By Sheila Plant, PhD, MHS, RAC, Senior Director, Regulatory Strategy, CATO SMS Special Interest Guidances/Information Date Posted Recommendations to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Components; Draft Guidance for Industry: Draft Guidance for Industry – Draft Guidance 30 Jan 2020 Arthroscopy Pump Tubing Sets …

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By Sheila Plant, PhD, MHS, RAC, Senior Director, Regulatory Strategy, CATO SMS    Special Interest Guidances/Information Date Posted Policy for Diagnostics Testing in Laboratories Certified to Perform High Complexity Testing under CLIA prior to Emergency Use Authorization for Coronavirus Disease-2019 during the Public Health Emergency: Immediately in Effect Guidance for Clinical Laboratories and Food and …

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By Sheila Plant, PhD, MHS, RAC, Senior Director, Regulatory Strategy, CATO SMS FDA guidances from March 2020 as well as upcoming advisory committee meeting announcements are below.  We note that approximately one-third of FDA’s guidances this past month are related to COVID-19.    Special Interest Guidances/Information Date Posted Enforcement Policy for Gowns, Other Apparel, and …

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By Ashley Henderson, PhD, CATO SMS Scientist 1.0 INTRODUCTION The COVID‑19 pandemic has added an unprecedented set of challenges to the conduct of clinical trials including quarantines, travel limitations, site closures, and interruptions in the supply chain of investigational products. In acknowledgement of these challenges, the Food and Drug Administration (FDA) recognizes that protocol modifications …

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By Zachary Swan, PhD, RAC, Associate Director, Regulatory Affairs at CATO SMS    Special Interest Guidances/Information Date Posted Exemption and Exclusion from Certain Requirements of the Drug Supply Chain Security Act During the COVID-19 Public Health Emergency: Guidance for Industry – Final Guidance 30 April 2020 FDA Deems Certain Tobacco Products Subject to FDA Authority, …

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The U.S. Food and Drug Administration approved a new high-pressure ventilator developed by NASA to treat coronavirus or COVID-19 patients. The space agency is offering the designs for licensing on a royalty-free basis during the time of the pandemic, hoping to increase the availability of life-saving medical devices.

Today's Daily Dose brings you news about Cassava Sciences' research grant from the National Institutes of Health for developing Alzheimer's disease drug; Edwards Lifesciences' Q1 financial results; Enzo Biochem's launch of the next-generation COVID-19 test kits and Johnson & Johnson's deal with Emergent BioSolutions related to COVID-19 Vaccine candidate.

Vir Biotechnology, Inc. (VIR) and Alnylam Pharmaceuticals, Inc. (ALNY) announced Monday that they have selected a development candidate (DC) for VIR-2703 (ALN-COV), an investigational RNAi therapeutic targeting the SARS-CoV-2 (COVID-19) genome.

Though it issued an Emergency Use Authorization (EUA) for anti-malaria drugs to treat or prevent coronavirus (COVID-19), the U.S. Food and Drug Administration (FDA) reiterated its warning about the known side effects of hydroxychloroquine and chloroquine, including serious and potentially life-threatening heart rhythm problems.

The FDA has issued emergency use authorization for Gilead Science Inc's (GILD) antiviral drug Remdesivir for the treatment of COVID-19 in adults and children hospitalized with severe disease.

Ocean Spray Cranberries, Inc. is recalling Pink Lite Cranberry Juice Drink citing potential for undeclared sulfites, the U.S. Food and Drug Administration said in a statement. The recall involves a single production lot of 5.5oz cans of the drink with lot number MH0030LPK4 and Best Before Date of 24JAN21. The product is sold in boxes containing six 5.5oz cans. They were distributed to retail

The U.S. Food and Drug Administration granted marketing authorization to Medtronic Inc.'s CARPEDIEM System, a new device for continuous dialysis therapy for use in pediatric patients with certain kidney conditions. The system is indicated to provide continuous hemodialysis or hemofiltration therapy to critically ill pediatric patients weighing between 2.5 and 10 kilograms.

