FDA proposes rule to offer over-the-counter hearing aids

 The Food and Drug Administration (FDA) is proposing a rule to offer a new category of over-the-counter hearing aids in an attempt to boost accessibility and lower costs for the devices for Americans.

The agency announced its proposal on Tuesday that would allow certain hearing aids to be sold directly to the millions of adults who have “perceived mild to moderate” hearing loss, once it is finalized. 

Under the updated rule, these patients could purchase specific air-conduction devices in stores or online without undergoing a medical exam or fitting. Adults with severe hearing loss or children with any hearing loss would still need a prescription. 

Officials expect the proposed regulations to “likely” allow less costly hearing aids to be sold and available to the public, thus increasing competition in the market. For safety, the rule covers specific device performance and design requirements, including a maximum volume limit.

The FDA’s proposal implements the Over-the-Counter Hearing Aid Act, which was signed into law as part of the FDA Reauthorization Act of 2017.

Health and Human Services Secretary Xavier Becerra said in a statement that the move “takes us one step closer to the goal of making hearing aids more accessible and affordable for the tens of millions of people who experience mild to moderate hearing loss.”

Sens. Elizabeth Warren (D-Mass.) and Chuck Grassley (R-Iowa), who introduced the 2017 law, praised the FDA’s proposal as “terrific news” in a joint statement.

“We’ve just cleared a major regulatory hurdle for over-the-counter hearing aids,” the senators said. “Soon, millions of people with mild to moderate hearing loss will finally have lower cost hearing aid options — and more options mean more competition in the market, further driving down the cost for consumers.”

The two senators had sent a letter to the FDA last week, pushing it to follow through with President Biden’s July executive order requesting the agency submit regulations for over-the-counter hearing aids within 120 days. 

About 37.5 million — or 15 percent — American adults say they have hearing issues, but only around one-fifth of people who could be assisted by a hearing aid use one.

Progressives have prioritized expanding Medicare to cover hearing, vision and dental care in Democrats' budget reconciliation package this year. With a slim majority in the House and Senate, the party has been negotiating with moderates in the hopes of achieving the goal, with Sen. Bernie Sanders (I-Vt.) calling its inclusion in the spending package “not negotiable.” 

https://thehill.com/homenews/administration/577365-fda-proposes-rule-to-offer-over-the-counter-hearing-aids

MeiraGTx Presents on 2 Novel Inherited Retinal Disease Programs

 Three Poster Presentations Highlight Versatility and Novelty of MeiraGTx’s Gene Therapy Development Platforms

Novel Synthetic Riboswitch Platform Reversibly Regulates Gene Expression to High Dynamic Range and Drives Precise Dose Responsive Activation of Transgene Expression In Vivo

MeiraGTx Holdings plc (Nasdaq: MGTX), a vertically integrated, clinical stage gene therapy company, today announced three poster presentations at the European Society of Gene and Cell Therapy (ESGCT) 2021 Annual Congress. Two pre-clinical programs addressing Inherited Retinal Diseases (IRDs) caused by mutations in KCNV2 and GUCY2D are presented with data supporting the development of these viral vectors as gene therapies.

A third presentation outlines MeiraGTx’s proprietary gene regulation platform demonstrating tight regulation of gene expression to high dynamic range in mammalian cells and precise regulation in vivo in response to dosing of an oral small molecule.

“We’re pleased to present data illustrating the depth and versatility of our scientific platform, including early data on optimized viral vectors for two Inherited Retinal Diseases, as well initial data from our novel gene regulation platform,” said Alexandria Forbes, Ph.D., President and Chief Executive Officer of MeiraGTx. “Since our formation more than six years ago, in addition to developing novel vectors for gene replacement therapies in inherited diseases such as IRDs, we have aimed to develop gene regulation technology that may be applied to larger more common diseases. The Company’s synthetic riboswitch gene regulation system provides an unprecedented platform for spatial and temporal control of gene therapy with broad implications for the applicability of genetic medicines for treating a wide range of potential disorders not limited to inherited diseases. We look forward to discussing our riboswitch gene regulation platform in more detail at an R&D Day later this year.”

MeiraGTx continues to anticipate up to two new INDs for novel viral vectors addressing IRDs in 2022.

