Machine learning and artificial intelligence (AI) have long been heralded as the future of transformative technologies. From diagnostic and imaging technologies to therapeutic applications and robotics, the potential for machine learning and AI technologies reaches almost every corner of the medtech world. So, what does that mean for the development and application of next-gen medical devices?

Dave Saunders is the chief technology officer of Galen Robotics, an emerging surgical robotics company that specializes in a new line of robotic technologies that provide a cooperatively controlled surgical platform. The company aims to provide robot-assisted technologies that can extend increased precision and unprecedented tool stabilization to microsurgery procedures.

Saunders has personally overseen the evolution of more than 40 different internet-based products from inception to market since 1991 and has led product development programs for virtual machine clustering and computer-vision-guided surgical tools. He’ll also be speaking at MD&M East in June where he’ll be covering the topic of “How Artificial Intelligence Has Changed Everything for Medical Devices.”

Saunders recently sat down to speak with MD+DI about how the current development and application for diagnostic and therapeutic devices is poised to explode once true AI arrives. He also discusses some of the challenges that new AI and machine learning technologies pose to device developers and explores the immediate impact that some of these new technologies will have on the market.

MD+DI: For starters, AI technology has been touted as a truly transformative technology for many years. Do you think we’re on the verge of machine learning and AI technologies finally having a real impact on the medical device market? How soon will we see any kind of significant impact?

Read more: https://www.mddionline.com/how-artificial-intelligence-changing-medical-devices

Scientists have identified a gene that helps prevent the harmful buildup of proteins that can lead to neurological disorders such as Alzheimer's and Parkinson's disease. The researchers found that the 'Ankrd16' gene acts like a failsafe in proofreading and correcting errors to avoid the abnormal production of improper proteins.

Read more: https://www.sciencedaily.com/releases/2018/05/180516162516.htm

US regulators have finally issued a green light for AstraZeneca’s Lokelma as a treatment for hyperkalaemia - elevated potassium levels in the blood - in adult patients.

The treatment, an insoluble, non-absorbed compound with a structure that was designed to preferentially capture potassium ions, was previously rejected by twice by the regulator largely because of manufacturing issues.

Risk of developing hyperkalaemia increases significantly for patients with chronic kidney disease and for those who take common life-saving medications for heart failure, such as renin-angiotensin-aldosterone system (RAAS) inhibitors, which can increase potassium in the blood.

Read more: http://www.pharmatimes.com/news/us_green_light_for_az_lokelma_1236110

Roche’s blockbuster ambitions for new haemophilia A therapy Hemlibra have been bolstered by new data showing the drug was able to cut bleeds by more than two thirds compared to standard factor VIII therapy.
It’s the first time that any medicine has been able to outperform factor VIII prophylaxis, with patients switched to Hemlibra (emicizumab) given as a once-weekly or biweekly injection seeing the number of bleeds reduced by 68% compared to their prior therapy. It also reduced bleeds by 98% in patients who did not get any preventive treatment in the HAVEN 3 trial, which enrolled people with haemophilia A without factor VIII inhibitors, antibodies that limit the effect of clotting factor replacement.
“Even with current prophylactic treatments, many people with haemophilia A continue to have bleeds that can lead to long-term joint damage, and there is a need for more treatment options,” commented HAVEN 3 investigator Johnny Mahlangu of the University of the Witwatersrand in Johannesburg, South Africa.

Read more: http://www.pmlive.com/pharma_news/roches_hemlibra_first_drug_to_top_standard_therapy_in_haemophilia_a_1236108

The U.S. Food and Drug Administration today approved Aimovig (erenumab-aooe) for the preventive treatment of migraine in adults. The treatment is given by once-monthly self-injections. Aimovig is the first FDA-approved preventive migraine treatment in a new class of drugs that work by blocking the activity of calcitonin gene-related peptide, a molecule that is involved in migraine attacks.
"Aimovig provides patients with a novel option for reducing the number of days with migraine," said Eric Bastings, M.D., deputy director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research. "We need new treatments for this painful and often debilitating condition."

Patients often describe migraine headache pain as an intense pulsing or throbbing pain in one area of the head. Additional symptoms include nausea and/or vomiting and sensitivity to light and sound. Approximately one-third of affected individuals can predict the onset of a migraine because it is preceded by an aura - transient sensory or visual disturbances that appear as flashing lights, zig-zag lines or a temporary loss of vision. People with migraine tend to have recurring attacks triggered by a number of different factors, including stress, hormonal changes, bright or flashing lights, lack of food or sleep and diet. Migraine is three times more common in women than in men and affects more than 10 percent of people worldwide.

