Supernus: FDA Assigns Early April 2021 PDUFA Date for SPN-812 NDA

 Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced that it received notice from the U.S. Food and Drug Administration (FDA) that the company’s New Drug Application (NDA) resubmission for SPN-812 for the treatment of ADHD in pediatric patients is considered a Class I resubmission thereby assigning a timeline of two months for review by the FDA and establishing a new Prescription Drug User Fee Act (PDUFA) target action date in early April 2021.

Supernus will continue to work closely with the FDA as it completes its review of the SPN-812 NDA. If approved by the FDA, the Company is preparing for the commercial launch of SPN-812 for the treatment of ADHD in pediatric patients in the second quarter of 2021.

In December 2020, Supernus announced positive results from a Phase III study for SPN-812 in adults with ADHD. The Company plans to submit a supplemental NDA (sNDA) to the FDA for SPN-812 for the treatment of ADHD in adult patients in the second half of 2021, assuming approval for pediatric patients.

https://www.globenewswire.com/news-release/2021/02/22/2179501/0/en/Supernus-Receives-FDA-Notice-Assigning-Early-April-2021-PDUFA-Date-for-SPN-812-NDA.html

FDA says Covid vaccine makers can modify shots as variants emerge

 The Food and Drug Administration has laid the groundwork for drugmakers to be able to react quickly to emerging coronavirus variants and get modified products to the public without the need for extended clinical trials.

"We are using every tool in our toolbox to fight this pandemic, including pivoting as the virus adapts," Dr. Janet Woodcock, acting FDA commissioner, said in a statement Monday.

The FDA guidance issued Monday is for companies that make Covid-19 vaccines, therapeutics and diagnostic tests as they work to keep up with evolving variants of SARS-CoV-2.

Evidence so far suggests that the two Covid-19 vaccines authorized in the U.S., from Moderna and Pfizer-BioNTech, appear to offer good protection against new variants.

But the fact that the virus continues to mutate means drugmakers will need to keep up, adapting quickly if necessary. The FDA guidance suggests companies may be able to pull back on lengthy clinical trials to prove safety and effectiveness each time a new variant emerges.

This is not unlike how the flu shot changes from year to year.

"For influenza, we are so accustomed to doing this," Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said on a call with reporters Monday. Because the flu shot is so well studied, human clinical studies are unnecessary each year. Manufacturers simply modify the shots based on the strains that are predicted to be in circulation.

Until experts have more data on Covid-19 vaccines, however, the FDA will continue to require drugmakers to study their vaccines' efficacy against emerging strains.

"We need to understand whether the new vaccine strain is able to cover both the new strain and the old strain," Marks said. Additional safety data, at least in the interim, will be necessary.

"After we do that three or four times, we'll look at everything, and if everything seems consistent, then we might move more towards the influenza-like model," Marks said.

The FDA guidance also recommends developers of Covid-19 diagnostic tests and makers of monoclonal antibody treatments monitor how emerging variants might affect their effectiveness.

https://www.nbcnews.com/health/health-news/fda-says-covid-vaccine-makers-can-modify-shots-variants-emerge-n1258528

Compugen Expands Deal with Bristol Myers Squibb with Phase 1b Combo Study of COM701 with Opdivo

  Compugen Ltd. (Nasdaq: CGEN), a clinical-stage cancer immunotherapy company and a leader in predictive target discovery, announced today the expansion of its clinical collaboration agreement with Bristol Myers Squibb. Under the amended agreement, Bristol Myers Squibb will supply Opdivo® (nivolumab), its PD-1 inhibitor, for Compugen's Phase 1b cohort expansion study designed to assess COM701, Compugen's first-in-class anti-PVRIG antibody, in combination with Opdivo® in selected cancer indications. Study initiation is expected in the second quarter of 2021.

https://www.prnewswire.com/news-releases/compugen-expands-clinical-collaboration-agreement-with-bristol-myers-squibb-with-phase-1b-combination-study-of-com701-with-opdivo-301232339.html

Amyris: Positive Pre-Clinical Results For COVID-19 RNA Vaccine Platform

 Amyris, Inc. (Nasdaq: AMRS), a leading synthetic biotechnology company active in the Clean Health and Beauty markets through its consumer brands and a top supplier of sustainable and natural ingredients, today announced highly promising preliminary data in a pre-clinical study of its ribonucleic acid (RNA) COVID-19 vaccine platform as well as the potential to address current manufacturing, supply scale-up and refrigerated storage and distribution challenges.

