Drug Safety

Advisory - Certain vials of fertility drug Cetrotide recalled because of potential contamination

Saturday, July 4, 2020 - 9:12pm

Issue:One lot of Cetrotide 0.25mg is being recalled because some vials may have missing stoppers, which could make the product unsterile.

Key Points: 
  • Issue:One lot of Cetrotide 0.25mg is being recalled because some vials may have missing stoppers, which could make the product unsterile.
  • What to do:Check the lot number on your product or contact your pharmacist to determine whether your product is subject to this recall.
  • If you have a recalled product, do not take the medication.
  • Contact your healthcare provider as soon as possible to obtain a replacement and avoid any interruption to your treatment.

Avadel Announces Sale of Hospital Sterile Injectable Drug Portfolio for $42.0 Million

Wednesday, July 1, 2020 - 1:00pm

By divesting our portfolio of sterile injectable drugs, we are now singularly focused on supporting the regulatory approval process, market planning and maximizing shareholder value for FT218.

Key Points: 
  • By divesting our portfolio of sterile injectable drugs, we are now singularly focused on supporting the regulatory approval process, market planning and maximizing shareholder value for FT218.
  • Under the terms of the agreement, Avadel will receive $14.5 million upfront and the remaining $27.5 million will be paid out to Avadel over the next 13 months.
  • FT218 has been granted Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of narcolepsy.
  • Such forward-looking statements include, but are not limited to, the anticipated benefits of the sale of the Companys sterile injectable drug portfolio, the planned submission of the FT218 NDA to the FDA and the commercial launch of FT218, if approved.

Alterity Therapeutics meeting with US FDA provides development pathway for ATH434

Tuesday, June 30, 2020 - 4:14am

The pre-IND (Investigational New Drug) meeting was to obtain input on the clinical development plan for ATH434, including feedback on the Phase 2 study design.

Key Points: 
  • The pre-IND (Investigational New Drug) meeting was to obtain input on the clinical development plan for ATH434, including feedback on the Phase 2 study design.
  • Alterity reached agreement with the FDA on the non-clinical investigations required to support the Phase 2 study.
  • In parallel with the US strategy, Alterity is also pursuing a regulatory pathway in Europe and Australia.
  • This announcement was authorized by Geoffrey Kempler, CEO and Chairman of Alterity Therapeutics Limited.

Novaremed Announces U.S. FDA Approval of IND Application to Initiate Phase 2 Clinical Study of NRD135S.E1 for the Treatment of Painful Diabetic Peripheral Neuropathy

Tuesday, June 23, 2020 - 1:24pm

Novaremed AG (Novaremed), a clinical-stage Swiss biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has cleared an Investigational New Drug (IND) application to initiate its US-based Phase 2 clinical study of the novel drug candidate, NRD135S.E1, for the treatment of Painful Diabetic Peripheral Neuropathy (PDPN).

Key Points: 
  • Novaremed AG (Novaremed), a clinical-stage Swiss biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has cleared an Investigational New Drug (IND) application to initiate its US-based Phase 2 clinical study of the novel drug candidate, NRD135S.E1, for the treatment of Painful Diabetic Peripheral Neuropathy (PDPN).
  • The acceptance of our IND is a major milestone in the clinical development of NRD135S.E1 for the treatment of PDPN, said Sara Mangialaio, M.D., Ph.D., CMO and Head of R&D at Novaremed.
  • Novaremed is currently in discussions with potential investors to raise the necessary funding to initiate the Phase 2 clinical study and prepare for further late-stage development activities of NRD135S.E1.
  • Novaremed Ltd, a wholly owned subsidiary of Novaremed AG was founded in 2008 in Israel and Novaremed AG was founded in 2017 in Switzerland.

Global OTC Drugs, Medical Devices and Diagnostics Markets to 2024 - Featuring 3M, Akron & Bayer Among Others - ResearchAndMarkets.com

Tuesday, June 23, 2020 - 10:30am

The "OTC Drugs, Medical Devices and Diagnostics: Global Markets" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "OTC Drugs, Medical Devices and Diagnostics: Global Markets" report has been added to ResearchAndMarkets.com's offering.
  • This report covers medical devices and diagnostic kits exempted by the U.S. FDA for OTC use.
  • Regulatory structure: new regulations that will influence the development of the OTC drugs, devices and diagnostics market.
  • Observations and conclusions on the future of OTC drugs, medical devices and diagnostics.

