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Eli Lilly Announces Topline Results for the Solanezumab from the Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU) Study

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Eli Lilly Announces Topline Results for the Solanezumab from the Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU) Study

Feb 10, 2020: Eli Lilly and Company announced that the analysis performed by the Washington University School of Medicine in the Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU) Study showed that the solanezumab did not meet the primary endpoint. Additional analyses of secondary endpoints and biomarkers are ongoing by the Washington University and Lilly.

Data will be presented at the Advances in Alzheimer’s and Parkinson’s Therapies (AAT-AD/PD™) Focus Meeting in April of 2020. At this time, Lilly does not plan to chase a submission for solanezumab in people with dominantly inherited Alzheimer’s disease (DIAD), also known as autosomal dominant Alzheimer’s disease, based on results of the primary endpoint. This outcome does not force the ongoing solanezumab Anti-Amyloid Treatment in the Asymptomatic Alzheimer’s (A4) Study.

The experiment on the DIAN-TU platform is a randomized, double-blind, placebo-controlled, Phase 2/3 test. The goal is to study possible disease-modifying treatments in individuals at risk for or with Alzheimer’s disease dominantly inherited, which is caused by unusual gene mutations. This started as a two-year study of biomarker goal involvement and progressed into a Phase 2/3 analysis of registration with a primary measure of cognitive performance and a total of four years of treatment. The primary efficiency analysis included 50 solanezumab and 40 placebo participants. The minimum four-year treatment period was finished by 36 solanezumab and 32 placebo participants. The initial dose for the study was 400 mg every 4 weeks. A late change to the analysis raised the dose, which resulted in approximately 25% of the total doses being administered at 1600 mg.

The DIAN-TU Study was established in 2010 and funded by Lilly, Roche and Genentech, National Institutes of Health, and other donors and is the first disease prevention trial in order to test investigational Alzheimer’s disease compounds with different mechanisms of action from two pharmaceutical companies.

Solanezumab is an investigational anti-amyloid monoclonal antibody tested in the Asymptomatic Alzheimer’s (A4) analysis of preclinical Alzheimer’s disease in Anti-Amyloid Therapy. The A4 Study is a clinical trial that studies solanezumab in older people who have signs of amyloid in their brains, but do not show memory loss symptoms.

The DIAN-Multivariate Cognitive Endpoint (DIAN MCE) is composed of Wechsler Memory ScaleRevised Logical Memory Delayed Recall, Cogstate International Shopping List Test, Wechsler Adult Intelligence ScaleRevised Digit Symbol Substitution Test, and Mini-Mental State Analysis.https://investor.lilly.com/news-releases/news-release-details/lilly-announces-topline-results-solanezumab-dominantly-inherited

Novartis announces MET inhibitor capmatinib, the first potential treatment for the METex14 mutated advanced non-small cell lung cancer, granted priority FDA review

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Novartis announces MET inhibitor capmatinib, the first potential treatment for the METex14 mutated advanced non-small cell lung cancer, granted priority FDA review

Feb 11, 2020:  Novartis announced that the U.S.FDA accepted and granted Priority Review to capmatinib’s (INC280) NDA. Capmatinib is a MET inhibitor being evaluated as a treatment for the  first-line and formerly treated patients with locally advanced or metastatic MET exon 14 skipping (METex14) mutated non-small cell lung cancer (NSCLC). If accepted, capmatinib will be the first therapy to specially target METex14 mutated advanced lung cancer, a type of the lung cancer with a particularly poor prognosis.

Priority Review is granted to therapies that the FDA determines have the potential in order to provide considerable improvements in the treatment, diagnosis or prevention of the serious conditions. This designation shortens the FDA review period following the approval of the NDA to six months compared to ten months under Standard Review. Previously, Novartis granted Breakthrough Therapy designation for capmatinib.There are currently no approved therapies that especially target METex14 mutated advanced NSCLC. NSCLC accounts for about 85% of the lung cancer diagnoses. METex14 mutations occur in 3-4% of newly diagnosed superior NSCLC casesand is a recognized oncogenic driver.

