FDA drafts guidance on NGS-based tests

The 90 day period is open for submitting comments on two draft guidances issued by the FDA regarding development of next generation sequencing tests. World Pharma News

Current regulations hamper fair drug prices

Modifying certain regulatory structures can encourage price competition and innovation simultaneously. HealthAffairsBlog

CRS report on Congress' medical innnovation bills

How does the Senate's medical innovation package compare to the House's 21st Century Cures Act? Congressional Research Service

Bioscience industry shows growth in jobs and wages

BIO and TEConomy Partners released latest analysis of bioscience activity across the U.S. GEN News Highlights

FDA updates compassionate use program

The FDA revamped application guidelines for expanded access to investigational therapies.

GMOs and a growing world

Biotechnology continues to improve crops that are needed to feed many millions worldwide. Texas A&M AgriLife

Price controls short-sighted

Policy that inhibits market factors serve to disincentivize innovation.  Boston Globe

Final guidance for naming drugs

FDA released final guidance for premarket review of proprietary drug names. Regulatory Focus

GSK new gene therapy headed for approval in Europe

The European Medicines Agency has given the nod to GSK's Strimvelis, a groundbreaking gene therapy for children with ADA-SCID. Reuters

Clinical Trial Protocol Template Posted for Public Comment

NIH and FDA are seeking feedback from stakeholders on a draft standardized format for submitting clinical trial protocols. FDA Voice

EMA launches PRIority MEdicines (PRIME)

The European Medicines Agency has added a priority medicines framework for accelerated assessment of treatment for patients with unmet medical needs. FierceBiotech 

Purdue University studies effects of no GMOs

Study looked at what would happen to the environment and economy if GMOs were banned. Purdue University Agriculture News

Industry comments on draft guidance for safety assessments

The FDA's current draft guidance on safety assessments for IND applications calls for the creation of safety assessment committees. RAPS

Research funding proposals in 2017 budget

ScienceInsider's look at President Obama's proposals for funding science in the next fiscal year.  Science

Petition to FDA for more data on biosimilar labels

BIO and PhRMA are calling for FDA biosimilar labeling guidance to require wider disclosure. RAPS

FierceBiotech reviews new drug approvals in 2015

The FDA approved 45 new drugs in 2015, its largest one-year tally since 1996. FierceBiotech

Genetic food progress in 2015

FDA approval of several genetically engineered foods this year provides further evidence of this technology's safety. The Wall Street Journal

ASH annual meeting highlights progress in hematology areas

New data presented at this year's American Society of Hematology annual meeting by Amgen, AbbVie, Johnson & Johnson and Novartis show significant progress in fighting blood-related diseases. FiercePharma

Gene-editing technology breakthrough against malaria

Scientists have identified two ways to lower the spread of malaria by mosquitoes. The Wall Street Journal

Novartis' Cosentyx cleared for wider use in Europe

Cosentyx has received approval from the European Medicine Agency for treating ankylosing spondylitis and psoriatic arthritis. FiercePharma

Asthma biologic Nucala approved in Europe

The European Commission has okayed GlaxoSmithKline's Nucala for treating adult patients with severe asthma. PharmaTimes

Boehringer and MD Anderson partner on cancer research

Boehringer Ingelheim and The University of Texas MD Anderson Cancer Center are partnering to develop new medicines for patients with pancreatic cancer. PR Newswire

Combo drug treatment for multiple myeloma approved

FDA priority review gave the green light to Bristol-Myers Squibb's and AbbVie's Empliciti for treating multiple myeloma patients who have had at least one line of therapy. PharmaTimes

Novartis to launch 2 new COPD drugs

Novartis' Seebri Neohaler and Utibron Neohaler have been approved for treatment of chronic obstructive pulmonary disease and will be available early next year. Pharmacy Times

Top 20 companies named by AAAS' Science Journal

Scientists surveyed by Science Careers value creative, innovative biopharma companies working to transform lives. Science Magazine

