HIGH-PROFILE Labor frontbencher Kate Ellis is facing a shock defeat to the Liberals in her inner-city seat of Adelaide, internal ALP polling reveals.

NHS staff must wait between 48 and 72 hours to hear back whether or not they are carrying coronavirus, but Premier League clubs and players will receive their results the following day

Ahead of Monday's crunch meeting of top-flight shareholders, the Hornets have joined Brighton and Aston Villa in making their opposition to the current 'Project Restart' plans clear

Ozil's Arsenal career is seemingly coming to an end with little over a year remaining on his current contract, but Leno has responded to claims his teammate is no longer up to the task

The anticipated proliferation of devices demands an innovative approach to managing, securing and delivering these endpoints and the applications that will run on them.

Keep on reading: Why End-User Computing Needs a Refresh

(MedPage Today) -- Study Authors: Robert Zeiser, Nikolas von Bubnoff, et al.; Nelson Chao Target Audience and Goal Statement: Oncologists, hematologists The goal of this study was to determine the benefit/risk profile of the Janus kinase (JAK...

(MedPage Today) -- A "hybrid convergent" surgical-plus-transcatheter procedure was better than endocardial catheter ablation alone for treating refractory atrial fibrillation (Afib) in the CONVERGE randomized trial. Additional ablation of the...

It is very unlikely Australian sports fans will be able to pack out stadiums on grand final weekend, even if the plan to lift restrictions is successful, Deputy Chief Medical Officer Paul Kelly says.

Responding to the COVID-19 pandemic, Cricket Australia calls for a halt to all community and grade cricket, cancelling the Sheffield Shield final and handing the title to New South Wales.

AFL players have been accused of being greedy and selfish during talks with the league over pay cuts now that the season is suspended, but the Cats coach says it is unfair.

The IOC and Olympics organisers have reset the clock on the Tokyo games for a year-long delay from the intended opening — but they warn there is no blueprint for getting to the new start line.

AFL chief executive Gillon McLachlan confirms club members can get their money back if they face financial hardship, but implores those who can afford it to stick with their clubs through the coronavirus pandemic.

It would be a short-sighted and costly move for Australia's sporting bodies to abandon women's leagues to help them cope with the financial fallout caused by coronavirus, writes Richard Hinds.

The former Australian skipper says he thinks the Twenty20 World Cup in Australia will be postponed if fans aren't allowed to attend matches because of the COVID-19 pandemic.

The NRL has a number of crucial questions it must answer if it wants to restart its premiership season on May 28 as planned following the coronavirus-forced suspension of the competition, writes David Mark.

When he went surfing with his old school buddy Nat Fyfe in Margaret River last week, Kookaburras co-captain Aran Zalewski had no idea he'd be thrust into the media spotlight — and it has made him appreciate his anonymity.

Todd Greenberg resigns with immediate effect after four years leading the NRL, in a decision the sporting body says was mutually agreed.

Raelene Castle says "the sport is bigger than any one individual", resigning after the Rugby Australia board told her it wanted "clear air" without her as chief executive.

He has claimed almost every individual honour there is in the AFL, but the highest goal continues to drive the Geelong star even during this uncertain 2020 season — a maiden premiership victory.

Former Cabinet minister Bridget McKenzie defends her actions in the sports grants scandal, saying it was her "responsibility" to exercise discretion and allocate grants to projects that had not been merit-listed.

The restart of the NRL could be jeopardised as Raiders forwards Sia Soliola, Joe Tapine and Josh Papalli join Titans forward Bryce Cartwright in refusing to sign an unedited version of the vaccination waiver.

The NRL announces players who choose not to have the flu vaccination on religious, medical or conscientious grounds will be allowed to train and play, but they must sign a revised waiver.

"Pose" star Mj Rodriguez discusses what's helping her endure the grief of losing her grandmother and her aunt to coronavirus.

The World Health Organization joined with global leaders to accelerate production of vaccines and treatments aimed at stamping out the coronavirus.

The new White House communications team is scrambling to keep Trump on TV but limit his ability to offer dangerous medical advice. The goal is to show him as a leader and push his reelection message. The problem is that Trump almost certainly will sabotage the plan.

For many Americans, Arbery's killing harks back to the old Jim Crow days when white mobs hunted black men down and killed them with impunity. In Brunswick, the shooting has sparked an uneasy conversation about race and power.

Eyefluence synchronizes biology and technology to deliver eye-interaction user interfaces for the HMD industry (head-mounted displays).

At the annual invite-only 2020 Enterprise Retreat in Half Moon Bay, CA, 100 enterprise leaders gathered in a social-media free environment, to network, discuss hot topics and dive into provocative, insightful off-the-record 'State of the Union' presentations. This report details their findings.

Keep on reading: The Enterprise 2020 Report: Software CEO Briefing

By Jennifer A. Davidson and Justine E. Johnson On February 21, 2020, FDA published a final rule that, effective March 23, 2020, amends the regulatory definition of “biological product” consistent with the statutory definition under the Biologics Price Competition and Innovation Act of 2009 (BPCIA), as amended by the Further Consolidated Appropriations Act, 2020 (FCAA),

The post FDA AMENDS THE DEFINITION OF “BIOLOGICAL PRODUCT” AND PREPARES FOR THE CONCLUSION OF A DECADE-LONG TRANSITION PERIOD appeared first on Kleinfeld Kaplan & Becker LLP.

