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Category: Regulations


Pricing, Regulations

Drug rebates were associated with higher out-of-pocket costs for patients

June 16, 2021

Via: Medical News

Federal agencies that regulate drug pricing and healthcare insurance are concerned that an industry practice of using rebates to lower drug costs for insurers has led to increases in list prices and out-of-pockets costs for patients. To investigate whether patients […]


FDA, News, Regulations

J&J must ditch 60m COVID jabs made at US plant, but 10m are okay, says FDA

June 14, 2021

Via: Pharmaphorum

The problems at the plant run by contract manufacturer Emergent BioSolutions first emerged a few weeks ago, after an FDA inspection uncovered a string of violations including that the building was “not maintained in a clean and sanitary condition.” While […]


FDA, Industry, News, Vaccines

Ocugen gets a black eye as FDA denies emergency OK for COVID jab

June 11, 2021

Via: Pharmaphorum

That will hold back the biotech’s Covaxin shot by several months, and the delay put pressure on Ocugen’s share price, which fell more than 25% after the announcement. The Philadelphia-based company said it had taken the decision to go down […]


FDA, Regulations

FDA approves Alkermes’ Lybalvi for schizophrenia and bipolar I disorder

June 2, 2021

Via: Pharma Times

Lybalvi (olanzapine and samidorphan) has been authorised as maintenance monotherapy of adults with schizophrenia or bipolar I disorder, for the acute treatment of manic or mixed episodes and as monotherapy or an adjunct to lithium or valproate. In clinical trials, […]


FDA, News, Regulations

J&J, Legend Biotech’s multiple myeloma CAR-T scores FDA priority review, setting up a clash with BMS’ Abecma

May 28, 2021

Via: FiercePharma

When Bristol Myers Squibb and bluebird bio scored an FDA nod for their multiple myeloma CAR-T drug Abecma in March, industry watchers knew a competitor from Johnson & Johnson and Legend Biotech wasn’t too far behind. Now, that rival is […]


FDA, Industry, Pharma, Regulations

FDA panel backs Provention Bio’s type 1 prevention drug teplizumab

May 28, 2021

Via: PMLiVE

The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted 10-7 in favour of the benefits of teplizumab outweighing its risks to support approval of the drug to delay type 1 diabetes. The EMDAC based its recommendation on data from […]


FDA, Regulations

FDA restricts use of Intercept drug due to liver injury risk

May 27, 2021

Via: Biopharma Dive

The FDA action won’t have an immediate impact on sales of Ocaliva because the majority of patients taking the drug don’t have advanced cirrhosis, according to Intercept. The company prepared investors for the move earlier this month when it released […]


FDA, Regulations

FDA Approves Third COVID Antibody Treatment for Emergency Use

May 27, 2021

Via: Drugs.com

A third antibody treatment designed to keep high-risk COVID-19 patients from winding up in the hospital was approved for emergency use by the U.S. Food and Drug Administration on Wednesday. Importantly, in lab tests the newly authorized drug, dubbed sotrovimab, […]


FDA, Regulations

FDA sets back Travere’s plans for kidney disease drug approval

May 26, 2021

Via: FierceBiotech

The FDA has crushed Travere Therapeutics’ hopes of seeking accelerated approval in a rare kidney disorder on the strength of existing interim data from a phase 3 clinical trial. Travere said it may have enough data to meet the FDA’s […]


FDA, News, Regulations

FDA approves Janssen’s Rybrevant

May 24, 2021

Via: Pharma Times

In the US, currently available targeted treatments such as EGFR tyrosine kinase inhibitors (TKIs) are not FDA-approved for treating NSCLC driven by EGFR exon 20 insertion mutations. On top of that, NSCLC driven by this particular mutation often carries a […]


FDA, News, Regulations

FDA fires broadside at CytoDyn over COVID-19 antibody data

May 19, 2021

Via: Pharmaphorum

It’s not uncommon for drug developers put a positive spin on lacklustre clinical data, but CytoDyn’s attempts seems to have irritated the US regulator, specifically relating to its use of subgroup analyses to try to indicate a benefit for leronlimab. […]


FDA, Regulations

FDA approves Apellis’ Empaveli for rare blood disease

May 17, 2021

Via: PMLiVE

The approval is based on the head-to-head PEGASUS study, which showed that complement C3 inhibitor Empaveli (pegcetacoplan) was better than Soliris (eculizumab) at improving haemoglobin levels in adults with PNH, an autoimmune disease characterised by the destruction of red blood […]