Boiron launches homeopathic medicines in India

Boiron India, subsidiary of Boiron France, worldwide leader in homeopathy has launched pre-medicated standardised homeopathic medicines for the first time in India. The initiative will boost homeopathy standards and ensure patients have access to high quality and reliable homeopathic products.

Available globally, the pre-medicated globules in innovative packaging provides superior quality, convenience and experience compared to traditional homeopathy products. The globules are manufactured in-house with a two-week long process and a proprietary technology to ensure uniform size, layered formation and optimal porosity for retention of the dilution. A proprietary triple medication system ensures uniform absorption of the dilution to the core of the globules. This innovative global product called Boiron Tubes provides the homeopathic remedies in an innovative delivery system. Boiron Tubes provide patients with ease-of-use & guaranteed delivery of the right dose.

Prashant Surana, MD, Boiron India said, We are introducing medicated globules in the form of Multidose Tubes and Single Dosages which are made in France and offer the highest level of standardisation and convenience to the patients. Indian patients and practitioners will tend to benefit from such high-quality offerings that includes evidence-based products with reproducible results. The same product is available in US and Europe at much higher price.

Boiron`s R&D effort is focused on developing effective & standardized products by conducting clinical trials. Boiron uses patented processes and technologies that combine traditional methods with modern science so that the products comply not only with homeopathic principles but also exhibit high quality standards.

Mr Surana said, Ever since our inception, our mission has been to improve technical manufacturing conditions to ensure large scale production of reproducible and reliable homeopathic medicines. Since we control the entire production process from the source of raw material to what the patient consumes, we can ensure that the patient receives an uncontaminated product of consistent purity and quality.

Boiron, headquartered in France, is the worldwide leader in the field of homeopathy, with presence in more than 50 countries. Boiron products are used by over 30 crorepatients and prescribed by over 4 lakh health professionals across the world. Since its inception in 1932, the company has been a pioneer in advancing the frontiers of homeopathy in various areas, such as education, practice, research, innovative technologies, quality, standardisation and ease of use. Boirons manufacturing plant is approved by US FDA and EMEA that ensures products are made under Current Good Manufacturing Practice (CGMPs) for the highest standards.

https://bit.ly/2tHCHAG

AzurRx Successful Phase 2a Trial in Exocrine Pancreatic Insufficiency

AzurRx BioPharma, Inc. (NASDAQ:AZRX) (AzurRx or the Company), a company specializing in the development of non-systemic, recombinant therapies for gastrointestinal diseases, today announced, in partnership with Mayoly Spindler, a European pharmaceutical company, the completion of its Phase IIa trial of MS1819-SD, a recombinant lipase, for the treatment of exocrine pancreatic insufficiency (EPI) caused by chronic pancreatitis. AzurRx expects to formally report the Phase IIa data in the Fall of 2018.

The primary objective of the open-label, multi-center, dose escalation Phase IIa study is to investigate the safety of escalating doses of MS1819-SD in patients with chronic pancreatitis. The secondary objective is to investigate the efficacy of MS1819-SD in these patients by analysis of the CFA (coefficient of fat absorption) and its change from baseline.

Initial data from the Phase IIa study shows a very strong safety and efficacy profile. Both clinical activity and a clear dose response have been observed, with the highest MS1819-SD dose cohort continuing to show greater than 21% improvement in CFA in evaluable patients. Additionally, maximal absolute CFA response to treatment was up to 57%, with an inverse relationship to baseline CFA. Favorable trends were also observed on other evaluated endpoints, including Bristol stool scale, number of daily evacuations and weight of stool, and these were consistent with the CFA results.

The Company enrolled 11 of a planned 12 chronic pancreatitis patients over the course of the Phase IIa trial. Due to a sufficient efficacy and safety signal from the enrolled patients, AzurRx will now focus on the treatment of EPI in the cystic fibrosis setting with a planned Phase II trial in patients with cystic fibrosis scheduled to begin in the second half of 2018.

We are very pleased that the MS1819-SD Phase IIa study has been completed and that results to date show that MS1819-SD succeeded in its safety and efficacy objectives, commented Thijs Spoor, CEO of AzurRx. With our recent capital raise and the addition of a clinical trial operations team with extensive experience in late stage cystic fibrosis clinical studies, we are very optimistic about the next phase of MS1819s clinical development as a new therapy for patients suffering from cystic fibrosis.

