Pear: Reductions in Symptoms of Chronic Insomnia, Anxiety and Depression with Somryst

 

• Interim results from the DREAM trial showed treatment with Somryst, a prescription digital therapeutic (PDT) for patients with chronic insomnia, achieved significant reductions in symptoms of insomnia, anxiety and depression severity through six months1

• New real-world data are consistent with the clinical effects previously observed in pivotal clinical trials for Somryst, the only FDA-authorized PDT to treat chronic insomnia

https://www.businesswire.com/news/home/20220608005412/en/Pear-Presents-Interim-Real-World-Data-Showing-Significant-Reductions-in-Symptoms-of-Chronic-Insomnia-Anxiety-and-Depression-with-Somryst%C2%AE-at-SLEEP-2022

Aldeyra Therapeutics Achieves Primary Endpoint in Phase 3 Trial in Dry Eye

 

• Reproxalap Statistically Superior to Vehicle for Both Prespecified Primary Endpoints of Schirmer Test (p=0.0001) and ≥10 mm Schirmer Test Responder Proportions (p<0.0001)
• TRANQUILITY-2 Results May Allow for the Most Comprehensive Dry Eye Disease New Drug Application (NDA) Submission to Date
• Pending Pre-NDA Meeting with the U.S. Food and Drug Administration (FDA), Clinical Efficacy Trials of Reproxalap Believed to Be Complete
• Company to Host Conference Call at 8:00 a.m. ET Today

Aldeyra will host a conference call to discuss this announcement at 8:00 a.m. ET today, June 8, 2022. The dial-in numbers are (844) 200-6205 for domestic callers and (929) 526-1599 for international callers. The access code is 879247. A live webcast of the conference call will also be available on the “Investors & Media” section of the Aldeyra website at https://ir.aldeyra.com. Presentation slides, which contain material information and should be reviewed in conjunction with this press release, will be available on the investor relations page prior to the start of the conference call and webcast.

After the live webcast, the event will remain archived on the Aldeyra website for 90 days.

https://www.biospace.com/article/releases/aldeyra-therapeutics-achieves-primary-endpoint-in-phase-3-tranquility-2-trial-in-dry-eye-disease-and-intends-to-submit-new-drug-application-for-symptoms-and-three-sign-endpoints-of-dry-eye-disease/

Passage Bio Gets FDA Clearance of Application for Treatment of Metachromatic Leukodystrophy

 Passage Bio, Inc. (Nasdaq: PASG), a clinical-stage genetic medicines company focused on developing transformative therapies for central nervous system disorders, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for PBML04, an adeno-associated virus (AAV)-delivery gene therapy that is being studied for the treatment of Metachromatic Leukodystrophy (MLD). MLD is a rare, fatal, pediatric, lysosomal storage disease that currently has limited available treatment options.

https://www.biospace.com/article/releases/passage-bio-receives-fda-clearance-of-ind-application-for-pbml04-for-treatment-of-metachromatic-leukodystrophy/

Bausch + Lomb First-Quarter 2022 Results and 2022 Guidance

 

• First-Quarter 2022 Financial Results
  • Revenues of $889 Million
  • GAAP Net Income of $20 Million
  • Adjusted EBITDA (non-GAAP)¹ of $170 Million
• Bausch + Lomb Commenced Trading Under "BLCO" Ticker
• Reported Revenues Grew 1%, and Organic Revenues^1,2 Grew 5%

Bausch + Lomb provided guidance for the full year of 2022 as follows:

• Full-year revenue range of $3.75 – $3.80 billion, reflecting anticipated 4-5% organic^1,2 growth
• Full-year Adjusted EBITDA (non-GAAP)¹ range of $740 – $780 million, reflecting approximately 5% base performance growth⁶

https://www.biospace.com/article/releases/bausch-lomb-announces-first-quarter-2022-results-and-provides-2022-guidance/

Moderna: updated Covid booster shows stronger antibody response against Omicron

 Moderna said on Wednesday its bivalent Covid-19 vaccine booster that contained a vaccine targeting the Omicron variant showed a stronger immune response against the variant.

Bivalent boosters address two viral strains in the same vaccine. The updated booster contains Moderna's original vaccine, and a vaccine candidate that targets the Omicron variant.

The vaccine was generally well-tolerated, the company said, with side effects similar to booster doses of the current vaccine.

The 50-microgram bivalent booster, called mRNA-1273.214, generated a stronger antibody response against Omicron than the original Moderna vaccine. Omicron subvariants are driving virtually all the new Covid-19 cases in the United States right now.

Stéphane Bancel, chief executive officer of Moderna, said in a news release "we anticipate more durable protection against variants of concern with mRNA-1273.214, making it our lead candidate for a Fall 2022 booster."

