Mass Life Sciences Center Launches Accelerator Loan Program 01/07/2013
Posted by Morse, Barnes-Brown Pendleton in Events, Life Sciences.Tags: accelerator loan, early stage, mass life sciences center
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On January 4, the Massachusetts Life Sciences Center announced it was launching the second year of its Accelerator Loan Program, in which early-stage life sciences companies apply for the opportunity to receive working capital to aid in the process of developing their science or technology, and to position these companies for subsequent investment. This year, loans for this program will be capped at $1 million per company. Applications are now being accepted and are due by February 8, 2013.
To date, the Accelerator Program has awarded $15.1 million in loans to 24 companies, six of which have paid back their Accelerator loans early with interest after generating more than $105 million in equity or acquisition proceeds.
To learn more or to apply for the Accelerator Loan Program, please visit Mass Life Sciences Center.
Information Session Life Sciences Tax Initiative Program 09/21/2012
Posted by Morse, Barnes-Brown Pendleton in Events, Legal Developments, Life Sciences.Tags: mass life sciences center, tax incentives, tax program
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On Tuesday, October 2nd MBBP is hosting a joint event with McGladrey, LLP on the 2012 round of the MLSC Tax Program. In order to expand life sciences-related employment opportunities, promote health-related innovations and stimulate research and development, manufacturing and commercialization in the life sciences, the Massachusetts Life Sciences Center is offering tax incentives in 2012 to companies engaged in life sciences research and development, commercialization and manufacturing in Massachusetts. The Life Sciences Initiative authorizes the Center to award up to $25 million in tax incentives each year.
The primary goal of the Program is to incentivize life sciences companies to create new long-term jobs in Massachusetts. To qualify companies must receive certification from the Center and must demonstrate both the scientific and academic merit of their expansion plans.
You won’t want to miss this chance to get details and answers to your questions with Program speaker Brad Rosenblum, Chief Financial and Administrative Officer for the Massachusetts Life Sciences Center. Mr. Rosenblum is responsible for MLSC’s Finance, Information Technology, Human Resources, Risk Management and Facilities, and has over 20 years finance experience with public and private companies in various roles.
For more information, directions, or to register, please visit the event page: Information Session – Life Sciences Tax Incentive Program.
FDA to Hold Public Hearing on May 11th, 2012 to Obtain Input on Draft Biosimilars Guidance 03/15/2012
Posted by Morse, Barnes-Brown Pendleton in Legal Developments, Life Sciences.add a comment
By: David Fazzolare
The Food and Drug Administration (FDA) plans to hold a public hearing on May 11, 2012, from 8:30 a.m. to 5 p.m., to gather feedback on its recently released draft biosimilars guidance documents. The FDA’s release of the draft guidance documents is a significant milestone toward the implementation of the Biologics Price Competition and Innovation Act of 2009, which establishes an abbreviated path for the approval of biologic products that are biosimilar to, or interchangeable with, a reference product. The FDA plans to finalize these draft guidance documents based on the information it receives during the hearing.
Individuals wishing to comment on the FDA’s draft biosimilars guidance may present at the hearing if they register by April 11, 2012, and may submit written comments until May 1, 2012.
The hearing will take place at the FDA’s White Oak Campus, which is located at 10903 New Hampshire Avenue, Building 31, Room 1503, in Silver Spring, Maryland. The FDA is broadcasting a live webcast of the hearing for those who are unable to attend. In addition, transcripts will become available no sooner than 30 days after the hearing.
Please review the FDA’s notice, or contact David A. Fazzolare for more information.
FDA Releases Long-Awaited Draft Guidance on Biosimilars 02/13/2012
Posted by Morse, Barnes-Brown Pendleton in Legal Developments, Life Sciences.Tags: biosimilar products, FDA, guidance documents
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By: David Fazzolare
The long-awaited guidance on biosimilar product development has finally been released by FDA. On Thursday, February 9th, FDA released three guidance documents on biosimilar product development which reflect the agency’s current thinking on important scientific and regulatory considerations pertinent to submitting biosimilar applications.
