Ajinomoto Althea, Inc. Receives European GMP Certification
Ajinomoto Althea, Inc. (“Althea”), a leading provider of biopharmaceutical contract development and manufacturing services announced today that it has officially received its European GMP certificate issued by the Medicines and Healthcare products Regulatory Agency (MHRA). The MHRA conducted an on-site inspection on June 19, 2014 that yielded no critical or major observations. This certification provides clearance to Althea to test commercial drug product for the European market. By issuing this certification, the MHRA officially recognizes that Althea’s quality control testing and overall quality systems are in strict compliance with the European GMP requirements.
“Althea is proud of this important regulatory milestone. We are well known for our impeccable regulatory track record in the US and now are very pleased to expand our commercial testing capabilities for European clients,” stated David Enloe, President and CEO of Althea. “Knowing that our testing and quality processes meet both the stringent FDA and EMA quality requirements really signifies a great accomplishment by our team and supports our leadership position in the CMO market.”
From SCRIP Intelligence: US gambles $24.9m to speed Ebola drug ZMapp
Gambling big that positive animal study results will translate into human efficacy, the US Biomedical Advanced Research and Development Authority (BARDA), part of the Department of Health and Human Services (HHS), put $24.9m on the table to support an 18-month contract with Mapp Biopharmaceutical to help speed the development of its experimental Ebola drug ZMapp.
The contract could ultimately be worth $42.3m to the tiny San Diego-based biotech, whose experimental monoclonal antibody cocktail has rocketed to fame in the past month, especially after two American healthcare aid workers given the drug recovered from the Ebola virus, which they acquired while volunteering in Liberia (scripintelligence.com, 22 August 2014, 07 August 2014, 05 August 2014).
BARDA, which develops and procures medical countermeasures intended to address the consequences of chemical, biological, radiological and nuclear accidents, incidents and attacks, pandemic influenza, and emerging infectious diseases, also is providing the nine-employee company with access to "subject matter expertise and technical support for manufacturing, regulatory and nonclinical activities" through the contract, the agency said, noting the ultimate goal is FDA approval of ZMapp.
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Millennium Laboratories Changes Name to Millennium Health, Reflecting Evolution to Broader Health Solutions Company
Millennium Laboratories has changed its name to Millennium Health, a move that better reflects the company’s market position as a broad health solutions company. Through expanded product and service offerings, a robust research and development program, and the acquisition earlier this year of RxAnte, Millennium Health is a leading provider of accurate, timely, clinically actionable information to help tailor patient care. The company is focused on providing clinical tools and solutions to help payers, health care providers, and their patients to cost-effectively optimize medication use.
“The nation spends about $300 billion dollars annually on prescription medications and an additional $300 billion paying for the consequences of improper and ineffective medication use. The high cost – in dollars and in loss of human life – due to misuse and abuse of medications is one of the biggest health care issues we face as a country,” said Millennium Health Chief Executive Officer Brock Hardaway. “Clinicians need effective tools and our comprehensive portfolio of products and services can play a vital role in appropriate, effective and safe prescribing to optimize medications and improve patient health.”
Sonendo Closes $35 Million Equity Financing Round
Sonendo, Inc., the developer of a transformative technology for the endodontic marketplace, announced today it has completed an equity financing totaling $35 million. The proceeds from the financing will be used to further technology development, fund clinical studies, and commercialize Sonendo’s GentleWave System for root canal therapy. The System debuted at the American Association of Endodontists (AAE) annual meeting in May of this year, and is currently in limited market release.
The round was led by Meritech Capital Partners with new investor SEB Private Equity joining Fjord Ventures, OrbiMed Advisors, LLC, and NeoMed Management to form the investor syndicate. Paul Madera, Co-founder and Managing Director of Meritech Capital Partners, has joined the Sonendo Board of Directors, increasing the total number of directors to nine. Mr. Madera has led Meritech's investments in several notable technology companies including 2Wire, BlueArc, Facebook, IntraLase, Riverbed Technology, Salesforce.com, and Yammer.
From SCRIP Intelligence: Allergan asks court to block Valeant, Pershing Square shareholder votes
Allergan is asking the US District Court for the Central District of California to block Valeant Pharmaceuticals and Pershing Square Capital Management from voting in favor of holding a shareholder meeting that is designed to support Valeant's $50.3bn acquisition of Allergan.
US District Judge David Carter previously denied Irvine, California-based Allergan's request to expedite its lawsuit against Valeant, Pershing Square and the hedge fund's CEO Bill Ackman, which accuses the Canadian specialty pharma company and Allergan's largest shareholder of violating US securities trading laws (scripintelligence.com, 23 August 2014). However, Allergan says the judge "provided a roadmap for adjudicating those claims on a prompt basis if and when the defendants submitted a sufficient number of stockholder requests for a special meeting."
Valeant and Pershing Square needed 25% of Allergan's shareholders to request a special meeting where stock owners will be asked to vote in favor of a mostly new Allergan board of directors and require the board to immediately consider Valeant's cash and stock proposal to buy Allergan. Pershing Square recently delivered requests for a shareholder meeting from investors owning 31% of Allergan's outstanding shares.
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The mystartupXX Program Receives $50,000 Grant from the U.S. Small Business Administration
The mystartupXX program, a collaboration of the Rady School of Management at UC San Diego and the von Liebig Entrepreneurism Center at the UC San Diego Jacobs School of Engineering is pleased to announce it has been chosen as the recipient of a $50,000 grant from the U.S. Small Business Association (SBA). The announcement was made at the Rady School by SBA Administrator, and Obama Administration Cabinet member, Maria Contreras-Sweet.
“There is so much innovation and job creation in San Diego and I believe the economic leadership at UC San Diego is extraordinary,” said Administrator Maria Contreras-Sweet. “I am pleased to announce the first winner of the grant based in California, mystartupXX. The mystartupXX program is doing something special and is a great contribution to America and to women.”