Nuk baby bottles sold on Amazon recalled over high lead levels

 A baby bottle manufacturer recalled a product sold exclusively on Amazon due to its high levels of lead. 

Last week, the Consumer Product Safety Commission (CPSC) announced the NUK baby bottles were being recalled because the markings on the outside of some bottles contained lead with levels higher than the federal limit. 

"The markings on the outside of the bottles contain levels of lead that exceeds the federal lead content ban. Lead is toxic if ingested by young children and can cause adverse health issues," the CPSC announced on their website. 

The agency noted that 100 units of the bottle were sold in the U.S., with 77 being purchased in Canada. The purchases took place over a four-year period between January 2018 and May 2022, and the product cost consumers approximately $20 per unit. 

The bottle was initially designed for newborn to six-month-old babies in the UK market.  (Getty Images / Getty Images)

The agency states that the product was made exclusively for the United Kingdom consumer market and was not intended to be sold in the U.S. The product was initially designed to be used by newborns to 6-month-old babies. 

"The glass bottles have a latex teat intended for 0 to 6 months old in 240 mL size," the CPSC said. "The brand name NUK is in white lettering, a graduated volume scale in white markings, and white and gray stars are on the outside of the bottle. Only the NUK-branded glass baby bottles described above that were manufactured for the UK market are included in this recall."

The agency urged customers to contact NUK, a German-based company, for how to return the item and receive a full refund. The Amazon seller, Astir Care, is also getting in contact with customers to return the product. 

NUK can be contacted toll-free at 888-685-1238 during normal work hours Monday through Friday. More information can be found on the company website under the "recall" page. 

The CPSC noted that no injuries or incidents have occurred as a result of the lead levels. 

https://www.foxbusiness.com/lifestyle/nuk-baby-bottles-sold-amazon-recalled-high-lead-levels

Pressure rises on Lucentis, as Coherus biosimilar gets FDA nod

 The US FDA has approved a new biosimilar of Roche and Novartis’ blockbuster ophthalmology therapy Lucentis – Coherus BioSciences’ Cimerli – which its developer claims is the first to be fully interchangeable with the originator product.

Cimerli isn’t the first biosimilar of Lucentis (ranibizumab) to be given the green light to be sold in the US, as that accolade goes to Samsung Bioepis’ Byooviz, which was cleared by the FDA last September.

It is, however, the first that can be substituted across all Lucentis’ five indications and to be fully interchangeable – which means it is considered to have no clinically meaningful difference compared to the reference drug in safety, purity, or potency and can be substituted for it without any prescriber intervention.

Byooviz launched on 1 July at a 40% discount to Lucentis, with a label that covers use of the biosimilar for wet age-related macular degeneration (AMD), macular oedema following retinal vein occlusion (RVO), and myopic choroidal neovascularisation. It has a list price of $1,130 per single-use vial.

Coherus, meanwhile, says it plans to launch Cimerli in October, with those three indications as well as diabetic macular oedema (DME) and diabetic retinopathy (DR), and for now, there’s no word on Coherus pricing strategy for the biosimilar.

Lucentis was first approved in the US in 2007 for wet AMD and grew quickly thereafter as additional indications were approved.

Roche has US marketing rights to the drug, and booked $1.3 billion in sales from it in 2021, while Novartis made $2.2 billion from sales in Europe – where Byooviz made its debut last year – and the rest of the world.

Coherus’ chief commercial officer Paul Reider said the availability of Cimerli will “provide both greater treatment access and choice for patients, payors and providers in the US retinal disease community.”

The availability of the Lucentis biosimilars could also have an impact on Bayer and Regeneron’s Eylea (aflibercept), which still has a few years of patent protection but could be affected by cut-price competition.

Novartis has attempted to protect its Lucentis franchise by developing follow-up Beovu (brolucizumab) which offers greater intervals between dosing but has been held back by safety issues.

