Today's Daily Dose brings you news about aTyr Pharma joining the COVID-19 battle; Cara's pivotal KALM-2 trial; LabCorp's at-home collection kit for COVID-19 testing securing Emergency Use Authorization from the FDA, and Myovant's much-awaited clinical trial catalyst.
Let's take a look at the biotech/pharma companies that are slated to report clinical trial results this quarter.
The following are some of the stocks in the healthcare sector that touched a high yesterday. Will the rally continue?
Neuroscience has had a tough run of news lately. With Amgen deprioritizing neuro this year, Pfizer doing the same last year, and others like BMS, GSK, and AZ cutting back on CNS a few years earlier, it would seem dark
The post The Promise Of Precision Neuroscience And Launch Of Arkuda Therapeutics appeared first on LifeSciVC.
Today Alkermes announced its acquisition of Rodin Therapeutics, a leader in the field of synaptic dysfunction and neuronal epigenetics. Alkermes extensive experience in CNS diseases made them an ideal partner for Rodin, and this acquisition helps expand Alkermes’ efforts into
The post Thinking Boldly: Alkermes Acquires Rodin Therapeutics appeared first on LifeSciVC.
This blog was written by Mark Manfredi, CEO of Ikena Oncology, and guest blogger Maude Tessier, CBO, as part of the From The Trenches feature of LifeSciVC. When we started to think about changing our company name, we knew it
The post Kyn to Ikena: The Art and Science of Rebranding appeared first on LifeSciVC.
This blog was written by Jeb Keiper, CEO of Nimbus Therapeutics LLC, as part of the From The Trenches feature of LifeSciVC. Like many middle-aged weekend warriors, I’ve been recently sidelined by injury simply through doing what I’ve regularly done:
The post Core (Values) Workout appeared first on LifeSciVC.
This blog was written by Ankit Mahadevia, CEO of Spero Therapeutics, as part of the From The Trenches feature of LifeSciVC. If CEOs have empowered their teams effectively, they have three roles during times of rapid change: Motivator in chief
The post The Balancing Act: Taking A Systematic Approach To Hard Decisions In Times Of Rapid Change appeared first on LifeSciVC.
Venture capital is a long investment cycle business, and never before has that been so clear as now in the face of the ongoing COVID pandemic. Even with the unprecedented public equity market volatility, venture investing into private biopharma companies
The post Booming VC-Backed Biopharma: Strong Market Despite Pandemic appeared first on LifeSciVC.
BASF recently announced the launch of Accelon™ absorption accelerating technology, developed as a breakthrough solution to the bioavailability challenge of today’s omega-3 supplements.
Baby Boomers, Gen X and Millennials are key consumer target groups for marketers, with three different sets of needs and buying propensities; it’s important that brands define their unique selling propositions.
In the 8th edition of The Star Outstanding Business Awards (SOBA), ExcelVite has emerged as Gold winner for two award categories–Best Innovation and Best Global Market.
DSM today published the first part of a new report in its Global Insight Series, focused on breakfast habits and behavior in Europe and the US.
Bergstrom Nutrition, manufacturer of OptiMSM®, a branded form of methylsulfonylmethane (MSM), recently published an article detailing how the small intestine absorbs MSM, particularly in relation to sulfur.
Emport LLC is pleased to introduce new training programs and materials to augment its food safety and allergen control portfolio.
Natural product brands can boost trade show ROI by investing in PR to work with trade press via press releases and onsite interviews.
Potential brain health benefits of cannabidiol (CBD) can make it an attractive ingredient for supplement brands, but federal regulations and FDA action may hinder product success in the market.
Alkemist Labs is pleased to announce a move to a new facility with over four times more space to expand capacity and accommodate continued growth.
Outside influences have shown strong correlations with what lives inside our bodies, and researchers are just beginning to understand how these environmental factors may affect the makeup of the gut microbiome.
Older adults who consumed large amounts of flavonoid-rich foods were two to four times less likely to develop Alzheimer's disease and related dementias over 20 years compared with people whose intake was low, in a study of 2,800 people.
A recent study conducted by researchers at Tufts University suggests that consuming 1.5 ounces of almonds per day, compared to no almond consumption, may help reduce CVD risk factors such as elevated LDL cholesterol levels, and as a result, reduce an individual's healthcare costs associated with treating such conditions.
