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ORGANIC SPECTROSCOPY

Read all about Organic Spectroscopy on ORGANIC SPECTROSCOPY INTERNATIONAL 

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DR ANTHONY MELVIN CRASTO Ph.D

DR ANTHONY MELVIN CRASTO Ph.D

DR ANTHONY MELVIN CRASTO, Born in Mumbai in 1964 and graduated from Mumbai University, Completed his Ph.D from ICT, 1991,Matunga, Mumbai, India, in Organic Chemistry, The thesis topic was Synthesis of Novel Pyrethroid Analogues, Currently he is working with GLENMARK PHARMACEUTICALS LTD, Research Centre as Principal Scientist, Process Research (bulk actives) at Mahape, Navi Mumbai, India. Total Industry exp 29 plus yrs, Prior to joining Glenmark, he has worked with major multinationals like Hoechst Marion Roussel, now Sanofi, Searle India Ltd, now RPG lifesciences, etc. He has worked with notable scientists like Dr K Nagarajan, Dr Ralph Stapel, Prof S Seshadri etc, He did custom synthesis for major multinationals in his career like BASF, Novartis, Sanofi, etc., He has worked in Discovery, Natural products, Bulk drugs, Generics, Intermediates, Fine chemicals, Neutraceuticals, GMP, Scaleups, etc, he is now helping millions, has 9 million plus hits on Google on all Organic chemistry websites. His friends call him worlddrugtracker. His New Drug Approvals, Green Chemistry International, All about drugs, Eurekamoments, Organic spectroscopy international, etc in organic chemistry are some most read blogs He has hands on experience in initiation and developing novel routes for drug molecules and implementation them on commercial scale over a 29 year tenure till date Aug 2016, Around 30 plus products in his career. He has good knowledge of IPM, GMP, Regulatory aspects, he has several International patents published worldwide . He has good proficiency in Technology transfer, Spectroscopy, Stereochemistry, Synthesis, Polymorphism etc., He suffered a paralytic stroke/ Acute Transverse mylitis in Dec 2007 and is 90 %Paralysed, He is bound to a wheelchair, this seems to have injected feul in him to help chemists all around the world, he is more active than before and is pushing boundaries, He has 9 million plus hits on Google, 2.5 lakh plus connections on all networking sites, 25 Lakh plus views on dozen plus blogs, He makes himself available to all, contact him on +91 9323115463, email amcrasto@gmail.com, Twitter, @amcrasto , He lives and will die for his family, 90% paralysis cannot kill his soul., Notably he has 13 lakh plus views on New Drug Approvals Blog in 212 countries......https://newdrugapprovals.wordpress.com/ , He appreciates the help he gets from one and all, Friends, Family, Glenmark, Readers, Wellwishers, Doctors, Drug authorities, His Contacts, Physiotherapist, etc

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FDA Approves First Device to Prevent Migraines


TUESDAY March 11, 2014, 2014 — The U.S. Food and Drug Administration on Tuesday approved the first device aimed at preventing migraines.

The device, called Cefaly, is a headband-like device that runs on a battery and sits across the forehead and over the ears, the FDA said in a statement.

“The user positions the device in the center of the forehead, just above the eyes, using a self-adhesive electrode,” the agency explained. “The device applies an electric current to the skin and underlying body tissues to stimulate branches of the trigeminal nerve, which has been associated with migraine headaches.”

Cefaly is made by Belgium-based Cefaly Technology and is available by prescription only. The device is only indicated for use by adults and should only be used for 20 minutes per day, the FDA said. The agency also noted that “the user may feel a tingling or massaging sensation where the electrode is applied.”

http://www.drugs.com/news/fda-approves-first-device-prevent-migraines-50727.html?utm_source=ddc&utm_medium=email&utm_campaign=Today%27s+news+summary+-+March+13%2C+2014

CEFALY DRUG-FREE MIGRAINE PAIN RELIEF

Cefaly is a drug free migraine pain reliever and migraine prevention solution. Cefaly is now available in Canada and a safe solution for all people suffering from migraine headaches - cefaly.ca
Millions of Cefaly treatments studied have proven that it is an effective, drug free, migraine pain reliever – Join the tens of thousands of people around the world who have tried Cefaly and are free of migraine pain and pain relieving medication.
Cefaly is a drug-free method for treating migraine pain and preventing migraine headaches from ever coming on. Cefaly treats migraine pain with neurostimulation. A stimulus that limits pain signals from the nerve centre by working on the trigeminal nerve where migraine headaches start. The patented Cefaly treatment changes the trigger threshold of migraine headaches. As the pain threshold becomes harder to reach, migraine headaches are less frequent, less painful, and simply disappear.

