Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 44
Drug Approval
Drug Approval | 02 September 2021

Reddy-Lenalidomide launched in Canada

Dr. Reddy's Laboratories Canada announces the launch of Reddy-Lenalidomide, one of the first generic medications of its kind for the Canadian market

Drug Approval
Drug Approval | 02 September 2021

Janssen announces U.S. FDA approval of Invega Hafyera

Invega Hafyera offers patients the fewest doses per year. Phase 3 non-inferiority study results showed over 92% of participants were relapse-free at 12 months

Drug Approval
Drug Approval | 01 September 2021

Zymo Research receives CE Mark for new Covid-19 SafeCollect kits

Self-collection devices designed for ease of use and safety

Drug Approval
Drug Approval | 01 September 2021

Positive results from Pfizer’s Phase 3 trail comparing efficacy of abrocitinib and dupilumab

JADE DARE trial met co-primary and key secondary endpoints and demonstrated a safety profile consistent with previous studies for moderate to severe atopic dermatitis

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

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