oval

Sanofi's Meningococcal Conjugate Vaccine secures FDA approval in patients aged two and up

Sanofi’s MedQuadfi Meningococcal Conjugate Vaccine has scored FDA approval for the prevention of invasive meningococcal disease, becoming the first and only product available in the US for this indication in patients of at least two years old.




oval

EU approval for Novartis' Cosentyx in active non-radiographic axial spondyloarthritis

Novartis has revealed that the European Commission has moved to approve Cosentyx (secukinumab) for the treatment of active non-radiographic axial spondyloarthritis (nr-axSpA) in adult patients.




oval

FDA approval for Tabrecta in metastatic non-small cell lung cancer with METex14

The FDA has awarded marketing authorisation to Novartis for the Oral MET inhibitor Tabrecta for the first-line treatment of metastatic non-small cell lung cancer in patients whose tumors have a mutation that leads to MET exon 14 skipping (METex14), regardless of whether they have previously received any type of treatment.




oval

FDA approval for Farxiga in new indication in heart failure patients

Farxiga (dapagliflozin) has been approved in the US to reduce the risk of cardiovascular (CV) death and…



  • AstraZeneca/Cardio-vascular/Diabetes/Farxiga/Focus On/Glucosides/Pharmaceutical/Regulation/SGLT2 inhibitors/UK/US FDA/USA

oval

Japan grants ‘exceptional’ approval for remdesivir in COVID-19

As had been widely expected, Gilead Sciences on Thursday announced that the Japanese Ministry of Health,…



  • Anti-virals/Asia Pacific/Coronavirus/Focus On/Gilead Sciences/Japan/Pharmaceutical/Regulation/Remdesivir/USA/Veklury

oval

AbbVie, Allergan score FTC approval for $63B merger with one final hurdle left to go

AbbVie and Allergan have waited for nearly a year for their much-discussed merger to pass muster. Finally, after pushback from consumer groups and tight scrutiny from regulators, the FTC has granted its green light. The partners face just one final hurdle to consummating their deal. 




oval

Justice Department Seeks Removal of Pittsburgh-Area Man Who Served as Nazi Concentration Camp Guard

The Department of Justice has initiated removal proceedings against a Sharon, Penn., resident who served as an armed SS guard at two Nazi concentration camps in Germany during World War II.



  • OPA Press Releases

oval

Attorney General Vacates Compean Order, Initiates New Rulemaking to Govern Immigration Removal Proceedings

Attorney General Eric Holder today vacated the order issued in Matter of Compean by Attorney General Mukasey in January and announced his intention to initiate a new rulemaking proceeding for regulations to govern claims of ineffective assistance of counsel in removal proceedings.



  • OPA Press Releases

oval

Justice Department Seeks Removal of Detroit-Area Man Who Shot Jews While Serving as Nazi Policeman

The Department has initiated removal proceedings against a Troy, Mich., resident based on his participation in violent acts of persecution while serving as an armed member of the Nazi-sponsored Ukrainian Auxiliary Police (UAP) in occupied L’viv, Ukraine, during World War II.



  • OPA Press Releases

oval

Statement of the Attorney General on Senate Judiciary Committee’s Approval of the Fair Sentencing Act

"I applaud the work of the Senate Judiciary Committee, particularly Chairman Leahy, Ranking Member Sessions and Senators Durbin and Graham, in taking such an important step toward reforming our sentencing laws. I look forward to the Senate and the House approving this legislation quickly so that it can be signed into law."




oval

Federal Government Announces Removal of Obsolete Ships from Suisun Bay

The federal government announced today that it would remove the remaining 52 ships that currently sit in the Suisun Bay as part of an agreement with environmental groups that was filed in federal court in Sacramento, Calif.



  • OPA Press Releases

oval

Rochester, New York, Contractor Convicted of Illegal Asbestos Removal and False Statements to OSHA

A jury in Rochester, N.Y., convicted Keith Gordon-Smith, and his Rochester-based asbestos abatement company, Gordon-Smith Contracting, Inc. (GSCI) of eight counts of knowing violations of the Clean Air Act asbestos work practice standards.



  • OPA Press Releases

oval

Associate Attorney General Tom Perrelli and Interior Secretary Ken Salazar Applaud Final Approval of Cobell Settlement

Today, the Departments of Justice and Interior applauded the final approval by U.S. Senior District Judge Thomas F. Hogan of Cobell v. Salazar, a long-running and contentious individual American Indian trust class-action lawsuit.



