| 02.02.22 | Gilead’s CD47 hold widens as CEO expresses ‘sense of urgency’; Pfizer snags Roche vet for crucial development role

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Today's Rundown

Gilead's CD47 clinical hold expands as CEO O'Day expresses 'sense of urgency' in getting trials back on track Pfizer poaches Roche's pharma R&D leader to fill MacKenzie's shoes as chief development officer Novartis JAKs in rival to Incyte's topical eczema drug after seeing clinical data Sponsored: Taking a Different Approach to Drug Development Biden revives Cancer Moonshot program to seek 50% drop in cancer death rate by 2047 Sponsored: Choose wisely. Biospecimens can make or break your biomarker-driven cancer research FDA puts LogicBio genome editing therapy trial on hold after 2nd infant suffers adverse event AliveCor's credit-card-sized ECG snags FDA clearance for 30-second arrhythmia detection Unvaccinated 23 times more likely than boosted to be hospitalized during omicron wave Gilead's COVID-19 antiviral Veklury blew past sales estimates in late 2021 as omicron surged, vaccinations lagged Shkreli and Vyera settle for $28M in yet another Daraprim antitrust suit Paragonix's lung transport system completes 4,700-mile, cross-country transplant Kindbody hits unicorn status with Vios Fertility Institute acquisition, new leadership additions

Featured Story

Gilead's CD47 clinical hold expands as CEO O'Day expresses 'sense of urgency' in getting trials back on track

By Annalee Armstrong

Gilead revealed that a partial clinical hold for its CD47 targeted cancer hopeful is larger than originally thought. Disclosed in the fine print of the pharma giant’s fourth-quarter earnings presentation Tuesday was that two more studies are subject to the hold, bringing the total number of affected trials to seven.

This week's sponsor is PIERRE FABRE.

Pfizer poaches Roche's pharma R&D leader to fill MacKenzie's shoes as chief development officer

By Kyle LaHucik

Pfizer's new development leader is on the way from Roche. Replacing 35-year Pfizer veteran Rod MacKenzie, Ph.D., as chief development officer will be William Pao, M.D., Ph.D.

Novartis JAKs in rival to Incyte's topical eczema drug after seeing clinical data

By Nick Paul Taylor

Strike Novartis from the list of rivals to Incyte’s topical eczema drug Opzelura. After getting a look at early clinical data, Novartis has dumped its topical pan-JAK inhibitor CEE321 over an unfavorable risk-benefit profile.

President Joe Biden unveiled his second attempt at a "cancer moonshot" with a renewed program focused on slashing the cancer death rate by more than 50% in the next 25 years.

LogicBio Therapeutics’ bid to develop a genome editing therapy in infants has hit more trouble. Months after the first infant to receive the therapy suffered a serious adverse event, LogicBio has revealed the second subject has experienced the same clinical syndrome, prompting the FDA to impose a clinical hold.

AliveCor's credit-card-sized ECG snags FDA clearance for 30-second arrhythmia detection

By Andrea Park

Thin is in for AliveCor: The personal electrocardiogram tech maker scored FDA clearance for its slimmest heart monitor yet, which is the size and shape of a credit card and is aptly named the KardiaMobile Card.

Unvaccinated 23 times more likely than boosted to be hospitalized during omicron wave

By Dave Muoio

New Los Angeles County public health surveillance data reaffirm vaccines and boosters' protection against COVID-19, and particularly against severe illness.

Gilead's COVID-19 antiviral Veklury blew past sales estimates in late 2021 as omicron surged, vaccinations lagged

By Kevin Dunleavy

The omicron variant has fueled a surge in demand for Gilead's Veklury, the company said on Tuesday when it reported fourth quarter and 2021 sales. The COVID-19 antiviral treatment rang up 2021 sales to $5.6 billion. The company is projecting Veklury to generate $2 billion in revenue in 2022.

Shkreli and Vyera settle for $28M in yet another Daraprim antitrust suit

By Fraiser Kansteiner

Blue Cross and Blue Shield of Minnesota has settled a class-action lawsuit against Martin Shkreli, his former company and another ex-CEO for $28 million, the insurance system said this week. The news comes after a federal judge ordered the "pharma bro" to pay nearly $65 million in disgorgement and exit the pharma industry for life.

Paragonix's lung transport system completes 4,700-mile, cross-country transplant

By Conor Hale

The high-stakes transplant procedure set a new record for the company’s LUNGguard system, pushing past its intended organ storage time of up to eight hours.

Kindbody hits unicorn status with Vios Fertility Institute acquisition, new leadership additions

By Rebecca Torrence

Fertility startup Kindbody hit a $1.15 billion valuation with its acquisition of Vios Fertility Institute, a deal that gives the company 13 more clinics, doubling its national footprint.