The NDA submission for capmatinib is maintained by results from the GEOMETRY mono-1 Phase II study, which established an overall response rate of 67.9% (95% CI, 47.6 – 84.1) and 40.6% (95% CI, 28.9 – 53.1) among treatment-naïve and formerly treated patients, respectively, based on the Blinded Independent Review Committee (BIRC) assessment per RECIST v1.1. The study also demonstrated that the capmatinib provided durable responses among all the patients: median duration of response was 11.14 months (95% CI, 5.55 – NE) in the treatment-naïve patients and 9.72 months (95% CI, 5.55 – 12.98) in formerly treated patients.

All results were based on the independent appraisal by the BIRC, and all tumor CT scans were evaluated in parallel by two radiologistsin order to confirm the response. The most common treatment-related adverse events (AE) (≥ 10% all grades) across all the cohorts (N=334), were peripheral edema (42%), nausea (33%), creatinine increase (20%), vomiting (19%), fatigue (14%), decreased appetite (13%) and also diarrhea (11%).

Capmatinib (INC280) is an investigational, oral, active, and selective MET inhibitor that 
Incyte Corporation licensed to Novartis in 2009. Under the Agreement, Incyte has given 
exclusive development and marketing rights to capmatinib and certain back up compounds 
worldwide to Novartis in all indications.
https://www.novartis.com/news/media-releases/novartis-announces-met-inhibitor-capmatinib-inc280-first-potential-treatment-metex14-mutated-advanced-non-small-cell-lung-cancer-granted-priority-fda-review

Bayer and Nuvisan generate new research unit in Berlin

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Bayer and Nuvisan generate new research unit in Berlin

Feb 11, 2020: Bayer AG announced that it entered into a definitive agreement to transfer a large part of its Berlin-based small molecule research unit to Nuvisan, an international service provider for clinical studies, laboratory services and contract manufacturing with several sites and clinics in Germany and France.

The strategic partnership will arrange the foundation for a brand-new research entity to be established by the Nuvisan in Berlin. At the same time, it will support Bayer’s improved focus on the flexibility and productivity of its R&D operating model.

Financial terms were not disclosed.
The Berlin-based research unit with around 400 workplaces comprises of a fully operational team specialized in the small molecule research.

The research center comes with capabilities and capacities across the entire drug discovery value chain, including Lead Discovery, Medicinal Chemistry, Pharmacology, Drug Metabolism & Pharmacokinetics, Investigational Toxicology, and Animal Management.

Bayer will maintain significant research activities in the Berlin, which remains the headquarters for the company’s Pharmaceuticals Division and one of its major global research sites.
Bayer and Nuvisan will work together in the coming years to build the new research center. The transaction is expected to seal mid of 2020 subject to successful completion of the consultation process with the employee representatives and the preparations for succession the research activities.


The Nuvisan group creates sales of approx. € 55 million with currently about 420 highly qualified employees. It originated from the LAB GmbH over 40 years ago and has been operating under the name NUVISAN with its headquarters in Neu-Ulm since 2010.

The Nuvisan group as the CRO and CDMO has six sites in Germany and France (Neu-Ulm, Berlin, Grafing, Gauting, Waltrop and Sophia-Antipolis) in addition to the monitoring activities with offices in Argentina, Peru and Brazil as well as in the USA.
https://media.bayer.com/baynews/baynews.nsf/id/Bayer-and-Nuvisan-create-new-research-unit-in-Berlin

U.S. FDA granted fast track designation for Nanobiotix for the investigation of first-in-class nbtxr3 in head and neck cancer

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U.S. FDA granted fast track designation for Nanobiotix for the investigation of first-in-class nbtxr3 in head and neck cancer

Feb 10, 2020: NANOBIOTIX , a clinical-stage nanomedicine company pioneering new approaches to the treatment of cancer announced that the U.S. FDA  has granted Fast Track designation for the investigation of NBTXR3 activated by the radiation therapy, with or without cetuximab, for the treatment of patients with locally advanced head and neck squamous cell cancer who are not appropriate for platinum-based chemotherapy.

