News Article | November 16, 2016
If you manufacture high value product, you should be concerned with cleanliness, contamination control, and reliability. Two new documents that are directed at the medical device community provide sensible, practical guidance for all manufacturers of high value product. ASTM standard F3127-16: “Guide for Validating Cleaning Processes Used During the Manufacture of Medical Devices” is a gold mine of useful approaches and procedures. While the scope of this newly published standard is limited to cleaning of single use medical devices during manufacture and prior to use, the document draws on knowledge from other high-value product including semiconductors, electronics, cleaning for oxygen environments, and aerospace. The comprehensive standard is a guidance document for developing and validating a cleaning process, not a step-by-step recipe. The detailed validation flowchart in the guidance document is a useful, adaptable resource. The approach encompasses the concept of “validation readiness” through process understanding and documentation. It emphasizes the importance of cleaning throughout the supply chain as opposed to depending on final cleaning. It also includes the concept that validation is not a one-time only event and instead alludes to ongoing validation and monitoring.1 The first decision point on the flowchart poses the question, “Is the device designed for cleanability?” This brings up our all-important issue of establishing communication between designers, assemblers, and quality managers. It is essential to achieve appropriate product safety and performance. We sometimes quip that the first step is to tie design engineers to a chair with duct tape and force them to try to assemble and clean a prototype of their proposed design. In actuality, a kinder, more productive approach to implementing the guidance document is to set up a manufacturing team early on in product development and to include design engineers. The phrase “regulatory issues” tends to evoke the FDA. However, there are other regulatory issues — worker safety and environmental compliance. The ASTM guide does not specifically address the mechanism of achieving safety and environmental compliance. Attendees at a recent program for critical cleaning in the life-sciences expressed frustration over pronouncements about allowable chemicals and activities voiced by their safety and environmental groups. Rather than avoidance, exclusion, or analogous use of duct tape, we suggest that safety and environmental professionals also be involved in product development. With the correct engineering controls, it is usually possible to implement cleaning processes that meet safety and environmental requirements while assuring product/patient safety. The guide is comprehensive. Other sections include approaches and procedures for determining the scope of contaminating materials, risk analysis, and developing limits of acceptable residue. Considerable detail is provided regarding both specific and non-specific analytical methods, in approaches to selecting the appropriate techniques for the application. The guide also recognizes the importance of sampling techniques. Additive manufacturing (3D printing) is entering the mainstream of manufacturing. The FDA has responded with an encompassing, interactive approach. In May 2016, the FDA Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER) issued a draft guidance document.2 The FDA hosted a workshop in 2014 to explore issues that might arise with medical devices manufactured by additive manufacturing.3 The 2016 draft guidance document builds on ideas and concerns presented at this workshop. What are some potential issues for cleaning and contamination control? Design for cleanability is an even greater concern with additive manufacturing. Additive manufacturing enables the design of complex shaped devices. Devices could be designed to contain inner recesses that are difficult to access. Cleaning and/or rinsing fluids need to access surfaces and be removed from those surfaces in order to have adequate cleaning function. Validation of both cleaning and sterilization requires access to these surfaces to verify that the cleaning or sterilization process has occurred. The order of manufacturing can be different for additive manufacturing than for traditional. Consider a bone replacement device that contains an external porous region to enable biological attachment (osseointegration) to living bone. A traditional technique might begin with machining, followed by cleaning to remove machining fluids, followed by coating with a porous layer. In contrast, with 3D printing, the porous layer might be fabricated as part of the initial build. Any post-printing machining and cleaning would be complicated by the presence of the porous layer. On primary strength of additive manufacturing, especially for medical devices, is that the technology enables an economically feasible approach to “one-offs.” Patient-specific devices raise the variations in dimensions and shapes. This in turn raises the issue of cleanability and of cleaning validation. Still more contamination and cleaning issues can occur due to one of the primary strengths of the additive approach, the ability to economically fabricate patient specific devices. Variations in dimensions and shapes can complicate both cleaning and cleaning validation. Industry standards and guides will continue to be developed or adapted in response to new technologies like additive manufacturing. In May, the ASTM F04 Committee on Medical and Surgical Materials and Devices held a workshop on Additive Manufacturing for Medical Applications4 in order to explore the need for new or revised ASTM standards. FDA CDRH personnel helped to plan and conduct the workshop. In our own view, additive manufacturing may not require an entirely new set of industry standards but rather a mindfulness of which standards might need to be modified to meet new challenges. 2. FDA draft document, “Technical Considerations for Additive Manufactured Devices; Draft Guidance for Industry and Food and Drug Administration Staff.”