The results obtained in all dosed patients are very encouraging and confirm the safety and efficacy of MS1819-SD, stated Dr. James Pennington, the Chief Medical Officer of AzurRx. Based on these data, we believe we have the basis for initiating a Phase IIb trial of MS1819 in cystic fibrosis patients in the fall of 2018.

https://bit.ly/2yXDoet

Dr Reddy Laboratories: FDA clears 2 plants

Pharma major Dr Reddys Laboratories Ltd has received Establishment Inspection Reports (EIRs) from the US Food and Drug Administration (USFDA) for two of its plants.

According to an intimation by the Hyderabad-based company, its Active Pharmaceutical Ingredients (API) plant 3 at Bollarum in Medak district of Telangana and API Hyderabad Plant I at Jinnram Mandal, also in Medak district, have received EIRs from the US Regulator.

https://bit.ly/2Nda6eP

Valneva new Lyme vaccine in early trials

Scientists are stepping up efforts in the battle against Lyme disease. A new Lyme vaccine is undergoing its first phase of trials, which involves three stages of approval before the vaccine can be sold to the public. There is currently no clinically approved Lyme disease vaccine for humans available on the market.

The Lyme vaccine works by stimulating the human immune system to produce antibodies that attack the disease-causing bacteria inside the tick, preventing it from entering its host. Lyme disease is a debilitating, inflammatory disease, that can make people develop a rash, and feel fatigued, and later, suffer from neurological and cardiac disorders.

Valneva, the French drug manufacturer developing the vaccine, announced in early June that its first human trial of the vaccine is proving to be up to 96 percent effective with no significant side effects. The U.S. Food and Drug Administration granted the companys vaccine, known as VLA15, a fast track designation in July of 2017.

Its exciting news, Dr. Peter Krause, of the Yale School of Medicine and Public Health, told The Block Island Times in a phone interview. Krause has been researching the effects of Lyme disease and babesiosis on Block Island since the early 90s. This vaccine could be very helpful for people living in Lyme areas like Block Island.

Krause said that due to the lengthy process of approving drugs like this one, it could take a few years before its available for sale on the market. Valneva is reporting that the vaccine would be sold at an affordable price, although the cost of the drug is not yet known.

Krause said the stages involved with clinical trials focus on safety and how the drug works. During the first stage the drug is tested on about 100 people; the second stage involves about 1,000 people; and the third and final stage incorporates a large sample of people.

Krause told The Times that he was involved with clinical trials for the first Lyme disease vaccine that was introduced by Smith Kline Beecham called LYMErix. Those trials, he said, were carried out in a few different locales, including on Block Island around 1991 or 1992. People on Block Island helped develop that vaccine, said Krause. Some participants received the vaccine, while others got a placebo.

Krause said that while the LYMErix vaccine was effective, the manufacturer pulled it off the market because it did not have government support, and the market was limited to certain locales. He said the vaccine also required multiple doses and a booster shot.

They found it did work, said Krause. (Valneva) is using the same idea with its drug (VLA15). Theyve taken the same protein (lipoprotein OspA) and increased it with the addition of six different sub-types. Krause said LYMErix could have been made more effective if the company continued manufacturing the drug. The original vaccine was an effective vaccine, but for financial reasons the company couldnt justify continuing with it.

Krause noted that his research of late has been focused more on babesiosis than Lyme disease, and looking at whats happened on Block Island over a period of time. He is planning on visiting the island in the fall to discuss his research, and speak with people about vector-borne disease. I havent done that in a number of years.

Krause, and Columbia University Professor Dr. Maria Diuk-Wasser, have been conducting a joint research effort on Block Island, including the annual free Lyme testing at the Block Island Medical Center. Dr. Diuk-Wasser has been piloting field research on the island for the past six years, and identified that the Lone Star Tick was now also inhabiting the island.

The researchers held free Lyme disease and babesiosis testing at the Block Island Medical Center on Memorial Day. Krause said that 100 people participated in the testing, and blood samples will be tested at the Yale University lab. He said that anyone who participated in the testing can contact him at: (203) 785-3223.

Diuk-Wasser is seeking participants for her Block Island field research via the Tick App (thetickapp.org). In July, we will visit houses to conduct tick collections and a quick one-time survey as well. People can sign up for a house visit by completing a form on our website and going to the Block Island tab, she said. At the end of the season well conduct another Lyme disease testing to match peoples activity patterns with their infection status.