Roche meanwhile recently secured FDA approvals for Susvimo, an implant version of ranibizumab that can extend the time between treatments to six months or more for wet AMD, as well as for Vabysmo (faricimab), a bispecific antibody that also provides less frequent dosing in wet AMD and DME.

https://pharmaphorum.com/news/pressure-rises-on-lucentis-as-coherus-biosimilar-gets-fda-nod/

San Diego County declares monkeypox public health emergency

 San Diego County has declared a public health emergency for monkeypox, two days after California Gov. Gavin Newsom (D) declared one for the entire state. 

Wilma Wooten, a public health officer for the county, made the declaration based on a limited vaccine supply being available, the large population and geographic area of the county, the global spread of the virus and the confirmed and probable local cases. 

Officials have confirmed 27 cases of monkeypox and consider an additional 19 cases as likely to be monkeypox as of last Friday, according to the declaration. 

Declaring a public health emergency will give the county more authority to use state resources to administer vaccines, utilize public health infrastructure to conduct testing and contact tracing and ensure health professionals have the resources they need with respect to the virus. 

The county’s Board of Supervisors must ratify the declaration within seven days and vote to extend it every 30 days as necessary, according to the county communications office. 

Newsom made the statewide declaration on Monday to help the state increase its efforts to combat the virus. Illinois and New York have also declared statewide emergencies for monkeypox. 

Monkeypox appears to be spreading mostly among men who have sex with men, but it can spread among anyone who has extended skin-to-skin contact with an infected individual. Symptoms can include rash, muscle aches, fever and respiratory symptoms. 

The communications office said that almost 4,000 doses of the monkeypox vaccine have been received. 

Only one infected patient has needed to be hospitalized, and no one has died. The case count will be updated daily from Monday to Friday, according to the office.

The Centers for Disease Control and Prevention have confirmed more than 6,000 cases nationwide.

https://thehill.com/homenews/state-watch/3586060-san-diego-county-declares-monkeypox-public-health-emergency/

Biden will order HHS to consider using Medicaid to support women seeking abortions across state lines

 President Biden on Wednesday will sign an executive order directing the Department of Health and Human Services (HHS) to consider using Medicaid to pay for expenses for those who cross state lines to seek abortions.

The executive order will direct HHS “to consider action to advance access to reproductive healthcare services, including through Medicaid for patients who travel out of state for reproductive healthcare services,” according to a White House fact sheet released on Wednesday.

The executive order will be the second that Biden has signed since the conservative Supreme Court struck down Roe v. Wade, the landmark abortion ruling, in June. Biden has been under pressure to take more aggressive actions to support abortion access as various states move to restrict the procedure following the ruling.

A senior Biden administration official told reporters on a call that the action would require states where abortion is legal to apply for Section 1115 Medicaid waivers to provide services for women crossing state lines for abortions.

The White House did not specify what costs Medicaid could potentially cover. A senior administration official told The Hill that HHS would soon provide more information on what a waiver could look like, saying it would help “cover certain costs” and largely target low-income women who receive Medicaid.

The White House had previously been looking at potentially turning to Medicaid to cover travel costs for women crossing states lines to receive an abortion, after the Supreme Court draft ruling leaked in May.

Medicaid funds could not be used to pay for abortions themselves because the Hyde Amendment prohibits the use of federal funds to pay for most abortions.

Biden will sign the new order Wednesday afternoon at the first meeting of a reproductive health care access interagency task force set up by his previous executive order. Vice President Harris, Health and Human Services Secretary Xavier Becerra, Attorney General Merrick Garland and other administration officials are scheduled to attend.

Biden is supposed to tune into the meeting virtually, as he is still isolating following a rebound infection of COVID-19.

The latest order will also instruct HHS to consider providing technical assistance and other actions to make sure health care providers comply with nondiscrimination laws in the wake of the ruling striking down Roe, according to the White House fact sheet.

Additionally, the order directs HHS to improve federal research and data collection in order to evaluate the impact that the striking down of Roe is having on maternal health, the fact sheet said.

The executive order is likely to be well-received by those asking the administration to take more forceful action on abortion access.

