Tag: FDA

Industry, Vaccines

CHMP Approves Manufacturing Scale-Up for Spikevax

August 5, 2021

Via: Biopharm International

The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) has approved the increased manufacturing capacity and supply of Moderna’s COVID-19 vaccine (Spikevax) active substance in its United States manufacturing site. CHMP’s decision is expected to impact […]

FDA, Regulations

FDA expands use of COVID-19 antibody cocktail

August 3, 2021


The FDA has expanded the use of Regeneron’s antibody cocktail, REGEN-COV, updating its emergency use authorisation (EUA) to include those at high risk of developing severe COVID-19 who have been exposed to the virus. The therapy – a combination of […]

FDA, Regulations

FDA rejects a biotech’s kidney drug, but some analysts still see a ‘sliver of hope’

July 30, 2021

Via: Biopharma Dive

The FDA’s decision wasn’t surprising to analysts, as “deficiencies” in an approval application have become somewhat of a prelude to rejection. This year alone saw two other drugmakers, Provention Bio and Acadia Pharmaceuticals, receive negative feedback about their applications shortly […]


Regulators call for clinical research to include pregnant and breastfeeding women

July 27, 2021

Via: European Pharmaceutical Review

Global regulators are calling for a paradigm shift in clinical research and urging pharma to include pregnant and breastfeeding women in their studies in order to “address inadequacies in research”. In a statement, various stakeholders at the US Food and […]

FDA, Regulations

Roche engaged in talks with FDA for Alzheimer’s drug candidate

July 23, 2021


CEO Severin Schwan told reporters on Thursday that Roche is in “a continued dialogue with the FDA. I wouldn’t be able to speculate what the outcome of this dialogue will be”. He also revealed that Roche is planning to complete […]

Industry, Pharma

Pfizer’s immunology ambitions delayed—again—as JAK drugs fall victim to FDA’s protracted safety review

July 22, 2021

Via: FiercePharma

Pfizer and its JAK inhibitors are falling deeper down a regulatory rabbit hole the company itself opened up. The FDA has once again pushed back two decisions key to Pfizer’s immunology franchise: Xeljanz in ankylosing spondylitis and abrocitinib in atopic […]

FDA, Regulations

Ardelyx stock craters as FDA slaps biotech with dreaded ‘deficiencies’ tag on kidney drug

July 20, 2021

Via: FierceBiotech

Shares in Ardelyx are in freefall after the FDA found a series of “deficiencies” with Ardelyx’ application for the kidney disease hopeful tenapanor. In what CEO Mike Raab said was an “extremely disheartening and disappointing communication from the FDA,” the […]

Cell and Gene Therapy, Industry

Bayer’s BlueRock Therapeutics gains FDA fast track for Parkinson’s disease cell therapy

July 20, 2021


BlueRock – a Bayer subsidiary – is currently evaluating the pluripotent stem cell-derived dopaminergic neuron therapy in a phase 1 study. This early-stage trial is set to enrol ten patients across the US and Canada, with its primary objective to […]

FDA, Regulations

FDA questions safety profile of AZ, FibroGen’s anaemia drug roxadustat

July 15, 2021


AZ and FibroGen are aiming for approval of roxadustat for the treatment of anaemia caused by chronic kidney disease (CKD). In briefing documents published ahead of a meeting of the Cardiovacular and Renal Drugs Advisory Committee meeting on 15 July, […]

Pricing, Regulations

Congress has a ‘time-limited window’ to shake up drug pricing, employers, health groups say

July 14, 2021

Via: FiercePharma

A chance for meaningful drug pricing reform is upon us, dozens of purchasers, healthcare and employer groups contend. But Congress needs to capitalize on its “time-limited” opportunity, or the problem could stagnate or worsen. In a letter to a bipartisan […]

Biotech, Industry

FDA suggests principles for implementing bio-fluorescent particle counters

July 13, 2021

Via: European Pharmaceutical Review

In a meeting between the US Food and Drug Administration (FDA) Emerging Technology Team (ETT) and the Process and Environmental Monitoring Methods Working Group (PEMM), the FDA addressed several concerns with regards to the implementation of bio-fluorescent particle counting (BFPC) […]

FDA, News, Regulations

Bayer’s finerenone gets FDA nod for diabetic kidney disease

July 12, 2021

Via: Pharmaphorum

The oral, non-steroidal mineralocorticoid receptor (MR) antagonist has been approved as Kerendia in the US – its first world market – to reduce the risk of kidney function decline, kidney failure, cardiovascular death, non-fatal heart attacks, and hospitalisation for heart […]