FDA piles on to BioCryst's voluntary hold
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Today's Rundown

Featured Story

Big pharma resisting temptation for biotech M&A spree until prices drop further

Plunging valuations may be forcing biotechs to lay off staff and strip back their pipelines, but Big Pharma is not yet tempted to go on an M&A spree. Judging by first-quarter earnings calls over the past two weeks, CEOs of many of the world’s pharma giants believe biotech prices still have a way to drop before they became irresistible acquisitions.

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Top Stories

Intellia puts pedal to the metal as 3 new candidates prepped for clinic

Intellia has three candidates from its gene editing and cell therapy platform headed to a clinic near you in the next year or so. The company previewed its next steps in a first-quarter earnings call Thursday morning, detailing recent clinical activities and the upcoming data readouts that will define the CRISPR biotech for years to come.

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BioCryst's voluntary pause turns FDA-hold as investigation reveals likely culprit behind safety signals

A voluntary pause for BioCryst Pharmaceuticals' complement-mediated disease therapy has been upgraded to a partial FDA clinical hold, but the biotech now believes it has an idea of what's behind the safety signals that have ground the program to a halt.

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Sponsored: Progress with Promise with Ibex® Design’s 11-month DNA to IND guarantee

Exactly what you need from your DNA to IND partner to succeed. A unique guarantee of speed and quantity, backed by Lonza’s 35 years of experience in biologics, for a fixed price.

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Jazz flexes deal chops, paying Sumitomo $50M for ex-Asia rights to early-phase narcolepsy prospect

Jazz Pharmaceuticals is continuing its double-time business development pace, with the company inking its third deal to license or divest an asset in the past five weeks. Sumitomo Pharma is the latest company to occupy the other side of the deal table, agreeing to grant Jazz rights to its narcolepsy prospect.

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Sponsored: With the makings of a hub, NYC primed to be life sciences leader

With a $1 billion public investment, diverse talent and science, space, and funding, NYC emerges as a global leader in life sciences.

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BerGenBio shifts focus from COVID—to COVID in new business strategy update

After a phase 2 fail in COVID-19 last year, BerGenBio is shifting its business strategy to focus on, well, still COVID-19.

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Bavarian Nordic's COVID-19 vaccine holds up against omicron in phase 2, fueling pivotal booster push

Bavarian Nordic has evidence its COVID-19 vaccine may hold up against omicron. With a midphase trial finding antibody titers were boosted to levels associated with a high level of protection, the biopharma is pushing ahead with plans to move into a phase 3 study.

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FDA rebukes Pfizer CEO's suggestion to take more Paxlovid if COVID-19 symptoms return

The FDA is taking another look at Paxlovid's clinical trial results amid reports of patients suffering from relapses in COVID-19 symptoms. The agency disagrees with Pfizer CEO Albert Bourla's suggestion to take another treatment course if symptoms return.

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Curebase attracts Gilead as backer in $40M financing to expand business

Curebase says $40 million raised through an investment round that attracted Gilead as a backer will fund platform expansion and help the CRO enter the complex interventional studies market.

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Change of heart: Antibody therapy reverses 'incurable' pulmonary hypertension in mice

Scientists have blocked a molecular pathway and developed an antibody therapy that may reverse characteristics of largely untreatable pulmonary arterial hypertension, according to new study findings from patient samples and mouse models.

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On a roll, AstraZeneca's Ultomiris hits goal in rare autoimmune disease

AstraZeneca is making new progress with its Ultomiris expansion plan. On the heels of an FDA approval, the C5 inhibitor has returned with a clinical win in a rare autoimmune disease affecting the central nervous system.

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Study: Only small amount of docs in some Medicaid managed care networks offer care to Medicaid patients

A new Health Affairs study finds a small amount of physicians in Medicaid managed care networks, prompting questions about state network adequacy standards.

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FDA clears Abbott test to spot 4 STIs at once amid soaring case rates

The test was cleared by the FDA for samples collected in a healthcare setting, but Abbott also aims to bring STI screening into the home.

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Asia-Pacific CRO Novotech makes US play with NCGS acquisition

Asia-Pacific CRO Novotech is getting into business on this side of the world with the acquisition of South Carolina-based clinical services company NCGS.

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Resources

Whitepaper: Medical Affairs Metamorphosis: Trends Driving Change & What They Mean

Recent trends are driving big changes in Medical Affairs. This paper explores why, and what MA teams can do to stay ahead of the curve.

eBook: Streamline HCP interactions management

Don’t miss these critical considerations when evaluating your HCP interactions management program.

Research: Healthcare Has No Borders: The Role of Rescue Sites in Times of Global Calamity

More than 570 clinical trials in Ukraine have been disrupted. Unanticipated disruptions to medical testing and clinical trials impede progress toward new breakthroughs and new therapies that millions of patients around the world hang their hope on. What role do rescue sites play?

Infographic: United Cargo: Providing Comprehensive Solutions For the Most Critical Shipments

The United Cargo team has made a commitment to pharmaceutical and medical partners that we are equipped to support their vaccine transportation needs safely and effectively across our expansive global and domestic network. The safety and security of these commodities is our priority, and we are proud to be a trusted partner in these efforts. Download infographic now.

Whitepaper: Uncovering the hidden value of quality in chemical supply

Learn how to position quality as a central component within your raw material sourcing strategies for the chemicals used throughout your workflows. Download the free whitepaper from Thermo Fisher Scientific.

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