From : Communities>>Regulatory Open Forum
Yes, exactly i asked same

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]

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…

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…

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…

There are major regulatory lapses in the manufacturing of similar biologics in India. The use of scientific audits could strengthen the regulatory system and improve the provision of high quality biosimilars in the country, according to a recent opinion piece [1] by Dr GR Soni, which was published in GaBI Journal.

Alexion agrees deal for Portola to gain access to its lead product, Andexxa, a treatment that counteracts anticoagulants.

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 →

PhillyCooke Consulting has added new services from the humble start more than five years ago, when I used to joke that the company included both me and my laptop.

In addition to continuing to provide regulatory consulting services, PhillyCooke Consulting now offers:

• Submission Preparation Services for Ad Agencies
• Medical Editing
• Proofreading, and 
• Medical Writing. 

You can learn a bit more about the expanded services here, or simply complete the "Contact Form" to request a free initial consultation.

Also, having completed law school (and been admitted to the bar in Pennsylvania), I am now able to offer legal services; however, the law practice is distinct from PhillyCooke Consulting. If you are interested in legal services related to the advertising and promotion of FDA-regulated products, please see FDAadLaw.com, which is a sister corporation to PhillyCooke Consulting.

Although the website is currently a bit spartan, the services offered are robust and address all aspects of advertising FDA-regulated products, including concerns related to the Lanham Act, privacy, and FDCA issues.

Community pharmacies need millions of pounds extra “to keep their heads above water” during the COVID-19 pandemic, pharmacy bodies have warned.

To read the whole article click on the headline

March 4, 2020 — The U.S. Supreme Court delivered a surprise on March 2 when it announced it will hear a challenge to the constitutionality of the Affordable Care Act (ACA) next term, leap-frogging over the process that was playing out in lower courts. Oral arguments have not yet been scheduled, but are likely to […]

Following in the footsteps of an increasing number of biopharmas that want to use data to get more bang for their buck in R&D, J&J has promoted Najat Khan, Ph.D., to the role of chief data science officer.

GlaxoSmithKline is hard at work with partner Sanofi in getting a vaccine tested for COVID-19, but this morning it said it was now also entering the race to treat patients already hit with the disease.

Just a few months after Alexion snapped up complement inhibitor biotech Achillion, Gemini Therapeutics has nabbed one of its key R&D execs as its new chief medical officer.

A recent study looking at the effects of caffeine on brief, high intensity exercise found the substance improved performance, regardless of genetic variations in how subjects metabolized caffeine.

Combining exercise with a bacterial strain isolated from an Olympic weightlifting gold medalist may synergistically increase endurance compared to training or the probiotic alone, suggests data from a mouse study.

Marketing experts recommend that brands formulate a strategy to be as nimble as possible to deal with the as yet unknown changes to the supplement marketplace in the post pandemic world. A greater online capability is seen as one of key parts of that toolkit.

By Monday at least 31 states will be open or partially open. This as President Trump pushed for the country to get back to work despite public health experts warning that it's too soon.

Modern innovation typically occurs one step-improvement at a time. Some clients initially question whether their new application of an existing technology is patentable. Usually, the answer is ‘yes.’ Under U.S. law (and most other jurisdictions), an innovation to an existing technology is patentable so long as at least one claim limitation is novel and non-obvious....… Continue Reading

Following the European Parliament’s vote, the Council has now also agreed to the Brexit with its decision on the conclusion of the withdrawal agreement on behalf of the EU. The EU Parliamentarians sang off the UK members and celebrated that they never have to speak to Nigel Farage again. UK EU civil servants are clearing […]

When it rains guidance, it pours. The MDCG just released Guidance on temporary extraordinary measures related to medical devices Notified Body audits during COVID-19 quarantine orders and travel restrictions. The guidance takes immediate effect and is valid for the whole period of duration of the pandemic COVID-19 as declared by the World Health Organisation. It […]

Guns N' Roses frontman Axl Rose criticized Steven Mnuchin and Trump's coronavirus response, which irked the Treasury secretary and started a Twitter spat.

Until millions of Americans can be tested weekly for coronavirus, states will walk blindly into restarts. But NIH director has a plan to ramp up.

Carson Meyer, daughter of an NBCUniversal executive and sister of jewelry designer Jennifer Meyer, is reaching parents-to-be virtually in the COVID-19 age.

Older Americans deserve our protection from coronavirus. They want to get back to their busy lives, too

U.S. and U.K. intel agencies are reviewing the private report, but intel analysts examined and couldn't confirm a similar theory previously.

