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Sep 22, 2022

After a recent FDA rejection for Spero Therapeutics’ oral antibiotic candidate, GSK is paying $66 million for near-global rights to the drug. The medicine will need to undergo another phase 3 trial.

Nearly a year after Amgen requested that the Supreme Court take up its long-running PCSK9 patent case against Sanofi and Regeneron, the Biden administration has weighed in. The U.S. solicitor general says the High Court shouldn’t take up the case and that lower courts have arrived at the right decision.

The FDA’s policies early in the pandemic enabled diagnostics to reach the market quickly, HHS' inspector general said in a new report. But they also opened the door to poor quality tests. - Eric Sagonowsky

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GSK plays the white knight, paying $66M to rescue Spero's oral antibiotic after FDA rejection

By Nick Paul Taylor

GSK is riding to the rescue of Spero Therapeutics’ oral antibiotic prospect, paying $66 million upfront for near-global rights to a drug candidate that needs to undergo another phase 3 trial following its recent rejection by the FDA. Spero is studying the drug as a treatment for complicated urinary tract infections.

Inspector general finds FDA's early COVID diagnostic policies came at a 'cost to test quality'

By Conor Hale

The watchdog office reviewed the FDA’s embrace of “regulatory flexibility” and its use of emergency use authorizations during the first months of 2020, at a time when no coronavirus tests were available anywhere in the country.

Biden admin says Supreme Court should reject Amgen's petition to take up Repatha patent case

By Zoey Becker

After Amgen asked the Supreme Court to rehear its years-long patent fight against Sanofi and Regeneron, SCOTUS turned to the U.S. Solicitor General, whose office suggested that the case should be denied.

New COVID-19 variant's spread draws concern from CDC

By Frank Diamond

In the last two weeks, the BF.7 subvariant has doubled its incidence nationally from 0.8% to 1.7%.

FDA threatens to clamp down on another PI3K blood cancer drug—this time a full approval

By Angus Liu

Safety red flags have previously drawn the FDA’s attention to accelerated approvals given to a group of blood cancer drugs called PI3K inhibitors. But through an upcoming expert panel discussion, the FDA is poised to get tough on a PI3K inhibitor that's marketed under a full approval.

Servier severs CAR-T collab with Allogene, handing back rights outside the US to 3 candidates

By James Waldron

CAR-T therapies targeting CD19 might be considered a hot ticket in biotech, but that hasn’t stopped French pharmaceutical research company Servier from scrapping its collaboration with Allogene Therapeutics.

Senate bill aims to narrow mental health workforce shortage by expanding GME slots

By Robert King

New legislation introduced in the Senate aims to increase the mental health workforce in an attempt to address a major shortage.

Mount Sinai AI uncovers new brain analysis method to predict dementia, Alzheimer's disease

By Andrea Park

A new AI-based method may make the Alzheimer's disease diagnostic process a much more objective one.

Rivus raises $132M series B as obesity, NASH prospects for metabolic drug heat up

By Gabrielle Masson

After a data drop earlier this year, investors are showing their support for Rivus Pharmaceuticals’ metabolic disorder treatment pipeline, flushing the biotech with $132 million—nearly $100 million more than its first financing round.

RAND: Drug treatment admissions fell 24% in 2020 as overdoses surged

By Robert King

Drug treatment program admissions declined by 24% in 2020 in the first year of the pandemic, as overdose deaths surged in the same year, a new RAND study found.

MicroTransponder grabs macro funding round with $73M for stroke rehab neurostimulator

By Andrea Park

A year after its Vivistim system became the first vagus nerve stimulation implant approved by the FDA for use in stroke rehabilitation, MicroTransponder has raked in an oversubscribed funding round to continue developing and commercializing the device.

AbbVie invests €60M, plots 70 hires to bolster aesthetics manufacturing in Ireland

By Kevin Dunleavy

With an investment of 60 million euros ($59.3 million) in its site on the outskirts of Cork, AbbVie will further grow its presence in Ireland. The expansion will pave the way for a new facility that will employ 70 in support of AbbVie’s aesthetics business.

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'The Top Line': What Merck trial flops at ESMO may portend, lessons from COVID for monkeypox test EUAs and more

This week on "The Top Line," we chat about this year’s European Society for Medical Oncology meeting, where Merck presented a series of trial flops for Keytruda. We also discuss the lessons learned from the COVID-19 pandemic and how they are being applied to the monkeypox test EUA.