Northwell CEO on perseverance in health leadership
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Today's Rundown

Featured Story

After Roe ruling, Perrigo's HRA Pharma asks FDA to make its birth control pill available OTC

Two manufacturers of contraceptive pills have been jockeying for FDA clearance to sell their medications over the counter for more than half a decade. Now, against the backdrop of an intense debate over reproductive rights, one of those drugmakers is officially in the running for an approval.

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Top Stories

MacroGenics closes solid tumor clinical trial after 7 people die

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.

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Medtronic begins Class I recall of 1 million dialysis catheters at risk of leaking

Medtronic has asked healthcare providers to immediately stop using more than 1 million catheters distributed across the U.S. and around the world after discovering a potential safety risk within the devices.

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Sponsored: Decentralized clinical trials, patient experience and the role of supply chain management

The rise of clinical trial complexity has been well-documented but the impact on logistics is not well understood. Here, we look at decentralized trials, patient experience and the role of logistics.

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Executive Spotlight—Northwell Health's Michael Dowling on 'good politics' and perseverance in health leadership

Northwell Health's president and CEO says the role of a leader is to ensure vying parties "coalesce around common values, programs and missions." He also stressed the need for healthcare organizations to remain committed when tackling complex, long-term goals such as Black maternal mortality.

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Brace yourself, Amgen. Lumakras' sales might disappoint as key data readouts draw near, analyst warns

Amgen’s first-in-class KRAS inhibitor Lumakras has been grabbing attention even before its approval. Now, after closely watching the drug’s commercial performance in non-small cell lung cancer, one team of analysts is sounding an alarm ahead of key clinical trial data readouts.

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Vertex absorbs ViaCyte and its stem cell-based diabetes treatment for $320M, clearing out competition

Just a week after Vertex’s stem cell therapy to treat type 1 diabetes was released from an FDA clinical hold, the company is clearing out potential competition by buying ViaCyte for $320 million. 

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FDA denies Lumos Diagnostics' bid for rapid test to differentiate between bacterial, viral infections

Lumos Diagnostics’ FebriDx point-of-care test will have to wait a bit longer to see the light of day in the U.S., as the Australian company announced Monday that its 510(k) submission to the FDA has been rejected.

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CVS names new chief data, digital and technology officer

Tilak Mandadi will step into the position on July 25, and in the role will lead the healthcare giant's strategy around data, digital and technology, CVS said.

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After Democrats unveil drug price negotiation plan, industry blasts it as 'misguided'

Legislation aimed at slashing high U.S. drug costs could undercut its own goals by depriving drugmakers of incentives for developing blockbuster medicines, plus lower-cost biosimilars and generics, several analysts and industry groups have warned.

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

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.

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Smith+Nephew aims to give its reps a surgeon’s-eye view through wearable smart glasses

By working with medical headset maker Rods&Cones, Smith+Nephew hopes to offer technical support and real-time troubleshooting for its products from anywhere in the world.

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California will tackle high drug prices by making its own low-cost insulin, Newsom says

Gov. Gavin Newsom announced on Twitter that a recently signed state budget allots $100 million for California to contract and make its own insulin.

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Hologic, Thermo Fisher launch molecular tests in EU for multiple respiratory viruses at once

Cold and flu season may still be several months away in the northern hemisphere, but diagnostic test makers like Hologic and Thermo Fisher Scientific are taking no chances.

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'Organize. Align': Women in biotech see Roe v. Wade ruling as a call to action

More than 100 women in biotech have signed on to a letter decrying the Supreme Court's ruling overturning Roe v. Wade. They say this is only the beginning of their activism.

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Resources

Case Study: Roche cuts feasibility process by 36%

Explore how Cognizant SIP helped Roche streamline its global feasibility process.

eBook: 12 Pitfalls in Europe

For an emerging biopharma company, Europe can be very attractive. But it can also be complex and confusing. This e-book covers the 12 most common pitfalls for companies entering European markets for the first time, offering guidance to help growing companies avoid them and succeed.

eBook: Download the Cell Therapy Handbook

Explore the new cell therapy handbook from Thermo Fisher Scientific.

Whitepaper: The Most Suitable Dosage Form Technologies for the Oral Delivery of Lipid-Based Formulations

What is the most suitable dosage form technology for the Oral Delivery of Lipid-Based Formulations?

Whitepaper: Jump Start for Biotech: New Lab Startup Guide

Sponsored by Thermo Fisher Scientific The journey for starting or expanding a lab can be exhilarating, while also being challenging--learn how this free program provides savings and solutions to support your goals.

Article: Formulation Strategies When Transitioning From Vial to PFS

Learn how formulation development for a PFS affects manufacturing to drive the industry toward optimizing delivery of injectable products and, ultimately, improving patient care.

Whitepaper: Intranasal Drug Product Development: Formulation to Manufacturing

What are key considerations for intranasal delivery in the treatment of acute and chronic conditions?