Baltimore, Maryland-based Medifast, Inc. is recalling certain Optavia Oatmeal products citing undeclared milk, a known allergen, the U.S. Food and Drug Administration said in a statement. The recall involves around 24,923 boxes of OPTAVIA Essential Old Fashioned Maple & Brown Sugar Oatmeal. The product is packaged in yellow and white cardboard boxes with the brand name.

Today's Daily Dose brings you news about Bristol-Myers' CheckMate -743 study results; Cyclacel Pharma's entry into COVID-19 drug bandwagon; Exelixis touching a new 52-week high and Novartis exploring anti-malaria drug for COVID-19.

The Health Impact Project’s toolkit contains resources that help communities, agencies, and other organizations take action to improve public health. The toolkit offers a collection of health impact assessments, guides, and other research to support policymakers’ efforts to consider health when making decisions across sectors, such as housing, planning, and education.

Care coordination is considered a hallmark of patient-centered treatment and has been shown to improve health outcomes and patient satisfaction as well as reduce costs. Defined as organizing patient care activities and sharing information among all participants concerned with an individual’s treatment plan in order to achieve safer and more effective results, care coordination is increasingly...

The spread of COVID-19 is placing unprecedented strain on Philadelphia’s hospitals, public health systems, and residents. Although the full effects of the emergency have yet to be realized, newly released data from 2018 and 2019 provides insight on the state of public health in the city before the pandemic.

The treatment gap continues to be an obstacle in addressing opioid use disorder (OUD) in the U.S. In 2018, an estimated 2 million Americans had OUD but only about 26% received specialty addiction treatment.

This blog post was written by Deanna Petersen, CBO of AVROBIO, as part of the From The Trenches feature of LifeSciVC. When AVROBIO went public in June 2018, I found myself on the steep end of an unexpected but interesting

The post Recipe For Managing Data Disclosure Successfully With Academic Partners: A Public Gene Therapy Company Perspective appeared first on LifeSciVC.

The biotech IPO market in 2020 remains strong, despite the volatility and COVID headwinds. We’ve seen stellar pricings and good after-market performance, with ten new offerings already this year. And the queue for companies with active S1’s on file is

The post Value Creation And Destruction: Dispersion of Performance In Biotech IPOs appeared first on LifeSciVC.

A study demonstrated Wellmune® may protect intestinal barrier function in adults when faced with stress.

innoVactiv announces today its study supporting the efficacy of InSea2® to beneficially affect post-meal cognition and mental energy has been accepted for publication.

InstantGMP, Inc. released a much-anticipated enhancement to the Equipment Logs feature.

Emport LLC is pleased to introduce new training programs and materials to augment its food safety and allergen control portfolio.

The cognitive-boost market just received another potent supplement ingredient–Quantum IQ Polygonum minus extract, exclusively from HP Ingredients, Inc. (HPI).

The best sports nutrition formulas designed to improve performance draw from a pool of ingredients researched for benefits to energy production, cognitive function and endurance both in general and specifically concerning muscles.

French beauty supplement firm D+ For Care has launched a mouth spray to aid sleep and has a flurry of holistic wellbeing innovation primed for 2020 â the year nutricosmetics could really take off, its founder says.

In scenic Puerto Varas, APEC delegates engaged in constructive dialogue about how to adopt to a changing world.

“Ten, twenty, thirty years ago, you were in the best position to go global if you were a large company and had a lot of resources and access to a lot of attorneys and advisors who could help you navigate regulations and issues that get more complicated as you go abroad.”

Ministers convened this week in Concepcion to talk about one of the most underrepresented but vital business sectors of the region.

APEC continues to bolster ethics in the healthcare sector in support of small and medium enterprises (SMEs) and patients, as Chile launches a consensus framework to improve ethical interactions in its healthcare system.

Policies impacting women’s economic advancement have improved in some areas, but more reforms are needed to enable women to fully thrive, reports the newly updated APEC Women and the Economy Dashboard 2019.

Ministers address developments in the global economy and take action to safeguard the region’s growth.

Structural reforms can counter slower economic growth in the Asia-Pacific region, says a new report by the APEC Policy Support Unit.

