Formoterol

ASLAN Pharmaceuticals Announces New Translational Data on Eblasakimab in COPD and Appoints Leading Respiratory Experts as Scientific Advisors

Retrieved on: 
Wednesday, March 6, 2024
Translational medicine, SAN, MD, Emergency medicine, Partnership, Atopic dermatitis, Asthma, Chronic obstructive pulmonary disease, Rutgers University, Formoterol, Associate, Patient, Disease, Constriction, Harvard Medical School, ASLN, Pharmaceutical industry

“I’m delighted to work with the ASLAN team on this exciting opportunity to evaluate development paths for eblasakimab in COPD, a Type 2-driven disease.

Key Points: 
  • “I’m delighted to work with the ASLAN team on this exciting opportunity to evaluate development paths for eblasakimab in COPD, a Type 2-driven disease.
  • In November 2023, ASLAN announced translational data from healthy donor tissue that suggested eblasakimab’s potential as a COPD therapeutic to inhibit Type 2 inflammation.
  • Further studies have been conducted using lung tissue from a COPD patient, comparing the same concentrations of eblasakimab and dupilumab.
  • Further translational data on eblasakimab in COPD will be submitted for publication at upcoming scientific congresses.

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.

Aucta announces FDA approval of a generic version of Perforomist® (Formoterol Fumarate) Inhalation Solution

Retrieved on: 
Thursday, December 1, 2022
Research, Therapy, CNS, Formoterol, Pharmaceutical industry, Fine chemical, Ophthalmology

PISCATAWAY, N.J., Dec. 1, 2022 /PRNewswire/ -- Aucta Pharmaceuticals, Inc. ("Aucta Pharmaceuticals"), announced today the U.S. approval of a generic version of Perforomist[1](formoterol fumarate) Inhalation Solution.

Key Points: 
  • PISCATAWAY, N.J., Dec. 1, 2022 /PRNewswire/ -- Aucta Pharmaceuticals, Inc. ("Aucta Pharmaceuticals"), announced today the U.S. approval of a generic version of Perforomist[1](formoterol fumarate) Inhalation Solution.
  • Formoterol fumarate inhalation solution had annual sales in the U.S. exceeding $268 million in the aggregate for the 12-month period ending September 2022 according to available data from IQVIATM.
  • Brian Zorn, Chief Commercial Officer of Aucta Pharmaceuticals stated, "We are pleased to have our third Aucta Pharmaceuticals-developed product approved for the U.S. market.
  • Its specialty division has a therapeutic focus in CNS, Ophthalmology, Respiratory and Other Specialty fields.

Viatris Wins Court Decision Invalidating AstraZeneca's Symbicort® Patent

Retrieved on: 
Thursday, November 10, 2022
YouTube, AstraZeneca, Private Securities Litigation Reform Act, Chronic obstructive pulmonary disease, Patent, COPD, Pandemic, Food, Epidemic, Research, ANDA, Multimedia, COVID-19, Budesonide, Regulation of tobacco by the U.S. Food and Drug Administration, Formoterol, Inhalation, SEC, NASDAQ, U.S. Securities and Exchange Commission, Asthma, Douglas v. U.S. District Court ex rel Talk America, Company, Reg, Upjohn, District court, Patient, Invention, Complaint, Pfizer, Security (finance), Combination, FDA, Budesonide/formoterol, Pharmaceutical industry, Generic drug, Viatris

(NASDAQ: VTRS), a global healthcare company, today announced that it and Kindeva Drug Delivery L.P. have won a significant court decision in which the U.S. District Court for the Northern District of West Virginia found that AstraZeneca's Symbicort patent, U.S. Patent No.

Key Points: 
  • (NASDAQ: VTRS), a global healthcare company, today announced that it and Kindeva Drug Delivery L.P. have won a significant court decision in which the U.S. District Court for the Northern District of West Virginia found that AstraZeneca's Symbicort patent, U.S. Patent No.
  • Today's decision marks the fourth Symbicort patent to be found either not infringed or invalid.
  • In May, after Viatris and Kindeva won an appeal, AstraZeneca stipulated that the Company's budesonide/formoterol fumarate dihydrate products would not infringe U.S. Patent Nos.
  • Such forward looking statements may include statements about the decision bythe U.S. District Court for the Northern District of West Virginia that AstraZeneca's Symbicort patent, U.S. Patent No.

ClickStream Appoints Former CFO of the NHL LA Kings, Michael Handelman as its CFO and to its BOD

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Thursday, October 20, 2022
Software, Technology, Mobile, Wireless, Apps, Applications, CFO, Happy path, VP, Los Angeles Kings, NASDAQ, COO, WNRS, BOD, Company, Industry, NHL, CEO, OTC, CPA, CUNY, Forward-looking statement, Formoterol, Terminology, Consultant

ClickStream Corp. (OTC PINK: CLIS), a technology company focused on developing apps & platforms that disrupt conventional industries, announced today that it has appointed Michael Handelman CFO & to its BOD.

