| 07.15.22 | Moderna's omicron booster triggers stronger responses against new subvariants; MacroGenics closes clinical trial after 7 deaths

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WELCOME TO FIERCE LIFE SCIENCES WEEKLY DIGEST

After the FDA urged COVID-19 vaccine makers to tweak their shots and target omicron’s BA.4 and BA.5 subvariants, Moderna unveiled promising data showing its bivalent booster delivered more neutralizing antibodies than the original shot. Meanwhile, the agency has said it would allow pharmacists to prescribe Pfizer’s Paxlovid antiviral, but it did not extend the same privilege to Merck’s Lagevrio, even though they were both authorized a day apart last December. And MacroGenics has closed a phase 2 trial of its anti-cancer antibody, enoblituzumab, after learning of seven deaths potentially linked with major bleeding events. Those stories, plus our top reads of the week, follow below.

Featured Story

Moderna's omicron booster triggers stronger response against subvariants than its original shot, company says

By Zoey Becker

Just a few weeks after the FDA recommended that vaccine makers update their boosters to protect against Omicron, Moderna unveiled positive data showing high neutralizing antibody responses in its updated booster trial.


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MacroGenics closes solid tumor clinical trial after 7 people die

By Nick Paul Taylor

MacroGenics has closed a phase 2 clinical trial of its anti-cancer antibody enoblituzumab after learning of seven deaths potentially associated with hemorrhagic events. The setback means two of MacroGenics’ three attacks on B7-H3 have hit setbacks but the biotech is forging ahead with the third candidate.

FDA is letting pharmacists prescribe Pfizer's Paxlovid but won't do the same for Merck's Lagevrio

By Kevin Dunleavy

After authorizing Pfizer’s COVID-19 oral antiviral Paxlovid to be prescribed by pharmacists, the FDA said it will not extend the same privilege to Merck and Ridgeback’s antiviral pill Lagevrio. The regulator cited Lagevrio’s side effect profile as reason to leave the decision in the hands of physicians.

AbbVie dumps Alector's Alzheimer's immunotherapy after phase 1 review

By Nick Paul Taylor

Alector’s new approach to amyloid beta has ended the way of many of the old ideas for how to tackle the troublesome peptide. After going over data including phase 1 results, AbbVie has severed its ties to the potential Alzheimer’s disease immunotherapy—and the asset has vanished from Alector’s pipeline.

Pfizer, Alnylam and BMS take note: The US is poised to see 'a staggering number' of cardiomyopathy cases this decade

By Ben Adams

There’s a new blockbuster heart disease market in town—and it's set to explode in size. As Pfizer, Bristol Myers Squibb and Alnylam are already fighting for their share of prescriptions, a new report finds they'll have millions more patients to treat in the coming years.

SEC charges ex-Mazor exec with insider trading over $1.6B Medtronic buyout

By Andrea Park

The SEC filed charges against a former Mazor Robotics executive and two associates, alleging that they made more than $500,000 in profits through an insider trading scheme related to Mazor's 2018 acquisition by Medtronic.

AstraZeneca escapes one Seroquel pay-for-delay claim but loses bid to scrap another

By Angus Liu

Apparently, a $107 million deal value isn't large enough to be considered anticompetitive when viewed in the context of delaying generics to a blockbuster brand. A Delaware federal judge reached that conclusion in throwing out an antitrust claim targeting a pay-for-delay deal involving AstraZeneca's antipsychotic Seroquel XR.

Roche hands over $55M for licensing rights to Ionis' kidney disease candidate

By Gabrielle Masson

Roche is handing over $55 million for the licensing rights to Ionis Pharmaceuticals’ rare kidney disease treatment candidate, an investigational med that the Big Pharma will advance into a phase 3 clinical trial.

After building new plant and signing on with AbbVie, Regenxbio enters commercial phase

By Kevin Dunleavy

ROCKVILLE, MARYLAND—After building a new $65 million manufacturing facility and partnering with AbbVie in a $370 million deal, Maryland gene therapy biotech Regenxbio is entering a new phase as a burgeoning commercial business. The companies hope to bring a first-of-its-kind gene therapy to the market to treat wet age-related macular degeneration.

Blood thinner's ability to boost fat burning could inspire new obesity therapies

By Angus Liu

Scientists in Germany have identified a molecular mechanism by which brown fat increases energy expenditure and showed how an anticoagulant may stimulate that process in mice.

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Wednesday, July 20, 2022 |11am ET | 8am PT

Attend this webinar to hear industry expert, Corinne Ramos, PhD, discuss validating the efficacy of the compound in the era of precision medicine, leveraging mass spectrometry imaging to understand efficacy and impact, creating strategies to further advance biomarker into drug development, and understanding trends for patient selection in clinical trials. Register now!