Seven therapies have been put forward for approval in the European Union, bringing closer new options for a range of conditions including Crohn’s disease, diabetes and cancer.

Included in the latest pack of Committee for Medicinal Products for Human Use (CHMP) recommendations is Tigenix’ Alofisel (darvadstrocel), a new advanced therapy medicinal product (ATMP) for the treatment of complex perianal fistulas in patients with Crohn’s disease.

Perianal fistulas, a common complication of Crohn’s disease, occur when an abnormal passageway develops between the rectum and the outside of the body, potentially leading to incontinence and sepsis. Complex fistulas, which are rare, are more treatment resistant than simple fistulas.

Alofisel contains expanded adipose stem cells that interrupt proliferation of lymphocytes and reduce the release of pro-inflammatory cytokines at inflammation sites, which lessens inflammation and potentially allows the tissues around the fistula tract to heal.

In clinical trials, after 24 weeks of treatment half of patients treated with Alofisel were found to be in remission, compared to a third of the patients given aplacebo.

Read more: http://bit.ly/EUTherapiesApproval

Teva, the Israeli drugmaker, plans to raise prices on a string of medicines in the US to help repair its ailing business — even as analysts warn that the move risks provoking a backlash among customers and politicians.

Like other generic drugmakers, Teva has signed multi-medicine contracts with many customers where it sells some products at break-even or a loss and tries to recoup the difference on more profitable lines.

However, Kåre Schultz, Teva’s recently appointed chief executive, has told investors he wants to either raise the price of some of these “non-economical” drugs or stop manufacturing them altogether.

More: http://on.ft.com/2oIIG8z

Teva Pharmaceutical TEVA +6.45% Industries Ltd. is cutting more than 25% of its workforce, or about 14,000 employees around the world, closing factories and research centers and suspending its dividend—the Israeli firm’s most recent move to cut costs and pare debt.

Teva, the world’s biggest seller of generic drugs, didn’t detail where it is cutting jobs. At the end of the third quarter, it employed about 53,000, most of them in Europe and the U.S.

Teva has been hit hard by declining generics prices in the U.S. and increased competition for its blockbuster multiple-sclerosis drug. It also recently emerged from a period of boardroom and executive-suite turmoil. Directors had clashed on the firm’s strategy after swallowing a big acquisition that saddled it with heavy debt.​

Read more: http://bit.ly/TevaPharma

Cooper Pharma, a Moroccan pharmaceutical company, will on Friday launch the construction of an antibiotics plant in Rwanda.

The plant will be built on a plot of 20,000 square meters at the Kigali Special Economic Zone in Gasabo District.

This project is among the 21 deals that were signed between Morocco and Rwanda in October 2016 during a 3-day visit of King Mohammed VI to Rwanda.

The projects were grouped into eight categories including; business, agriculture, politics, infrastructure, education, health, social welfare and security.

Of these projects, Rwanda and Morocco sealed a deal to invest in pharmaceutical industry, and the Moroccan Cooper Pharma, a renowned producer of antibiotics among other drugs, committed to set up its facility at the Special Economic Zone.

Already exporting to 21 countries across the world, Cooper Pharma said it wanted to make Rwanda a strategic store for East Africa.

More: http://bit.ly/PharmaRwanda

The FINANCIAL -- The EBRD is lending US$ 8 million to Monos Holding LLC – a holding company of Monos Group, one of the leading pharmaceutical conglomerates in Mongolia – to help the firm invest in new equipment to expand manufacturing capacity, develop training, and reorganise long-term capital financing to support its wholesale business.

The five-year loan will enable Monos Group to become more competitive, by supporting the certification of manufacturing capacity and improving employee skills through training. By the end of 2019 the firm aims to secure Good Manufacturing Practice (GMP) certification and to have at least 30 new employees who are trained regularly according to GMP standards.

The optimisation of the company’s balance sheet will support Monos Group – which is owned by Mr Luvsan Khurelbaatar, a prominent Mongolian businessman, and his wife and two children – in becoming more resilient, according to the EBRD.

