Pharma/Biotech General Discussion


Aldeyra Therapeutics Phase 3 GUARD Trial

8 months ago

Aldeyra Therapeutics (Nasdaq: ALDX) enrolled the first patient today into the Phase 3 GUARD Trial of ADX-2191 for the prevention of proliferative vitreoretinopathy (PVR).

“Initiation of patient enrollment in the GUARD Trial marks an important step toward our goal of improving clinical outcomes for the thousands of patients with this rare but devastating condition,” said Todd C. Brady, M.D., Ph.D., President and CEO of Aldeyra. “Today, the only option for patients who develop PVR is surgery…

Apex Life Sciences

9 months ago

Here is a link to their career page if you are looking to work for Apex. Either way, they are a great resource and organization to be a part of.

BioSpace

9 months ago

I always thought BioSpace was more of a news site but I noticed they have an entire BioSpace jobs section and the ability to search for Biotech and lifesciences jobs all over their website. Have they turned into a job site for biotech?

Have any of the recruiters or companies that you work with used BioSpace to find candidates? Additionally, has anyone used their services to find a job in the biotech and lifesciences industry?

What is a Complete Response Letter (CRL)

9 months ago

I bet Amarin AMRN is going to get a complete response letter at their upcoming AdCom meeting.

Biologics License Application BLA

9 months ago

What is a Biologics License Application, or BLA? We have a number of visitors who search for this question so we thought we would help answer it.

According to Wikipedia, A biologics license application (BLA) is defined by the U.S. Food and Drug Administration (FDA) as follows:

The biologics license application is a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce (21 CFR 601.2). The BLA is regulated under 21 CFR 600 – 680. A BLA is su…

Trump to Allow Americans to Get Drugs From Canada?

1 year ago

Trump is usually a clown but he ends up doing some rational things every so often.


The Trump administration is exploring ways to allow Americans to import cheaper prescription drugs from Canada, the Department of Health and Human Services said on Wednesday.

The move holds out the promise of lower-cost prescription drugs, but many details would still need to be worked out. The administration will look into new rules to allow states, pharmacies and other parties to bring in drugs from Canada as par…

Biosimilars being delayed cost US healthcare system $7.6B

1 year ago

A new whitepaper published by the Association for Accessible Medication's Biosimilars Council found that patent tactics preventing biosimilars from entering the market have cost the U.S. healthcare system $7.6 billion since 2015.

Although the FDA has approved 20 biosimilars, only seven are available for patient use in the U.S.

The paper claims, "This is a direct result of the patent schemes used by some brand-name pharmaceutical companies to maintain their lucrative product pricing monopolies be…

Vylessi Approved to treat loss of sexual desire in women

1 year ago

Brutal takedown from Stat:

The Vyleesi data don’t prove me wrong. Only 8% more of the women who injected themselves with the drug compared to a placebo shot had a modest increase in sexual desire. On a separate sexual “distress” score, the difference between Vyleesi and placebo was 4%.

Women struggling with sexual dysfunction, like men struggling with sexual dysfunction, deserve safe, efficacious treatments; unfortunately, the market has not given women many options. Vyleesi did not help wom…

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