News Article | November 8, 2016
GAITHERSBURG, Md., Nov. 08, 2016 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) today announced the appointment of Kathryn C. Zoon, Ph.D. to the company’s Board of Directors. Dr. Zoon is currently a Scientist Emeritus with the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health (NIH). Dr. Zoon’s affiliation with NIH spans four decades, beginning with her early research alongside Nobel Laureate Christian B. Anfinsen. During her distinguished career, Dr. Zoon has held various leadership positions at NIH including Chief of the Cytokine Biology Section (NIAID), Director of the Division of Intramural Research (DIR/NIAID), Deputy Director for Planning and Development at the DIR/NIAID, and Principal Deputy Director of the Center for Cancer Research at the National Cancer Institute. Dr. Zoon also spent 23 years at the U.S. Food and Drug Administration (FDA), where she served as Director of the Center for Biologics Evaluation and Research (CBER) for 10 years and Director of the Division of Cytokine Biology in CBER previously. “We are excited to welcome Dr. Zoon as a member of the Emergent BioSolutions Board of Directors,” said Fuad El-Hibri, executive chairman of the board of Emergent BioSolutions. “As Emergent renews its focus on meeting the medical countermeasure and preparedness needs of the U.S. government, Dr. Zoon’s expertise in regulatory matters and product development will add greater depth and breadth to our diverse board and will be instrumental in helping ensure continued growth for the company.” “I am pleased with this appointment to serve on the board of Emergent BioSolutions, whose corporate mission – to protect and enhance life – aligns with my life’s work and passion for bringing to market medical discoveries that improve the quality of human life,” said Dr. Zoon. “I look forward to contributing to Emergent's success and hope to leverage my experience to assist the management team and the company in achieving their goals.” Dr. Zoon has been a member of the NIH Board of Scientific Directors since 1992, a member of the National Academy of Medicine since 2002, and has served on the World Health Organization’s Expert Committee on Biological Standards for almost two decades. She has authored more than 130 scientific papers and has received numerous awards, including the 2001 HHS Secretary’s Award for Distinguished Service for outstanding leadership in positioning FDA as an important contributor to the nation’s capability to respond to bioterrorism and a 2003 HHS award for counter-bioterrorism, to name a few. Dr. Zoon received her B.S. degree, cum laude, in Chemistry from Rensselaer Polytechnic Institute and was granted a Ph.D. from the Johns Hopkins University. About Emergent BioSolutions Emergent BioSolutions is a global specialty biopharmaceutical company dedicated to one simple mission—to protect and enhance life. We develop, manufacture, and deliver a portfolio of medical countermeasures for biological and chemical threats as well as emerging infectious diseases. Through our work, we envision protecting and enhancing 50 million lives with our products by 2025. Additional information about the company may be found at www.emergentbiosolutions.com. Follow us @emergentbiosolu.
