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    • July 18, 2018 12:06 PM BST
    • Janssen’s Symtuza has been approved US regulators as the first and only complete, darunavir-based single-tablet regimen for the treatment of HIV in adults.

      According to Janssen, single table regimens have the capacity to boost adherence and reduce the medicine burden

      Symtuza darunavir (cobicistat/emtricitabine/tenofovir alafenamide) offers patients “the proven protective barrier to resistance of darunavir in a formulation designed for improved tolerability and the convenience,” it said.

      Read more: http://www.pharmatimes.com/news/us_approves_janssens_hiv_pill_symtuza_1244683

    • July 13, 2018 1:05 PM BST
    • GlaxoSmithKline’s new game plan for R&D under new R&D chief Hal Barron continues to take shape, and in the latest move the firm has sold off its lead immuno-inflammation disease asset.
      Psoriasis and atopic dermatitis (eczema) candidate tapinarof is being transferred to Roivant Sciences group company Dermavant in return for £150m upfront and another £100m in the offing if it meets development targets. The deal covers all markets except for China.
      Tapinarof, a therapeutic aryl hydrocarbon receptor modulating agent (TAMA), is being developed as a once-daily, topical treatment for the skin disorders that could provide an alternative to topical and oral steroids, which have side effects. In phase II trials the drug had a dose-dependent impact on plaque psoriasis lesions, and it is ready to move to phase III testing.

      Read more:

      http://www.pmlive.com/pharma_news/gsk_sells_eczema_and_psoriasis_drug_to_dermavant_for_250m_1244181

    • July 13, 2018 1:03 PM BST
    • Pfizer Inc. (NYSE:PFE) announced it will organize the company into three businesses: a science-based Innovative Medicines business which will now include biosimilars and a new hospital business unit for anti-infectives and sterile injectables; an off-patent branded and generic Established Medicines business operating with substantial autonomy within Pfizer and a Consumer Healthcare business. These changes will be effective at the beginning of the company's 2019 fiscal year.


      "This new structure represents a natural evolution of these businesses given the ongoing strength of our in-market products and our late-stage pipeline and the expected significant reduction in the impact of patent protection losses post-2020 following the loss of exclusivity for Lyrica in the U.S which is expected to occur in or after December 2018. As we transition to a period post-2020 where we expect a higher and more sustained revenue growth profile we see this new structure better positioning each business to achieve its growth potential," said Ian Read, Pfizer Chairman and Chief Executive Officer.


      Read more: http://www.worldpharmanews.com/pfizer/4479-pfizer-to-organize-for-future-growth

    • July 13, 2018 1:01 PM BST
    • Engineering cellular biology, minus the actual cell, is a growing area of interest in biotechnology and synthetic biology. It's known as cell-free protein synthesis, or CFPS, and it has potential to provide sustainable ways to make chemicals, medicines and biomaterials. Unfortunately, a long-standing gap in cell-free systems is the ability to manufacture glycosylated proteins - proteins with a carbohydrate attachment. Glycosylation is crucial for a wide range of important biological processes, and the ability to understand and control this mechanism is vital for disease treatment and prevention.
      Matthew DeLisa, the William L. Lewis Professor of Engineering in the Smith School of Chemical and Biomolecular Engineering at Cornell University, and Michael Jewett, associate professor of chemical and biological engineering at Northwestern University, have teamed up on a novel approach that bridges this gap. Their system, the first of its kind, capitalizes on the recent advances in CFPS while adding the crucial glycosylation component in a simplified, "one-pot" reaction. The protein of choice could then be freeze-dried and reactivated for point-of-use synthesis by simply adding water.

      Read more:http://www.worldpharmanews.com/research/4481-bioengineers-create-pathway-to-personalized-medicine

    • July 13, 2018 12:57 PM BST
    • Janssen says it is disappointed that NHS cost regulators are not backing NHS use of Darzalez (daratumumab) plus bortezomib and dexamethasone (DBd) for previously treated multiple myeloma in adults.

      According to Janssen, the decision comes despite the consultation papers highlighting the regimen as an innovative treatment combination, which the firm said boosts overall survival and slashes the risk of death by 50 percent.

      However, the National Institute for Health and Care Excellence noted that the size of the DBd’s benefit in the long-term is “unclear”, because currently available trial data were collected over a short period of time.

      Also, the benefits of DBd compared with alternative therapy carfilzomib plus dexamethasone “are less clear because they haven’t been compared directly in a trial”, according to the draft guidelines.

      Should NICE’s decision become final, up to 2,900 eligible patients in England will be unable to access “this much-needed treatment option” after their first relapse on the NHS, Janssen said.

