Pharmaceutical Technology

FEBRUARY 14, 2023

Precision oncology firm Corbus Pharmaceuticals and CSPC Megalith Biopharmaceutical have entered an exclusive licensing agreement for the latter’s new clinical stage antibody drug conjugate (ADC), CRB-701 (SYS6002). upfront payment and eligible for royalties on net sales. CSPC Megalith is a subsidiary of CSPC Pharmaceutical Group.

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AUGUST 25, 2023

Paragonix Technologies , a leading organ transplant company, received US Food and Drug Administration (“FDA”) clearance for its next-generation donor lung preservation system, BAROguard. Lisa Anderson, CEO and President of Paragonix. For more information, visit www.paragonix.com. Are you hiring?

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SEPTEMBER 13, 2023

Food and Drug Administration (FDA) via the 510(k) pathway, with potential clearance expected during the first half of 2024. Legacy systems for breathing assistance are causing multiple complications leading to physical damage, infection and possible death. ” About Inspira Technologies OXY BHN Ltd.

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JANUARY 31, 2023

Food and Drug Administration has approved the company’s fourth-generation rechargeable sacral neuromodulation system. The Axonics R20 neurostimulator utilizes the same small 5cc form factor as the Axonics R15 and is paired with the same tined lead and intuitive patient remote control. Axonics, Inc., Are you hiring?

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DECEMBER 1, 2022

HemoSonics, LLC , a leading medical device company delivering individualized diagnostic solutions for Patient Blood Management (PBM), announced that it has received 510(k) market clearance from the U.S. Food and Drug Administration (FDA) for the Quantra Hemostasis System with QStat Cartridge. market today.

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MARCH 21, 2023

a privately held company focused on innovative fluorescence-guided imaging technologies for cancer surgery, today announced a New Drug Application (NDA) for its LUMISIGHT Optical Imaging Agent has been submitted to the U.S. Food and Drug Administration (FDA). Lumicell, Inc.,

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Pharmaceutical Technology

APRIL 12, 2023

Under its terms, Pharming has paid a $10m milestone payment to Novartis for the first commercial sale of Joenja. In March 2023, Joenja secured approval from the US Food and Drug Administration (FDA) to treat the targeted patients.

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AUGUST 23, 2023

Food and Drug Administration (FDA) Circulatory Systems Devices Panel of the Medical Devices Advisory Committee met to discuss the pre-market approval application (PMA) for the Paradise Ultrasound Renal Denervation (RDN) system, indicated to reduce blood pressure in patients with hypertension. Are you hiring?

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AUGUST 17, 2023

Welldoc ® , a digital health leader revolutionizing chronic care, today announced the receipt of its 10th 510(k) clearance from the Food and Drug Administration (FDA) for its award-winning diabetes digital health solution, BlueStar ®. This enhanced functionality will be made available commercially in 2024.

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JULY 18, 2023

ReddyPort announced today that the US Food and Drug Administration (FDA) granted 510(k) premarket clearance for the ReddyPort elbow device used in non-invasive ventilation (NIV). The ReddyPort elbow safely delivered 45,000 compliant oral care sessions to patients under FDA Emergency Use Authorization (EUA).

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SEPTEMBER 5, 2023

a medical software innovator dedicated to enhancing clinical impact in ablation therapy, announced today that it has received 510(k) clearance from the USA Food and Drug Administration (FDA) for its VisAble.IO Techsomed Ltd., VisAble.IO The BioTrace.IO Are you hiring?

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APRIL 27, 2023

Food and Drug Administration (FDA) for the company’s SIRA RFA Electrosurgical Device (SIRA). However, conventional RF devices are not optimized to treat lumpectomy cavities and can lead to variable treatment depths and incomplete ablations. For more information, visit Innoblative.com. Are you hiring?

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AUGUST 21, 2023

Food and Drug Administration for its new, advanced Activit-E polyethylene for the Truliant® knee replacement system. Muratoglu invented the first crosslinked polyethylene, and the first of multiple generations of vitamin E, antioxidant polyethylene for leading orthopaedic companies. “We Are you hiring?

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APRIL 11, 2023

Food and Drug Administration (FDA) granted marketing authorization of the MISHA Knee System, an implantable shock absorber (ISA) for the knee. Also, we recognize the dedicated reviewers at FDA for completing their thorough benefit-risk assessment of our breakthrough technology. Are you hiring?

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JUNE 14, 2023

Nasdaq: SRDX), a leading provider of medical device and in vitro diagnostic technologies, announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Pounce LP (Low Profile) Thrombectomy System. Surmodics, Inc. mm to 6 mm in diameter. About Surmodics, Inc.

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JANUARY 18, 2023

Food and Drug Administration (FDA) 510(k) clearance to aid in the early detection of sepsis for the approximately 30 million adult patients with signs and symptoms of infection who present to US emergency departments (ED) each year. Are you hiring? Contact us to discuss partnering with Legacy MedSearch on your position.

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Pharmaceutical Technology

MAY 10, 2023

Roche has acquired the worldwide rights to develop and commercialise Chinese biotechnology company Zion Pharma’s lead programme, ZN-A-1041. The company will also be eligible for additional payments of up to $610m after achieving specified development, regulatory and sales-based milestones, and for tiered royalties on sales.

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APRIL 25, 2023

Food and Drug Administration (FDA). Potential benefits include: Reduction in Radiation: Removing the need for high-radiation intraoperative scans throughout the procedure can lead to a 10x reduction in radiation exposure. ” For more information, visit: www.propriovision.com. Are you hiring?

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JUNE 13, 2023

CorNeat Vision’s EverPatch , a synthetic tissue substitute, has been granted 510(k) clearance by the US Food & Drug Administration (FDA). This recent FDA clearance of our first device for ophthalmic use advances us toward our ultimate goal of promoting human health and equality.” Are you hiring?