The first guidance document, entitled “Scientific Considerations in Demonstrating Biosimilarity to a Reference Product”, focuses on therapeutic protein products, and aims to help biosimilar applicants show that a biologic is biosimilar to a licensed biologic.
The second guidance document, entitled “Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product”, details analytical considerations (e.g., biological characterization) involved in evaluating biosimilarity.
The third guidance document, entitled “Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009”, addresses common questions biosimilar applicants may face in developing biosimilars, particularly in early product development stages.
FDA is expected to publish a request for public comments on the draft guidance documents in the Federal Register, and will consider such comments while finalizing its guidance.
Contact David A. Fazzolare for more information.
Expanded Track I Prioritized Examination of Patent Applications 01/26/2012
Posted by Morse, Barnes-Brown Pendleton in Legal Developments, Life Sciences.Tags: patent applications, patent process, USPTO
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By: Stan Chalvire
The U.S. Patent and Trademark Office (USPTO) has issued final rules (75 Fed. Reg. 78566) extending the prioritized examination (Track I) provisions to patent applications in which a Request for Continued Examination (RCE) has been filed (see, Three Track Patent Examinations: USPTO Provides Further Guidance). The recently issued final rules provide patent applicants with the flexibility to accelerate the processing and examination of their applications in which an RCE has been filed by according such applications special status. An application that is accorded special status is placed on the Examiner’s special docket throughout its entire course of continued prosecution before the Examiner until a final disposition (e.g., the mailing of a notice of allowance or final office action, or the filing of a notice of appeal or subsequent RCE) is reached. The USPTO’s goal for handling applications under prioritized examination is to, on average, provide a final disposition of the application within twelve months of prioritized status being granted.
Requesting prioritized examination after the filing of an RCE requires that:
- The RCE be filed in an original utility or plant non-provisional application filed under 35 U.S.C. 111(a) or that has entered the national stage under 35 U.S.C. 371, accompanied by, among other things, a prioritized examination fee of $4,800 (which is subject to a fifty percent small entity discount);
- The request for prioritized examination be filed via the USPTO’s electronic filing system (EFS-Web) either concurrently with, or subsequently to, the filing of an RCE;
- Upon filing the request for prioritized examination, the application must contain or be amended to contain no more than four independent claims and no more than thirty total claims and no multiple dependent claims and, to the extent that an amendment is filed in an application that has been granted prioritized examination that exceeds these requirements, the prioritized examination will be terminated; and
- The request is filed prior to the USPTO’s acceptance of 10,000 requests for Track I prioritized examination under Sec. 1.102(e) in the fiscal year.
The final rules concerning the prioritized examination of applications in which an RCE has been filed became effective on December 19, 2011, and are applicable to any patent application in which an RCE has been filed before, on, or after December 19, 2011. For more information regarding prioritized examination, or to discuss other strategies for expediting the examination of your patent applications, please contact Stan Chalvire.
Boston Area Claims Top U.S. Life Sciences Hub in New Report 12/16/2011
Posted by Morse, Barnes-Brown Pendleton in Life Sciences.Tags: boston life science, jones lang lasalle, mass high tech
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Mass High Tech recently published an article describing a new global report released by real estate services firm Jones Lang LaSalle which names Boston the number one life sciences cluster spot in the United States. The US Life Sciences cluster rankings were based on scores in each of the following six categories:
- High-Tech Research & Hospital/Medical Employment
- Science & Engineering Graduate students
- National Institute of Health Funding
- VC Funding
- Research and Development Spending as % of GDP
- Academic and Research Institute Facilities
Boston ranked number one in five of the six methodology categories, beating out 13 other regions. The only area in which Boston did not take the top spot – in this case, claiming the number two ranking – was in venture capital funding.
To view the full report, please visit Jones Lang LaSalle.
