23 Aug

FDA Approves Kala Pharmaceuticals Drug for Post-Surgery Eye Pain

Kala Pharmaceuticals has won FDA approval for a drug developed to treat pain and inflammation following eye surgery.

While the approval is new, the drug, loteprednol etabonate (Inveltys), is not. Kala’s drug is a new formulation of a Bausch Health (NYSE: BHC) topical steroid that is approved to treat pain and inflammation after eye surgeries. Both are eye drops. The difference is the version from Waltham, MA-based Kala uses nanoparticle technology intended to more efficiently deliver the therapeutic through the barriers of mucous in the eyes.

Compared to Baush’s drug, Kala says its product offers better efficacy and safety, and… Read more »

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23 Aug

BUILDING A LOW-CARBON, CLIMATE RESILIENT FUTURE: SECURE, CLEAN AND EFFICIENT ENERGY

[Source: http://ec.europa.eu/health/ageing/innovation/index_en.htm] Identifier: H2020-LC-SC3-2018-2019-2020Pillar: Societal ChallengesOpening Date: Deadline: Tue, 16 Oct 2018 17:00:00 (Brussels local time)Modification Date: Thu, 23 Aug 2018Latest information: Due to some technical issues related to the participant register, the submission deadline of 23 August 2018 in theH2020-LC-SC3-2018-RES-TwoStages (2nd stage) call has been postponed to 28 August 2018, 17:00:00 (Brussels Local Time). This extension applies to the following topics:
– LC-SC3-RES-4-2018 (RIA)

– LC-SC3-RES-11-2018 (RIA)

23 Aug

#MakeHistory: Highlighting History I China

Venture capital investment in US biotech companies has skyrocketed as Chinese investors continue to fuel the US pharmaceutical startup sector. With over $1.4 billion invested by Chinese VC funds into private US biotechnology firms in Q1 2018 alone, the Chinese investment community represents a materially significant and growing source of growth capital for the industry.

While recent trade rifts between the US and China have threatened industries including US coal producers, farmers and crude oil industries, the biotechnology hubs of Cambridge and Silicon Valley continue to see Chinese investment coming in. Over this past summer, we’ve seen a flurry of retaliatory tariffs enacted by policymakers in both countries that have made many industries concerned of the future strength of their market. However, the biotechnology sector remained relatively unscathed with Q4 2017 and Q1 2018 reports reflecting a growth of almost $1.5 billion, per Pitchbook.

Just over a decade ago, the Chinese pharmaceutical market had been solely dominated by the generics industry. The significant resources required to support innovative drug development forced most domestic pharmaceutical companies to prioritize short-term revenue through developing generic drugs. While the strength of the generics industry in China still remains significant, policies that put innovation at the forefront have placed the Chinese pharmaceutical sector at a turning point. Today we are seeing a transformation in a market that once focused on solely manufacturing products to one that funds innovative cures through fostering a strong domestic sector and foreign investment.

Recent government initiatives have even further invigorated the industry making the biotech field eligible for expanded government R&D subsidies, additional funds for science parks, and incentives to innovate personalized treatment and drugs that treat critical disease. Specifically, these initiatives could provide preferential tax policies that would aid small to micro-sized enterprises that are focused on these development areas.

Further, announcements made earlier this year that the Hong Kong Stock Exchange (HKEX) will allow pre-revenue biotech companies to list onto its stock exchange has potential to further expand the Chinese market and serve a great opportunity for Chinese investors. Allowing for this second listing may provide legitimacy and help companies attract additional investment.

Despite the recent increase in political and financial support strengthening the Chinese biotech sector, the threat of deepening trade disputes has created a relatively unpredictable political climate.

Recently, on August 13, 2018, President Trump signed into effect the Foreign Investment Risk Review Modernization Act of 2018 (FIRRMA), which provides more vigilant scrutiny of foreign acquisitions and investments in the US. These FIRRMA reforms expand the jurisdiction of the Committee on Foreign Investment in the United States (CFIUS) that President Trump states, “closes the gap” between what transactions CFIUS can review and what they previously could not. While FIRRMA does not mention China specifically in the legislation, over the next few months it will be important to consider the country’s role in this narrative as Chinese investment continues to expand in the US biotech market.