Cheaper substitute for Turing drug available

Imprimis Pharmaceuticals has a combination therapy that uses the same active ingredients as Daraprim and will sell it for 99 cents a tablet. Wall Street Journal

Amgen's Imlygic gets FDA nod for treating melanoma

The U.S. Food and Drug Administration approved Amgen's first-in-class oncolytic drug, Imlygic, an immunotherapy for treating melanoma lesions in the skin and lymph nodes. Reuters

GMO labels key topic at Senate Ag Committee hearing

Senator Debbie Stabenow called for compromise legislation by year end to standardize labeling of GMO foods across the country. AgriPulse

GSK submits antiseptic gel candidate for preventing umbilical cord infections

The European Medicines Agency has granted accelerated assessment status to GSK's application for its antiseptic chlorhexidine gel to help prevent umbilical cord infections in newborns. Development of this antiseptic is a product of GSK's partnership with Save the Children and is intended exclusively for use in developing countries. FirstWord Pharma

GMO-labeling law headed to court

While Congress considers bills establishing a federal policy for labeling GMO foods, a NYC federal appeals court prepares to hear a challenge to Vermont's law. Hartford Courant

New medicines lower health-care costs

Many new medicines represent an upfront, one-time cost to rid patients of vicious diseases that would ultimately cost the healthcare system far more in the long run. CT Mirror

FDA approves Bristol-Myers' melanoma combination treatment

Study data showed longer progression-free survival and higher tumor reduction rates among advanced melanoma patients who received a combination of Yervoy and Opdivo versus treatment with Yervoy alone. This marks the first and only FDA-approved combination of two immuno-oncology agents. Press release

Massachusetts Biotechnology Caucus convenes biotech panel

Panel of experts agree that legislating disclosure of development costs is not the way to lower healthcare costs. State House News Service

EACT removes barrier to clinical trial participation

The Ensuring Access to Clinical Trials Act of 2015 (EACT) passed the House this week and is on its way to the President's desk for signature. EACT makes permanent a 2009 law that allows exclusion under the Supplemental Security Income and Medicaid programs for compensation to people who participate in clinical trials for rare diseases. RAPS

FDA to engage patients via Advisory Committee

The Food and Drug Administration is launching a Patient Advisory Committee to advise them on complex issues relating to the use of medical devices. RAPS

Two new drugs slow progress of fatal lung disease

Boehringer Ingelheim's Ofev and Genentech's Esbriet are helping extend the lives of patients with idiopathic pulmonary fibrosis, a deadly lung disease affecting middle-aged and older adults. Wall Street Journal

Opdivo scores breakthrough tag for kidney cancer

Bristol-Myers Squibb's Opdivo, already approved for treating advanced melanoma and lung cancer, received FDA breakthrough status for kidney cancer. PharmaTimes

FDA approves SPIRIVA Respimat for asthma

Boehringer Ingelheim's maintenance treatment for COPD, SPIRIVA Respimat, has received FDA approval for treating asthma in patients at least 12 years old. Lung Disease News

Congress needs to address patent reform issues

Abuse of Inter Partes Review system threatens medical innovation. Medium

Amgen and Novartis team up to slow Alzheimer's

Amgen and Novartis will collaborate to develop drugs from a new class that inhibits the buildup of amyloid in the brain, which is thought to be the main cause of Alzheimer's disease. LA Times

Breakthrough multiple myeloma drug to get priority review

The FDA will reach a final decision within 6 months in their review of Empliciti, a new immuno-oncology drug developed by Bristol-Myers Squibb and AbbVie for treating multiple myeloma. FierceBiotech

2016 BIO Convention Call for Sessions

The floor is open for submitting your proposal to present a cutting-edge topic at next year's BIO International Convention in San Francisco (June 6-9, 2016). BIO 2016 Convention

