Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 62
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

Drug Approval
Drug Approval | 19 August 2021

Finding a cure for HIV

The group, known as the HIV Obstruction by Programmed Epigenetics (HOPE) Collaboratory, will be led by researchers at Gladstone Institutes, Scripps Research Florida, and Weill Cornell Medicine. Their approach, which aims to both silence and permanently remove HIV from the body, takes advantage of knowledge about how other viruses have become naturally inactivated over time.

Drug Approval
Drug Approval | 18 August 2021

Novartis secures new approval in China for Cosentyx in pediatric psoriasis

Cosentyx is a proven treatment, supported by long-term five-year sustained efficacy and safety data across several inflammatory conditions and with more than 500,000 patients treated worldwide since launch

Drug Approval
Drug Approval | 18 August 2021

Novartis announces positive results from Phase 3 trials of Beovu for diabetes

Results from year two of the pivotal Phase 3 KITE clinical trial reaffirmed visual acuity gains and fluid reduction findings as well as safety profile from year one

Drug Approval
Drug Approval | 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

Drug Approval
Drug Approval | 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

Drug Approval
Drug Approval | 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

Drug Approval
Drug Approval | 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

Drug Approval
Drug Approval | 16 August 2021

Researchers develop remote ultrasound imaging using robotic technology

The project is a collaboration between IIT Delhi and AIIMS

Drug Approval
Drug Approval | 16 August 2021

Zydus Cadila receives final approval for Mesalamine extended-release capsules

The group has a total of 320 ANDA approvals

Drug Approval
Drug Approval | 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

Drug Approval
Drug Approval | 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

Drug Approval
Drug Approval | 12 August 2021

Cipla receives USFDA approval for Difluprednate Ophthalmic Emulsion 0.05%

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

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