Read more: http://bit.ly/MongolianPharma

OXFORD, England, December 15, 2017 /PRNewswire/ --

PharmaVentures Capital Limited is pleased to announce that it acted as adviser to Biosceptre International Limited ("Biosceptre") for the successful Series A private placement from the Chinese conglomerate Tuspark Science & Technology Service Group (Tuspark) through its investment vehicle, Bluesky Partnership II L.P. As Tuspark's first major overseas investment into biotech, this represents a strong belief in the Biosceptre team and the potential transformative effects their therapies may bring to cancer patients.
Biosceptre's therapies are focused upon a novel cancer target, nfP2X7, that is completely absent in healthy tissue, but present on tumour tissue in the majority of cancers, including lung, breast, colorectal and prostate. For more information on Biosceptre's therapies see http://www.biosceptre.com/pipeline/.

This first institutional raise will allow Biosceptre to advance its three oncology clinical assets which are BIL010t, a polyclonal antibody ointment for the topical treatment of non-melanoma skin cancers, BIL06v, a peptide protein conjugate and BIL03s, fully human domain monoclonal, both for systemic uses targeting solid and blood cancers. Clinical trials are being planned in Australia, UK and EU.

Fintan Walton, Chairman and Chief Executive of PharmaVentures, said: "This investment by the Chinese company Tuspark S&T in Biosceptre represents a significant landmark for both the UK Biotechnology sector and PharmaVentures Capital Limited."

Adrian Dawkes, Managing Director at PharmaVentures, added; "As a long-standing client, PharmaVentures is pleased to have advised Biosceptre on this transaction. We are delighted to have been able to leverage our relationships in China to secure this investment for the company."

For the past 25 years, PharmaVentures has acted as an advisor to over 700 global pharmaceutical and biotechnology clients in transactions; many covering licensing, mergers, acquisitions, divestments and joint venture activities for companies.

Read more: http://bit.ly/PharmaventuresBiosceptre

(Friday) - Cancer Research UK today announced the signing of a five-year drug-discovery collaboration between its subsidiary, Cancer Research Technology (CRT), and Celgene Corporation (link is external), to discover, develop and commercialise new anti-cancer treatments.

This arrangement represents an expansion of Cancer Research Technology’s theme-based translational model that now encompasses six industry partnerships, including this new collaboration with Celgene.

The collaboration is centred on mRNA translation, the cellular process of assembling proteins, which is a promising area of research with the potential to produce treatments that can target a fundamental characteristic of cancer cells.

Dr Iain Foulkes, Cancer Research Technology’s CEO, said: “This bold and exciting collaboration between one of industry’s leading innovators, Celgene, and CRT is part of our theme-based drug discovery approach and helps leverage our understanding of cancer biology and the needs of patients to drive the most promising discoveries into the clinic.

“This is our largest drug discovery collaboration to date and represents a major endorsement of the reputation and scale of our capacity and expertise in both drug discovery and clinical development by a leading industry partner.”

Cancer Research Technology will lead drug discovery R&D activity and can progress clinical candidates through phase one trials.

Read more: http://bit.ly/CRUKCelgene

By Satoshi Suwa and Yusuke Tomiyama / Yomiuri Shimbun Staff Writers
Nov. 21 marked 10 years since Kyoto University Prof. Shinya Yamanaka and his colleagues announced that they had produced human induced pluripotent stem (iPS) cells (see below). In September, the application of iPS cells for the development of new drugs entered a new phase, when a clinical trial began at Kyoto University Hospital for a candidate drug discovered using iPS cells from people suffering from an incurable disease.

At the opening ceremony for the university’s Center for iPS Cell Research and Application (CiRA) in May 2010, Yamanaka, CiRA’s director, said, “Although regenerative medicine is usually considered to be the field in which iPS cells should be put to use, our primary objective is to develop drugs for incurable and rare diseases.”

He emphasized the importance of using iPS cells not just in regenerative medicine for the recovery of lost bodily functions, but also in discovering new medicines.

In the field of regenerative medicine, research institute RIKEN and others in 2014 became the first to use iPS cells in clinical research in a study of patients with an incurable eye disease. RIKEN leads the world in such research, and next year it plans to carry out clinical studies for diseases of the heart and spinal cord as well.

The latest clinical trial at the hospital represents the first to use iPS in the field of drug discovery. The trial is being carried out on persons suffering from fibrodysplasia ossificans progressiva (FOP), an incurable disease in which muscle tissue turns into bone. The number of people in the nation suffering from this disease is extremely small, estimated at just 60 to 80, but the research began to move forward thanks to skin samples donated by a sufferer.