Fast Track is a process designed in order to facilitate the development and accelerate the review of drugs for the serious conditions and that have the potential to address unmet medical needs. The purpose is to speed up the availability of new treatment options for the patients.
The products that receives Fast Track designation is eligible for :
 • More frequent meetings with the FDA to examine the drug’s development plan and make sure about the collection of appropriate data needed to support drug approval.
 • More numerous written communication from the FDA about such things as the design of the proposed clinical trials and the use of biomarkers.
 • Eligibility for the Accelerated Approval and Priority Review, if relevant criteria are met.
• Rolling Review, which means that the drug company can submit completed sections of the NDA for review by the FDA, rather than waiting until the entire NDA is completed before the application can be reviewed

 NBTXR3 NBTXR3 is a first-in-class product designed in order to destroy tumors through physical cell death when activated by the radiotherapy. It has a high degree of biocompatibility, requires one single administration before the first radiotherapy treatment session, and has the capability to fit into current worldwide radiotherapy radiation therapy standards of the care.
https://www.nanobiotix.com/wp-content/uploads/2020/02/PR_ENGLISH-Fast-Track-Designation.pdf

Astex Pharmaceuticals announces U.S. Food and Drug Administration (FDA) acceptance for the review of NDA for the combination oral hypomethylating agent cedazuridine and decitabine for the treatment of MDS and CMML

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Astex Pharmaceuticals announces U.S. Food and Drug Administration (FDA) acceptance for the review of NDA for the combination oral hypomethylating agent cedazuridine and decitabine for the treatment of MDS and CMML

Feb 11, 2020: Astex Pharmaceuticals, Inc., a wholly owned subsidiary of Otsuka Pharmaceutical Co. Ltd., based in Japan  announced that the U.S. FDA has accepted for Priority Review its NDA for oral C-DEC (cedazuridine and decitabine) as a treatment for adult patients with previously untreated intermediate- and high-risk MDS including CMML.

The NDA submission is based on the data from the ASCERTAIN phase 3 study which evaluated the 5-day decitabine exposure equivalence of oral C-DEC and IV decitabine.

The FDA grants Priority Review to the applications for drugs that, if approved, would provide significant improvements in the safety and efficacy of the treatment, diagnosis or prevention of serious conditions. The Priority Review designation means the FDA’s goal is to take action on an NDA application within six months. Oral C-DEC (investigational compound) not currently approved in any country.

 About C-DEC (Cedazuridine 100 mg and Decitabine 35 mg) Fixed-Dose CombinationC-DEC is a novel, orally administered fixed dose combination of the cedazuridine, an inhibitor of cytidine deaminase with the anti-cancer DNA hypomethylating agent, decitabine.

It inhibit cytidine deaminase in the gut and the liver, C-DEC is designed to permit for oral delivery of the approved DNA hypomethylating agent, decitabine, at exposures which follow exposures achieved with the approved intravenous form of the decitabine administered over 5 days.


C-DEC has been evaluated in the phase 1/2 pharmacokinetics-guided dose escalation and dose confirmation study in the patients with MDS and CMML see https://www.clinicaltrials.gov NCT02103478) and also pivotal phase 3 study (ASCERTAIN)see https://www.clinicaltrials.gov NCT03306264) conducted at investigator sites in the US and Canada and designed in order to confirm the results from the phase 1/2 study.

The phase 3 study is now being comprehensive to include patients with acute myeloid leukemia (AML) unsuitable to receive intensive induction chemotherapy.

Astex announced that C-DEC had received orphan drug designation in September 2019 for the treatment of MDS and CMML from the U.S. FDA. The concept of using cedazuridine is to block the action of cytidine deaminase is also being evaluated in the low dose formulation of cedazuridine and decitabine for the treatment of lower risk MDS (see   https://www.clinicaltrials.gov NCT03502668).