      Read more: http://www.pharmatimes.com/news/nice_turns_down_darzalex_combo_for_pre-treated_multiple_myeloma_1244164

    • July 10, 2018 12:56 PM BST
    • CTI BioPharma has been poleaxed by the news that its much-anticipated late-stage trial for Pixuvri in non-Hodgkin’s lymphoma (NHL) has ended in failure.

      The PIX306 trial paired Pixuvri (pixantrone) – already sold in some European markets as a monotherapy for hard-to-treat NHL – with Roche’s MabThera (rituximab) and compared it to MabThera plus gemcitabine in aggressive B-cell NHL, but found that CTI’s drug was unable to improve progression-free survival (PFS), its primary endpoint.

      Shares in CTI were suspended as the news broke but slumped after trading resumed as investors came to terms with both a threat to the drug’s EU approval, and little chance of a route towards US approval.


      Read more: http://www.pmlive.com/pharma_news/cti_slumps_as_servier-partnered_lymphoma_drug_fails_1243683

    • July 10, 2018 12:54 PM BST
    • Takeda says it has received unconditional clearance from the US Federal Trade Commission for the proposed acquisition of Shire.

      The FTC’s unconditional clearance of the move “is another significant milestone in the transaction process,” the firm said.

      Takeda announced plans to buy Shire in a deal valued at around £46 billion back in May, ranking as one of the industry’s biggest.

      Read more: http://www.pharmatimes.com/news/takeda_gets_us_nod_for_shire_buy_1243748

    • July 9, 2018 1:00 PM BST
    • The U.S. Food and Drug Administration issued a draft guidance to provide recommendations for consideration when drafting the Indications and Usage section of human drug and biological product labeling. The FDA regulations require the Indications and Usage section of drug labeling to state that the drug is indicated for the treatment, prevention, mitigation, cure or diagnosis of a disease or condition, or for the relief of the disease or condition’s symptoms.


      "FDA-approved labeling is the primary communication tool for providing information on the safe and effective use of drugs to the medical community," said Jacqueline Corrigan-Curay, M.D., J.D., director of the Office of Medical Policy in FDA's Center for Drug Evaluation and Research. "This guidance provides recommendations for drafting the Indications and Usage section of the labeling, including a discussion of the scope of an indication and the inclusion of age groups in indications. We believe this guidance will help health care providers identify appropriate treatment options for their patients."

      Read more: http://www.worldpharmanews.com/fda/4474-fda-takes-steps-to-encourage-more-informative-labeling-on-prescription-drug-and-biological-products-indications-and-usage

    • July 5, 2018 1:53 PM BST
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    • July 4, 2018 12:57 PM BST
    • Merck, a leading science and technology company, today announces the launch of the new online portal fertility.com. Fertility.com is the entrance to access two unique and bespoke portals:
      Fertility.com/hcp; developed for fertility Healthcare Professionals (HCPs)
      Fertility.com/support; created for women, men and couples who are looking for information about fertility and/or are undergoing fertility treatment
      The Healthcare Professional Portal (fertility.com/hcp) offers a wide range of resources relevant to physicians’ daily practice. On the portal, healthcare professionals can find key medical and scientific content. This includes the latest news, publications and developments in the field of fertility as well as expert opinion videos and educational materials. The portal also provides the opportunity to discover more about Merck's therapeutics, technologies and services.

      Read more: http://www.worldpharmanews.com/merckgroup/4468-merck-launches-online-platform-fertility-com

    • July 4, 2018 12:50 PM BST
    • Though you may not hear of it often, cytomegalovirus is a fairly common virus. It is usually harmless, but once contracted, it remains in the system for the rest of a person's life.

      According to the BMJ Best Practice resource, "Cytomegalovirus (CMV) is a ubiquitous beta-herpes virus that infects the majority of humans."

      Infected individuals typically do not experience any symptoms. The virus can be transmitted by coming into direct contact with the bodily fluids, such as blood, of an already-infected individual.

      Once acquired, it remains in a person's body for their entire life.

      In a new study that was conducted in mice, Dr. Janko Nikolich-Žugich — of the University of Arizona College of Medicine in Tucson — and team decided to look into how, and under what conditions, aging individuals would mount a stronger immune response against viral infections.

      Typically, young bodies have stronger defenses. But as we age, our immunity begins to decrease. "That's why older people are more susceptible to infections than younger people," explains Dr. Nikolich-Žugich.

      The scientists involved with the new study were interested in finding out how the immune systems of aging individuals might be fortified and rendered more efficient once more.

