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Aligning CMC with Clinical Trials in 505(b)(2) Product Development

In 505(b)(2) development, a sponsor can often abbreviate its nonclinical and clinical program by using already-available regulatory information, and the CMC program becomes a rate-limiting factor at the time of regulatory filings as a result. Download our guide to learn what phase-appropriate CMC issues you should consider when developing a 505(b)(2) product.

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Today's Rundown

Atara's stock plummets 55% following inconclusive phase 2 MS analysis
Orion's rebooted R&D strategy pays off with $290M Merck deal for prostate cancer drug
Humanigen's COVID-19 prospect flunks NIH trial, sinking stock and raising doubts about its future
Sponsored: Ramp up your AAV production with Lonza’s HEK 293 cell line and patented vectors technologies
FDA chief says US has 'got to do better' at generating medical product data
Sponsored: Decentralized clinical trials, patient experience and the role of supply chain management
Amgen touts early combo data with Sanofi-backed KRAS partner in a bid to lift Lumakras' prospects
Pfizer jumps into bed with Agomab, leading series B extension and lending support to Crohn’s program
Abbott's personalized brain stimulator earns FDA breakthrough tag for treating depression
CRO Inotiv continues M&A strategy with $11M Protypia buy
After pivot, Agios names Alexion vet Goff its next CEO as Fouse transitions to board chair
Consumers seeking personalized, integrated care post-COVID, CVS survey finds
FDA clears Eko’s heart murmur analysis AI for digital stethoscopes
Epizyme SEC filing details its desperate days in free fall before $247M sale to Ipsen

Featured Story

Atara's stock plummets 55% following inconclusive phase 2 MS analysis

By Gabrielle Masson

Atara Biotherapeutics’ stock plunged following an interim analysis that deemed phase 2 data for its progressive multiple sclerosis candidate to be inconclusive.

Orion's rebooted R&D strategy pays off with $290M Merck deal for prostate cancer drug

By James Waldron

Orion’s slimmed-down R&D focus appears to have paid off as the Finnish biotech pockets $290 million from Merck & Co. for a prostate cancer drug.

Humanigen's COVID-19 prospect flunks NIH trial, sinking stock and raising doubts about its future

By Nick Paul Taylor

Humanigen’s COVID-19 program has ended in defeat. After failing to win emergency authorization on the strength of its phase 3 trial, the New Jersey-based biotech has seen its prospect flunk an NIH study, sinking the stock and raising doubts about its future.

FDA chief Robert Califf, M.D., says the U.S. has "got to do better" at generating medical product evidence to better inform regulators and clinicians.

Amgen is touting early phase 1 combo data testing Lumakras with a Sanofi-backed KRAS partner as part of a bid to boost the commercial prospects of the lung cancer therapy. Data suggested the combo was more effective in patients that had yet to be treated with a KRAS inhibitor versus those that had.

Pfizer jumps into bed with Agomab, leading series B extension and lending support to Crohn’s program

By Nick Paul Taylor

Pfizer is throwing its weight behind Agomab Therapeutics, leading a $40.5 million extension to a series B round and agreeing to provide expertise in support of a clinical-phase treatment for fibrostenotic Crohn’s disease.

Abbott's personalized brain stimulator earns FDA breakthrough tag for treating depression

By Andrea Park

Abbott has earned the FDA’s acknowledgement for an ongoing project to apply its deep brain stimulation system to treatment-resistant depression. The designation gives the technology a more expedited pathway toward potential FDA clearance.

CRO Inotiv continues M&A strategy with $11M Protypia buy

By Gareth Macdonald

The non-clinical CRO announced the $11 million acquisition of Tennessee-based Protypia last week, citing its capabilities in protein bioanalysis and tissue-based protein and peptide mass spectrometry as the motivation for the deal.

After pivot, Agios names Alexion vet Goff its next CEO as Fouse transitions to board chair

By Eric Sagonowsky

Agios has had an eventful three-plus years with Jackie Fouse, Ph.D., as its CEO. Now, the company is gearing up for a CEO switch.

Consumers seeking personalized, integrated care post-COVID, CVS survey finds

By Paige Minemyer

COVID-19 reignited consumers' interest in health and well-being, and they are looking for more personalized care to align with that, according to a new survey from CVS Health.

FDA clears Eko’s heart murmur analysis AI for digital stethoscopes

By Andrea Park

Eko’s smart stethoscopes have been used by U.S. physicians to automatically detect signs of atrial fibrillation and heart murmurs since its first FDA clearance arrived in 2020. A new regulatory OK unveiled this week aims to make the devices even smarter.

Epizyme SEC filing details its desperate days in free fall before $247M sale to Ipsen

By Kevin Dunleavy

As its stock price plummeted early this year, what did Massachusetts biotech Epizyme do to try to stop the bleeding? In a Tuesday SEC filing, Epizyme offered an intriguing blow-by-blow of how it tried to resolve its financial woes on its way to its $247 million sale to Ipsen.