background.”

(Mitch, 66, Independent White Male, North Carolina)

Exclusive polling and focus groups from America’s New Majority Project reveal deep concerns about the potential consequences of policies that would reduce Medicare spending on prescription drugs.  

WHY IT MATTERS – The White House will announce a list of 10 drugs it is targeting for Medicare drug price negotiations on August 29th.

• The negotiation process gives the government enormous leverage, allowing it to offer the manufacturers a take-it-or-leave-it price.

WHERE THE PUBLIC STANDS – While public polling shows that the idea of Medicare drug price negotiation is superficially popular, our research reveals deep concerns once the potential consequences of the policy are known.

KEY TAKEAWAYS –

• Proposals to reduce Medicare spending on prescription drugs – including price controls and repealing the noninterference clause – have mixed support.
• The most effective arguments against giving the government more authority to reduce prescription drug spending in Medicare focus on:
  • The impact of lobbying and politics on drug coverage decisions.
  • Fewer patients receiving the medicines they need.
  • Money being taken from Medicare and spent elsewhere.
• There is overwhelming agreement that any savings in Medicare should be kept in Medicare – and most believe that money should be used to improve benefits.
  • Independents in focus groups reacted negatively upon learning that the Inflation Reduction Act took savings from drug price negotiation out of Medicare to spend on green energy initiatives.
• Americans believe Medicare spends much more on prescription drugs than it does. After learning drugs are only 12% of Medicare spending, while hospitals services are 40%, voters wonder why so much attention is paid to drug spending.

READ THE REPORT – Click on the image below to read the full report…or read the summary below.

Americans worry about the government becoming more involved in medical decisions and are suspicious of the government’s motives.

“I don’t trust the government making these decisions, and I sure do not trust big pharma.”

(Scotti, 40, Independent White Woman, Texas)

• 40% favor proposals that would give the government new authority to reduce Medicare spending on prescription drugs. 33% oppose and 27% don’t know.
• 65% say it is likely that these policies would lead to drug coverage decisions becoming more influenced by lobbying rather than doctor and patient decisions. 74% say this would be concerning.
• 63% say it is likely that fewer patients would receive the medicines their doctors recommend because the government won’t pay for them. 75% say this would be concerning.
• 59% say it is likely that savings in Medicare would be used to pay for other government programs instead of lowering what patients pay for medicines. 73% say this would be concerning.

Americans want savings found in Medicare to stay in Medicare – a principle the Inflation Reduction Act violated by diverting money from Medicare to green energy initiatives.

“The purpose of saving the money was for Medicare. If you don’t do that, then it just disappears.”

(Darlyn, 67, Independent White Woman, North Carolina)

• 67% of Americans say any savings found in Medicare should be kept in Medicare rather than used to reduce the budget deficit or other priorities.
  • 59% of those who want the money to stay in Medicare say it should be used to improve benefits rather than improve the financial health of the program.
• Older voters are more likely to say the money should be kept in Medicare, but even Gen Z voters have a plurality (47%) in favor of keeping Medicare savings in the program.

Americans are shocked to learn how little Medicare spends on prescription drugs relative to hospitals and physician services.

“Why are they so concerned about prescription drugs and not concerned about the high cost of anything related to hospitals?”

(Lisa, 57, Independent Black Woman, Arkansas)

• A plurality (34%) of Americans incorrectly believe Medicare spends more on prescription drugs than on hospitals or physicians.
  • In fact, Medicare spends nearly 40% of its budget on hospital services, about 25% on physicians services, and only 12% of prescription drugs.
• Focus group participants expressed surprise at learning the real percentages of spending and wondered why so much attention was paid to drug costs.

METHODOLOGY – The poll results in this report come from two surveys commissioned by America’s New Majority Project:

• The Winston Group, June 29-July 2, 2023, 1,200 Registered Voters
• McLaughlin and Associates, July 27-30, 2023, 2,000 Registered Voters

Focus groups with Independents were conducted by America’s New Majority Project on August 17 and 20, 2023.

https://americasnewmajorityproject.com/voters-concerned-about-efforts-to-reduce-medicare-spending-on-prescription-drugs/

Race to Succeed President Biden Is Heating Up on the 2024 Campaign Trail

 High-profile Democratic governors are stumping for President Biden’s 2024 re-election campaign and simultaneously auditioning to become the party’s next standard-bearer.

Their efforts signal they are unlikely to cede that role in 2028 to Vice President Kamala Harris, whose sluggish approval ratings have raised doubts among some donors and party officials about whether she can effectively succeed Biden.

California Gov. Gavin Newsom has toured red states such as Idaho, Mississippi, Arkansas and Alabama to campaign for Biden and other Democrats, and earlier this year launched a political-action committee targeting Republican policies. He has found a foil in Florida Gov. Ron DeSantis, a contender for the 2024 Republican nomination. They have run attack ads against each other, sparred over issues such as climate change, abortion rights and gun control and agreed to a debate moderated by Sean Hannity on Fox News.

Maryland Gov. Wes Moore raised money for Democratic governors on the sidelines of the annual Allen & Co. Sun Valley Conference in July, offered a televised response to the first GOP debate and attended recent fundraisers in New York’s summer enclaves of the Hamptons.

