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Government Plans New Pharma Policy That May Bring Down Prices
New Delhi: The Centre plans to bring a new pharmaceutical pricing policy, a move expected to cut prices of medicines and various other pharmaceutical products in the country. Sources said the policy is expected to be stricter and in line with PM Narendra Modi's directive of making drugs affordable for the poor. The policy is also likely to bring more products under its purview. The Centre's think tank, the Niti Aayog, and the department of pharmaceuticals (DoP) have already started deliberations in this direction. The policy will replace the existing National Pharmaceutical Pricing Policy, 2012 - which forms the core of the Drugs Price Control Order, 2013 and hence drives prices of all essential medicines as well as many other pharmaceutical products including stents and medical devices. While the DoP has already started consultation with various stakeholders including pharmaceutical companies and civil society organisations, the Aayog held the first inter-ministerial meeting on the issue on Monday. Representatives from regulatory bodies such as the Drugs Controller General of India and chairman of the National Pharmaceutical Pricing Authority were also present. Apart from revamping the existing policy , the Centre is also moving to introduce changes to the Drug Price Control Order, 2013. According to officials present in the meeting, the DoP suggested balancing the new policy by taking care of the interest of the industry as well as consumers. However, officials and regulators also highlighted existing price anomalies. While the current policy is also up for review next year after completion of five years, the new one may change the pricing regime. Meanwhile, civil society organisations have raised objections to the deliberations since a case is pending in the Supreme Court contesting the market-based mechanism adopted by the policy to fix drug prices.
Source:- The Times of India

 


 
Centre plans E-Portal to Track Sale of Medicines
Mumbai: In order to ensure that drugs meet quality standards, the union health ministry could create a digital platform to track and regulate their sale in the country. A notice posted on the ministry's website announced that the move is aimed to make the entire trade channel, from manufacturers to wholesalers/retailers to the patients, including e-pharmacies, more transparent. This "track and trace" mechanism could also curb anti-microbial resistance (AMR) and regulate supply of medicines through the internet to persons in and outside India. Currently, bar-coding on medicine packs are done only for exports whereas the drugs sold in the domestic market are not subjected to quality checks. A recent survey had revealed that around 3% of the drugs sold in India are substandard. According to the notice, all drug manufacturers would be required to register themselves with the portal, and enter data relating to sale with details of batch number, quantity supplied and expiry date. All stockists/wholesalers will also be required to register and enter details of stocks received and supplied by them to further distributors or retailers. The data could be entered online or through mobile phones and pharmacies located in remote areas will have the option to upload the data once every fortnight. The notice further adds that medicines will be dispensed only against a prescription of a registered medical practitioner, with the doctor's registration number (MCI/ state medical council). The government is expected to finalise the guidelines under the Drugs and Cosmetics Act, 1940 by April 15. "The move is a good initiative to drive better compliance, transparency and adherence to drug guidelines. As regards the implication of cost for companies, we are awaiting the details of the proposed guidelines," A Vaidheesh, MD GlaxoSmithKline Pharmaceuticals & VP South Asia.
Source: The Times of India

 


 
CDSCO Finds 60 Common Drugs Substandard
New Delhi: Government drug regulators have detected quality-related problems in specific batches of a popular painkiller, several antibiotics and an anti-allergy medication among 60 drugs that failed quality tests in the latest cycle of sample-based screening. The latest monthly safety bulletin from the Central Drugs Standard Control Organisation (CDSCO), the national drug regulatory agency, lists 60 drugs declared as "not of standard quality, spurious, adulterated, or misbranded" based on tests on specific production batches. The problem drugs include Combiflam, which combines paracetamol and ibuprofen and is prescribed for relief of pain and fever; D-Cold, a remedy for relief from colds; the anti-allergy medication cetirizine, and specific batches of the antibiotics ciprofloxacin, ofloxacin and capsules combining amoxicillin and clavulanic acid. The quality issues differ from drug to drug. An injection of gentamycin was found to contain particulate matter. Both the batches of Combiflam and D-Cold tablets failed because of "disintegration" while the ofloxacin samples, among other antibiotics, failed in "assay" or quantitative tests for their ingredients. The 60 failed drug samples in the CDSCO's March 2017 safety bulletin is the highest number of drugs declared substandard in a single month's tests over the past year. The number of drugs labelled substandard ranged from 13 in July 2016 to 29 in November 2016. The CDSCO has been releasing monthly safety bulletins based on screening tests of batches of drugs since November 2012. Nationwide screening of drugs has in the past indicated that six to seven per cent of drugs from various batches fail quality tests. Pharmacologists say the quality failure could have any one or more of multiple sources, including poor manufacturing processes, poor transportation or storage and handling along the distribution chain.
Source:- The Tele Graph

 