Key Points: 
  • ClickStream Corp. (OTC PINK: CLIS), a technology company focused on developing apps & platforms that disrupt conventional industries, announced today that it has appointed Michael Handelman CFO & to its BOD.
  • Mr. Handelman, a CPA holds an accounting degree from CUNY.
  • Frank Magliochetti, CEO of ClickStream, stated, Its extremely gratifying having Michael return to the Company.
  • He will be immensely helpful as we embark on a new chapter, revenue generation.

HaemaLogiX strengthens Board with appointment of Dr. Geoff Nichol

Retrieved on: 
Thursday, July 7, 2022
Patient, Carmine, Achondroplasia, CEO, Medarex, B cell, Novartis, Pulmonology, Physiology, BMS, Amoxicillin/clavulanic acid, Bay, BioMarin Pharmaceutical, Nobel Prize, Senior advisor, Formoterol, SA, BMN, Nobel Prize in Physiology or Medicine, CMO, MBA, Non-executive director, GlaxoSmithKline, SVP, Bristol Myers Squibb, Haemophilia, EVP, Physician, Royal Australasian College, Royal college, Sangamo Therapeutics, VP, Board, Multiple myeloma, Drug development, Batten disease, Lymphatic system, Pharmaceutical industry, Pegvaliase, Medicine, Omalizumab, Phenylketonuria

Bryce Carmine, HaemaLogiX's Chairman and CEO commented: "Geoff's impressive, globally recognised background in drug development, and in particular, in antibody development, makes him a valuable contribution to the HaemaLogiX board.

Key Points: 
  • Bryce Carmine, HaemaLogiX's Chairman and CEO commented: "Geoff's impressive, globally recognised background in drug development, and in particular, in antibody development, makes him a valuable contribution to the HaemaLogiX board.
  • Importantly, during his time at Medarex, Geoff oversaw the preclinical and clinical development of KappaMab, our multiple myeloma drug candidate.
  • He brings outstanding industry knowledge and a highly translatable skillset to our Board mix.
  • Dr. Nichol brings nearly 30 years' experience in drug development.

Viatris Inc. Announces Receipt of the First FDA Approval for Generic Version of Symbicort® Inhalation Aerosol, Breyna™ (Budesonide and Formoterol Fumarate Dihydrate Inhalation Aerosol), in Partnership with Kindeva

Retrieved on: 
Wednesday, March 16, 2022
PAUL, Twitter, Inhalation, SEC, Gaps, LinkedIn, District court, U.S. Securities and Exchange Commission, Patient, Partnership, Private Securities Litigation Reform Act, Reg, Chronic obstructive pulmonary disease, FDA, Federal Circuit Court of Australia, Formoterol, Multimedia, COVID-19, United States Court of Appeals for the Federal Circuit, Breathe Me, AstraZeneca, Combination, COPD, Respiratory disease, Judgement, Regulation Fair Disclosure, Security (finance), Asthma, NASDAQ, List, Pfizer, Douglas v. U.S. District Court ex rel Talk America, Maintenance, Upjohn, Chronic lung disease, Food, CDMO, Pandemic, CEO, ANDA, Epidemic, Budesonide, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, YouTube, Generic drug, Pharmaceutical industry, Budesonide/formoterol, Loughborough, Viatris

PITTSBURGH and ST. PAUL, Minn., March 16, 2022 /PRNewswire/ -- Viatris Inc. (NASDAQ: VTRS) and Kindeva Drug Delivery L.P. today announced that, Mylan Pharmaceuticals Inc., a Viatris subsidiary, has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Breyna™ (Budesonide and Formoterol Fumarate Dihydrate Inhalation Aerosol), the first approved generic version of AstraZeneca's Symbicort®.  Breyna, a drug-device combination product, is indicated for certain patients with asthma or chronic obstructive pulmonary disease (COPD) and will be available in 160 mcg/4.5 mcg and 80 mcg/4.5 mcg dosage strengths.

Key Points: 
  • Viatris CEO Michael Goettler commented: "The FDA final approval of Breyna, the first FDA-approved generic version of Symbicort, is an exciting milestone both for our company and the many patients living with asthma and COPD.
  • This approval also builds on our past successes of bringing other complex product firsts to market and demonstrates the continued delivery of our strong pipeline."
  • Aaron Mann, CEO of Kindeva Drug Delivery, added: "We are pleased that Viatris has received full FDA approval for this important respiratory product.
  • Viatris undertakes no obligation to update these statements for revisions or changes after the date of this release other than as required by law.

FDA Approves First Generic of Symbicort to Treat Asthma and COPD

Retrieved on: 
Tuesday, March 15, 2022
MDIS, Inhalation, Plasma protein binding, Quality of life, Research, Pain scale, National Heart, Lung, and Blood Institute, Patient, Lung, Swelling, Nasal congestion, Wheeze, Bronchitis, Chronic obstructive pulmonary disease, PSG, FDA, Muscle, Nose, Complex, Conditional sentence, COPD, Center for Drug Evaluation and Research, Respiratory disease, Upper respiratory tract infection, Vomiting, Thought, Budesonide, PSG College of Arts and Science, Asthma, FDA Center for Devices and Radiological Health, Mouth, Food, Formoterol, Back pain, MDI, Sinusitis, Inflammation, Headache, Industry, Maintenance, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Common, Pharmaceutical industry, Medical device, Budesonide/formoterol

SILVER SPRING, Md., March 15, 2022 /PRNewswire/ -- Today, the U.S. Food and Drug Administration approved the first generic of Symbicort (budesonide and formoterol fumarate dihydrate) Inhalation Aerosol for the treatment of two common pulmonary health conditions: asthma in patients six years of age and older; and the maintenance treatment of airflow obstruction and reducing exacerbations for patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. This complex generic drug-device combination product, which is a metered-dose inhaler, should not be used to treat acute asthma attacks.