News Article | November 29, 2016
As the legal marijuana industry continues to see high levels of competition within the marketplace, Cannabis operators in the sector are executing strategies by developing innovative services and products as well as acquiring resources and other assets to leverage the substance's momentum behind increased legalization after the recent election season. Active companies today include: Marapharm Ventures Inc. (OTC: MRPHF), Terra Tech Corp (OTC: TRTC), Cannabis Sativa, Inc. (OTC: CBDS), PharmaCyte Biotech, Inc. (OTC: PMCB) and INSYS Therapeutics, Inc. (NASDAQ: INSY). Marapharm Ventures Inc. (OTCQB: MRPHF) (CSE: MDM.CN) announces the purchase of the remaining 25% equity interest in EcoNevada, LLC, ("EcoNevada"), a private company based in Las Vegas, Nevada, such that Marapharm now owns 100% of the issued and outstanding shares of EcoNevada. EcoNevada has provisional marijuana licenses and special use permits over 204,000 square feet of cultivation and 16,000 square feet of production. Read this full Press Releases and recent news for Marapharm at http://financialnewsmedia.com/profiles/mrphf.html "We have now completed the deal which was made a year ago, when we purchased control of EcoNevada. The price for the minority position of 25% was 100,000 shares of Marapharm, as agreed to in the original transaction, to suit the needs of the sellers for tax and other reasons. Since recreational use of marijuana has been legalized in the state of Nevada, EcoNevada has increased in value to Marapharm, both as an asset and as a main vehicle to drive revenue in Nevada." said Linda Sampson, CEO of Marapharm. "We just bought the adjoining 1.1 acres to the 5.9 acres we acquired, in order to accommodate parking requirements from the City of North Las Vegas to allow for the three licenses to be consolidated on one property," added Linda Sampson. In addition, further to its November 23, 2016, news release, Marapharm reports it is in advanced discussions with several large casinos in Las Vegas for the placement of automated cannabis machines (ACMs) in casinos. It is proposed that the ACMs will stock and only sell Marapharm products from its 380,000-square-foot facility located in Las Vegas. There is no guarantee that such discussions will result in any agreements or be fruitful or beneficial to Marapharm. TERRA TECH CORP (OTCQX: TRTC) based in Newport Beach , a cannabis-focused agriculture company yesterday announced that Derek Peterson , Chief Executive Officer, will present live at VirtualInvestorConferences.com on December 1, 2016 . View investor presentations 24/7 at http://www.virtualinvestorconferences.com. - View investor presentations 24/7 at http://www.virtualinvestorconferences.com. More - DATE: Thursday, December 1, 2016 - TIME: 12:15 pm ET - LINK: http://tinyurl.com/1201prepr Cannabis Sativa, Inc. (OTCQB: CBDS) was up slightly on Tuesday at $5.59 by 11:46am EDT. Cannabis Sativa, Inc., through its subsidiaries, develops, manufactures, and sells herbal based skin care products in the United States and internationally. PharmaCyte Biotech, Inc. (OTCQB: PMCB) was up over 30% at $0.068 on Tuesday trading over 15.9 Million shares by 11:46am EDT. PharmaCyte Biotech, a clinical stage biotechnology company focused on developing targeted treatments for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box®, today announced that a Pre-Investigational New Drug (Pre-IND) meeting with the Center for Biologics Evaluation and Research (CBER) of the U.S. Food and Drug Administration (FDA) has been granted by the FDA. During the meeting with representatives from CBER, they will respond to PharmaCyte's previously submitted questions to the FDA as part of a Pre-IND information package related to PharmaCyte's clinical trial in locally advanced, inoperable pancreatic cancer (LAPC) INSYS Therapeutics, Inc. (NASDAQ: INSY) was up slightly on Tuesday at $12.79 by 11:46am EDT. Insys Therapeutics, Inc., a specialty pharmaceutical company, develops and commercializes supportive care products. The company markets Subsys, a sublingual fentanyl spray for breakthrough cancer pain in opioid-tolerant cancer patients in the United States. DISCLAIMER: FN Media Group LLC (FNMG) is a third party publisher and news dissemination service provider, which disseminates electronic information through multiple online media channels. FNMG is NOT affiliated in any manner with any company mentioned herein. 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News Article | November 29, 2016