He said the company will submit its preliminary data and analysis to regulators so that the Omicron-containing bivalent booster will be available in late summer. The US Food and Drug Administration's vaccine advisers are set to meet June 28 to discuss whether coronavirus vaccine compositions should be modified for fall 2022.

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In April, Moderna announced its first bivalent Covid-19 booster shot candidate -- which combined elements of the current vaccine with updates based on the Beta variant -- induced higher antibody responses against all variants of concern, including Omicron, when compared to the company's original Covid-19 booster shot.

https://www.cnn.com/2022/06/08/health/moderna-omicron-booster-results/index.html

Marks: US has 'very serious' problem with Covid-19 vaccine uptake

 The United States has a "very serious" problem with Covid-19 vaccination uptake, a top health official has warned.

Vaccines are by far the most powerful tool available against the coronavirus, protecting people from getting seriously ill, being hospitalized, and dying from the virus.

Unlike many less developed countries, the US has enough doses to vaccinate everyone as well as the necessary infrastructure to support the rollout.

The problem: not everyone wants the shot.

"We do have a problem with vaccine uptake that is very serious in the United States and anything we can do to get people more comfortable to be able to accept these potentially life-saving medical products is something that we feel we are compelled to do," said Dr. Peter Marks, director of the Center for Biologics Evaluation and Research.

According to the US Centers for Disease Control and Prevention, 48.7% of people over the age of 12 have been fully vaccinated and received at least one booster dose in the US.

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That is a lower rate than in other countries with similar access to vaccines. For example, 69.6% of people over the age of 12 have been boosted in the United Kingdom and 55.5% in Canada. Across the 27 European Union countries, 62.6% of adults have been boosted.

Marks was speaking to the US Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee, as it considered the approval of a new Covid-19 vaccine developed by the US biotechnology company Novavax on Tuesday.

The committee voted overwhelmingly in favor of approving the vaccine, saying its emergency authorization by the FDA would be beneficial, CNN's Jacqueline Howard writes.

Vaccine hesitancy was among the topics discussed in the meeting.

The Novavax Covid-19 vaccine uses different technology from the three vaccines currently in use in the US and so it might be an option for people allergic to an ingredient used in mRNA vaccines.

Asked why there is a need for another Covid-19 vaccine in the United States when three vaccines have already been authorized for use -- Pfizer/BioNTech, Moderna and Johnson & Johnson's Janssen, the latter a non-mRNA shot -- Marks responded: "The Janssen vaccine is currently not being used as a frontline vaccine, the same way as the mRNA vaccines, which leaves the issue of vaccines for those who might not want to take an mRNA vaccine because of concerns they might have with an mRNA vaccine."

The FDA in May limited the emergency use authorization of Johnson & Johnson's Janssen Covid-19 vaccine to adults who cannot or will not have another type of vaccine, because of the risk of a rare and dangerous clotting condition after receiving it.

Novavax's Covid-19 vaccine -- administered as two doses three weeks apart -- is made using small laboratory-built pieces of the coronavirus to stimulate immunity.

This protein-based approach is a more traditional method of vaccine development than the mRNA vaccines from Pfizer/BioNTech and Moderna.

https://edition.cnn.com/2022/06/08/world/coronavirus-newsletter-intl-06-08-22/index.html

Relief: Partner, Acer in Statement Re PDUFA Target Action Date

 RELIEF THERAPEUTICS Holding SA (SIX:RLF)(OTCQB:RLFTF)(OTCQB:RLFTY) ("Relief"), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet needs, reported today that its collaboration partner, Acer Therapeutics, Inc. ("Acer"), announced that it has not yet received a decision from the U.S. Food and Drug Administration ("FDA") on its 505(b)(2) New Drug Application ("NDA") for ACER-001 (sodium phenylbutyrate), for the treatment of urea cycle disorders ("UCDs"). The NDA for ACER-001 for UCDs was accepted for review by FDA on October 5, 2021, at which time FDA assigned a PDUFA target action date of Sunday, June 5, 2022. According to the press release, the FDA has informed Acer that review for ACER-001 is ongoing and the agency currently does not have a set target date. Acer reported that, under the Prescription Drug User Fee Act (PDUFA), FDA's review performance goal is to review and act on 90 percent of NDA submissions by the target action date. The related Acer press release can be accessed through the following link.\

Acer and Relief will issue a joint press release once the FDA has provided its written decision to Acer.

https://www.biospace.com/article/releases/relief-reports-that-its-collaboration-partner-acer-therapeutics-issued-a-statement-regarding-the-pdufa-target-action-date-for-acer-001/