Cefaly offers patients suffering from migraine pain and headaches an efficient electrotherapeutical system delivered via an extremely comfortable, ergonomic and simple-to-use medical device.

WHAT IS CEFALY
Cefaly is a CE and ISO certified medical device designed to treat and prevent migraine headaches. Cefaly can considerably reduce or replace the consumption of side effect producing medications. Cefaly is the first cranial analgesic electrotherapeutic device to acquire ISO medical certification proven effective on migraine pain with no side effects.
Cefaly’s patented design uses TENS technology which has been researched in medical circles for over 40 years. TENS technology is known for its safety and dramatic absence of side effects, making Cefaly unique to all other headache and migraine pain treatments.
Cefaly is designed and developed in accordance with the strictest quality standards eliminating all possible short-term and long-term dangers.
Cefaly is an innovative, lightweight and extremely cost effective pain relieving solution. Its self adhesive electrode is placed directly on to the forehead. Worn conveniently like a pair of eyeglasses, Cefaly connects to the electrode and begins its subtle treatment.
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Roche wins FDA approval for novel diabetes Dx


Roche’s next-generation diabetes diagnostic works on the Cobas Integra 800 analyzer. –Courtesy of Roche

Read more: Roche wins FDA approval for novel diabetes Dx – FierceMedicalDevices

Links

http://www.fiercemedicaldevices.com/story/roche-wins-fda-approval-novel-diabetes-dx/2013-05-24#ixzz2USeoTa9T

NOVARTIS TOBI Podhaler receives FDA approval for cystic fibrosis patients with Pseudomonas aeruginosa


Tobramycin

MAR 22.2013, FDA approves TOBI Podhaler to treat a type of bacterial lung infection in cystic fibrosispatients

The U.S. Food and Drug Administration today approved TOBI Podhaler (tobramycininhalation powder) for the management of cystic fibrosis patients with Pseudomonas aeruginosa, a bacterium that causes lung infections.

Cystic fibrosis is a genetic disease that affects about 30,000 pediatric and adult patients in the United States. Cystic fibrosis causes the body to produce thick, sticky mucus that builds up in the lungs and blocks airways. The buildup of mucus makes it easy for bacteria like P. aeruginosa to grow and cause a chronic lung infection that, over time, can severely damage the lungs. Many patients with cystic fibrosis are treated with antibiotics using a nebulizer machine.

Tobramycin is an aminoglycoside antibiotic derived from Streptomyces tenebrarius and used to treat various types of bacteria infections, particularly Gram-negative infections. It is especially effective against species of Pseudomonas.

TOBI Podhaler, a plastic, handheld inhaler device, contains a dry powder formulation of tobramycin, an antibiotic used to treat P. aeruginosa infection. The powder is inhaled twice daily using the Podhaler device for 28 days. Patients should then stop TOBI Podhaler therapy for 28 days before resuming again.

“Today’s approval broadens the available delivery mechanism options for patients withcystic fibrosis who require treatment for P. aeruginosa,” said Edward Cox, M.D., M.P.H, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research. “This product is the first dry powder antibacterial drug delivered with a handheld dry powder inhaler.”

Vital 5 Receives Clearance from the FDA for a First-To-Market, Dual Function Catheter System that Provides Simultaneous Anesthetic Infusion and Wound Drainage, ReLeaf™


VentureMD

Mar 6, 2013 ,

Vital 5, LLC, a VentureMD portfolio company, announces that it has received clearance from the U. S. Food and Drug Administration (FDA) for ReLeaf™, a first-to-market, dual function catheter system that provides simultaneous anesthetic infusion and wound drainage.

Continuous anesthetic infusion to the surgical site in the immediate post-operative period has been clinically proven to provide significant improvements to pain management, but this therapy is currently not compatible with the millions of surgical cases where a wound drain is prescribed. By offering an integrated system that provides effective continuous local anesthetic infusion while also providing an effective wound drain function, the Vital 5 ReLeaf will greatly expand the number of patients who can benefit from local anesthetic infusion therapy.

The clinical applications for the Vital 5 ReLeaf include any invasive surgical procedure, including spine, orthopedic, cardiothoracic, plastic, general, obstetrics and gynecological procedures.

About Vital 5, LLC

Vital 5 is an early stage medical device company focused on developing advanced catheter technologies to meet the increasing demand for improved post-operative pain management.

About VentureMD

VentureMD (venturemd.com) is an angel capital firm and medical device incubator focused on musculoskeletal products. The company provides financial, human and intellectual capital to start-up medical device companies. Focused on the orthopedic, spine, endoscopy and dental markets, the company partners with entrepreneurs, inventors, technology transfer offices and seed stage start-ups to launch and manage new medical device companies.