LAGUNA HILLS, Calif., Nov. 29, 2016 (GLOBE NEWSWIRE) -- PharmaCyte Biotech, Inc. (OTCQB:PMCB), a clinical stage biotechnology company focused on developing targeted treatments for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box®, today announced that a Pre-Investigational New Drug (Pre-IND) meeting with the Center for Biologics Evaluation and Research (CBER) of the U.S. Food and Drug Administration (FDA) has been granted by the FDA. During the meeting with representatives from CBER, they will respond to PharmaCyte’s previously submitted questions to the FDA as part of a Pre-IND information package related to PharmaCyte’s clinical trial in locally advanced, inoperable pancreatic cancer (LAPC). PharmaCyte will be submitting a full Pre-IND package of information to the FDA that describes what PharmaCyte intends on submitting in its Investigational New Drug (IND) application. The FDA will review PharmaCyte’s manufacturing, preclinical pharmacology and toxicology and clinical trial plans for the company’s therapy to treat LAPC. After the FDA has responded to the questions and issued comments, PharmaCyte will undertake steps to address them to the FDA's satisfaction which will lead directly to the preparation of the IND application itself. Once the IND application is found to be acceptable to the FDA, patients can be enrolled in PharmaCyte’s clinical trial. PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, commented about the Pre-IND meeting saying, "We are pleased that the FDA has granted us a Pre-IND meeting in connection with our planned clinical trial for LAPC patients whose disease has already received maximum response from the gold standard of care - the combination therapy of Abraxane® plus gemcitabine. Our Pre-IND meeting is the next step in getting our pancreatic cancer therapy into a clinical trial and approved by the FDA. We believe PharmaCyte is well on its way to accomplishing this goal.” PharmaCyte’s clinical trial in patients with LAPC is designed to meet a clear unmet medical need for those whose cancer no longer responds after 4-6 months of treatment with the combination of Abraxane® plus gemcitabine. The trial will be open-label and multi-site in nature, with sites in the U.S. and Europe. Patients with LAPC will be randomized equally into two groups. One group will receive gemcitabine chemotherapy alone, and the other group will receive PharmaCyte’s pancreatic cancer therapy (encapsulated genetically modified live human cells that can activate the cancer prodrug ifosfamide plus low doses of the prodrug to eliminate side effects from the chemotherapy). In addition to comparing the anticancer activity and safety of the two therapies, a major aspect of the trial will be to determine if, and how well, PharmaCyte’s therapy can shrink inoperable tumors so that they may become operable. PharmaCyte Biotech a clinical stage biotechnology company developing therapies for cancer and diabetes based upon a proprietary cellulose-based live cell encapsulation technology known as “Cell-in-a-Box®.” This technology will be used as a platform upon which therapies for several types of cancer and diabetes are being developed. PharmaCyte’s therapy for cancer involves encapsulating genetically engineered human cells that convert an inactive chemotherapy drug into its active or “cancer-killing” form. These encapsulated cells are implanted as close to the patient’s cancerous tumor as possible. Once implanted, a chemotherapy drug that is normally activated in the liver (ifosfamide) is given intravenously at one-third the normal dose. The ifosfamide is carried by the circulatory system to where the encapsulated cells have been implanted. When the ifosfamide comes in contact with the encapsulated cells they act as an artificial liver and activate the chemotherapy drug at the source of the cancer. This “targeted chemotherapy” has proven effective and safe to use in past clinical trials and results in no side effects. In addition to developing a novel therapy for cancer, PharmaCyte is developing a treatment for Type 1 diabetes and insulin-dependent Type 2 diabetes. PharmaCyte plans to encapsulate a human cell line that has been genetically engineered to produce, store and release insulin in response to the levels of blood sugar in the human body. The encapsulation will be done using the Cell-in-a-Box® technology. Once the encapsulated cells are implanted in a diabetic patient they will function as a “bio-artificial pancreas” for purposes of insulin production. This press release may contain forward-looking statements regarding PharmaCyte Biotech and its future events and results that involve inherent risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend", "plan" and similar expressions, as they relate to PharmaCyte or its management, are intended to identify forward-looking statements. Important factors, many of which are beyond the control of PharmaCyte, could cause actual results to differ materially from those set forth in the forward-looking statements. They include PharmaCyte's ability to continue as a going concern, delays or unsuccessful results in preclinical and clinical trials, flaws or defects regarding its product candidates, changes in relevant legislation or regulatory requirements, uncertainty of protection of PharmaCyte’s intellectual property and PharmaCyte’s continued ability to raise capital. PharmaCyte does not assume any obligation to update any of these forward-looking statements. More information about PharmaCyte Biotech can be found at www.PharmaCyte.com. It can also be obtained by contacting Investor Relations.