About Myelodysplastic Syndromes (MDS) and Chronic Myelomonocytic Leukemia (CMML): Myelodysplastic syndromes are a heterogeneous group of the hematopoietic stem cell disorders characterized by the dysplastic changes in myeloid, erythroid, and megakaryocytic progenitor cells, and associated with cytopenias distressing one or more of the three lineages.  U.S. incidence of the MDS is estimated to be 10,000 cases per year, even though the condition is thought to be under-diagnosed.
https://astx.com/astex-pharmaceuticals-announces-u-s-food-and-drug-administration-fda-acceptance-for-review-of-an-nda-for-the-combination-oral-hypomethylating-agent-cedazuridine-and-decitabine-astx727-or-oral-c-de/

U.S. FDA Acceptance of New Drug Application for FibroGen’s Roxadustat for the Treatment of Anemia of Chronic Kidney Disease

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U.S. FDA Acceptance of New Drug Application for FibroGen’s Roxadustat for the Treatment of Anemia of Chronic Kidney Disease

Feb. 11, 2020: FibroGen announced that the U.S.FDA has completed its filing review of its New Drug Application (NDA) for roxadustat for the treatment of anemia of chronic kidney disease (CKD), both in non-dialysis-dependent (NDD) and dialysis-dependent (DD) patients. The application will be measured filed on Feb. 18, 2020. The FDA has set a Prescription Drug User Fee Act (PDUFA) date of the December 20, 2020. 

“The FDA’s acceptance of the roxadustat NDA  is the critical step towards as long as a new treatment option in the United States for the chronic kidney disease patients suffering from anemia, a severe and often life-threatening disease,” said Enrique Conterno, Chief Executive Officer, FibroGen.

The filing of the roxadustat NDA triggers  $50 million milestone payment from AstraZeneca to FibroGen. Roxadustat is the first small molecule hypoxia-inducible factor prolyl hydroxylase (HIFPH)orally administered inhibitor approved by the FDA for the treatment of CKD anaemia.The submission is supported by positive results from the global Phase 3 program encircling more than 8,000 patients.

Roxadustat is currently approved in China for the treatment of anemia in the patients with CKD, regardless of whether they necessitate dialysis, and in Japan for the treatment of dialysis patients with anemia of the CKD.FibroGen’s partner Astellas also plans to file an application for marketing authorisation with the European Medicines Agency in the first half of 2020.

About Anemia Associated with CKD: Anemia results from the reduced oxygen-carrying capacity of the blood, in which patients usually have insufficient red blood cells and/or low levels of the hemoglobin, a protein in red blood cells that carries oxygen to cells all the way through the body. CKD anemia, which can be associated with the increased risk of hospitalization, cardiovascular complications, and death, also recurrently causes significant fatigue, cognitive dysfunction, and reduced quality of the life. Severe anemia is common in patients with the CKD, cancer, myelodysplastic syndromes (MDS), inflammatory diseases, and other severe illnesses.
https://fda.einnews.com/pr_news/509481763/fibrogen-announces-u-s-fda-acceptance-of-new-drug-application-for-roxadustat-for-the-treatment-of-anemia-of-chronic-kidney-diseases

Fennec Pharmaceuticals Completes Rolling Submission of NDA to U.S. Food and Drug Administration for PEDMARK™ and Also Submits Marketing Authorization Application (MAA) to the European Medicines Agency

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Fennec Pharmaceuticals Completes Rolling Submission of NDA to U.S. Food and Drug Administration for PEDMARK™ and Also Submits Marketing Authorization Application (MAA) to the European Medicines Agency

Feb,11, 2020: Fennec Pharmaceuticals announced it has completed its rolling submission of an NDA to the U.S. FDA for PEDMARK™ (a unique formulation of sodium thiosulfate) for intravenous use and submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for sodium thiosulfate (tradename to be determined).

The PEDMARK™ indication requested is for the prevention of ototoxicity induced by the cisplatin chemotherapy in the patients one month to < 18 years of age with localized, non-metastatic, solid tumours.

Fennec’s PEDMARK regulatory submissions follow: The pre-NDA meeting with FDA in the December 2018 after which Fennec initiated a rolling NDA; and pre-submission meetings with the EMA and also an approved pediatric investigation plan (PIP). Both applications are based upon the clinical results from two pivotal Phase 3 clinical trials:

  • SIOPEL 6 by the International Childhood Liver Tumor Strategy Group (SIOPEL), with the results published in June 2018 in the New England Journal of Medicine and
  • ACCL0431 by the Children’s Oncology Group (COG), with the results published in 2016 in 

 “Fennec would like to thanks countless parents, children and investigators who were participated in the clinical trials, as well as our dedicated employees who helped us attain this important milestone.

