Pharmacy

GC Pharma Submits Biologics License Application to US FDA for Immune Globulin 'GC5107'

Friday, February 26, 2021 - 2:57am

GC Pharma demonstrated positive results in a Phase III study in North America, meeting its primary efficacy endpoint of acute serious bacterial infections (SBI).

Key Points: 
  • GC Pharma demonstrated positive results in a Phase III study in North America, meeting its primary efficacy endpoint of acute serious bacterial infections (SBI).
  • In the trials included in the submission, with PI (Primary Humoral Immunodeficiency) patients, all primary efficacy and safety endpoints corresponding to FDA guidelines were satisfied.
  • In general, the FDA has a 60-day filing review period to determine whether GC Pharma' Biologics License Application for GC5107 is complete and acceptable for filing.
  • GC Pharma (formerly known as Green Cross Corporation) is a biopharmaceutical company that delivers life-saving and life-sustaining protein therapeutics and vaccines.

Dr. Reddy's Recalls Prescription Drug Blister Packages Due to Risk of Poisoning

Thursday, February 25, 2021 - 9:49pm

The prescription medications were distributed by third party wholesalers to retail pharmacies and could have been dispensed to consumers.

Key Points: 
  • The prescription medications were distributed by third party wholesalers to retail pharmacies and could have been dispensed to consumers.
  • The packaging of the products is not child resistant and can pose a risk of poisoning if the contents are swallowed by young children.
  • Consumers should immediately store the recalled medications in a safe location out of reach of children and contact Dr. Reddy's for a full refund.
  • This recall involves blister packages of prescription medications.

Arcus Biosciences Announces New Employment Inducement Grants

Thursday, February 25, 2021 - 9:10pm

The stock options were granted pursuant to the Companys 2020 Inducement Plan, which was approved by the Companys Board of Directors in January 2020 pursuant to the inducement exception under NYSE Listed Company Manual Rule 303A.08.

Key Points: 
  • The stock options were granted pursuant to the Companys 2020 Inducement Plan, which was approved by the Companys Board of Directors in January 2020 pursuant to the inducement exception under NYSE Listed Company Manual Rule 303A.08.
  • Arcus Biosciences is an oncology-focused biopharmaceutical company leveraging its deep cross-disciplinary expertise to discover highly differentiated therapies and to develop a broad portfolio of novel combinations addressing significant unmet needs.
  • AB308, an anti-TIGIT antibody that is FcR-enabled, is advancing into clinical development to investigate additional indications, with a focus on hematological malignancies.
  • For more information about Arcus Biosciences, please visit www.arcusbio.com .

MacroGenics Provides Update on Corporate Progress and 2020 Financial Results

Thursday, February 25, 2021 - 9:01pm

ROCKVILLE, Md., Feb. 25, 2021 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (NASDAQ: MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today provided an update on its recent corporate progress and reported financial results for the year ended December31, 2020.

Key Points: 
  • ROCKVILLE, Md., Feb. 25, 2021 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (NASDAQ: MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today provided an update on its recent corporate progress and reported financial results for the year ended December31, 2020.
  • Recent progress and anticipated events in 2021 related to MacroGenics approved and investigational product candidates in clinical development, as well as an advanced preclinical program, are highlighted below.
  • The launch, which is being coordinated with MacroGenics commercial partner, EVERSANA, is expected in March.
  • MacroGenicswill host a conference call today at4:30 pm (ET)to discuss financial results for the year endedDecember 31, 2020and provide a corporate update.

The Year 2020 Marks the 7th Consecutive Year Certara Customers Received 90 Percent of US FDA Novel Drug and Biologic Approvals

Thursday, February 25, 2021 - 8:19pm

Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today announced that 2020 marked the seventh consecutive year where 90% of new drug and biologic approvals by the US Food and Drug Administration (FDA), excluding diagnostic agents, were received by Certaras customers.

Key Points: 
  • Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today announced that 2020 marked the seventh consecutive year where 90% of new drug and biologic approvals by the US Food and Drug Administration (FDA), excluding diagnostic agents, were received by Certaras customers.
  • Certaras customers use its biosimulation software and tech-enabled services to increase confidence in decisions across the entire R&D lifecycle.
  • The data generated from Certaras platforms helps to advance the safety and efficacy of therapies, accelerating critical medicines to patients.
  • The majority of new drug approvals had orphan drug designation, and approximately half had breakthrough therapy designation.

