New Drug Application

Anavex Life Sciences Announces Expansion of Leadership Team

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onsdag, maj 22, 2024
Marketing, Drug, Gen-Probe, European Medicines Agency, FDA, Drug development, North Carolina State University, Senior, Rett syndrome, HCV, Therapy, Pharmacology, Clinical research, Ritonavir, MD, James Madison University, Ipilimumab, AbbVie, CNS, Clinical pharmacology, Bristol Myers Squibb, New Drug Application, Arena Pharmaceuticals, Nobel Prize, Schizophrenia, Nivolumab, Amylin Pharmaceuticals, Yale University, Molecular biology, Pharmacokinetics, Doctor of Philosophy, Acer, Rochester Institute of Technology, Research and development, University, Overalls, Pramlintide, Intercept Pharmaceuticals, DSM-IV codes, Assistant, EMA, DMPK, Roche, Development, Central nervous system, Pharmaceutical industry

“The most important part of building a long-term, commercially sustainable, growing business is putting the right players on the field,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex.

Key Points: 
  • “The most important part of building a long-term, commercially sustainable, growing business is putting the right players on the field,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex.
  • Prior to Anavex Dr. Lopez-Talavera held key leadership positions at Fractyl Health, Intercept Pharmaceuticals, AbbVie, Bristol Myers Squibb and Roche.
  • Dr. Edwards brings to Anavex 18 years of experience in various aspects of drug development including DMPK (drug metabolism and pharmacokinetics), Clinical Pharmacology, and Clinical Science.
  • Before joining Anavex, Dr. Edwards served as Vice President of Clinical Science at Acer Therapeutics, and positions of increasing responsibility at Madrigal Pharmaceuticals, Intercept Pharmaceuticals, Amylin Pharmaceuticals, and Arena Pharmaceuticals.

Silo Pharma Announces Positive Results from Study for Depression Treatment, Remission, and Relapse Prevention

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tisdag, maj 21, 2024
New Drug Application, Patient, SILO, Depression, FDA, IND, Silo, Research, Columbia University, Therapy, Administration, Pharmaceutical industry

SARASOTA, FL, May 21, 2024 (GLOBE NEWSWIRE) -- Silo Pharma, Inc. (Nasdaq: SILO) (“Silo” or the “Company”), a developmental stage biopharmaceutical company focused on developing novel formulations and drug delivery systems for traditional therapeutics and psychedelic treatments, today announced new results in its research focused on depression remission and relapse prevention.

Key Points: 
  • The study has identified a potentially new drug formulation that could potentially extend the period of remission and prevent relapse in patients with depression.
  • SARASOTA, FL, May 21, 2024 (GLOBE NEWSWIRE) -- Silo Pharma, Inc. (Nasdaq: SILO) (“Silo” or the “Company”), a developmental stage biopharmaceutical company focused on developing novel formulations and drug delivery systems for traditional therapeutics and psychedelic treatments, today announced new results in its research focused on depression remission and relapse prevention.
  • “The recently completed study demonstrated marked improvements in mood stability, which we see as a potentially significant development for combatting depression and preventing relapse,” said Silo CEO Eric Weisblum.
  • Silo has exercised its option to license SPC-15 from Columbia University, pursuant to a sponsored research and option agreement originally established in 2021.

VERRICA ALERT: Bragar Eagel & Squire, P.C. is Investigating Verrica Pharmaceuticals, Inc. on Behalf of Long-Term Stockholders and Encourages Investors to Contact the Firm

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lördag, maj 18, 2024
New Drug Application, Symantec Endpoint Protection, News, Food, NDA, Telephone, CMO, Molluscum contagiosum, Defendant, P.C, Cryptocurrency

Our investigation concerns whether the board of directors of Verrica have breached their fiduciary duties to the company.

Key Points: 
  • Our investigation concerns whether the board of directors of Verrica have breached their fiduciary duties to the company.
  • In December 2020, Verrica submitted its New Drug Application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) seeking regulatory approval of VP-102 for the treatment of molluscum.
  • On this news, the Company’s stock price fell $1.00, or 8.3%, to close at $11.03 per share on September 21, 2021, on unusually heavy trading volume.
  • In November 2021, Verrica resubmitted the NDA for VP-102, claiming “[t]he resubmission addresses the successful resolution of inspection deficiencies” at the manufacturing facility.

Fortress Biotech Reports First Quarter 2024 Financial Results and Recent Corporate Highlights

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onsdag, maj 15, 2024
Amyloidosis, Doxycycline, HIV, NDA, FDA, Vaccination, CRL, New Drug Application, Bangladesh Technical Education Board, Gout, Infection, Erythema, Mustang, Fortification, Inflammation, Fortress Biotech, Hyperuricemia, AstraZeneca, IGA, Disease, Allopurinol, Food, Red, Dotinurad, Safety, Liver transplantation, Carcinoma, Cytomegalovirus, CMV, Minocycline, CKPT, Patient, Exercise, Radiation, PDUFA, Dermatology, Menkes disease, Rosacea, Mortality, BLA, URAT1, Pharmaceutical industry

MIAMI, May 15, 2024 (GLOBE NEWSWIRE) -- Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress”), an innovative biopharmaceutical company focused on acquiring and advancing assets to enhance long-term value for shareholders through product revenue, equity holdings and dividend and royalty revenue, today announced financial results and recent corporate highlights for the first quarter ended March 31, 2024.