FDA greenlights Amgen's PCSK9 blocking drug

Amgen's Repatha is the 2nd injectable LDL-lowering drug to be approved by the FDA for patients with hereditary forms of high cholesterol and those with cardiovascular disease. Wall Street Journal

Novartis' oral treatment for skin cancer approved

The U.S. Food & Drug Administration and the European Commission have okayed Novartis' Odomzo for treatment of locally advanced basal cell carcinoma. PharmaTimes

HIV treatment receives breakthrough designation

Based on positive results from a Phase II clinical study, Bristol-Myers Squibb has received breakthrough designation from the FDA for its investigational compound for heavily treatment-experienced HIV patients. Wall Street Journal

Amgen's Kyprolis added to second-line treatment of multiple myeloma

The U.S. Food and Drug Administration approved Kyprolis for use with Revlimid and dexamethasone following a phase 3 study that showed a 50% improvement in progression-free survival for patients with relapsed cases of this blood cancer. Pharmacy Times

Abbott launches iDesign system for LASIK procedures in U.S.

The same technology created by Abbott scientists to calibrate the mirrors on NASA's space telescope is used in their iDesignAdvanced WaveScan Studio System to map the human eye with greater precision during LASIK treatments. FierceMedicalDevices

Entresto fast-tracked to FDA approval

The FDA approved Novartis' Entresto, a new drug for heart failure that lowers a patient's chance of death or hospitalization by about 20%. The New York Times

Vermont labeling law could cost food companies millions

The Grocery Manufacturers Association says that Vermont's new biotech food-labeling law establishes fines that could cost food companies up to $10 million each day.
FoodEngineering Magazine 

BMS plans to open new facility in Cambridge

Bristol-Myers Squibb announced that it will open a new state-of-the-art research facility at 100 Binney Street in Kendall Square in 2018.
Press release

Panel recommends approval of new cholesterol drug, with caveats

A FDA advisory panel recommends approval of Sanofi and Regeneron's Praulent, a PCSK9-inhibitor, for certain high-risk groups, such as people with very high cholesterol for genetic reasons. Panel members say that more data over time is needed before approving PCSK9-inhibitors for broader use.  
Wall Street Journal

Achillion and Janssen team up to combat hepatitis C

Janssen Pharmaceuticals, a Johnson & Johnson company, and Achillion Pharmaceuticals have entered into a licensing and collaboration agreement to develop and commercialize several of Achillion's hepatitis C treatments.
Press release

Boehringer to develop Pharmaxis' anti-inflammatory drug candidate

Boehringer Ingelheim has acquired Pharmaxis' investigational drug PXS4728A to continue development of this small molecule inhibitor for the treatment of NASH, a progressive form of liver disease.

Coalition founds Biosimilars Forum

A coalition of 11 biopharma companies have formed the Biosimilars Forum to expand access and availability of biological medicines in the United States.
PR Newswire

 Alexion broadens rare disease therapies portfolio

Alexion Pharmaceuticals, Inc. announced today that it has agreed to buy Synageva BioPharma Corp. for $8.4 billion. Together the companies' developmental pipelines will contain eight experimental medicines in clinical trials for eleven rare diseases. Alexion/Synageva BioPharma Wall Street Journal

Finalized guidelines for biosimilars from FDA, finally

The FDA issued policy documents for biosimilars pertaining to the 2010 passage of the Biologics Price Competition and Innovation Act. Regulatory Focus

BMS CheckMate-057 trial stopped early

A Phase III trial evaluating Bristol-Myers Squibb's Opdivo for treating patients with advanced non-squamous non-small cell lung cancer was stopped early when the study met its endpoint. FiercePharma

Amgen gets FDA OK for heart drug ivabradine

The FDA approved Amgen's ivabradine, a new class of drug aimed at preventing hospitalization for worsening heart failure. MedPage Today

Farm Bureau backs bill related to GMO labeling

The American Farm Bureau Foundation supports a federal bill that proposes to unite states' GMO labeling efforts. Augusta Free Press