Phase III Study of Teva’s Milprosa (Progesterone) Vaginal Ring Published in Fertility and Sterility


Progesterone

Data Demonstrated Once-Weekly Milprosa™ Provides Similar Pregnancy Rates to Daily 8 Percent Progesterone Vaginal Gel

Mar 4, 2013 –

Teva Pharmaceutical Industries Ltd.  today announced the publication of results of the Phase III clinical trial of Milprosa™ (progesterone) vaginal ring in Fertility and Sterility. The study compared the efficacy and safety of once-weekly Milprosa™ to daily 8 percent progesterone vaginal gel for luteal phase support in in vitro fertilization (IVF) and found that clinical pregnancy rates per retrieval at eight and 12 weeks were comparable between patient groups. Adverse event (AE) profiles were similar between the two treatment groups and consistent with known AEs associated with progesterone.

“The study results demonstrate that Milprosa™ may be an effective and safe option for progesterone supplementation during the luteal phase among women undergoing IVF,” said Laurel Stadtmauer, M.D., Ph.D., professor of Obstetrics and Gynecology at Jones Institute for Reproductive Medicine at Eastern Virginia Medical School and study author. “Since normal luteal function may be compromised among women undergoing IVF, progesterone supplementation is essential and the more options patients have, the better. If approved, the once-weekly dosing of Milprosa™ may offer convenience for patients.”

The Phase III randomized, single-blinded, multicenter, noninferiority study was conducted at 22 clinical sites in the U.S. and included 1,297 patients between the ages of 18 and 42. Of enrolled patients, 646 were randomized to Milprosa™ and 651 to the 8 percent progesterone vaginal gel.

“The Fertility and Sterility publication of the Milprosa™ Phase III data is a significant milestone for Teva, especially because fertility is a meaningful new area of specialization for the company and one in which significant unmet need exists,” said Jill DeSimone, senior vice president & general manager, Global Teva Women’s Health. “We look forward to continuing to share important updates about Milprosa™ and demonstrating our investment in and commitment to women’s health.”

About the Study

The Phase III study randomized patients into two treatment groups: one group received once-weekly Milprosa™ and the other received daily 8 percent progesterone vaginal gel. Milprosa™ and the vaginal gel were initiated on the day following egg retrieval and continued through 12 weeks’ gestation. Efficacy was evaluated by comparing clinical pregnancy rates of patients at eight and 12 weeks gestation.

  • At week eight, clinical pregnancy rates per retrieval were 48.0 percent for the Milprosa™ group and 47.2 percent for the vaginal gel group (between-group difference, 0.8%; 95% CI, -4.6%, 6.3%).
  • At week 12, clinical pregnancy rates per retrieval for Milprosa™ and the vaginal gel were 46.4 percent and 45.2 percent respectively (between-group difference, 1.3%; 95% CI, -4.1%, 6.7%).

A secondary efficacy endpoint was the rate of live birth.

  • The overall live birth rate per retrieval for women using Milprosa™ was 45.2 percent; among women using the vaginal gel, the rate was 43.3 percent.
  • The majority of patients pregnant at week 12, when progesterone treatment ended, went on to have a live birth: 97.4 percent for the Milprosa™ group and 96.5 percent for the vaginal gel group.

The most commonly reported adverse events (those greater than or equal to 10% in the Milprosa™ treatment group) were nausea, headache, abdominal pain, post-procedural discomfort, abdominal distension, back pain, fatigue, vomiting and constipation. Serious adverse events (SAEs) occurred in approximately 12 percent of all patients, with no significant difference in the rate between treatment groups. The majority of SAEs that occurred were mild to moderate in severity and not related to treatment. Rates of discontinuation of treatment due to AEs were low and similar between both groups (approximately 6%).

About Milprosa™ (Progesterone) Vaginal Ring

Milprosa™ is an investigational, once-weekly progesterone ring inserted in the vagina. It is flexible and designed to continuously release a steady dose of micronized progesterone. Milprosa™ is in development to support embryo transplantation and early pregnancy (up to 10 weeks post-embryo transfer) by supplementation of corpus luteal function as part of an Assisted Reproductive Technology (ART) treatment program for infertile women.

About Supplementation of Corpus Luteal Function

The corpus luteum is a temporary endocrine gland that develops during the luteal phase of a woman’s menstrual cycle. It is an important contributor of progesterone and is critical for the maintenance of early pregnancy. During in vitro fertilization, progesterone supplementation is needed because natural levels of the hormone may be insufficient. This supplementation improves implantation rates and thus pregnancy rates. Additionally, progesterone supplementation supports early pregnancy.