 
Lens on Companies Tweaking Drugs to Beat Price Cap
New Delhi: Major drug makers including Lupin, Wockhardt and Abbott have come under the scanner of the drug price regulator for allegedly tweaking essential medicine formulations to circumvent price control and overcharge consumers. The National Pharmaceutical Pricing Authority (NPPA) has issued a bulk show-cause notice in over 200 such cases alleging these medicines were launched without prior price approval. In an office memorandum, the regulator said these companies altered essential medicines, prices of which are capped by the government, by either changing the strength or dosage or by combining the drug with another which is outside price control to circumvent price control. Besides, these companies had not even applied for price approval for the new products, the regulator said. Queries through phone and email to Lupin, Abbott and Wockhardt did not elicit any response. Industry executives said that since no price was approved by the regulator in these cases, the companies will have to pay back the whole amount of sales minus taxes, an official explained. NPPA caps prices of all essential medicines or scheduled drugs and companies are required to seek its permission for price revision. Other companies on the NPPA list for non-compliance include Biocon, Zydus Cadila, Unichem Laboratories, Sanofi India, Ranbaxy Laboratories, Reliance Formulation, Novartis India, Morepan Laboratories, Ozone Pharmaceuticals, GlaxoSmithkline Pharmaceuticals, etc. The pharmaceutical pricing regulator has asked the companies to explain non-compliance by June 15 and give details of production and sales along with maximum retail price of the concerned products duly certified by chartered or cost accountant.
Source: The Times of India

 


 
NPPA to Look Into Diabetes Drug Price-Fixing Allegations
Mumbai: India’s drug regulator will look into allegations that four leading pharmaceutical companies are colluding to set the price of anti-diabetic drug Vildagliptin, a move that may rattle the almost Rs 10,000-crore market in the country. A whistle blower has written to the National Pharmaceutical Pricing Authority (NPPA) alleging that Swiss drugmaker NovartisBSE 1.18 %, US-headquartered AbbottBSE -0.70 % and domestic companies Emcure and USV Pharma have together kept prices of various brands of Vildagliptin at artificial levels, going against fair trade practices. ET has a copy of the letter, written on February 27. “We will look into this issue,” NPPA chairman Bhupendra Singh told ET. While Novartis denied the allegations, an Abbott spokesperson said, “These allegations are false. We have not received any complaint from NPPA on this matter. Abbott has a non-exclusive licence with Novartis for Zomelis. Abbott determines the price of Zomelis in trade channels and institutions. Abbott does not discuss prices of its products with any other companies.” Comments from the other companies could not be immediately obtained. Vildagliptin is a proprietary drug of Novartis sold under the brand Galvus and comes under a new class of anti-diabetic drugs known as DPP 4 inhibitors. These drugs are prescribed for patients with Type 2 diabetes and are considered to be far more effective in controlling blood glucose levels than the older class of drugs. Novartis has licensed the drug to other three companies, which sell it in India under their own brand names. Abbott sells it as Zomelis, USV as Jalra and Emcure as Vysov. The combined sales of these brands stood at Rs 822 crore last year. The whistleblower alleged that Novartis controls the pricing structure that is followed by the licence holders. Although there is no written communication between them, these companies also synchronise every price change. “Though business agreement does not specify the control that Novartis exercises on its co-marketer partners in terms of controlling the market and pricing, but in reality all these companies have formed a price cartel both in trade business and institutions business,” the whistle blower said in the letter. The same pattern, the complaint said, is followed in government and institutional businesses, where one company corners the large tender business monopolising the market and makes sure others do not quote a lower price during the tender process. “Novartis has received no communication from NPPA about any complaint against Galvus. All our business partners have the freedom to set their prices for the products where they have marketing/sales agreements with us and we do not decide their MRPs,” Novartis said. Abbott and Emcure did not immediately respond to ET’s queries. Repeated phone calls to USV’s Mumbai office went unanswered and one of the numbers was unreachable. Emails sent to the company’s official email ID bounced back. According to data from All Indian Origin Chemists & Distributors, all four brands of Vildagliptin are sold in the same price range. Ten 500-mg tablets of Novartis’ Galvus and Metformin combinations cost Rs 258 and so do such combinations of Jalra by USV and Vysov by Emcure. Abbott’s Zomelis costs Rs 235. India’s large burden of diabetes has made it one of the most lucrative markets for drug makers across the world. An estimated 7.8% of adults in India have diabetes, according to the World Health Organisation. The anti-diabetic therapy is one of the fastest-growing segments in the country, recording sales worth Rs 9,314 crore in 2016 and growing at an 18% compared with the industry average of 10%. MerckBSE -0.15 %, AstraZeneca, Boehringer Ingelheim and Novartis have licensed this new class of drugs to other companies. Whistle blowers in India face a tough fight when taking on big companies and public authorities, risking their careers and, in extreme cases, their lives. Some efforts have been rewarded handsomely, although not by Indian authorities. Dinesh Thakur, an ex-employee of Ranbaxy, was awarded $40 million by the US Department of Justice for exposing malpractices in his company. Thakur now has become a champion for improving drug quality systems in India.
Source:- Economic Times