Key Points: 
  • In January 2024, Fortress raised gross proceeds of approximately $11.0 million in a registered direct offering priced at-the-market under Nasdaq rules.
  • Fortress’ consolidated net revenue totaled $13.0 million for the first quarter ended March 31, 2024, all of which was generated from our marketed dermatology products.
  • Consolidated research and development expenses including license acquisitions totaled $24.8 million for the first quarter ended March 31, 2024, compared to $39.5 million for the first quarter ended March 31, 2023.
  • Consolidated selling, general and administrative costs were $17.9 million for the first quarter ended March 31, 2024, compared to $25.3 million for the first quarter ended March 31, 2023.

Reviva Announces Enrollment Update for Open Label Extension Study Evaluating Brilaroxazine in Schizophrenia

Retrieved on: 
onsdag, maj 15, 2024
New Drug Application, Patient, Food, NDA, De novo, FDA, OLE, Safety, Trial of the century, CNS, Schizophrenia, Central nervous system, Pharmaceutical industry

CUPERTINO, Calif., May 15, 2024 (GLOBE NEWSWIRE) -- Reviva Pharmaceuticals Holdings, Inc. (NASDAQ: RVPH) (“Reviva” or the “Company”), a late-stage pharmaceutical company developing therapies that seek to address unmet medical needs in the areas of central nervous system (CNS), inflammatory and cardiometabolic diseases, today announced an enrollment update to the ongoing 1-year open-label extension (OLE) study evaluating the long-term safety and tolerability of brilaroxazine in patients with schizophrenia.

Key Points: 
  • “We are very pleased with the pace of enrollment of our OLE study, which is progressing well across sites in the USA, Europe and Asia.
  • As of mid-May we have 358 patients enrolled in the study, 223 patients that are currently on treatment, over 90 patients have completed 6-9 months, and 23 patients who have completed one year of treatment,” said Laxminarayan Bhat, Ph.D., Founder, President, and CEO of Reviva.
  • To date, brilaroxazine has been generally well tolerated across patients with acute and stable schizophrenia in the OLE study.
  • The OLE study will include both double-blind rollover and de novo subjects with stable schizophrenia.

Phathom Pharmaceuticals to Present VOQUEZNA® (vonoprazan) Data at DDW 2024 Annual Meeting

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onsdag, maj 15, 2024
New Drug Application, Patient, DDW, Food, NDA, Congress, FDA, Enzyme inhibitor, Heartburn, PDUFA, Esophagitis, Vonoprazan, PPI, GERD, Poster, NERD, Gastrointestinal disease, Physician, Pharmaceutical industry

2,3,4

Key Points: 
  • 2,3,4
    “This year’s abstracts showcase the breadth of the data we will be presenting at DDW, reaffirming Phathom’s continued commitment to helping improve the lives of people affected by acid-related gastrointestinal disorders,” said Eckhard Leifke, M.D., Chief Medical Officer at Phathom.
  • “Notably, we are excited to unveil novel findings highlighted in three posters and an oral presentation during the conference, including the first time data from our Phase 3 study of the investigational use of VOQUEZNA in Non-Erosive GERD will be presented during a medical congress.
  • In addition to these three poster sessions and one oral presentation, Phathom will sponsor a product theater highlighting VOQUEZNA as an approved treatment for Erosive Esophagitis, also referred to as Erosive GERD, and will also have a presence on the exhibit floor at booth #911 throughout the conference.
  • A high-level schedule of Phathom activities at DDW 2024 can be found below:

Ascendis Pharma Announces Extension of U.S. Food and Drug Administration Review Period for TransCon™ PTH for Adults with Hypoparathyroidism

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tisdag, maj 14, 2024
New Drug Application, Patient, Microsoft Access, EAP, Food, NDA, FDA, PDUFA, Hypoparathyroidism, Pharmaceutical industry

COPENHAGEN, Denmark, May 14, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that the U.S. Food and Drug Administration (FDA) notified the Company that information submitted in response to the FDA’s ongoing review of the New Drug Application (NDA) for TransCon PTH (palopegteriparatide) for adults with hypoparathyroidism constituted a major amendment to the NDA. Accordingly, the FDA has extended the PDUFA target action date by three months, to August 14, 2024, to provide time for a full review of the submission.