      Read more: https://www.medicalnewstoday.com/articles/322347.php

    • July 4, 2018 12:39 PM BST
    • US biotech Anavex has been cleared to start a phase IIb/III trial of an Alzheimer’s drug that is designed to tackle three features of the disease – amyloid, tau and inflammation.
      The company is hoping that by tackling all three characteristics linked to the pathology of Alzheimer’s it may be able to succeed where dozens of other trials – mainly looking at blocking the formation of amyloid deposits in the brain – have failed.

      Anavex’ candidate is Anavex 2-73, a sigma-1 receptor (S1R) transmembrane protein activator that is thought to be involved in regulating homeostasis in cells, keeping them in a healthy, steady state by reducing factors such as oxidative stress, protein misfolding, mitochondrial dysfunction and inflammation – all of which are seen in the brains of Alzheimer’s patients.

      Read more: http://www.pmlive.com/pharma_news/anavex_sets_up_trial_of_triple-action_alzheimers_drug_1243155

    • July 4, 2018 12:36 PM BST
    • Novartis is intending to hand back rights to Aveo Oncology’s experimental antibody AV-380, which it acquired in August 2015 in a deal valued at at least $326 million.

      The antibody targets GDF15, a pro-inflammatory cytokine elevated levels of which have been correlated with cachexia - a complex metabolic syndrome linked with malnutrition and severe involuntary weight loss due to the loss of muscle and fat tissue - in patients with cancer and other conditions.

      Read more : http://www.pharmatimes.com/news/novartis_to_hands_back_rights_to_aveos_av-380_1243124

    • July 3, 2018 1:08 PM BST
    • The European Medicines Agency has approved a label extension for UCB’s Cimzia allowing its use to treat adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy.

      The approval makes Cimzia (certolizumab pegol), the first Fc-free, PEGylated anti-TNF treatment option for use in moderate-to-severe plaque psoriasis “and marks the entry of UCB into immuno-dermatology, where significant unmet need currently exists,” the firm noted.

      The CIMPASI-1 and -2 and CIMPACT trials confirmed the efficacy and safety of the drug in this setting.

      In all three trials, the drug showed “statistically significant improvements for all primary and co-primary endpoints compared to placebo at all tested doses”, and the clinical benefit was maintained through to week 48, according to the firm.

      Read more: http://www.pharmatimes.com/news/eu_green_light_for_cimzia_to_treat_psoriasis_1243024

    • July 3, 2018 1:03 PM BST
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      Use this link to purchase your paid subscription ($200/year for individuals and $1,000/year for companies of every size): https://endpts.com/subscribe
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      Several big pharmas have recently shuttered their research operations in China, but Sanofi is apparently buckling down in the region with a new global R&D hub. The company is hiring 300 people in Chengdu, China to run a tech-focused operation that’s meant to speed up analysis of its clinical trials.

      Sanofi is investing €66 million ($76.6 million) in the hub and will have it fully staffed by 2020. The R&D center is supposed to support Sanofi’s drug development by managing global multi-center clinical trial data and files. The company says it will “take advantage of local talents” to strengthen Sanofi’s digital capabilities, speeding up trials results.

      Read more: https://endpts.com/sanofi-gets-serious-in-china-with-plans-to-hire-300-for-76m-rd-site-in-chengdu/

    • July 3, 2018 1:00 PM BST
    • Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that it has commenced a cash tender offer for all of the outstanding shares of common stock of Foundation Medicine, Inc. (NASDAQ: FMI) at a price of US$ 137.00 per share. The tender offer is being made pursuant to the previously announced merger agreement dated as of 18 June 2018 among Foundation Medicine, Inc., Roche Holdings, Inc., an indirect wholly owned subsidiary of Roche Holding Ltd, and 062018 Merger Subsidiary, Inc., a wholly owned subsidiary of Roche Holdings, Inc. The tender offer period will expire at 12am midnight, Eastern Time, at the end of the day on 30 July 2018, unless the offer is extended.
      Roche has filed a tender offer statement on Schedule TO with the United States Securities and Exchange Commission (SEC). 062018 Merger Subsidiary, Inc. is the acquirer in the tender offer. The Offer to Purchase contained within the Schedule TO sets out the terms and conditions of the tender offer.