APEC focuses on the progress the forum has made on the four priorities set by Chile this year.
“I would like to express our appreciation to APEC member economies that put their faith in Malaysia’s leadership and made it a point to participate.”
Reflecting the discussions of the Health Working Group which met at the First APEC Senior Officials Meeting, 7-8 February 2020, Putrajaya, Malaysia
From : Communities>>Regulatory Open Forum
Hello Anon, In the version, I usually put the last year or the year generally recognised, e.g. ISO 14971 being 2007. Then for the publication date, I do put the latest version when published so would be April 2010. Because of the way standards are amended and revised, it can be quite difficult to determine what to put on the cover sheet. I would also rely a bit on the Recognized Standards list the FDA publishes: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm to list [More]
From : Communities>>Regulatory Open Forum
Yes, I think there were some previous posts where people uploaded Word versions you can get; just need to look around a little. ------------------------------ Richard Vincins RAC Vice President Global Regulatory Affairs ------------------------------
From : Communities>>Regulatory Open Forum
Great! Thanks Anna --------------------------------- Anna Alonzi MD Sr. Regulatory Associate Newtown PA United States ---------------------------------
From : Communities>>Regulatory Open Forum
From a clinical perspective, nothing will make your medical device "safe" as this word is defined in a dictionary. Different jurisdictions will adopt what are essentially legal definitions of this word. Devices that meet this definition are "safe" only within the scope of that definition, which is more than just the words, but also includes the process the regulatory agency follows to determine whether the device meets that definition. Two different jurisdictions may adopt the same literal definition, [More]
From : Communities>>Regulatory Open Forum
The short answer is "yes" provided that the development cell bank was the source for the GMP bank and is comparable in terms of performance. However, the devil is in details and you need to evaluate "comparability" carefully between the development bank and the GMP bank with respect to the characterization data you plan to use for, e.g., to support GMP bank for production, etc. Two ICH guidance documents are useful to look at, Q7 Table 1 and Q5D. The US FDA generally follows ICH guidance but EMA [More]
From : Communities>>Regulatory Open Forum
This message was posted by a user wishing to remain anonymous Why not use Adobe to fill out the form? You will need it to compile the submission anyway.
From : Communities>>Regulatory Open Forum
Hi Annie, I knew before that I wouldn't be able to attend to the webcast, so I did not register for it. But I am very curious on Dr. Akras insights. Is it possible to view a recording of it? Thanks, Britta ------------------------------ Britta Cyron Bochum Germany ------------------------------
From : Communities>>Regulatory Open Forum
Hi All, Always appreciate and respect the great advice that comes through this forum: The scope of my question is CE Mark of a Class IIa medical device system under the MDD (and then eventually MDR): We have Class I devices which will be CE Marked through self-certification. These devices can be used with other CE marked products (not owned by us). One of which is not CE Marked as a medical device (conformity to machinery and low voltage directives). In terms of what we consider this vendor, what [More]
From : Communities>>Regulatory Open Forum
This message was posted by a user wishing to remain anonymous When this was first issued we printed it out, filled in the answers with careful handwriting and then scanned it back in - which seemed to be perfectly acceptable. Since then we've converted their form to a fillable PDF.