Key Points: 
  • This complex generic drug-device combination product, which is a metered-dose inhaler, should not be used to treat acute asthma attacks.
  • Asthma impacts 25 million people , more than five million of whom are children, while COPD afflicts more than 16 million , according to the National Heart, Lung, and Blood Institute .
  • The FDA requires sponsors to submit appropriate data and information to demonstrate that complex generic drug-device combination products meet the agency's rigorous approval standards.
  • The FDA granted approval of this generic budesonide and formoterol fumarate dihydrate inhalation aerosol to Mylan Pharmaceuticals, Inc.

HONEYWELL TEAMS WITH ASTRAZENECA TO DEVELOP NEXT-GENERATION RESPIRATORY INHALERS THAT USE NEAR-ZERO GLOBAL WARMING POTENTIAL PROPELLANT

Retrieved on: 
Tuesday, February 22, 2022
Online, Carbon, Climate change, VOC, Partnership, Formoterol, Death, Budesonide, Perception, American Innovators for Patent Reform, Securities Exchange Act of 1934, Prevalence, Security (finance), Atmosphere, Asthma, Industry, LON, Environment, Safety, Degenerative disease, Meta-analysis, U.S. Securities and Exchange Commission, AIM, HFO, Solvent, U.S. EPA, News, Aircraft, Atmosphere of Earth, Systematic review, COPD, World Health Organization, Patient, GWP, Technology, Goal, Supermarket, CARB, Research, AstraZeneca, Pharmaceutical industry, Propane, Jet fuel, Renewable energy, Honeywell

CHARLOTTE, N.C., Feb. 22, 2022 /PRNewswire/ -- Honeywell (Nasdaq: HON) today announced a commercial partnership with AstraZeneca (LON: AZN) to develop and bring to market next-generation respiratory inhalers that use near-zero global warming potential (GWP) propellants to treat asthma and chronic obstructive pulmonary disease (COPD).

Key Points: 
  • AstraZeneca expects Breztri Aerosphere to be the first medicine to transition to the next generation pMDI platform, subject to regulatory approval.
  • Following these positive results from the Phase I trial, AstraZeneca will advance a commercial partnership with Honeywell to develop their triple-combination therapy,Breztri Aerosphere, using Honeywell's near-zero GWP propellant technology.
  • "The work we are doing with AstraZeneca developing a respiratory inhaler, with a new near-zero Global Warming Potential propellant, is tremendously important for both the environment and patients with respiratory issues," said Darius Adamczyk, chairman and chief executive officer of Honeywell.
  • A nonflammable and low global warming potential (GWP) alternative to hydrofluorocarbons, it is non-ozone-depleting, VOC-exempt (U.S. EPA and CARB), with an ultra-low GWP close to 1.

Glenmark inks agreement with AstraZeneca to commercialize its product Pulmicort Respules® in Colombia

Retrieved on: 
Monday, February 14, 2022
NASDAQ, Glenmark Pharmaceuticals, Asthma, Salmeterol, Patient, Mometasone, Dow Jones, LSE, Glenmark, Company, Degenerative disease, Index, Formoterol, Budesonide, Corporate sustainability, Business development, Dermatology, OTC, Montelukast, Fluticasone, AstraZeneca, Metabolism, Biopharmaceutical, Immunology, Partnership, GPL, Industry, DJSI, Pharmaceutical industry

BOGOTA, Colombia, Feb. 14, 2022 /PRNewswire/ -- Glenmark Pharmaceuticals, an innovation–driven, global pharmaceutical company, today announced that its subsidiary Glenmark Pharmaceuticals Colombia S.A.S. and AstraZeneca Colombia S.A.S. have entered into an exclusive licensing agreement for the commercialization of AstraZeneca's drug Pulmicort Respules®. Under the terms of the agreement, AstraZeneca remains the holder of the registration for Pulmicort Respules® and will be responsible for manufacturing and supplying the drug. Glenmark will be responsible for commercialization of Pulmicort Respules® in the Colombian market.

Key Points: 
  • - As per this agreement, AstraZeneca remains the holder of the registration for Pulmicort Respules and will manufacture the drug.
  • Glenmark will commercialize the product in Colombia.
  • have entered into an exclusive licensing agreement for the commercialization of AstraZeneca's drug Pulmicort Respules.
  • Under the terms of the agreement, AstraZeneca remains the holder of the registration for Pulmicort Respules and will be responsible for manufacturing and supplying the drug.