Abbreviated New Drug Application

Newron Announces H1 2023 Results and Provides R&D Update

Retrieved on: 
Friday, August 4, 2023
Science, Neurology, Other Science, Biotechnology, Research, Pharmaceutical, General Health, Health, Business development, US Foods, Partnership, Psychosis, Schizophrenia, TRS, Paragraph, XETRA, AGM, Don, Evenamide, The International Journal of Neuropsychopharmacology, CNS, Movement, Clozapine, Medication, Tablet, Sale, Congress, Incidence, European College of Neuropsychopharmacology, Orange Book, Patient, Canadian International Council, NCE, ECNP, Abbreviated New Drug Application, Phase, FDA, Food, Safety, Peripheral nervous system, Pharmaceutical industry, Medical imaging, Management, Newron Cup

We have reported three striking sets of data from our evenamide development program for treatment-resistant schizophrenia (TRS), presented these results at international psychiatry scientific conferences, and published key results in a peer-reviewed journal.

Key Points: 
  • We have reported three striking sets of data from our evenamide development program for treatment-resistant schizophrenia (TRS), presented these results at international psychiatry scientific conferences, and published key results in a peer-reviewed journal.
  • The exciting results triggered substantial interest from potential partners on future collaboration opportunities for the development of evenamide.”
    In Q1 2023, Newron announced three exciting new sets of data evaluating evenamide as an add-on treatment for patients with TRS.
  • Study 008A is continuing to enroll patients in this indication, and results are expected by end of 2023/early in 2024.
  • Financial Summary (IFRS) H1 2023 and H1 2022:

EQS-News: Newron announces H1 2023 results and provides R&D update

Retrieved on: 
Friday, August 4, 2023
Business development, US Foods, Partnership, Psychosis, CET, Schizophrenia, TRS, Paragraph, XETRA, AGM, Don, Evenamide, The International Journal of Neuropsychopharmacology, CNS, Movement, Clozapine, Sale, Tablet, Congress, Incidence, European College of Neuropsychopharmacology, Orange Book, Patient, Canadian International Council, NCE, ECNP, Abbreviated New Drug Application, Phase, FDA, Food, Safety, Peripheral nervous system, Pharmaceutical industry, Medical imaging, Management, Newron Cup

We have reported three striking sets of data from our evenamide development program for treatment-resistant schizophrenia (TRS), presented these results at international psychiatry scientific conferences, and published key results in a peer-reviewed journal.

Key Points: 
  • We have reported three striking sets of data from our evenamide development program for treatment-resistant schizophrenia (TRS), presented these results at international psychiatry scientific conferences, and published key results in a peer-reviewed journal.
  • Study 008A is continuing to enroll patients in this indication, and results are expected by end of 2023/early in 2024.
  • The results seen validate the rule of glutamate release inhibition in repairing disturbed neural connectivity in the TRS population.
  • Financial Summary (IFRS) H1 2023 and H1 2022:

Viatris Announces Launch of Breyna™ (budesonide and formoterol fumarate dihydrate) Inhalation Aerosol, the First FDA-Approved Generic Version of Symbicort® for People with Asthma and Chronic Obstructive Pulmonary Disease, in Partnership with Kindeva

Retrieved on: 
Monday, July 31, 2023
COPD, Budesonide, Maintenance, Asthma, Emphysema, Viatris, New Drug Application, Prescription, Inhalation, AstraZeneca, Bronchitis, Chronic obstructive pulmonary disease, Periodic breathing, Patient, Abbreviated New Drug Application, ANDA, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Formoterol, Food, Pharmaceutical industry, Budesonide/formoterol

PITTSBURGH and WOODBURY, Minn., July 31, 2023 /PRNewswire/ -- Viatris Inc. (NASDAQ: VTRS), a global healthcare company, and Kindeva Drug Delivery L.P. today announced the launch of Breyna™ (budesonide and formoterol fumarate dihydrate) Inhalation Aerosol, the first generic version of AstraZeneca's Symbicort® with an Abbreviated New Drug Application (ANDA) approved by the U.S. Food and Drug Administration (FDA). Breyna, a drug-device combination product, is indicated for certain patients with asthma or chronic obstructive pulmonary disease (COPD) and will be immediately available in both 80 mcg/4.5 mcg and 160 mcg/4.5 mcg dosage strengths.