  • OPA Press Releases

oval

Statements by Attorney General Holder and Agriculture Secretary Vilsack on Court Approval of Pigford II Settlement Agreement

“This settlement allows the Department of Agriculture and African-American farmers to focus on the future, and brings us one step closer to giving these farmers a chance to have their claims heard,” said Attorney General Holder.



  • OPA Press Releases

oval

Justice Department Seeks Court Approval of Plan to Provide Comprehensive Services to ELL Students in Denver Public Schools

The Department of Justice, the Congress of Hispanic Educators (CHE) and the Denver Public Schools (DPS) have jointly requested court approval of a consent decree that requires that the more than 20,000 English Language Learner (ELL) students enrolled in DPS receive the services they need to overcome language barriers and meaningfully participate in school. The proposed consent decree will benefit all ELLs and LEP parents in the district, including not only the 87 percent of ELL students who are native Spanish speakers, but those who speak one of the 137 other languages spoken in the district as well.



  • OPA Press Releases

oval

FDA approval delayed for Sanofi Genzyme’s next blockbuster

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…




oval

Sanofi receives FDA approval for quadrivalent meningococcal vaccine

The company receives approval for MenQuadfi to prevent meningococcal disease.



  • Markets & Regulations

oval

Impact of COVID-19 on Regulatory Enforcement and Approvals

The impacts of the COVID-19 pandemic bring change shifts the status quo on a daily basis with both breadth and depth. Everything we as individuals and as a society would normally do is undergoing change. FDA regulatory oversight is one … Continue reading




oval

Impact of COVID-19 on Regulatory Enforcement and Approvals – Part 2

Earlier this month I published a blog posting that raised questions related to the potential for disruption of approvals in the wake of FDA actions to limit inspections due to the COVID-19 pandemic. Subsequently I had the opportunity to pose … Continue reading




oval

Impact of COVID-19 on Regulatory Enforcement and Approvals – Part 3 – FDA Adds Resources to Facilitate COVID-19 Research

With the COVID-19 impact making itself apparent on a daily basis as the numbers climb and organizations respond, the effects on the pharma and biotech sector also shifts. Yesterday FDA announced a new concentration of agency assets to be focused … Continue reading




oval

Impact of COVID-19 on FDA Enforcement and Approvals – Part 5 – FDA Provides Update to Shape Expectations on New Approvals

In response to written questions submitted last month regarding the potential for delays, FDA had stated that “CDER remains fully capable to continue daily activities, while responding to the public needs of the current COVID-19 outbreak.” In a subsequent blog … Continue reading




oval

COVID-19 Pandemic Likely to Affect FDA Product Approval Timelines

April 27, 2020 – As the COVID-19 pandemic continues, the Food and Drug Administration (FDA) must balance safeguarding public health with the desire for timely product reviews. Staff members at the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research are working diligently to keep all of these balls in […]




oval

EMA starts reviewing Gilead's remdesivir data to accelerate approval of COVID-19 antiviral

The European Medicines Agency has begun a rolling review of data on Gilead’s remdesivir, positioning it to cut the time it takes to decide whether to approve the drug in COVID-19 patients.




oval

FDA delays decision on approval of Bristol Myers' CAR-T

The FDA has delayed its decision on whether to approve Bristol Myers Squibb’s CAR-T cell therapy by three months. Bristol Myers attributed the delay to its submission of additional information upon the request of the FDA.




oval

MdMYB6 regulates anthocyanin formation in apple both through direct inhibition of the biosynthesis pathway and through substrate removal




oval

Central catheter removal timing and growth patterns in preterm infants




oval

It wasn't safe to pit - Kovalainen

While the sight of Heikki Kovalainen grabbing a fire extinguisher and trying to put out a blaze on his Lotus provided one of the more spectacular images of the season, opinion was divided on the wisdom of his actions




oval

Why legislative proposals to improve drug and device development must look beyond FDA approvals


Legislative proposals to accelerate and improve the development of innovative drugs and medical devices generally focus on reforming the clinical development and regulatory review processes that occur before a product gets to market. Many of these proposals – such as boosting federal funding for basic science, streamlining the clinical trials process, improving incentives for development in areas of unmet medical need, or creating expedited FDA review pathways for promising treatments – are worthy pursuits and justifiably part of ongoing efforts to strengthen biomedical innovation in the United States, such as the 21st Century Cures initiative in the House and a parallel effort taking shape in the Senate.

What has largely been missing from these recent policy discussions, however, is an equal and concerted focus on the role that postmarket evidence can play in creating a more robust and efficient innovation process. Data on medical product safety, efficacy, and associated patient outcomes accrued through routine medical practice and through practical research involving a broad range of medical practices could not only bolster our understanding of how well novel treatments are achieving their intended effects, but reinforce many of the premarket reforms currently under consideration. Below and in a new paper, we highlight the importance of postmarket evidence development and present a number of immediately achievable proposals that could help lay the foundation for future cures.

