Regulatory
Regulatory | 18 August 2021

Test At Home (TAH), offers convenient saliva-based testing for Covid-19

TAH is now undergoing regulatory clearance and final quality control procedures for the swab deployment in India, EU, Singapore, UK, US, Australia and others for COVID-19 testing

Regulatory
Regulatory | 17 August 2021

Lupin receives tentative U.S. FDA approval for Brivaracetam tablets

Brivaracetam tablets are indicated for the treatment of partial-onset seizures in patients four years of age and older

Regulatory
Regulatory | 17 August 2021

India-Sweden Healthcare innovation challenge launched

The focus of this year’s challenge is to find solutions within Covid management and treatment of cardiovascular, renal, neuro, cancer and lung diseases

Regulatory
Regulatory | 17 August 2021

Caplin Point Lab's subsidiary receives nod from Brazil's ANVISA for sterile injectable manufacturing site

The approval allows it to market its products in the country

Regulatory
Regulatory | 16 August 2021

Researchers develop remote ultrasound imaging using robotic technology

The project is a collaboration between IIT Delhi and AIIMS

Regulatory
Regulatory | 16 August 2021

Zydus Cadila receives final approval for Mesalamine extended-release capsules

The group has a total of 320 ANDA approvals

Regulatory
Regulatory | 14 August 2021

Novatek Pharma initiates Phase II study of oral COVID-19 drug

This therapy may provide the first potential oral treatment for COVID-19, recognizing the global emergency of new SARS-CoV-2 variants

Regulatory
Regulatory | 13 August 2021

USFDA grants distinct indication for Chronic Sleep Disorder

Idiopathic hypersomnia is a life-long condition, and the approval of Xywav will be instrumental in providing treatment for symptoms such as excessive sleepiness and difficulty waking, and in effectively managing this debilitating disorder

Regulatory
Regulatory | 12 August 2021

Cipla receives USFDA approval for Difluprednate Ophthalmic Emulsion 0.05%

It’s an AB-rated generic therapeutic version of Durezol

Regulatory
Regulatory | 12 August 2021

Human studies begin on AI discovered COVID-19 treatment with up to 97% effectiveness

A treatment to prevent extreme symptoms and cut hospitalisation

Regulatory
Regulatory | 12 August 2021

Research demonstrates Hoth Therapeutics HT-KIT for mast cell cancers reduces size and spread

Targeting KIT by frameshifting mRNA transcripts as a therapeutic strategy for aggressive mast cell neoplasm

Regulatory
Regulatory | 12 August 2021

SAB Biotherapeutics nonclinical data indicates SAB-185 neutralizes Delta and Lambda SARS-CoV-2 Variants

SAB-185 is currently being evaluated in NIH-sponsored Phase 2/3 adaptive trial

Regulatory
Regulatory | 12 August 2021

Biocon Biologics and Viatris receive approval for first interchangeable biosimilar Semglee

The company is eligible for 12 months exclusivity from launch

Regulatory
Regulatory | 12 August 2021

Low-cost flexible tactile sensors for robotics and biomedical applications developed

The sensors have been tested for their different level of strains like micro and large scale motion monitoring and have potential applications in biomedical devices, skin electronics, and minimally invasive surgery

Regulatory
Regulatory | 11 August 2021

QIAGEN and GT Molecular collaborate to detect SARS-CoV-2 in wastewater

Wastewater surveillance is becoming increasingly critical for community health monitoring for detecting COVID-19 outbreaks and the spread of other infectious diseases

Regulatory
Regulatory | 11 August 2021

GW Pharmaceuticals receives approval for Epidyolex to treat seizures

TSC causes epilepsy in up to 85 % of patients, and up to 60 % of those patients do not respond to standard anti-seizure medicines

Regulatory
Regulatory | 10 August 2021

QIAGEN and OncXerna Therapeutics sign licensing and master companion diagnostic agreements

QIAGEN and OncXerna enter into a global master agreement to advance the development of the Xerna TME panel as a potential Next Generation Sequencing (NGS) companion diagnostic for OncXerna’s Navicixizumab

Regulatory
Regulatory | 10 August 2021

Pillar Biosciences Receives Premarket Approval from FDA for its oncoReveal Dx Lung and Colon Cancer Assay

The product can be used by any lab that conducts NGS testing, making precision medicine accessible to all cancer patients

Regulatory
Regulatory | 10 August 2021

NRx Pharmaceuticals announces initiation of Phase 2b trial of BriLife vaccine for Covid-19

Preclinical and early human data indicate BriLife may confer enhanced immunity against Delta variant

Regulatory
Regulatory | 09 August 2021

Antengene and MindRank AI to advance the development of difficult-to-drug molecular targets

Both companies aim to improve the efficiency and success rate of the current drug discovery process.

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