 


 
Transfer of Drug IP Assets Abroad Under RBI Lens
For years, many pharma companies in India have been moving their intellectual property (IP) assets -the firms' prized possessions -to offshore subsidiaries in destinations like Dubai, Ireland, Switzerland and the UK for strategic reasons or to lower, or even escape, tax. With all companies being required to file annual performance report on their overseas subsidiaries and joint ventures (JVs) with the Reserve Bank of India since last one year, the practice has come under the glare of the regulator. The central bank has questioned the way these foreign subsidiaries have raised loans abroad to pay for the IPs that were transferred to them. A transfer of assets from India has to be done at arm's length price to fulfill transfer pricing norms. Typically, the loan raised by an overseas pharma subsidiary to pay for the asset is against guarantee or collateral given by the parent in India. Such a transaction is unacceptable to the RBI, which believes it's in violation of Foreign Exchange Management Act (FEMA) and against the rules on external commercial borrowings (ECB). In the past three months at least five pharma companies have been asked by the RBI to explain such transactions, two persons aware of the development told ET. According to ECB rules, funds borrowed by an overseas arm against the Indian parent's support should be used for overseas expansion or takeovers -and cannot be sent back to India. “Indian companies are allowed to extend guarantees for loan availed by their overseas subsidiaries under the ODI Guidelines. Under the ECB guidelines, while an overseas parent company can extend loan to its Indian subsidiaries, a foreign subsidiary cannot extend loan to its Indian parent company . Clearly , if an overseas subsidiary raises loan overseas on the strength of guarantee from its Indian parent company and thereafter advances the funds to the Indian parent company as loan, it could be construed as non-compliance of the ECB guidelines,“ said Prem Rajani, partner at law firm Rajani Associates. In pharmaceutical business, IP involves everything that can be monetised to earn revenue: new drug applications (NDA), abbreviated new drug applications (ANDA), 505(b)(2) NDA, product dossiers, and so on -all are considered IP assets. For instance, it is not uncommon to find bulk of the ANDAs filed by the company housed under subsidiaries outside India. Consequently, several pharma companies including some of the leading ones have over the years steadily transferred most of their IPs outside India and reduced their tax burden in the country. Countries like the UK and Ireland also have `patent box' regime wherein companies pay tax at concessional rates if they register their patents there. However, not all IP transfers are aimed at tax avoidance or round-tripping of funds. “Sometimes JVs and joint R&D (research and development) programmes make it imperative for pharma companies to register the IP in Europe or with the foreign partner,“ said a pharma company executive. Another instance of a valid transfer is when the subsidiary takes on the IP at an early stage along with all the risk involved and takes insurance for the risk. “Such structures have been in existence for a long time. In any event, it has been clear to all concerned that the intention of such guarantees is not to obtain overseas funding for the India business. Perhaps, FEMA can at this stage, identify such structures and clarify what is permissible or prescribe more guidelines,“ said Anoop Narayanan, principal, ANA Law Group, a Mumbai-based law firm.
Source:- Economic Times

 


 
Dongkook Signes Licensing Deal with Alniche Lifesciences for commercializing Bellast in India
Seoul: ("Dong Kook") announced recently it has entered into a license agreement with Alniche Lifesciences Pvt. Ltd. ("Alniche"), under which Dongkook Pharmaceutical co. Ltd granted to Alniche an exclusive license to market and sell Dongkook's Dermal filler range Bellast in India. Bellast® is already available in South East Asian markets and under regulatory clearance in select markets in Europe. Mr. HungJu Oh, President and Chief Executive Officer of Dongkook commented, "India is a very important market for Dongkook and we are confident that Alniche will be able to secure a commendable market in India. I believe that Bellast as a new growth engine will be one of momentums for both companies in a short time and I appreciate for efforts of NCF UK for this business." Mr Girish Arora, Managing Director of Alniche added that“we are pleased to add Bellast in our cosmeceutical range. Bellast embodies our philosophy- radiating elasticity and youthful looks!.Bellast range will place Alniche in a premium niche segment in a fast growing dermal filler market. We also thank NCF, UK to assist us in securing this deal.”

