Benzimidazoles

FDA Approves First Oral Blood Thinning Medication for Children

Retrieved on: 
Monday, June 21, 2021

Pradaxa is the first FDA-approved blood thinning medication that children can take by mouth; the only other approved blood thinning medication for children is given by injection.

Key Points: 
  • Pradaxa is the first FDA-approved blood thinning medication that children can take by mouth; the only other approved blood thinning medication for children is given by injection.
  • "With today's approval of Pradaxa, pediatric patients have another therapeutic option to treat and prevent potentially deadly blood clots."
  • Blood clots can be a serious problem in children as well as adults.
  • The primary endpoints of the study were recurrence of blood clots, major and minor bleeding events, and death (both overall and related to blood clots).

Phase 3 Clinical Trial Subgroup Analysis Across Solid Organ Transplant (SOT) Types Supports Efficacy of Maribavir Over Conventional Therapies in Post-Transplant Recipients With Cytomegalovirus (CMV) Infection (Refractory, With or Without Resistance)

Retrieved on: 
Monday, June 7, 2021

Most recently, the FDA has granted priority review of maribavir for the treatment of post-transplant recipients with CMV infection in those R/R to prior anti-CMV treatment.

Key Points: 
  • Most recently, the FDA has granted priority review of maribavir for the treatment of post-transplant recipients with CMV infection in those R/R to prior anti-CMV treatment.
  • Avery R. Randomized Phase 3 Open-Label Study of Maribavir vs Investigator-Assigned Therapy for Refractory/Resistant Cytomegalovirus Infection in Transplant Recipients: Subgroup Analyses of Efficacy by Organ.
  • Duarte R. Maribavir Versus Investigator-Assigned Therapy for the Treatment of Transplant Recipients with Refractory/Resistant Cytomegalovirus Infection: Efficacy Data From a Randomized Phase 3 Open-Label Study.
  • Clinical impact of neutropenia related with the preemptive therapy of CMV infection in solid organ transplant recipients.

Albendazole Market by Target Pathogen, End-use and Distribution Channel - Global Forecast up to 2026 - ResearchAndMarkets.com

Retrieved on: 
Tuesday, May 25, 2021

The "Albendazole Market based on Target Pathogen, End-use and Distribution Channel and Geography - Global Forecast up to 2026" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Albendazole Market based on Target Pathogen, End-use and Distribution Channel and Geography - Global Forecast up to 2026" report has been added to ResearchAndMarkets.com's offering.
  • The Albendazole Market is projected to grow at the rate of 7.4% CAGR by 2026.
  • On the other hand, the negative effects of albendazole drugs are likely to hamper the albendazole market growth potential.
  • Online pharmacies are the significant distribution channel in the albendazole market due to the rising online purchases and the availability of various drugs in online pharmacies.

Global Telmisartan Market (2020 to 2027) - by Indication, Distribution Channel and Geography - ResearchAndMarkets.com

Retrieved on: 
Tuesday, May 18, 2021

Telmisartan is available in tablets of different strengths such as 20, 40 and 80 mg tablets under the trade name Micardis.

Key Points: 
  • Telmisartan is available in tablets of different strengths such as 20, 40 and 80 mg tablets under the trade name Micardis.
  • The daily dose of telmisartan for hypertension is 40 to 80 mg and for cardiovascular risk reduction it is 80 mg.
  • In addition, surge in geriatric population and sedentary lifestyle act as key drivers of the global market.
  • Conversely, surge in research related to telmisartan drug in emerging economies is expected to offer lucrative opportunities during the forecast period.\nThe global telmisartan market is segmented into indication, distribution channel, and region.

Phathom Pharmaceuticals Announces Positive Topline Results from Pivotal Phase 3 Trial of Vonoprazan in Helicobacter pylori (H. pylori) Infection; Study Met All Primary and Secondary Endpoints

Retrieved on: 
Thursday, April 29, 2021

PHALCON-HP is the largest Phase 3 registration trial ever conducted in H. pylori infection, randomizing 992 patients with confirmed H. pylori infection.\nThe primary endpoints in the PHALCON-HP study were non-inferiority of the H. pylori eradication rate for each of vonoprazan triple and dual therapy compared to lansoprazole triple therapy.

Key Points: 
  • PHALCON-HP is the largest Phase 3 registration trial ever conducted in H. pylori infection, randomizing 992 patients with confirmed H. pylori infection.\nThe primary endpoints in the PHALCON-HP study were non-inferiority of the H. pylori eradication rate for each of vonoprazan triple and dual therapy compared to lansoprazole triple therapy.
  • Based on U.S. Food and Drug Administration (FDA) feedback, the primary endpoint excluded patients with amoxicillin or clarithromycin resistant strains of H. pylori.\nBoth vonoprazan-based regimens successfully met their primary endpoints.
  • pylori is a bacterial pathogen that is estimated to infect over 200 million individuals in the United States and Europe.
  • The inclusion of forward-looking statements should not be regarded as a representation by Phathom that any of its plans will be achieved.

