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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

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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

FDA clearance for HealthLytix for breakthrough prostate imaging solution, RSI-MRI+

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FDA clearance for HealthLytix for breakthrough prostate imaging solution, RSI-MRI+

Nov 26, 2019:  HealthLytix, announced that it has received 510(k) clearance from the U.S. Food and Drug Administration for its breakthrough prostate imaging software, RSI-MRI+ which utilizes a patented advanced diffusion MRI technique called Restriction Spectrum Imaging (RSI) in order to improve early detection and diagnosis of prostate cancer by clinicians.

This software  uses artificial intelligence and an innovative tissue microstructure modelin order to increase the visibility of constrained water in the body’s tissue. All types of cancer including prostate cancer restrict or trap water.

Conventional diffusion MRI has its limitation that it does not measure restricted water directly, instead of that it relies on a simpler measure known as the apparent diffusion coefficient (ADC).ADC is an important biomarker affected by a number of impenetrable factors that can negatively impact its sensitivity and specificity to cancer, which can result in missed or inaccurate diagnoses. https://fda.einnews.com/article__detail/503400363-healthlytix-receives-fda-clearance-for-breakthrough-prostate-imaging-solution-rsi-mri?vcode=XIbw

USFDA Approved Silodosin Capsules, 4 mg and 8 mg for the treatment of signs and symptoms of benign prostatic hyperplasia (BPH)

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USFDA Approved Silodosin Capsules, 4 mg and 8 mg for the treatment of signs and symptoms of benign prostatic hyperplasia (BPH)

Nov 25, 2019: Alembic Pharmaceuticals  Abbreviated New Drug Application (ANDA) Silodosin Capsules, 4 mg and 8 mg approved by US Food & Drug Administration (USFDA).

This approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Rapaflo Capsules, 4 mg and 8 mg, of Allergan Sales, LLC. Silodosin capsule, (a selective alpha1 adrenergic receptor antagonist) used for the treatment of signs and symptoms of benign prostatic hyperplasia (BPH). 

Estimated market size of  Silodosin Capsules is  US$ 114 million for twelve months ending June 2019 according to IQVIA. https://www.alembicpharmaceuticals.com/wp-content/uploads/2019/11/Press-Release-USFDA-Approval-Silodosin-Capsules-4-mg-and-8-mg-November-2019-1.pdf

Healx commits $20M to launch Rare Treatment Accelerator programme that focus on finding new treatments for rare diseases

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Healx commits $20M to launch Rare Treatment Accelerator programme that focus on finding new treatments for rare diseases

Nov 26, 2019: Healx’s Applications are now being accepted for its Rare Treatment Accelerator (RTA), new programme that focus on finding new treatments for rare diseases.

The AI-powered and patient-inspired technology company sponsors the project with a total of $20m funding injection, contemplate to invest up to $1m of that in AI and drug discovery resources per disease project.

The collaboration offers rare disease patient groups and clinicians the prospect to work with Healx to reveal new treatments for rare disease, combining their data, AI capabilities and disease proficiency to discover new treatments and move them towards the clinic within 24 months.
https://healx.io/news/

KEYTRUDA, Merck’s anti-PD-1 therapy Now Approved by the National Medical Products Administration in China for First-Line Treatment of Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC) in Combination with Chemotherapy

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KEYTRUDA, Merck’s anti-PD-1 therapy Now Approved by the National Medical Products Administration in China for First-Line Treatment of Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC) in Combination with Chemotherapy

Nov 26, 2019: Merck announced that KEYTRUDA (Merck’s anti-PD-1 therapy) in combination with carboplatin and paclitaxel for the first-line treatment of patients with metastatic squamous non-small cell lung cancer (NSCLC) has been approved by the National Medical Products Administration (NMPA) in China.

This new indication was granted full approval based on pivotal Phase 3 KEYNOTE-407 trial and data from the global study in Chinese patients. In china death rate increase every year due to lung cancer, this approval represents an important milestone for the patients facing such difficulties for the treatment.

KEYTRUDA (pembrolizumab Inj) is an humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, in that way activating T lymphocytes which may affect both tumor cells and healthy cells. https://www.mrknewsroom.com/news-release/oncology-newsroom/mercks-keytruda-pembrolizumab-now-approved-china-first-line-treatment

Tonix Pharmaceuticals Announces Tonmya® (cyclobenzaprine) as a Potential New Treatment for posttraumatic stress disorder (PTSD)

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Tonix Pharmaceuticals Announces Tonmya® (cyclobenzaprine) as a Potential New Treatment for posttraumatic stress disorder (PTSD)

Nov 26, 2019: Tonix Pharmaceuticals, a clinical-stage biopharmaceutical company announced that from the Clinical Guidance meeting with the U.S. Food and Drug Administration (FDA)  it received the official minutes from the Breakthrough Therapy Type B for Tonmya®* (or TNX-102 SL, cyclobenzaprine sublingual tablets) for the treatment of posttraumatic stress disorder (PTSD).

The minutes from our Breakthrough Therapy Clinical Guidance meeting are consistent with the agreement that we previously announced. the primary endpoint of the RECOVERY Phase 3 trial will be at Week 12, and the Company plans to add an unblinded interim analysis that allows for a potential sample size adjustment, With more than 50 percent of the current target number of participants enrolled, results of the  report of the interim analysis will be in the first quarter of 2020. https://fda.einnews.com/pr_news/503308754/tonix-pharmaceuticals-announces-receipt-of-fda-official-minutes-from-breakthrough-therapy-type-b-clinical-guidance-meeting-for-tonmya-as-a-potential

California-based food manufacturer agrees to stop production after repeated food safety violations

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California-based food manufacturer agrees to stop production after repeated food safety violations

Nov 26, 2019: After several inspections conducted by the FDA, Golden Gate Soy Products, a California-based food manufacturer agreed to stop the progress of selling food products until the company complies with federal regulations and other requirements.

Listeria monocytogenes was found (L. mono) in the company’s food preparation area, also company was holding food for distribution in insanitary conditions. Golden Gate Soy Products specializes in manufacturing a variety of tofu and soy-based products, including soy milk.

This practice of Golden Gate Soy Products not only violated the law, but also put customers in harm. food contaminated with L. mono may develop a disease called listeriosis that will  effect women who are or may become pregnant, the elderly and people with weakened immune systems.

Defendants are restricted from receiving, preparing, processing, packing, holding, labeling and/or distributing foods at or from their facility until certain requirements are met, If they choose to restart operations, the consent decree requires them to notify the FDA and take corrective actions before resuming operations. https://fda.einnews.com/pr_news/503311206/california-based-food-manufacturer-agrees-to-stop-production-after-repeated-food-safety-violations

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