Chinese Taipei has voluntarily contributed USD 550,000 in funding to support APEC initiatives that advance regional economic integration and inclusive sustainable growth across the Asia-Pacific.

Trade Ministers agree to work together towards a healthy, resilient and inclusive Asia-Pacific community.

From : Communities>>Regulatory Open Forum
Thank you Dinar! ------------------------------ MARIA GUDIEL Brea CA United States ------------------------------

From : Communities>>Regulatory Open Forum
Thank you Richard! ------------------------------ MARIA GUDIEL Brea CA United States ------------------------------

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
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]

What if your favorite movie quotes were written for QA professionals? Would they be as memorable? We think so, but we’ll let you decide.

In the fall of 2015, the internet was rife with tweets sporting the hashtag #ScienceMovieQuotes.  Creative scientists repurposed their favorite movie quotes, gleefully infusing them with nerdy humor for the entertainment of their colleagues.  Such a great idea was just asking to be stolen.  And who are we to resist the siren call of piracy?  So here’s our best attempt at making #QAmovieQuotes go viral.*

…And because the rhymes were just too good, we couldn’t resist…




If you’re feeling creative, here are the American Film Institute’s 100 greatest movie quotes of all time.  Please share your humor!  (Fair warning – we took all the good ones.)

By Laurie Meehan

________________________________________________
* Thanks to Robyn Barnes of MasterControl for this fun idea.

Photo credits

Brando: User:Aggiorna / CC BY-SA-3.0, changes made
Badge: User:Dandvsp / Wikipedia Commons / CC BY-SA-3.0
Nicholson: User:Nikita~commonswiki / CC BY-SA-2.5, changes made
Shawn: Sam Felder / CC BY-SA-2.5, changes made
Leigh: Trailer Screenshot, A Streetcar Names Desire,1951, Public domain
Freeman: User:FRZ / CC BY-SA-2.5, changes made
Aladdin Chocolates: Hans Lindqvist, 2009, Public domain
Flower: Walt Disney, Bambi, 1942, Public Domain
Doune Castle: Keith Salveson / CC BY-SA-2.0
Bogart: Trailer Screenshot, Casablanca,1942, Public domain
Newman: Warner Bros. Entertainment, Cool Hand Luke, 1967, Public Domain

Anx·i·ety (noun)
The state of uneasiness caused by apprehension of possible misfortune.

Yep.  That’s the word that comes to mind whenever anyone mentions FDA inspections.

But anxiety often stems from a lack of control, and in a regulatory inspection, you have more control than you might think.  There are many steps you can take -- before, during, and even after an inspection is over -- that can give you a fair degree of control over the outcome.   Here, Polaris auditors Lauren Kelley and Michele Commins share some of those steps with you.



Pre-inspection Preparation
For-cause inspections may be unannounced, but routine FDA inspections of submission data are scheduled in advance*.  That means most inspections are not pop quizzes; they’re final exams.
Remember how happy you were when a teacher gave you access to a prior year’s exam to study from?  You knew the type of questions that would be asked.  You knew how to prepare.

So this is the first tip we’d like to share.  FDA has, indeed, given you a copy of their exam in advance, in the form of its Compliance Program Guidance Manual, CPGM 7348.811.  This is the document all FDA field investigators use to conduct inspections at clinical sites.  It outlines in great detail what documents investigators will review, what dates they’re going to verify, what processes they’ll evaluate, what data they’ll collect, and what records they’re going to compare.  Despite its rather uninspired title, this is your copy of the final exam.

You know cramming is a risky strategy, so the earlier you get familiar with the CPGM the better.  Inspection readiness is a state of preparedness more than it is a laundry list of activities; it takes some time to get there.

When the Inspector’s in the House
According to the CPGM, one of the first pieces of information the FDA investigator will obtain is a list of all of the studies performed by the clinical investigator, including protocol number, sponsor, and study dates.  So even though FDA has scheduled its inspection with you, and has told you what study the investigator is coming to inspect, any study is fair game.  An FDA investigator can look at any document she wants, or talk to any staff member he chooses, whether related to the “assigned” study or not.

