Anders (singer)

Over the Counter Drugs Market Report 2022: Rising Trend of Self-Medication and Demand for OTC Drugs Fuels Growth - ResearchAndMarkets.com

Retrieved on: 
Thursday, December 8, 2022
Health, Pharmaceutical, Perrigo, Stomach, Anders (singer), OTC, Pfizer, Mylan, Bayer, Patient, GlaxoSmithKline, US, RX, Geography, Market share, Famotidine, Tablet, COVID-19, Pharmacist, Growth, Reckitt, Ulcer, Marketing, Sanofi, Acquisition, Retail, Pharmaceutical industry, Novartis

Over-the-counter drugs treat a variety of illnesses and their symptoms and help cure some diseases simply and without the cost of seeing a doctor.

Key Points: 
  • Over-the-counter drugs treat a variety of illnesses and their symptoms and help cure some diseases simply and without the cost of seeing a doctor.
  • Increase in disease burden, increase in demand for OTC drugs, rising trend of self-medication, the outbreak of COVID-19, and inclination of pharma companies toward OTC drugs from RX drugs are major factors expected to drive growth of the global during the counter drugs market over the forecast period.
  • The global over the counter drugs market report caters to various stakeholders in this industry including investors, suppliers, product manufacturers, distributors, new entrants, and financial analysts.
  • Stakeholders would have ease in decision-making through various strategy matrices used in analyzing the global over the counter drugs market.

Calyptus Pharmaceuticals Announces Approval of Arformoterol Tartrate Inhalation Solution, EQ 0.015 mg Base/2 ml

Retrieved on: 
Wednesday, August 24, 2022
Respiratory disease, Partnership, Chinese Pharmaceutical Association, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Arformoterol, Maintenance, Chronic obstructive pulmonary disease, Food, Bronchoconstriction, ANDA, Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., FDA, COPD, Abbreviated New Drug Application, Anders (singer), Patient, Pharmaceutical industry, IQVIA

PRINCETON, N.J., Aug. 24, 2022 /PRNewswire/ --Calyptus Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration ("FDA") granted approval to an Abbreviated New Drug Application (ANDA) for a generic version of Brovana (Arformoterol Tartrate inhalation solution, EQ 0.015 mg Base/2 ml) to Calyptus' partner - VistaPharm, Inc., ("VistaPharm" - a Pharmaceutical Associates, Inc company).

Key Points: 
  • PRINCETON, N.J., Aug. 24, 2022 /PRNewswire/ --Calyptus Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration ("FDA") granted approval to an Abbreviated New Drug Application (ANDA) for a generic version of Brovana (Arformoterol Tartrate inhalation solution, EQ 0.015 mg Base/2 ml) to Calyptus' partner - VistaPharm, Inc., ("VistaPharm" - a Pharmaceutical Associates, Inc company).
  • Arformoterol Tartrate inhalation solution, EQ 0.015 mg Base/2 mlis indicated for the long-term, twice daily (morning and evening) maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.
  • The successful development, and approval of a generic formulation of Arformoterol Tartrate inhalation solution is a testimony to these efforts".
  • According to IQVIA, a leading healthcare data and analytics provider, U.S. annual sales for Arformoterol Tartrate inhalation solution, EQ 0.015 mg Base/2 mlfor the 12 months ended June 2022 were approximately $104 million.

Calyptus Pharmaceuticals Announces Partnership with Provepharm to Accelerate Development of an Acute Care Injectable Product

Retrieved on: 
Monday, August 22, 2022
D, LinkedIn, Business development, Union, Anders (singer), USP, Marketing, Patient, Pharmaceutical industry

PRINCETON, N.J., Aug. 22, 2022 /PRNewswire/ -- Calyptus Pharmaceuticals, Inc., ("Calyptus") announced that it entered into an agreement with Provepharm SAS ("Provepharm"), to accelerate the development, marketing and distribution of a complex injectable product used in acute care settings.

Key Points: 
  • PRINCETON, N.J., Aug. 22, 2022 /PRNewswire/ -- Calyptus Pharmaceuticals, Inc., ("Calyptus") announced that it entered into an agreement with Provepharm SAS ("Provepharm"), to accelerate the development, marketing and distribution of a complex injectable product used in acute care settings.
  • With the consummation of the transaction, Provepharm acquired global rights to the product from Calyptus and will take on all development activities and ultimately commercial distribution upon approval.
  • Calyptus Co-founders - Sujeet Singh, Dr. Puiho Yuen and Shubhayu Sinharoy said, "We are thrilled to partner with Provepharm on this lead pipeline asset.
  • Matthieu Leuwers, Provepharm's Chief Business Development Officer said, "Provepharm strengthens its portfolio of sterile injectables in development to reinforce its product offering commercialized directly to hospital health care professionals in U.S.A. and Europe."

