Euro Biotechnology

National Immunization Awareness Month might be coming to a close, but it’s important to continue helping people understand why vaccines are so important throughout the entire year.

To bolster these efforts, the National Vaccine Program Office teamed up with the Office of Disease Prevention and Health Promotion to create a series of short videos highlighting the importance of vaccines. Each segment focuses on a specific condition like whooping cough, shingles, or pneumococcal disease, and helps the general public understand why they should get vaccinated – and just how important vaccines are to society.

As BIO has pointed out before, vaccines have tremendous societal value, responsible for saving more than 730,000 children over the past 20 years in the U.S. One study found that the vaccination of children born in the United States in 2009 is projected to generate $184 billion in lifetime social value – or about $45,000 per child.

The truth is, vaccines have been used with great success over the years against viruses and bacteria that cause everything from polio to some forms of cancer. Beyond National Immunization Awareness Month, help spread the word about these prevention miracles and the many benefits that come along with them.

A Tetraphase Pharmaceuticals antibiotic has earned FDA approval, adding a new treatment to the effort to address drug-resistant infections.

The FDA decision for the Tetraphase (NASDAQ: TTPH) drug, eravacycline (Xerava), covers complicated intra-abdominal infections (cIAI) in adults. It’s the first drug approval for the Watertown, MA-based drug developer, and shares of the company rose 5.5 percent in after-hours trading Monday.

Gut infections can become complicated when they spread, due to a tear or other damage in the gastrointestinal tract. In two Phase 3 studies, Tetraphase tested a twice-daily infusion of its drug against ertapenem (Invanz), a now off-patent antibiotic… Read more »

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IQVIA – a nonpartisan health care research firm – is out with troubling new data showing a direct correlation between high out-of-pocket costs and patients forgoing the medicines they need. In 2017, 69% of patients covered in the commercial market did not fill a new prescription when their insurance company required them to pay out of pocket costs exceeding $250.

In recent years, patients have been subjected to spending more on deductibles and coinsurance. To offset this financial burden not covered by their insurers, many pharmaceutical companies have begun to offer various forms of patient assistance, and according to IQVIA, this assistance is making a difference for patients.

Yet in recent months, health plans have implemented “co-pay accumulator” programs – an effort to prevent funds provided by these assistance programs from applying to a patient’s out of pocket maximum or deductible. As a result, patients are left with steep costs and are less likely to fill the prescriptions they need.

It’s time for the insurance industry to step up and do its part to help ensure patients have access to the medicines they need at costs they can affordable.

See the full IQVIA report here.

The FDA has rejected the rare-disease drug volanesorsen (Waylivra), which is being developed by Ionis Pharmaceuticals (NASDAQ: IONS) and its subsidiary Akcea Therapeutics (NASDAQ: AKCA). Ionis, based in San Diego, and Akcea, in Cambridge, MA, had high hopes for approval after a committee of outside experts in May recommended the drug by a 12-8 vote. A majority of advisers voted for volanesorsen, a treatment for familial chylomicronemia syndrome, or FCS, despite safety concerns. FCS causes a painful, often damaging buildup of fat in a patient’s organs. In Monday’s announcement, Ionis and Akcea did not say why the… Read more »

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[Source: Research & Innovation] The EuroGEOSS Workshop is co-organised by the Swiss Federal Office for the Environment and the European Commission with the support of the University of Geneva. It brings together European players interested in and actively contributing to the Global Earth Observations System of Systems (GEOSS). The aim is to look for synergies among the participants and to discuss how Europe can contribute to this international effort.
The EuroGEOSS Workshop programme will be a combination of Plenary sessions, thematic sessions, hands-on demonstrations and numerous networking opportunities.

[Read More …]

Allogene has appointed Susie Jun to serve as chief development officer. Jun comes to the cancer immunotherapy developer from AbbVie (NYSE: ABBV), where she was vice president and head of development for the company’s Stemcentrx subsidiary. Her experience also includes posts at Gilead Sciences (NASDAQ: GILD) and Amgen (NASDAQ: AMGN). South San Francisco, CA-based Allogene raised $300 million in Series A financing in April to take over U.S. development of a Pfizer (NYSE: PFE) program pursuing an “off-the-shelf” cell therapy for cancer.

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In comments filed to the EPA August 17 on the 2019 proposed volumes for the renewable fuel standard, BIO urged the agency to “seize the opportunity afforded by the RFS program to promote the type of innovation that will help grow advanced and cellulosic biofuels, create good paying jobs, and help revitalize rural America by strengthening our world-leading biobased economy.”

Specifically, BIO comments are with regards to the low number of approvals the EPA has issued for advanced and cellulosic ethanol.

As Marc Heller reports for E&E News, “EPA is sharply underestimating the amount of cellulosic ethanol that U.S. companies could produce – and its own administrative lag is partly to blame, industry sources say.”

Because yearly cellulosic ethanol volumes mandated under the RFS are determined by the number of cellulosic facilities already registered, and the number of facilities officials believe will come on line during the year, the lack of approvals by EPA significantly hinders the growth of the cellulosic ethanol industry.

As a result, biotechnology companies like Edeniq have several applications pending. Brian Thome, president and CEO of Edeniq, noted to Heller that this means cellulosic ethanol production is not reaching its full potential.

With approvals in place, the industry could provide as much as 50 million gallons more than that, Edeniq said in comments submitted to the agency. Thome told E&E News that as much as 100 million gallons of the biofuel could be at stake.

Thome later goes on to add, “This is real volume and growth that appear to be sitting still now.”

In its comments, BIO noted that EPA’s lag in approving cellulosic ethanol applications is particularly hurting rural America. In sections of the country where farmers grow the corn that is turned into cellulosic ethanol and where biorefineries are headquartered, countless good paying jobs are at stake. In a time when farmers and businesses in rural America are grappling with low crop prices and trade uncertainty, the EPA should work diligently on its backlog of applications to help grow cellulosic ethanol production, thus helping corn growers and biorefinery’s across America’s heartland.

After all, as Brian Thome notes to Heller, “the pipeline [for approving cellulosic ethanol applications] wasn’t always so slow.”

To read BIO’s comments on the 2019 proposed RFS volumes click here. To read BIO’s press release on its comments, click here.

[Source: http://ec.europa.eu/health/ageing/innovation/index_en.htm] Identifier: JUST-NETW-2017Pillar: Justice programme 2014-2020Opening Date: Deadline: Tue, 30 May 2017 17:00:00 (Brussels local time)Modification Date: Fri, 24 Aug 2018Latest information: The results of calls JUST-JCOO-NETW-2017 (Framework Partnership Agreements) and JUST-JCOO-NETW-SGA-2017 (Operating Grants 2018) are published under TOPICCONDITIONSANDDOCUMENTS – ADDITIONALDOCUMENTS.

Event tech service Eventbrite is hoping to raise $200 million in an initial public offering during what has already been a busy year for IPOs.

San Francisco-based Eventbrite lets users list and sell tickets to any type of event, from fundraisers to music festivals-for a fee on each ticket. The company had $201.6 million in revenue in 2017, about $68 million more than the previous year, according to a securities document the business filed Thursday.

Still, Eventbrite operated at a net loss of $38.5 million last year, as its operating expenses totaled more than $153 million from making new hires and… Read more »

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