Pharmaceuticals policy

$158 Billion Drug Delivery Systems (DDS) Markets - Global Forecast to 2027 - Necessity of Drug Delivery Systems for Enhancing Therapeutic Efficiency and Safety Profile of Drugs - ResearchAndMarkets.com

Retrieved on: 
Thursday, July 29, 2021
Health, Pharmaceutical, Health sciences, Health, Pharmaceuticals policy, Drug delivery, Medical equipment, Pharmacovigilance, Pharmaceutical industry, Drug

The "Drug Delivery Systems (DDS) Global Market - Forecast To 2027" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Drug Delivery Systems (DDS) Global Market - Forecast To 2027" report has been added to ResearchAndMarkets.com's offering.
  • Global drug delivery systems market is expected to reach $158,006.4 million by 2027 growing at a mid single digit CAGR from 2020 to 2027 due to escalating necessity of targeted and controlled drug delivery systems to increase the therapeutic efficiency and safety profile of medications.
  • The top five pharmaceutical players occupy majority of the market share and the remaining minority share of the market is occupied by other players.
  • The drug delivery system enhanced product providers market is consolidated with the top five pharmaceutical players occupying 60.9% of the market share and the remaining 39.1% of the market being occupied by other players.

Arrowhead Pharmaceuticals Receives Breakthrough Therapy Designation from U.S. FDA for ARO-AAT for the Treatment of Alpha-1 Antitrypsin Deficiency Associated Liver Disease

Retrieved on: 
Thursday, July 29, 2021
Infectious diseases, Automotive, General Automotive, FDA, Clinical trials, Cardiology, Biotechnology, Pharmaceutical, Health, Oncology, Health sciences, Life sciences, Health, Hepatology, Pharmacy, Food and Drug Administration, Pharmaceuticals policy, Breakthrough therapy, Alpha-1 antitrypsin deficiency, Fast track, Orphan drug, Alpha-1 Antitrypsin-Associated Liver Disease, Arrowhead Pharmaceuticals, ALPHA-1 ANTITRYPSIN-ASSOCIATED LIVER DISEASE, ARROWHEAD PHARMACEUTICALS

Investigational therapy ARO-AAT was also previously granted Orphan Drug designation and Fast Track designation from the FDA, and Orphan designation from the European Commission.

Key Points: 
  • Investigational therapy ARO-AAT was also previously granted Orphan Drug designation and Fast Track designation from the FDA, and Orphan designation from the European Commission.
  • Javier San Martin, M.D., chief medical officer at Arrowhead, said: Patients with AATD associated liver disease currently have no available treatment options other than a liver transplant.
  • Being granted Breakthrough Therapy designation from the FDA is an important milestone for the investigational ARO-AAT program.
  • Individuals with the homozygous PiZZ genotype have severe deficiency of functional AAT leading to pulmonary disease and liver disease.

Concert Pharmaceuticals to Report Second Quarter 2021 Results on August 5, 2021

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Thursday, July 29, 2021
Health, Other Science, Clinical trials, Research, Science, Pharmaceutical, Biotechnology, Pharmaceutical industry in China, Pharmaceuticals policy, Pharmacy in China, Science and technology in the People's Republic of China, Health care

Concert Pharmaceuticals, Inc. (NASDAQ: CNCE) today announced that it will report its financial results for the second quarter of 2021, on Thursday, August 5, 2021, before the U.S. financial markets open.

Key Points: 
  • Concert Pharmaceuticals, Inc. (NASDAQ: CNCE) today announced that it will report its financial results for the second quarter of 2021, on Thursday, August 5, 2021, before the U.S. financial markets open.
  • ET to discuss its second quarter 2021 financial results and provide a business update.
  • Individuals interested in participating in the call should dial (855) 354-1855 (U.S. and Canada) or (484) 365-2865 (International).
  • Concert Pharmaceuticals is a clinical stage biopharmaceutical company that is developing small molecule drugs that it discovered through the application of its DCE Platform (deuterated chemical entity platform).