Most of your preparation will have been study-specific; questions about other studies will catch your staff off-guard, and a review of records for other studies may find them less than inspection-ready.  So here’s our second tip.   Avoid anything that might pique the investigator’s curiosity about a study that is not the original subject of the inspection.  Make sure the room you reserve as your investigator’s “home base” is free of any documents, reports, notes, phone lists, and post-its.  Make sure you tidy up offices, workspaces, and facilities site-wide, and keep extraneous chatter in check.

After the Visit
If your FDA inspection resulted in zero observations, then stop reading, thank your awesome staff members, and go celebrate.  If, however, you did receive a Form FDA 483, it’s probably not the end of the world, but you do have some work to do.  Our third tip is this:  remember that the sponsor/CRO is your ally here.  They have as much invested in FDA’s assessment of your study data as you do, and they have the regulatory, QA, even legal resources that you might not.   You’re not required to formally respond to 483s, but if you do, you’re likely to receive a more favorable Establishment Inspection Report (EIR) in the end.  Let your sponsor/CRO help you with your response.

Tips Do Not a Plan Make
Tips are helpful, but you’ll need more than that to ensure a successful FDA site inspection.  You need an inspection readiness plan -- a plan that you document and keep current.  All site staff members need to train on the inspection procedures and the individual roles they will play.  (Fourth tip: don’t forget to train your temporary employees; an office temp working at the receptionist desk could be the first person your FDA investigator speaks with.)

A Last Thought
Inspections are stress-inducing events, and nervous people make mistakes.  Investigators know this, and expertly exercise the “pregnant pause,” knowing how difficult it is for people to withstand an excruciating silence without volunteering unsolicited information.

So one last tip:  conduct a mock inspection before the FDA comes to visit.  It will stress test your procedures and identify improvements you need to implement.  A thorough mock inspection will give staff members an opportunity to rehearse their roles and interview techniques so they can execute your plan and speak to the FDA investigator with confidence.

_______________________________
* For-cause inspections are also known as Investigator-oriented, and routine inspections are also known as study-oriented.

 A version of this article originally appeared in InSite, the Journal of the Society for Clinical Research Sites

What can small sponsors do to secure the outsourcing resources they need as large CROs form strategic alliances with Big Pharma?

Partenships between large pharmaceutical companies and large CROs have become the norm.  The advantages for sponsor companies include shared risk, knowledge transfer, dedicated resources, shorter time to market, and the ability to implement the massive data integration that clinical development requires.  Strategic alliances are arguably as advantageous for their outsourcing partners, providing a steady pipeline of work that’s larger in scope and longer in duration than is typical under traditional arrangements.



Strategic Partnerships in Big Pharma: Implications for the Rest
Advantages for one segment of the industry can introduce disadvantages for another.  Alliances among the large players increase competition for top-drawer CRO resources. Smaller sponsors may find it more difficult to receive the quality of service and level of commitment they might otherwise expect.  A large CRO is likely to assign their most talented personnel to projects associated with their strategic partners.  And if a partner study were to run into trouble, it would be hard to fault a CRO for pulling experienced staff members off a smaller project in order to help out with the big client.  Though a reputable CRO wouldn’t jeopardize the relationship with the smaller client, their responsiveness to routine requests might suffer.  It might take longer to get a question answered, receive requested documentation, making the job of vendor oversight difficult.

Though selecting a large, well-established CRO at the outset may have seemed like the safe bet, what do you do if you’re a small sponsor or biotech start-up who is dissatisfied with the level of service you’re receiving?

“Let’s Bring It In-house.”
Put off by a negative experience, many companies decide to curtail outsourcing, and bring functions like monitoring and project management in-house.

This response is understandable, but it rarely goes well.  There’s good reason to outsource study functions to a CRO, especially if you’re small, or new, or both.  Mid-study is a terrible time to realize you’re in over your head.  You may find it difficult to contract with the service providers you want in the timeframe you need them.  Services you would have preferred be performed by a single company may now have to be farmed out piecemeal, which has the overhead of multiple contracts and makes vendor oversight more difficult to manage.  You don’t have time to go through a thorough qualification process.  You’re not in a good bargaining position; you’re trying to buy a new car after they’ve towed away your old one.  And now you have to rely on your new service provider(s) – the ones who may not be your first choice, whom you had to choose in haste, whom you didn’t get to thoroughly vet – to jump in midstream and pick up a study that is already in trouble.

