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Today's Rundown

Pfizer says former employee stole trade secrets on megablockbuster COVID-19 vaccine
FDA halts phase 1b Kura Oncology trial in acute myeloid leukemia following patient death
Federal jury holds pharmacy chains CVS, Walgreens and Walmart responsible for role in opioid crisis
Elizabeth Holmes admits to OK'ing shady practices at Theranos
Amid Talkspace leadership exodus and stock freefall, law firms investigating potential claims of securities violations
Chasing Regeneron, Pfizer posts data on $250M cardiovascular bet
BeiGene plans to spend 'several hundred million dollars' on initial build-out of landmark US site
Regulatory interaction pinpointed that could pave new pathway for treating inflammatory diseases
UCB latest drugmaker to restrict 340B access to contract pharmacies
Philips debuts AI-equipped MRI machines plus spectral angio-CT combination scanners
Takeda's post-transplant CMV drug Livtencity, shouldering $800M in sales expectations, scores FDA nod
BD snags new senior VP of investor relations from Medtronic

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Pfizer says former employee stole trade secrets on megablockbuster COVID-19 vaccine

By Eric Sagonowsky

Pfizer and other drugmakers go to great lengths to protect their proprietary information. When it comes to the world's best-selling pharmaceutical product, the company's BioNTech-partnered COVID-19 vaccine, Pfizer's defense of trade secrets carries even more weight. That's why the company is working to get a handle on information allegedly stolen by a "soon-to-be former employee."

FDA halts phase 1b Kura Oncology trial in acute myeloid leukemia following patient death

By Kyle LaHucik

A patient has died in a Kura Oncology phase 1b trial in people with acute myeloid leukemia leading the FDA to place a clinical hold on the study. The investigational oral treatment was potentially associated with differentiation syndrome, an adverse event that the biotech's management said is "part and parcel of this mechanism of action."

Federal jury holds pharmacy chains CVS, Walgreens and Walmart responsible for role in opioid crisis

By Heather Landi

A federal jury in Cleveland on Tuesday found that three of the nation’s largest pharmacy chains, CVS, Walgreens and Walmart, were liable for contributing to the opioid epidemic in two Ohio counties.

Elizabeth Holmes admits to OK'ing shady practices at Theranos

By Andrea Park

Nearly three months into her federal trial over a dozen counts of fraud, Elizabeth Holmes took the stand last week, undergoing questioning by her defense team that has so far stretched across three days.

Amid Talkspace leadership exodus and stock freefall, law firms investigating potential claims of securities violations

By Heather Landi

It's been a tumultuous two weeks for teletherapy company Talkspace as three key executives have left, its stock has tumbled and now shareholder rights law firms say they are investigating potential claims that the company's officers and directors violated federal securities laws.

Chasing Regeneron, Pfizer posts data on $250M cardiovascular bet

By Nick Paul Taylor

Pfizer has reported top-line results on its $250 million antisense bet. The phase 2b clinical trial of the cardiovascular disease drug met its primary endpoint but, with Pfizer still considering next steps and yet to share data, it is unclear whether the asset can muscle in on a market targeted by Regeneron.

BeiGene plans to spend 'several hundred million dollars' on initial build-out of landmark US site

By Joseph Keenan

When BeiGene this summer laid out plans to build a "flagship" U.S. manufacturing and R&D site in New Jersey, the company kept its planned investment amount under wraps. As the project proceeds, the company now says it plans to spend hundreds of millions during the initial phase of construction.

Regulatory interaction pinpointed that could pave new pathway for treating inflammatory diseases

By Kyle LaHucik

Researchers identified a molecule that interacts with the regulator of certain immune cells as a potential target to treat immune and bone metabolic diseases. The team at Tokyo University of Science found that when a ligand known as NA2 interacts with the dendritic cell regulator, the pairing is able to suppress autoimmune diseases.

UCB latest drugmaker to restrict 340B access to contract pharmacies

By Robert King

UCB became the ninth drugmaker to cut off sales of 340B-discounted products to contract pharmacies despite an ongoing legal feud between several drugmakers and the federal government.

Philips debuts AI-equipped MRI machines plus spectral angio-CT combination scanners

By Conor Hale

Philips raised the curtain on a new portfolio of smart MRI machines equipped with artificial intelligence programs to help speed up image acquisition and diagnosis as well as a new scanner combining spectral CT with real-time, image-guided therapy hardware.

Takeda's post-transplant CMV drug Livtencity, shouldering $800M in sales expectations, scores FDA nod

By Angus Liu

Transplant patients who experience a potentially deadly viral infection that doesn’t respond to existing treatments have a new FDA-approved treatment option. For the therapy’s developer, Takeda, the approval adds another component to its growth plans in the years to come.

BD snags new senior VP of investor relations from Medtronic

By Andrea Park

As it nears the halfway point of its BD2025 plan to accelerate companywide growth and stakeholder value, BD has tapped a seasoned exec from one of its competitors to oversee all investor-facing communications.

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