Read more: http://www.worldpharmanews.com/fda/4409-fda-approves-novel-preventive-treatment-for-migraine

(Reuters) - Eli Lilly and Co (LLY.N) will buy AurKa Pharma Inc in a deal potentially worth up to $575 million, the U.S. drugmaker said on Monday, seeking access to the privately-held firm’s experimental cancer treatment for solid tumors.

The deal is Lilly’s second in less than a week that aims to broaden its portfolio of lucrative cancer drugs. On Thursday, Lilly said it would buy Armo BioSciences Inc (ARMO.O) for about $1.6 billion.
AurKa Pharma will receive $110 million upfront and is eligible to earn up to $465 million more if it achieves regulatory and sales milestones.

AurKa’s chief drug under development was discovered by Lilly, but the drugmaker sold the compound in 2016 to TVM Capital Life Science, which established AurKa.

The drug, AK-01, is being studied in early-stage trials to treat multiple types of solid tumors.

Source: Reuters
https://uk.reuters.com/article/us-aurka-pharma-m-a-lilly/lilly-to-buy-cancer-drug-developer-aurka-pharma-idUKKCN1IF1IE

Electroconvulsive therapy (ECT) may be effective and cost-effective for U.S. patients with treatment-resistant depression, according to research published online May 10 in JAMA Psychiatry.

Eric L. Ross, from the University of Michigan Medical School in Ann Arbor, and colleagues examined the cost-effectiveness of ECT versus pharmacotherapy/psychotherapy for treatment-resistant major depression. Data were included from multiple meta-analyses, randomized trials, and observational studies.

Read more: https://www.drugs.com/news/ect-effective-resistant-depression-74289.html

The U.S. Food and Drug Administration today approved Gilenya (fingolimod) to treat relapsing multiple sclerosis (MS) in children and adolescents age 10 years and older. This is the first FDA approval of a drug to treat MS in pediatric patients.
"For the first time, we have an FDA-approved treatment specifically for children and adolescents with multiple sclerosis," said Billy Dunn, M.D., director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research. "Multiple sclerosis can have a profound impact on a child’s life. This approval represents an important and needed advance in the care of pediatric patients with multiple sclerosis."

Gilenya was first approved by the FDA in 2010 to treat adults with relapsing MS.

MS is a chronic, inflammatory, autoimmune disease of the central nervous system that disrupts communication between the brain and other parts of the body. It is among the most common causes of neurological disability in young adults and occurs more frequently in women than men. For most people with MS, episodes of worsening function and appearance of new symptoms, called relapses or flare-ups, are initially followed by recovery periods (remissions). Over time, recovery may be incomplete, leading to progressive decline in function and increased disability. Most people with MS experience their first symptoms, like vision problems or muscle weakness, between the ages of 20 to 40. Two to five percent of people with MS have symptom onset before age 18 and estimates suggest that 8,000 to 10,000 children and adolescents in the U.S. have MS.

Read more: http://www.worldpharmanews.com/fda/4399-fda-expands-approval-of-gilenya-to-treat-multiple-sclerosis-in-pediatric-patients

AstraZeneca and MedImmune, its global biologics research and development arm, today announced top-line results from the GALATHEA Phase III trial for Fasenra (benralizumab) in patients with moderate to very severe chronic obstructive pulmonary disease (COPD). The trial did not meet the primary endpoint of a statistically-significant reduction of exacerbations in patients with COPD.
Dr. Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer, said: "COPD is a debilitating disease with significant unmet need among patients whose disease remains uncontrolled despite treatment with existing inhaled therapies. We will now await the results of TERRANOVA and a full evaluation of both trials to determine next steps for Fasenra in COPD."

The pivotal Phase III trials GALATHEA and TERRANOVA are randomised, double-blinded, 56-week placebo-controlled, multi-centre trials assessing the safety and efficacy of Fasenra as an add-on to dual or triple inhaled therapy compared to placebo in patients with moderate to very severe COPD with a history of exacerbations across a range of baseline blood eosinophils.(1)

Read more: http://www.worldpharmanews.com/astrazeneca/4400-astrazeneca-provides-update-on-galathea-phase-iii-trial-for-fasenra-in-chronic-obstructive-pulmonary-disease

The Medicines Discovery Catapult, the Centre for Drug Safety Sciences at the University of Liverpool and the National Centre for the Replacement Refinement & Reduction of Animals in Research are working together to “propel” the UK into the race to advance organ on a chip technology.

