Ohio lawmakers introduce abortion bill that goes further than Texas law

 Ohio Republicans introduced a bill on Wednesday that calls for a total ban on abortions in the state, reaching farther than the Texas “heartbeat” law that is currently under examination by the Supreme Court.

The bill, called the 2363 Act, which the lawmakers said is the number of children lost to abortion everyday in the U.S., seeks to ban all abortions in Ohio and, like the Texas law, empower “any person” to bring civil action against an individual who performs and abortion or “knowingly engages in conduct that aids or abets the performance or inducement of an abortion.”

Individuals who filed such lawsuits will be permitted to ask for $10,000 or more, according to Cleveland.com.

The legislation does not include exceptions for rape or incest, but it would shield abortion patients from being sued by individuals who may have gotten them pregnant through rape or another form of sexual violence.

The controversial Texas law bans abortion after a fetal heartbeat is detected, something that can occur as early as six weeks into a pregnancy — a point where many women will not know they are pregnant.

The U.S. Supreme Court is currently debating the Texas law, which sparked outrage nationwide when it was enacted in September.

The justices previously denied a request to block the law largely along ideological lines, but they are now giving the text another look.

The Ohio bill, if passed and signed into law, would ban defendants in civil suits from claiming ignorance or mistake of law as a defense, in addition to any personal belief that the legislation is unconstitutional.

Additionally, the text says that defendants cannot point to a court decision’s ruling as a defense if it is later overruled — even if it remained intact at the time of the abortion.

Ohio Rep. Jena Powell (R), who introduced the bill, said it is about protecting life.

“The sanctity of human life, born and preborn, must be preserved in Ohio,” Powell said, according to Cleveland.com. “The 2363 Act is about protecting our fundamental, constitutional right to be born and live. Abortion kills children, scars families, and harms women. We can and must do better.”

Ohio House Minority Leader Emilia Sykes (D) slammed the bill, calling it "an egregious assault on women, a dangerous attack on healthcare rights and an embarrassment for our state,” adding that “Ohio Republicans want to control women, but we won’t be silent.”

“Criminalizing care will disproportionately impact women of color, nonbinary people and those already at a disadvantage in our health and criminal justice system. ...Once again, Republicans are showing that the everyday needs of Ohioans are less important than scoring political points, likes and retweets,” Sykes said, according to Cleveland.com.

The Ohio state House has a 65 to 35 Republican majority.

A number of abortion-rights groups also condemned the bill.

Lauren Blauvelt-Copelin, the vice president of government affairs and public advocacy at Planned Parenthood Advocates of Ohio, said “lawmakers and anti-abortion vigilantes have no business making personal medical decisions for their neighbors.”

“Ohio has once again proved it is one of the most extreme states for abortion access. This bill goes further than Texas Senate Bill 8, the most extreme abortion ban in the country, and would ban all abortions. It allows anyone — including anti-abortion protesters who have no connection to the patient — to act as paid bounty hunters and take doctors, health centers, and anyone who helps another person access abortion to court and get no less than $10,000. Banning abortion would be catastrophic to communities across Ohio,” she added in a statement.

https://thehill.com/homenews/state-watch/579944-ohio-lawmakers-introduce-abortion-bill-that-goes-further-than-texas-law

WHO approves use of India's Covaxin in boost to global vaccine campaign

 The World Health Organization approved India’s Covaxin for emergency use on Wednesday, a move likely to bolster global supply of vaccines to fight the COVID-19 pandemic. 

The WHO noted that the Covaxin COVID-19 vaccine is 78 percent effective against the virus at least two weeks after the second dose is administered. 

WHO’s Strategic Advisory Group of Experts on Immunization (SAGE), which provides policies and recommendations on vaccines, recommended that adults take two doses of Covaxin spaced out over four weeks.

WHO noted that it is the eighth vaccine the organization has authorized for emergency use. 

The seven other vaccines approved for use by WHO include Moderna, Pfizer-BioNTech, Johnson & Johnson, two versions of Oxford/AstraZeneca, and China's Sinopharm and Sinovac-CoronaVac. 

“This emergency use listing expands the availability of vaccines, the most effective medical tools we have to end the pandemic,” Mariângela Simão, WHO assistant director general for access to medicines and health products, said in a statement.

