Medical Tidbits,TAGRISSO (OSIMERTINIB) SHOWS CLINICAL ACTIVITY IN PATIENTS WITH LEPTOMENINGEAL DISEASE FROM LUNG CANCER

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simertinib data reported at ASCO 2016 demonstrated improved neurological function in patients with EGFRm NSCLC and leptomeningeal disease

Latest results reinforce pre-clinical evidence that osimertinib crosses the blood-brain barrier

CAMBRIDGE, England–(BUSINESS WIRE)–AstraZeneca today announced clinical and safety data for Tagrisso (osimertinib) in patients with leptomeningeal (LM) disease, a complication of epidermal growth factor receptor (EGFR) mutation-positive advanced non-small cell lung cancer (NSCLC),1 where cancer cells spread to the cerebrospinal fluid (CSF). LM is a devastating disease associated with advanced lung cancer.

The updated BLOOM Phase I trial results, presented at the American Society of Clinical Oncology (ASCO) annual meeting, showed that irrespective of T790M status of patients, osimertinib led to a change in MRI signal intensity indicative of a reduction in central nervous system (CNS) lesions. 1

Data from 21 patients treated with osimertinib 160mg once daily showed intracranial radiological improvement in seven patients, neurological function improvement in five patients, and clearance of tumour cells from the CSF at two consecutive visits in two patients.1 None of the 21 patients treated with osimertinib received concomitant radiotherapy or intrathecal chemotherapy. Fifteen patients remained on treatment at data cut-off (10 March 2016), of whom seven had been on treatment for more than nine months.1 read more

Boston Scientific Announces Restructuring Program to Support Long-Term Growth and Innovation

Accelerates momentum to bring differentiated value to patients and health care systems

MARLBOROUGH, Mass., June 8, 2016 /PRNewswire/ — Boston Scientific Corporation (NYSE: BSX) today announced a global restructuring program to build on the progress the company has made in executing long-term growth strategies and bringing differentiated value and innovation to patients and healthcare systems. The program is focused on developing global commercialization, technology and manufacturing capabilities in key growth markets, continuing implementation of the company’s plant network optimization strategy and expanding operational efficiencies in support of the company’s operating income margin goals. read more

Baricitinib significantly reduces joint damage progression in rheumatoid arthritis in patients who do not respond to conventional DMARDs

Patients from pivotal 24-week phase 3 trial RA-BUILD who entered long-term extension study, RA-BEYOND, demonstrate baricitinib continues to inhibit radiographic progression of structural joint damage over one year read more

Consumer Health at the forefront of Merck’s plans to considerably
expand on the African continent over the next five years
• – 2016 will be an investment year in selected African countries for Merck’s Consumer Health business, with a focus on its global strategic brands  Seven Seas, Nasivin and Neurobion

Merck, a leading science and technology company, today outlined the role its Consumer Health business will play within the company’s new Africa growth strategy. Merck, which has been delivering healthcare services in Africa since 1897, unveiled an ambitious objective to more than double sales in Africa to about € 500 million by 2020, during an Executive Board
visit to ten African countries in November 2015. As part of this strategy, 2016 will be a year of investment in selected African countries for Merck’s Consumer Health business. Among others, the company plans to focus on its well-known global strategic brands such as Seven Seas®, Nasivin® and Neurobion® on the continent. Focusing on innovation and access to health, Merck’s Consumer Health business is expected to play a pivotal role in Merck’s commitment to supporting healthy families, healthy communities and healthy economies in Africa.

Studies Demonstrate Lilly’s Taltz(R) (ixekizumab) Maintained or Achieved High Levels of Skin Clearance for Patients with Moderate-to-Severe Plaque Psoriasis through 60 Weeks: Results Published in the New England Journal of Medicine

/PRNewswire/ — Eli Lilly and Company (NYSE: LLY) announced today that the New England Journal of Medicine has published detailed results from three pivotal Phase 3 studies—UNCOVER-1, UNCOVER-2 and UNCOVER-3—that demonstrated the efficacy and safety of Taltz® (ixekizumab) through 60 weeks in patients with moderate-to-severe plaque psoriasis. This publication also detailed 12-week efficacy data for patients treated with Taltz in UNCOVER-1.

