Drug Safety

Over The Counter (OTC) Analgesics Market to Reach USD 5.85 bn by 2024, Bayer AG and Cipla Inc. emerge as Key Contributors to growth | Technavio

Retrieved on: 
Tuesday, October 6, 2020
General Health, Pharmaceutical, Health, Finance, Articles, Money, Pharmaceuticals policy, Financial markets, Drug Safety, Drugs, Over-the-counter drug, Over-the-counter

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.
  • While a few industries will register a drop in demand, numerous others will continue to remain unscathed and show promising growth opportunities.
  • Technavios in-depth research has all your needs covered as our research reports include all foreseeable market scenarios, including pre- & post-COVID-19 analysis.
  • Over the Counter (OTC) Analgesics Market 2020-2024: Segmentation
    Over the Counter (OTC) Analgesics Market is segmented as below:

OTC Drugs, Medical Devices and Diagnostics 2020-2024 with Profiles of Leading Market Players Including 3M, Akron, Bayer AG, Celgene and Eli Lilly and Co.

Retrieved on: 
Thursday, October 1, 2020
Pharmaceuticals policy, Drug Safety, Medical device, Over-the-counter drug

DUBLIN, Oct. 1, 2020 /PRNewswire/ -- The "OTC Drugs, Medical Devices and Diagnostics: Global Markets" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • DUBLIN, Oct. 1, 2020 /PRNewswire/ -- The "OTC Drugs, Medical Devices and Diagnostics: Global Markets" report has been added to ResearchAndMarkets.com's offering.
  • This study aims to provide an understanding of the dynamics and forecasts of the OTC drugs, medical devices and diagnostic kits market worldwide and provides key market propositions over a five-year forecast period.
  • Detailed description and analysis of current OTC drugs, medical devices and diagnostic kits.
  • Regulatory structure: new regulations that will influence the development of the OTC drugs, devices and diagnostics market.

IRLAB's mesdopetam IND accepted by the US FDA

Retrieved on: 
Thursday, October 1, 2020
Health, Drug Safety, Organ systems, Clinical research, Levodopa-induced dyskinesia, Pharmaceutical industry, Investigational New Drug, Dyskinesia, Parkinson's disease, Food and Drug Administration, New Drug Application

STOCKHOLM, Oct. 1, 2020 /PRNewswire/ -- IRLAB (Nasdaq Stockholm: IRLAB A) announced today that the U.S. Food and Drug Administration (FDA) has accepted IRLAB's investigational new drug application (IND) for the drug candidate mesdopetam (IRL790).

Key Points: 
  • STOCKHOLM, Oct. 1, 2020 /PRNewswire/ -- IRLAB (Nasdaq Stockholm: IRLAB A) announced today that the U.S. Food and Drug Administration (FDA) has accepted IRLAB's investigational new drug application (IND) for the drug candidate mesdopetam (IRL790).
  • The planned Phase IIb/III study for mesdopetam will thus include hospitals and enrol patients in the US and Europe.
  • Mesdopetam is in development for the treatment of levodopa-induced dyskinesias in Parkinson's disease, PD-LIDs, with the objective to increase daily good ON-time.
  • The FDA clearance of the IND is a quality stamp on the mesdopetam project and validates mesdopetam as a safe and tolerable drug candidate.

IRLAB's mesdopetam IND accepted by the US FDA

Retrieved on: 
Thursday, October 1, 2020
Health, Drug Safety, Organ systems, Clinical research, Levodopa-induced dyskinesia, Pharmaceutical industry, Investigational New Drug, Dyskinesia, Parkinson's disease, Food and Drug Administration, New Drug Application

STOCKHOLM, Oct. 1, 2020 /PRNewswire/ -- IRLAB (Nasdaq Stockholm: IRLAB A) announced today that the U.S. Food and Drug Administration (FDA) has accepted IRLAB's investigational new drug application (IND) for the drug candidate mesdopetam (IRL790).