Some Buckeyes are not comfortable being told by a "woman in power" to quarantine, one expert said.

The WHO has come under criticism for its deferential tone toward China, but the organization denies it withheld information about COVID-19.

ExRobotics B.V., a Netherlands-based developer of robotics technology for hazardous environments, and Yokogawa Electric Corporation (TOKYO: 6841), a global provider of industrial automation, control, and measurement technology, announce the signing of a licensing agreement that will enable Yokogawa to sell and deploy ExRobotics' inspection robot hardware and software platforms worldwide.

Yokogawa Electric Corporation (TOKYO: 6841) announces the November 15 release of ProSafe-RS R4.05.00, an enhanced version of the ProSafe-RS safety instrumented system. ProSafe-RS is a core product of the OpreX Control and Safety System family.

Yokogawa Electric Corporation (TOKYO: 6841) announces the November 14 release of Plant Resource Manager (PRM) R4.03, the latest version of a software package in the OpreX Asset Management and Integrity family that facilitates the monitoring and control of plant operations by centralizing the management of large volumes of data from instrumentation and manufacturing equipment. PRM R4.03 features powerful device diagnostic functions that help to optimize plant maintenance and ensure safe operations.

Yokogawa Electric Corporation (TOKYO: 6841) and MetaMoJi Corporation announce that they have jointly developed SensPlus Note, a low cost and easy to implement solution for the digitization of plant data on mobile devices. SensPlus Note, a solution in Yokogawa's OpreX Operation and Maintenance Improvement family, improves the efficiency and quality of maintenance work and the precision of post-maintenance analyses by enabling data from plant field work to be used more efficiently. This solution will be released in all markets worldwide on January 31.

Yokogawa Electric Corporation (TOKYO: 6841) announces the release of Exaquantum R3.20, an enhanced version of its plant information management system (PIMS) software package in the OpreX Asset Operations and Optimization family.

Yokogawa Electric Corporation (TOKYO: 6841) announces that it has acquired capital in APB Corporation (APB), a pioneer in the development of a next-generation lithium-ion battery called the “All Polymer Battery,” with the aim of growing Yokogawa’s energy management system (EMS) business. The two companies have agreed that Yokogawa will provide energy management technology needed for the efficient operation and optimization of large-scale storage batteries.

The centre issued the order restricting the sale and distribution of Hydroxychloroquine to prevent its misuse. 

RBI's COVID-19 Regulatory Package: From Repo Rate & CRR Cuts to 3-months moratorium on term loans, RBI Governor Shaktikanta Das announced several measures while addressing the media after the release of Seventh Bi-monthly Monetary Policy Statement 2019-20.

The committee will examine the merits and demerits of various dates for the commencement of the its report by 31 December 2016.

Sarva Shiksha Abhiyan (SSA), Department of School Education Punjab, has published the recruitment notification for the post of Master/Mistress Cadre.

Former CEO Achmad Zaky stepped down from his position, in a surprise move, in December 2019.

The post Indonesian unicorn Bukalapak’s co-founder & CTO Herucahyono exits appeared first on DealStreetAsia.

Charles Lin will take on his leading role at CLSA, the HK-based broker Citic Securities acquired in 2013.

The post China’s Citic Securities hires Vanguard ex-Asia boss for global drive appeared first on DealStreetAsia.

A Grab-Singtel joint venture has roped in former Citigroup executive Charles Wong as its senior managing director while AIA Singapore has named Wong Sze Keed as its new CEO. Grab-Singtel joint venture hires Citigroup’s former retail banking head A Grab–Singtel joint venture, which is in the fray for a digital

The post People Digest: Grab-Singtel JV hires former Citi exec; AIA names new SG CEO appeared first on DealStreetAsia.

Jiang joined Alibaba in 2013 after selling his app analytics company Umeng to the e-commerce giant.

The post Alibaba demotes top executive Jiang Fan after probe into behaviour appeared first on DealStreetAsia.

The pay cuts were cited in a company note to employees dated April 29.

The post India’s Reliance said to cut pay of execs in oil-and-gas division appeared first on DealStreetAsia.

He guided Zuora from startup through a successful IPO and subsequent quarters as a public company.

The post SaaS unicorn Freshworks appoints ex-Zuora executive Tyler Sloat as CFO appeared first on DealStreetAsia.

Li’s departure raises questions around succession planning and HKEX’s strategic direction.

The post Hong Kong stock exchange CEO Charles Li to step down next year appeared first on DealStreetAsia.