On October 22, 2020, Amyris announced that it entered into a collaboration agreement and exclusive license with the Infectious Disease Research Institute (IDRI) to advance a novel RNA vaccine platform, including the development of a COVID-19 vaccine.

Preliminary data from a pre-clinical study of IDRI's Nanostructured Lipid Carrier (NLC) vaccine platform demonstrated a significant level of antibody production against the COVID-19 spike protein using a self-adjuvanting RNA vaccine. The results were consistent with similar data published by Moderna and Pfizer/BioNTech on their respective messenger RNA technologies. The Amyris/IDRI platform will be advancing to phase 1 clinical trials with the support of the Portuguese government and other partnerships.

The Amyris/IDRI RNA platform technology is expected to offer manufacturing, storage, and distribution advantages for the use and development of future vaccines, and to address the ongoing evolution of SARS-CoV-2 (COVID-19) and other potential pandemics.

https://finance.yahoo.com/news/amyris-announces-positive-pre-clinical-130000222.html

Intra-Cellular Applies for FDA Approval of CAPLYTA for Bipolar

 

• ITCI submits Supplemental New Drug Applications (sNDAs) for the treatment of depressive episodes associated with bipolar I or II disorder both as monotherapy and as adjunctive therapy in adults.
• If approved, CAPLYTA has the potential to treat the broadest range of patients with bipolar depression.

Intra-Cellular Therapies, Inc. (Nasdaq: ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, announced that it has recently submitted supplemental New Drug Applications (sNDAs) to the U.S. Food and Drug Administration (FDA) for two indications for CAPLYTA (lumateperone): 1) as monotherapy; and 2) as adjunctive therapy with lithium or valproate for the treatment of depressive episodes associated with bipolar I or II disorder (bipolar depression) in adults. If approved, CAPLYTA would be the first therapy indicated for the treatment of depressive episodes associated with bipolar I or II disorder both as monotherapy and as adjunctive therapy in adults. The Company anticipates an FDA target action date for the sNDAs in the second half of 2021.

Two positive Phase 3 global placebo-controlled bipolar depression studies, Study 402 and Study 404, form the basis of the sNDAs. In these trials, lumateperone 42 mg demonstrated a favorable tolerability and safety profile, consistent with findings in all of the Company’s previous studies in schizophrenia. The most commonly reported adverse events (defined as a rate greater than or equal to 5% and at least twice the rate of placebo) were somnolence, dizziness and nausea. Importantly, the rates of akathisia, restlessness and extrapyramidal symptoms were low and similar to placebo.  

Results from Study 404 have been presented at scientific conferences. Results from Study 402 will be presented at the American Psychiatric Association annual meeting in May of this year.

https://www.globenewswire.com/news-release/2021/02/22/2179539/0/en/Intra-Cellular-Therapies-Applies-for-FDA-Approval-of-CAPLYTA-lumateperone-for-the-Treatment-of-Bipolar-Depression.html

Regeneron, Sanofi in new I-O market with FDA nod for Libtayo in basal cell carcinoma

 Regeneron and Sanofi’s anti-PD-1 cancer drug Libtayo has been pegged as an immuno-oncology laggard in diseases such as lung cancer, where well-established players like Merck’s Keytruda rule the market. But there’s one area where Regeneron and Libtayo can claim a lead: skin cancer.