The trial uses rapamycin, a drug already being used to prevent rejection in organ transplants. First, iPS cells made from the cells of FOP sufferers were used to recreate the disease in vitro, and then roughly 6,800 types of compounds were sprinkled over the FOP cells individually. With this process, the researchers discovered that rapamycin is effective against the disease.

Read more: http://bit.ly/iPS10years

Conor McKeever introduces an exciting new technology, developed by researchers at The Institute of Cancer Research, London.magine if a blood test could show whether a tumour is responding to treatment, without the need for invasive and sometimes painful biopsies. Imagine if it could give doctors an early warning that a drug has stopped working, and offer valuable information about the next one to try. Thanks to our research, these tests are now becoming a reality.

No two cancers are alike. Their genetic make-up – their DNA code – varies from person to person and can change over time. But a cancer’s specific genetics can have a big impact on how it responds to treatment.

Our researchers are developing new blood tests to stay one step ahead of this process, allowing us to predict which available treatments will give the most benefit to patients.

Quicker, simpler, less invasive

Known as liquid biopsies, the tests are already routinely used in clinical trials, including those we run with our partner hospital, The Royal Marsden NHS Foundation Trust.

Because they don’t require a tissue sample, liquid biopsies are quicker, simpler and far less invasive than a traditional biopsy. Instead, the tests analyse cancer DNA circulating in the blood to determine whether a drug is working.

This also means they can pick up DNA from multiple tumours throughout the body, giving a more comprehensive picture than has previously been possible.

Read more: http://bit.ly/ICRProstateCancer

Dec 11 (Reuters) - The U.S. Food and Drug Administration on Monday proposed creating a new fast track to market for certain medical devices and a potential reduction in the amount of safety data required for approval.

Commissioner Scott Gottlieb announced the proposal in a blog posted on the FDA's website. If implemented, it could save device companies millions of dollars in product testing and shave years off development times.
Gottlieb's proposal would offer an alternative route to market for certain companies which do not meet the criteria for clearance under the agency's existing fast track route, known as the 510(k) pathway.

To win 510(k) clearance a product must be moderate risk and substantially equivalent to an existing device, called a predicate. High-risk products such as implantable heart devices must go through a more rigorous process.

Gottlieb said that advancing technology means it can be hard for companies to identify a suitable predicate, "which can create an obstacle to certain kinds of innovation and lead to inefficiency in the review process."

His new proposal would dispense with the need for a predicate and offer the option of using a benchmark consisting of a set of performance standards or guidance documents. The plan would be voluntary.

Read More: http://bit.ly/FDANewPath

Teva Pharmaceutical Industries Ltd.’s new Chief Executive Officer Kare Schultz is working with advisory firm Evercore Inc. to review options for the beleaguered drugmaker’s outstanding debt, according to people familiar with the matter.

Executives from the Israeli company including Chief Financial Officer Mike McClellan have met with the main lenders in recent weeks to assess options including shrinking a revolving credit facility and extending the repayment period for some loans, the people said, asking not to be identified because the deliberations are private. Teva may also seek to reset some debt covenants and extend bond maturities, the people said. The stock rose in New York.The world’s biggest maker of copycat drugs, saddled with almost $35 billion in debt, may launch the refinancing plans as early as in January, the people said. No final decision has been made on the debt proposals, which may change or include other options, the people said. While lenders realize the company will take at least two or three years to recover, they are welcoming efforts to reduce debt load and cut expenses, the people said.

“We’re in constant discussions with our banks and rating agencies and prudently taking all measures to address our financial situation,” a spokeswoman for Petach Tikva, Israel-based Teva said in response to questions. A representative for Evercore didn’t immediately return calls seeking comment.

Read More: http://bit.ly/TevaEvercore

As part of a larger effort to curb antimicrobial resistance, officials with the FDA have announced a new tool for providing critical information to health care providers about better managing antibiotics and antifungal drugs.

According to an FDA announcement, the new website will streamline how the FDA updates information used to help providers choose the most appropriate treatment for a patient’s infection.

