Drug Safety

Moleac Announces US FDA Approval of IND Application for Phase 1 Study of MLC1501 Programme in Post-Traumatic Brain Injury Recovery

Retrieved on: 
Monday, May 31, 2021

SINGAPORE, May 31, 2021 /PRNewswire/ -- Moleac, a biopharmaceutical company based in Singapore, announced the approval by the U.S. Food and Drug Administration (FDA) of an investigational new drug (IND) application for MLC1501 in traumatic brain injury (TBI).

Key Points: 
  • SINGAPORE, May 31, 2021 /PRNewswire/ -- Moleac, a biopharmaceutical company based in Singapore, announced the approval by the U.S. Food and Drug Administration (FDA) of an investigational new drug (IND) application for MLC1501 in traumatic brain injury (TBI).
  • The approval of this IND comes 3 years after the opening of the first IND by the U.S. FDA for MLC1501 in Post-Stroke Recovery, allowing Moleac to conduct a phase 1 study (safety study) in healthy volunteers which has been successfully completed.
  • "This approval represents another milestone for Moleac, supporting our ambition to provide best in class therapeutic options to patients in need.
  • In 2018, the U.S. FDA has approved an IND for MLC1501 in post-stroke recovery, the phase 1 was completed in 2020.

Eton Pharmaceuticals Receives Complete Response Letter from U.S. FDA for Dehydrated Alcohol Injection

Retrieved on: 
Friday, May 28, 2021

DEER PARK, Ill., May 28, 2021 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (Nasdaq: ETON), today announced that the company has received a Complete Response Letter (CRL) from the U.S. Food & Drug Administration (FDA) in response to the submission of its New Drug Application (NDA) for dehydrated alcohol injection for the treatment of methanol poisoning.

Key Points: 
  • DEER PARK, Ill., May 28, 2021 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (Nasdaq: ETON), today announced that the company has received a Complete Response Letter (CRL) from the U.S. Food & Drug Administration (FDA) in response to the submission of its New Drug Application (NDA) for dehydrated alcohol injection for the treatment of methanol poisoning.
  • A Pre-Approval Inspection (PAI) of the products European contract manufacturer is pending due to what the company believes are COVID-related travel restrictions.
  • The company believes all other FDA questions raised in the letter can be fully addressed in a response in the coming months.
  • Eton Pharmaceuticals, Inc. is an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases.

Children's Health Defense Says Vaccine Adverse Event Reporting System Disregarded Regulations on Counting Serious Cases for Years, Resulting in a Grossly Inaccurate Safety Assessment

Retrieved on: 
Thursday, May 27, 2021

Vaccine Adverse Event Reporting System (VAERS).

Key Points: 
  • Vaccine Adverse Event Reporting System (VAERS).
  • The FDA and CDC officials excluded "a persistent or significant disability/incapacity" as "serious" despite federal regulations to the contrary.
  • Empirical evidence suggests that the VAERS mis-categorization of "serious" events hid major safety problems with Gardasil and possibly with other vaccines.
  • "The failure of the VAERS system is profound," said Robert F. Kennedy, Jr., Chair of Children's Health Defense.

Two Day Online Course: FDA's Regulation of OTC Drug Products - What It Is, How to Analyze It, Make It Work for You (August 10-11, 2021) - ResearchAndMarkets.com

Retrieved on: 
Wednesday, May 26, 2021

The "FDA's Regulation of OTC Drug Products - What It Is, How to Analyze It, Make It Work for You" conference has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "FDA's Regulation of OTC Drug Products - What It Is, How to Analyze It, Make It Work for You" conference has been added to ResearchAndMarkets.com's offering.
  • Available without a prescription and for purchase directly off-the-shelf, OTC drug products currently represent nearly 60% of all drug products sold in the United States.
  • Some of the most recognized OTC drug products include ibuprofen tablets, anti-itch creams, nasal decongestant sprays, cough syrups, antacids, allergy medicines and topical pain relievers.
  • The U.S. Food and Drug Administration ("FDA") is responsible for the regulation and oversight of the U.S. OTC drug market.

Veterinary Drug Approval Process and FDA Regulatory Oversight: Two Day Online Seminar (June 15-16, 2021) - ResearchAndMarkets.com

Retrieved on: 
Wednesday, May 26, 2021

The "The Veterinary Drug Approval Process and FDA Regulatory Oversight" conference has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "The Veterinary Drug Approval Process and FDA Regulatory Oversight" conference has been added to ResearchAndMarkets.com's offering.
  • This two-day interactive seminar online will provide attendees with an understanding of FDA's veterinary drug approval process in 2021.
  • The U.S. Food and Drug Administration's Center for Veterinary Medicine (CVM) is responsible for the approval of veterinary drug products intended for family pets, food-producing animals, and other animal species.
  • This seminar will cover the process for obtaining federal government approval for marketing new animal drug products that are under the jurisdiction of the FDA, and also briefly covers animal products that are regulated by other federal agencies.