“But we must keep up the pressure to meet the needs of all populations, giving priority to the at-risk groups who are still waiting for their first dose, before we can start declaring victory,” she added. 

WHO said that because it is easier to store compared to other vaccines, the Covaxin vaccine was considered an “extremely suitable” choice for lower- and middle-income nations. 

The announcement is sure to be welcomed by the Covax initiative, given that the Covaxin vaccine can now be  distributed to other lower income countries, according to The Washington Post. India is the world's largest manufacturer of vaccines. 

“The Emergency Use Listing approval by WHO validates the international safety and quality standards of COVAXIN®. Bharat Biotech is motivated to mitigate the worldwide pandemic,” Bharat Biotech, the developer behind the Covaxin vaccine, said in a tweet on Wednesday.

The Emergency Use Listing approval by WHO validates the international safety and quality standards of COVAXIN®. Bharat Biotech is motivated to mitigate the worldwide pandemic. #Indianinnovationglobalvalidation #indiasfirstindigenouscovidvaccine #covid19 #covaxin @WHO pic.twitter.com/zN7wefyP5U

— BharatBiotech (@BharatBiotech) November 3, 2021

https://thehill.com/policy/healthcare/579995-who-approves-use-of-indias-covaxin-in-boost-to-global-vaccine-campaign

Democrats circulate new drug pricing outline with big carveout for small biotechs

 A proposed version of drug pricing legislation circulating among Capitol Hill aides and lobbyists includes an expansive carveout for small biotechnology companies and significantly waters down a provision to let Medicare negotiate drug prices, according to a draft obtained by STAT.

The new compromise would only allow the health secretary to negotiate the price of drugs that are manufactured by a single company that have outlasted their initial exclusivity periods granted by the Food and Drug Administration. The number of negotiation-eligible drugs would be small, too: 10 medicines beginning in 2025, with a gradual increase to 30 by 2028. Insulin products would also be eligible.

The draft also includes a number of generous protections for small biotechnology companies, a $2,000 cap on out-of-pocket costs for seniors, and a system of mandatory discounts on drugs whose prices rise faster than the rate of inflation.

Though the document provides new details about lawmakers’ deliberations, a Democratic leadership aide warned that a final drug pricing deal might include changes to the policies included in the document. Separately, two Democratic congressional staffers and multiple lobbyists cautioned that it may be outdated.

It’s not clear whether the compromise has full buy-in from enough Democrats in the House or Senate. Democrats cannot afford to lose a single vote in the Senate, where they hold just 50 seats. In the House, Democrats hold just an eight-seat majority, meaning they can lose up to three votes among their 220 members.

Democratic leaders including House Speaker Nancy Pelosi, Senate Majority Leader Chuck Schumer, and Congressional Progressive Caucus Chair Pramila Jayapal (D-Wash.) said Tuesday that talks on prescription drug pricing are ongoing.

On Medicare negotiation, lawmakers appear to be taking a different approach than tying negotiated prices to international prices or other domestic metrics, as they had previously discussed. Instead, the negotiated price would be subject to strict ceilings, depending on the expiration date of the drug’s initial exclusivity period — five years for small-molecule drugs and 12 for biologics.

The negotiated price ceilings are proposed in tiers. Under the proposal, Medicare would pay no more than 76% of the price that non-federal insurers pay for small-molecule drugs that have been on the market for between five and 12 years. For a drug on the market between 12 and 16 years, the cap would be 55% of the non-federal price, and after 16 years, the cap would be 30%.   

The framework also preserves an excise tax on drug makers’ revenue if they fail to participate in the negotiation process, though the outline doesn’t give a specific level for the tax. Earlier versions had put that tax as high as 95%.

The scaled-back policy is sure to disappoint many progressive lawmakers, who have long advocated a far stronger form of Medicare negotiation, aimed in particular at expensive new drugs that account for the lion’s share of the program’s spending on medicines. 

The proposal includes three other major elements: Namely, a restructure of Part D, Medicare’s prescription drug benefit; a number of “special rules” that exempt biotechnology companies from negotiation requirements; and a provision forcing rebates for drugs whose prices rise faster than the rate of inflation. 

The document provides little insight into the cap on price hikes, besides clarifying that the formula to determine penalties for drug makers would be based on 2021 prices, not retroactively based on 2016 prices, as Democratic leadership had hoped.

