Karen Carey

York

Managing Editor at BioWorld

Managing Editor at BioWorld MedTech

Analyst for Clarivate Analytics' BioWorld

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Articles

BIO 2025: Makary lays out FDA’s path, launches pilot review program

1 week ago | bioworld.com | Karen Carey

BIO 2025: Makary lays out FDA’s path, launches pilot review programOn the same day that FDA Commissioner Martin Makary spoke in a fireside chat during the 2025 Biotechnology Innovation Organization’s International Convention, the agency unveiled a pilot commissioner’s national priority voucher program that will enable companies to receive a shortened FDA review time of one to two months. BioWorld Conferences Regulatory BIO International Convention Vaccine U.S. FDA Policy
BIO 2025: Bridging the gap with a ‘molecule-to-medicine expressway’

1 week ago | bioworld.com | Karen Carey

Home » BIO 2025: Bridging the gap with a ‘molecule-to-medicine expressway’ BioWorld briefs for June 17, 2025. BioWorld MedTech briefs for June 16, 2025. During a conference call after the U.S. FDA approval of Zusduri (mitomycin), Urogen Pharma Ltd. CEO Liz Barrett offered candid observations about a... The 23andme Holding Co.’s saga came full circle with founder Anne Wojcicki regaining control of the bankrupt genetic testing company in a bidding battle against...
New orphan drug, CSL’s garadacimab, cleared for hereditary angioedema

1 week ago | bioworld.com | Karen Carey |Tamra Sami

New orphan drug, CSL’s garadacimab, cleared for hereditary angioedemaFollowing a complete response letter issued last October over CMC issues, CSL Behring LLC gained U.S. FDA approval June 16 of its humanized anti-factor XIIa monoclonal antibody, garadacimab (CSL-312), to prevent hereditary angioedema attacks. BioWorld Regulatory Dermatologic Monoclonal antibody Asia-Pacific Australia U.S. FDA
BIO 2025: Building biosecurity through public-private partnership

1 week ago | bioworld.com | Karen Carey

During a conference call after the U.S. FDA approval of Zusduri (mitomycin), Urogen Pharma Ltd. CEO Liz Barrett offered candid observations about a...
Biontech’s $1.25B Curevac buyout removes mRNA lawsuit uncertainty

2 weeks ago | bioworld.com | Karen Carey

Biontech’s $1.25B Curevac buyout removes mRNA lawsuit uncertaintyThree years after litigation started over technology used in an mRNA vaccine for COVID-19, Biontech SE is acquiring its adversary, Curevac NV, through an all-stock transaction valued at about $1.25 billion. BioWorld Deals and M&A Cancer Infection Coronavirus Vaccine Europe
Phase II home run: Insmed’s TPIP hits hypertension endpoints

2 weeks ago | bioworld.com | Karen Carey

Phase II home run: Insmed’s TPIP hits hypertension endpointsInsmed Inc.’s chair and CEO, Will Lewis, called the phase IIb trial of TPIP in pulmonary arterial hypertension a “clear and unequivocal success,” with analysts and investors wholeheartedly agreeing, as the company’s shares surged 28.7% June 10. BioWorld Clinical Cardiovascular Respiratory Small molecule U.S.
Allay’s $57.5M extends postsurgical pain relief with ATX-101

2 weeks ago | bioworld.com | Karen Carey

Allay’s $57.5M extends postsurgical pain relief with ATX-101As it advances its nonopioid analgesic ATX-101 breakthrough therapy through a phase IIb registration trial, Allay Therapeutics secured $57.5 million in a series D round, which included an investment from the company’s Japanese partner. ATX-101, a configuration of sodium ion channel blocker bupivacaine and a biopolymer, which is in a phase IIb registration study, is designed to offer pain relief following total knee arthroplasty.
Allay’s $57.5M extends postsurgical pain relief with ATX-101

3 weeks ago | bioworld.com | Karen Carey

Allay’s $57.5M extends postsurgical pain relief with ATX-101As it advances its nonopioid analgesic ATX-101 breakthrough therapy through a phase IIb registration trial, Allay Therapeutics secured $57.5 million in a series D round, which included an investment from the company’s Japanese partner. ATX-101, a configuration of sodium ion channel blocker bupivacaine and a biopolymer, which is in a phase IIb registration study, is designed to offer pain relief following total knee arthroplasty.
Signify Bio’s $15M round advances in situ protein therapeutics

3 weeks ago | bioworld.com | Karen Carey

Investor hopes rose sharply for Merus NV’s phase III trials – data should roll out next year – with bispecific antibody petosemtamab after mid-stage results...
Signify Bio’s $15M round advances in situ protein therapeutics

3 weeks ago | bioworld.com | Karen Carey

Newco newsSignify Bio’s $15M round advances in situ protein therapeuticsTurning the human body into a biofactory of precision protein therapeutics is the focus of newly launched Signify Bio, which emerged with an oversubscribed $15 million initial financing to advance three platforms with broad potential across therapeutic areas. BioWorld Newco news Protein Seed U.S.