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The European Commission approved Celltrion’s Remsima SC (infliximab) trials for the treatment of Chron’s disease, ulcerative colitis and rheumatoid arthritis

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The European Commission approved Celltrion’s Remsima SC (infliximab) trials for the treatment of Chron’s disease, ulcerative colitis and rheumatoid arthritis

Nov 29, 2019: Evaluating a subcutaneous (SC) biosimilar version of the treatment in patients with Chron’s disease, ulcerative colitis and rheumatoid arthritis, Celltrion has revealed data from its Remsima SC (infliximab) trials.

The European Commission approved this drug  for patients with rheumatoid arthritis, marking it as the world’s first approved subcutaneous formulation of infliximab.

Patients with Remsima SC  shown to have a stable potency while patients with RA on Remsima SC develop fewer anti-drug antibodies – which leads to improve the effectiveness of a treatment – compared with those on CT-P13 IV.

On the 19th September of this year the European Medicines Agency’s (EMA) human medicines committee (CHMP) issued an optimistic opinion for the subcutaneous version of the drug, also known as CT-P13, as a line extension, and the data from that  trials was submitted to the EMA as part of the application.

Celltrion has also announced the submission a advance variation to the marketing authorisation of Remsima SC, to extend the indication in inflammatory bowel disease with the approval decision expected in mid-2020. https://www.celltrionhealthcare.com/en-us/board/newslist

EOS imaging receives U.S. FDA 510(k) clearance for EoSedge™ its new generation innovative imaging system , EoSedge in Europe, Canada and Australia

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EOS imaging receives U.S. FDA 510(k) clearance for EoSedge™ its new generation innovative imaging system , EoSedge in Europe, Canada and Australia

Nov 29, 2019 – EOS imaging announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its new generation imaging system, EOSedge (Europe, Canada and Australia).

New system will be unveiled in Radiological Society of North America (RSNA) 2019 Annual Meeting which is going to be held on December 1st, in Chicago.EOSedge is the first general X-ray system motorized by a high-resolution photon counting detector, delivering optimal image quality for outstanding musculoskeletal imaging exams. Flex Dose™ technology by

EOSedge in order to modulate radiation dose along the patient’s body, as well as an open cabin with a motorized, enlarged patient platform to facilitate easy and comfortable access for a broad range of patients in order to deliver larger fields of examination.

EOSedge and the first-generation EOS system are designed to work flawlessly with the Advanced Orthopedic Solutions, that include 3DServices, EOSapps 3D surgical planning for spine, hip and knee as well as EOSlink™, which delivers the EOS surgical plan into the operating room to be used with advanced surgical technologies. https://www.eos-imaging.us/sites/default/files/press-release/PR_EOS%20imaging_FDA%20Clearance_29.11.19_EN_vf_0.pdf

Y-mAbs Initiates Submission of Biologics License Application to U.S. FDA for naxitamab for the treatment of patients with relapsed/refractory high-risk neuroblastoma

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Y-mAbs Initiates Submission of Biologics License Application to U.S. FDA for naxitamab for the treatment of patients with relapsed/refractory high-risk neuroblastoma

Nov. 29, 2019 : Y-mAbs Therapeutics, Inc., announced that it is the submitted to the U.S. Food and Drug Administration (“FDA”) the first portions of its Biologics License Application (“BLA”) for naxitamab for the treatment of patients with relapsed/refractory high-risk neuroblastoma under the FDA’s Rolling Review process.

In August 2018, naxitamab, which is an anti-GD2 monoclonal antibody, inward Breakthrough Therapy Designation by the FDA that facilitates frequent interactions with the FDA review team.

The Rolling Review process allows Y-mAbs to submit individual portions of the BLA for review, rather than waiting until all portions are completed and submitted to the FDA for review. Upon potential approval, the Company intends to commercialize naxitamab in the U.S. https://fda.einnews.com/pr_news/503569114/y-mabs-initiates-rolling-submission-of-biologics-license-application-to-u-s-fda-for-naxitamab-for-treatment-of-neuroblastoma

US Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application (sBLA) and granted Priority Review for AstraZeneca’s Imfinzi (durvalumab) for the treatment of patients with extensive-stage small cell lung cancer

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US Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application (sBLA) and granted Priority Review for AstraZeneca’s Imfinzi (durvalumab) for the treatment of patients with extensive-stage small cell lung cancer

Nov 29, 2019:US Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application (sBLA) and granted Priority Review for AstraZeneca’s Imfinzi (durvalumab) for the treatment of patients with previously untreated extensive-stage small cell lung cancer (SCLC).

SCLC is an aggressive, fast-growing form of lung cancer that recurs and progresses rapidly even with initial response to platinum-based chemotherapy.A Prescription Drug User Fee Act date is set for the first quarter of 2020.The sBLA was based on positive results from the Phase III CASPIAN trial published in The Lancet, showing Imfinzi in combination with standard-of-care (SoC) chemotherapy (etoposide with either cisplatin or carboplatin) established a statistically considerable and clinically meaningful improvement in overall survival (OS) vs. SoC.