Since bacteria and fungi change over time, which may result in decreased susceptibility, it is crucial that providers have access to updated testing criteria, or “breakpoints,” on whether resistance to a particular drug has occurred. The FDA intends the website to provide direct and timely access to this information to allow them to make more informed prescribing decisions.

Read More: http://bit.ly/FDAAntibioticUse

Researchers at University of California San Diego School of Medicine report that a single infusion of wildtype hematopoietic stem and progenitor cells (HSPCs) into a mouse model of Friedreich's ataxia (FA) measurably halted cellular damage caused by the degenerative disease. The findings, published online in the October 25 issue of Science Translational Medicine, suggest a potential therapeutic approach for a disease that currently is considered incurable.

Friedreich's ataxia is an inherited, degenerative neuromuscular disorder that initially impairs motor function, such as gait and coordination, but can lead to scoliosis, heart disease, vision loss and diabetes. Cognitive function is not affected. The disease is progressively debilitating, and ultimately requires full-time use of a wheelchair. One in 50,000 Americans has FA.FA is caused by reduced expression of a mitochondrial protein called frataxin (FXN) due to a two mutated or abnormal copies of the FXN gene. In their study, Stephanie Cherqui, PhD, associate professor in the UC San Diego School of Medicine Department of Pediatrics, and colleagues used a transgenic mouse model that expresses two mutant human FXN transgenes, and exhibits the resulting progressive neurological degeneration and muscle weakness.

Human hematopoietic stem and progenitor cells (HSPCs), derived from bone marrow, have become a primary vehicle for efforts to replace or regenerate cells destroyed by a variety of diseases. Previous research by Cherqui and colleagues had shown that transplanting wildtype or normal mouse HSPCs resulted in long-term kidney, eye and thyroid preservation in a mouse model of cystinosis, another genetic disorder.

Read More: http://bit.ly/2zGsLIs

Just wanted to let everyone know that there's a new law pertaining to fire extinguisher size in healthcare facilities. If anyone would like more info, just Google "new healthcare fire extinguisher law". Just wanted everyone to be proactive before the fire marshal comes knocking!

A recent report from security firm WhiteScope describes more than 8,600 flaws in pacemaker systems and the third-party libraries that power various components of the devices.The broad list of flaws includes a lack of encryption and authentication, simple bugs in the code and poor design that can put patient lives at risk. These vulnerabilities were associated with outdated libraries used in pacemaker programmer software.WhiteScope analyzed seven different pacemaker programmers from four different manufacturers with a focus on programmers that rely on modern radio frequency. The programmers are used to monitor the function of implantable devices and set therapy parameters. http://bit.ly/2recatS

More health insurance companies are deciding to pay for a drug based on whether it's effective and provides the patient a good outcome as value-based care inches toward the pharmaceutical industry, insurers and a new analysis indicate.One in four health plans now have “at least one outcomes-based contract” with a drug maker,an Avalere Health survey showed. Such contracts tie health outcomes to whether the drug is paid for by the health plan. http://bit.ly/2rnniDi

For the millions of people every year who have or need medical devices implanted, a new advancement in 3D printing technology developed at the University of Florida promises significantly quicker implantation of devices that are stronger, less expensive, more flexible and more comfortable than anything currently available.In a paper published today in the journal Science Advances, researchers lay out the process they developed for using 3D printing and soft silicone to manufacture items that millions of patients use: ports for draining bodily fluids, implantable bands, balloons, soft catheters, slings and meshes.Silicone is 3D printed into the micro-organogel support material. The printing nozzle follows a predefined trajectory, depositing liquid silicone in its wake. The liquid silicone is supported by the micro-organgel material during this printing process.http://bit.ly/2r4YE9S

Japan's Takeda Pharmaceutical Co Ltd (4502.T) on Wednesday forecast operating profit to grow 16 percent in the current fiscal year on strong sales of drugs like cancer treatment Ninlaro and bowel disease drug Entyvio.The company's outlook for an operating profit of 180 billion yen ($1.58 billion) in the year to March 31, 2018, was below an average forecast of 197.7 billion yen from 15 analysts surveyed by Thomson Reuters.Takeda reported a 19 percent rise in operating profit for the year just ended to 155.87 billion yen.http://reut.rs/2q5qvJh