The biotech carveout is far more detailed. No drug that accounts for less than $200 million in Medicare spending would be eligible for negotiation, according to the draft. Companies “meeting the definition of small biotech” would be excluded from negotiations for three years after the program takes effect, meaning they wouldn’t be subjected to the process until 2028 at the earliest. 

Small biotechs would also get negotiated prices phased in over two years if their drugs are chosen for negotiation, as STAT first reported was under consideration.

The document defined “small biotech” as companies where a single drug accounts for 80% or more of revenue, but constitutes less than 1% of the overall Medicare expenditure on prescription medicines. 

The Part D restructure would cap out-of-pocket costs for seniors at $2,000, and cap co-pays for insulin products at $35 each month. Drug makers would also take on 20% of the payment liability when seniors’ costs exceed the cap, compared with the zero liability they currently have. But small biotech companies would have their liability phased in over six years to lessen the blow.

https://www.statnews.com/2021/11/02/new-drug-pricing-outline-limited-medicare-negotiation-carveout-small-biotechs/

COVID-19 is a Sprint AND a Marathon, Requiring New and Better Vaccines

 With about 51% of the world at least partially vaccinated against COVID-19 and 23 vaccines authorized for use in various countries, companies are still developing new vaccines for this pandemic and, in some cases, for what may come afterward. While some may wonder about the commercial future of these late-to-the-market solutions, the developers themselves are taking a long view.

“COVID-19 is both a sprint and a marathon,” Martin Moore, Ph.D., CEO of Meissa Vaccines told BioSpace. “It’s obvious COVID-19 isn’t going away, and few would say the Delta variant will not be the last variant of interest. If you look at the vaccines in use now, they’re injectable. They prevent serious diseases, but many experts think they won’t block transmission, and that is important for the next generation of vaccines –  especially ones that can be administered intranasally.”

Andrey Zarur, Ph.D., co-founder and CEO of GreenLight Biosciences, acknowledged the dire nature of the virus but also stressed another aspect. “We’re a family. We need to care for one another. We have a responsibility to make technological advancements available to everyone,” he said, noting low vaccination rates throughout Africa, Eastern Europe and parts of Asia. It’s also a matter of self-preservation, he explained. “If a large portion of the global population isn’t vaccinated, people get infected. Then the virus mutates and comes back to us.”

The mutating and seemingly persistent nature of the SARS-CoV-2 virus, therefore, calls for new types of vaccines. “The current vaccines are still quite effective against SARS-CoV-2 and current variants,” Dr. Barton Haynes, M.D., director of the Duke Human Vaccine Institute at Duke University School of Medicine, told BioSpace. “However, if variants arise that are completely resistant to the current COVID-19 vaccines, we need to have vaccines ‘on the shelf’ that can be rapidly deployed.

“Moreover,” Haynes continued, “for future pandemic preparedness, we need vaccines that will be effective for any new coronaviruses that arise in humans. We have now had three coronavirus outbreaks during the past 20 years, and one that became a global pandemic. It is probable we will see more coronavirus outbreaks in the future.” 

Researchers at Duke, therefore, developed a pancoronavirus vaccine that targets SARS-like coronaviruses, including the current variants of concern. “Now we are moving to other groups of more disparate coronaviruses that are different from the SARS-CoV-2 virus, like the Middle Eastern Respiratory Syndrome (MERS) coronavirus group,” Haynes said. The Duke Human Vaccine Institute was just awarded a three-year, $17.5 million grant from the National Institute of Allergy and Infectious Disease to do that. Duke researchers also are trying to develop a vaccine against the coronaviruses that cause about 30% of the common cold syndromes.

For the current pandemic, Meissa is focused upon a method to block transmission and generate a better immune response against the SARS-CoV-2 virus and its variants by using an intranasal vaccine. The rationale for an intranasal vaccine, Moore explained, is to establish immunity at the site of infection – the nose. Injected vaccines typically induce only serum (IgG) antibodies that circulate in the blood. Intranasal administration also generates mucosal (IgA) antibodies in the nasal cavity.

Just-announced Phase I clinical data from 49 patients shows a strong nasal IgA antibody response in seropositive and seronegative adults after a single dose of MV-014-212. This vaccine is specifically designed to overcome the typical trade-off among live attenuated vaccines and be both highly attenuated (safe) yet confer broad and durable immunity that resembles natural immunity to SARS-CoV-2. “This could be a tool to get back to normal,” Moore said.