We are interested in understanding better which behaviors affect exposure to ticks and how that determines human infection, said Diuk-Wasser. And this also has to do with peoples knowledge and perceptions about the disease ticks can transmit. Thus, its our intention to match the data from the Lyme disease testing and tick data with peoples knowledge, preventing practices and activities that might increase or decrease their risk.

https://bit.ly/2IDW3LS

Sensorion Shows Protective Effect of Product in Hearing Loss Models

Sensorion (FR0012596468 ALSEN), a biotech company specializing in the treatment of inner ear diseases, presented data showing that its clinical stage product-candidate SENS-401 demonstrated protective effects in two preclinical models of hearing loss. Data from these studies were presented at the 15th International Conference on Cochlear Implants and Other Implantable Auditory Technologies(Ci2018), at the Flanders Meeting & Convention Center in Antwerp, Belgium, which took place from June 27th to 30th, 2018.

Data from the presented studies showed that SENS-401 protected inner ear function and enhanced sensory hair cell survival in preclinical models of acoustic trauma and, separately, cisplatin infusion. These data support the potential of SENS-401 as a therapeutic agent that may preserve residual hearing for patients undergoing cochlear implant surgery, an application which is being explored in Sensorions partnership with Cochlear Ltd, the world leader in cochlear implant technology.

Nawal Ouzren, Sensorions chief executive officer, said: Sensorion is pleased to have had the opportunity to present its findings at Ci2018 to leaders in the field. We are currently collaborating with Cochlear Ltd., the largest global developer of cochlear implants, and the Phase 1 clinical and preclinical data on SENS-401 presented at this conference continue to validate the rationale behind our collaboration. We are eager to conduct this project to hopefully enable much greater patient access to cochlear implants.

SENS-401 is a clinical-stage drug candidate that completed Phase 1 testing in healthy volunteers, demonstrating satisfactory safety and tolerability as well as a favorable pharmacokinetic (PK) profile. The product is expected to enter Phase 2 clinical proof of concept studies in the coming weeks.

Title of the oral presentation: Potential for Pharmacological Protection Against Loss of Residual Hearing After Cochlear Implant Surgery Using the Clinical-Stage Oral Otoprotectant SENS-401

In the preclinical studies, Sensorion used two hearing loss models, acoustic trauma noise-induced hearing loss (NIHL) and cisplatin-induced hearing loss (CIHL), to assess hearing loss and outer hair cell survival in animals treated with SENS-401. Results from both models showed that SENS-401 not only demonstrated strong perilymph and inner ear tissue penetration of 25-30% and 35-50% of plasma levels, respectively, but SENS-401 also significantly reduced hearing loss and enhanced outer hair cell survival in animals exposed to acoustic trauma or cisplatin infusion. Efficacy was measured in terms of both otoacoustic emissions (DPOAE) and auditory evoked potentials auditory (ABR). These data in combination with positive Phase 1 safety and PK profile of SENS-401 support the potential of SENS-401 as a hearing loss treatment.

https://bit.ly/2lKeTaT

Broad, Bayer Expand Heart Failure Therapy Research Partnership

The Broad Institute of MIT and Harvard and Bayer are launching the Precision Cardiology Laboratory, a new endeavor that will pursue scientific insights aimed at developing new therapies for heart failure.

According to the American Heart Association, more than 900,000 people are diagnosed with heart failure every year in the United States. The condition, which results from the failure of the heart to pump enough blood, is one of the most common reasons for hospitalization among adults. There are many causes of heart failure, and the Precision Cardiology Laboratory (PCL) will use new tools and methods to more fully understand and treat them.

Research in the new PCL will bring scientists from both organizations into an integrated work space at the Broad Institute, effectively combining Broad’s innovative methods for basic scientific discovery and the clinical expertise of its practicing physician/researchers with Bayer’s long history of drug development. The effort will be led by Broad Associate Member Patrick Ellinor, who directs the Cardiac Arrhythmia Service at Massachusetts General Hospital and is a professor of medicine at Harvard Medical School.

The PCL’s initial goal is to develop high-resolution, single-cell maps of cardiovascular tissues in human and animal models. Using tissue samples donated by healthy individuals as well as people suffering from cardiovascular disease, researchers will build datasets to accelerate insights into heart failure.

“Such high-resolution maps of cells and tissues will be a profound asset for understanding heart failure and for developing new and better drugs,” said Ellinor. “I am extremely excited by the potential of this expanded partnership to benefit patients.”