VFMCRP announces U.S. Court upholds validity of Velphoro® patent

Retrieved on: 
Monday, August 22, 2022
Medical Supplies, Health, Other Health, Clinical Trials, Pharmaceutical, Biotechnology, Orange Book, Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc., Fresenius Medical Care, District court, Sucroferric oxyhydroxide, Chronic kidney disease, Teva, Vifor Pharma, Judgement, Blood, Dialysis, CSL, Patent, Multimedia, Nephrology, ANDA, District, Douglas v. U.S. District Court ex rel Talk America, Abbreviated New Drug Application, ASX, Intellectual property, Anders (singer), Marketing, Patient, Generic drug

Vifor Fresenius Medical Care Renal Pharma (VFMCRP) today announced that the U.S. District Court for the District of Delaware issued a judgment in VFMCRPs favor regarding U.S. patent no.

Key Points: 
  • Vifor Fresenius Medical Care Renal Pharma (VFMCRP) today announced that the U.S. District Court for the District of Delaware issued a judgment in VFMCRPs favor regarding U.S. patent no.
  • Currently, Velphoro is protected by multiple Orange Book listed patents which expire between May 2029 and May 2035.
  • View the full release here: https://www.businesswire.com/news/home/20220821005007/en/
    A further ANDA patent infringement lawsuit against Teva based on patents no.
  • CSL Vifor welcomes the decision by the U.S. District Court to uphold the patent validity of Velphoro which highlights the innovation and strength of our intellectual property, said Florian Jehle, Chief Executive Officer of VFMCRP.

Calyptus Pharmaceuticals Announces FDA Approval of Cetrorelix Acetate for Injection, 0.25 mg/vial

Retrieved on: 
Friday, August 19, 2022
FDA, Woman, Regulation of tobacco by the U.S. Food and Drug Administration, Industry, Akorn, Abbreviated New Drug Application, ANDA, Patient, Cetrorelix, Eye, Projection, AP, CGT, Food, Injection, Anders (singer), Pharmaceutical industry, IQVIA

PRINCETON, N.J., Aug. 19, 2022 /PRNewswire/ -- Calyptus Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration ("FDA") granted approval to an Abbreviated New Drug Application (ANDA) for an AP-rated generic version of Cetrotide(Cetrorelix Acetate for Injection, 0.25 mg/vial) to Calyptus' partner - Akorn Operating Company LLC ("Akorn").

Key Points: 
  • PRINCETON, N.J., Aug. 19, 2022 /PRNewswire/ -- Calyptus Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration ("FDA") granted approval to an Abbreviated New Drug Application (ANDA) for an AP-rated generic version of Cetrotide(Cetrorelix Acetate for Injection, 0.25 mg/vial) to Calyptus' partner - Akorn Operating Company LLC ("Akorn").
  • In addition, the FDA granted the Competitive Generic Therapy (CGT) designation, which makes the product eligible for 180 days of CGT market exclusivity for the 0.25 mg/vial dose.
  • Cetrorelix Acetate for Injection, 0.25 mg/vial is indicated for the inhibition of premature luteinizing hormone surges in women undergoing controlled ovarian stimulation.
  • Calyptus is a pharmaceutical company based in Princeton, N.J., whosemission is to improve lives of patients by increasing access and affordability of quality medicines.

Dr. Reddy's Laboratories enters into a licensing agreement with Slayback Pharma to obtain exclusive rights in the first-to-file ANDA for the private label version of Lumify® in the U.S.

Retrieved on: 
Friday, July 29, 2022
Pharmaceutical, Health, Optical, R, Eye, Mortality, ANDA, Pandemic, CIS, BSE, Lists of disasters, Industry, U.S. Securities and Exchange Commission, Dermatology, CEO, NYSE, Epidemic, USFDA, Mission statement, Founder, COVID-19, Pain management, Disease, Anders (singer), Review, Security (finance), Vii, Annual report, NSE, OTC, PIV, API, Coronavirus, RDY, Generic drug, Fine chemical, Princeton University

The agreement also provides Dr. Reddys exclusive rights to the product outside the U.S.

Key Points: 
  • The agreement also provides Dr. Reddys exclusive rights to the product outside the U.S.
    Slayback Pharma is the first company to file an ANDA for the private label equivalent for Lumify with the USFDA under Paragraph IV certification.
  • The ANDA is currently under USFDA review and covers Brimonidine Tartrate Ophthalmic Solution 0.025% in 2.5 ml and 7.5 ml fill volumes.
  • We are pleased to license this important OTC ophthalmic product for the U.S. market, says Marc Kikuchi, Chief Executive Officer, North America Generics, Dr. Reddys.
  • This product complements Dr. Reddys growing OTC product portfolio in the eyecare category that includes the private label versions of Pataday Once Daily Relief and Pataday Twice Daily Relief.