Saniona publishes its interim report for the first quarter of 2021

Retrieved on: 
Wednesday, May 26, 2021

The U.S. FDA provided further clarity on a regulatory path for Tesomet in the treatment of hypothalamic obesity (HO).

Key Points: 
  • The U.S. FDA provided further clarity on a regulatory path for Tesomet in the treatment of hypothalamic obesity (HO).
  • The FDA indicated overall agreement with Sanionas Risk Evaluation and Mitigation Strategy (REMS) proposal and cardiovascular monitoring proposal.
  • Saniona announced the receipt of manufacturing feedback from the FDA that will delay the start of the Tesomet Phase 2b trials into the second half of 2021.
  • Saniona presented preclinical data on SAN903 in a model of idiopathic pulmonary fibrosis at theAmerican Society of Pharmacology and Experimental Therapeutics(ASPET) Annual Meeting at Experimental Biology (EB) 2021.

Statement from the Chief Public Health Officer of Canada on May 20, 2021

Retrieved on: 
Thursday, May 20, 2021

This will help us stay healthy, while allowing us to safely enjoy more activities and small reunions outdoors.

Key Points: 
  • This will help us stay healthy, while allowing us to safely enjoy more activities and small reunions outdoors.
  • Maintaining a cautious approach now, will set up us up for a better summer and fall .
  • At the same time, the Public Health Agency of Canada is providing Canadians with regular updates on COVID-19 vaccines administered , vaccination coverage and ongoing monitoring of vaccine safety across the country.
  • Working together, Health Canada , the Public Health Agency of Canada , the National Advisory Committee on Immunization , Canada's Chief Medical Officers of Health and other health professionals across the country are closely monitoring vaccine safety , effectiveness and optimal use to adapt approaches.

Medicago and GSK Announce Positive Interim Phase 2 Results for Adjuvanted COVID-19 Vaccine Candidate

Retrieved on: 
Tuesday, May 18, 2021

These results are part of the ongoing Phase 2/3 study and reiterate the promising profile observed during Phase 1 testing.

Key Points: 
  • These results are part of the ongoing Phase 2/3 study and reiterate the promising profile observed during Phase 1 testing.
  • No related severe adverse events were reported and reactogenicity was generally mild to moderate and short in duration.\n\xe2\x80\x9cWe are very excited to see such positive results from the Phase 2 data.
  • After two doses, the adjuvanted vaccine candidate induced robust neutralizing antibody and cellular immune responses in all subjects, irrespectively of age,\xe2\x80\x9d said Nathalie Landry, Executive Vice President, Scientific and Medical Affairs at Medicago.
  • \xe2\x80\x9cThese results give us confidence as we continue to move forward with our Phase 3 clinical trial.

Medicago and GSK announce positive interim Phase 2 results for adjuvanted COVID-19 vaccine candidate

Retrieved on: 
Tuesday, May 18, 2021

These results are part of the ongoing Phase 2/3 study and reiterate the promising profile observed during Phase 1 testing.

Key Points: 
  • These results are part of the ongoing Phase 2/3 study and reiterate the promising profile observed during Phase 1 testing.
  • No related severe adverse events were reported and reactogenicity was generally mild to moderate and short in duration.\n"We are very excited to see such positive results from the Phase 2 data.
  • After two doses, the adjuvanted vaccine candidate induced robust neutralizing antibody and cellular immune responses in all subjects, irrespectively of age," said Nathalie Landry, Executive Vice President, Scientific and Medical Affairs at Medicago.
  • "These results give us confidence as we continue to move forward with our Phase 3 clinical trial.

U.S. FDA Accepts Regulatory Submission for Sintilimab in Combination with Pemetrexed and Platinum Chemotherapy for the First-Line Treatment of People with Nonsquamous Non-Small Cell Lung Cancer

Retrieved on: 
Tuesday, May 18, 2021

To date, sintilimab has two indications approved in China, three regulatory submissions under review in China, and this regulatory application under review in U.S..

Key Points: 
  • To date, sintilimab has two indications approved in China, three regulatory submissions under review in China, and this regulatory application under review in U.S..
  • This regulatory application was submitted to the FDA in March 2021, primarily based on the results of the Phase 3 ORIENT-11 trial.
  • The Prescription Drug User Fee Act (PDUFA) goal date for the FDA to make a decision on the sintilimab application is in March 2022.
  • It is currently planning to hold an Advisory Committee meeting to discuss this application.\n"We are pleased the sintilimab submission is progressing.