Key Points: 
  • Breyna, a drug-device combination product, is indicated for certain patients with asthma or chronic obstructive pulmonary disease (COPD) and will be immediately available in both 80 mcg/4.5 mcg and 160 mcg/4.5 mcg dosage strengths.
  • Viatris Head of North America Jose Cotarelo said: "We are excited to bring Breyna to the U.S. market for the many Americans living with asthma and COPD.
  • COPD is a term used to describe a certain kind of chronic lung disease and is characterized by breathlessness; it affects more than 16 million Americans.
  • Asthma causes swelling of the airways resulting in difficulty breathing, and approximately 25 million Americans have the chronic condition.

Orexo's patent win for ZUBSOLV® appealed

Retrieved on: 
Monday, July 24, 2023
US Foods, Abbreviated New Drug Application, United States Court of Appeals for the Federal Circuit, The Orange Book, Naloxone, Sun Pharma, Buprenorphine, Sun, SUN, ORX, Orexo, CIII, SEK, Tablet, United States district court, Orange Book, District court, Patent, United States District Court for the Eastern District of Texas, Food, Generic drug, Appeal

The litigation was initiated in September 2020 because of Sun's submission of an Abbreviated New Drug Application with the US Food and Drug Administration seeking approval of generic versions of ZUBSOLV®.

Key Points: 
  • The litigation was initiated in September 2020 because of Sun's submission of an Abbreviated New Drug Application with the US Food and Drug Administration seeking approval of generic versions of ZUBSOLV®.
  • Sun has now appealed the district court's decision to the US Court of Appeals for the Federal Circuit.
  • We remain very confident in the strength of the patent portfolio and that the Court of Appeals will come to the same conclusion."
  • ZUBSOLV® is currently protected by ten patents listed in the Orange Book with expiration dates ranging from December 2027 to September 2032.

Orexo's patent win for ZUBSOLV® appealed

Retrieved on: 
Monday, July 24, 2023
US Foods, Abbreviated New Drug Application, United States Court of Appeals for the Federal Circuit, The Orange Book, Naloxone, Sun Pharma, Buprenorphine, Sun, SUN, ORX, Orexo, CIII, SEK, Tablet, United States district court, Orange Book, District court, Patent, United States District Court for the Eastern District of Texas, Food, Generic drug, Appeal

The litigation was initiated in September 2020 because of Sun's submission of an Abbreviated New Drug Application with the US Food and Drug Administration seeking approval of generic versions of ZUBSOLV®.

Key Points: 
  • The litigation was initiated in September 2020 because of Sun's submission of an Abbreviated New Drug Application with the US Food and Drug Administration seeking approval of generic versions of ZUBSOLV®.
  • Sun has now appealed the district court's decision to the US Court of Appeals for the Federal Circuit.
  • We remain very confident in the strength of the patent portfolio and that the Court of Appeals will come to the same conclusion."
  • ZUBSOLV® is currently protected by ten patents listed in the Orange Book with expiration dates ranging from December 2027 to September 2032.

Orexo wins patent litigation for ZUBSOLV® in the US

Retrieved on: 
Saturday, July 1, 2023
US Foods, Abbreviated New Drug Application, The Orange Book, Naloxone, Sun Pharma, Buprenorphine, Sun, ORX, CIII, Tablet, Orange Book, United States district court, Patent, Patient, Food, Generic drug, Orexo

The district court found that Orexo´s patents are valid and infringed by Sun.

Key Points: 
  • The district court found that Orexo´s patents are valid and infringed by Sun.
  • As a result of the decision, Sun is prohibited from launching its generic ZUBSOLV® tablets until September 2032, and Orexo's patent protection remain unchanged.
  • ZUBSOLV® is currently protected by ten patents listed in the Orange Book with expiration dates ranging from December 2027 to September 2032.
  • Now we look forward to focusing on continuing to grow our business and bringing innovative treatment solutions to patients."

Orexo wins patent litigation for ZUBSOLV® in the US

Retrieved on: 
Saturday, July 1, 2023
US Foods, Abbreviated New Drug Application, The Orange Book, Naloxone, Sun Pharma, Buprenorphine, Sun, ORX, CIII, Tablet, Orange Book, United States district court, Patent, Patient, Food, Generic drug, Orexo

The district court found that Orexo´s patents are valid and infringed by Sun.