The Company will hold a research and development day in December 2021 in which further data on its synthetic riboswitch gene regulation platform as well as the Company’s proprietary promoter platforms will be presented.

https://www.kulr8.com/news/money/meiragtx-announces-the-presentation-of-two-novel-inherited-retinal-disease-ird-programs-and/article_60882b5b-f134-50b0-8f1c-309814913910.html

Galera misses primary endpoint in Phase 3 trial

 Primary endpoint of reduction in incidence of severe oral mucositis (SOM) not met

Trial demonstrated relative reduction in all key SOM endpoints, including more than halving the median duration

Avasopasem was generally well tolerated compared to placebo

Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, today announced results from the Phase 3 ROMAN trial of avasopasem manganese (avasopasem) for severe oral mucositis (SOM) in patients with locally advanced head and neck cancer (HNC) undergoing standard-of-care radiotherapy. The trial did not meet its primary endpoint of reduction in the incidence of SOM. The Company is continuing to analyze the results.

“While the data, as in previous trials, showed reductions in the incidence, duration and severity of SOM, we are surprised and disappointed that the trial did not achieve statistical significance in its primary endpoint,” said Mel Sorensen, M.D., Galera’s President and CEO. “We would like to extend our heartfelt thanks to the patients who participated in this trial while they underwent radiotherapy for head and neck cancer. As we evaluate next steps for this program, we remain committed to our goal of transforming radiotherapy in cancer treatment with our selective dismutase mimetics.”

https://finance.yahoo.com/news/galera-announces-results-phase-3-110000634.html

Bayer sees no guidance hit from hurricane, planting trends

 

Bayer sees no impact on its full-year guidance from customers' changing planting habits or a five-week shutdown at its main glyphosate production site in Louisiana after Hurricane Ida, the German life science group said on Tuesday.

"We lost five weeks of production. This will, of course, involve some cost that will have an impact on sales, but nothing to any degree that would impact our full year guidance for this year," Liam Condon, president of Bayer's agricultural unit, told investors during an online event.

Asked if rising crop protection prices may push some customers to shift to soybeans from corn, Condon said he would see any changes as seasonal fluctuations rather than anything that could affect the unit's outlook.

"Most farmers have a fixed rotation between corn and soybeans. They usually look at what they what they had in the past season and aim to rotate to keep the soil fertile," he said.

https://www.marketscreener.com/quote/stock/BAYER-AG-436063/news/Bayer-sees-no-guidance-hit-from-hurricane-planting-trends-36719421/

Yes, the water in Central Park can be toxic — especially for dogs

 This water in Central Park could spell out doomsday for dogs across NYC.

Toxic algae has been spotted within several water sources in Manhattan’s ecological jewel, and while the effects on people are minimal, pets can be at great risk.

Harmful algal blooms (HABs), which are found mostly in times of warm weather, have been reported as recently as Oct. 5 in the Central Park Lake and Turtle Pond near Belvedere Castle, the New York State Department of Environmental Conservation (NYSDEC) confirmed.

NYSDEC also found HABs in the Harlem Meer on Sept. 13 and the park’s catch and release fishing has been suspended there due to the algae, according to the Central Park Conservancy.

“The toxins emitted from algal blooms can be especially dangerous for dogs,” a spokesperson for the Central Park Conservancy told The Post in a written statement.

Yuck! The algae in Central Park’s bodies of water can contain toxins that are highly dangerous for animals, especially dogs.

Stephen Yang

HABs can even be fatal for dogs, Manhattan-based veterinarian Dr. Lisa Lippman told The Post.

“We have a lot of patients who are concerned about it. Ingesting the algae can range in symptoms from mild to severe and can be deadly.”

According to Lippman, concerned dog owners should look out for symptoms such as excessive drooling, vomiting, diarrhea, disorientation, jaundice, seizures and difficulty breathing, all of which can appear days after ingestion.

“It’s very complicated because it’s difficult to tell how toxic the algae is just from looking at it.”

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Since the toxic ones are difficult to identify by eyesight alone, “it’s important to avoid contact with any algae” in the park, according to NYC Department of Parks & Recreation press officer Megan Moriarty, who noted that pets should not be drinking from the regularly tested water sources — unless it’s in a specifically designated area.

While most people know to avoid lapping up green water in Central Park, the same can’t be said for canine companions.

Jorge Krauss steers Roma, his daughter Josefina’s dog, away from the lake in Central Park.

Stephen Yang

“Some dogs will try running straight to the water but I never let them near it. I can’t have a dog die on my hands,” dog walker and sitter Ashley Vaello of Fordham told The Post, while keeping an eye on a client’s purebred Staffordshire named Boots.

An owner of both a pit bull and a miniature pinscher who frequents the park, Vaello said the challenge with her own pups is that they love playing with turtles and she has to constantly stop them from trying to lick their shells.

Kavita Shah’s “very agile” dog Nina is chomping at the bit to go near water.

Stephen Yang

Vaello, who is familiar with HABs, said she’s seen plenty of irresponsible dog owners break the park’s seemingly obvious rules and do the unthinkable.