Astellas to team up with University of Texas

The University of Texas MD Anderson Cancer Center is partnering with Astellas Pharma Inc. to develop a more potent treatment for leukemia patients. MD Anderson Cancer Center

Pfizer lengthens alliance with BIND Therapeutics

Pfizer and BIND extended their agreement to work together on a new class of targeted and programmable therapeutics through March 2016. Genetic Engineering and Biotechnology News

Genetically engineered foods adding health benefits

New foods in development aim to help lower cancer and heart disease risk. New Zealand Herald

Vaccines for Meningitis B to begin in UK

Babies in the United Kingdom will be the first babies worldwide to be routinely vaccinated against Meningitis B with GlaxoSmithKline's Bexsero. BBC News

Biopharma companies form GENE Consortium

Alexion, GlaxoSmithKline and AstraZeneca are among 10 biopharma companies working with Genomics England to analyze genome data in search of new medical breakthroughs. Genomics England

AstraZeneca and Harvard Stem Cell Institute research collaboration

AstraZeneca will be working with Doug Melton's group at Harvard Stem Cell Institute to search for new diabetes treatments. FierceBiotech

FDA approves biotech apples, potatoes

The FDA approved two varieties of biotech apples and six types of biotech potatoes reporting that they are "as safe and nutritious as their conventional counterparts." Los Angeles Times

New Hampshire moves closer to oral parity law

New Hampshire's Senate Commerce Committee approved Senate Bill 137 that assures cancer patients will not have to pay higher out of pocket costs for oral anticancer drugs than for intravenous medication. Union Leader

PSK9 inhibitors may lower chance of heart attack

Several small studies show that PSK9 inhibitor drugs, already known to lower cholesterol, may also help reduce the number of major cardiovascular events. FierceBiotech

FDA approval of Opdivo expands to lung cancer

Bristol-Myers Squibb's immunotherapy drug, Opdivo, was approved by the FDA for treatment of one of the most common forms of lung cancer. New York Times

Amgen's Krypolis bests Tekada's Velcade in study

The latest trial, dubbed ENDEAVOR, showed that Krypolis held off disease progression twice as long as Velcade. FiercePharma

Bristol-Myers applies for PD-1 lung cancer treatment approval

The FDA has accepted Bristol-Myers Squibb's application to get Opdivo approved to treat lung cancer. BMS press release

New disease-resistant vegetable seeds

Monsanto's Seminis Home Garden unit unveiled 10 varieties of disease-resistant seeds that are adaptable to grow in a wide geographic distribution. American City Business Journals

Pfizer's Ibrance gets early approval from FDA

The FDA cleared Ibrance for use in combination with an older cancer drug, letrozole, in the treatment of advanced breast cancer. Fortune

89% of scientists say genetically modified foods are safe

A Pew Research Center study found that 57 percent of Americans believe GM foods are unsafe while 89% of scientists surveyed agree that they are generally safe. Genetic Literacy Project

Modified DNA not always present in biotech foods

Processing can degrade ingredients to the point that modified proteins and DNA are undetectable in some biotech foods. National Public Radio

FDA approves Novartis drug for plaque psoriasis

Novartis has obtained the FDA's approval to market its monoclonal antibody drug Cosentyx. Yahoo/Reuters

Monsanto Gets Nod from USDA For Next Generation Weed Control Technology

Last week, Monsanto announced the USDA's decision to deregulate Roundup Ready 2 Xtend soybeans and Bollgard II XtendFlex cotton. CBIA Manufacturing News

Bill to speed approval of new antibiotics reintroduced

Sens. Orrin Hatch and Michael Bennet have reintroduced the Promise for Antibiotics and Therapeutics Act (PATH) which would allow the FDA to expedite approval of new antibiotics. The Hill

Astellas Pharma has named Eric Terhaerdt senior vice president of global development