But as for now, it is too close to tell what CFIUS may mean specifically for biotech deals between Chinese investors and US companies. While the logistics of the law will be flushed out in the coming months, it will be important for companies and investors alike to be aware of the potential implications these reforms may have on Chinese acquisitions of US companies and rates of investment.

To stay abreast of these important issues in the global biotech investment community, we invite you to attend the 17th annual BIO Investor Forum in San Francisco on October 17-18, 2018. Learn more about China’s investor boom, the HK stock exchange, and the implications new CFIUS legislation may have on your investment deals during the two full days of education sessions.

Below are a few featured sessions from the 2018 BIO Investor Forum program:

Reaching Chinese Investors: Considerations for an IPO in Hong Kong

Wednesday, October 17, 2:00-2:55 pm

The Hong Kong Stock Exchange is capturing worldwide attention as it modifies listing rules to permit biotech companies, opening the door for Chinese firms seeking public market financing as well international firms eyeing the support of investors in China. In just the exchange’s first few weeks more than USD 1 billion in new offerings have generated funding that will be applied to accelerate clinical research on behalf of patients.  This session will examine cross-border perspectives on the appetite of China-based investors for biotechs and the criteria to determine the attractiveness of listing on the exchange for foreign entities as Hong Kong sets its sights at becoming a major biotech funding source.

Policy Outlook- Implications of the Trump Administration’s Healthcare Initiatives

Wednesday, October 17, 3:15-4:10 pm

Across 2018 the U.S. federal government has launched multiple new initiatives regarding how new medicines will be authorized, commercialized, and reimbursed, including in such areas as genome editing, continuous manufacturing, and Medicare rebates.  This panel of people close to the policy making process will share the latest data on FDA expectations, plus discuss the Trump Administration’s stances on healthcare spending, the opioid addiction crisis, trade tariffs, and tax policies that will affect biopharmas both immediately and in the years ahead.

Explore additional educational programming and investor partnering opportunities here. We welcome you to join us this year at the BIO Investor Forum.

22 Aug

Digital Security

[Source: http://ec.europa.eu/health/ageing/innovation/index_en.htm] Identifier: H2020-SU-DS-2018-2019-2020Pillar: Societal ChallengesOpening Date: Deadline: Thu, 23 Aug 2018 17:00:00 (Brussels local time)Modification Date: Wed, 22 Aug 2018Latest information: The submission session is now available for: SU-DS01-2018(IA), SU-DS05-2018-2019(IA), SU-DS04-2018-2020(IA)

22 Aug

Plant Biotech Pioneer Retires

In February, as part of our 25th anniversary innovation series, we profiled the discovery and subsequent harnessing of Agrobacterium to modify crops, leading to great advances in agriculture and food production. Moreover, we highlighted scientist Mary-Dell Chilton – among other researchers – and the role she played in discovering the potential of the microbe.

Sonja Begemann with Ag Professional reports that Chilton is “putting away her lab goggles for the last time,” retiring from her role at Syngenta, where she founded the company’s biotechnology lab and conducted extensive research into plant genetics.

Read more about Mary-Dell Chilton from BIO’s 25th anniversary blog exploring the innovation of Agrobacterium for plant gene modification.

As Begemann notes, Chilton recently reflected on her career:

“My career in biotechnology has been an exciting journey, and I am amazed to see the progress we have made over the years,” Chilton said in a previous interview. “My hope is that through continued scientific discoveries, we will be able to provide a brighter and better future for the generations that follow us.”

Mary-Dell Chilton (left) with 2018 Rosalind Franklin Award recipient  Krysta Harden (right).

A pioneer not only for women in science but anyone working in plant biotechnology, Chilton has received high-praise over the years, including from some influential leaders in agriculture. As Begemann puts it, “Chilton’s influence in biotech and the direction it’s moving is well-documented and respected.”

“Dr. Chilton’s research has forever changed the way we conduct plant research and her groundbreaking accomplishments have shaped the way genetic plant research is conducted today,” says former Secretary of Agriculture Tom Vilsack, when Chilton was inducted into USDA’s Hall of Heroes.

