24 Apr

FDA Panel Splits on Lilly Arthritis Drug, Backs Lower of Two Doses

Eli Lilly said enough to convince an FDA advisory panel that its experimental rheumatoid arthritis drug is effective in treating the inflammatory disorder. But on safety, the independent experts were not uniformly persuaded, and they voted to recommend approval only for the lower of two doses. It’s the second time the Lilly drug is up for an approval decision in the past two years.

Of the independent panel’s 15 members, 10 voted against approving Lilly drug baricitinib (Olumiant) at the 4 mg dose based on risks of the pill versus its benefit. But at the 2 mg dose, the vote was… Read more »

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23 Apr

Earth Day: Biotechnology to Save the Planet

To understand the significance of Earth Day, it’s important to understand how it was first established. As Jim Greenwood wrote in a piece one year ago, we’ve recognized Earth Day every April 22 since 1970. In that year, America was in the midst of the Vietnam War, making our way to the moon and still recovering from the scars left behind by the civil rights era. Even so, the nation’s concerns around mankind’s impact on the environment were so intense it motivated millions to take to the streets on April 22, 1970 to establish environmental protections of our planet.

Today, Earth Day is a global event celebrated by over 1 billion people in hundreds of countries. It is arguably the largest civic-focused day of action on earth. It has perhaps inspired researchers’, farmers’, educators’ and scientists’ work every day to lessen man’s environmental footprint. Biotechnology can help us take better care of the planet throughout the year, especially when applied to agriculture and environmental and industrial practices.

Greener Fields

Biotechnology is an essential part of agriculture practices that help save the environment by lessening the inputs needed to grow essential foods.

  • Drought Tolerant Crops. Through genetic engineering, researchers have been able to alter the genes of plants to require less water, which is crucial to limiting our impact on the environment. For example, researchers have been successful in modifying the genes of corn – through transgenic mutation – to be drought tolerant. By altering crops to require less hydration, farmers are able to limit their water waste. This is especially important in dry regions with limited access to water, a chronic challenge shared by many developing countries.
  • Resistant Crops. Probably the most widely desired trait when modifying the genes of plants, crops resistant to insects and diseases can help save the environment too. When faced with insect infestation, farmers are forced to spray crops with chemicals, thus reducing environmental impact. Additionally, crops that have been modified to be disease resistant tend to produce higher yields, thus reducing the amount of land and resources needed to grow the crop and lessening the farmer’s environmental impact.

Cleaner Industrial Practices

Equally as important is the role biotechnology can play in developing greener industrial and environmental practices.

  • Biobased products. Through biotechnology we have created numerous biobased alternatives to petroleum-based plastics. These biobased products are naturally biodegradable. Companies like Coca-Cola, Heinz and Ford have been working with biotechnology companies to develop a 100 percent biobased alternative to PET – a plastic widely used in bottles. Until then, however, researchers have discovered a natural microorganism that evolves new enzymes to break down petroleum-based PET. Using biotechnology, the researchers believe they can improve the enzyme further, leading to an energy efficient method for recycling  plastic, and to new biobased plastics. Through biotechnology we may be able to one day eliminate excess plastic found in landfills, oceans and in all corners of the earth.
  • Biofuels. Unlike fossil fuels, biofuels are produced from living matter, such as corn. In the U.S., the Renewable Fuel Standard (RFS) mandates that a certain volume of renewable fuel be blended to the fuel supply to encourage the advancement of biofuels. Every year, the RFS slightly increases the required amount, thus expanding the market for biofuels. By increasing our biofuel supply, the U.S. can limit its reliance on fossil fuels, reducing our greenhouse emissions.

Since 1970, plenty of other historic events have taken place that could’ve easily distracted us from caring about Earth day. However, as we celebrate its 48th anniversary, our concerns around mankind’s impact on the environment seem to be growing stronger. Luckily, through biotechnology there is promise that in the future we will be able to eliminate some of the main culprits that have blemished this planet.

23 Apr

Sage Postpartum Depression Drug Heads to FDA Review

A new treatment for postpartum depression has inched closer to market.

Sage Therapeutics this morning filed for FDA approval of brexanolone, which could become the company’s first marketed product as well as the first-ever drug approved specifically for PPD, which affects some 10 to 20 percent of women giving birth every year in the U.S.

In November, Sage’s (NASDAQ: SAGE) brexanolone succeeded in two Phase 3 trials in PPD, beating a placebo at reducing a measure of patients’ depression symptoms. Still, whether the drug-which requires a 60-hour IV infusion-will succeed commercially is an open question. In a recent research note,… Read more »

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23 Apr

Clean Sky 2 Call for Proposals 08

[Source: http://ec.europa.eu/health/ageing/innovation/index_en.htm] Identifier: H2020-CS2-CFP08-2018-01Pillar: Societal ChallengesPlanned Opening Date: Deadline: Thu, 12 Jul 2018 17:00:00 (Brussels local time)Modification Date: Mon, 23 Apr 2018Latest information: Release 1 of the Questions & Answers document was added on 23 April 2018. See the “Additional Documents” section inside thetopic areas below.