“In the big picture, I think our vaccine could be useful as a primary vaccine in children and as an intranasal booster in vaccinated people,” he continued. It offers relatively low manufacturing costs, needleless administration and can be given in a single dose, which makes it particularly beneficial for those unable or unwilling to return to vaccination sites for second injections or for those who have issues with needles.

GreenLight also is taking a newer approach, focusing on improved mRNA vaccines and more scalable manufacturing. As Zarur said of mRNA vaccines, “we’ve learned what works and doesn’t work,” and so have the opportunity to use those learnings to make mRNA vaccines “more stable, more efficient and better in general.” The mRNA vaccine being developed by GreenLight isn’t yet in clinical trials, he said.

In studies involving Syrian golden hamster models, however, the vaccine-induced Th1-biased cell-mediated immune responses. At a single dose, Zarur said, “we’re achieving titers of neutralization antibodies and activation of T cells that are comparable with data from approved vaccines.” GreenLight plans to begin a Phase I clinical study in South Africa in Q1 2022 to determine whether those results will translate to humans.

For any of these vaccines to gain traction in developing regions (where refrigeration may not be reliable), temperature stability will be an issue. GreenLight is working toward that goal with several different lipid nanoparticles, some of which are stable at room or refrigerated temperatures.

If the COVID-19 pandemic becomes endemic, as many suggest it will, vaccinations against the coronavirus are likely to become as regular as vaccinations against the seasonal influenza. In that scenario, vaccine developers will have plenty of time to perfect their vaccines and get them approved, regardless of where they are in development today.

https://www.biospace.com/article/covid-19-is-a-sprint-and-a-marathon-requiring-new-and-better-vaccines-/

COVID proteins that trigger strokes and heart attacks identified by Israeli team

Israeli scientists have identified the virus proteins that are triggering strokes and heart attacks in COVID-19 patients, in a breakthrough they expect will pave the way for new drugs.

The scientists made the discovery by taking a “peek in the virus’s black box,” Dr. Ben Maoz of Tel Aviv University told The Times of Israel, explaining that his team analyzed all 29 proteins of the virus to figure out which of them are wreaking havoc in the vascular system.

“Coronavirus isn’t the purely respiratory disease we first thought, and we have identified the proteins that put patients at increased risk of stroke, heart attack, and other problems associated with the vascular system,” Maoz said.

He identified the five proteins in SARS-CoV-2 that lead to vascular problems in the peer-reviewed journal eLife.

“This work could well help scientists to develop drugs to counter the effect of the coronavirus on the vascular system, by providing an understanding of exactly which proteins, or pieces of the virus, are causing problems,” said Maoz.

His lab, which focuses on biomedical engineering and neuroscience, collaborated with other Tel Aviv University departments to create a simulation of a human vascular system and observe the impact of all 29 coronavirus proteins. From their analysis, they were able to identify which of them affected the vascular system — and how.

“We have not only discovered which proteins have an impact on the vascular system, but also seen how exactly they exert their effect,” said Maoz. “What we found is these specific proteins make your vasculature more leaky. The tubes become more porous and cannot hold liquid as you would hope. This information is also valuable in efforts to develop drugs.”

Maoz hopes to lay foundations for more nuanced treatment of coronavirus.

“To this day the virus has been treated as one entity, despite the fact that it affects different parts of the body in different ways,” he said.

“All the evidence shows that the virus severely damages the blood vessels or the endothelial cells that line the blood vessels. I hope that our research will prove useful in enabling more targeted treatment.”

https://www.timesofisrael.com/covid-pieces-that-trigger-strokes-and-heart-attacks-identified-by-israeli-team/

CDC Panel: All Adults Ages 59 and Younger Should Get Hep B Vaccine

 Adults ages 59 and younger, and adults ages 60 and up who have risk factors for hepatitis B virus (HBV), are recommended to be vaccinated against HBV, the CDC Advisory Committee on Immunization Practices (ACIP) said in a unanimous vote Wednesday.