Death rate was reduced by 27% with median OS of 13.0 months for Imfinzi plus chemotherapy vs. 10.3 months for SoC. Result data showed an approximate of 33.9% of patients were alive at 18 months following treatment with Imfinzi plus chemotherapy vs. 24.7% of patients receiving SoC. https://www.astrazeneca.com/media-centre/press-releases/2019/imfinzi-granted-fda-priority-review-for-the-treatment-of-patients-with-extensive-stage-small-cell-lung-cancer.html

Collaboration of Bayer and Pharmaron to develop new molecular entities for veterinary medicines

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Collaboration of Bayer and Pharmaron to develop new molecular entities for veterinary medicines

Nov 28, 2019:Bayer and Pharmaron jointly develop new molecular entities for veterinary medicines, this will include drug substance and drug product manufacturing to support Bayer’s research, development and commercialization needs.

The goal of Bayer and Pharmaron is to provide veterinarians, pet owners and farmers with modern therapies that address unmet medical needs of their animal patients.

Pharmaron will provide state-of-the-art CMC capabilities and resources to speed up the development of preclinical and clinical projects for Bayer Animal Health.

To offer a variety of future therapeutic options for diseases that still cannot be adequately treated today,they facilitate the exploration of the small molecule-based chemical space as small molecules have always been the backbone of innovative drugs in veterinary medicines. https://media.bayer.com/baynews/baynews.nsf/ID/4E1384544C3EEC21C12584BF0041B78C?OpenDocument

QIAGEN and DiaSorin receive FDA approval for the LIAISON QuantiFERON-TB Plus Test the fourth-generation modern gold standard for latent tuberculosis (TB) detection, on DiaSorin’s LIAISON platforms

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QIAGEN and DiaSorin receive FDA approval for the LIAISON QuantiFERON-TB Plus Test the fourth-generation modern gold standard for latent tuberculosis (TB) detection, on DiaSorin’s LIAISON platforms

Nov 27, 2019: QIAGEN and DiaSorin received FDA approval for the LIAISON QuantiFERON-TB Plus Test (QFT-Plus), the fourth-generation modern gold standard for latent tuberculosis (TB) detection, on DiaSorin’s LIAISON platforms.

This test was developed by QIAGEN and DiaSorin in order to offer streamlined laboratory automation for latent TB screening, supporting the conversion from tuberculin skin tests to modern blood-based QuantiFERON technology.

QFT-Plus users are gaining admittance to the LIAISON’s powerful, highly elastic automation for all throughput segments, as well as to LIAISON’s broad list of more than 100 tests. This test was introduced in Europe in 2018 and is planned for China in 2020. https://corporate.qiagen.com/newsroom/press-releases/2019/20191127_diasorin_fda

 

NICE approves Ibrance via Cancer Drugs Fund in combination with fulvestrant for the treatment of women who have hormone receptor positive (HR+) and HER2- breast cancer

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NICE approves Ibrance via Cancer Drugs Fund in combination with fulvestrant for the treatment of women who have hormone receptor positive (HR+) and HER2- breast cancer

Nov 28, 2019: The National Institute for Health and Care Excellence (NICE) approves Pfizer’s Ibrance (palbociclib), through the Cancer Drugs Fund (CDF), for use in combination with fulvestrant for the treatment of women who have hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) locally advanced or metastatic breast cancer, who have inwarded prior endocrine therapy.  This is based on data from the Phase III clinical trial, PALOMA-3, which shows that Ibrance delayed disease progression by 6.6 months, compared to fulvestrant alone.

This breakthroughs in breast cancer therapy will be very useful of more than 3,200 women in England living with advanced HR+, HER2- breast cancer will now be eligible for the treatment. https://www.nice.org.uk/guidance/ta495/documents/final-appraisal-determination-document

Elsevier acquires 3D4Medical, initiator of world-leading 3D anatomy technology and design

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Elsevier acquires 3D4Medical, initiator of world-leading 3D anatomy technology and design

Nov 27, 2019: Elsevier has acquired 3D4Medical, the global anatomy education company headquartered in Dublin, Ireland.

This is the world’s most advanced 3D anatomy platform, revolutionizing how students, educators, health professionals and patients understand and interact with anatomy.

Because of this outstanding technology and design, people learn using advanced 3D visualization tools, Complete Anatomy has garnered above a million registered users at more than 300 of the world’s top universities.

3D4Medical was the  winner of the US-Ireland Research Innovation Awards. https://www.elsevier.com/about/press-releases/corporate/elsevier-acquires-3d-4medical-creator-of-world-leading-3d-anatomy-technology

USFDA Approves Biocon and Mylan’s supplemental Biologics License Application (sBLA) for Pegfilgrastim Drug Substance to be manufactured at Biocon’s new Biologics manufacturing facility

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USFDA Approves Biocon and Mylan’s supplemental Biologics License Application (sBLA) for Pegfilgrastim Drug Substance to be manufactured at Biocon’s new Biologics manufacturing facility

Nov. 27, 2019: U.S. Food and Drug Administration (FDA) approved Biocon and Mylan’s supplemental Biologics License Application (sBLA) for Pegfilgrastim  Drug Substance to be manufactured at Biocon’s new Biologics manufacturing facility.