We are well underway with the commercialization readiness activities to support the potential launch of the PEDMARK and our transition to becoming a commercial-stage organization.”

The FDA has a 60-day review period in order to determine whether the PEDMARK NDA is acceptable for filing. PEDMARK has been granted Orphan Drug, Fast Track designations and Breakthrough Therapy from the FDA.

If PEDMARK is approved a priority review, the Prescription Drug User Fee Act (PDUFA) action date is expected in the third quarter of 2020.  In the US PEDMARK is proposed by tradename, European tradename is under evaluation.

About PEDMARK™ (Sodium Thiosulfate (STS): Cisplatin and other platinum compounds are necessary chemotherapeutic agents for many pediatric malignancies.  unluckily, platinum-based therapies cause ototoxicity, or hearing loss, which is permanent, irretrievable and is particularly harmful to the survivors of the pediatric cancer. In the U.S. and Europe, it is estimated annually that more than 10,000 children may accept platinum-based chemotherapy.
https://fda.einnews.com/pr_news/509436868/fennec-pharmaceuticals-completes-rolling-submission-of-new-drug-application-nda-to-u-s-food-and-drug-administration-for-pedmark-and-also-submits

Roche provides topline results from the investigator-led Phase II/III trial with gantenerumab in exceptionally inherited form of Alzheimer’s disease

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Roche provides topline results from the investigator-led Phase II/III trial with gantenerumab in exceptionally inherited form of Alzheimer’s disease

Feb 10, 2020: Roche announced that the gantenerumab arm of the Phase II/III DIAN-TU-001 study did not meet its primary endpoint in the people who have an early-onset, inherited form of the Alzheimer’s disease (AD), known as autosomal dominant AD (ADAD), accounts for less than 1% of all cases of the disease.

Gantenerumab’s safety profile in DIAN-TU-001 was reliable with that from other clinical trials of the investigational medicine and no new safety issues were recognized.

Roche is conducting additional analyses in order to understand the totality of the gantenerumab data from the study, in collaboration with the Washington University School of Medicine. Data will be presented at  AAT-AD/PD Focus meeting in April 2020.

Gantenerumab, a latestage clinical drug, is still being tested in two major global Phase III trials (GRADUATE 1 and 2) in the wider population of people with AD not directly caused by gene mutations (sporadic AD).

Each individual with ADAD who received gantenerumab in DIAN-TU001 started on a lower dose and started titrating only about halfway through the trial at a five-fold higher target dose, prompted by lessons from other gantenerumab studies. The GRADUATE studies have been designed from the outset in order to maximise exposure to gantenerumab, bringing all the patients to target dose with minimal or no dose interruption within the study period.

Roche’s AD pipeline covers research medicines for different AD goals, forms, and phases. Roche tests semorinemab in phase II trials of intermittent AD, in addition to gantenerumab programme. Crenezumab also continues to be tested in ADAD’s Phase II trial of the 
Alzheimer’s prevention program.

DIAN-TU-001 is a Phase II/III study sponsored by the Washington University School of Medicine in St. Louis, US. The study tested two investigational therapies compared to placebo (Roche’s gantenerumab and Eli Lilly’s solanezumab) just to determine if whichever of these treatments could slow the rate of cognitive decline and improve disease-related biomarkers in the people who are known to have a genetic mutation for inherited AD. 

The study’s primary outcomes measures – The DIAN Multivariate Cognitive Endpoint is a novel outcome measure designed to assess cognitive performance in ADAD individuals.


The Scottish Medicines Consortium approves first two ‘ultra-orphan’ pathway meds

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The Scottish Medicines Consortium approves first two ‘ultra-orphan’ pathway meds

Feb 10, 2020: Appraisal reports have been published for THE two medicines to treat exceptionally rare conditions, voretigene neparvovec (Luxturna) and burosumab (Crysvita). These are the first drugs to be tested along the ultra-orphan pathway a new approach introduced  earlier this year.