      Read more: http://www.worldpharmanews.com/roche/4466-roche-commences-tender-offer-for-all-shares-of-foundation-medicine-inc-for-us-137-00-per-share-in-cash

    • July 3, 2018 12:59 PM BST
    • Bolstering the notion that RNA should be considered an important drug-discovery target, scientists at Scripps Research have found that several existing, FDA-approved anti-cancer drugs may work, in part, by binding tightly to RNA, the regulators of the basic activities of life within cells. The research offers another approach for tackling diseases that have been considered "undruggable," including amyotrophic lateral sclerosis (ALS), muscular dystrophy, cystic fibrosis and certain cancers.
      "Known drugs made in the era when RNAs were not considered drug targets are, in fact, binding RNA, and causing some of the drug's effects by modulating targets that were not previously considered," says chemist Matthew D. Disney, PhD, professor on the Florida campus of Scripps Research, who led the study. "We found broad drug classes that bind RNA. There is reason to believe that not only could known drugs bind RNA in a disease setting, but there is more evidence that one should consider RNA as a target in drug-discovery efforts."

      While the universe of human proteins consists of about 20,000 varieties, the universe of human RNAs is closer to 200,000, potentially offering other effective opportunities to intervene, Disney says.

      Read more: http://www.worldpharmanews.com/research/4465-some-existing-anti-cancer-drugs-may-act-in-part-by-targeting-rna

    • July 3, 2018 12:56 PM BST
    • US regulators have assigned a priority review to MSD’s application to market the immunotherapy Keytruda in combination with chemotherapy as a first-line treatment for squamous non-small cell lung cancer (NSCLC).

      The application is based on data from the Phase III KEYNOTE-407 trial, in which Keytruda (pembrolizumab) plus chemotherapy cut the risk of death by 36 percent compared to chemotherapy alone, when used as a first-line treatment for patients with metastatic squamous NSCLC.

      The addition of Keytruda to chemotherapy also significantly improved progression-free survival (PFS), with a reduction in the risk of disease progression or death of 44 percent, according to the results.

      Read more: http://www.pharmatimes.com/news/us_priority_review_for_keytrudachemo_combo_in_first-line_squamous_nsclc_1243027

    • June 29, 2018 1:00 PM BST
    • The European Commission has approved Pfizer’s Xeljanz as a treatment for psoriatic arthritis (PsA), significantly expanding the drug’s scope.

      European regulators are allowing use of Xeljanz (tofacitinib citrate) 5mg twice daily in combination with methotrexate for to treat active PsA in adults who have had an inadequate response or who have been intolerant to a prior disease-modifying anti-rheumatic drug (DMARD) therapy.

      The decision gives patients the opportunity to access a new treatment approach, as the drug is the first and only oral Janus kinase (JAK) inhibitor to be approved in EU for the condition, which affects between 1.5 and 3 million people in the region.

      Approval came on the back of data from the Phase III Oral Psoriatic Arthritis TriaLs (OPAL) clinical development programme, which demonstrated statistically significant improvements in American College of Rheumatology 20 (ACR20) response and change from baseline in the Health Assessment Questionnaire–Disability Index (HAQ-DI) score.

      Read more: http://www.pharmatimes.com/news/eu_approves_pfizers_xeljanz_for_psoriatic_arthritis_1242439

    • June 29, 2018 12:56 PM BST
    • A genetically modified poliovirus therapy developed at Duke Cancer Institute shows significantly improved long-term survival for patients with recurrent glioblastoma, with a three-year survival rate of 21 percent in a phase 1 clinical trial. Comparatively, just 4 percent of patients at Duke with the same type of recurring brain tumors were alive at three years when undergoing the previously available standard treatment.
      Phase 1 clinical trial results of the poliovirus therapy are being presented June 26 at the 22nd International Conference on Brain Tumor Research and Therapy in Norway and simultaneously published in The New England Journal of Medicine.

      "Glioblastoma remains a lethal and devastating disease, despite advances in surgical and radiation therapies, as well as new chemotherapy and targeted agents," said Darell D. Bigner, M.D., Ph.D., emeritus director of The Preston Robert Tisch Brain Tumor Center at Duke and senior author of the study.

      "There is a tremendous need for fundamentally different approaches," Bigner said. "With the survival rates in this early phase of the poliovirus therapy, we are encouraged and eager to continue with the additional studies that are already underway or planned."

      Read more: http://www.worldpharmanews.com/research/4461-poliovirus-therapy-for-recurrent-glioblastoma-has-three-year-survival-rate-of-21-percent

    • June 29, 2018 12:54 PM BST
    • Novartis has announced plans to spin off its eye-care unit Alcon into a standalone entity.

      The Swiss drug giant said it is seeking shareholder approval for the move, after a strategic review concluded spinning off the business would be consistent with Novartis’ strategy of focusing as a medicines company.

      The Alcon ophthalmology pharmaceuticals portfolio – which made 2017 sales of $4.6 billion and includes the potential blockbuster RTH258 (brolucizumab) for neovascular AMD and diabetic macular edema - will remain in house.

