Top 5 News 12/13/14 – 12/19/14

Top 5 logo1) State gives $1M grant for Cambridge researchers to develop first-ever Ebola testBoston Business Journal, December 16, 2014
The state is giving $1 million as the first payment in which it hopes will be $5.5 million for a Cambridge diagnostics firm to develop the world’s first Ebola diagnostic test within six months. Marcus Lovell-Smith, president and CEO of Diagnostics For All in Cambridge, told the Boston Business Journal that the science for the test has already been developed, and the money will be used to make it commercially available for “substantially less” than $10 per test. Link

2) Patrick names new life science center board member at pivotal time for agencyBoston Business Journal, December 17, 2014
In his waning days as governor, Deval Patrick today named the seventh and final board member on one of his signature accomplishments over the past eight years, the Massachusetts Life Sciences Center, at a pivotal time for the agency’s future. Link

3) Pfizer continues spending spree with $295M upfront for PhIII growth hormoneFierceBiotech, December 15, 2014
Pfizer’s business development team is on a spending spree. Today the pharma giant said it is partnering with Miami-based Opko Health on a Phase III long acting growth hormone, paying $295 million upfront and promising up to $275 million more on regulatory milestones. Link

4) Novartis wins an FDA nod for a long-acting spin on its rare disease drugFierceBiotech, December 16, 2014
The FDA signed off on a once-a-month version of Novartis’ ($NVS) Signifor designed to treat acromegaly, a rare growth hormone disorder that can lead to disfigurement and death. Link

5) J&J rents Halozyme’s R&D technology for up to $581MFierceBiotech, December 17, 2014
Johnson & Johnson ($JNJ) has signed a deal to use Halozyme Therapeutics’ ($HALO) drug delivery platform in its own R&D efforts, agreeing to pay as much as $581 million for the privilege. Link

Welcome New Members!

agilis-logoAgilis Biotherapeutics utilizes innovative DNA, vector and drug delivery approaches to develop novel gene therapies to improve the lives of patients affected by life-threatening rare diseases, with technologies and capabilities extending to larger disease indications. Link

alliedmindsAllied Minds (LSE: ALM) is an innovative U.S. science and technology development and commercialization company. Operating since 2006, Allied Minds forms, funds, manages and builds products and businesses based on innovative technologies developed at leading U.S. universities and federal research institutions. Allied Minds serves as a diversified holding company that supports its businesses and product development with capital, central management and shared services. Link

flexFlex Pharma is a biopharmaceutical company dedicated to creating innovative, novel treatments for neuromuscular disorders, and has demonstrated human efficacy related to muscle cramping. Link

global regulatoryGlobal Regulatory Partners-LLC provides tailored Regulatory Affairs, Clinical, Quality and Safety services to Pharma , Biotech and Medical device companies in US and Globally. Link

ivaIn Vitro ADMET Laboratories is proud to present our products and contract services, which represent three decades of expertise in the application of in vitro experimental systems to evaluate drug absorption, metabolism, drug-drug interactions and drug toxicity. Our forte: high-quality hepatocytes and cell culture media to support in vitro research.
In addition to the “routine” in vitro ADME studies that are offered by many contract research organizations, we have developed techniques that allow the use of hepatocytes in higher throughput screening assays to aid the selection of best drug candidates for during early phases of drug development: Organ-specific toxicity evaluation (e.g. hepatotoxicity; nephrotoxicity; neurotoxicity) using primary cells either as mono-cell type studies or as multiple organ co-cultures using our patented Integrated Discrete Multiple Organ Co-culture (IdMOC) experimental system; human hepatocyte P450 inhibition assays, and human hepatocyte P450 induction assays; as well as a comprehensive screening assay for adverse drug properties. Link

ippIndustrial Protection Products Inc. is our newest Purchasing Consortium Vendor. In 1977, Dick Murphy founded Industrial Protection Products, Inc. an industrial safety distributor. IPP quickly became one of the most trusted and respected names in the safety business. IPP quickly expanded into the prescription safety eyewear business, pioneering the now famous “Vision Van” concept, involving mobile eyewear dispensation. The mobile service concept expanded within the business and, in 1989, IPP begain its Mobile Safety Footwear business. IPP is now New England’s largest safety footwear supplier. Link

purehoneyPureHoney Technologies is a Contract Research Organization working with pharmaceutical and biotechnology drug discovery scientists. PureHoney Tech offers services in high-throughput screening including assay development; primary and secondary screening; SAR applications; method development (where required); along with ADME analyses of CYP inhibition, microsomal stability, PAMPA and PPB assays (using customer assays or those that we develop).We use the Agilent RapidFire technology platform to deliver thousands of data points in a few days. Link

restorgenexRestorGenex Corporation is a specialty biopharmaceutical company initially focused on developing products for oncology, dermatology, ophthalmology and women’s health. The Company is reviewing and intends to continue to review its products and technologies. The Company’s prescription dermatology business primarily is based upon Company compounds under development for the treatment of keloid scarring and androgen excess, e.g. acne and hirsutism (unwanted excess hair). The Company’s ophthalmology product will target age-related macular degeneration, based on inhibition of the PI3K/Akt/mTOR pathway. The Company’s prescription women’s health business is based upon a “soft” estrogen compound under development for vulvar and vaginal atrophy (VVA), a condition affecting peri- and post-menopausal women due to declining levels of estrogen. Link

Top 5 News Stories 12/4/14 – 12/12/14

Top 5 logo1) Merck splashes into antibiotics with $9.5B Cubist deal - FierceBiotech, December 8, 2014
Merck ($MRK) is shelling out $9.5 billion for antibiotics specialist Cubist Pharmaceuticals ($CBST), joining the wave of major drugmakers with a renewed interest in anti-invectives. Under the deal, Merck will hand over $102 in cash for each Cubist share, a 35% premium to the company’s average stock price last week. That gives Cubist an equity value of $8.4 billion, and Merck is signing up to cover another $1.1 billion in debt, expecting to close the acquisition in the first quarter of next year.  Link