An organ on a chip (OOAC) is essentially a multi-channel 3D microfluidic cell culture chip that simulates the activities, mechanics and physiological response of entire organs and organ systems.

Although still in early stages, the technology is widely used and researched in the US and across Europe, and many believe it could revolutionise drug discovery and development.

According to the partners, the field represents a significant opportunity for UK researchers, as it has the potential to provide “sophisticated models of human organ systems which better mimic what happens when patients receive drug molecules; providing patient relevant data, enabling risk-free biomedical testing and reducing the need for animal disease models”.

Ultimately, this will save the UK drug discovery community vital time, resource and money, as well as significantly cut the number of failed trials and disappointments further down the line, the groups note.

Read more: http://www.pharmatimes.com/news/groups_hails_potential_of_organ_on_a_chip_tech_for_uk_1235484

A long-term contract extension has been agreed by Proteon Therapeutics and Lonza Pharma & Biotech for the commercial supply of the investigational vonapanitase’s active pharmaceutical ingredient (API).

“Proteon and Lonza have had a strong relationship for nearly a decade, and this amendment extends that relationship,” said Timothy Noyes, president and chief executive officer of Proteon. “The amendment provides Proteon with access to a top-tier manufacturing site for the long-term commercial supply of investigational vonapanitase after potential FDA approval.”

Read more: https://www.epmmagazine.com/news/proteon-and-lonza-expand-long-term-contract/

AstraZeneca has entered into an agreement with Luye Pharma Group, Ltd. (Luye Pharma) for the sale and licence of the rights to Seroquel and Seroquel XR in the UK, China and other international markets, including Brazil, Australia, Saudi Arabia, Mexico, South Korea, Thailand, Argentina, Malaysia and South Africa.
The transaction is part of AstraZeneca’s strategy to focus on its three main therapy areas of Oncology, Cardiovascular, Renal & Metabolism and Respiratory. Seroquel, used primarily to treat schizophrenia and bipolar disease, has lost its compound patent protection globally; the Seroquel XR formulation patents have now also expired in the vast majority of markets. AstraZeneca partnered the rights to Seroquel and Seroquel XR in Japan and Venezuela under prior agreements.

Read more: http://www.worldpharmanews.com/astrazeneca/4391-astrazeneca-and-luye-pharma-group-enter-agreement-for-rights-to-seroquel-and-seroquel-xr-in-the-uk-china-and-other-international-markets

Takeda is moving ahead with its quest to acquire UK-listed Shire, after the latter approved an offer equating to around £46 billion.

The boards of both companies have finally settled on terms of the deal, which will see the Japanese drugs giant pay out $30.33 in cash and either 0.839 New Takeda Shares or 1.678 Takeda ADSs for each Shire share.

The bid represents a 59.6 percent premium to Shire’s closing price on March 27, before Takeda unveiled its intentions to buy the company.

The acquisition will leave Shire shareholders with an approximate 50 percent stake in the combined group, which is to be headquartered in Japan.

The move ends weeks of wrangling between the two firms, during which Takeda put forward four unsuccessful proposals for buying the business.

“Shire’s highly complementary product portfolio and pipeline, as well as experienced employees, will accelerate our transformation for a stronger Takeda,” said Takeda’s chief executive Christophe Weber, commenting on the deal.

Read more: http://www.pharmatimes.com/news/takeda_to_buy_shire_for_46_billion_1234811

Vertex Pharmaceuticals will begin testing a combination of VX-445, tezacaftor and ivacaftor as a potential treatment for people with cystic fibrosis (CF) in two Phase III studies.

The first trial will evaluate the combination in around 360 people with CF who have one copy of the F508del mutation and one minimal function mutation, and is designed to support the submission of a New Drug Application (NDA) in the US.

The second will include around 100 CF patients who have two copies of the F508del mutation, the most common genetic form of the disease, and is also designed to support submission of an application for this subset in the US, Vertex said.

Read more: http://www.pharmatimes.com/news/vertex_to_test_cf_triple_combo_therapy_in_phase_iii_trials_1233503

Mobidiag, a Finnish biotech, has launched a diagnostic test that can rapidly detect the most common disease-causing microbes in the gut. The test can help manage infections more effectively at an earlier stage.