      Read more:http://www.pharmatimes.com/news/novartis_to_spin_off_eye_unit_alcon_1242441

    • June 28, 2018 1:01 PM BST
    • Shares in Puma Biotechnology shot up nearly 30 percent on news that the firm’s breast cancer drug Nerlynx is now likely to get a green light from European regulators.

      The group said the European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive trend vote supporting approval of Nerlynx (neratinib) for the extended adjuvant treatment of early-stage, HER2-positive hormone receptor-positive breast cancer.

      This is particularly good news for the firm given that the CHMP initially rejected the drug back in February, prompting it to request a re-examination of the application.

      At the time, the CHMP said that while trial data showed that a greater proportion of women given Nerlynx lived for two years without their disease coming back versus those given placebo (around 94 percent versus 92 percent, respectively), “it is uncertain that this difference in benefit would be seen in clinical practice.”

      Read more: http://www.pharmatimes.com/news/puma_shares_jump_as_breast_cancer_drug_approval_seems_likely_1242144

    • June 26, 2018 1:02 PM BST
    • Roche (SIX: RO, ROG; OTCQX: RHHBY) and Foundation Medicine, Inc. (NASDAQ: FMI) have entered into a definitive merger agreement for Roche to acquire the outstanding shares of FMI's common stock not already owned by Roche and its affiliates at a price of US$ 137.00 per share in cash. This corresponds to a total transaction value of US$ 2.4 billion on a fully diluted basis, and a total company value of US$ 5.3 billion on a fully diluted basis. This price represents a premium of 29% to FMI’s closing price on 18 June 2018 and a premium of 47% and 68% to FMI’s 30-day and 90-day volume weighted average share price on 18 June 2018, respectively. The merger agreement has been unanimously approved by the board of Roche and a Special Committee of the independent directors of FMI and by its full board of directors with the Roche designated directors abstaining from the deliberations and vote. All current members of the FMI board have indicated that they intend to tender their FMI shares in the tender offer.

      Daniel O'Day, CEO Roche Pharmaceuticals, said, "This is important to our personalised healthcare strategy as we believe molecular insights and the broad availability of high quality comprehensive genomic profiling are key enablers for the development of, and access to, new cancer treatments. We will preserve FMI's autonomy while supporting them in accelerating their progress."

      Foundation Medicine, based in Cambridge, Massachusetts, is a market leading molecular information company dedicated to a transformation in cancer care, where each patient's treatment is informed by a deep understanding of the molecular changes that contribute to their disease. Their services include a full suite of comprehensive genomic profiling (CGP) assays to identify the molecular alterations in a patient's cancer and match them with relevant targeted therapies, immunotherapies and clinical trials.

      "Foundation Medicine and Roche share the philosophy that every cancer patient should have access to personalized care informed by validated molecular information. Joining forces with Roche as an independent operating company allows Foundation Medicine to continue its collaboration with Roche, as well as our biopharma partners, to drive ubiquitous access to CGP testing and innovative data services," said Troy Cox, Chief Executive Officer for Foundation Medicine.

      Read more: http://www.worldpharmanews.com/roche/4457-roche-and-foundation-medicine-reach-definitive-merger-agreement-to-accelerate-broad-availability-of-comprehensive-genomic-profiling-in-oncology

    • June 26, 2018 12:58 PM BST
    • GW Pharmaceuticals’ Epidiolex has become the first cannabinoid prescription medicine to be approved in the US, winning clearance to treat two rare forms of epilepsy.

      In a historic move, the US Food and Drug Administration has given the green light for the drug’s use to treat seizures associated with Lennox-Gastaut Syndrome or Dravet Syndrome, two rare, severe and notoriously difficult-to-treat childhood-onset epilepsies.

      “This approval is the culmination of GW’s many years of partnership with patients, their families, and physicians in the epilepsy community to develop a much needed, novel medicine,” noted the UK firm’s chief executive Justin Gover.

      “These patients deserve and will soon have access to a cannabinoid medicine that has been thoroughly studied in clinical trials, manufactured to assure quality and consistency, and available by prescription under a physician’s care.”

      Epidiolex contains cannabidiol (CBD), a chemical component of the cannabis sativa plant, more commonly known as marijuana. CBD does not cause intoxication or euphoria that comes from tetrahydrocannabinol (THC), the primary psychoactive component of the drug.

      “This approval serves as a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies. And, the FDA is committed to this kind of careful scientific research and drug development,” said FDA Commissioner Scott Gottlieb.

      Read more: http://www.pharmatimes.com/news/fda_approves_gws_cannabinoid_drug_epidiolex_1241983