Options for Small Sponsors and Start-ups
So what’s the answer?  You have several good options we’ve seen work well for smaller organizations.

(1) Go smaller.  Look beyond traditional outsourcing choices and consider selecting smaller vendors who may well be in a better position to focus on individual projects and give priority to shorter term engagements.  After all, a project that’s small to a big CRO will be comparatively big to a small CRO.

(2) Go long-term.  Consider establishing strategic partnerships of your own.   Doing so would increase the expertise and technology to which you’d have ready access, and could extend your global reach.

(3) Go big, but go vigilantly.  There’s a reason companies hire big, reputable CROs.  ‘Big’ means the CRO has an impressive set of resources at its disposal.  ‘Reputable’ means it has a proven record of successfully completing studies, producing reliable data, and preserving subject safety.  Smaller sponsors can still take advantage of everything a big CRO offers if they can commit to conducting very strict vendor oversight.  They need to closely monitor the quality of the work the CRO performs, frequently assess adherence to the many written study plans, and make sure deadlines are being met.  Service contracts should guarantee a certain level of responsiveness (by specifying maximum turn-around times, for example), especially for those requests that enable these oversight activities.


Qualification is Key
While the key to Option 3 is effective vendor management, the key to Options 1 and 2 is effective vendor qualification.  Resources are tight in a small company, so you need to direct them where your exposure is greatest, where they’ll do the most good.  What could be more essential to the success of your study than choosing the right company to conduct it?   Many sponsors conduct on-site vendor audits.  That’s good.  That’s necessary.  But it’s not sufficient.  To consistently choose the best possible CRO for your study, sponsors need to:

• Formally document and maintain vendor selection criteria and qualification process
• Form selection committees that represent all sides of your business – finance, contracting, operations, finance, QA, data management, pharmacovigilance, biostatistics, etc.
• Conduct on-site audits with well-trained, well-prepared QA auditors
• Track the resulting CAPA activities
• Ensure outstanding issues are resolved before the contract is signed
• Periodically re-evaluate vendors to make sure they can continue to deliver the same level of quality they’ve delivered in the past

Strategic partnerships among large companies have reshaped the research environment for industry players of every size.  Small and mid-sized companies who take the time to review current outsourcing arrangements, assess alternative models, and thoroughly qualify new vendors and partners will fare the best.

Photo Credit: FreeImages.com/Svilen Milev

As a sponsor or CRO, you understand the importance of a thorough site selection process. A site needs to be able to meet enrollment targets and time frames, protect the rights and safety of study participants, execute the protocol, deliver quality data, and maintain GCP compliance. That’s what your site feasibility surveys and pre-study visits are designed to evaluate. And as you’re assessing a site’s abilities, the site is conducting its own feasibility process. They’re mining their patient database and assessing inclusion/exclusion criteria. They’re reviewing staff credentials and ensuring they have adequate resources to manage the number of subject visits and collect the data the protocol requires.

But when we conduct GCP audits, we find there’s one perspective that is sometimes overlooked by both sides: the needs of the study drug itself.




Study Drug Attributes Affecting Site Selection Process

IP Environment.  Aside from needing sufficient storage space, many drugs have special storage requirements. Does the site have the equipment and resources needed to maintain and adequately monitor and record environmental conditions such as temperature or humidity? Do they have agreements with their vendors that guarantee a specific response time for repairing or replacing faulty equipment? If they lose electricity, do they have back up power, or at least provisions to move the IP off-site? (This is a common auditor question in hurricane-prone areas.)


Preparation of Study Drug.  Does your investigational product need to be reconstituted in a liquid? Do doses need to be compounded in different concentrations? Does the protocol require that an IV solution be prepared, filtered, and sterilized? These activities take time, specially trained personnel, and sometimes specialized equipment such as ventilation hoods. If your protocol demands an involved IP prep, your feasibility survey must include questions that allow you to assess these site capabilities and your pre-study visit should definitely include some time in the pharmacy. 