'What the Health?': The Drug Price Dilemma

Retrieved on: 
Friday, July 30, 2021
Health sciences, Health, Pharmaceutical industry, Pharmacy, Pharmaceuticals policy, Clinical pharmacology, Drug pricing, Medication costs, Medical prescription, Medication, Prescription drug, Prescription drug prices in the United States

That is because the dilemma faced by many Americans is the struggle of paying the price for filling their prescriptions.

Key Points: 
  • That is because the dilemma faced by many Americans is the struggle of paying the price for filling their prescriptions.
  • Among other G7 nations the UK, France, and Italy have the lowest prescription drug prices.
  • Canada's drug prices are higher, but still considerably less than the cost for the same medications in the USA.
  • That improved access has yet to be seen, and so the dilemma of figuring out ways to afford prescription medication continues for many Americans.

Medical Device and Pharmaceutical Industries Can Leverage New GS1 US Guideline for Sharing Vital Data

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Thursday, July 29, 2021
Articles, Health, Pharmaceuticals policy, Barcodes, GS1 US, GS1, Health care quality, Traceability, Medical device, Unique Device Identification, Medical guideline, Food and Drug Administration

EWING, N.J., July 29, 2021 /PRNewswire/ -- GS1 US has published a new guideline, " Best Practice Guide for Sharing Vital Attributes in Healthcare ," to help healthcare trading partners share data about medical devices or pharmaceutical products.

Key Points: 
  • EWING, N.J., July 29, 2021 /PRNewswire/ -- GS1 US has published a new guideline, " Best Practice Guide for Sharing Vital Attributes in Healthcare ," to help healthcare trading partners share data about medical devices or pharmaceutical products.
  • The guideline is a resource for healthcare professionals charged with master data management, procurement, regulatory compliance and data governance.
  • This guideline also covers data recommendations for the U.S. Food and Drug Administration (FDA) Drug Supply Chain Security Act (DSCSA) enabling pharmaceutical traceability and Unique Device Identification Rule (UDI) requirements for medical device traceability.
  • For more information about GS1 US, the guideline and additional data quality healthcare resources, visit www.gs1us.org.

Rocky Mountain Poison & Drug Safety (RMPDS) Launches Public Online Dashboard Showing Non-Medical Prescription and Illicit Drug Use Data in the United States

Retrieved on: 
Thursday, July 29, 2021
Health, Pharmaceuticals policy, Pharmacovigilance, Prescription drug, Opioid epidemic in the United States

Real time surveillance data is used to design treatment programs, preventative measures, and implement policy changes, such as prescription drug monitoring programs.

Key Points: 
  • Real time surveillance data is used to design treatment programs, preventative measures, and implement policy changes, such as prescription drug monitoring programs.
  • Federal data sources such as the National Survey for Drug Use and Health do not offer publicly available state-based data and can take up to two years to release new drug use data.
  • Rocky Mountain Poison & Drug Safety (RMPDS) is stepping up to help solve this problem with the NMURx Public Access Dashboard to get current data to the people who need it.
  • "Having accurate, timely data on drug use is a big factor in addressing the drug epidemic in the US.

Panaxia & AxioNovo GmbH will market cannabis-based products in Germany

Retrieved on: 
Thursday, July 29, 2021
Medicinal chemistry, Pharmacy, Symbols, Oncology, Pharmaceuticals policy, Articles

This is a significant step in recognizing our contribution and fulfilling our potential within the largest market in Europe".

Key Points: 
  • This is a significant step in recognizing our contribution and fulfilling our potential within the largest market in Europe".
  • Udo Wieners, CEO of AxioNovo GmbH:"As part of PharmaMed Group, we offer various services and products in the field of oncology in Germany.
  • The agreement was signed for 5 years, during which Panaxia will be responsible for manufacturing the products under the European standard (EU-GMP), and their registration according to regulatory requirements in Germany.
  • AxioNovo GmbH will be in charge of marketing, sale and distribution of medical cannabis-based products by Panaxia to cancer patients through direct purchase in pharmacies, following prescriptions from oncologists at cancer specialized clinics in Germany.

