16th March 2022 | Pharma Updates

PharmaState Updates – Latest Pharma Happenings

Apollo Hospitals earned ISO accreditation for its AI-based apps

British Standards Institution (BSI) has granted Apollo Hospitals the ISO 13485:2016 BSI registration for AI-based software solutions that provide clinical decision support.

Experts believe that intelligent application of AI is required for universal healthcare

Artificial intelligence (AI) will aid in the interpretation of large amounts of data in the health industry, allowing for early disease detection and prevention.

Sanofi reports a decline in sales as a result of a trial setback for a breast cancer drug

Sanofi’s shares dropped 5% after a medication candidate for a prevalent kind of breast cancer failed to reduce disease progression in a clinical trial, undermining the French drugmaker’s drug development competence.

Cellular treatment improves the signs and symptoms of Duchenne muscular dystrophy

A recent clinical research led by the University of California demonstrated that cellular treatment is safe and effective in halting the deterioration of upper limb and cardiac functioning in patients with late-stage Duchenne muscular dystrophy.

Italy has reported 28,900 coronavirus infections and 129 deaths

Italy reported 28,900 COVID-19 related cases on Monday, up from 48,886 the day before, while the number of deaths increased to 129 from 86.

FDA has approved the first Symbicort generic

First generic Symbicort Inhalation Aerosol was approved by the US FDA for the treatment of two major pulmonary health conditions: asthma and COPD, which includes chronic bronchitis and emphysema.

FDA has issued a warning against using the Renuvion/J-Plasma device

The device has not been determined to be safe intended to improve the appearance of the skin. As a result, the FDA is warning not to use the device for dermal resurfacing or skin contraction.

Significant decline in medical device reports on Bayer's Essure in 2021

FDA has given additional data on issues with Bayer’s Essure birth control device, including an examination of medical device reports received in 2021

USFDA aiming to shape the narrative of accelerated approval reform

Indicating that failure is to be expected may be a subtle warning of the potential repercussions of adding extra safeguards to the expedited approval pathway.

Pfizer seek FDA approval for a second booster vaccine

Pfizer and BioNTech are likely to seek emergency approval for a second coronavirus vaccination booster shot for anyone aged 65 and older.