News Article | December 22, 2016
ALK today announced that it has acquired the activities and assets of Allergy Laboratories, Inc. and Crystal Laboratory LLC, both based in Oklahoma, USA, in a single transaction that will bolster ALK’s supply chain in North America. The two companies had previously been under the same private ownership and produce allergen extracts and other material used in allergy immunotherapy treatments. Allergy Laboratories, Inc. and Crystal Laboratory LLC have a combined staff of around 100. ALK’s Chief Financial Officer, Flemming Pedersen, said: "In addition to bringing business synergies and long-term value creation, this acquisition strengthens ALK’s supply chain, particularly for vials and diluents which are important to the overall North American allergy business. It also adds to our know-how in producing certain raw materials and sterile materials.” The transaction is valued at approximately USD 20 million (DKK 138 million) on a debt and cash free basis. The purchase price reflects a 2015 notice by the US Food and Drug Administration's Center for Biologics Evaluation and Research (CBER) that intends to revoke Allergy Laboratories' biological license. ALK is confident that it can resolve this issue. However, part of the purchase price will be held back pending full resolution of the matter. He continued: “As a world leader in allergy immunotherapy, ALK is well-placed to help resolve the license issue with the FDA and we will work urgently and diligently with the authorities to resolve the issues.” The acquisition continues ALK’s strategy of expanding its global presence and strengthens ALK’s market position by enhancing its ability to grow sales of allergen extracts and related products in North America, confirming its commitment to providing allergy specialists with high quality products. ALK expects that the acquisition will add revenue of approximately USD 15 million in 2017 and contribute positively to earnings and cash flow from 2018. For 2017, ALK expects a minor positive effect on earnings as there will be added costs related to the integration and upgrade of the acquired assets. The transaction will be effective on 3 January 2017. For further information please contact: Investor Relations: Per Plotnikof, tel. +45 4574 7527, mobile +45 2261 2525 Media: Jeppe Ilkjær, tel. +45 7877 4532, mobile +45 3050 2014 About Allergy Laboratories, Inc. and Crystal Laboratory LLC Allergy Laboratories, Inc. of Oklahoma is an FDA-licensed pharmaceutical manufacturer of allergen extracts for the diagnostic testing and therapeutic treatment of allergy. Crystal Laboratory LLC produces raw allergenic products. The company primarily caters to allergy specialists, and its main products are vials and diluents. In 2015, the FDA's Center for Biologics Evaluation and Research (CBER) issued a Notice of Intent to Revoke Allergy Laboratories' biological license. For additional information, please go to www.allergylabs.com and www.crystallabsllc.com. About ALK ALK is a research-driven global pharmaceutical company focusing on allergy prevention, diagnosis and treatment. ALK is a world leader in allergy immunotherapy – a treatment of the underlying cause of allergy. The company has approximately 2,200 employees, with subsidiaries, production facilities and distributors worldwide. ALK has entered into partnership agreements with Torii, Abbott, and Seqirus to commercialise sublingual allergy immunotherapy tablets in Japan, Russia, and South-East Asia, and Australia and New Zealand, respectively. The company is headquartered in Hørsholm, Denmark, and listed on NASDAQ Copenhagen. Find more information at www.alk.net.