Brokerages predict that AcelRx Pharmaceuticals Inc (NASDAQ:ACRX) will report $2.36 million in sales for the current fiscal quarter, Zacks reports. Two analysts have issued estimates for AcelRx Pharmaceuticals’ earnings, with estimates ranging from $1.5 million to $3.22 million. AcelRx Pharmaceuticals reported sales of $3.03 million in the same quarter last year, which would suggest a negative year-over-year growth rate of 22.1%. The company is scheduled to issue its next earnings results after the market closes on Monday, May 8th.On average, analysts expect that AcelRx Pharmaceuticals will report full-year sales of $2.36 million for the current fiscal year, with estimates ranging from $7.1 million to $11.4 million. For the next fiscal year, analysts forecast that the company will post sales of $28.3 million per share, with estimates ranging from $16 million to $40.6 million. Zacks Investment Research’s sales calculations are an average based on a survey of sell-side research firms that that provide coverage for AcelRx Pharmaceuticals.http://bit.ly/2qRE64P

Patent protection in the pharmaceutical industry is different from protection in other sectors.The pharmaceutical industry relies on innovation to develop new medical treatments, but bringing a product to market is high risk and high cost. It can take between 10 and 15 years to develop a new medicine and according to a new study by the Tufts Center for the Study of Drug Development, can cost as much as $2.56 billion.Once a new product has been developed, protecting intellectual property (IP) can also be costly. Every industry needs to evolve individual IP policies, management style and strategies, but patents and trademarks are critical for the pharmaceutical industry in particular.Patents help to protect companies from IP infringement and copycats looking to reproduce generic products at a low cost and high volume.http://bit.ly/2pIEMZO

North Carolina based Biomarck Pharmaceuticals has received FDA allowance to begin human trials for their patented compound BIO-11006, for adults with lung cancer. Discovered by Dr Ken Adler at North Carolina State Universityworking in partnership with Biomarck, inhaled Bio-11006 has demonstrated effectiveness on human cell cultures and animals in the laboratory. It demonstrated impressive results in adult tumours and childhood cancers, specifically, Rhabdomyosarcoma, Neuroblastoma and Osteosarcoma in children.http://bit.ly/2q4N0eO

CAMBRIDGE, Mass., April 25, 2017 /PRNewswire/ -- Aquinnah Pharmaceuticals, a privately held biotechnology company focused on RNA binding proteins for neurodegenerative disease, announced today that two additional pharmaceutical companies, Pfizer Inc. (NYSE:  PFE) and AbbVie Inc. (NYSE: ABBV), have invested in Aquinnah's work to treat ALS (Amyotrophic Lateral Sclerosis), Alzheimer's disease and other neurodegenerative diseases. This $10 million adds to an earlier $5 million investment made by Takeda Pharmaceuticals in December 2015.http://prn.to/2pz7gZ2

VANCOUVER, British Columbia, April 25, 2017 (GLOBE NEWSWIRE) -- Kalytera Therapeutics, Inc. (TSXV:KALY), a clinical-stage biopharmaceutical company developing next-generation cannabinoid-derived therapeutics, today announced that it has developed the multi-center location component of the plan for the proposed clinical trials to evaluate cannabidiol (“CBD”) for the prevention and treatment of Graft versus Host Disease (“GvHD”). Kalytera is developing this clinical trial plan with the intent of obtaining FDA and EMEA approval for commercialization.Kalytera expects to finalize and publish the details of its clinical trial plan during the current quarter ending June 30, 2017. The plan will include the clinical trial designs, the anticipated timelines for initiation and completion, as well as the principal endpoints. The trials are intended to build on the encouraging data seen in the recently completed Phase 2a Clinical Trial.http://bit.ly/2pgQWLB

Teleflex has launched a connected asthma management device. The AsthmaMD Peak Flow Meter is designed to help asthma patients track and measure lung performance. http://bit.ly/2p8VBwY

In the fight against disease, many weapons in the medicinal arsenal have been plundered from bacteria themselves. Using CRISPR-Cas9 gene-editing technology, researchers have now uncovered even more potential treasure hidden in silent genes.Read more at: https://phys.org/news/2017-04-crispr-bacterial-genome-hidden-pharmaceutical.html#jCp