Approvals for sleep and seizures, mRNA finds other SPACs, senior notes for CROs, FTC does a double take, IPOs, and boosters

Device acquisitions, rare disease approvals, COVID success stories, and clinical research ups and downs

This week, look closer – with drops, controlled gene therapy, acquisitions in antibodies, new antifungals, new biosimilars, and several IPOs

In this special bonus episode, Dr. Noah Goodson sits down with biotech founders Dr. Shawn Carbonell and Dr. Brent Witgen to discuss their new founder-friendly biotech incubator Brazen Bio.

Sequencing technology, decentralized Alzheimer’s trials, busts in gene therapy and microbiomes, and a $2.4B oncology collaboration

Dopamine deals, Merck vaccine approval, Epipen settlements, billions in buildings, and outsized Oncology IPO.

Muddy waters of data privacy and genetic databases, antibody-drug conjugate approvals, unabetted wild enthusiasm for CROs, and mobile MRIs go public

Welcome to a special bonus episode as we kick off Season 2 the Niche Podcast. I sat down with Dr. Jayne Morgan, the head of the COVID19 task force at Piedmont Health to talk about her career in clinical research.

This is the last episode of Season 1 of the Niche Podcast. In line with that, I’ve got some announcements right at the top of the episode. Also, this week, congressional brakes, internal brakes, FDA brakes, and the first human CRISPR data.

kidney research, pet health, manufacturing is valuable, and a couple of biotech IPOs.

We dive deep into Alzheimer’s, Regeneron execs might be overpaid, a merger in clinical research, and the FDA issues a Class 1 recall

Pending FDA approvals, expanded FDA approvals, new FDA approvals, and a lawsuit about FDA approvals.

M&A Speed Bumps, “Normal” IPO but not approach, two updates, and FDA gives nod to menstrual bleeding, prostate cancer, and COVID19 monoclonal antibodies.

Oncology on the move, an industry report looking at broader trends, good news in Alzheimer’s, and another niche oncology therapy approved.

Two FDA approvals, cellulite and tattoos, Ginkgo pulls in $2.5B, and Caris massive growth equity for oncology testing.

Critical intellectual property move by Biden-Harris, Pfizer goes for full approval, SPAC 1, SPAC 2, Regeneron drops big numbers, and an IPO gets punted.

Welcome to a monthly bonus episode. I sat down with Dr. Amir Kalali, the co-chair of the Decentralized Trials & Research Alliance (DTRA) – a clinical research coalition of the most influential companies in the field to talk about decentralized research and collaborating for our success as an industry.

The FDA slaps wrists and takes names, Farxiga expands FDA approval, BioVie makes cash-light acquisition, Pfizer targets fungus, and one IPO down, another to go.

Billion-dollar amendments, billion-dollar funds, GSK gets oncology nod from FDA, and two stories in clinical research.

Massive acquisitions in the CRO space, Trodelvy 2x, diagnostic acquisitions, Merck closes COVID vaccine program, Xolair get’s self-injection nod, and tiny robots go for massive SPAC.