News Article | November 10, 2016
BERKELEY, CA and VANCOUVER, BC--(Marketwired - November 10, 2016) - BriaCell Therapeutics Corp. ("BriaCell" or the "Company") (TSX VENTURE: BCT) ( : BCTXF), a clinical-stage immuno-oncology company dedicated to the development of immuno-oncology treatments that can enhance the lives of cancer patients, today provided a comprehensive clinical development update for BriaVax™, its proprietary vaccine for advanced breast cancer. BriaVax™ is a genetically engineered whole-cell vaccine derived from a human breast tumor cell line. It is believed to activate the immune system to recognize and eliminate cancerous cells by inducing tumor-directed T cell and potentially antibody responses. BriaVax™ is entering an open-label Phase I/IIa clinical trial designed to evaluate its safety and activity in patients with metastatic breast cancer. The clinical trial will be conducted under the leadership of Dr. Jarrod P. Holmes, a prominent breast cancer vaccine expert, at St. Joseph Health-Sonoma County. The Company has decided to only use BriaVax™ newly generated by the UC Davis Good Manufacturing Practice (GMP) facility in its upcoming Phase I/IIa clinical trial and not material generated more than a decade ago, as previously planned. In compliance with the most recent guidelines of the Center for Biologics Evaluation and Research (CBER) division of the FDA, BriaCell is currently conducting extensive testing on newly generated lots -- to ensure patient safety. The Company expects the testing results for the material intended to dose the first patient in late December 2016, and for the clinical trial to initiate mid to late Q1 2017. "We are very excited with the prospects of BriaVax™ as a potential second line treatment for advanced breast cancer," said Dr. Williams, BriaCell's President & CEO. "We look forward to working closely with the experts at the manufacturing site, UC Davis GMP certified facility, Cancer Insight, our Clinical Research Organization, and Dr. Holmes, the study's principal investigator to initiate the Ph I/IIa clinical trial in the coming months. BriaVax™ has been undergoing extensive testing in collaboration with the UC Davis GMP production facility with excellent results to date." BriaCell is an immuno-oncology biotechnology company developing a more targeted and potentially less toxic approach to cancer management compared to traditional chemotherapy strategies. BriaCell's mission is to serve late-stage cancer patients with limited treatment options. Immunotherapy has come to the forefront of the fight against cancer, harnessing the body's own immune system to recognize and selectively destroy cancer cells while sparing normal cells. Immunotherapy, in addition to generally being more targeted than commonly used types of chemotherapy, is also thought to be a highly potent approach aimed at preventing cancer recurrence. BriaVax™, the Company's lead product, is a genetically engineered whole-cell vaccine derived from a human breast tumor cell line. It is believed to activate the immune system to recognize and eliminate cancerous cells by inducing tumor-directed T cell and potentially antibody responses. The Company has already demonstrated encouraging clinical results, and is intent on building upon these results to further advance BriaVax™ through additional FDA-approved clinical trials in order to help cancer patients with limited therapeutic options. The results of two previous FDA Phase I clinical trials (one with the precursor cell line not genetically engineered to produce GM-CSF and one with BriaVax™) have been encouraging in patients with advanced solid tumors. Most notably, one patient with metastatic breast cancer responded to BriaVax™ with substantial reduction in tumor burden including lung and brain metastases. For more information on the previous clinical trials, please visit http://briacell.com/novel-technology/clinical-trials/, and on BriaCell per se, http://briacell.com/. The TSX Venture Exchange Inc. has in no way passed upon the merits of the Company and has neither approved nor disapproved the contents of this press release. Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release. Except for the statements of historical fact, this news release contains "forward-looking information" within the meaning of the applicable Canadian securities legislation which involves known and unknown risks relevant to the Company in particular and to the biotechnology and pharmaceutical industries in general, uncertainties and other factors that may cause actual events to differ materially from current expectation. These risks are more fully described in the Company's public filings available at www.sedar.com. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. The Company disclaims any intention or obligation, except to the extent required by law, to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