This additional approval will enable Biocon and Mylan to scale up capacity multi-fold and deal with the growing market opportunities in the U.S. and other global markets.

Pre-Approval Inspection conducted by  U.S. FDA for new Drug Substance manufacturing facility from Sep 10 to Sep 19, 2019. 

Continued dispersion of biosimilars will facilitate higher cost savings for the U.S. healthcare system leading to development of patient access to high quality affordable biologics.

Biocon Biologics with Mylan has commercialized three of its co-developed biosimilars in developed markets like U.S., Canada, EU and Australia.  

Fulphila® was the first biosimilar Pegfilgrastim to be approved in the U.S.,it was one of the most successful biosimilar launches in the U.S. Biocon Biologics, by providing innovative affordable healthcare solutions going beyond the product is committed to serve the needs of patients, people and partners.

It aims to impact 2.6 million patient lives in FY 20 and pursue to position the company as a global leader.
https://www.biocon.com/biocon_press_release_20191127.asp

The U.S. Food and Drug Administration orders Puerto Rico fertility clinic to stop manufacturing immediately for significant violations Due to significant violations of FDA regulations

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The U.S. Food and Drug Administration orders Puerto Rico fertility clinic to stop manufacturing immediately for significant violations Due to significant violations of FDA regulations

Nov 27, 2019: Due to significant violations of FDA regulations, The U.S. Food and Drug Administration has ordered Gynecology, Reproductive Endocrinology and Fertility Institute of San Juan, Puerto Rico and its Medical Director and Owner to immediately stop manufacturing that pose a danger to health.

After FDA inspection and subsequent record review, significant violations of regulations regarding donor eligibility determinations, including donor screening and testing were revealed.

The lack of requirements puts patients at risk for exposure to communicable diseases, including HIV and hepatitis.

After finding that the establishment is in violation of FDA regulations, they issued this order to to prevent the introduction, transmission, and spread of communicable diseases by human cells, tissues, or cellular or tissue-based products (HCT/Ps) manufactured by the establishment pose a danger to health. https://www.fda.gov/news-events/press-announcements/fda-orders-puerto-rico-fertility-clinic-cease-manufacturing-immediately-significant-violations-pose

IMCD again expands global network with the opening of three Pharma Technical Centres in Asia Pacific in India, Southeast Asia and China and offers a complete range of formulation capabilities (oral solid, semi solid and topical)

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IMCD again expands global network with the opening of three Pharma Technical Centres in Asia Pacific in India, Southeast Asia and China and offers a complete range of formulation capabilities (oral solid, semi solid and topical)

Nov 27, 2019: IMCD, a leading distributor of speciality chemicals and food ingredients announces the expansion of its global network of Pharmaceutical Technical Centres by opening of three new locations in India, Southeast Asia and China.

These centres will provide formulation support to the Pharma industry in their respective geographies, offering a complete range of formulation capabilities( oral solid, semi solid and topical pharmaceutical formulations).

These capabilities will support customers in formulation development as well as provide training and development opportunities for IMCD’s sales team in Asia Pacific.

While each centre will offer a regional support and training function as part of IMCD’s efforts to cross-fertilise expertise in its growing global network. The Mumbai location  for  topical pharmaceutical applications; SEA will specialise in nutraceuticals, controlled release and coatings expertise; while China is going to  focus on being a Centre of Excellence for reverse engineering and for supporting our generic customers. https://www.imcdgroup.com/media/news/imcd-further-expands-global-network-opening-three-pharma-technical-centres-asia-pacific

Zebra Medical Vision received US Food and Drug Administration (FDA) clearance for its AI-based pleural effusion diagnosis tech to identify pleural effusion

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Zebra Medical Vision received US Food and Drug Administration (FDA) clearance for its AI-based pleural effusion diagnosis tech to identify pleural effusion

Nov 27,2019 : Zebra Medical Vision received US FDA clearance for its artificial intelligence-powered solution in order to identify pleural effusion, also known as “water on the lungs.”Zebra Medical Vision received three previous FDA clearances for AI-powered medical imaging technologies, has now received approval for its HealthCXR device for the identification and triage of pleural effusion in chest x-rays.

Experience and deep-learning will automatically help to identify findings indicative of pleural effusion based on CR, DR and DX scans and than speedily notifying radiologists and enabling them to both effectively address and prioritize urgent cases.


In the United States, approx 1.5 million people diagnosed annually with pleural effusion, most commonly caused by congestive heart failure, pleural infection and malignancy, approximately one-third of pleural effusion patients die within one year. https://fda.einnews.com/article__detail/503386785-zebra-wins-fda-clearance-for-ai-based-pleural-effusion-diagnosis-tech?vcode=XIbw

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