The news summaries appearing in BIO SmartBrief are based on original information from news organizations and are produced by SmartBrief, Inc., an independent e-mail newsletter publisher. The information is not compiled or summarized by BIO. Questions and comments should be directed to SmartBrief at bio@smartbrief.com.

Today's Top Story

• Genentech-ImmunoGen breast cancer drug wins FDA approval
  Roche Holding unit Genentech and ImmunoGen obtained FDA approval to market Kadcyla, or ado-trastuzumab emtansine, as a treatment for patients who have HER2-positive, metastatic breast cancer who don't respond to other treatments. Because of associated mortality, liver and heart risks, the drug will carry a boxed warning. The approval means a $10.5 million milestone fee will be paid to ImmunoGen. Reuters (2/22), Genetic Engineering & Biotechnology News (2/22)     

Cash-Healthy Achillion Plans to Raise $125M Via Offering

With its hepatitis C virus (HCV) pipeline percolating and $77.4 million in the coffers as of the end of last year, Achillion Pharmaceuticals Inc. disclosed its plan to begin a public offering that would raise $125 million more pursuant to a shelf registration. Find out the details.

Health Care & Policy

• EU approves Alexza's Adasuve for agitation control
  The European Commission approved Alexza Pharmaceuticals' inhaled antipsychotic drug Adasuve, or loxapine, for the control of mild-to-moderate agitation in adult patients with schizophrenia or bipolar disorder. The approval was based on results of two late-stage trials showing that Adasuve reduced agitation compared with a placebo. PharmaTimes (U.K.) (2/22)     

• EU panel backs approval of Sanofi Pasteur's Hexyon vaccine
  Sanofi Pasteur MSD's Hexyon, a 6-in-1 pediatric vaccine, was recommended for approval by the European Medicines Agency's Committee for Medicinal Products for Human Use. The product combines vaccines that intended to stop hepatitis B, poliomyelitis, diphtheria, tetanus, pertussis and invasive infections caused by Haemophilus influenzae type b. Reuters (2/22)     

• Relypsa kicks of Phase III study of hyperkalemia drug
  Relypsa has begun patient enrollment for a late-stage, pivotal trial of patiromer, or RLY5016, a high capacity non-absorbed oral potassium to control high levels of potassium in the blood. The trial will assess patiromer as a treatment for hyperkalemia among patients with chronic kidney disease. Pharmaceutical Business Review Online (2/21)     

• Gene screening in children topic of guidelines
  Decisions on conducting genetic tests and screening for children must focus on their best interests and should include genetic counseling, according to a policy statement issued by the American Academy of Pediatrics and the American College of Medical Genetics and Genomics. While both groups agree that gene tests should be performed on newborns, they do not support routine carrier testing for minors. The joint statement was published in the journal Pediatrics. PhysiciansBriefing.com/HealthDay News (2/21)     

Company & Financial News

• StemBioSys raises $2M for stem cell culturing technique
  StemBioSys has secured $2 million in an equity offering to support the development of a method of growing stem cells. The company has said it plans to put the money toward validating its three-dimensional culture for growing mesenchymal stem cells from bone marrow, umbilical cord blood and fat. MedCityNews.com (2/21)     

• Mass. diagnostics company gets $2M boost for autism assay
  Laboratory Corporation of America has invested $2 million in SynapDx. The Lexington, Mass.-based company will use the funding to develop a blood-based assay that can diagnose autism spectrum disorder in children earlier than existing tests. Boston Herald (2/21)     

• Nuclea obtains $1 million in equity funding round
  Nuclea Biotechnologies has secured $1 million in a round of equity financing from 10 investors. The Pittsfield, Mass.-based company focuses on the commercialization of cancer and diabetes diagnostic tests, including a blood-based assay that CEO Patrick Muraca said has been clinically tested for monitoring prostate cancer and other uses. American City Business Journals/Boston/BioFlash blog (2/21)     

Food & Agriculture

• Biotech corn trial planned in Thailand
  Naresuan University, in collaboration with Monsanto Thailand, plans to conduct a field trial of NK 603 biotech corn's resistance to grass-killing chemicals. The seven-month trial could begin in March at an agricultural research station in Wang Thong district. Bangkok Post (2/23)     

Hot Topics

Top five news stories selected by BIO SmartBrief readers in the past week.

• Breaking down the list of biopharma's most influential (Forbes)

• Tech moguls launch life sciences awards totaling $33M (The New York Times (tiered subscription model))

• FDA accelerates review of ViiV's HIV/AIDS drug dolutegravir (Yahoo)

• Valeant pays $65M upfront for U.S. rights to Eisai's Targretin (Genetic Engineering & Biotechnology News)

• Chiasma licenses acromegaly drug candidate Octreolin to Roche (PharmaTimes (U.K.))

• Results based on number of times each story was clicked by readers.

Industrial & Environmental

• Canadian biofuel incentive program will end in 2017, official says
  Joe Oliver, Canada's minister of natural resources, wrote a letter to the country's biofuel producers denying their request for an extension of a program that provides financial incentives to ethanol and biodiesel production projects. The government won't extend the program's funding beyond its scheduled expiration in 2017, Oliver said. "During this time of fiscal restraint and challenging global fiscal realities, our government has committed to ensuring that we balance our budget," he wrote. The Globe and Mail (Toronto) (tiered subscription model) (2/22)     

News from BIO

• Are you taking full advantage of your membership?
  BIO's cost-savings program, BIO Business Solutions, is helping 2,700 companies nationwide save on the cost of essential products and services. Members of BIO and 43 state and regional biotech associations are eligible to receive preferential pricing and other benefits at no additional cost beyond their membership dues. VWR International, FedEx, Office Depot and Business Wire are just a few of the industry leading providers that offer special pricing through this members-only program. Learn more or enroll here.     

SmartQuote

It is wonderful how much news there is when people write every other day; if they wait for a month, there is nothing that seems worth telling." --Anna Masterton Buchan, Scottish writer