Telmisartan Market Size to Reach $4.25 Bn, Globally, by 2027 at 3.4% CAGR: Allied Market Research

Retrieved on: 
Tuesday, April 6, 2021

According to the report, the global telmisartan market size generated $3.45 billion in 2019, and is expected to reach $4.25 billion by 2027, manifesting a CAGR of 3.4% from 2020 to 2027.

Key Points: 
  • According to the report, the global telmisartan market size generated $3.45 billion in 2019, and is expected to reach $4.25 billion by 2027, manifesting a CAGR of 3.4% from 2020 to 2027.
  • However, drug shortages of telmisartan tablets hinder the market growth.
  • On the other hand, high growth potential in developing countries is expected to create new opportunities in the next few years.
  • The outbreak of covid-19 impacted the manufacturing facilities and disrupted the supply chain, thereby creating a shortage of telmisartan tablets.

Telmisartan Market Size to Reach $4.25 Bn, Globally, by 2027 at 3.4% CAGR: Allied Market Research

Retrieved on: 
Tuesday, April 6, 2021

According to the report, the global telmisartan market size generated $3.45 billion in 2019, and is expected to reach $4.25 billion by 2027, manifesting a CAGR of 3.4% from 2020 to 2027.

Key Points: 
  • According to the report, the global telmisartan market size generated $3.45 billion in 2019, and is expected to reach $4.25 billion by 2027, manifesting a CAGR of 3.4% from 2020 to 2027.
  • However, drug shortages of telmisartan tablets hinder the market growth.
  • On the other hand, high growth potential in developing countries is expected to create new opportunities in the next few years.
  • The outbreak of covid-19 impacted the manufacturing facilities and disrupted the supply chain, thereby creating a shortage of telmisartan tablets.

Subgroup Analysis from Phase 3 Clinical Trial Supports Efficacy of Maribavir Over Conventional Therapies in Transplant Recipients With Cytomegalovirus Infection (Refractory, With or Without Resistance)

Retrieved on: 
Monday, March 15, 2021

Transplant recipients receiving maribavir exhibited lower incidence of treatment-related toxicities common with conventional antiviral therapies.

Key Points: 
  • Transplant recipients receiving maribavir exhibited lower incidence of treatment-related toxicities common with conventional antiviral therapies.
  • The FDA has also granted maribavir Breakthrough Therapy Designation as a treatment for CMV infection and disease in transplant patients resistant or refractory to prior therapy.
  • Duarte R. Maribavir Versus Investigator-Assigned Therapy for the Treatment of Transplant Recipients with Refractory/Resistant Cytomegalovirus Infection: Efficacy Data From a Randomized Phase 3 Open-Label Study.
  • Definitions of Resistant and Refractory Cytomegalovirus Infection and Disease in Transplant Recipients for Use in Clinical Trials.

Dr. Reddy's Laboratories Announces the Launch of Lansoprazole DR Orally Disintegrating Tablets in the U.S. Market

Retrieved on: 
Monday, February 22, 2021

Dr. Reddys Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY, along with its subsidiaries together referred to as Dr. Reddys) today announced the launch of Lansoprazole DR Orally Disintegrating Tablets, a therapeutic equivalent generic version of Prevacid SoluTab Delayed-Release Orally Disintegrating Tablets, 15 mg and 30 mg, approved by the U.S. Food and Drug Administration (USFDA).

Key Points: 
  • Dr. Reddys Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY, along with its subsidiaries together referred to as Dr. Reddys) today announced the launch of Lansoprazole DR Orally Disintegrating Tablets, a therapeutic equivalent generic version of Prevacid SoluTab Delayed-Release Orally Disintegrating Tablets, 15 mg and 30 mg, approved by the U.S. Food and Drug Administration (USFDA).
  • The Prevacid brand and generic had U.S. sales of approximately $87 million MAT for the most recent twelve months ending in December 2020 according to IMS Health*.
  • https://www.drreddys.com/pi/lansoprazoledr_odtus_outsert_v_3.pdf
    Prevacid is a trademark of Takeda Pharmaceuticals U.S.A., Inc.
    About Dr. Reddys: Dr. Reddys Laboratories Ltd. ((BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY) is an integrated pharmaceutical company committed to providing affordable and innovative medicines for healthier lives.
  • Our major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology.

Takeda’s Maribavir Phase 3 Clinical Trial Met Primary Endpoint of Superiority to Conventional Antiviral Therapy in Transplant Recipients With Refractory, With or Without Resistance, Cytomegalovirus Infection/Disease

Retrieved on: 
Friday, February 12, 2021

Any treatment-emergent adverse events (TEAEs) were 97.4% (228/234) for maribavir and 91.4% (106/116) for the conventional therapy group.

Key Points: 
  • Any treatment-emergent adverse events (TEAEs) were 97.4% (228/234) for maribavir and 91.4% (106/116) for the conventional therapy group.
  • TEAEs leading to study drug discontinuation were 13.2% (31/234) in the maribavir group and 31.9% (37/116) in the conventional therapy group.
  • We are pleased that the SOLSTICE trial, which compared maribavir to available antiviral treatments for transplant patients with refractory/resistant cytomegalovirus infections, met its primary endpoint.
  • The FDA has also granted maribavir Breakthrough Therapy Designation as a treatment for CMV infection and disease in transplant patients resistant or refractory to prior therapy.