The Broad-Bayer partnership began in 2013 with an oncology program. In 2015, the organizations launched a cardiovascular-specific collaboration aimed at using genomics to better understand cardiovascular disease. Now, the PCL will use non-genomic approaches to jumpstart the development of new therapeutics for heart failure.

Through this expanded partnership, Bayer is dedicating an additional $22 million to the collaboration over the next five years.

https://bit.ly/2Nf4xMH

Why you think things are getting worse when they are actually getting better

If it seems the state of the world is on an endless downward trajectory these days, take heart. Things might not be quite as bad as you think. New research, published on June 29 in Science, suggests that as social problems such as extreme poverty or violence become less prevalent, people may be prone to perceive that they linger—and are perhaps even getting worse.

Led by psychologist Daniel Gilbert at Harvard University, the researchers found people readily and unconsciously change how they define certain concepts—ranging from specific colors to unethical behavior—based on how frequently they run into them. “On almost every dimension, the world is getting better. And yet when people are asked, they consistently say it’s not getting better, and in fact it’s getting worse,” Gilbert says. “As we solve problems, we also unknowingly expand our definitions of what counts as them.”

Concept expansion itself is not a new observation. In 2016 social psychologist Nicholas Haslam at the University of Melbourne in Australia introduced the term “concept creep” to describe the broadening of modern psychological terminology—especially negative examples such as abuse, bullying, trauma, mental disorder, addiction and prejudice—to include cases previously judged benign or inoffensive.

In some cases, the expansion of concepts such as aggression (and more recently, “microaggressions”) in the public consciousness has sparked heated debate; some critics argue these shifts reflect political correctness run amok whereas others claim they signal growing social awareness. Gilbert is emphatically agnostic on the issue. “Expanding a concept isn’t necessarily good or bad,” he says. “Science doesn’t weigh in on whether it’s a good or bad thing.” He and others are simply interested in understanding how the phenomenon happens.

A number of factors likely contribute to these changes, among them political, social or economic forces. But the latest study highlights another intriguing player. “This is the first time someone has actually said there’s a cognitive mechanism that could account for that,” Haslam says.

In one of their experiments Gilbert’s team showed volunteers a series of 1,000 dots, ranging in color between very purple and very blue. Participants had to judge whether each dot was blue or not. Partway through the test, researchers began showing fewer blue dots (and more purple or purplish dots) to some participants. By the end of the experiment, these study participants were more likely to say “blue” to hues in the middle of the spectrum, including some dots they had previously seen and judged “not blue.”

The change was involuntary—it even occurred when volunteers were warned the frequency of blue dots would decrease. Instructing participants to maintain consistent responses did not eliminate the shift, nor did offering monetary bonuses for the most consistent performers. The effect worked both ways: Reversing the experiment and increasing the frequency of blue dots made participants less likely to call dots in the middle of the color range blue (in other words, their concept of “blue” had contracted).

Next, the researchers moved on to more complex concepts. They showed participants a series of computer-generated faces that had been independently rated on a continuum from very nonthreatening to very threatening. Those in the study had to assess whether a given face was a threat or not. Mid-experiment, researchers began showing fewer threatening faces to some participants. By the end of the session, these people had grown more likely to judge relatively innocuous faces as threats.

Finally, Gilbert’s team prepared hundreds of mock research proposals, which were designed—and verified by independent raters—to range from ethical to ambiguous to unethical. (An example unethical proposal: “Participants will be asked to lick a frozen piece of human fecal matter. Afterwards, they will be given mouthwash. The amount of mouthwash used will be measured.”) Volunteers in Gilbert’s study were asked to play the role of an institutional review board, which oversees the ethics of university research projects. They had to either approve or reject a series of these proposals. Once again, when researchers began showing fewer “unethical” proposals to some of the participants, they shifted to rejecting more “ambiguous” proposals than they did earlier in experiment. “It’s a very creative, provocative study,” says Scott Lilienfeld, professor of psychology at Emory University. He notes the study’s strength lies in showing the same effect across a range of situations—from simple perceptual problems to ethical judgments. “The challenge will be to see the extent to which it generalizes outside the lab to the real world,” says Lilienfeld, who did not take part in the work

Going forward, Gilbert’s team is working on computational models that might point to the thought processes that lead people to change their concepts based on how often they come upon instances of them. For those looking to glean practical lessons from their initial results, Gilbert says, “We’re prone to never see the end of a problem. Before we try to solve it, we should try to say what would count as having solved it.” But even he acknowledges that for some complex, real-world issues, these measures will be extremely hard to define.

https://bit.ly/2MveIMb