ACIP voted 15-0 to recommend this split philosophy for HBV vaccination. The initial recommendation from CDC staff was universal HBV vaccination for all adults ages 18 and up, but an amendment to separate out the age groups, and retain the risk-based recommendation for older age groups, passed 8-7 earlier in the day.

The current risk-based recommendation applies to:

• People at risk for infection by sexual exposure or percutaneous or mucosal exposure, such as injection-drug users
• Other risk groups, such as international travelers with high or intermediate levels of endemic HBV infection
• People with chronic liver disease
• Incarcerated people
• People living with HIV

This would be consistent with the current immunization schedule, with CDC staff adding that any adult who wishes to receive protection may receive the vaccine, meaning all adults ages 60 and up who do not have any HBV risk factors.

At issue was mainly cost parameters. CDC staff presented a slide that showed the cost-effectiveness analysis with an age limit of 59 versus all adults. The total incremental cost was $10 billion less for adults ages 59 and younger versus all adults (around $22 billion vs $32 billion), and the doses given rose from 298 million to 352 million.

Interestingly, a recommendation for universal vaccination was only estimated to reduce acute HBV infections by 24% compared to a 23% reduction for an age limit of 59 or younger.

ACIP chair Grace Lee, MD, also pointed out that while the cost analysis examined a vaccination program, it did not include the full scale of the intervention, which included a screening program for HBV seropositivity.

She speculated the cost was "probably a conservative estimate" and pointed out that there was little gain for increased cost.

"The cost is high for people over 60," added Beth Bell, MD, of the University of Washington in Seattle.

The other side of the argument -- and one supported by the majority of liaison members who spoke up -- was for universal vaccination, with committee members arguing that it would help to promote health equity, especially given the racial/ethnic disparity among HBV cases, with more adults affected in minority communities.

"A simplification of this recommendation will reach more individuals at risk ... and promote health equity," especially among those disproportionately affected by HBV, said Sybil Cineas, MD, of the Warren Alpert Medical School of Brown University in Providence, Rhode Island.

Liaison members agreed. Former ACIP chair Carol Baker, MD, spoke on behalf of the Infectious Diseases Society of America (IDSA) and said the organization "strongly supports universal hepatitis B vaccination."

"Risk-based [recommendation] is a failed policy. The evidence is overwhelming," she added.

Jason Goldman, MD, of the American College of Physicians, noted that any risk-based recommendation would mean patients would have to disclose their risk factors to their providers, which many may not be comfortable doing.

As always, all ACIP recommendations are not considered final until they are published in the Morbidity and Mortality Weekly Report.

https://www.medpagetoday.com/meetingcoverage/acip/95427

Supernus ups guidance after Q3 results

 Full Year 2021 Financial Guidance

For full year 2021, the Company increases its financial guidance for operating earnings, lowers its financial guidance for total combined R&D and SG&A expenses, and lowers the top end of its financial guidance range for total revenues as set forth below:

	Full Year 2021 Guidance (excluding Adamas-related transaction costs) ($ in millions)
	Current			Prior
Total revenues (1)	$550 - $570			$550 - $580
Combined R&D and SG&A expenses	$370 - $400			$380 - $410
Operating earnings (2)	$90 - $95			$70 - $90
Amortization of intangible assets	$24			$24
Effective tax rate (3)	28% - 31%			28% - 31%

___________________________________________
⁽¹⁾ Total revenues include net product sales and royalty revenue. Includes $10 million for Qelbree net product sales.
⁽²⁾ Operating earnings include amortization of intangible assets and contingent consideration expense (gain).
⁽³⁾ The full year 2021 effective tax rate guidance of 28% - 31% is above the normally expected range of 26% - 28% primarily due to the effect of a one-time tax item in the period.

Conference Call Details

Supernus will host a conference call and webcast today, November 3, 2021, at 4:30 p.m. Eastern Time to discuss these results.

Please refer to the information below for conference call dial-in information and webcast registration. Callers should dial in approximately 10 minutes prior to the start of the call.

Conference dial-in:	(877) 288-1043
International dial-in:	(970) 315-0267
Conference ID:	7595459
Conference Call Name:	Supernus Pharmaceuticals Third Quarter 2021 Results Conference Call

Following the live call, a replay will be available on the Company's website, www.supernus.com, under “Investor Relations”.

https://www.biospace.com/article/releases/supernus-announces-third-quarter-2021-financial-results/