Why is postmarket evidence development important?

There are a number of reasons why evidence developed after a medical product’s approval should be considered an integral part of legislative efforts to improve biomedical innovation. First and foremost, learning from clinical experiences with medical products in large patient populations can allow providers to better target and treat individuals, matching the right drug or device to the right patient based on real-world evidence. Such knowledge can in turn support changes in care that lead to better outcomes and thus higher value realized by any given medical product.

Similarly, data developed on outcomes, disease progression, and associated genetic and other characteristics that suggest differences in disease course or response to treatment can form the foundation of future breakthrough medical products. As we continue to move toward an era of increasingly-targeted treatments, this important of this type of real-world data cannot be discounted.

Finally, organized efforts to improve postmarket evidence development can further establish infrastructure and robust data sources for ensuring the safety and effectiveness of FDA-approved products, protecting patient lives. This is especially important as Congress, the Administration, and others continue to seek novel policies for further expediting the pre-market regulatory review process for high-priority treatments. Without a reliable postmarket evidence development infrastructure in place, attempts to further shorten the time it takes to move a product from clinical development to FDA approval may run up against the barrier of limited capabilities to gather the postmarket data needed to refine a product’s safety and effectiveness profile. While this is particularly important for medical devices – the “life cycle” of a medical device often involves many important revisions in the device itself and in how and by whom it is used after approval – it is also important for breakthrough drugs, which may increasingly be approved based on biomarkers that predict clinical response and in particular subpopulations of patients.

What can be done now?

The last decade has seen progress in the availability of postmarket data and the production of postmarket evidence. Biomedical researchers, product developers, health care plans, and providers are doing more to collect and analyze clinical and outcomes data. Multiple independent efforts – including the U.S. Food and Drug Administration’s Sentinel Initiative for active postmarket drug safety surveillance, the Patient-Centered Outcomes Research Institute’s PCORnet for clinical effectiveness studies, the Medical Device Epidemiology Network (MDEpiNet) for developing better methods and medical device registries for medical device surveillance and a number of dedicated, product-specific outcomes registries – have demonstrated the powerful effects that rigorous, systematic postmarket data collection can have on our understanding of how medical products perform in the real-world and of the course of underlying diseases that they are designed to treat.

These and other postmarket data systems now hold the potential to contribute to data analysis and improved population-based evidence development on a wider scale. Federal support for strengthening the processes and tools through which data on important health outcomes can be leveraged to improve evidence on the safety, effectiveness, and value of care; for creating transparent and timely access to such data; and for building on current evidence development activities will help to make the use of postmarket data more robust, routine, and reliable.

Toward that end, we put forward a number of targeted proposals that current legislative efforts should consider as the 2015 policy agenda continues to take shape:

Evaluate the potential use of postmarket evidence in regulatory decision-making. The initial Cures discussion draft mandated FDA to establish a process by which pharmaceutical manufacturers could submit real-world evidence to support Agency regulatory decisions. While this is an important part of further establishing methods and mechanisms for harnessing data developed in the postmarket space, the proposed timelines (roughly 12 months to first Guidance for Industry) and wide scope of the program do not allow for a thoughtfully-, collaboratively-considered approach to utilizing real-world evidence. Future proposals should allow FDA to take a longer, multi-stakeholder approach to identify the current sources of real-world data, gaps in such collection activities, standards and methodologies for collection, and priority areas where more work is needed to understand how real-world data could be used.

Expand the Sentinel System’s data collection activities to include data on effectiveness. Established by Congress in 2007, Sentinel is a robust surveillance system geared toward monitoring the safety of drugs and biologics. In parallel to the program for evaluating the use of RWE outlined above, FDA could work with stakeholders to identify and pursue targeted extensions of the Sentinel system that begin to pilot collection of such data. Demonstration projects could enable faster and more effective RWE development to characterize treatment utilization patterns, further refine a product’s efficacy profile, or address pressing public health concerns – all by testing strategic linkages to data elements outside of Sentinel’s safety focus.

Establish an active postmarket safety surveillance system for medical devices. Congress has already acted once to establish device surveillance, mandating in 2012 that Sentinel be expanded to include safety data on medical devices. To date, however, there has been no additional support for such surveillance or even the capability of individually tracking medical devices in-use. With the recently finalized Unique Device Identifier rule going effect and the ability to perform such tracking on the horizon, the time is now to adopt recent proposals from FDA’s National Medical Device Postmarket Surveillance System Planning Board. With Congressional authorization for FDA to establish an implementation plan and adequate appropriations, the true foundation for such a system could finally be put into place.