ANI Pharmaceuticals Acquires ANDAs from Oakrum Pharma, LLC

Retrieved on: 
Thursday, July 28, 2022
Biotechnology, Pharmaceutical, Health, Clinical Trials, Regulation of tobacco by the U.S. Food and Drug Administration, Acquisition, Food, U.S. Securities and Exchange Commission, SEC, ANI, Private Securities Litigation Reform Act, Risk, Failure, Marketing, Nature, News, Anders (singer), Company, Security (finance), Patient, Nasdaq, Annual report, Terminology, LLC, Form 10-K, Growth, Pharmaceutical industry

ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced the purchase of four abbreviated new drug applications (ANDAs) from Oakrum Pharma, LLC, a privately owned biopharmaceutical company.

Key Points: 
  • ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced the purchase of four abbreviated new drug applications (ANDAs) from Oakrum Pharma, LLC, a privately owned biopharmaceutical company.
  • We are pleased to expand our generics product portfolio with the acquisition of four limited competition ANDAs.
  • Bourne Partners served as the exclusive financial advisor to Oakrum Pharma, LLC in this transaction.
  • ANI Pharmaceuticals, Inc. is a diversified bio-pharmaceutical company serving patients in need by developing, manufacturing, and marketing high quality branded and generic prescription pharmaceutical products, including for diseases with high unmet medical need.

Lachman Consultant Services, Inc. Names Marty Shimer as Executive Director, Regulatory

Retrieved on: 
Monday, July 11, 2022
OGD, Control, Regulatory affairs, FDA, Pulitzer Prize Special Citations and Awards, AMA Foundation Leadership Award, U.S. Public Health Service reorganizations of 1966–1973, CEO, Industry, Commendation Medal, Medication, Commissioner, Food, Knowledge, Abbreviated New Drug Application, Lachmann, Patent, Division, Science and technology, Consultant, United States Public Health Service, Achievement, Compliance, Technology, Pharmacy (shop), II, ANDA, Anders (singer), PET, PHS, Development aid, Publication, Organization, Risk management, Pharmaceutical industry, Biotechnology, Science, Device

WESTBURY, N.J., July 11, 2022 /PRNewswire-PRWeb/ -- In this role, Mr. Shimer will assist clients with regulatory submissions and strategy, communications with FDA, and navigating the approval process while offering guidance on issues related to therapeutic equivalence, patent certifications, 180-day exclusivity, the Competitive Generic Therapy pathway, New Drug Application exclusivities, regulatory requirements for ANDAs and more.

Key Points: 
  • Frances Zipp, President and CEO of Lachman Consultant Services, Inc. (Lachman Consultants), a leading provider of compliance, regulatory affairs, and technical services to global life sciences organizations, announced today that CAPT Martin H. Shimer, II joined the firm as Executive Director, Regulatory, effective July 11, 2022.
  • His time with the FDA also included roles as Senior Supervisory Regulatory Management Officer, Deputy Director; Supervisory Regulatory Management Officer, Branch Chief; and Senior Regulatory Management Officer.
  • During his time with the FDA, Mr. Shimer actively supported a range of important public health initiatives, both domestically and abroad.
  • Founded in 1978, Lachman Consultants maintains three practice groups: Compliance, Regulatory Affairs, and Science and Technology.

Glenmark Pharmaceuticals Inc., USA continues to expand its Over-The-Counter (OTC) Portfolio with the acquisition of approved ANDAs from Wockhardt Limited

Retrieved on: 
Tuesday, June 28, 2022
Dermatology, Glenmark, OTC, Acquisition, Patient, Anders (singer), BSE, Dow Jones, Growth, Ethics in pharmaceutical sales, Abbreviated New Drug Application, Social media, NSE, Social, DJSI, Generic, Generic drug

Glenmark's current portfolio consists of 175 products authorized for distribution in the U.S. marketplace and 48 ANDAs pending approval with the U.S. FDA.

Key Points: 
  • Glenmark's current portfolio consists of 175 products authorized for distribution in the U.S. marketplace and 48 ANDAs pending approval with the U.S. FDA.
  • In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.
  • Glenmark Pharmaceuticals Ltd. (BSE: 532296) (NSE: GLENMARK) is an innovation-driven global pharmaceutical company with a presence across Specialty, Generics and OTC businesses.
  • The company has 10 world-class manufacturing facilities spread across 4 continents and operations in over 80 countries.

ANDA Submission and GDUFA Guidance Webinar - ResearchAndMarkets.com

Retrieved on: 
Monday, June 20, 2022
Health, Pharmaceutical, ANDA, Review, FDA, Pass, PAS, Anders (singer), Goal, Generic drug, Pharmaceutical industry, Medical device

The "ANDA Submission and GDUFA Guidance" webinar has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "ANDA Submission and GDUFA Guidance" webinar has been added to ResearchAndMarkets.com's offering.
  • The FDA's process for classifying major, minor, and unsolicited amendments to ANDAs or PASs.
  • How ANDA or PAS deficiencies that will cause the FDA to request a major amendment or classify deficiency responses as a major amendment.
  • How the FDA will process amendments submitted before GDUFA II.