Pennsylvania Gov. Josh Shapiro will travel to New Hampshire next month for a keynote address to the state Democratic Party’s convention. And Gov. Gretchen Whitmer of Michigan, who was vetted as a possible Biden running mate in 2020, promoted the recent anniversary of the president’s climate and jobs legislation.

California Gov. Gavin Newsom is one of the Democrats currently building a national network, a common task for future presidential hopefuls. PHOTO: ASHLEY LANDIS/ASSOCIATED PRESS

The Democratic governors, including Illinois Gov. J.B. Pritzker, New Jersey Gov. Phil Murphy and North Carolina Gov. Roy Cooper, have endorsed Biden’s re-election and played down their presidential ambitions. But their work to build a national network, a common task by future presidential hopefuls, is more noteworthy this year as the president nears his 81st birthday and questions linger about whether he could serve a full second term that would take him to age 86.

Some Democrats privately say that should an unexpected health scare derail Biden’s re-election campaign, many high-profile Democrats, including governors and members of Congress, would consider getting in the 2024 race alongside Harris. 

Former Housing and Urban Development Secretary Julián Castro, who sought the Democratic nomination in 2020, said he expected any primary race to succeed Biden in 2028 would be “contested” and called Harris a “dynamic, compelling candidate in 2028.” But he added: “Do I think everybody’s just going to get out of the way? That’s hard to imagine.”

Biden faces minimal opposition in the primaries from Robert F. Kennedy Jr., the nephew of President John F. Kennedy, who has promoted various conspiracies.

A Biden campaign aide said the president had promised to be a conduit to the next generation of Democratic leaders and has intentionally ensured his re-election campaign would help do that through surrogates.

The party is only three years removed from its last presidential cycle, when more than two dozen Democrats sought its nomination. Those include candidates who could mount future presidential campaigns, including Harris, Transportation Secretary Pete Buttigieg and Sens. Cory Booker of New Jersey and Amy Klobuchar of Minnesota.

“In the absence of having a young, vibrant president, the party needs to put forward new faces, new voices,” said Nina Smith, a Democratic operative who worked for Buttigieg’s presidential campaign. “I think you’re seeing the next generation of political leadership in this country emerging through the Biden re-election campaign and who the surrogates are.”

Maryland Gov. Wes Moore offered a televised response to the first GOP debate. PHOTO: ULYSSES MUNOZ/THE BALTIMORE BANNER/ASSOCIATED PRESS

Harris’s political abilities have been a prominent focus of Biden’s first term and now his re-election campaign. Some Republican presidential candidates, such as former South Carolina Gov. Nikki Haley, have said that re-electing Biden would lead to a Harris presidency. Polls of Democrats suggest voters would have preferred an alternative candidate at the top of the ticket. 

Harris has recently stepped up her public engagements, countering complaints from some Democrats that the vice president has faded from public view, and emerged as the administration’s leading voice on issues such as abortion access and voting rights. Allies say Harris is singularly focused on the 2024 re-election campaign and not her political future, although some insist she will be a front-runner to lead the Democratic Party should she make another run for the White House.

Jamal Simmons, a former Harris communications director, said the vice president is an effective messenger against Republicans and suggested a contested primary would only make her stronger.

“I just think it would be incredibly hard to beat her with the institutional power she has, the democratic reach she has and her commitment to the issues that Democrats care about,” he said.

Buttigieg has focused on official travel as transportation secretary. His extensive travels promoting the infrastructure law and frequent cable television appearances have helped him maintain his role as one of the most recognizable Biden cabinet officials.

Vice President Kamala Harris will likely face opposition in the 2028 campaign from other Democrats. PHOTO: MARK BLACK/ASSOCIATED PRESS

The former South Bend, Ind., mayor has effectively frozen his political committee since joining the cabinet but still wields clout from his 2020 campaign. After Biden announced his re-election bid, Buttigieg helped organize a New York City fundraiser in May at the home of former Blackstone executive Tony James.

Newsom has been arguably the most visible among the governors in elevating his profile. While he has maintained those efforts are simply in the service of his party, those stops have enabled the California governor to cultivate a database of potential supporters and meet with donors in states often overlooked by national Democrats.

It is not uncommon for sitting or ex-vice presidents to face competition when seeking their party’s presidential nomination and ultimately prevail. George H.W. Bush and Al Gore both went through contested primaries. Mike Pence has struggled to gain traction in a crowded 2024 Republican field dominated by former President Donald Trump. Biden himself faced a crowded Democratic field in 2020. 

Shapiro’s trip to New Hampshire is expected to focus on the importance of Democrats winning the governor’s race next year following the decision by Republican Gov. Chris Sununu to not seek another term. The speech will take place a week before a Democratic National Committee meeting in St. Louis where the fate of New Hampshire’s first-in-the-nation primary could be decided.

“The most prominent figures on the Democratic bench are the ones out raising money for the Biden-Harris re-elect, and most of them are our Democratic governors,” said Alex Heckler, a Miami attorney who serves as deputy finance chair of the Democratic National Committee.

https://www.wsj.com/politics/elections/the-race-to-succeed-president-biden-is-heating-up-on-the-2024-campaign-trail-c23e70b1