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Product recall concept image

FDA rapidly lists raft of class I device recalls

June 6, 2025
By Mark McCarty
The U.S. FDA posted notice of six class I device recalls between June 3 and June 5, 2025, four of which are for corrections.
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Knee pain illustration

Allay’s $57.5M extends postsurgical pain relief with ATX-101

June 6, 2025
By Karen Carey
No Comments
As 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.
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Signify Daniel-Siegwart and RA Session II
Drug design, drug delivery & technologies

Signify Bio’s $15M round advances in situ protein therapeutics

June 6, 2025
By Karen Carey
No Comments
Turning 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.
Read More
White puzzle pieces on blue background

Highridge sells bone healing business to Avista

June 5, 2025
By Annette Boyle
In the midst of June’s peak wedding season, Highridge Medical LLC called it splitsville – selling its bone healing division to Avista Healthcare Partners. The latest separation continues the sundering of what Zimmer Biomet Holdings Inc. so carefully joined together a decade ago.
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Laptop displaying FDA logo

FDA’s device center playing guidance catch-up

June 5, 2025
By Mark McCarty
The U.S. FDA’s Center for Devices and Radiological Health is recovering from a guidance drought that spanned several months in the first part of calendar year 2025, starting with a guidance on the Q-sub process.
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Handshake with cityscape

Ligachem inks two mystery ADC deals with CSPC subsidiary Novarock

June 5, 2025
By Marian (YoonJee) Chu
No Comments
Ligachem Biosciences Inc. signed two license agreements with Novarock Biotherapeutics Inc., a subsidiary of CSPC Pharmaceutical Group Ltd., to bring in two of Novarock’s antibodies and create antibody-drug conjugate (ADC) candidates with novel cancer targets.
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Signify Daniel-Siegwart and RA Session II
Newco news

Signify Bio’s $15M round advances in situ protein therapeutics

June 5, 2025
By Karen Carey
No Comments
Turning 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.
Read More

Regulatory, financial hurdles the gap between science and access

June 5, 2025
By Mari Serebrov
No Comments
Children with solid tumors who relapse are being treated with the same chemotherapy they would have been given 40 years ago, as “there have been no major approvals for pediatric solid tumors,” Catherine Bollard, senior vice president and chief research officer at Children’s National Hospital, said at a June 5 FDA roundtable on cell and gene therapies (CGTs). The problem isn’t the science. Bollard said many groups are working on curative CGTs “for these children who have lost all other hope for survival.” The real gap is that “big pharma doesn’t see the business model because it’s a rare disease,” she added.
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Ascletis’ denifanstat meets phase III endpoints in acne

June 5, 2025
By Tamra Sami
No Comments
Ascletis Pharma Inc.’s once-daily oral fatty acid synthase inhibitor, denifanstat, demonstrated statistically significant and clinically meaningful improvements compared to placebo, meeting all primary and secondary endpoints in a phase III trial for moderate to severe acne vulgaris.
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DNA mutations or genetic disorder concept art

Regenxbio’s Duchenne gene therapy data positive as shares falter

June 5, 2025
By Lee Landenberger
No Comments
Regenxbio Inc.’s gene therapy in treating Duchenne muscular dystrophy (DMD) produced positive initial phase I/II results from its first five patients. However, the company’s stock (NASDAQ:RGNX) shuddered on June 5 as shares closed at $8.36 each, a drop of 17% on the day.
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