Global executive Eric Terhaerdt will lead the global direction of drug development operations at Astellas, working primarily in the U.S. and the Netherlands. FierceBiotech

Pfizer developing a cholesterol-lowering vaccine

Pfizer is developing a vaccine that targets the "bad" cholesterol protein, PCSK9. FierceVaccines

Biotech and Biopharma Industry Get Boost From Business Community

CBIA forms the Connecticut Bioscience Growth Council. CT News Junkie

AbbVie wins approval for Parkinson's treatment

The U.S. Food and Drug Administration approved AbbVie's Duopa treatment for advanced Parkinson's disease. FierceDrugDelivery

BI and Sanofi enter manufacturing alliance

Boehringer Ingelheim and Sanofi have entered into a manufacturing contract for therapeutic monoclonal antibodies. FiercePharma

Researchers developing a more thermo-tolerant wheat

Researchers at Kansas State University are developing a wheat with heat-resistant properties that could increase wheat yields up to 35%. Brownfield

Most important drugs approved in 2014

BMS' Opdivo and Merck's Keytruda are the most important drugs approved in 2014, according to Forbes' Matthew Herper. Forbes

Novartis receives approval for Cosentyx in Japan

The Japanese Ministry of Health, Labor and Welfare has approved Cosentyx for the treatment of psoriasis vulgaris and psoriatic arthritis. Japan is the first country in the world to approve it; FDA approval in the same indication is expected in early 2015. Drug Discovery and Development

Bayer CropScience's biotech soybean cleared for import in China

The Chinese governmet has approved the importation of Bayer CropScience's LL55 Liberty Link biotech soybean variety. Bayer plans to fully release the soybean in the Chinese market in 2015. Agweek

Astellas deal with Cytokinetics expands by $675M

Astellas deal is aimed at getting Cytokinetics' CK-2127107 into Phase II development. Genetic Engineering & Biotechnology News

Shingles vaccine study a success for GlaxoSmithKline

GlaxoSmithKline scored a Phase III win for its shingle vaccine more than four years after the study was launched. FierceBiotech

Pfizer's Duchenne muscular dystrophy drug enters Phase II trial

Pfizer has initiated a midstage trial to evaluate the safey, tolerability and efficacy of its experimental compound PF-06252626 for treating Duchenne muscular dystrophy.  The drug holds orphan status in the U.S. and Europe. PharmaTimes (U.K.)

China reportedly OKs import of Syngenta's biotech corn

The Chinese government reportedly approved the importation of Syngenta's Agrisure Viptera biotech corn. Reuters

Novartis' acromegaly drug gets FDA approval

Novartis has won the FDA's approval to market Signifor LAR for the treatment of adults with acromegaly, a life-threatening hormonal disorder. Reuters

Cubist accepts Merck's $9.5B buyout offer

Merck will pay $8.4 billion in equity and assume $1.1 billion in debt to purchase antibiotics maker Cubist Pharmaceuticals. Genetic Engineering & Biotechnology News

Novartis says biosimilar Neupogen shows promise

Novartis unit Sandoz's biosimilar version of Amgen's Neupogen, or filgrastrim, performed well in a Phase III trial. Reuters

Spark's hemophilia drug pact with Pfizer may be worth $280M

Pfizer and Spark Therapeutics agreed to collaborate in the development and marketing of Spark's investigational drugs for hemophilia B. American City Business Journals

Amgen drug for leukemia wins FDA approval

The FDA has approved Amgen's Blincyto for treatment of a form of leukemia.  Approval came five months ahead of schedule. Reuters

Astellas wins EU approval for prostate cancer drug

The European Commission has approved Astellas' Xtandi as a first-line treatment for some chemotherapy-naive patients. PharmaTimes (U.K.)