From : Communities>>Regulatory Open Forum
Hi @Britta Cyron , Thanks for your question. Let me connect with my RAPS colleagues on this to get you an answer and then I will follow-up with you directly. Best, Annie ------------------------------ Annie O'Brien Community Manager Regulatory Affairs Professional Society regex@raps.org ------------------------------
From : Communities>>Regulatory Open Forum
Hello , I would like to understand when can we release a new product/accessories under Letter to File for a 510(k) cleared device. ------------------------------ Shikha Malik Regulatory Affairs Specialist II Dallas TX United States ------------------------------
From : Communities>>Regulatory Open Forum
Hello, If there is a significant change to an accessory cleared under a 510(k) of a product, are we supposed to file a significant change to the FDA for the original 510(k) for the accessory? ------------------------------ Shikha Malik Regulatory Affairs Specialist II Dallas TX United States ------------------------------
From : Communities>>Regulatory Open Forum
See FDA Guidance For Industry: When to submit a new 510(k) for an existing device. It will walk you through a decision tree. ------------------------------ William Coulston PMP, MS, RAC Quality & Regulatory Manager San Antonio TX United States ------------------------------
From : Communities>>Regulatory Open Forum
Annie: Thank you for sharing this news. I am curious whether the Board considers this a limited exception or a potential new normal option going forward? Scott ------------------------------ Scott Bishop Houston TX United States ------------------------------ ------------------------------------------- Original Message: Sent: 04-May-2020 08:50 From: Annie O'Brien Subject: New: Take the RAC Exams Online this Summer! The RAC board has been working hard to find solutions offering more flexibility [More]
From : Communities>>Regulatory Open Forum
Hello Shikha, This depends on whether the form, function, and operation of the medical device is affected by the change to the accessory. Without knowing the device, the accessory, or the type of change, it is hard to say, but I refer you to the FDA Guidance document for when to complete a 510(k) for an existing device. If you go through the flowchart and read the descriptors for each there is the item B.5 and then the sub-boxes 1 through 4. There is the question whether a change to accessory [More]
From : Communities>>Regulatory Open Forum
Thank you for posting this here Annie as the webcast was excellent (as would be expected from Dr. Akra haha) - but really it was great to have this publicly available as there was nice information about the EU MDR conveyed. ------------------------------ Richard Vincins RAC Vice President Global Regulatory Affairs ------------------------------
Trying to comply with the GDPR got you down?
Maybe our parody will cheer you up.
(Sung to the tune of Lennon-McCartney's "Back in the U.S.S.R.")
The nation’s largest pharmacy serving elder care facilities will pay Massachusetts nearly half a million dollars to settle allegations that it got kickbacks more than eight years ago from Abbott Laboratories to promote the anti-seizure drug, Depakote. The settlement was signed by Omnicare, a pharmacy services company that was acquired by CVS Health Corporation (NYSE: CVS) in August 2015. The $476,216 payment to Massachusetts is part of a $28 million multi-state settlement that included 47 states…
Vertex Pharmaceuticals announced a plan late Tuesday to begin trials before the end of the year of the third in its so-called “triple combo” of pills designed to treat as much as 90 percent of the 75,000 patients worldwide who suffer from cystic fibrosis. That news, announced in conjunction with the Boston-based drugmaker’s third-quarter financial results last night, spurred a 6 percent stock increase after hours, implying the company’s market cap could increase by about half a billion dollars…
Wednesday’s initial public offering for Cambridge-based Ra Pharmaceuticals marked the ninth biotech startup to go public this year, tying the number in 2013 but still less than either of the two years since. Ra (Nasdaq: RARX), which has 40 employees in one of the former Pfizer buildings in Alewife, ended up with the third-largest IPO size for any Massachusetts-based biotech in 2016, with a total of $92 million raised from the sale of 7 million shares for $13 each. That’s more than the $86 million…
Editor's note: This story was originally published Friday morning, and has been updated to reflect the FDA's decision regarding the drug later that day. A U.S. approval decision for a major drug planned to be marketed by Cambridge-based Sanofi Genzyme that had been expected last Friday has been delayed due to “deficiencies” found during a manufacturing site inspection in France. In its third quarter report, released Friday morning, French drugmaker Sanofi (NYSE: SNY) disclosed that “manufacturing…
Third Rock Ventures, the Boston-based venture capital firm behind some of the Bay State’s most prominent biotechs, has reclaimed its title as the biggest life science-focused VC firm in the state with a new $616 million round, and has also named its first female partner in eight years. With the announcement of its Fund IV today — its largest ever — the firm now has raised $1.9 billion in the nine years since it was formed. That eclipses its rival across the Charles River, Flagship Ventures,…
The results of a 33-patient study conducted by a Burlington biotech suggest its long-acting steroid injection for osteoarthritis of the knee may be safer for the large percentage of those patients who also have type 2 diabetes. Flexion Therapeutics (Nasdaq: FLXN) has for years been developing its lead drug candidate, Zilretta (formerly called FX006), a reformulation of a common corticosteroid that’s used with osteoarthritis patients. Flexion’s version combines the drug with a employs proprietary…
Biological drugs remain unaffordable for many in the US due to strategies used by pharmaceutical companies and negative messaging about biosimilars, explains a recent commentary by Dr Joel Lexchin, School of Health Policy and Management at York University, Canada [1].