Key Points: 
  • STOCKHOLM, Oct. 1, 2020 /PRNewswire/ -- IRLAB (Nasdaq Stockholm: IRLAB A) announced today that the U.S. Food and Drug Administration (FDA) has accepted IRLAB's investigational new drug application (IND) for the drug candidate mesdopetam (IRL790).
  • The planned Phase IIb/III study for mesdopetam will thus include hospitals and enrol patients in the US and Europe.
  • Mesdopetam is in development for the treatment of levodopa-induced dyskinesias in Parkinson's disease, PD-LIDs, with the objective to increase daily good ON-time.
  • The FDA clearance of the IND is a quality stamp on the mesdopetam project and validates mesdopetam as a safe and tolerable drug candidate.

Genexa Launches First-to-Market Clean Over-the-Counter Medicine

Retrieved on: 
Tuesday, September 29, 2020
Other Retail, Medical Supplies, General Health, Health, Specialty, Convenience store, Retail, Other Health, Health, Drug Safety, Drugs, Over-the-counter drug, Pharmaceuticals policy, Pharmaceutical industry, Articles, Medication

Genexa, the first clean medicine company, is disrupting the over-the-counter (OTC) industry with the launch of its first-to-market clean medicine line for kids and adults.

Key Points: 
  • Genexa, the first clean medicine company, is disrupting the over-the-counter (OTC) industry with the launch of its first-to-market clean medicine line for kids and adults.
  • View the full release here: https://www.businesswire.com/news/home/20200929005330/en/
    Genexa Launches First-to-Market Clean Over-the-Counter Medicine (Photo: Business Wire)
    Cold and flu season is fast approaching and nearly 7 in 10 parents turn to the OTC medicine aisle to treat sudden symptoms.
  • With consumers more conscious of the ingredients in their products than ever before, Genexa medicines are the clean choice for effective medicine without any artificial inactive ingredients.
  • At Genexa, weve pioneered a way to deliver clean medicine with safe, clean ingredients that the whole family can feel confident taking.

Ad Hoc Analysis of ARAMIS Showed a High Percentage (97.2%) of Men with Non-Metastatic Castration-Resistant Prostate Cancer Received Full, Planned Dosing of NUBEQA® (darolutamide)

Retrieved on: 
Monday, September 21, 2020
Research, Clinical trials, Other Health, Biotechnology, General Health, Pharmaceutical, Health, Science, Oncology, Other Science, Medicine, Health, Adverse effect, Clinical pharmacology, Drug Safety, Medical terminology, Patient safety, NUBEQA® (darolutamide)2, Prostate Cancer, Prostate Cancer at Bayer, Oncology at Bayer, Bayer

The most frequent adverse reactions requiring discontinuation in patients who received NUBEQA plus ADT included cardiac failure (0.4%) and death (0.4%).

Key Points: 
  • The most frequent adverse reactions requiring discontinuation in patients who received NUBEQA plus ADT included cardiac failure (0.4%) and death (0.4%).
  • The most frequent adverse reactions requiring dosage interruption in patients who received NUBEQA plus ADT included hypertension (0.6%), diarrhea (0.5%) and pneumonia (0.5%).
  • Dose reductions due to an adverse reaction occurred in 6% of patients treated with NUBEQA plus ADT.
  • The most frequent adverse reactions requiring dosage reduction in patients treated with NUBEQA plus ADT included fatigue (0.7%), hypertension (0.3%) and nausea (0.3%).

Aerie Pharmaceuticals Announces U.S. Food and Drug Administration Approval of its Athlone, Ireland Facility for Production of Rhopressa® (netarsudil ophthalmic solution) 0.02%

Retrieved on: 
Tuesday, September 15, 2020
Health, FDA, Other Health, General Health, Pharmaceutical, Optical, Biotechnology, Medicine, Health, Drug Safety, Food and Drug Administration, United States Public Health Service, Conjunctiva, Adverse effect

This approval comes following the FDA review of the New Drug Application Prior Approval Supplement (PAS), which added the Athlone production facility as a drug product manufacturer for Rhopressa.