Her “personal scientific discoveries stand out on their own, but also weave together with vast commercial and academic innovative research that allows the world to benefit from productive farming and even greater positive environmental conditions,” said Jay Croom, CEO of CropLife America, a national trade association representing manufacturers, formulators and distributors of pesticides, in a recent letter to Chilton. “Her work continues to influence progress in agriculture and humanity for generations to come.”

After years as a university researcher, Chilton joined Syngenta (what was at the time CIBA-Geigy Corporation) in 1983, founding the company’s first biotechnology research lab. In 2013, Chilton, along with two other researchers, received the World Food Prize for her work in discovering the power of Agrobacterium. Additionally, Chilton is honored in USDA’s Hall of Heroes and is an inductee in the National Inventors Hall of Fame.

Read the full piece on Chilton’s retirement here.

22 Aug

After Launching Women’s Mentor Network, Lisa Suennen Sets Sail from GE

Lisa Suennen, a high-profile life-sciences investor, is leaving a top post at GE Ventures after two years. Based in the San Francisco Bay Area, Suennen is widely known for her investment work as well as her writing-her blog is called “Venture Valkyrie“-and podcasting about people, companies, and industry trends, notably the gender equity gap among life-science executives and investors.

In 2016 she launched CSweetener, a mentoring network for women in the health and life-science business. The idea sprang from the many informal requests for advice she receives from women. “If I said yes to everyone, I… Read more »

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22 Aug

Is Twitter down? Maybe. And people aren’t happy about it.

Is Twitter down? That seems to be the question of the day. Some users – including some IndyStar journalists – realized that the Lists feature wasn’t …

21 Aug

Senate Has the Power to Get Miracle Medications to Opioid Addicts

BIO President and CEO Jim Greenwood posted the following op-ed on Linked-In today, making the case for the U.S. Senate to act on legislation that would empower the Centers for Medicaid and Medicare Services to broaden coverage of medication-assisted treatment to help Americans in the throes of opioid addiction.


How serious is our national opioid emergency? More than 115 Americans die every day from an opioid overdose. By contrast, 44 people in this country died a day during the peak of the AIDS crisis.

Decades ago, we saw how effective the HIV/AIDS community was in asserting its political power to demand a government solution. Investment into breakthrough antiretroviral treatments – and public-private collaborations to make these drugs accessible – transformed a lethal epidemic into a manageable, chronic condition.  Now, three decades later, government and industry again must work together once again to end a public health cataclysm.

Opioid addiction fundamentally alters a person’s brain chemistry, producing potent cravings and horrible withdrawal symptoms for those trying to stop using. But thanks to biotech breakthroughs made possible by our deepening understanding of neuroscience, medications already approved by the U.S. Food and Drug Administration can reduce opioid cravings, dampen euphoric side effects and diminish withdrawal symptoms.

Buprenorphine and methadone are called “essential medicines” by the World Health Organization. Using another pharmaceutical to help reverse damaging effects of opioid addiction isn’t “more of the same.” In fact, research shows that medication-assisted treatment (MAT) – where medicine is administered alongside cognitive or behavioral care – is the most successful way to facilitate long-term recovery. Administered properly, MAT decreases overdose deaths, criminal activity and infectious disease transmission, according to the National Institute on Drug Abuse, while increasing patient retention in therapy programs.

The problem is, the pathway to receive MAT is not always clear, with a patchwork system of varying coverage levels across different states and insurance carriers. Even when payers will pay, most rehab facilities still do not offer MAT. Research suggests that only 1 in 3 people enrolled in privately funded specialty treatment programs receives medication-assisted treatment for opioid dependence.

So the Biotechnology Innovation Organization (BIO) decided to go talk to Americans in recovery programs to get their perspective. We recently took a group of biotech leaders to Ohio, where 1 in 5 fatal opioid overdoses occurs. We brought together scientists working on pain and addiction therapies with recovering addicts for a candid conversation.

We met a 30-something who got lost so deep into her addiction that foster care took her daughter away. Then, she got pregnant again. She managed to stay off opioids for the last three months of her pregnancy to give birth to a healthy baby. But three minutes after her child was born, she was back on them. That’s how addiction takes your soul.