Q2i's OARS software application moves to Phase II of National Institute of Health (NIH) clinical trial which will evaluate the application's efficacy in improving Opioid Use Disorder treatment

Thursday, February 25, 2021 - 7:33pm

This comes after a successful Phase I trial and with over 1000 patients it's the largest trial of its kind in the country.

Key Points: 
  • This comes after a successful Phase I trial and with over 1000 patients it's the largest trial of its kind in the country.
  • OARS is designed to increase patient engagement, program adherence, and MAT program availability as well as increasing treatment retention.
  • UCLA is Q2i's academic partner for this project with Dr. Steven Shoptaw leading the research team that is evaluating the OARS software application.
  • Dr. Shoptaw said, "The availability and access gap for OUD patients seeking treatment is a real issue that needs addressing.

Global $5.4 Billion Drug Discovery Outsourcing Market to 2028

Thursday, February 25, 2021 - 3:30pm

The global drug discovery outsourcing market size is expected to reach USD 5.4 billion by 2028 registering a CAGR of 7.4% over the forecast period.

Key Points: 
  • The global drug discovery outsourcing market size is expected to reach USD 5.4 billion by 2028 registering a CAGR of 7.4% over the forecast period.
  • This has forced pharmaceutical and biotech companies to opt for outsourcing their research activities to academic and private Contract Research Organizations (CROs).
  • Thus, factors such as high R&D costs, patent expiration of best-selling drugs, and the need to speed up the drug discovery process, are expected to boost the demand for outsourcing of drug discovery in the coming years.
  • Thus, the pandemic has brought the pharmaceutical industry to center-stage, with drug discovery outsourcing becoming a key aspect to develop effective treatments against the virus.

Global $71.43 Billion Telepharmacy Market to 2027 - ResearchAndMarkets.com

Thursday, February 25, 2021 - 2:33pm

Certain services involved in telepharmacy includes patient counselling, drug therapy monitoring, refill authorization and prior authorization needed for the prescription drugs.

Key Points: 
  • Certain services involved in telepharmacy includes patient counselling, drug therapy monitoring, refill authorization and prior authorization needed for the prescription drugs.
  • Other telepharmacy services comprises of monitoring the formulary compliance through the deployment of videoconferencing or teleconferencing.
  • The prominent factors favoring the global market growth include advancement in technology, substantial investments in telepharmacy and rise in the prevalence of diseases.
  • Players in the market are focusing on strategic partnership with other key companies to strengthen their market position across the globe.

Aimmune Presents New Clinical Data From Pooled Safety Analysis in Patients Treated With PALFORZIA® for up to ~3.5 Years

Thursday, February 25, 2021 - 2:00pm

These data provide insight into the long-term safety of PALFORZIA as a treatment option.

Key Points: 
  • These data provide insight into the long-term safety of PALFORZIA as a treatment option.
  • PALFORZIA is contraindicated in patients with uncontrolled asthma, or with a history of eosinophilic esophagitis and other eosinophilic gastrointestinal disease.
  • Only prescribers, healthcare settings, pharmacies, and patients certified and enrolled in the REMS Program can prescribe, receive, dispense or administer PALFORZIA.
  • PALFORZIA, AIMMUNE and AIMMUNE THERAPEUTICS are trademarks of Aimmune Therapeutics, Inc.
    1 N Engl J Med.

Global Pharmacies and Healthcare Stores Market Report 2021: COVID-19 Impact and Recovery to 2030 - ResearchAndMarkets.com

Thursday, February 25, 2021 - 12:24pm

The "Pharmacies and Healthcare Stores Global Market Report 2021: COVID-19 Impact and Recovery to 2030" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Pharmacies and Healthcare Stores Global Market Report 2021: COVID-19 Impact and Recovery to 2030" report has been added to ResearchAndMarkets.com's offering.
  • Pharmacies and Healthcare Stores Global Market Report 2021: COVID-19 Impact and Recovery to 2030 provides the strategists, marketers and senior management with the critical information they need to assess the global pharmacies and healthcare stores market as it emerges from the COVID-19 shut down.
  • Major companies in the pharmacies and healthcare stores market include MedPlus; Medzone; Medicap; Apollo Pharmacy and Discount Drug Stores.
  • The pharmacies and healthcare stores market is segmented into pharmacies and drug stores and other health and personal care stores.