However, the Biden administration has thus far resisted calls from some Democrats to declare a public health emergency exists with respect to abortion access.

The senior administration official told reporters that the White House continues to review options to protect access to abortion services, but suggested that such a declaration would not yield much in the way of additional resources or legal authority.

A number of states have moved to enact restrictions on abortion following the ruling striking down Roe. On Tuesday, the Justice Department filed a lawsuit challenging Idaho’s six-week abortion ban in its first legal action since the Supreme Court’s ruling.

Back in June, Biden called on the Senate to alter the legislative filibuster — the 60-vote threshold needed to pass most bills in the upper chamber — in order to pass legislation codifying abortion rights, but he has since acknowledged that Democrats do not have the votes to do so and urged voters to elect more Democrats to Congress in November.

Wednesday’s task force meeting will take place a day after Kansas voters rejected an amendment that would have paved the way for abortion restrictions.

“This vote makes clear what we know: the majority of Americans agree that women should have access to abortion and should have the right to make their own health care decisions,” Biden said in a statement Tuesday night.

“Congress should listen to the will of the American people and restore the protections of Roe as federal law. While that is the only way to secure a woman’s right to choose, my Administration will continue to take meaningful action to protect women’s access to reproductive health care,” he said.

https://thehill.com/policy/healthcare/3585637-biden-will-order-hhs-to-consider-using-medicaid-to-support-women-seeking-abortions-across-state-lines/

Todos Medical Initiates Validation Plan for PCR-based MonkeyPox Test

 Todos Medical Ltd. (OTCQB: TOMDF), a comprehensive medical diagnostics and related solutions company, today announced that its CLIA/CAP-certified laboratory Provista Diagnostics has initiated a validation plan for PCR-based MonkeyPox testing. Under the plan, the Company is validating multiple PCR assays for MonkeyPox and will launch the most sensitive for lesion-based and saliva-based sample collections. While lesion-based testing is the current standard of care according to CDC guidelines, saliva-based sample collection is currently undergoing intense research that could open up the potential for testing of asymptomatic or very early-stage patients at high risk of severe disease (such as immunocompromised patients) that could result in earlier diagnosis and early intervention with therapeutic drugs such as Tecovirimat (TPOXX). TPOXX is an investigational drug candidate, and currently only available under an expanded access Investigational New Drug (EA-IND) protocol. The MonkeyPox tests are being developed as Laboratory Developed Tests (LDTs). A recent peer-reviewed article describing strong correlation of the sensitivity of lesion and saliva-based PCR testing was recently published in the journal Eurosurveillance: https://www.eurosurveillance.org/content/10.2807/1560-7917.ES.2022.27.28.2200503

“The significant investment we made to automate PCR testing at Provista to maximize COVID testing capacity can now be partially redeployed towards MonkeyPox as we prepare to help the nation scale-up MonkeyPox testing capacity to meet the emerging public health crisis,” said Gerald E. Commissiong, President & CEO of Todos Medical.

https://www.biospace.com/article/releases/todos-medical-initiates-validation-plan-for-pcr-based-monkeypox-test-at-clia-cap-clinical-testing-laboratory-provista-diagnostics/

Amylyx: FDA to Reconvene to Review for AMX0035 for ALS on September 7

 Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) today announced that the U.S. Food and Drug Administration’s (FDA) Peripheral and Central Nervous System Drugs Advisory Committee (PCNSDAC) will reconvene to review the New Drug Application (NDA) for AMX0035 (sodium phenylbutyrate and taurursodiol [also known as ursodoxicoltaurine]) for the treatment of amyotrophic lateral sclerosis (ALS). The second virtual meeting of the PCNSDAC to discuss the AMX0035 NDA is scheduled, as published in the Federal Register, for September 7, 2022.

The PCNSDAC previously met on March 30, 2022, to discuss the NDA for AMX0035 for the treatment of ALS. The FDA is reconvening the committee to discuss the additional analyses of data from the Company’s clinical studies that were determined by the FDA to constitute a major amendment to the NDA. As a result, FDA extended the Prescription Drug User Fee Act (PDUFA) target action date for the AMX0035 NDA to September 29, 2022, from the original date of June 29, 2022.