These next steps are practical, immediately achievable, and key to fully realizing the intended effect of other policy efforts aimed at both improving the biomedical innovation process and strengthening the move to value-based health care.

Authors

      




oval

Biggest Financers of Mountaintop Removal Coal Mining Exposed

PNC, Citi, and UBS are the top three financial enablers of mountaintop removal coal mining, according to a new report by Rainforest Action Network and the Sierra Club that ranks ten of the world's largest banks.These




oval

GMO salmon gets final FDA approval

The U.S. Food and Drug Administration has approved the first genetically engineered animal for human consumption.




oval

Court sides with the bees, overturns EPA approval of a pesticide

Appeals court calls EPA approval of bee-threatening sulfoxaflor “based on flawed and limited data.”




oval

EPA catches Dow in weed-killer lie, asks court to reverse approval

The agro giant made contradictory claims to the government about the herbicide Enlist Duo, the EPA isn’t happy.




oval

EPA surprise: Agency seeks to cancel approval of toxic pesticide

And the company that makes the chemical, Bayer CropScience, refuses to agree.




oval

Even Former Coal Miners Want to End Mountaintop Removal Mining

It's time to end this destructive practice, and Appalachian residents descended upon Washington, D.C., this week to demand action.




oval

Biggest dam removal in European history has begun with the Vezins dam

Removal of the 118-foot-high dam in France will free the Sélune River, bringing wildlife back to the waterway and the bay of Mont-Saint-Michel.




oval

Reward fund for information on Jairo Mora Sandoval's murder now $56,000

Thank you to all the generous donors!




oval

Flexible cooling strip breakthrough for heat removal

This could keep people from overheating in their wearable electronic outfits or simply in the heat of the ever-warming days




oval

Greenpeace Protests Coal & Mountaintop Removal Atop 400 Ft Power Plant

The green activist group's stunt seeks to draw attention to the devastation wrought by coal.




oval

Quid Pro Quo on Keystone approval? Not likely.

As we wait for President Obama and the State Department to make a decision on the proposed Keystone XL pipeline, talk seems to have shifted away from why the pipeline should be rejected to what should be done in the event the project is approved.








oval

Trump contradicts nurse in testy Oval Office exchange over coronavirus protective gear

President Donald Trump contradicted a nurse who said that access to sufficient supplies of personal protective equipment during the coronavirus pandemic "has been sporadic."




oval

A massive renewable energy scheme in Australia has been recommended for environmental approval

Several big firms, including Danish wind turbine manufacturer Vestas, are involved in the project.




oval

Moderna's vaccine candidate could potentially get regulatory approval in 2021

Moderna has received FDA approval for the company's Covid-19 vaccine to continue into the second phase. CNBC's Meg Tirrell reports.




oval

Pharma giants granted coronavirus approvals but doubts remain on manufacturing a global vaccine

Experts warn that vaccine timelines look ambitious and argue more thought is needed on manufacturing.




oval

Gottlieb: Covid-19 vaccine may be available for selective use before official approval

Dr. Scott Gottlieb, member of the boards of Pfizer and biotech company Illumina and former FDA commissioner, tells "Squawk Box" that a Covid-19 vaccine could be made available for use in "selected circumstances" before it receives official approval for wider distribution.




oval

Walter Sandoval of CD Guadalajara celebrates with Angel Zaldivar after scoring his team's first goal

AL AIN, UNITED ARAB EMIRATES - DECEMBER 18: Walter Sandoval of CD Guadalajara celebrates after scoring his team's first goal with Angel Zaldivar of CD Guadalajara during the FIFA Club World Cup UAE 2018 5th Place Match between ES Tunis and CD Guadalajara at Hazza Bin Zayed Stadium on December 18, 2018 in Al Ain, United Arab Emirates. (Photo by David Ramos - FIFA/FIFA via Getty Images)




oval

Walter Sandoval of Guadalajara celebrates with Angel Zaldivar after scoring his team's first goal

AL AIN, UNITED ARAB EMIRATES - DECEMBER 18: Walter Sandoval of CD Guadalajara celebrates after scoring his team's first goal with Angel Zaldivar of CD Guadalajara during the FIFA Club World Cup UAE 2018 5th Place Match between ES Tunis and CD Guadalajara at Hazza Bin Zayed Stadium on December 18, 2018 in Al Ain, United Arab Emirates. (Photo by Francois Nel/Getty Images)