In that department, the FDA has added another jewel to Regeneron and Sanofi’s crown, approving Libtayo to treat patients with advanced basal cell carcinoma (BCC). It’s the first immunotherapy drug cleared by the FDA to treat that disease, and it comes two years after Libtayo’s first approval in metastatic cutaneous squamous cell carcinoma.

The new approval, for patients whose BCC advanced after treatment with a hedgehog pathway inhibitor or who are not eligible for that class of drug, was based on results from a phase 2 trial. In that study, the drug spurred a response in 21% of patients with metastatic BCC and 29% of those with locally advanced disease, and most patients benefited for more than six months.

When Sanofi and Regeneron reported data from the BCC trial at the virtual meeting of the European Society of Clinical Oncology last September, they estimated the probability of survival would be 92% in patients taking Libtayo.

“This is a horribly disfiguring disease in the advanced stage. We’ve seen some amazing improvements in patients,” Israel Lowy, M.D., Ph.D., Regeneron's senior vice president of translational and clinical science in oncology, said in an interview at the time.

The new approval will no doubt nudge Libtayo closer to the blockbuster status analysts have predicted the drug can achieve. The product brought in $251 million in sales in the first nine months of 2020, doubling its haul from the same period a year before. Analysts expect Libtayo’s dominance in skin cancer will turn it into a $1.4 billion-a-year product.

But Sanofi and Regeneron have ambitions beyond skin cancer. The companies are anticipating a verdict from the FDA by the end of this month on their bid for approval of Libtayo in advanced non-small cell lung cancer (NSCLC).

The FDA granted priority review to Libtayo in NSCLC in October after Sanofi and Regeneron released trial data showing the drug cut the risk of death by 43% in patients with PD-L1 levels of at least 50%, as compared to platinum chemotherapy.

Sanofi and Regeneron won’t have the benefit of being the sole PD-1 players in the lung cancer market, however. Merck’s Keytruda has approvals in NSCLC as a solo therapy and as part of a market-leading chemo combination. And Bristol Myers Squibb’s Opdivo-Yervoy combination was approved in first-line NSCLC last May.

Still, Libtayo’s developers see opportunities well beyond skin and lung cancers. They have a massive clinical trial program underway examining the drug’s potential in cervical cancer, solid tumors and blood cancers.

https://www.fiercepharma.com/pharma/regeneron-and-sanofi-bust-into-new-i-o-market-fda-nod-for-libtayo-basal-cell-carcinoma

Teachers may play role in in-school COVID-19 transmission: CDC

 Teachers may play an important role in the transmission of COVID-19 within schools, the U.S. Centers for Disease Control and Prevention (CDC) said on Monday, citing a study conducted in elementary schools in a Georgia school district.

The report comes after researchers from the agency last month said there was little evidence that schools were spreading COVID-19 infections in the country - based in part on a study of schools in Wisconsin - easing concerns about allowing in-person learning. The Wisconsin study found significantly lower virus spread within schools compared with transmission in the surrounding communities.

An investigation involving about 2,600 students and 700 staff members of a Georgia school district’s elementary schools showed nine clusters of COVID-19 cases involving 13 educators and 32 students at six elementary schools, the CDC said.

Of these, two clusters involved probable teacher-to-teacher transmission that was followed by teacher-to-student transmission in classrooms, the agency said in its Morbidity and Mortality Weekly Report.

Transmission from teachers resulted in about half of 31 school-related cases, according to the investigation.

The study was subject to some limitations including difficulty in determining whether coronavirus transmission happened in school or out in the local community, the agency noted.

Distinguishing between the two types of transmission was particularly challenging when the 7-day average number of cases per 100,000 persons exceeded 150, the agency said.

The CDC said COVID-19 vaccination of educators should be considered as an additional mitigation measure to be added when available, although not required for reopening schools.

https://www.reuters.com/article/us-health-coronavirus-usa-schools/teachers-may-play-role-in-in-school-covid-19-transmission-u-s-cdc-idUSKBN2AM1Z9