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FDA reversal sets up high-stakes hearing on Sarepta gene therapy

Dive Brief: The Food and Drug Administration will convene a panel of experts to review Sarepta Therapeutics’ application for approval of a muscular dystrophy gene …

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Merck TIGIT drug misses goal in lung cancer trial, adding to doubts over approach

Dive Brief: An experimental Merck & Co. drug that pairs Keytruda with a new type of immunotherapy did not help people with lung cancer in …

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In Pfizer-Seagen review, FTC has chance to set new pharma precedent

Pfizer’s planned $43 billion acquisition of Seagen will be a major test for the Federal Trade Commission since the monopoly-regulating agency revised its views of …

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Takeda, chasing Bristol Myers, unveils awaited TYK2 drug data

Three months ago, Japanese pharmaceutical giant Takeda paid a biotechnology startup $4 billion for an experimental drug in one of the largest deals of its …

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Sanofi joins other diabetes drugmakers in cutting insulin prices

Dive Brief: Sanofi said Thursday it will cut the prices for its insulin products by as much as 78%, following two of its rivals who …

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PCI Pharma Services Expands Biologics Leadership with new Center of Excellence Facility in the Midwest

New Building at Rockford, Illinois site will significantly increase equipment and capacity for injectable biologics and other self-administered therapies   PCI Pharma Services (PCI), a …

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FDA finds at least 19 cases of skin cancer in breast implant data, including 3 deaths

Though the FDA has long been aware of the risk that some people with breast implants may develop a rare form of T-cell lymphoma—now known …

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DOJ charges former Stimwave CEO with fraud scheme that added a fake receiver to neurostim device

Laura Perryman, former CEO of neurostimulation device maker Stimwave, was arrested in Florida on Thursday after being accused of running a yearslong scheme to defraud …

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After slimming down, Applied Molecular Transport no closer to taking UC drug into phase 3

Applied Molecular Transport has already sacrificed a lot last year to keep its chronic pouchitis treatment on track—including 40% of its staff and early-stage pipeline …

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FDA’s first ‘safer technologies’ nod goes to Endolumik’s glowing tube to guide weight-loss surgeries

The FDA’s nascent Safer Technologies Program, or STeP, is getting a major glow-up. Half a decade after first proposing the program—which aims to speed up …

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A ‘magic whistle’: Hands-free version of COPD breath tech improves airflow, study finds

A common treatment for the breathlessness experienced by many people with chronic obstructive pulmonary disease (COPD) relies on the use of a positive-expiratory pressure (PEP) …

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FDA clears Galaxy robotic surgery system, sending lung cancer diagnosis to a new frontier

A surgical robot system developed by Noah Medical and newly cleared by the FDA is out of this world—or, at least, the current world of …

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CZI in Chi: Chan Zuckerberg Initiative sets first location for $1B biohub expansion

Just over a year after lining up another $3.4 billion to keep developing new tools and technologies toward its long-standing goal of honing our knowledge …

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Veru’s EUA ambitions crash after FDA declines to authorize its COVID treatment

When Veru swiftly wrapped up a phase 3 trial of its COVID treatment last April, expectations bubbled that the company may be able to pry …

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Viz.ai secures Bristol Myers Squibb’s backing for hypertrophic cardiomyopathy-spotting AI

Viz.ai is already an old hand at putting its disease-spotting artificial intelligence algorithms through the FDA review process, having secured the agency’s sign-off for seven …

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Olympus mounts $370M bid to acquire GI stent maker Taewoong Medical

At the end of 2019, Olympus outlined an updated game plan for its medical device business, directing its focus toward gastrointestinal, urological and respiratory care, …

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3D-printed hearts made from real patient data could pump up accuracy of TAVR implants

There are no treatments for aortic stenosis, a heart valve problem afflicting as many as a fifth of people over 65. The only solution is …

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Insulet Omnipod’s ‘higher-than-expected demand’ helps set new revenue record

Insulet broke new ground in 2021 as its annual revenues surged past the $1 billion mark for the first time—even without a splashy new product …

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Medtronic pads the case for MiniMed closed-loop system with one-year data, study of automated meal-detection app

Nearly two years after submitting its MiniMed 780G insulin delivery system to the FDA for clearance, Medtronic is still awaiting the agency’s nod—though not for …

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Destiny seals C. diff therapy’s phase 3 fate with Sebela

Destiny Pharma could be in line for $570 million thanks to a new co-development agreement with U.S.-based Sebela Pharmaceuticals for a Clostridium difficile treatment. The …

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