Key Points: 
  • The district court found that Orexo´s patents are valid and infringed by Sun.
  • As a result of the decision, Sun is prohibited from launching its generic ZUBSOLV® tablets until September 2032, and Orexo's patent protection remain unchanged.
  • ZUBSOLV® is currently protected by ten patents listed in the Orange Book with expiration dates ranging from December 2027 to September 2032.
  • Now we look forward to focusing on continuing to grow our business and bringing innovative treatment solutions to patients."

Evofem Biosciences Announces Financial Results for the First Quarter of 2023

Retrieved on: 
Friday, June 16, 2023
Abbreviated New Drug Application, Marketing, Lactic acid, OTCQB, Research, EBITDA, Patent, SAN, Citric acid, Growth, ANDA, FDA, Pharmaceutical industry, Birth control

SAN DIEGO, June 16, 2023 /PRNewswire/ -- Evofem Biosciences, Inc. (OTCQB: EVFMD) today announced financial results for the first quarter of 2023, including growth in net product sales of its hormone-free prescription contraceptive gel, Phexxi® (lactic acid, citric acid and potassium bitartrate).

Key Points: 
  • -- Increased net product revenue 37% in the first quarter of 2023 vs. prior year quarter --
    SAN DIEGO, June 16, 2023 /PRNewswire/ -- Evofem Biosciences, Inc. (OTCQB: EVFMD) today announced financial results for the first quarter of 2023, including growth in net product sales of its hormone-free prescription contraceptive gel, Phexxi® (lactic acid, citric acid and potassium bitartrate) .
  • Highlights for and since the quarter include:
    Increased Phexxi net product sales 37% to $5.8 million.
  • We also have the benefit of a committed and loyal prescriber and patient base due to our past, focused marketing efforts," said Saundra Pelletier, CEO of Evofem Biosciences.
  • For the three months ended March 31, 2023, net product sales were $5.8 million compared to $4.3 million in the prior year period.

PADAGIS ANNOUNCES TWO FIRST-TO-FILE ANDA SUBMISSIONS

Retrieved on: 
Thursday, June 15, 2023
Abbreviated New Drug Application, Pregnancy, Central nervous system, Depression, Emergency, IQVIA, Birth, Naloxone, Lactic acid, Citric acid, District court, Investment, Patient, ANDA, Douglas v. U.S. District Court ex rel Talk America, Acid, Generic drug, Birth control

ALLEGAN, Mich., June 15, 2023 /PRNewswire/ -- Padagis announced today two first-to-file ANDA submissions.

Key Points: 
  • ALLEGAN, Mich., June 15, 2023 /PRNewswire/ -- Padagis announced today two first-to-file ANDA submissions.
  • Padagis President, Pam Hoffman, stated "The investments in our pipeline made by Padagis since our inception have begun to bear fruit.
  • Two first-to-file ANDA submissions speak to the innovation and execution capabilities of the Padagis team.
  • Annual market sales for Phexxi® were approximately $28 million in the 12 months ended April 2023 as measured by IQVIA.

China Medical System: The first 'Diazepam Nasal Spray' Approved for Marketing in China

Retrieved on: 
Monday, June 12, 2023
Epilepsy, Seizure, Consciousness, Status epilepticus, CMS, Vitamin E, Benzodiazepine, Marketing, Abbreviated New Drug Application, Diazepam, Clinical trial, New Drug Application, NDA, Quality of life, Absorption, National Association Medical Staff Services, Incidence, Protein, Patient, Nasal mucosa, Peptide, National Medical Products Administration, Ecosystem, NMPA, Caregiver, Pharmaceutical industry, Fine chemical

CMS is pleased to announce the NDA of the first Diazepam Nasal Spray has been approved for marketing in China.

Key Points: 
  • CMS is pleased to announce the NDA of the first Diazepam Nasal Spray has been approved for marketing in China.
  • The Product is the first diazepam nasal spray in China, and it is indicated for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e.
  • The Product is a proprietary formulation of diazepam administered through the nasal mucosa, and has high bioavailability, outstanding absorbability, tolerance and reliability.
  • Diazepam Nasal Spray is CMS's third innovative drug approved for marketing in China this year, following the approval of Methotrexate Injection and Tildrakizumab Injection.