 


 
First-in-class innovation a key strategy for pharmaceutical companies in a harsh market environment, says GBI Research
Fewer than two in 10 medicines exceed the average pharmaceutical R&D cost required to bring a drug to market when the risks of failure to reach market approval are factored in, according to business intelligence provider GBI Research. The company’s latest report states that, across the pharmaceutical industry, a product entering into clinical development has a 72% likelihood of failing to reach the market across any of the indications for which it is in development. On top of this, it is widely understood that bringing drugs to market is becoming increasingly expensive. Dominic Trewartha, Managing Analyst for GBI Research, explains: “The growth in drug development costs has been attributed to higher failure rates for drugs tested in clinical trials. Additionally, a range of factors are thought to have increased clinical trial costs, including increased trial complexity, larger average trial sizes, higher costs of inputs from the medical sector, and increased targeting of chronic and degenerative diseases. “Overall, these higher costs appear to stem from an increased clinical failure rate and emphasis on proving superiority over comparator drugs in healthcare technology assessments, as well as an increasing level of sophistication from payers when assessing the cost-effectiveness of drugs. The additional trials needed to provide adequate evidence of a drug’s efficacy have significantly added to the cost of development.” Due to growing R&D costs and the limited lifecycles of patented drug products, it is imperative that pharmaceutical companies maximize annual product revenue following market approval and maximize the lifecycles of their drugs, primarily by minimizing the impact of generic entry. Trewartha continues: “First-in-class innovation is a key strategy that companies have been employing to achieve these imperatives. Over recent decades, in addition to an increase in the yearly number of new chemical entity approvals by the FDA, the number of first-in-class products also increased. Indeed, the proportion of first-in-class approvals has increased steadily each year since 1994.”

 


 
PureCircle Has Been Granted More Stevia-Related Patents Than Any Other Company Globally in Each of the Last 5 Years
Kuala Lumpur, Malaysia (PRNewswire): PureCircle (LSE: PURE), the world's leading producer and innovator of great-tasting stevia sweeteners for the global beverage and food industry, continues to build on its strong patent protection, reflecting its advanced innovation, research and development. As a result of its cutting-edge work with stevia, PureCircle has been granted more stevia-related patents than any other company globally in each of the last five years. In the year ended April 30, 2017 , the company was granted 15 new patents globally. In addition, during that one-year period, it applied for 70 additional patents. Those new patents and patent applications are in addition to the company's already significant patent protection and activity. As of April 30, 2017 , PureCircle held a total of 72 granted patents, and had 205 applied-for patents pending worldwide. These patents -- and applied-for patents -- cover stevia-related products and processes. Beyond patents, and further enhancing its broad-based intellectual property, the company has extensive trade secrets and know-how. PureCircle CEO Magomet Malsagov noted: "Our intellectual property, including the hundreds of patents we hold and have applied for globally -- and the additional patents for which we shall apply -- reflect the strength and depth of our R&D and the importance of that R&D to our success." Given the growing global concerns about increases in obesity and diabetes, beverage and food companies are working quickly to reduce sugar and calories in their products, responding to both consumers and health and wellness advocates. Sweeteners from the stevia plant are becoming an increasingly important tool for these companies. With PureCircle's extensive R&D on the stevia plant and on its use and applications, the company is quickly scaling up its ability to produce the newer, innovative and great-tasting stevia sweeteners which will work well in a broad range of beverages and foods and enable an even greater degree of calorie reduction.

 


 
Sartorius Stedim Biotech Partners with Nova Biomedical
Goettingen, Germany, (B3C newswire): Sartorius Stedim Biotech (SSB), a leading international supplier to the biopharmaceutical industry, today announced an agreement with Nova Biomedical (Nova), a well-known US manufacturer of cell culture analyzers, to integrate their BioProfile® FLEX2 into the ambr® multi-parallel bioreactor systems for automated, at-line cell culture analytics. SSB and Nova are collaborating to combine two highly innovative technologies. Both the BioProfile® FLEX2 analyzer and the parallel bioprocessing functionality of the ambr® create a unique tool able to simultaneously run, sample and analyze a massive number of cell culture conditions during high-throughput cell line, media and process development by Design of Experiments (DoE). This will allow biopharmaceutical companies to develop well-characterized cell culture processes in less time while preventing the process development bottleneck being shifted to the analytical laboratory. The partnership will deliver full integrated analytics for the ambr® 15 cell culture system in Q3 2017 and later in 2017 for the ambr® 250 high throughput. The ambr® platform mimics the characteristics of classical bioreactors at the microscale by allowing automated parallel processing of single-use bioreactors. Integrating ambr® and the BioProfile® FLEX2 will benefit users by allowing independent sampling, sample transfer, analysis and automated feedback control in each mini bioreactor.