Mobidiag has launched a molecular diagnostic test on the European market that checks patient samples for numerous bacterial targets, including the most common bacteria causing diarrhea. The technology speeds up the diagnostic process by providing results in around an hour, while conventional diagnostics using cell culture take several days.

Read more: https://labiotech.eu/mobidiag-diagnostic-test-launch/

Boehringer Ingelheim and Eli Lilly and Company (NYSE:LLY) have announced an academic collaboration with the University of Oxford. EMPA-KIDNEY will investigate the effects of empagliflozin on the progression of kidney disease and the occurrence of cardiovascular death, in people with established chronic kidney disease with and without diabetes. The study will be independently conducted, analysed and reported by the Medical Research Council Population Health Research Unit at the University of Oxford (MRC PHRU), which is based in the Clinical Trial Service Unit and Epidemiological Studies Unit (CTSU). Boehringer Ingelheim and Eli Lilly and Company will provide the funding fort he study.

Read more: http://www.worldpharmanews.com/boehringer-ingelheim/4365-boehringer-ingelheim-and-lilly-announce-an-academic-collaboration-with-university-of-oxford

Cancer Research UK and the American Association for Cancer Research (AACR) are launching a new international alliance dedicated to accelerating progress against cancer.

The overarching aim of the alliance is to “stimulate leading-edge discoveries in cancer research that will ultimately help to save lives from this complex disease,” according to the press release.

Read more: http://www.pharmatimes.com/news/cr_uk,_aacr_form_international_cancer_alliance_1232283

GSK and Orchard Therapeutics have announced a strategic agreement, under which GSK will transfer its portfolio of approved and investigational rare disease gene therapies to Orchard, securing the continued development of the programmes and access for patients. This acquisition strengthens Orchard's position as a global leader in gene therapy for rare diseases. GSK will continue to invest in the development of its platform capabilities in cell and gene therapies, with a focus on oncology.
Under the agreement, GSK will become an investor in Orchard Therapeutics, receiving a 19.9% equity stake along with a seat on the company's board. GSK will also receive financial considerations in the form of royalties and commercial milestone payments related to the acquired portfolio. GSK and Orchard will exchange manufacturing, technical and commercial insights and learnings on the development of gene therapy medicines to ensure the success of the assets.

Orchard Therapeutics is a clinical-stage gene therapy company based in the United Kingdom and United States, dedicated to transforming the lives of patients with rare diseases through innovative gene therapies. The acquisition of GSK's programmes complements Orchard’s pipeline of clinical and preclinical gene therapies for primary immune deficiencies and inherited metabolic disorders.

Read more: http://www.pharmanews.eu/gsk/1812-gsk-signs-strategic-agreement-to-transfer-rare-disease-gene-therapy-portfolio-to-orchard-therapeutics

Shire has agreed to sell its cancer drugs business to French drugmaker Servier for $2.4bn, even as it prepared for a possible takeover offer from Takeda.
The Dublin-based company said the deal covers its already-marketed drug Oncaspar (pergaspargase) for acute lymphoblastic leukaemia (ALL), as well as ex-US rights to pancreatic cancer therapy Onivyde (irinotecan pegylated liposomal formulation) and long-acting Oncaspar follow-up calaspargase pegol - under FDA review for ALL.
The agreement comes as Takeda’s chief executive Christophe Weber is reported to be in the US canvassing investor support for a potential bid for Shire, and will no doubt complicate attempts to put a fair value on the business with just a few days to go before the Japanese company must propose an offer or press pause for six months as required under EU takeover laws.

Read more: http://www.pmlive.com/pharma_news/shire_offloads_oncology_unit_to_servier_for_$2.4bn_1231984

US regulators have approved a combination of Bristol-Myers Squibb’s immunotherapy drugs Opdivo and Yervoy as a first-line treatment for patients with advanced renal cell carcinoma.

Approval was based on data from the Phase III CheckMate -214 clinical trial, in which the Opdivo (nivolumab) + Yervoy (ipilimumab) combination showed “a significant and unprecedented increase in overall survival (OS) in this patient population compared to a current standard of care, sunitinib,” according to BMS.