News Article | December 22, 2016
De to selskaber, der tidligere har været under samme private ejerskab, producerer allergenekstrakter og andre materialer til allergibehandling. Allergy Laboratories, Inc. og Crystal Laboratory LLC har tilsammen ca. 100 medarbejdere. Købsprisen udgør ca. USD 20 mio. (DKK 138 mio.) på en netto gældfri basis. Prisen afspejler, at Allergy Laboratories i 2015 har modtaget en påtale fra FDAs Center for Biologics Evaluation and Research (CBER) om, at man overvejer at inddrage selskabets licens til at fremstille biologiske produkter. ALK er overbevist om, at problemerne kan løses, men en væsentlig del af købsprisen tilbageholdes, indtil sagen er afklaret. Han fortsætter: "Som verdensleder inden for allergivaccination er ALK godt rustet til at løse Allergy Laboratories' licensproblemer med FDA. Vi vil samarbejde hurtigt og dedikeret med myndighederne om at løse problemerne." Overtagelsen er en del af ALKs strategi om at udbygge sin globale tilstedeværelse. Med købet vil ALKs markedsposition i Nordamerika blive styrket, og mulighederne for at øge salget af allergenekstrakter og relaterede produkter vil blive øget. Overtagelsen bekræfter dermed ALKs mål om at levere produkter af høj kvalitet til allergispecialister. Om Allergy Laboratories, Inc. og Crystal Laboratory LLC Allergy Laboratories, Inc., Oklahoma, er en FDA-godkendt farmaceutisk virksomhed, der producerer allergenekstrakter til diagnostisering og behandling af allergi. Crystal Laboratory LLC producerer råvarer til allergiprodukter. Selskabet leverer hovedsageligt til allergispecialister, og virksomhedens hovedprodukter er hætteglas og fortyndervæsker (diluenter). I 2015 meddelte FDA, at man overvejer at inddrage Allergy Laboratories biologiske licens. Læs mere på www.allergylabs.com og www.crystallabsllc.com. Om ALK ALK er en global, forskningsbaseret medicinalvirksomhed, der fokuserer på forebyggelse, diagnosticering og behandling af allergi. ALK er en af verdens førende virksomheder inden for allergivaccination (immunterapi) – en behandling af selve årsagen til allergi. Virksomheden har ca. 2.200 medarbejdere, og har datterselskaber, produktionsfaciliteter og distributører over hele verden. ALK har indgået partnerskabsaftaler med Torii, Abbott og Seqirus om kommercialisering af tabletbaserede allergivacciner i henholdsvis Japan, Rusland, Sydøstasien, Australien og New Zealand. Virksomheden har hovedkvarter i Hørsholm og er børsnoteret på NASDAQ Copenhagen. Læs mere på www.alk.net.
News Article | February 27, 2017
ENGLEWOOD, Colo., Feb. 27, 2017 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE MKT: AMPE) announced that the Office of Tissue and Advanced Therapies (OTAT), a branch of the Center for Biologics Evaluation and Research (CBER) of the FDA, has recently provided additional guidance for the...
News Article | November 10, 2016
ENGLEWOOD, Colo., Nov. 10, 2016 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE MKT: AMPE) updates its continuing discussions with the CBER Division of the FDA seeking the best path forward to obtain a Biological License for Ampion™ to treat patients suffering from pain caused by severe...
News Article | December 25, 2016
— PharmSource - CMO Scorecard: Outsourcing of NDA Approvals and CMO Performance - 2016 Edition Our research team crunched the numbers on 2015 drug approvals authorized by FDA's CDER, CBER, Fast Track and Breakthrough drugs, and selected EMA approved drugs. The bottom line of this report is that a shrinking number of CMOs are getting the lion's share of the contract manufactured new products. Complete report On CMO Scorecard: Outsourcing of NDA Approvals and CMO Performance - 2016 Edition addition with 7 market data tables and 8 figures, spread across 25 pages is available at http://www.reportsnreports.com/reports/789725-pharmsource-cmo-scorecard-outsourcing-of-nda-approvals-and-cmo-performance-2016-edition.html We identified at least three harbingers of a likely sustained increase in NME approvals in coming years - • Total approvals using a CMO grew, but the share of NDA that are outsourced was flat in 2015 • The number of NDA approvals will continue to grow, which is good news for CMOs • But outsourcing by global bio/pharma companies may be on the decline Scope • PharmSource's data-rich Trend Report, CMO Scorecard: Outsourcing of NDA Approvals and CMO Performance - 2016 Edition, concludes that these factors will provide both headwinds and tailwinds for the CMO industry. Reasons to buy • The report includes data that is valuable to CMOs offering dose manufacturing services For more information, please visit http://www.reportsnreports.com/reports/789725-pharmsource-cmo-scorecard-outsourcing-of-nda-approvals-and-cmo-performance-2016-edition.html