 


 
Stable economy will drive German pharmaceuticals market to $86.3 billion by 2021, says GlobalData
The German pharmaceuticals market is set to rise from $67.9 billion (€52.9 billion) in 2016 to around $86.3 billion (€67.2 billion) in 2021, representing a compound annual growth rate of 4.9%, according to research and consulting firm GlobalData. The company’s latest report states that Germany’s mature healthcare market, which is the largest of all EU member states, will be driven by an increasing elderly population and associated disease burden, while government initiatives to reduce healthcare expenditure will limit growth. As part of the Eurozone’s austerity measures, the German government is focused on reducing healthcare expenditure by regulating reimbursement and pricing policies through cost-benefit analysis, reference pricing, and analysis of the therapeutic characteristics of medicines, in an attempt to maintain the country’s economic stability. Despite the pressures of the Eurozone crisis, however, Germany’s stable fiscal environment has allowed for sustained economic growth, which offers an optimal base for corporate projects. Low corporate taxes and interest rates, a well-educated workforce, and very little structural debt create a clear perspective to guide capital spending. Outside investors face a relatively transparent regulatory system, where the foreign investment landscape is one of the least restrictive in the world. The importance of biopharmaceuticals continues to increase in Germany, with a large number of drugs currently in Phase III clinical trials. In 2015, there were approximately 100 biologically active ingredients in one of the three phases of clinical trials, and 12 biologics received approval, meaning the country is expected to be a future hub of innovative medicines. On top of this, the German government provides infrastructure support for domestic as well as foreign multinationals to open new manufacturing centers or to expand existing R&D sites. Pharmaceutical companies in Germany benefit from their close proximity to leading device and equipment manufacturers, resulting in streamlined production and shorter down-times.

 


 
3D Printing Applications for Healthcare Will Transform Medical Devices and Pharma Industries
Santa Clara, Calif.: 3D printing technology is the ideal solution for the healthcare industry’s need for the efficient production of complex and personalized products. A large number of market majors have shown deep interest in adopting 3D printing for its ability to customize drugs, active pharmaceutical ingredients (APIs) and medical devices, driving an era of personalized medicine. The field that is most likely to be disrupted by 3D printing is pharmacy distribution of drugs because of the ease of obtaining customized dosage quantities of medication. “Using 3D-printed tissues for drug testing, clinical trials and toxicity testing will have a huge impact in the pharmaceutical sector, as they will help eliminate costly animal testing and use of synthetic tissues,” noted Frost & Sullivan Analyst. “However, traditional, large-scale manufacturing is still more economical for mass production of drugs; 3D printing will be viable for small-volume production in orphan diseases.” 3D Printing for Healthcare Applications, recent research from Frost & Sullivan’s TechVision (Medical Devices & Imaging) Growth Partnership Service program, finds that there is a slow shift in pharma toward continuous manufacturing (CM), which can shrink production time to less than 10 days. When this practice is merged with 3D printing, pharma companies can develop various dosage forms for a specific, customized demographic. 3D printing will also bring about a change in the structure of the medication, making it easier to swallow or dissolve, and more attractive to children by printing them in any shape and size.

 


 
Bain Capital & Cinven buy German Generic Drug Maker Strada for € 4.1 bn
Germany: Private equity firms Bain Capital and Cinven have jointly agreed to takeover Stada Arzneimittel AG, the Germany-based generic drug maker, in a € 4.1 billion bid. Bain and Cinven have offered the shareholders of Stada a cash consideration of € 65.28 per share plus the 2016 dividend in the amount of € 0.72 per share as proposed by the management board of Stada resulting in a total offer value of € 66.00 per share. The offer of Bain Capital and Cinven contains the most attractive overall combination. In addition to the highest price we were able to reach comprehensive protection provisions especially for our employees and to initiate a future-oriented growth strategy,” said Ferdinand Oetker, chairman of the supervisory board of Stada Arzneimittel AG. Stada offers a comprehensive portfolio of high-quality, low-cost generic products including selected biosimilars. The company has also built an attractive portfolio of well-established branded products, including the cold medicine Grippostad and the Ladival range of sun protection products. In 2016, Stada achieved adjusted group sales of € 2.167 billion, and adjusted net income of € 177.3 million

 


