Alliance for Regenerative Medicine Published its Response to EU Pharmaceutical Roadmap

Alliance for Regenerative Medicine | July 07, 2020

The Alliance for Regenerative Medicine (ARM), the leading international advocacy organisation dedicated to realising the promise of regenerative medicines and advanced therapies, today published its response to the EU Pharmaceutical Strategy Roadmap which is designed to improve and accelerate patients’ access to safe and affordable medicines and to support innovation in the EU pharmaceutical industry. The full response can be found on the European Commission website.

While ARM welcomes the Roadmap’s recognition of the wider industry’s contribution to the EU economy and its focus on ensuring patients’ access to safe, state-of-the-art therapies, ARM wants to ensure a continued pathway for the EU to benefit from innovative and life-changing advanced therapy medicinal products (ATMPs).

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Spotlight

Food For Thought? Pills. Three times a day, all your nutrients, all your favorite flavors. Feel like having lobster for breakfast? Done. Trying to like mushrooms, but can’t stand the texture? Problem solved. Meal replacement pills are the future. At least, that’s what people have been saying for the past century. So what if we got them now? How would they affect our diet? Would we be healthier? Could they solve world hunger? Will we see them in our lifetime?

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PHARMACY MARKET

Lilly Collaborates with Samsung to boost COVID-19 antibody manufacturing amid supply concerns

Lilly | November 18, 2020

Seven days after Eli Lilly won a FDA crisis approval for its COVID-19 counter acting agent, worries over restricted supplies are as of now springing up, and the organization is getting an accomplished assembling accomplice to help with the worldwide scale-up. Under a drawn out arrangement with Samsung Biologics, the organizations are set to "incredibly quicken the worldwide gracefully" for Lilly's COVID-19 antibodies, Samsung Biologics said in a delivery. Lilly would like to make up to 1 million dosages this year and a lot more in 2021, Reuters reports. The accomplices entered an underlying assembling association back in May, and, from that point forward, Samsung created a first clump of dynamic drug fixing in spite of struggling getting crude materials. The organizations took care of the tech move in under a quarter of a year, a consequence of routine collaborations between specialists at both medication creators, Samsung Biologics said. Lilly's bamlanivimab scored a FDA crisis use approval a week ago in gentle to-direct COVID-19 patients who are at a high danger of advancing to extreme illness. The FDA said the medication isn't approved in hospitalized patients, and Lilly is instructing imbuement inside 10 days concerning manifestation beginning. Before the crisis gesture, the organization entered a flexibly manage the U.S. government for 300,000 dosages at $1,250 per portion. All things considered, the stock could last only multi week dependent on current disease patterns, Reuters reports. While the arrangement incorporates a possibility for additional portions, specialists told the news administration they expect the medications will turn into a business drug sooner or later.

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POLICY AND REGULATION

EpiEndo Pharmaceuticals Secures Funding to Advance Clinical Development of its Non-Antibiotic Macrolide for the treatment of COPD