In all three studies, responders to Taltz through 12 weeks demonstrated high levels of skin clearance through 60 weeks.

“This group of studies show that patients on Taltz are able to achieve high levels of efficacy, and that the majority of patients are able to maintain or continue to improve their response with continued treatment through 60 weeks,” said Kenneth Gordon, M.D., a professor of dermatology at Northwestern University Feinberg School of Medicine and first author of the paper. read more

ASTRAZENECA ENTERS COMMERCIALISATION AGREEMENT WITH ASPEN FOR ANAESTHETIC MEDICINES PORTFOLIO 

Agreement expands commercial reach for anaesthetics and supports the Company’s sharp focus on innovative new medicines in its three main therapy areas 

 AstraZeneca today announced it has entered into a commercialisation agreement with Aspen Global Incorporated (AGI), part of the Aspen Group, for rights to its global anaesthetics portfolio outside the US. The agreement covers seven established medicines – Diprivan (general anaesthesia), EMLA (topical anaesthetic) and five local anaesthetics (Xylocaine/Xylocard/Xyloproct, Marcaine, Naropin, Carbocaine and Citanest).

Under the terms of the agreement, AGI will acquire the commercialisation rights, outside the US, to AstraZeneca’s portfolio of anaesthetic medicines for an upfront consideration of $520 million. Additionally, AGI will pay AstraZeneca up to $250 million in a Product Sales-related payment, as well as double-digit percentage trademark royalties on Product Sales. AstraZeneca will manufacture and supply the products on a cost plus basis to AGI for an initial period of 10 years. Upon completion, Aspen will assume responsibility for all activities relating to the sale of the portfolio in all relevant markets.

Pascal Soriot, Chief Executive Officer, AstraZeneca, said: “AstraZeneca has a rich heritage in anaesthetic medicines and this agreement will extend the reach of our established portfolio to a greater number of patients through AGI’s extensive commercial network. This agreement supports our strategic focus on the new medicines in three main therapy areas.”

AbbVie Reinforces Commitment to Hematologic Oncology at 21st European Hematology Association Annual Congress Including 10 Abstracts on Investigational Medicine Venetoclax

Data to be presented on investigational medicines venetoclax and duvelisib in some of the most common blood cancers

– Presentations across hematologic malignancies reinforce AbbVie’s commitment to discovering and developing innovative therapies

COPENHAGEN, Denmark, June 9, 2016 /PRNewswire/ — AbbVie (NYSE: ABBV), a global biopharmaceutical company, will present data on its investigational medicine venetoclax, a B-cell lymphoma -2 (BCL-2) inhibitor, and duvelisib, an investigational phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma inhibitor, at the 21stEuropean Hematology Association (EHA) Annual Congress, June 9-12, in Copenhagen, Denmark. Data will be presented in some of the most common hematological malignancies, including chronic lymphocytic leukemia (CLL), multiple myeloma (MM), acute myeloid leukemia (AML) and follicular lymphoma.

Galderma Trifarotene Development Program Meets Key Milestone for Lamellar Ichthyosis Orphan Disease

LAUSANNE, Switzerland–(BUSINESS WIRE)–Galderma today announced that its trifarotene development program targeting lamellar ichthyosis, a debilitating orphan disease resulting in the formation of scales covering the skin, was demonstrated to be safe and well-tolerated in a phase I study. Trifarotene is a first-in-class molecule being developed by Galderma, the medical solutions business of Nestlé Skin Health. read more

Samsung Bioepis Announces New Data on Three Anti-TNF-α Biosimilar Molecules at the Annual European Congress on Rheumatology (EULAR 2016)

  • Switching data on Benepali® (etanercept), Flixabi® (infliximab) and SB5 (adalimumab) investigational biosimilar candidate shows sustained comparable efficacy and safety profiles after switching from reference product to biosimilar version
  • Long-term data shows Benepali® (etanercept) and Flixabi® (infliximab) sustain comparable efficacy and safety profiles to etanercept and infliximab reference products up to Week 100 and Week 78, respectively
  • In one-year Phase III study, SB5 (adalimumab) investigational biosimilar candidate demonstrates comparable efficacy and safety profile to adalimumab reference product
  • Samsung Bioepis to operate booth and host satellite symposium on biosimilars
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