 
PMMI Shares Latest Trends in Global Packaging Consumer trends toward healthy eating, sustainability and convenience are impacting the global packaging market
Reston, Va.: Consumer focus on wellness, environmental impact and macroeconomic factors such as the growth of the middle class creating more disposable income are shaping the global packaging market, said Charles D. Yuska, president and CEO, PMMI, The Association for Packaging and Processing Technologies, at a press luncheon during interpack (Düsseldorf, Germany; May 4–10). These trends, highlighted in the 2017 Global Packaging Trends report, produced by Euromonitor and sponsored by leading packaging associations PMMI, Australian Packaging and Processing Machinery Association, Italian Manufacturers of Automatic Packing and Packaging Machinery, and the Processing & Packaging Machinery Trade Association, are impacting the types of machinery sourced by consumer packaged goods companies. Yuska cited global consumer demand for healthier foods as the impetus towards fresher food, clean labeling and organic products becoming center stage. In particular, clean labels are becoming critical, according to PMMI’s recently released Trends in Food Processing Operations report. “Thirty seven percent of U.S. consumers find it important to understand ingredients on food labels while 91 percent believe that products with recognizable ingredients are healthier,” Yuska said. “And, the rise in demand for organic food has fueled a more than 10 percent growth in this sector.” In order to meet evolving customer wants, many food manufacturers are looking to new technology, such as High Pressure Processing (HPP) to extend shelf life while delivering fresher, safer food to the consumer. To help advance this technology, the Cold Pressure Council, convened by PMMI, is focused on the progression of HPP as a critical technology in the food and beverage industry. The next trend emphasized by Yuska is the continued move to more sustainable packaging. PMMI’s 2016 Global Trends Impacting the Market for Packaging Machinery Market Research report highlighted sustainability as a key factor influencing all major regions. Customers are demanding minimal and less packaging waste while increases in the price of virgin materials are also driving demand for recycled materials. Flexible packaging is also growing due to recyclability, affordability, lightweight and growth in packaged foods overall. This increase is especially evident in regions such as Asia Pacific, Western Europe, the Middle East and Africa. “The increased focus on sustainability drives the growing demand for more energy-efficient machines,” said Yuska. “With the growth of flexible packaging, we are seeing additional demand for filling and closing machines able to handle this type of packaging material.” Lastly, one of the major macroeconomic trends that is impacting our industry is the growth of the middle class and a rise in disposable income. In developed regions, increased travel, busy lifestyles and growing health consciousness have increased demand for indulgent yet healthy foods, convenience foods, different portion sizes, different packaging designs and completely new foods. “Consumer purchasing preferences are also changing. Online food sales are growing rapidly, a trend reinforced by the growing use of mobile phones and shopping applications,” adds Yuska. Consumers welcome additional choices and are willing to pay more for products that are locally sourced, produced with quality ingredients and resonate as authentic. This trend toward more customization and increased premiumization, has fueled the need for increasingly flexible equipment that can handle shorter runs and more frequent changeovers. To learn more about these trends, be sure to attend PACK EXPO Las Vegas (Sept. 25-27; Las Vegas Convention Center). Co-located with Healthcare Packaging EXPO, the show will bring together top consumer packaged goods companies from around the world to explore state-of-the-art packaging technologies, equipment and materials as well as exchange ideas with peers and build professional relationships. The event boasts an expected 30,000 attendees, including 5,000 international visitors from more than 125 countries, combined with 2,000-plus exhibiting companies spanning 800,000 net square feet of a nearly sold-out show floor. Beyond the technologies displayed on the show floor, attendees will find tremendous educational opportunities on the Innovation Stage where suppliers present free 30-minute seminars on breakthrough technologies throughout the day.

 