“Dogs totally swim in that water, I’ve seen owners let their dogs in it during off-leash hours. I don’t get it. I was in the park last year when they pulled a body from a pond. How do you let your dog go in there?”

While the risks associated with incidental contact like licking a turtle’s shell are minimal, plunging into the infested water presents an extreme risk, Lippman said.

“A dog swimming in it who then licks their coat could become a fatal case.”

Warning signs for HABs appear throughout Central Park, especially where there is open water.

Stephen Yang

Meanwhile, Central Park has posted bright yellow warning signage near HAB-contaminated water.

Still, many pet owners are unfamiliar with HABs and the dangers they can present.

However, common sense usually kicks in.

“You can just tell by looking at the water that it’s bad news,” said nurse and Upper West Side resident Josefina Krauss, while walking her cavapoo, Roma, near Bethesda Fountain. “There’s no chance I’d ever let my dog in there.”

Josefina Krauss would never let her dog into the Central Park water, she said.

Stephen Yang

Other dog owners have a more laissez-faire attitude, such as Greenwich Village resident and jazz singer Kavita Shah, who was recently in the park with her border collie Nina.

“I think she’s intuitive enough to know that this water is bad … no, Nina, stop!” Shah yelled mid-interview as her dog lunged for the lake.

HABs were previously spotted in Manhattan’s Harlem Meer and Brooklyn’s Prospect Park Lake in August 2019.

NYSDEC offers an interactive map that flags reports of HABs around the state. They have recently been spotted in Brooklyn’s Prospect Park, the Bronx’s Crotona Park, Kissena Park in Queens and on Long Island’s East End.

https://nypost.com/2021/10/18/the-water-in-central-park-can-be-toxic-especially-for-dogs/

Merck gains after Atea, WHO news

 Atea Pharmaceuticals  (ATEA)  shares collapsed Tuesday after the drugmaker said its developing COVID treatment failed to meet expectations of reducing patient virus levels in critical mid-stage trial.

The drug, developed in partnership with Swiss pharma giant Roche, did provide some reduction in the viral load of high-risk patients with underlying conditions, but failed to meet the goal of a 'clear reduction' in patients with mild or moderate forms of the disease. 

The treatment, known as AT-527, was meant to be a potential competitor to Merck & Co.'s  (MRK) - Get Merck & Co., Inc. (MRK) Report 'molnupiravir', a pill designed for treatment of "mild-to-moderate COVID-19 in adults who are at risk for progressing to severe COVID-19 and/or hospitalization."

“The primary endpoint was not achieved in the overall study population in patients with mild or moderate COVID-19, however, MOONSONG topline data suggest that AT-527 has antiviral activity in high-risk patients with underlying health conditions as we previously reported in the Phase 2 hospitalized study," said founder and Atea CEO Jean-Pierre Sommadossi. 'Based on these and other AT-527 data, we with our partner Roche, are assessing potential modifications to the Phase 3 MORNINGSKY protocol that may likely lead to improved clinical outcomes” 

“We remain committed to our goal of developing and delivering AT-527 as an oral antiviral that will address treatment needs as COVID-19 continues to evolve,” he added.

Atea Pharmaceutical shares were marked 73% lower in pre-market trading Tuesday to indicate an opening bell price of $11.05 each, a move that could wipe more than $2 billion from its market value. 

Merck shares, meanwhile, jumped 2.66% to $79.20 each on the back of both the Atea trial results and a Reuters report that suggested the World Health Organization would lead the purchase of hundreds of millions of COVID treatments, tests and vaccines that could include the molnupiravir pill.

https://www.thestreet.com/markets/atea-pharma-stock-plunges-after-covid-treatment-trial-disappoints

Sage, Biogen Plan to Submit New Drug Application for Depression Med in 2H 2022

 Following the pre-NDA meeting, the companies confirmed the current efficacy and safety databases are expected to be adequate for filing with confirmed pathways for MDD and PPD

The planned initial submission package will be for the treatment of MDD with an anticipated PPD filing thereafter

Sage Therapeutics, Inc. (Nasdaq: SAGE) and Biogen Inc. (Nasdaq: BIIB) today announced their plan to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for zuranolone, an investigational two-week, once-daily therapeutic in the second half of 2022. The planned initial submission package will seek approval of zuranolone for the treatment of major depressive disorder (MDD) and an additional filing for postpartum depression (PPD) is anticipated in the first half of 2023. The decision to submit the application follows recent discussions with the FDA, including a pre-NDA meeting held this fall. Data from completed studies in the LANDSCAPE and NEST programs, as well as data from the ongoing clinical and pharmacology studies, are planned to be included as part of the submission packages.

https://finance.yahoo.com/news/sage-therapeutics-biogen-announce-plans-103000890.html