About Teva

Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) is a leading global pharmaceutical company, committed to increasing access to high-quality healthcare by developing, producing and marketing affordable generic drugs as well as innovative and specialty pharmaceuticals and active pharmaceutical ingredients. Headquartered in Israel, Teva is the world’s leading generic drug maker, with a global product portfolio of more than 1,000 molecules and a direct presence in about 60 countries. Teva’s branded businesses focus on CNS, oncology, pain, respiratory and women’s health therapeutic areas as well as biologics. Teva currently employs approximately 46,000 people around the world and reached $20.3 billion in net revenues in 2012.

FDA Approves Natrelle 410 Breast Implant


Silicone gel-filled breast implants Image/FDA

Silicone gel-filled breast implants
Image/FDA

Feb. 20, 2013

The U.S. Food and Drug Administration (FDA) approved Allergan’s  new silicone gel-filled breast implant today, making it the fourth FDA-approved silicone gel-filled breast implant product available in the U.S, according to an FDA news release Feb. 20.

Silicone gel-filled breast implants Image/FDA

The product, the Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Gel Filled Breast Implant, can be used increase breast size (augmentation) in women at least 22 years old and to rebuild breast tissue (reconstruction) in women of any age.

According to the FDA, the approval is based on seven years of data from 941 women. Most complications and outcomes reflect those found in previous breast implant studies including tightening of the area around the implant (capsular contracture), re-operation, implant removal, an uneven appearance (asymmetry), and infection.

It’s important to remember that breast implants are not lifetime devices. Women should fully understand the risks associated with breast implants before considering augmentation or reconstruction surgery, and they should recognize that long-term monitoring is essential,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health.

“The data we reviewed showed a reasonable assurance of safety and effectiveness,” said Shuren.

The FDA requires that Allergan conduct a series of post-approval studies to assess long-term safety and effectiveness outcomes and the risks of rare disease.

FDA approves first retinal implant for adults with rare genetic eye disease


2sight_argus_iiArgus II (credit: Second Sight)
Argus II Retinal Prosthesis System
February 14, 2013
FDA approves first retinal implant for adults with rare genetic eye diseaseThe U.S. Food and Drug Administration today approved the Argus II Retinal Prosthesis System, the first implanted device to treat adult patients with advanced retinitis pigmentosa (RP). The device, which includes a small video camera, transmitter mounted on a pair of eyeglasses, video processing unit (VPU) and an implanted retinal prosthesis (artificial retina), replaces the function of degenerated cells in the retina (a membrane inside the eye) and may improve a patient’s ability to perceive images and movement. The VPU transforms images from the video camera into electronic data that is wirelessly transmitted to the retinal prosthesis.RP is a rare genetic eye condition that damages the light-sensitive cells that line the retina. In a healthy eye, these cells change light rays into electrical impulses and send them through the optic nerve to the area of the brain that assembles the impulses into an image. In people with RP, the light-sensitive cells slowly degenerate resulting in gradual loss of side vision and night vision, and later of central vision. The condition can lead to blindness.The retina lines the back of the eye’s inner surface and records images in patterns of light and color. The Argus II implant actually relies on a mini camera mounted on a pair of sunglasses to capture an image and send the information to a video processor, worn on the belt along with a wireless microprocessor and battery pack. After the video processor converts the images to an electronic signal, a transmitter on the glasses sends that information wirelessly to the receiver implanted under the eyeball’s clear mucus membrane, called the conjunctiva.  The receiver in turn conveys the signals through a tiny cable to an electrode array placed on the retina. The array directly stimulates the cells that lead to the optic nerve.On receiving the pulses, the brain perceives patterns of light and dark spots corresponding to the electrodes stimulated. Patients learn to interpret the visual patterns produced into meaningful images.

Second Sight Medical Products, Inc., is the manufacturer and is already approved in Europe

Argus II components (credit: FDA)

The Argus II design consists of an external video camera system matched to the implanted retinal stimulator, which contains a microelectrode array that spans 20 degrees of visual field.

An external camera system, built into a pair of glasses, streams video to a belt-worn computer, which converts the video into stimulus commands for the implant.

The belt-worn video processing unit (computer) encodes the commands into a wireless signal that is transmitted to the implant, which has the necessary electronics to receive and decode both wireless power and data.

Artificial retina device, consisting of a glasses-mounted camera and a microchip surgically implanted on the retina

Based on those data, the implant stimulates the retina with small electrical pulses. The electronics are hermetically packaged and the electrical stimulus is delivered to the retina via a microelectrode array.

Medical Device Using Evonik’s VESTAKEEP® PEEK Receives First FDA Spinal 510(K) Approval


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