Key Points: 
  • Accordingly, the FDA has extended the PDUFA target action date by three months, to August 14, 2024, to provide time for a full review of the submission.
  • “We have responded to all requests received to date from FDA and will work with the agency as they continue their review of our NDA,” said Jan Mikkelsen, Ascendis Pharma’s President and Chief Executive Officer.
  • “Adults with hypoparathyroidism in the United States, who are receiving TransCon PTH in our clinical trials and our Expanded Access Program (EAP) will continue to receive their medication, and the EAP remains open for enrollment for eligible patients.
  • We remain committed to bringing TransCon PTH to adults with hypoparathyroidism in the United States, who face an urgent need for new treatments.”

scPharmaceuticals Inc. Reports First Quarter 2024 Financial Results and Provides Business Update

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tisdag, maj 14, 2024
Hypersensitivity, New Drug Application, Patient, Creatinine, Ototoxicity, Uric acid, Azotemia, Huber loss, Coma, Anuria, Cerebral edema, Urinary retention, Erythema, NYHA, Furosemide, Heart failure, Ascites, Hepatic encephalopathy, Kidney, Bruise, Shanda, Urine, FDA, Glucose, Trial of the century, GTN, Edema, PDUFA, Chronic kidney disease, Cirrhosis, Change Healthcare, Growth, Research, Diuresis, BUN, Dehydration, Thrombosis, Deafness, Congestion, CO2, Oliguria, Benign prostatic hyperplasia, Organic acid, History, Blood volume, Hypoproteinemia, Embolism, Tinnitus, Pharmaceutical industry

BURLINGTON, Mass., May 14, 2024 (GLOBE NEWSWIRE) -- scPharmaceuticals Inc. (Nasdaq: SCPH), a pharmaceutical company focused on developing and commercializing products that have the potential to optimize the delivery of infused therapies, advance patient care, and reduce healthcare costs, today announced financial results for the first quarter ended March 31, 2024, and provided a business update. 

Key Points: 
  • Product revenues were $6.1 million for the first quarter of 2024, compared to $2.1 million for the first quarter of 2023.
  • Costs of product revenues were $1.8 million for the first quarter of 2024, compared to $0.6 million for the first quarter of 2023.
  • Research and development expenses were $2.7 million for the first quarter of 2024, compared to $2.1 million for the first quarter of 2023.
  • scPharmaceuticals reported a net loss of $14.1 million for the first quarter of 2024, compared to $11.2 million for the first quarter of 2023.

Marinus Pharmaceuticals Announces Key Business Updates for Tuberous Sclerosis Complex Program

Retrieved on: 
fredag, maj 17, 2024
Pharmaceutical, Genetics, Health, Clinical Trials, New Drug Application, Patient, Seizure, Epilepsy, TSC, Food, Patent, Medication, Drug discovery, Trust, Marinus, Therapy, Pharmaceutical industry

“We are pleased to announce we have completed enrollment in our pivotal Phase 3 trial in tuberous sclerosis complex,” said Alex Aimetti, Ph.D., Chief Scientific Officer at Marinus Pharmaceuticals.

Key Points: 
  • “We are pleased to announce we have completed enrollment in our pivotal Phase 3 trial in tuberous sclerosis complex,” said Alex Aimetti, Ph.D., Chief Scientific Officer at Marinus Pharmaceuticals.
  • Marinus is targeting submission of a supplemental New Drug Application to the U.S. Food and Drug Administration in April 2025 with priority review requested.
  • Marinus also announced that the United States Patent and Trademark Office (USPTO) has granted a new method of use patent (U.S. Patent No.
  • This is Marinus’ second method of use patent granted for ganaxolone in TSC, further strengthening the Company’s intellectual property position.

UroGen Pharma Announces Date for ENVISION Data, New Long-Term Jelmyto Durability Data, and Reports 2024 First Quarter Financial Results and Business Highlights

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måndag, maj 13, 2024
Health, Hospitals, Clinical Trials, General Health, Pharmaceutical, Biotechnology, New Drug Application, Mitomycins, Patient, Medicare, American Urological Association, Investment, AUA, Food, NDA, Recurrence, FDA, IND, Safety, Conference, Gesellschaft mit beschränkter Haftung, Growth, IP, LG, ATLAS, DFS, Software, Research, RTW, Webcast, Cancer, Annual general meeting, Pharmaceutical industry

The company plans to complete the submission in Q3 2024 with a potential FDA decision as early as the first quarter of 2025.

Key Points: 
  • The company plans to complete the submission in Q3 2024 with a potential FDA decision as early as the first quarter of 2025.
  • A soon-to-be-published post-hoc analysis of the OLYMPUS trial assessed the long-term effects in treating LG-UTUC with JELMYTO.
  • The results show that JELMYTO treatment demonstrated favorable recurrence free survival rates for patients with LG-UTUC who respond to initial induction.
  • JELMYTO Revenue: JELMYTO net product revenues were $18.8 million and $17.2 million for the three months ended March 31, 2024 and 2023, respectively.