2) Groups merge to form big California biotech lobbying groupSF Gate, December 8, 2014
The Bay Area biotech industry’s advocacy organization is merging with another group to become a newly created organization that will represent all of California’s biomedical industry. The new group, the California Biomedical Innovation Alliance, will be made up of the Bay Area Bioscience Association, or BayBio, and the California Healthcare Institute, a San Diego think tank focused on the state’s biopharmaceutical community, the groups said Monday. Link

3) GE Healthcare Life Sciences, Sigma-Aldrich License CRISPR/Cas9 PatentsGenetic Engineering & Biotechnology News, December 4, 2014
The Broad Institute of MIT and Harvard signed non-exclusive license agreements granting access to its intellectual property relating to the CRISPR/Cas9 gene engineering system for research purposes to GE Healthcare Life Sciences and Sigma-Aldrich, the companies said separately today. Link

4) Teva Announces Launch of First Generic Celebrex® Capsules in the United StatesBusiness Wire, December 10, 2014
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) announces the launch of the first FDA-approved generic equivalent to Celebrex® (Celecoxib) Capsules in the United States. Teva is offering 50, 100, 200, and 400 mg strengths of Celecoxib Capsules. Link

5) EMD Serono launches app to help patients verify medicineBoston Business Journal, December 10, 2014
In a move likely to be replicated over the next couple years by other drug firms, Rockland-based EMD Serono has launched an app that allows patients to scan its prescription drugs with a smartphone in order to verify that they aren’t counterfeit. Link

Top 10 Questions About the New Sick Time Law, Guest Blog Post by Foley Hoag’s Lyndsey Kruzer

FH07041-logo_cf4Last month, Massachusetts voters approved a new sick time law that will affect all employers in the Commonwealth. The law, which takes effect on July 1, 2015, has raised several questions for employers. The questions below are addressed by Lyndsey Kruzer, an Associate in Foley Hoag’s Employment Law Department. They are intended to help guide employers as they prepare to comply with the law.

  1. What employers are covered by the law?

All Massachusetts employers are covered by the new law. Under the law, employers must allow employees to accrue and use up to 40 hours of sick time per calendar year. For employers with 11 or more employees, whether full-time or part-time, the sick time must be paid. For smaller employers, the sick time can be unpaid.

  1. Who counts as an “employee” for determining whether a company has 11 or more employees?

Both full-time and part-time employees, regardless of how many hours they work per week, count as employees under the law.

  1. Does the law specify how sick time accrues?

Yes. The law states that employees will earn one hour of sick time for every 30 hours worked.

  1. Do new employees start accruing sick time immediately?

Yes. Once the law takes effect, newly-hired employees must be allowed to start accruing sick time immediately. However, the employer does not need to allow the employee to use the sick time until the employee has been employed for 90 days.

  1. When must a company allow employees to use accrued sick time?

Employees must be permitted to use earned sick time for the following reasons: (1) to care for a physical or mental illness, injury or medical condition affecting the employee or the employee’s child, spouse, parent, or parent of a spouse; (2) to attend routine medical appointments of the employee or the employee’s child, spouse, parent, or parent of a spouse; or (3) to address the effects of domestic violence on the employee or the employee’s dependent child. Notably, employers must allow employees to use sick time in increments as small as one hour, and employers may not require employees to “make up” the time they missed when using sick time.
Read the rest of this entry

Top 5 News Stories 12/1/14 – 12/5/14

Top 5 logo1) Allena Pharmaceuticals Secures $25 Million Series B FinancingYahoo! December 5, 2014
Allena Pharmaceuticals, Inc., a specialty biopharmaceutical company focused on developing and commercializing innovative non-systemic oral protein therapeutics to treat metabolic and orphan diseases, today announced the succesful completion of a $25 million Series B financing. The financing was led by HBM Partners, joined by existing investors Frazier Healthcare, Third Rock Ventures, Bessemer Venture Partners and new investor Pharmstandard International. Link

2) Amgen snags a lightning-fast approval for its leukemia immunotherapyFierceBiotech, December 3, 2014
The FDA approved Amgen’s ($AMGN) new leukemia treatment more than 5 months ahead of schedule, green-lighting the first contender among a new class of immunotherapies that promise to change the standard of care in blood cancer. Link

3) Patients make their voices heard in drug approval processBoston Globe, December 4, 2014
“We’re seeing a trend of people getting more involved in their health care decisions,” said Michael Ringel, a partner and managing director at Boston Consulting Group who focuses on health care business. “Because of the Internet, it’s a lot easier for groups to self-organize. That is helping to drive the increased involvement of patient groups.” Link

4) U.S. patients get Genzyme drug for MSBoston Herald, December 4, 2014
An injectable multiple sclerosis drug developed by Cambridge biotech giant Genzyme was made available to patients in the U.S. for the first time yesterday, less than a month after federal regulators reversed course and approved the medication. Link

5) Sky-High Genetic Cholesterol Targeted for Blockbuster Drug. Now to Find the PatientsBloomberg, December 5, 2014
Rader, head of preventive cardiology and human genetics at the University of Pennsylvania in Philadelphia, is looking for fatty buildups in the knees and ankles or white arcs around the cornea of the eye. The hereditary condition he’s seeking, known as familial hypercholesterolemia, affects as many as 1.5 million Americans — a group drug companies see as one of the first markets for a set of potential blockbuster cholesterol drugs. Link