Muscarinic antagonists

LANNETT expands respiratory pipeline, signs exclusive distribution agreement for generic SPIRIVA® handihaler®

Retrieved on: 
Thursday, July 29, 2021

PHILADELPHIA, July 29, 2021 /PRNewswire/ -- Lannett Company, Inc. (NYSE: LCI) today announced that it has entered into an exclusive U.S. commercialization agreement for a therapeutically equivalent generic of Spiriva Handihaler (Tiotropium Bromide inhalation powder) with Respirent Pharmaceuticals Co. Ltd.

Key Points: 
  • PHILADELPHIA, July 29, 2021 /PRNewswire/ -- Lannett Company, Inc. (NYSE: LCI) today announced that it has entered into an exclusive U.S. commercialization agreement for a therapeutically equivalent generic of Spiriva Handihaler (Tiotropium Bromide inhalation powder) with Respirent Pharmaceuticals Co. Ltd.
  • U.S. sales of Spiriva Handihaler were $1.5 billion for the 12 months ending May, 2021 according to IQVIA, although actual generic market values are expected to be lower.
  • "With generic Spiriva Handihaler, our strategic relationship with Respirent now includes three inhaler products, each of which has the potential to be a meaningful contributor to our company's financial performance.
  • The generic Spiriva Handihaler product is currently in development and tracking to Abbreviated New Drug Application (ANDA) submission in 2023."

Eyenovia to Participate in a Presbyopia Panel Discussion at Eyecelerator 2021

Retrieved on: 
Monday, July 19, 2021

A replay of the Ladenburg Thalmann presentation, which took place on July 14, can be found here .

Key Points: 
  • A replay of the Ladenburg Thalmann presentation, which took place on July 14, can be found here .
  • Eyenovia, Inc. (NASDAQ: EYEN) is a clinical stage ophthalmic biopharmaceutical company developing a pipeline of microdose array print (MAP) therapeutics.
  • Eyenovia is currently focused on the late-stage development of microdosed medications for presbyopia, myopia progression and mydriasis.
  • The companys lead product candidate, Mydcombi (tropicamide/phenylephrine fixed combination) for use in diagnostic eye exams, has an FDA PDUFA date of October 28, 2021.

Chronic Obstructive Pulmonary Disease Forecast and Market Analysis to 2026: Triple Therapies will Drive Modest Growth of the COPD Market - ResearchAndMarkets.com

Retrieved on: 
Tuesday, July 6, 2021

The "Chronic Obstructive Pulmonary Disease Forecast and Market Analysis to 2026" drug pipelines has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Chronic Obstructive Pulmonary Disease Forecast and Market Analysis to 2026" drug pipelines has been added to ResearchAndMarkets.com's offering.
  • Chronic obstructive pulmonary disease (COPD) is defined by persistent airflow limitation (reduction in the ability to exhale at a normal rate and volume).
  • While chronic and progressive dyspnea (shortness of breath) is a key symptom, patients may also present with productive cough.
  • Triple inhaled corticosteroid/long-acting beta 2 agonist/long-acting muscarinic antagonist (ICS/LABA/LAMA) fixed-dose combination therapies delivered through a single inhaler bring convenience to more severe patients.

Hangzhou Chance Pharmaceuticals Announces NMPA Acceptance of Marketing Authorization Application for CXF11

Retrieved on: 
Friday, July 2, 2021

HANGZHOU, China, July 02, 2021 (GLOBE NEWSWIRE) -- Hangzhou Chance Pharmaceuticals (Chance), a clinical-stage biotechnology company focusing on discovering, developing, and commercializing transformative inhalation therapies for the worlds most debilitating diseases, announced that the National Medical Products Administration (NMPA) of China has accepted its Marketing Authorization Application for CXF11 for the treatment of chronic obstructive pulmonary disease (COPD).

Key Points: 
  • HANGZHOU, China, July 02, 2021 (GLOBE NEWSWIRE) -- Hangzhou Chance Pharmaceuticals (Chance), a clinical-stage biotechnology company focusing on discovering, developing, and commercializing transformative inhalation therapies for the worlds most debilitating diseases, announced that the National Medical Products Administration (NMPA) of China has accepted its Marketing Authorization Application for CXF11 for the treatment of chronic obstructive pulmonary disease (COPD).
  • The NMPA Acceptance of Marketing Authorization Application for CXF11is the first important milestone in product development for Chance.
  • CXF11 is Chances tiotropium bromide inhalation drug intended for prevention of bronchospasm in adults with chronic obstructive pulmonary disease (COPD).
  • Chance Pharmaceuticals is a clinical-stage biotechnology company focusing on discovering, developing and commercializing transformative inhalation therapies for the worlds most debilitating diseases.

Valeo Pharma Announces Commercial Launch of Enerzair® Breezhaler® and Atectura® Breezhaler®

Retrieved on: 
Tuesday, June 22, 2021

"The commercial launch of Enerzair Breezhaler and Atectura Breezhaler is a key milestone for Valeo.

Key Points: 
  • "The commercial launch of Enerzair Breezhaler and Atectura Breezhaler is a key milestone for Valeo.
  • Commenting on the Enerzair Breezhaler and Atectura Breezhaler commercial launch, Frederic Fasano, President and Chief Operating Officer said; "We are very excited to start promoting and selling our first respiratory products.
  • Nelly Komari, a seasoned pharma executive, has recently joined Valeo to lead the medical team in support of our asthma product launches.
  • Enerzair Breezhaler and Atectura Breezhaler have demonstrated, against the current standard of care, that they improve the level of control of asthma symptoms and better prevent the related complications.