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SEPTEMBER 12, 2023

Food and Drug Administration (FDA) has approved the LimFlow System to help people with CLTI who have no other suitable endovascular or surgical treatment options and are facing major amputation. The LimFlow System has not been approved for sale in Canada or Japan.

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Pharmaceutical Technology

MARCH 29, 2023

In September 2021, Bristol Myers Squibb in-licensed the first programme, EVT8683, after the successful filing of an investigative new drug (IND) application with the Food and Drug Administration (FDA). This programme has now proceeded into a Phase I clinical trial.

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MARCH 15, 2023

The acquisition extends HeartBeam’s reach in remote monitoring and detection with full ownership of an existing cutting-edge FDA-cleared product. Founded in 2016, LIVMOR developed the Halo+ Atrial Fibrillation (AF) Detection System, the world’s first FDA-cleared prescription wearable for continuous cardiac rhythm monitoring.

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DECEMBER 14, 2022

The biotechnology and drug sectors performed well in the second half of 2022 after struggling in the first six months. Despite the uncertainty surrounding the global economy, the drug and biotechnology sectors have continued to perform well in the second half of 2022. This can lead to significant losses for large companies.

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Pharmaceutical Technology

MAY 16, 2023

The company is also in line to receive an additional $110m in future milestone payments, depending on the Chikungunya vaccine development and sales performance of the two marketed vaccines. Following the completion of the deal, Bavarian Nordic now boasts the only oral vaccine licensed by the U.S.

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Pharmaceutical Technology

NOVEMBER 8, 2022

Oyster Point Pharma introduced Tyrvaya, a nasal spray approved by the Food and Drug Administration (FDA) to treat dry eye disease, in November last year. These acquisitions could possibly add a minimum of $1bn in sales of Viatris by 2028. Famy Life Sciences has an ophthalmology portfolio that complements Viatris.

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JULY 6, 2023

Food and Drug Administration (FDA). More than half of stroke survivors aged 65 and older experience reduced mobility, and stroke has become a leading cause of long-term disability. Earlier this year, MedRhythms announced successful completion of a pivotal clinical trial for InTandem. Are you hiring?

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JANUARY 11, 2023

Micronoma , the first biotech company offering early cancer detection with a microbiome-driven liquid biopsy platform, announced that its OncobiotaLUNG assay received the Breakthrough Device Designation from the Food and Drug Administration (FDA). Early detection of lung cancer can lead to a higher survival rate.

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APRIL 12, 2023

These new FDA clearances follow the highly successful clinical introduction of MONTAGE use on bleeding bone, which has garnered excellent physician feedback and surpassed 22,000 product uses with thousands of patients now multiple years removed from surgery. Pacifico, Founding President and Chief Executive Officer of Abyrx.

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JULY 13, 2022

Food and Drug Administration (FDA) has granted Breakthrough Device Designation to the AccuCinch ® Ventricular Restoration System. Food and Drug Administration. Ancora Heart , Inc., a company developing a novel device-based therapy to address heart failure, announced that the U.S. About Ancora Heart.

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Pharmaceutical Technology

AUGUST 3, 2022

on meeting specific near-term regulatory, approval and initial commercial sale milestones. A New Drug Application (NDA) for olutasidenib filed by Forma was accepted by the US Food and Drug Administration (FDA), and a regulatory decision is anticipated on 15 February next year. and tiered royalty payments.

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Pharmaceutical Technology

MAY 3, 2023

CBMG will receive $245m in an upfront payment and will also be entitled to potential development, regulatory filing, commercialisation and sales milestones along with tiered royalty payments on net trade sales. The regulator has also granted orphan drug designation for the therapy to treat follicular lymphoma (FL).

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Pharmaceutical Technology

JULY 1, 2022

Ayvakit has received the US Food and Drug Administration (FDA) approval to treat advanced systemic mastocytosis in adults. Gavreto (pralsetinib) is approved by the FDA for three indications. The therapy is used to treat adults with metastatic RET fusion-positive non-small cell lung cancer (NSCLC).

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APRIL 7, 2023

Food and Drug Administration (FDA) has granted 510(k) clearance to the Axiom PSR System for use with the company’s Kinos Axiom Total Ankle System. restor3d, a research-driven medical device company, announced that the U.S. Our clients include both blue-chip companies and innovative startups within the MedTech space.

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Pharmaceutical Technology

APRIL 4, 2023

While Scorpion will lead the development of STX-721, Pierre Fabre will handle STX-241. The Boston, Massachusetts-based Scorpion expects to submit an investigational new drug (IND) application for STX-721 to the US Food and Drug Administration (FDA) in mid-2023, with an IND application for STX-241 expected in H1 2024.

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MAY 18, 2023

the leading developer of high data-rate brain-computer interfaces (BCI), today announced a $33 million Series A funding round led by Prime Movers Lab. “This designation recognizes the transformative promise of our device, and we look forward to continued coordination with the FDA to accelerate its availability. Paradromics Inc.,

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JANUARY 12, 2023

Food and Drug Administration (FDA) has granted the coveted Breakthrough Device Designation for its LifeGel Absorbable Surgical Hemostat. Medcura, Inc., a medical device company dedicated to transformatively improving the management of surgical bleeding, announces that the U.S.

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MARCH 16, 2023

This delay often leads to cognitive impairment, worse health outcomes, and increased costs,” said Dr. Frans Leijten, Head of EEG Department, UMC Utrecht, the Netherlands. 4 “FDA clearance is a major milestone in our mission to make brain state assessments and follow-up interventions an integral part of standard practice.

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