Abeona Therapeutics Announces Successful Type B Meeting with U.S. FDA for ABO-102 AAV-based Gene Therapy in Sanfilippo Syndrome Type A (MPS IIIA)

Retrieved on: 
Wednesday, July 28, 2021
Health sciences, Life sciences, Pharmaceutical sciences, Pharmacy, Breakthrough therapy, Food and Drug Administration, Pharmaceuticals policy, Regenerative Medicine Advanced Therapy, Biotechnology, Biopharmaceutical, ABO, Therapy

NEW YORK and CLEVELAND, July 28, 2021 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in gene and cell therapy, today announced that the Company completed a successful Type B meeting with the U.S. Food and Drug Administration (FDA) regarding the pivotal trial to support filing and approval for its AAV-based gene therapy ABO-102 for the treatment of patients with Sanfilippo syndrome type A (MPS IIIA). ABO-102 is currently being evaluated in the single-arm Transpher A study in patients with MPS IIIA.

Key Points: 
  • ABO-102 is currently being evaluated in the single-arm Transpher A study in patients with MPS IIIA.
  • Abeona intends to work closely with the FDA through the regenerative medicine advanced therapy (RMAT) mechanism to assemble the most robust pivotal data package possible for the registration of ABO-102.
  • Abeona Therapeutics Inc. is a clinical-stage biopharmaceutical company developing gene and cell therapies for serious diseases.
  • The Companys development portfolio also features AAV-based gene therapies for ophthalmic diseases with high unmet medical need.

Optinose Announces Preliminary Second Quarter 2021 XHANCE Net Revenue of $18.4 Million

Retrieved on: 
Wednesday, July 28, 2021
Clinical pharmacology, Medical prescription, Patient safety, Symbols, Health, Pharmaceuticals policy, Drug pricing

YARDLEY, Pa., July 28, 2021 (GLOBE NEWSWIRE) -- Optinose (NASDAQ:OPTN), a pharmaceutical company focused on patients treated by ear, nose and throat (ENT) and allergy specialists, today announced preliminary XHANCE® (fluticasone propionate) net product revenue of $18.4 million for the three months ended June 30, 2021. This represents a 79% increase compared to the three months ended June 30, 2020, and a 67% increase compared to the three months ended March 31, 2021. The Company expects XHANCE net product revenue for the full year of 2021 to be at least $80 million.

Key Points: 
  • The Company expects XHANCE net product revenue for the full year of 2021 to be at least $80 million.
  • In addition, the number of XHANCE prescriptions increased by 33% from 62,500 in the second quarter 2020 to 82,900 in the second quarter 2021 based on third-party prescription data and data from XHANCE preferred pharmacy network partners.
  • XHANCE net revenue per prescription increased 35% from $164 in the second quarter 2020 to $221 in the second quarter 2021 based on preliminary second quarter net product revenue of $18.4 million.
  • We are pleased with the growth in demand for XHANCE and increased net product revenue per prescription based on preliminary second quarter net product revenue of $18.4 million, stated CEO Peter Miller.

TFF Pharmaceuticals to Participate in the BTIG Virtual Biotechnology Conference

Retrieved on: 
Wednesday, July 28, 2021
Health sciences, Pharmaceutical industry, Pharmaceutical industry in China, Pharmaceuticals policy, Pharmacy in China, Science and technology in the People's Republic of China, Health, Medication

BTIG Virtual Biotechnology Conference August 9-10, 2021

Key Points: 
  • BTIG Virtual Biotechnology Conference August 9-10, 2021
    If you are interested in arranging a one-on-one meeting, please contact your BTIG conference representative.
  • TFF Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing, or TFF, technology platform.
  • TFF Pharmaceuticals has two lead drug candidates: Voriconazole Inhalation Powder and Tac-Lac Inhalation Powder.
  • To learn more about TFF Pharmaceuticals and its product candidates, visit the Companys website at https://tffpharma.com .