Key Points: 
  • This approval comes following the FDA review of the New Drug Application Prior Approval Supplement (PAS), which added the Athlone production facility as a drug product manufacturer for Rhopressa.
  • The PAS approval for Rhopressa represents another important manufacturing achievement for Aerie in 2020, said Vicente Anido, Jr., Ph.D., Chairman and Chief Executive Officer at Aerie.
  • In clinical trials of Rhopressa, the most common adverse reactions were conjunctival hyperemia, corneal verticillata, instillation site pain, and conjunctival hemorrhage.
  • In particular, statements in this press release regarding our Athlone, Ireland facility are forward looking statements.

Gannex Filed US IND for Its NASH Drug ASC42, an FXR Agonist

Retrieved on: 
Monday, September 14, 2020
Drug Safety, Food and Drug Administration, Hepatitis, Health, Medical specialties, Pharmaceutical industry, Steatohepatitis, New Drug Application, Investigational New Drug, Nash, Non-alcoholic fatty liver disease

SHANGHAI, Sept. 13, 2020 /PRNewswire/ --Gannex Pharma Co., Ltd., a wholly owned company of Ascletis Pharma Inc. (HKEX:1672)announces today that it has filed investigational new drug application (IND) with US FDA for its non-alcoholic steatohepatitis (NASH) drug candidate ASC42.

Key Points: 
  • SHANGHAI, Sept. 13, 2020 /PRNewswire/ --Gannex Pharma Co., Ltd., a wholly owned company of Ascletis Pharma Inc. (HKEX:1672)announces today that it has filed investigational new drug application (IND) with US FDA for its non-alcoholic steatohepatitis (NASH) drug candidate ASC42.
  • Gannex has two additional drug candidates at clinical stage in its NASH pipeline, ASC40 and ASC41.
  • ASC41 is an oral thyroid hormone receptor beta (THR-beta) agonist which recently received IND approval from China's National Medical Products Administration (NMPA) to conduct clinical trials for NASH indication.
  • NASH: global development of novel drug candidates against three different targets FASN, THR-beta and FXR, which are expected to be used alone or in combination.

BeyondSpring Receives Breakthrough Therapy Designations from Both U.S. FDA and China NMPA for Plinabulin in Chemotherapy-Induced Neutropenia Indication

Retrieved on: 
Tuesday, September 8, 2020
Chemistry, Physical sciences, Food and Drug Administration, Health, Diketopiperazines, Imidazoles, Plinabulin, Drug Safety, New Drug Application, Priority review

Products with BTD from the CDE may be considered for conditional approval and priority review when submitting New Drug Applications (NDAs).

Key Points: 
  • Products with BTD from the CDE may be considered for conditional approval and priority review when submitting New Drug Applications (NDAs).
  • We look forward to continuing to work with the FDA as we advance the development of Plinabulin to address this urgent medical need.
  • The Company has submitted an NDA for Plinabulin for the CIN indication to the NMPA on a rolling basis in Q1 2020.
  • Plinabulin is currently in late-stage clinical development to increase overall survival in cancer patients, as well as to alleviate chemotherapy-induced neutropenia (CIN).

Worldwide Over-the-Counter Drugs Industry to 2025 - Featuring Bayer, Pfizer & Sanofi Among Others

Retrieved on: 
Monday, September 7, 2020
Health, Pharmaceuticals policy, Articles, Pharmaceutical industry, Drugs, Drug Safety, Over-the-counter drug, Medication

The key players in the OTC drugs market are leveraging the brand equity of the major products during their patent period to improve sales and revenue.

Key Points: 
  • The key players in the OTC drugs market are leveraging the brand equity of the major products during their patent period to improve sales and revenue.
  • This, in turn, is majorly driving the global over-the-counter drugs market.
  • Moreover, the growing trend of self-medication among the population is also contributing to the growing demand for OTC drugs.
  • On the flip side, the sale of over-the-counter drugs in developing countries such as India is anticipated to grow rapidly.