COVID-19: Significant Shift in Strategy of Over The Counter (OTC) Analgesics Market 2020-2024 | Increasing Prevalence of Pain-related Conditions to Boost Growth | Technavio

Tuesday, June 23, 2020 - 9:00am

The report offers an up-to-date analysis regarding the current market scenario, latest trends and drivers, and the overall market environment.

Key Points: 
  • The report offers an up-to-date analysis regarding the current market scenario, latest trends and drivers, and the overall market environment.
  • View the full release here: https://www.businesswire.com/news/home/20200623005077/en/
    Technavio has announced its latest market research report titled Global Over the Counter (OTC) Analgesics Market 2020-2024 (Graphic: Business Wire)
    The global over the counter analgesics market will not witness any major impact due to the spread of COVID-19.
  • The increasing prevalence of pain-related conditions has been instrumental in driving the growth of the market.
  • https://www.technavio.com/report/over-the-counter-analgesics-market-indu...
    Over the Counter (OTC) Analgesics Market 2020-2024: Segmentation
    Over the Counter (OTC) Analgesics Market is segmented as below:

FDA In Brief: FDA Launches New Export Certification Application System for Animal Products

Monday, June 22, 2020 - 7:29pm

"Our new electronic export certification application system will help U.S. animal food, drug and device manufacturers facilitate export of their products, as well as enable foreign governments to verify the authenticity of U.S. export certificates for FDA-regulated animal products."

Key Points: 
  • "Our new electronic export certification application system will help U.S. animal food, drug and device manufacturers facilitate export of their products, as well as enable foreign governments to verify the authenticity of U.S. export certificates for FDA-regulated animal products."
  • Today the U.S. Food and Drug Administration's Center for Veterinary Medicine launched the Export Certification Application and Tracking System (CVM eCATS), a new online system that enables U.S. animal food, drug and device manufacturers to apply for, track and receive export certificates electronically for CVM-regulated animal products.
  • Previously, manufacturers of CVM-regulated products were required to submit a paper application via mail.
  • The new portal will also help the FDA to more efficiently review applications in a paperless environment and better track applications and export certificates that have been issued.

Advisory - Best-before and expiration dates of foods: what you should know

Monday, June 22, 2020 - 2:00pm

Issue: Important information onbest-before and expiration dates of foods.

Key Points: 
  • Issue: Important information onbest-before and expiration dates of foods.
  • What to do:Best-before dates and expiration dates are not the same.
  • An expiration date is not the same as a best-before date.
  • These types of foods have strict compositional and nutritional specifications that may not be met after the expiration date.

OTC Drugs, Medical Devices and Diagnostics: Global Markets

Monday, June 15, 2020 - 4:20pm

- Detailed description and analysis of current OTC drugs, medical devices and diagnostic kits.

Key Points: 
  • - Detailed description and analysis of current OTC drugs, medical devices and diagnostic kits.
  • The global market for OTC drugs (e.g., pharmaceutical OTC drugs, nutritional products [vitamin and mineral supplements]) and medical devices and diagnostics was valued at REDACTED in 2019.
  • In 2019, the U.S. accounted for REDACTED (REDACTED) of the global OTC drugs, medical devices and diagnostics market.
  • The U.S. is expected to maintain dominance in the OTC drugs, nutritional products (vitamin and mineral supplements), medical devices and diagnostics segments of the global OTC market.

IntelGenx Provides Update on RIZAPORT® VersaFilm® NDA Resubmission Process Following Type A Meeting with the FDA

Thursday, June 11, 2020 - 1:00pm

On March 27, 2020, IntelGenx received a Complete Response Letter (CRL) from the FDA regarding its resubmitted 505(b)(2) New Drug Application (NDA) for RIZAPORT VersaFilm for the treatment of acute migraines.

Key Points: 
  • On March 27, 2020, IntelGenx received a Complete Response Letter (CRL) from the FDA regarding its resubmitted 505(b)(2) New Drug Application (NDA) for RIZAPORT VersaFilm for the treatment of acute migraines.
  • At the meeting, IntelGenx obtained clarity from the Agency on the Chemistry, Manufacturing and Controls (CMC) information required for resubmission of the NDA.
  • The Type A meeting with the FDA was very productive and we are pleased with the outcome, said Dr.Horst G. Zerbe, CEO ofIntelGenx.
  • IntelGenxs superior film technologies, including VersaFilm, VetaFilm and transdermal, allow for next generation pharmaceutical products that address unmet medical needs.