Euro Biotechnology

The House Agriculture Committee approved on Wednesday, April 18, amendments to the panel’s Farm Bill addressing some key BIO policy priorities:

• Trade: An amendment by Rep. Neal Dunn (R-Fla.) would create a Biotechnology and Agricultural Trade Program. This amendment is reflective of BIO-supported R. 5379, the Growing American Food Exports Act, introduced by Reps. Dunn (R-FL) and Panetta (D-CA) on March 22.The amendment reaffirms Foreign Agriculture Service (FAS) has the authority to advocate to our trade partners on all new agricultural production techniques in addition to biotechnology.
  

  “Trade is critical to the American agricultural economy, as 20 percent of U.S. grown goods are bound for foreign markets,” explains BIO.  “It is essential that USDA is properly equipped to advocate for the fair treatment of the American farmer and U.S. grown goods around the world, which this legislation will ensure.” 

• Biotech Education: Another provision offered by Rep. Dunn would set up a national science-based education campaign to increase public awareness of the kinds of technology used in food and agricultural production.This amendment establishes that USDA, in consultation with FDA, the Department of Education, and stakeholders, should establish a biotechnology education campaign aimed at providing consumers accurate, reliable information on the rigorous, science-based regulatory system that products of biotechnology undergo.
  

  “Congress invests tens of millions of dollars annually in USDA, FDA, and EPA to carefully scrutinize products of biotechnology and ensure they are safe for both the environment and human and animal health. Yet many consumers do not even know these products are reviewed by federal scientists and regulators, as regulators have not historically shared their story or defended their work,” says BIO.  “Congress and the Administration have a strong interest in the public knowing that these products are carefully regulated using robust, sound science.”

• Gene Edited Plants: An amendment offered by Rep. Ted Yoho (R-Fla.) directs USDA, in consultation with FDA and EPA, to issue a report to Congress within 180 days of enactment with plans on how to improve the federal government’s policies and procedures with respect to gene edited plants.The report requirement directs the agencies to minimize the regulatory burdens, ensuring a positive environment for research and development, clarify that certain gene edited products do not warrant pre-market review, among other criteria.

• Gene Edited Animals: Yoho also offered an amendment (discussed and then withdrawn) that would have directed USDA, in consultation with FDA, to within 180 days of enactment to issue a report on existing authorities within USDA to regulate products of animal biotechnology.Rep. Yoho gave very concerned remarks accompanying his amendment about how innovation in animal biotechnology has been stifled, and he is eager to help alleviate the regulatory challenges facing the animal biotechnology industry.

• Biostimulant Definition: A BIO-supported amendment defining “biostimulants” was included in the base language. Such as a definition will help create a clearer regulatory path for these valuable products.

The House legislation cleared the Committee by a 26-20 party-line vote.

“As the bill heads to the floor, I hope the House recognizes the long-term certainty it provides for America’s farmers, just as it preserves nutrition programs for people who need help feeding themselves and their families,” said U.S. Secretary of Agriculture Sonny Perdue. “USDA stands ready to provide technical assistance as the bill progresses in the House, and we look forward to working with our friends in the Senate as well.”

“As Republicans and Democrats have farm interests in their own districts and states, we are hopeful that the 2018 Farm Bill can move forward in a bipartisan manner,” Perdue added.

 

It takes away the pain — and satisfaction — of assembling an IKEA furniture on your own.
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John Dobak, a life sciences serial entrepreneur in San Diego, said a new startup he’s leading has raised $2.66 million to advance a drug that is already approved to shrink varicose veins through early-stage clinical trials testing it in a new use -fat reduction body sculpting.

The biotech, 10xBio, announced earlier this month that the FDA had approved its application to begin clinical trials in Phase 1b/2a studies testing the unnamed injectable drug. “We’ve already dosed patients,” Dobak said Tuesday. The studies are intended to establish the safety and tissue responses of the injectable drug, said Dobak, who is the chairman… Read more »

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Frequency Therapeutics has appointed William Chin to serve as the Woburn, MA, company’s chief medical officer. Chin’s previous experience includes posts at Eli Lilly (NYSE: LLY), where he was senior vice president, drug discovery and clinical investigation, and the Pharmaceutical Research and Manufacturers of America, where he was executive vice president of scientific and regulatory affairs. Frequency, an MIT spinout that raised $32 million in a Series A round of financing last year, is developing drugs that treat hearing loss.