Read more: http://www.pharmatimes.com/news/bms_opdivoyervoy_combo_cleared_for_kidney_cancer_1232129

The U.S. Food and Drug Administration today permitted marketing of the first medical device to use artificial intelligence to detect greater than a mild level of the eye disease diabetic retinopathy in adults who have diabetes. Diabetic retinopathy occurs when high levels of blood sugar lead to damage in the blood vessels of the retina, the light-sensitive tissue in the back of the eye. Diabetic retinopathy is the most common cause of vision loss among the more than 30 million Americans living with diabetes and the leading cause of vision impairment and blindness among working-age adults.
"Early detection of retinopathy is an important part of managing care for the millions of people with diabetes, yet many patients with diabetes are not adequately screened for diabetic retinopathy since about 50 percent of them do not see their eye doctor on a yearly basis," said Malvina Eydelman, M.D., director of the Division of Ophthalmic, and Ear, Nose and Throat Devices at the FDA's Center for Devices and Radiological Health. "Today's decision permits the marketing of a novel artificial intelligence technology that can be used in a primary care doctor's office. The FDA will continue to facilitate the availability of safe and effective digital health devices that may improve patient access to needed health care."

Read more: http://www.worldpharmanews.com/fda/4359-fda-permits-marketing-of-artificial-intelligence-based-device-to-detect-certain-diabetes-related-eye-problems

Orchard Therapeutics has snapped up GlaxoSmithKline’s portfolio of approved and investigational rare disease gene therapies.

The deal sees GSK become an investor in Orchard, with a 19.9 percent equity stake along with a seat on the firm’s board. The UK drugs giant also stands to receive royalties and commercial milestone payments related to the acquired portfolio.

The parties also noted that they intend to share manufacturing, technical and commercial insights and learnings on the development of gene therapy medicines to ensure the success of the assets.

The programmes acquired by Orchard includes Strimvelis, the first autologous ex vivo gene therapy for children with adenosine deaminase severe combined immunodeficiency (ADA-SCID), approved in Europe in 2016, and two late-stage clinical programmes in ongoing registrational studies for metachromatic leukodystrophy and Wiskott Aldrich syndrome, and one clinical programme for beta thalassaemia.

Read more: http://www.pharmatimes.com/news/gsk_hands_rare_disease_gene_therapies_over_to_orchard_1231505

AstraZeneca has bought rights to an experimental antisense therapy from Ionis Pharmaceuticals, in a deal that could be worth more than $300 million.

The move, which builds on an existing strategic partnership between the firms, was triggered by the drug’s advance into development, Ionis said.

IONIS-AZ6-2.5-LRx/AZD2693 is designed to inhibit an undisclosed target to treat patients with nonalcoholic steatohepatitis (NASH), a progressive form of non-alcoholic fatty liver disease.

AZ will pay a $30 million license fee to Ionis, and takes over responsibility for further development and commercialization of the drug.

Read more: http://www.pharmatimes.com/news/az_buys_ionis_nash_candidate_1231077

One of the hallmarks of advanced prostate cancer is a faulty PTEN tumor suppressor gene. Now, after screening compounds for their effect on cells lacking PTEN, scientists have discovered that a natural insecticide called deguelin can kill such cells by disrupting their energy supply.

Deguelin belongs to a class of drugs known as mitochondrial inhibitors. The drugs block the action of mitochondria.

Mitochondria are the tiny compartments inside cells that convert glucose in the cell into molecules of adenosine triphosphate (ATP), which serve as units of energy for fueling the various workings of the cell.

Scientists at Cold Spring Harbor Laboratory in New York found that treating cells lacking PTEN with some types of mitochondrial inhibitor caused the cells to use glucose from their environment to make ATP and then transport it into their mitochondria to preserve them.

Read more: https://www.medicalnewstoday.com/articles/321399.php

Poor animal study design and reporting thwarts the ethical review of proposed human drug trials, according to a study led by researchers at Hannover Medical School, Germany, in cooperation with researchers from McGill University, Canada. The study, publishing 5 April in the open access journal PLOS Biology, analyzed the descriptions of animal studies found in "investigator brochures" - the documents used by regulatory authorities and ethics committees to assess the potential efficacy of drugs that are being tested in patients for the first time.
Independent assessments of animal evidence are key to ensuring that patients are not exposed to undue risk when volunteering in trials. Based on documents obtained from three prominent German medical research centers, the study authors recommend that regulators need to develop standards to ensure the rigorous design and reporting of preclinical animal studies when trials of new drugs are launched.

Read more: http://www.worldpharmanews.com/research/4354-human-drug-trials-are-compromised-by-poor-reporting-of-animal-research