“We are determined to do everything we can to bring AMX0035 to people living with ALS, and we look forward to another robust scientific discussion with the members of the advisory panel regarding the additional analyses from our clinical studies and the potential of AMX0035,” said Jamie Timmons, M.D., Head of Scientific Communications of Amylyx. “We remain confident in the data, including the recently published analyses supporting the previously reported functional and overall survival benefit for AMX0035. There is an urgent unmet need for new and effective treatments in ALS, and our team is working nonstop to continue our mission to end the suffering caused by neurodegenerative diseases.”

https://www.biospace.com/article/releases/amylyx-pharmaceuticals-announces-fda-advisory-committee-will-reconvene-to-review-new-drug-application-for-amx0035-for-the-treatment-of-als-on-september-7-2022/

New Genetic Target Discovered by Regeneron could be Game-Changer for NASH

 Last week, the Regeneron Genetics Center shared exciting results from a study investigating the role of the CIDEB gene in liver disease. The center’s researchers have demonstrated a potential link between loss-of-function mutations in the gene and protection from disease development, including nonalcoholic steatohepatitis (NASH).

Using the genetic material and redacted health records of 540,000 people, encompassing a diverse demographic set, the potential link was discovered. People whose genetic material includes a loss-of-function mutation in a copy of the CIDEB gene are 54% less likely to develop nonalcoholic cirrhosis and 53% less likely to develop nonalcoholic liver diseases such as NASH. In addition to these protections, the mutations granted additional resilience against type 2 diabetes and obesity.

“The unprecedented protective effect that these CIDEB genetic variants have against liver disease provides us with one of our most exciting targets and potential therapeutic approaches for a notoriously hard-to-treat disease where there are currently no approved treatments," Aris Baras, M.D., SVP and head of the Regeneron Genetics Center, said. "RGC has repeatedly demonstrated the value of large-scale genetic sequencing in identifying novel and important targets for many serious diseases and this is yet another example of how we are fueling our pipeline through genetics discovery. Our growing dataset enables us to discover more rare and more powerful protective variants with the ultimate goal of improving human health."

The study was published in the New England Journal of Medicine, revamping an area of medical treatment that has failed to launch thus far. According to the American Liver Foundation, roughly 5% of the adult U.S. population suffers from NASH. Inflammation, liver cell damage and swelling of the liver are all possible manifestations. The condition can develop into cirrhosis after several years. There are no treatments available for conditions under the nonalcoholic fatty liver disease umbrella, including NASH. Several candidates have entered clinical settings without making it to the U.S. Food and Drug Administration (FDA) approval finish line.

Luca Lotta, M.D., Ph.D., vice president and head of cardiometabolic and musculoskeletal disease genetics at Regeneron highlighted the company’s range of liver disease candidates.

"RGC's discovery of CIDEB mutations, with one of the most powerful protections from liver disease seen to date, is a milestone in our understanding of the genetic basis of this disease," he said. "By catalyzing multiple therapeutic development programs targeting distinct genetic mechanisms of liver disease, the RGC's insights are helping Regeneron develop a diversified slate of genetically-validated targets for NASH, including HSD17B13, PNPLA3 and now CIDEB."

This study marks the CIDEB gene as a possible therapeutic target. A treatment that mirrors the effects of the loss-of-function mutation seen in this subset of the population could bring the risk of disease development down significantly.

Regeneron and partner Alnylam have developed an siRNA therapeutic candidate targeting CIDEB that the companies anticipate entering the clinic within the next year. This collaboration has yielded two other investigational gene silencing treatments for NASH, targeting the PNPLA3 and HSD17B13 genes. The latter is already in early clinical studies. All three candidates make use of Alnylam’s RNA interference technology to silence specific genes in the liver.

https://www.biospace.com/article/new-genetic-target-discovered-by-regeneron-could-be-game-changer-for-nash-/