UNDERWRITERS AND PARTNERS

          

          

            

[Source: http://ec.europa.eu/health/ageing/innovation/index_en.htm] Identifier: H2020-DT-2018-2020Pillar: Industrial LeadershipPlanned Opening Date: Deadline: Wed, 14 Nov 2018 17:00:00 (Brussels local time)Modification Date: Wed, 18 Apr 2018Latest information:
On 17 April 2018,call H2020-DT-2018-1 closed at 17:00.35 proposals were submitted in total. The table below shows thenumber of proposals that were submitted by topic and type of action:

Submitted to topic
CSA
IA
Total

DT-ICT-02-2018
1
10
11

DT-ICT-06-2018
8
0
8

DT-ICT-07-2018-2019
0
16
16

9
26
35

As BIO CEO, everywhere I go – including Tokyo and Hong Kong last month – I talk about what sets America apart as the country responsible for innovating more new medicines than the rest of the world combined. Other countries have great scientists, but no other country can match U.S. innovation policy, our world-leading biotech ecosystem or the diverse financing opportunities we provide for biotech companies at every stage of growth.

On Tuesday, BIO honored the Member of Congress who has arguably done more than any other to create this competitive advantage and stand up the U.S. biotechnology sector over the last four decades – U.S. Senator Orrin Hatch (R-Utah).

When the story of the BIO century and the new golden age of cures is written, the leadership of Utah’s senior senator will be on page one. He has driven almost every piece of groundbreaking legislation that has ensured our industry will thrive. He is the architect of the modern biotech ecosystem. If his name is not actually on the legislation, he has pushed it through Congress as the Chairman of the Senate HELP, Finance and Judiciary Committees.

Hatch – the Senate President pro tempore and third in line to the presidency – is retiring at the end of his term next January after 42 years in the upper body. In a time of extreme partisanship, it is difficult to lose a Senator who has made it his mission to have strong relationships across the aisle and ensure that pro-science legislation incorporates many voices and ideas.

Nowhere is this more evident than the groundbreaking law known as the Hatch-Waxman Act – the single most important piece of legislation ever crafted to commercialize biotech products and broaden patient access to life-saving treatments. This legislation created a true balance by allowing patients to get timely access to cheaper generic drugs, while ensuring that strong market incentives exist to continue the innovation cycle and bring new therapies to market.

Hatch-Waxman passed in 1984, but Senator Hatch wasn’t through yet. In 2010, he honored his friend – the late Senator Ted Kennedy – by passing their bill to create a similar pathway for biosimilars that includes 12 years of data exclusivity for new biologic drugs. He once again applied the tenets of Hatch-Waxman, recognizing the important differences between biologics and small-molecule drugs. In so doing, Senator Hatch championed legislation that will drive the biotech industry forward for the next four decades.

Senator Hatch has been a champion for patients. He helped enact the Orphan Drug Act, which has led to more than 500 new treatments for rare diseases. On international deals, he worked tirelessly to secure foreign commitments to protect and respect our intellectual property, and he fought to ensure that changes to U.S. patent law were mindful of the importance of life sciences IP. He also helped double the medical research budget at the National Institutes of Health, providing critical new funding for university studies that biotech companies rely upon to commercialize new medicines and reduce suffering.

This year BIO is celebrating our 25^th anniversary with the theme “Make History.” That’s exactly what Orrin Hatch has done. The United States would not be the global leader in biotech – and we wouldn’t have the treatments and cures that exist today – without him. His work in Washington D.C. has helped transform modern medicine, and that’s why he’s such a worthy recipient of the BIO Lifetime Achievement Award.

Patients who have rickets experience a softening and weakening of their bones traced to a vitamin deficiency. In a rare, inherited form of the disease, vitamin D supplements don’t work.

Ultragenyx (NASDAQ: RARE) has received FDA approval for a drug to treat patients who have this form of the disease, called X-linked hypophosphatemia (XLH). The Novato, CA-based company said Tuesday that the regulatory approval for its drug, burosumab (Crysvita), covers adults as well as children over the age of 1. The FDA’s nod, which came following a priority review given to drugs developed to offer significant improvement in the treatment… Read more »

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[Source: http://ec.europa.eu/health/ageing/innovation/index_en.htm] Identifier: H2020-ICT-2018-2020Pillar: Industrial LeadershipPlanned Opening Date: Deadline: Wed, 14 Nov 2018 17:00:00 (Brussels local time)Modification Date: Tue, 17 Apr 2018Latest information: On 17 April 2018,call H2020-ICT-2018-2 closed at 17:00. 530 proposals were submitted in total. The table below shows thenumber of proposals that were submitted by topic and type of action:

Submitted to topic

PCP

RIA

CSA

IA

Total

ICT-02-2018

0

60

0

0

60

ICT-03-2018-2019

0

0

0

2

2

ICT-04-2018

0

22

0

12

34

ICT-07-2018

0

57

2

2

61

ICT-11-2018-2019

0

0

0

15

15

ICT-12-2018-2020

0

76

1

0

77

ICT-13-2018-2019

0

31

5

0

36

ICT-16-2018

0

38

5

14

57

ICT-18-2018

0

0

0

6

6

ICT-21-2018

0

0

6

0

6

ICT-24-2018-2019

0

15

10

0

25

ICT-25-2018-2020

0

0

6

0

6

ICT-26-2018-2020

0

7

0

0

7

ICT-27-2018-2020

0

0

9

0

9

ICT-28-2018

0

23

3

11

37

ICT-29-2018

0

35

0

2

37

ICT-31-2018-2019

0

0

6

0

6

ICT-32-2018

0

36

3

0

39

ICT-34-2018-2019

2

0

0

0

2

ICT-35-2018

0

0

8

0

8

Total

2

400

64

64

530

Inocucor, an agtech startup that develops and sells microbial products intended to improve plant and soil health, is now expanding its reach with a deal that gives it a market position in plant nutrition.

Denver-based Inocucor announced Tuesday that it has acquired plant nutrition company ATP Nutrition. No financial details of the deal were disclosed. But Inocuor says that the deal will allow the companies to merge their respective research and development efforts with the goal of developing products that offer both biological and nutritional benefits.

Inocucor currently markets two products, Synergro, a formulation of microbes that supports plant roots, and… Read more »

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At the end of March, the U.S. Department of Agriculture, the government agency regulating genetically engineered plants, clarified that under its biotechnology regulations the agency “does not regulate or have any plans to regulate plants that could otherwise have been developed through traditional breeding techniques.” Essentially, this statement signals that the USDA does not, and has no intentions to, regulate gene edited plants, because using gene editing to make changes in plants is no different than selective breeding.

You could almost hear a collective sigh of relief on many farms throughout the nation, as this statement provides growers some certainty that researchers will not be forced to spend countless years and millions of dollars investing in their product through the regulatory process. The promise of gene-editing to solve some of the nation’s toughest agricultural challenges, suddenly became more promising.

In the wake of this new certainty, however, Wall Street Journal reporters Jacob Bunge and Amy Dockser Marcus dive into the question, “Will people eat it?”

And rightfully so. Even with the Federal Drug Administration and the World Health Organization determining that GMOs are safe, activists worked hard to sow fear and skepticism about the technology in the public. And it worked. Today, these same activists are looking to do the same by blurring the lines between GMOs and gene-editing. However, as Bunge and Marcus explain, these technologies are not the same:

“Those older techniques generally involve adding in genes from outside species, including bacteria, viruses and other plants. Inserting such genes enables crops to survive herbicide sprays or repel destructive bugs.

“The new gene-editing technologies enable scientists to achieve some of the same effects by altering the plants’ own DNA, without inserting new genes. With Crispr-Cas9, the most widely used system, scientists can program genetic guides to target a location along the plant’s DNA, where the Cas9 protein cuts the DNA. The cells change the DNA sequence as the cut is repaired. Scientists are using Crispr to make drought-resistant corn, reduced-gluten wheat and tomatoes with easy-to-remove stems.”

And just like the USDA alludes to in its statement, growers understand that gene-editing should instead be considered an advancement in selective breeding:

“[The agricultural industry] describes the editing technologies as an extension of plant breeding, the centuries-old practice of crossing plant strains to create improved offspring. Gene editing, the industry says, can yield the same results as crossbreeding, only faster.”

Bunge and Marcus note that the distinction between GMOs and gene-editing is “critical” for an industry that looks to develop plants that carry beneficial traits, such as disease-resistance and drought-intolerance, without breaking the bank or wasting precious time. According to the agriculture consulting firm Phillips McDougall, Ltd., it takes an average of 13 years and $136 million to develop and launch a traditional biotech crop (i.e. GMOs) through the current regulatory framework.

Therefore, USDA’s guidance on gene-editing is a step in the right direction, especially for researchers and farmers looking to harness the technology without heavy burden; however, as this Wall Street Journal piece outlines, for the public to embrace the technology they’ll need to understand that it is a continuum of selective breeding, not GMO 2.0.