GlaxoSmithKline leads in getting drugs to poor

Early editions of the Access to Medicine Index focused on infectious and tropical diseases, but the list has been refined to include access to drugs for mental illnesses. New York Times

Alexion starts Soliris trial for kidney treatment

Alexion Pharmaceuticals has begun an international study of Soliris for the prevention of delayed graft function after kidney transplants. Soliris is marketed for the treatment of paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome. Hartford

Prior to 2012

New England Biotech Association Applauds Governor Patrick, Mass. Lawmakers for Allowing Patient Assistance Programs. Read Full Release

Will President Obama’s plan help save the bioscience economy? Some industry experts aren’t so sure. Paul Pescatello, president of the New England Biotechnology Association, likes that the administration’s plans "emphasize that breakthroughs very much save money for our economy in the long-term. Biotechniques

August, 10 2011
NEBA OPED: Cutting Medicare a Regional Mistake

July 17, 2011
New England Biotech Association and Medicare 

July 15, 2011
“An Act Concerning Health Insurance Coverage of Prescription Drugs for Pain Treatment” signed into law in Connecticut. 

July 12, 2011
Governor Signs LD 719

May 4, 2011
NEBA Maine LD 719

March 18, 2011
March 2011 NEBA Newsletter

March 23, 2011
President Paul Pescatello presents testimony on behalf of the New England Biotechnology Association (NEBA) and Connecticut United for Research Excellence, Inc. (CURE) In support of HB6610—An Act Concerning Vaccines.  Click here for the testimony.

January 18, 2011
Paul Pescatello re-elected Chairman

October 7, 2010
Paul Pescatello on NBC CT

October 6, 2010
Recent story about the MA Gubernatorial forum on the biotechnology industry. All three candidates said they would support changes to the current "gift ban" and would support overturning the current law that prohibits the use of discounts and rebates on the purchase of prescription medications.

September 28, 2010
Tech Collective, Rhode Islands Information Technology and Bioscience Industry Association, announces a new format to its Bio Tuesday industry event series

September 23, 2010
NEBA's September Newsletter

May 12, 2010
NEBA Newsletter

April 8, 2010
*Video* MIPA press conference on prescription drug plan

April 2, 2009
Regional Biotech Association Warns Vermont Legislation Could Have Profound Negative Impact

March 30, 2010
*Radio* - NEBA teams with MIPA to support a prescription drug discount plan for Massachusetts

March 30, 2010 launched to help consumers

March 15, 2010
New England Biotech Association elects new Chair

February 12, 2010
Andrew Witty - Ally for the poor

February 9, 2010
NEBA urges Maine Legislators to Oppose LD 821 and Support Maine's Biotech Community

January 20, 2010
Carcieri wants to protect RI's bioscience industry 

November 5, 2009
Vermont Updates Marketing Disclosure Guidance with Respect to Samples

September 29, 2009
Governors join NEBA in sending letter to Congress in support of biotech industry on biosimilars.

September 21, 2009
NEBA sends letter to New England Delegation on biosimilars legislation.

July 8, 2009
The Providence Journal
NEBA and Biogroup urge Senators to ensure that Rhode Island remains a biotech leader.

June 9, 2009
Rhode Island ranks among top Biotech Hubs

April 15, 2009
Boston Globe
Strong Growth Seen in MA Biotechnology Firms since ’02

March 9, 2009
Biotech Association Warns about Connecticut proposed legislation

January 19, 2009
NEBA's comments to MA DPH regulations

January 5, 2009
Worcester Business Journal Online
Biotech Group Pushes Back On Marketing Regs

December 6, 2008
The Boston Globe 
America needs a strong FDA

December 4, 2008
New Haven Register
Connecticut one of world's hotbeds of research, which is at risk

November 25, 2008
Worcester Business Journal Online
Regional biotech group adds another voice

November 24, 2008
Letter to Massachusetts Governor
NEBA Letter to Governor Deval Patrick

November 14, 2008
Boston Business Journal
New association to promote region's biotech sector

November 13, 2008
Press Release
New England Biotech formed