 
Rockwell Automation to Sponsor PACK gives BACK™
Reston, Va.: In conjunction with its participation in PACK EXPO 2017, Rockwell Automation will help to support scholarships for future packaging professionals through a title-level sponsorship of this year’s PACK gives BACK™ event, reports PACK EXPO producer, PMMI, The Association for Packaging and Processing Technologies. The event will feature legendary rock and roll band, The Doobie Brothers, and take place at PACK EXPO Las Vegas and Healthcare Packaging EXPO 2017 (Sept. 25-27, 2017, Las Vegas Convention Center). PACK gives BACK™ is an annual fundraising event with a portion of the ticket sales going to a charitable cause. This year’s event will benefit the PACK EXPO Scholarship which provides grants to U.S. and Canadian colleges with processing and packaging programs. “Rockwell Automation has worked closely with PMMI for many years as a member and exhibitor at the PACK EXPO trade shows. We’ve seen first-hand what this organization has done not only for the current packaging industry, but for the next generation of professionals that will lead this industry into the future,” says Christopher Zei, vice president Global OEM and Global Industries, Rockwell Automation. “We are pleased to contribute to this scholarship and continue sponsorship of PACK gives BACK.” The event will take place on Monday, Sept. 25 at 4 p.m. in the Grand Ballroom of the Las Vegas Convention Center. “Our industry has given back to the community year after year through this charitable event, and this year, we want to give back to the future generation with generous scholarship opportunities,” says Jim Pittas, chief operating officer, PMMI. “We are grateful to Rockwell Automation for their continued support of this event and this community.” Tickets for PACK gives BACK™ are available online for registered PACK EXPO Las Vegas and Healthcare Packaging EXPO attendees and exhibitors at www.packexpolasvegas.com/pack-gives-back and cost $75 each (buy 10, and get the tenth ticket free). Buy your ticket before the event sells out!
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CPhI Worldwide Advisory Board returns With Five New Global Experts
Amsterdam: CPhI Worldwide, organised by UBM EMEA, announces its Advisory Board for 2017. The new board features some of the industry’s most experienced and well-respected executives, consultants and experts, and is designed to bring a wealth of experience to help shape the agenda at the eponymous CPhI Worldwide event – taking place this year in Frankfurt, Germany (24-26 October, 2017 at the Messe Frankfurt). The board also helps navigate improvements to the event’s co-located zones and sessions, as well identifying future opportunities and the industry’s current hot topics. This year, the advisory board welcomes five new high-profile members: Jim Miller, President of PharmSource; Rita Peters, Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe and BioPharm International; Peter Schmitt, President of Montesino; Claudia Lin, General Manager at AlphaMab; and Kate Kuhrt, Head of GTM Life Sciences, Clarivate Analytics. Jim Miller joins the board on the back of the internationally renowned industry analysis he provides to global pharma and contract services companies through his consultancy, PharmSource. Mr Miller is one of the most influential and respected experts in bio/pharmaceutical outsourcing, and regularly speaks at pharma events and is a member of several editorial boards. Another prominent industry analyst to join the board is Kate Kuhrt, a leading authority on the global API and generics markets, and pharma product launches. She has two decades of experience in covering the industry and is a speaker and adviser to some of the world’s largest pharma companies. Her specialities include emerging biopharma segments and rapid growth markets. Peter Schmitt will be utilizing over 30 years of industry experience to provide invaluable global insights into the packaging sector. In 1996, he founded Montesino Associates, followed in 2000 by Montesino Technologies. Mr. Schmitt will be leveraging his knowledge to offer insights across M&A and industry consolidation, regulatory initiatives such as serialization, track and trace, Type III Drug Master Files, sustainability, OEE, new materials and technology, and the ever-present challenge of cost optimization. Bringing knowledge from the Chinese R&D industry is Dr. Claudia Lin, General Manager at AlphaMab Co. Ltd – a leading Chinese biotech company known for its excellent R&D capabilities. Prior to AlphaMab, Dr. Lin was Head of Quality for Innovent Biologics in China, where she built the company’s international standard GMP capabilities from the ground up. Over her career, Dr. Lin has demonstrated a passion for women’s leadership in the industry, and is both a mentor and a leading voice on furthering women in senior roles across pharma. The final new panellist for 2017 is Rita Peters, Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe and BioPharm International, who brings her decade long experience of editing three of the industry’s biggest publications. Ms. Peters is a leading producer of industry thought-leadership and has a wide ranging global knowledge having covered many of the biggest stories, new technology developments and trends of the last 10-years. These new members will join together with the seven current members of the expert panel Dilip G. Shah, CEO of Vision Consulting; Alan Sheppard, Principal of Global Generics and Biosimilars at QuintilesIMS; Martin Folger, Head of Global CMC Development – Pharmaceuticals at Boehringer Ingelheim Vetmedica GmbH; Nigel Walker, Managing Director of That’s Nice; Roger Bakale, Vice President of CMC and Clinical Supply Chain at Receptos; Jan Ramakers, Owner of Fine Chemical Consulting Group; Will Downie, Senior Vice President of Global Sales & Marketing, Catalent Pharma Solutions. “CPhI Worldwide has firmly asserted itself as the leading global platform for doing business and finding new opportunities in the worldwide pharmaceutical community. We are really delighted to be able to call upon such a unique mix of industry experts to provide such invaluable insights into hot topics within the industry, alongside an abundance of knowledge and experience. We now look to further enhance the new opportunities and services we bring to our customers”, Orhan Caglayan, Brand Director at UBM EMEA
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CPhI Expert Calls for ANDA Approvals to be Reduced by Two-Thirds in Order to lower Drug Costs
Amsterdam: Girish Malhotra, President of EPCOT International, and CPhI Worldwide Annual Industry Report member, discusses the necessity of time reduction for ANDA approvals, arguing that if the current approval time can be reduced from ten months to three months, drug costs will decrease. Malhotra states that in order to decrease the time for ANDA approvals, there are three main challenges to overcome. Currently, it takes up to four review cycles to approve an ANDA, and the first and foremost challenge is with submission completeness. On average, it takes the FDA reviewing team 45 days to determine application completeness. This time can potentially be reduced to 15 days if the FDA modifies their review process. Last month the Pre-ANDA program was proposed, a first-step Quality by Analysis (QbA) implementation in the application filing process. Although applications for every product are different in content, the information filing requirements are essentially the same. For example, a template application that covers 90% of the filing requirements can be designed whereby a standard format could reduce four reviews to a single review. However, to avoid confusion and delay, the FDA would have to create applications that clearly state what is expected from companies; this must then be transformed into a standard template. “Workshops that train the FDA industry staff to become familiarized with the application requirements would allow the Pre-ANDA program to be implemented efficiently”, Malhotra explained. The volume of applications is the second challenge, which can be minimized if the FDA goes with a streamlined best basis planning scenario strategy. Brand companies use Risk Evaluation and Mitigation Strategies to delay generic entry and so the FDA must develop a strategy to prevent such harassment. FDA or US legislature has to intervene and assure that necessary samples are available to potential generic companies to complete necessary studies for approval. In addition to this, the FDA cannot approve generics until the patent on a product expires. Malhotra added, “If the approval process were lowered to three months, the need for priority review would likely disappear entirely”. Lastly, the 90-day frame can be further broken down into three segments. The FDA will complete the initial review within 15 days and companies would then have 30 days to respond to FDA’s requirements. Following this, the FDA will then have 45 days to review the application and return to the company with a final proposal. Companies that cannot fulfill obligations after the 15-day FDA review combined with the 30-day deficiency completion will be required to start the process over. This will encourage companies to ensure that they provide the best application possible. Malhotra commented, “I keep banging the drum, but not enough of the industry is willing to change. Until we take on challenges, progress will never be made. It will be worth it if we can make regulatory process improvements and consequently lower the overall cost of drugs.

