Biotechnology

News & Analysis as of

IMDRF Releases International Framework for Regulating Device Software

On October 14, 2014, the International Medical Device Regulators Forum (IMDRF) issued a final version of “Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations” (“the...more

Introducing a New Drug Into the Marketplace in the Lifecycle of a Pre-Sales Revenue Biotechnology Venture Destined for IPO Success

Mindful that this series of articles describes biotech ventures that are ripe for initial public offerings even before launching an income-producing drug product into the commercial market, the paramount objective for all...more

Success Protecting Intellectual Property in the Lifecycle of a Pre-Sales Revenue Biotechnology Venture Destined for IPO

For a drug discovery start-up, patent protection of the intellectual property underlying the commercialization pursuit is critically important. If the company is a university or research institution spin-out that obtained...more

The FDA Drug Approval Process in the Lifecycle of a Pre-Sales Revenue Biotechnology Venture Destined for IPO Success

The U.S. Food & Drug Administration regulates new drug approvals in a process that is extremely thorough, lengthy and expensive. Regulations apply to a drug candidate’s product development phase, the approval process and...more

Tech Transfers in the Lifecycle of a Pre-Sales Revenue Biotechnology Venture Destined for IPO Success

Many biotech ventures begin life as an invention conceived by a scientist/professor working in a laboratory at a federally-funded university or scientific institute. The intellectual property underlying such inventions is...more

Sherry Knowles Addresses Real World Impact of Myriad-Mayo Guidance at BIO Symposium

Last month, at the Biotechnology Industry Organization (BIO) IP & Diagnostics Symposium in Alexandria, VA, Sherry Knowles of Knowles IP Strategies addressed the impact of the U.S. Patent and Trademark Office's Myriad-Mayo...more

“Why Biobased?” Report Released by USDA

On October 7, 2014, the U.S. Department of Agriculture (USDA) released "Why Biobased?," a report that comprehensively synthesizes findings from the existing government, academia, and non-governmental organizations on...more

DuPont And P&G Announce Plans To Use Cellulosic Ethanol In Tide® Detergent

On October 6, 2014, DuPont and Proctor & Gamble announced their joint plan to replace currently used corn-based ethanol with cellulosic ethanol in North American Tide® laundry detergent. According to DuPont's press release on...more

Dutch Ministry Of Economic Affairs Releases Biobased Packaging Catalogue

The Dutch Ministry of Economic Affairs (DMEA) has launched the first edition of a Biobased Packaging catalogue that was compiled by Wageningen UR Food & Biobased Research. The catalogue came about as a result of companies...more

CMS Publishes Open Payments Data Detailing Payments and Transfers of Value Provided by Life Sciences Manufacturers to Physicians...

On September 30, 2014, CMS published data regarding payments and transfers of value that pharmaceutical, biologic, and medical device manufacturers provided to U.S. physicians and teaching hospitals during the period August 1...more

Amgen Poised to Enter Biosimilars Market

As reported in Fierce Biotech earlier today, Amgen announced the results of a Phase III clinical trial of its biosimilar drug (designated ABP 501) for moderate-to-sever plaque psoriasis conducted in comparison with adalimumab...more

Guest Post: Nature's Indelible Marker - Naturally abundant, stable isotopes have already protected the identity and origin of $1.5...

The pharmaceutical industry is an important segment of the world economy. In 2013, worldwide sales of prescription drugs were over $830 billion. If one adds in over-the-counter medicines and other health-related products...more

Malama Composites Wins "Most Innovative Technology" Award From PortTech For Biobased Rigid Urethane Foams

On September 25, 2014, Biobased and Renewable Products Advocacy Group (BRAG®) member Malama Composites, Inc. (Malama) announced that its biobased rigid urethane foams won the PortTech Los Angeles Entrepreneur Pitch...more

The Revitalize American Manufacturing And Innovation Act Passes House Of Representatives

On September 15, 2014, the U.S. House of Representatives passed H.R. 2996, the Revitalize American Manufacturing and Innovation (RAMI) Act. The Act "earmarks up to $300 million in federal funding -- $30 million annually for...more

Full Federal Court confirms isolated nucleic acids are patentable in Australia

• The Full Federal Court has unanimously confirmed that isolated nucleic acids, either DNA or RNA, are patentable in Australia. • The decision is in contrast to the recent decision of the US Supreme Court, which held a...more

Update on Mayo Myriad Patent Eligibility From USPTO BCP Partnership Meeting

On September 17, 2015, the USPTO held the first “bicoastal” Biotechnology/Chemical/Pharmaceutical Customer Partnership meeting, with live participation from the USPTO’s main campus in Alexandria, VA and from San Jose...more

Court Report -- Part III: September 2014

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Forest Laboratories LLC et al. v. Sigmapharm Laboratories LLC 1:14-cv-01119; filed September 3, 2014 in the District...more

Big Jumps Proposed to Size Standards for Environmental Remediation and Other Employee-Based Size Standards

On September 10th, SBA released proposed increases to the small business size standards for many of the industries that use employee-based size standards. The affected industries include some very popular ones for the...more

Court Report -- Part II: September 2014

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Roxane Laboratories, Inc. v. Zydus Pharmaceuticals USA, Inc. 2:14-cv-05423; filed August 28, 2014 in the District Court...more

The Return of Biotech IPOs

Biotech IPO market activity has recently returned to levels not seen since before the financial crisis. This has been brought about in part by the accommodations afforded issuers under the Jumpstart Our Business Startup Act...more

Court Report - August 2014 #4

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Aptalis Pharmatech Inc. et al. v. Apotex Inc. et al. 1:14-cv-01038; filed August 11, 2014 in the District Court of...more

Court Report - August 2014 #3

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Unimed Pharmaceuticals LLC et al. v. Perrigo Co. et al. 1:14-cv-01004; filed July 31, 2014 in the District Court of...more

FDA Releases Another Prospective Guidance

On August 5th, the U.S. Food and Drug Administration issued a "Guidance for Industry" entitled "Reference Product Exclusivity for Biological Products file under Section 351(a) of the PHS Act." Before setting forth the first...more

Corporate Governance in the Lifecycle of a Pre-Sales Revenue Biotechnology Venture Destined for IPO Success

So how do biotech ventures govern themselves to run efficiently while complying with state corporate law statutes and state and federal securities laws and regulations imposed by stock exchanges? Frugality that is often...more

Examination of Myriad-Mayo Guidance Comments -- International Bioindustry Associations

On March 4, the U.S. Patent and Trademark Office issued a guidance memorandum, entitled "Guidance For Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, & Natural...more

262 Results
|
View per page
Page: of 11