Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 45
Drug Approval
Drug Approval | 01 September 2021

SK Bioscience and GSK start Phase 3 trial of an adjuvanted COVID-19 vaccine candidate

Advance to Phase 3 follows positive interim Phase 1/2 immunogenicity and safety data. The global clinical trial will evaluate vaccine candidate GBP510 against the AZ/Oxford COVID-19 vaccine

Drug Approval
Drug Approval | 31 August 2021

US FDA clears InnoCare’s clinical trial of pan-TRK Inhibitor ICP-723

The clinical trial will evaluate the safety, tolerability and pharmacokinetic properties of ICP-723 in patients with solid tumours, and evaluate the anti-tumour efficacy of ICP-723 on NTRK fusion-positive cancers

Drug Approval
Drug Approval | 30 August 2021

Visby Medical receives FDA approval and CLIA waiver for PCR sexual health test

The Visby Medical sexual health click test is the first instrument-free PCR test for the detection of chlamydia, gonorrhoea and trichomonas, with results available within 30 minutes, during the patient visit

Drug Approval
Drug Approval | 28 August 2021

DCGI approves Enzene biosimilar Denosumab for Osteoporosis

This is Enzene Biosciences third biosimilar to be approved

Drug Approval
Drug Approval | 28 August 2021

Indian National Institute validates Livinguard’s face mask

Textiles treated with the technology have also been proven to deactivate viruses, including SARS-CoV-2 (the virus that causes COVID-19).

Drug Approval
Drug Approval | 28 August 2021

U.S. FDA approves drug-free VNS system for stroke

When used alongside rehabilitative exercise, this device may offer benefit to those who have lost function in their upper limbs due to ischemic stroke

Drug Approval
Drug Approval | 28 August 2021

Japan approves AstraZeneca’s Forxiga for chronic kidney disease

Over 13 million people in Japan suffer from chronic kidney disease and this will transform treatment options

Drug Approval
Drug Approval | 28 August 2021

Roche withdraws the US accelerated approval for Tecentriq

Roche is notifying healthcare professionals and patients in the US about this withdrawal. Patients being treated with Tecentriq for PD-L1-positive mTNBC should discuss their care with their healthcare provider

Drug Approval
Drug Approval | 27 August 2021

Aurobindo subsidiary, Eugia gets US FDA approval for Cyclophosphamide injection

The product will be available in 500 mg/2.5 mL and 1 g/5 mL vials

Drug Approval
Drug Approval | 27 August 2021

Indoco’s AnaCipher receives UK-MHRA accreditation

The clinical research organisation located in Hyderabad is a USFDA inspected facility

Drug Approval
Drug Approval | 26 August 2021

Johnson & Johnson booster dose indicate impressive results

New interim data from these studies demonstrate that a booster dose of the Johnson & Johnson Covid-19 vaccine generated a rapid and robust increase in spike-binding antibodies, nine-fold higher than 28 days after the primary single-dose vaccination.

Drug Approval
Drug Approval | 26 August 2021

Pfizer and BioNTech initiate rolling submission for Comirnaty booster dose

The submission to the US FDA has been initiated and they intend to file these data with the European Medicines Agency and other regulatory bodies in the coming weeks

Drug Approval
Drug Approval | 26 August 2021

Wockhardt and Jemincare partner for novel respiratory antibiotic Nafithromycin

The company to receive upfront and milestone payments, in addition to royalties

Drug Approval
Drug Approval | 26 August 2021

RedHill Biopharma's Opaganib demonstrates strong inhibition of COVID-19 Delta variant

Opaganib, a leading novel small molecule investigational oral pill in development for Covid-19, is a unique host targeted, dual antiviral and anti-inflammatory drug that acts on the cause and effect of the disease

Drug Approval
Drug Approval | 25 August 2021

US FDA approves Medtronic’s TAVR System

The Evolut FX TAVR system is used for treatment of symptomatic severe aortic stenosis and it has features that enhance ease-of-use and predictable valve deployment

Drug Approval
Drug Approval | 20 August 2021

US FDA approves Jardiance to treat adults living with heart failure with a reduced ejection fraction

New treatment options are critical, as approximately half of all people with heart failure die within five years of diagnosis. Heart failure accounts for more than one million hospitalisations a year in the US

Drug Approval
Drug Approval | 20 August 2021

Zydus ties up with CHEMI to launch Enoxaparin Sodium injection in the US

Enoxaparin Sodium Injection, USP is used for prophylaxis of Deep Vein Thrombosis (DVT) in patients undergoing abdominal, hip or knee replacement surgery, and also for the treatment of acute DVT

Drug Approval
Drug Approval | 19 August 2021

Sai Life Sciences opens discovery biology facility in Hyderabad

The company's discovery services support a wide range of global innovator companies from start-ups to large pharma companies, across a diverse set of therapeutic areas including oncology, CNS, antivirals, and inflammation among others

Drug Approval
Drug Approval | 19 August 2021

MedAlliance enrols patients for ED study with Sirolimus Drug-Eluting Balloon

It is estimated that 300 million men worldwide were affected by ED in 2020, a figure projected to increase to 322 million by 2025. Nearly 30% of these were aged between 40 and 70

Drug Approval
Drug Approval | 19 August 2021

FDA grants breakthrough device designation to Impella ECP, the world’s smallest heart pump

It measures 9 French (3 millimetres) in diameter upon insertion and removal from the body. While in the heart, it expands to support the heart’s pumping function, providing flow greater than 3.5 L/min

Startup

Digitization