EpiEndo Pharmaceuticals | August 19, 2021

EpiEndo Pharmaceuticals , a privately held biopharmaceutical company focused on a novel barrier enhancing approach to the treatment of chronic inflammatory airway diseases such as chronic obstructive pulmonary disease (COPD), announces the closing of a €20m Series A financing round led by Flerie Invest and Iðunn Venture Fund, with existing investors ABC Ventures participating, along with the European Innovation Council (EIC) Fund joining the round. The financing secures funds to advance clinical development of EpiEndo’s lead compound EP395, which entered phase I clinical trials in April, through Phase IIa, targeting COPD as a primary indication. EpiEndo’s development rationale is based on a newly acknowledged therapeutic paradigm, that loss of integrity of epithelial barriers plays a critical role in propagating chronic inflammatory diseases in lungs and contributes to vulnerability to infections associated with acute exacerbations of airway diseases. “I am delighted to announce the closing of this new investment round,” commented Maria Bech, CEO of EpiEndo Pharma. “We are very pleased to welcome such well-reputed investors as Flerie Invest and Iðunn Venture Fund to help us build our company and are honoured that the European Innovation Council Fund has chosen EpiEndo as its first follow-on investment. We are also grateful for the continued support of our existing investors. This financing is a major step for EpiEndo, not only funding our lead compound through clinical development in patients with COPD, but also enabling exploration of other important potential therapeutic application areas such as dermatology and gastrointestinal disorders, where compromised epithelial integrity is known to contribute to disease pathophysiology.” Macrolide antibiotics such as azithromycin have been known for decades to exhibit good disease modifying efficacy against many chronic inflammatory airway diseases in addition to their antibacterial properties, in which their long-term use reduces the frequency and severity of inflammatory flare-ups and exacerbations. Although beneficial for overall health and prognosis, their off-label use in these patient populations has led to the emergence of macrolide resistance in the host flora. EpiEndo’s lead compound EP395 is a new chemical entity in which the epithelial regenerative properties and anti-inflammatory effects seen with macrolides have been augmented, and the anti-bacterial properties removed. Using this Series, A funding, EpiEndo aims to advance the clinical development of EP395 towards approval as the first disease modifying non-antibiotic macrolide that can be prescribed safely and effectively as a long-term treatment for patients with COPD. “We have followed EpiEndo for some time and have seen impressive progress towards clinical phase of their lead compound EP 395. We are proud to take part in their continuing journey with the aim to deliver substantially improved treatment of COPD,” said Carl-Johan Spak, Senior Advisor at Flerie Invest. “EpiEndo is an attractive investment opportunity for Iðunn and a good fit for our fund’s investment strategy. We are looking forward to work with the company in the coming years to develop its lead candidate through the coming clinical phases. It is important for Iðunn to participate in the translation of new scientific discovery into clinical practice,” commented Hilmar Bragi Janusson, Managing Director of Iðunn Venture Fund. “ABC is thrilled to obtain, in this round, a group of new investors to co-lead with us and support EpiEndo´s quest to create a solution to some of the most problematic diseases,” commented Ivar Gudjonsson, Managing Director of ABC Venture and a board member of EpiEndo. “EpiEndo Pharmaceuticals’ challenge is to develop a new class of drugs and we are delighted to take part in this scale up journey,” said José Fernando Figueiredo, EIC Fund Investment Committee member, “The EIC Fund is taking part in this financial round to help this great example of a life science company to develop and deploy breakthrough treatment of chronic obstructive inflammatory pulmonary disease.” About EpiEndo Pharmaceuticals EpiEndo is a clinical-stage biopharmaceutical company with a unique approach to inflammatory disorders that focuses on enhancement of epithelial barrier integrity as a critical pathophysiological factor underlying the etiology of a number of major diseases. Epithelial cells are a key component of the barrier that makes up human lung tissue and other organs such as the gut and skin. Compromised integrity of this barrier is implicated in the progression and non-resolution of several chronic inflammatory diseases. EpiEndo is developing a proprietary portfolio of orally available macrolide drugs with promise as first-in-class disease-modifying therapeutics, to address the huge global burden of chronic diseases of the lung and other organs where there is other significant unmet medical need. EpiEndo’s lead drug candidate, EP395, aims to be the first on-market oral, non-antibiotic, barrier strengthening and anti-inflammatory macrolide for the treatment of COPD.

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RESEARCH

Pfizer/Biontech Weren't Alone: Moderna Covid-19 Vaccine Data Aimed in Ema Cyberattack

Moderna | December 16, 2020

It would appear that Pfizer and BioNTech's COVID-19 immunization was not the sole objective of a new cyberattack at the European Medicines Agency. Moderna said Monday that reports from its pre-accommodation conversations with EMA about its shot, mRNA-1273, were "unlawfully gotten to" by programmers, refering to a warning from the organization. The assailants didn't get individual data about preliminary members, Moderna said. The organization's EMA accommodation did exclude any information recognizing people in the examination. Now, no extra insights concerning the cyberattack, for example, the size of the penetrate or the character of any suspects—are accessible, and Moderna said it anticipates results from EMA's progressing examination. The disclosure came days after the EMA initially uncovered the cyberattack, and Pfizer and BioNTech's COVID-19 immunization applicant, BNT162b2, was the principal distinguished as an objective. EMA choices on the two immunizations are moving close. Medication commentators at the EMA's Committee for Medicinal Products for Human Use are booked to evaluate BNT162b2 on Dec. 29 and mRNA-1273 on Jan. 12. Moderna was recently focused by programmers looking for its COVID-19 examination, in a cyberattack supposedly upheld by the Chinese government. The U.S. Branch of Justice in July arraigned two Chinese nationals for running a 10-year hacking effort that most as of late rotated to focusing on organizations doing COVID research. Reuters later affirmed Moderna as the antibody producer referenced in the arraignment. China has denied any function in such practices. Other than Moderna and Pfizer/BioNTech, rival COVID immunization designers AstraZeneca, Johnson and Johnson and Novavax apparently have arrived in the line of sight of North Korean programmers. In those hacking endeavors, the assailants regularly conveyed noxious reports or connections by means of email under the appearance of occupation enrollment specialists, partners or different associates of the person in question, as indicated by individuals acquainted with the issue refered to by The Wall Street Journal. Country state programmers from Iran and Russia have likewise been blamed for attempting to take COVID-related data.

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