21 Apr

Call restricted to Member States for projects aiming to increase law enforcement cooperation to address migrant smuggling

[Source: http://ec.europa.eu/health/ageing/innovation/index_en.htm] Identifier: ISFP-2017-AG-SMUGGPillar: Organised crime and human traffickingOpening Date: Deadline: Wed, 27 Jun 2018 17:00:00 (Brussels local time)Modification Date: Fri, 20 Apr 2018Latest information: The submission session is now available for: ISFP-2017-AG-SMUGG(ISFP-AG)

21 Apr

Tocagen Reaches Exclusive Deal in China for Brain Cancer Therapy

Roughly a year and a half after Tocagen (NASDAQ: TOCA) named Marty Duvall as CEO, the San Diego biotech said it has signed a deal that gives Beijing-based ApolloBio an exclusive license to its gene therapy treatment for a deadly type of brain cancer.

Under terms of the deal, ApolloBio agreed to make a $16 million upfront payment to Tocagen, with another $4 million to come in “near-term” milestone payments. Tocagen has granted ApolloBio rights to commercialize its two-part treatment in mainland China, Hong Kong, Macao, and Taiwan. The experimental treatment is currently being tested in a global late-stage clinical… Read more »

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20 Apr

Torque Taps Thomas Andresen for Chief Scientific Officer

Thomas Andresen has been appointed chief scientific officer of immune-oncology therapies developer Torque. Andresen comes to the Cambridge, MA-based company from the Technical University of Denmark, where he was a professor in the department of micro-and nanotechnology. Andresen is also a Torque co-founder. Torque, which raised $25 million in a Series A round of financing last year, is developing cell therapies intended to offer a more targeted and durable tumor-killing approach.

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20 Apr

Research Headlines – Keeping track of ocean plastic

[Source: Research & Innovation] EU-funded research is developing advanced modelling tools to help assess the full extent of the problem of plastic pollution in our oceans and how it is affecting the marine environment. The tools will help policymakers design targeted measures to address a big and growing issue.

20 Apr

The Latest Good News on Prescription Drug Costs

Two-hundred biotech allies from more than 40 different states visited Washington D.C. this week. These advocates met with policymakers on Capitol Hill and in the administration to share BIO’s vision and policy priorities for a strong biotech industry.

When it came to the topic of prescription drug costs, part of our message to both Republican and Democratic lawmakers was that facts matter. And the facts are that we are on the cusp of amazing biopharmaceutical breakthroughs and the trend on prescription drug costs is heading in the right direction. Both are wins for patients and society more broadly.

A new report released by the IQVIA Institute – a health care data analytics firm – helps reaffirm these and other facts that are often ignored. The report is IQVIA’s annual review of medicine use and spending on prescription drugs, and their most recent report takes a close look at what happened in 2017. Here are four key takeaways:

Prescription drug costs are remarkably stable. IQVIA reports that national spending on prescription drugs increased less than 1% last year. Looking at retail and mail-order pharmacies only, where the vast majority of patients purchase medicines, spending actually declined 2.1%. Furthermore, this slow trend is expected to continue in the coming years, with growth projected to be in the 2-5% range annually for the next five years, well in-line with expected overall healthcare spending trends. Brand-name drug prices are remarkably steady too. The average net price for patented brand name drugs grew less than 2% in 2017, which is below the rate of inflation.

Competition in the marketplace is working. An estimated 90% of all drugs dispensed in the U.S. are lower-cost generics, up from 72% a decade ago. Additionally, generics were dispensed 97% of the time “it was possible to do so.” Looking at the next five years, competition from generics and biosimilars is expected to decrease the sales of brand-name drugs by $105 billion. This is further proof that our drug discovery ecosystem strikes the right balance between the need for both continued innovation and affordable access.

Drugmakers continue to provide substantial discounts and rebates to lower overall costs. While many news stories and industry critics focus on headline-grabbing list prices for new medicines, the reality is that manufacturers continue to provide substantial discounts, rebates, and other price concessions that substantially lower the cost burden. Last year, that amounted to nearly $130 billion in total savings. Unfortunately, for far too many patients, their out-of-pocket costs for drugs do not take these rebates into account. It’s time for all insurers to pass these savings along to patients.

Innovation is happening at a rapid pace. The IQVIA report highlights the amazing advances taking place aimed at helping patients with cancer and rare diseases. IQVIA notes that new drug launches “rebounded in 2017,” with 21 new drugs tackling rare diseases and 14 new cancer therapies. This innovation is occurring thanks to the hard work and dedication of the biopharmaceutical community, but also because of “significant shifts in the regulatory process.”

19 Apr

Call for proposals for ERC Proof of Concept Grant

[Source: http://ec.europa.eu/health/ageing/innovation/index_en.htm] Identifier: ERC-2018-PoCPillar: Excellent ScienceOpening Date: Deadline: Wed, 18 Apr 2018 17:00:00 (Brussels local time)Modification Date: Thu, 19 Apr 2018Latest information: A total of 132 proposals were submitted in response to the second intermediate deadline (18 April 2018) of ERC 2018 Proof of Concept call (ERC-2018-PoC). This represents 5 % less than the second cut off of the 2017 call, and 10,92 % more than the first cut-off of 2018 call.
The final deadline for submission to this call is 11 September 2018 (17:00:00 Brussels local time).
NB: According to the new rules on restrictions on applications (ERC 2018 WP), a Principal Investigator may submit only ONE application per call.

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