Voretigene neparvovec (Luxturna) is a onetime treatment for an extremely rare form of hereditary retinal dystrophy (an inherited eye condition) caused by a mutation (genetic modification) in the gene RPE65. 

The condition causes severe loss of sight from an early age with most patients leading to complete blindness, and no cure is currently available. Voretigene neparvovec has been shown to improve vision that would have a substantial impact on the quality of life.

Burosumab (Crysvita) is a treatment for X linked pituitary hypophosphateemia,an 

extremely rare,debilitating, genetic condition characterized by low blood phosphate levels. The disease results in debilitating deformities of the skeleton that occur in infancy and continues in adulthood and have a profound effect on day-to-day functioning and quality of life. Burosumab was shown to correct childhood bone defects. 

This is expected to result in lifelong benefits but it is not currently known how this  treatment will impact the disease’s development into adulthood.

Cemiplimab (Libtayo) was accepted for the interim use subject to ongoing evaluation and future reassessment by the SMC, used for the treatment of a type of skin cancer called advanced cutaneous squamous cell carcinoma (CSCC) in the patients who are not candidates for curative surgery or curative radiation. This treatment was considered through the Patient and Clinical Engagement (PACE) phase of SMC, which is used for drugs to treat end-of-life disorders and very unusual ones.

Also accepted through PACE was teduglutide (Revestive) for the treatment of adult patients with short bowel syndrome, a rare condition in which nutrients and fluids are not accurately absorbed by the gut. Patients are usually given nutrients as an infusion directly into veins (a process known as parenteral nutrition). Parenteral nutrition is administered through a tube into a vein over 10 to 14 hours at a time and for up to seven days per week. Teduglutide can reduce the level of parenteral nutrition that is necessary, enabling patients and their carers in order to experience an improved quality of life.

Encorafenib (Braftovi) was established through PACE for the treatment of metastatic melanoma (advanced skin cancer). Encorafenib is used in combination with the other medicine, binimetinib (Mektovi), and is only for the patients whose cancer cells have a specific mutation (change) in the ‘BRAF’ gene. In the PACE meeting, participants emphasised that this is a severe, violent form of cancer with a poor prognosis. Encorafenib provides another efficient treatment option with a different side effect profile that may be preferable for some patients.

https://www.scottishmedicines.org.uk/about-us/latest-updates/february-2020-decisions-news-release/

Zealand Pharma announces proposal to acquire Valeritas

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Zealand Pharma announces proposal to acquire Valeritas

Feb 10, 2020: Zealand Pharma, a biotechnology company focused on the discovery and development of the innovative peptide-based medicines, announces a bid in order to acquire substantially all assets from Valeritas Holdings, Inc. for a total cash consideration of $23 million and the assumption of certain liabilities related to the ongoing business, pursuant to the terms of the “stalking horse” asset purchase agreement entered into with Valeritas.

On February 9, 2020, Valeritas and its subsidiaries filed the voluntary petitions under Chapter 11 of the U.S. Bankruptcy Code in the U.S. Bankruptcy Court for the District of Delaware.

At that time, Zealand entered into a definitive agreement on order to acquire substantially all assets from the Valeritas. Under the terms of the agreement, Zealand serves as the stalking horse bidder in the sale process.

The proposed sale is to be conducted through a Court-supervised sale process under Section 363 of the Bankruptcy Code and will be subject to the Court-approved bidding procedures and receipt of competing for offers at the auction. 

If Zealand’s bid is selected, the sale will be subjected to approval by the Bankruptcy Court and certain other closing conditions. No assurance for the transaction to be concluded.

Zealand’s strategy is to become a fully integrated biotechnology company with commercial operations in the U.S., and Zealand is preparing for the anticipated launch of the dasiglucagon HypoPal® rescue pen in 2021, if approved by the U.S. FDA.

The contemplated bid provides Zealand with an opportunity to acquire a revenue-generating business and infrastructure, accelerating in efforts ongoing to prepare for the anticipated dasiglucagon HypoPal® launch while leveraging the Valeritas organization’s experience and relationships within the U.S. diabetes market.