Alkermes Announces FDA Approval of LYBALVI™ for the Treatment of Schizophrenia and Bipolar I Disorder

Retrieved on: 
Tuesday, June 1, 2021

"Schizophrenia and bipolar I disorder are complex, chronic diseases and there remains a persistent need for new medications with proven efficacy and safety.

Key Points: 
  • "Schizophrenia and bipolar I disorder are complex, chronic diseases and there remains a persistent need for new medications with proven efficacy and safety.
  • "LYBALVI represents an important new treatment option for adults with schizophrenia or bipolar I disorder, their clinicians and caregivers, and reflects Alkermes' commitment to developing new therapies that support patient-centered care," said Richard Pops, Chairman and Chief Executive Officer at Alkermes.
  • The most common adverse events (AEs) for both the LYBALVI and olanzapine treatment groups were weight gain, somnolence and dry mouth.
  • ENLIGHTEN-2 evaluated the weight gain profile of LYBALVI compared to olanzapine over six months in 561 patients with stable schizophrenia.

Alkermes Announces FDA Approval of LYBALVI™ for the Treatment of Schizophrenia and Bipolar I Disorder

Retrieved on: 
Tuesday, June 1, 2021

"Schizophrenia and bipolar I disorder are complex, chronic diseases and there remains a persistent need for new medications with proven efficacy and safety.

Key Points: 
  • "Schizophrenia and bipolar I disorder are complex, chronic diseases and there remains a persistent need for new medications with proven efficacy and safety.
  • "LYBALVI represents an important new treatment option for adults with schizophrenia or bipolar I disorder, their clinicians and caregivers, and reflects Alkermes' commitment to developing new therapies that support patient-centered care," said Richard Pops, Chairman and Chief Executive Officer at Alkermes.
  • The most common adverse events (AEs) for both the LYBALVI and olanzapine treatment groups were weight gain, somnolence and dry mouth.
  • ENLIGHTEN-2 evaluated the weight gain profile of LYBALVI compared to olanzapine over six months in 561 patients with stable schizophrenia.

Update for Patient Access Solutions Opening and Managing New Center in Long Island, N.Y.

Retrieved on: 
Thursday, May 20, 2021

In addition to strategic relations efforts, PASO is aggressively moving forward into the exciting new area of Biological Mental health solutions.

Key Points: 
  • In addition to strategic relations efforts, PASO is aggressively moving forward into the exciting new area of Biological Mental health solutions.
  • To add value and experience to our Ketamine Therapy product offering, PASO has engaged in ongoing discussions with one of the country\xe2\x80\x99s leading Ketamine Therapy Clinic Companies.
  • A psychiatrist referral is also required.\nAfter an initial consultation, patients will be set up into a 6-9 session program.
  • This information is qualified in its entirety by cautionary statements and risk factors disclosure contained in certain of Patient Access Solutions Inc. Securities and Exchange Commission filings available at http://www.sec.gov .\n'

Valeo Pharma Inc. Enters into an Agreement for Enerzair® Breezhaler® and Atectura® Breezhaler® in Canada

Retrieved on: 
Monday, March 29, 2021

Valeo to commercialize Enerzair Breezhaler and Atectura Breezhaler, 2 innovative asthma therapies approved by Health Canada

Key Points: 
  • Valeo to commercialize Enerzair Breezhaler and Atectura Breezhaler, 2 innovative asthma therapies approved by Health Canada
    Almost 4 million Canadians afflicted with asthma1; Canadian market for asthma medication exceeds $700M annually2
    MONTREAL, March 29, 2021 /PRNewswire/ - Valeo Pharma Inc .
  • Under the Agreement, Valeo will be responsible for medical and commercial activities for Enerzair Breezhaler and Atectura Breezhaler for an initial 8 year period.
  • Commercializing Enerzair Breezhaler and Atectura Breezhaler will immediately position Valeo as one of the leading Canadian respiratory companies providing first in-class and best in-class asthma therapies.TheCanadian asthma maintenance market exceeds $700M annually," said Steve Saviuk, CEO of Valeo.
  • The Enerzair Breezhaler andAtectura Breezhaler will both be available in the hydrofluoroalkane/chlorofluorocarbon (HFA/CFC)-free Breezhalerdevice.

Eyenovia Announces Publication of MIST Pivotal Studies Demonstrating the Efficacy and Safety of its MAP™ Fixed-Combination Tropicamide-Phenylephrine Product for Mydriasis

Retrieved on: 
Wednesday, March 17, 2021

Adverse events with tropicamide-phenylephrine were infrequent at 3% and mild with fewer than 1% of patients reporting blurred vision, reduced acuity, photophobia or instillation site pain.

Key Points: 
  • Adverse events with tropicamide-phenylephrine were infrequent at 3% and mild with fewer than 1% of patients reporting blurred vision, reduced acuity, photophobia or instillation site pain.
  • This publication follows the U.S. Food and Drug Administrations recent acceptance of Eyenovias New Drug Application (NDA) for MydCombi, the micro-dosed fixed-combination tropicamide-phenylephrine agent evaluated in these pivotal studies.
  • Eyenovia, Inc. (NASDAQ: EYEN) is a clinical stage ophthalmic biopharmaceutical company developing a pipeline of microdose array print (MAP) therapeutics.
  • Eyenovia is currently focused on the late-stage development of microdosed medications for presbyopia, myopia progression and mydriasis.