Drug Administration. Handing over a bottle of capsules to a study participant is one thing; inserting a butterfly catheter into an antecubital vein is something else again. If drug administration is very invasive, you’ll want to verify that the site has taken this into account when providing you enrollment projections. During subject visits, staff members may have to calculate doses, give intramuscular injections, perform infusions, or conduct sterilization procedures. You’ll want to verify that site staff has this expertise if required. Some clinical trials require a blinded dispenser who cannot be involved in any other study procedure or activities. If so, does the site have the resources for this?

Site Selection: it’s not just the PI, it’s the IP too
The study success and patient safety are jeopardized when a site can’t meet its enrollment target or doesn’t have the resources to execute the protocol. IP requirements can affect a site’s ability to do both. It’s critical that your site selection process – both your feasibility questionnaire and your pre-study visit – evaluate how well the site can meet the storage, preparation, and administration requirements of the study drug.

__________________________________________________________________________
A version of this article originally appeared in InSite, the Journal of the Society for Clinical Research Sites.

Photo Credit: By Harmid (Own work) [Public domain], via Wikimedia Commons

We may call them “site inspections”, but it’s not the site that’s being inspected when a regulator visits; it’s the Principal Investigator. Though a PI typically delegates study tasks to other staff members, he or she remains solely responsible for the conduct of the study. In fact, the ICH E6(R2) addendum adds two new sections to the international guidance that emphasize PI supervision.

That’s what makes the Delegation of Authority (DoA) log so important and why regulatory inspectors care about it so much. A DoA log serves as evidence that a PI has assigned study tasks only to those staff members with the education, training, and experience to carry them out. If delegates are unqualified to perform their tasks, subject safety could be at risk and it’s highly likely that the study data would be unusable.



Monitors – you can really make a big contribution here. At the outset of the study, you can verify that your PI has made appropriate delegations and the DoA log is complete. You can cross-match the log with training records, CVs, licenses, and source documents and correct any problems as early in the study as possible. Then, throughout the study, you can verify that the DoA log is being maintained.

Coverage
Without referencing any other site document, monitors can spot two types of DoA log omissions.

(1) Missing Assignments. Are there study tasks to which no one has been delegated? The tasks in a DoA log are often represented by a short code to conserve space. A legend at the end of the log translates the code into its corresponding task. Monitors can compare the legend to the DoA log entries to see if any tasks are omitted.


(2) Gap in Assignments. Due to staff turnover, reassignment, leaves of absence, etc., delegation for a task frequently does not last the duration of the entire study. A column in the DoA log indicates the delegation start and stop date.  Monitors can check to make sure that when the delegation for a task ends for one staff member, it is picked up by another.

Qualifications
Once you’re satisfied the DoA log completely covers all tasks for the duration of the study, you can check to make sure delegates have the necessary qualifications. You’ll want to compare the log with training records, CVs, and medical licenses from the regulatory binder.

• Has the staffer charged with recording vital signs during a subject visit been formally trained to take blood pressure? Is it documented?
• Did an incoming pharmacist receive protocol training prior to the start date of his study assignments?
• Does state law allow a registered nurse to dispense investigational product, or is a nurse practitioner or physician’s assistant required? Does the protocol require only an M.D. conduct certain procedures? Does the DoA log show the requirement is being followed?

Study Procedures
Even after the focus of the monitoring visit moves past the DoA log itself, you should revisit the log during source document review.

• Have any study tasks been conducted by staff members who have not received official delegation to do so?
• Perhaps the protocol requires a blinded IP dispenser. If so, has the delegated dispenser conducted any other study procedure?

PI Oversight
The PI is responsible for ensuring subject safety, compliance with the regs and the protocol, and control of the investigational product. That obligation cannot be delegated away. PI oversight is critical to a successful study, and the DoA log is where PI oversight starts.

Procedures that are performed by unqualified or ineligible personnel put both study participants and study data at risk. These are the very things regulatory inspectors work to guard against. Good monitors know it and make verifying the DoA log a priority.

__________________
A version of this article originally appeared in InSite, the Journal of the Society for Clinical Research Sites.

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