Valeritas is a multinational medical technology company based in the United States with a focus on improving health and simplifying life for people with diabetes. The V-Go ® Wearable Insulin Delivery system, Valeritas ‘ company, is a simple, inexpensive, all-in-one basal bolus insulin delivery device for adult patients needing insulin that is worn like a patch and can remove the need to take multiple daily shots.

Valeritas posted $22.4 million in revenue and a $41.9 million loss before income taxes for the nine months ending September 30th, 2019. Because of the complexity of this bankruptcy sale process, no statements can be made about the financial impact of the proposed transaction or any guidelines relevant to it.

As a reminder, on 12 March 2020, Zealand Pharma is planning to announce results for the fourth quarter and fiscal year 2019. When appropriate information becomes available Zealand will provide further updates. In this deal, Cooley LLP is working as legal adviser to Zealand Pharma.
https://fda.einnews.com/pr_news/509318162/zealand-pharma-announces-bid-to-acquire-valeritas

Extended coronavirus outbreak in China may affect the Indian pharmaceutical industry

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Extended coronavirus outbreak in China may affect the Indian pharmaceutical industry

Feb 9, 2020: Indian Pharma firms are closely monitoring the outbreak of the coronavirus in China as it could impact the supply of active pharmaceutical ingredients in the country, if the situation in the neighbouring nation does not improve soon.

China accounted for 67.56 per cent of the total imports of bulk drugs and drug intermediates in the 2018-19 at USD 2,405.42 million. India imports bulk drugs / active pharmaceutical ingredients (APIs) from China for the manufacture of medicines including certain basic medicines.

The government has said earlier that most of the bulk product imports and APIs are being undertaken because of economic considerations. 

On the government sector, India has revoked all visas issued to foreign nationals coming from China as it has stepped up efforts to fight coronavirus spread after 150 passengers were diagnosed with symptoms of the deadly virus and sent to isolation units. 

It has also increased passenger screening at 21 airports, as well as at 12 major seaports and all minor ports.
https://www.coronaviral.org/india/prolongation-of-coronavirus-outbreak-in-china-could-hit-indian-pharma-sector-00208080

Clariant Masterbatches introduces brilliant new metallic aesthetic; targets premium packaging

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Clariant Masterbatches introduces brilliant new metallic aesthetic; targets premium packaging

Feb 07, 2020: Clariant Masterbatches has developed a novel chrome color that opens new opportunities for the designers and manufacturers of high-end products, bottles and packaging.

Targeted particularly at polyethylene terephthalate (PET) containers, the color is somewhat translucent, so it is ideal for the applications where it is necessary or enviable for the contents in the bottle to be visible.

Yet it has the power to conquer slightly off-colour resins, including post-consumer recycled (PCR) PET. In fact, the effect was first demonstrated on the bottles made of recycled PET resin.

The team at Clariant ColorWorks™ design and the technology centers developed the new color masterbatches in response to growing interest, predominantly in the technology sector, for truly metallic looks.

Designers recently began focusing on the silver and chrome with a liquid feel, explains Judith van Vliet, ColorWorks Senior Designer and a recognized colour expert. “You see it a lot in the glass and that kind of transparency is also very trendy.

Clariant’s new chrome masterbatch develops the look that is the closest I’ve seen to a true metallized effect. It does a  good job of bringing those bright qualities to plastics for use in bottles containing prestige products.”

The secret to achieving the brilliant chrome effect lies in the pigment particle-size distribution and the way it is integrated into the masterbatch. Reflectivity is the dramatically increased compared to more conventional silver or chrome colors.

The chrome effect has other profits as well, including the way it reacts to the laser radiation. Unlike other colors, which turn grey or black under the laser radiation and leave a physical, palpable mark on the surface, the chrome pigment simply disappears leaving only the natural transparent polymer behind.

The new Clariant liquid-look chrome masterbatch is the first product in order to arise from NewAesthetix, a new ColorWorks initiative aimed at the developing unique color and effect options that deliver aesthetic qualities not normally expected in the plastic materials.
https://www.clariant.com/en/Corporate/News/2020/02/Clariant-introduces-brilliant-new-metallic-aesthetic-targets-premium-packaging

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