We met with addicts at different stages of recovery who could easily be anyone’s friend or neighbor. These were good people wrestling with powerful chemical dependency. The statistics show that the vast majority will relapse. Even addicts clean for years told us the monster never leaves their brain. They said that once they succumb and start to use again, they don’t care about their families, jobs or reputations. They care only about getting that drug back into their system. That’s why MAT is so important, because it can help their resolve overpower their cravings.

Of course, the ultimate solution lies in stopping addiction before it starts. That means innovating more non-addictive painkillers for people living with severe and chronic pain. One in three Americans – roughly 100 million people – report suffering from some type of pain, according to the National Academy of Science’s Institute of Medicine. That’s more people than suffer from diabetes, cancer and heart disease combined.

We need to expand coverage for alternative painkillers and innovate new ones. There are non-opioid analgesics on the market for certain painful conditions, but too many insurers are pushing beneficiaries to cheaper alternatives. They’re effectively saying, “First, go ahead and try a generic opioid. If you fail on that, maybe we’ll cover a different approach.” This utilization management practice hooks more people.

It’s in the interest of insurers to step up to the plate and be part of the solution. Otherwise, they’ll end up paying for rehabilitation, hospitalization and all kinds of health problems that will be more expensive in the long run.

We need to cover existing treatments and invest in new ones. There are 125 new painkillers being tested in clinical trials, 87 percent of which are non-opioids. But compare that to a pipeline of 1,700 novel cancer programs, a disease area that receives 17 times more venture capital than novel pain meds. Meanwhile, R&D investment for new addiction medications is virtually non-existent. Why? If insurance won’t pay, investors won’t invest, innovation stalls and American families wrestling with opioid dependency ultimately pay the price.

About four in 10 of our country’s more than 2 million opioid addicts are covered by state Medicaid programs. This makes the Centers for Medicare & Medicaid Services (CMS) a pivotal agency in addressing this crisis.

This summer, the U.S. House of Representatives passed comprehensive legislation to address the opioid crisis by a vote of 396-14.  The House bill directs CMS to create an Opioid Action Plan that can help ensure medication-assisted treatment is not placed on expensive specialty tiers or priced at levels where high patient out-of-pocket costs preclude access. The bill would encourage CMS to work with state Medicaid programs in using waivers to cover holistic addiction treatment. Finally, it would empower CMS to educate treatment providers about the latest research on the efficacy of innovative treatment options.

Companion opioid legislation now awaits floor consideration in the Senate. Inclusion of a stand-alone bipartisan bill by Senators Dean Heller (R-NV) and Bob Menendez (D-NJ) to authorize the CMS Opioid Action Plan is a crucial piece of the puzzle if we’re serious about helping Americans get off and stay off these drugs.

Overdose deaths from prescription painkillers, fentanyl and heroin have quadrupled in the last 15 years. Every 20 minutes, another American dies from an opioid overdose. The urgency of Senate action this year cannot be overstated. The only long-term solution is to innovate our way out of the opioid crisis – and work together to ensure patient access to the breakthroughs that scientists discover. We did it during the AIDS epidemic, and we can and must again.

21 Aug

Cybersecurity

[Source: http://ec.europa.eu/health/ageing/innovation/index_en.htm] Identifier: H2020-SU-ICT-2018-2020Pillar: Industrial LeadershipPlanned Opening Date: Deadline: Tue, 19 Nov 2019 17:00:00 (Brussels local time)Modification Date: Tue, 21 Aug 2018Latest information: An overview of the evaluation results (called ‘Call results’) of the topic SU-ICT-03-2018 is now available under section Topic conditions and documents – Additional documents.

21 Aug

TraceLink Bags $93M, Plans A.I. & Blockchain Tools for Drug Tracking

Step one for TraceLink, a maker of software that helps track the supply chain of pharmaceuticals, was recruiting hundreds of thousands of companies and organizations to its digital platform.

Now, much like the playbooks of social media companies and other tech firms, step two will be to develop “new applications on top of that infrastructure”-thereby taking advantage of “the information and the network that we’ve built to drive even greater value for our customers” says TraceLink CEO Shabbir Dahod.

A new cash infusion might help the company in that endeavor. On Tuesday, the North Reading, MA-based firm announced it closed a… Read more »

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