 


 
CPhI Worldwide to Launch Global Pharma Market Ranking Index
Amsterdam: CPhI Worldwide – the global pharmaceutical event, with an attendee base that acts as an accurate barometer of pharma’s overall health – is conducting an extensive survey of international pharmaceutical companies and executives to rank the most prominent pharma countries. This first of a kind survey has been sent to over 100,000 pharmaceutical professionals globally and will evaluate the relative international reputations of all of the major pharmaceutical economies. The anonymous survey will provide a strong indication of the major trends, changes and developments throughout the industry, alongside the international reputation of each major pharmaceutical economy. This will create a country specific pharmaceutical league table across areas such as ‘API production’, ‘finished dosage formulations’, ‘individual market competitiveness’, ‘innovation’, ‘access to research’ and ‘regulatory acumen’ amongst others. CPhI Worldwide is the world’s largest pharma event and effectively acts as a bellwether of global pharma. Utilizing this reach, the survey results will produce a global ranking of the strength of the world’s leading pharma economies, providing foresight into the markets with the greatest business prospects. CPhI is encouraging all of the global industry to contribute and the results will be available later in the year on the CPhI Pharma Insights webpage. For respondents that wish to receive a copy of the findings, there is also an option to leave an email address.

 


 
Waters Introduces LiveID Software for Real-Time, Direct-from-Sample Food Analysis and Plant Phenotyping
Milford, Mass. (Business Wire): Waters Corporation (NYSE:WAT) today introduced its new LiveID™ Software for near-instantaneous, direct-from-sample measurement and classification of food products including meat and crops by Waters’ quadrupole, time-of-flight (QTof) mass spectrometers. The new software enables Waters® Xevo® G2-XS QTof or SYNAPT® G2-Si Mass Spectrometers equipped with an iKnife™ Sampling device, Rapid Evaporative Ionization Mass Spectrometry (REIMS™) ion source and MassLynx® Mass Spectrometry Software to help laboratories detect food fraud. Waters LiveID Software is now available on a worldwide basis.
“Information on food samples separated in time and space from where it is needed most isn’t efficient and hurts productivity. We’ve designed LiveID Software to make the process of getting real-time information about samples as intuitive, as quick and as easy as possible,” said Ronan O’Malley, Senior Director of Informatics Products, Waters Corporation.
Food fraud - when food is labelled and sold as something that it is not - is a growing and pernicious problem that funds organized crime, cheats consumers and jeopardizes the reputation of food producers and the health of economies dependent on food exports.
In recent years, QTof mass spectrometry has emerged as a promising technique for detecting food fraud. One who has pioneered its use for this application is Professor Chris Elliott, Director – Institute for Global Food Security, Queens University Belfast. “The REIMS QTof technology platform has the potential to revolutionize food authenticity analysis due to its speed and ability to detect multiple issues simultaneously that impact the integrity of the food we eat. I am not aware of any other technology developments that will provide this level of support to the food industry.”
Faster than conventional techniques like immunosassay and PCR, mass spectrometry enabled by LiveID Software produces definitive results in seconds. With iKnife Sampling and REIMS, no sample pretreatment or separation is typically necessary. When the hand-held iKnife sampling device comes in contact with a sample of animal or plant tissue or other processed foodstuffs such as butter, it creates smoke containing compound-specific molecules which are directed to the REIMS source where the molecules are ionized and then passed on to be detected by the mass spectrometer. In very little time, the LiveID software then creates a molecular profile or chemical fingerprint of the sample, compares it to a user-generated database of reference fingerprints and then classifies the sample as belonging to one of a number of sample types or groupings.
Waters introduced iKnife Sampling and REIMS technologies to its QTof mass spectrometers in 2015. Since then, Waters has evolved the design of the REIMS source to make real-time decision-making using mass spectrometry straightforward and accessible by researchers who wish to explore the potential of the technology.

 

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