The ABCs for Life Sciences Entrepreneurs: From Start-Up to Exit 12/21/2010
Posted by Morse, Barnes-Brown Pendleton in Events, Life Sciences, MBBP news.Tags: Life Sciences, patents, trademarks
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Thinking about starting or joining a life sciences company, now or in the future? If so, please join Morse, Barnes-Brown & Pendleton for a series of engaging and interactive discussions on the basic topics with which entrepreneurs in the life sciences today must be familiar. There will be four sessions, each covering a different topic:
All sessions will be held at our Waltham office from 5:30 to 6:30 pm. Though inter-related, each session stands alone, so feel free to attend some or all of the sessions according to your interest. Complimentary refreshments will be provided.
For more information and to register, please contact Jaclyn Jefgood or 781-622-5930. Please provide the date(s) of the sessions you would like to attend.
Massachusetts Life Sciences Center Announces New Small Business Matching Grant Program 02/02/2010
Posted by Morse, Barnes-Brown Pendleton in Life Sciences.Tags: grant, Massachusetts Life Sciences Center, small business
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The Massachusetts Life Sciences Center (MLSC) has announced the launch of its new Small Business Matching Grant (SBMG) Program. The program is designed to support early-stage life sciences companies and grow employment opportunities, promote manufacturing and commercialization, and stimulate innovation across the Commonwealth.
The primary objective of the SBMG is to provide grants to commercialization-ready life sciences companies that have received at least the equivalent of a Phase II small business innovation research (SBIR) or small business technology transfer (STTR) grant from federal agencies such as the National Institutes of Health (NIH), National Science Foundation (NSF), Department of Defense (DOD), etc. Grants will provide “matching” support – capped at $500,000 per company — to Phase II or Post Phase II SBIR or STTR grants already received by applicant companies.
MLSC is targeting an FY ’10 investment of $3 million in the Small Business Matching Grant Program.
For more information on the program, please visit the Massachusetts Life Sciences Center.
Allegro Diagnostics Receives Grant From The National Cancer Institute 10/27/2009
Posted by Morse, Barnes-Brown Pendleton in Client News, Life Sciences.add a comment
MBBP client Allegro Diagnostics has received a $2.8 million Phase 1/2 Fast Track Small Business Innovation Research grant from The Cancer Institute to be used for a clinical study of its lung cancer diagnostic test, BronchoGen. Allegro Diagnostics, a Boston-based medical test developer, has enrolled 800 people throughout the United States to receive the BronchoGen test, which studies the RNA gene expression levels of patients’ airway-lining cells that are accessed during bronchoscopy.
The full article can be read here.
New Marketing Rules for Pharmaceutical and Med Dev Companies 07/20/2009
Posted by Morse, Barnes-Brown Pendleton in Legal Developments, Life Sciences.add a comment
MA Regulations Regarding Compliance with Pharmaceutical and Medical Device Manufacturer Code of Conduct Take Effect
On July 1, 2009 the recently enacted Massachusetts Pharmaceutical and Medical Device Manufacturer Conduct regulations (the “Marketing Code of Conduct”) went into effect. The Marketing Code of Conduct governs the behavior of both pharmaceutical and medical devices manufacturers that commercialize FDA-approved products in the Commonwealth (collectively “Manufacturers”), and in particular addresses the relationships between those Manufacturers and health care practitioners who are licensed to practice in the Commonwealth (“Practitioners”).
In implementing the Marketing Code of Conduct, the objectives of the Massachusetts Department of Public Health are, among other things, to minimize potential conflicts of interest, to enhance the transparency of relationships between Manufacturers and Practitioners and to preserve the independent judgment of Practitioners. In furtherance of these objectives, the Marketing Code of Conduct imposes specific compliance requirements, marketing restrictions and disclosure obligations on Manufacturers that employ or contract with a sales representatives or agents to commercialize their products in the Commonwealth.
Click here to read more.