By: Jacqueline Chan and Vanessa Fulton Consumers are increasingly demanding environmentally-friendly products and packaging.  Driven by this increased demand and desire to create positive environmental change, companies are working hard to shift to more sustainable materials and packaging and seeking to communicate such efforts to consumers through product labels and advertising.  “Recyclable.”  “Biodegradable.”  “Made of

The post It’s Not Always Easy Being Green – Lawsuit Related to “Recyclable” Claims Highlights Risks Related to Environmental Benefit Claims appeared first on Kleinfeld Kaplan & Becker LLP.

According to the World Health Organization, 47% of childhood deaths worldwide occur in the first four weeks of life. This neonatal mortality rate is particularly prevalent in sub-Saharan Africa, where nearly one million newborns die every year. Many of these deaths can be prevented with medical devices that more developed countries often take for granted, […]

The Advanced Medical Association (AdvaMed) has requested the United States Trade Representative (USTR) provides additional tariff exclusions for medical devices, components and supplies coming from China which are necessary to help with Covid-19.

BCC marks the second non-melanoma skin cancer for which Libtayo has demonstrated first-in-class data, the firms note

House Energy and Commerce Committee Chairman Frank Pallone Jr. (D-NJ) and Senate Finance Committee Ranking Member Ron Wyden (D-OR) called on the Trump administration to address the lack of financial relief for Medicaid providers fighting the COVID-19 pandemic. The two Committee leaders voiced concerns that, to date, roughly $70 billion has been distributed to health care providers under the CARES Act in a way that discriminates against Medicaid-dependent health care providers. “HHS’s continued neglect for the needs of Medicaid-dependent providers struggling to deal with the COVID-19 crisis is unacceptable,” the members wrote. “The country is in the middle of a pandemic. The Medicaid program is a first responder, and the providers it relies on must be treated with equity. At a bare minimum that should include expeditious access to the [provider fund] as intended by Congress.”  The Provider Relief Fund that Congress created as a part of the CARES Act, within the Public Health and Social Services Emergency Fund (PHSSEF), was intended to support health care providers including those who participate in Medicare and Medicaid. However, to date only Medicare-enrolled providers have been able to access funds, and these funds are being allocated according to a methodology that rewards providers with high levels of privately-insured individuals while providers supporting the safety net are left waiting. This imbalance discriminates against critical health care providers that primarily service the Medicaid population, such as frontline hospitals, nursing homes and home-based providers, behavioral health providers, maternal health care providers and pediatricians. In the letter, sent to Health and Human Services (HHS) Secretary Alex Azar, Pallone and Wyden called on the Trump administration to describe how much funding will go to Medicaid-dependent providers and the steps it has taken to understand the needs of these providers during the pandemic. The full letter is available here. ###

Energy and Commerce Chairman Frank Pallone, Jr. (D-NJ) and Ways and Means Chairman Richard E. Neal (D-MA) sent a letter to Health and Human Services (HHS) Secretary Alex Azar and Centers for Medicare & Medicaid Services (CMS) Administrator Seema Verma today raising a series of concerns over the methodology used to distribute and the lack of transparency into how COVID-19 relief funds and loans for health care providers are being spent.  “We write to raise serious concerns about the Provider Relief Fund and the Accelerated and Advance Payment Programs,” Pallone and Neal wrote.  “With respect to each, we are concerned about the lack of transparency with Congress and the American people about how funds are being spent or loans are being made.  We also have grave concerns regarding the methodology being used to distribute $175 billion Congress appropriated for the Provider Relief Fund.” The Chairmen’s letter documents concerns with how the programs are being run, in particular the Administration’s methodologies for distributing funding that has shortchanged a number of critical providers and makes clear that more transparency is needed for Congress to accurately assess the ongoing needs of health care providers as the COVID-19 crisis unfolds. “The Administration’s efforts to establish the Provider Relief Fund to date has been at best, a series of missteps, and at worst, a disregard of Congress’ intent for the program,” Pallone and Neal continued in their letter. Pallone and Neal wrote that when Congress passed the CARES Act, it was clear that the funding provided to HHS for the Provider Relief Fund was for the express purpose, “to prevent, prepare for, and respond to coronavirus.”  The two Chairs voiced concern that some of the funding formulas adopted to date fail to target funding based on the statutory framework relating to COVID-19 driven costs.  In fact, the Chairs write that the level of funding appears to be, “completely disconnected from need.” The Chairmen requested an immediate response from HHS regarding documents and information pertaining to the Provider Relief Fund and the Accelerated and Advanced Payment Program.  Pallone and Neal also wrote that if HHS is unable to immediately provide the information, it should provide a timeline of when the Committees would receive the requested information. While recognizing the incredible demands on the Department at this difficult time, the Chairmen emphasized that, “This crisis demands that we work swiftly and based on the best data available.  Currently, despite repeated requests, this Administration has prevented Congress from obtaining the data that the Department has available on funding for our health care system, data that is necessary to inform near future legislation.  We look forward to receiving this information so that we can conduct the business the American people expect of us.  We look forward to having you join us at the earliest possible date in each of our Committees to discuss these and other COVID-related issues.” To read the full letter, click HERE. ###

Chief Executive Mike Thompson is to retire from his role at the Association of the British Pharmaceutical Industry (ABPI) by the end of this year.

His decision to leave the association marks the end of a three-year run beginning in March 2016, when stepped in to take up the mantle from Alison Clough, who had served as the acting Chief Executive for much of 2015.

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Dr Reshma Kewalramani has been made the new Vertex CEO.

Vertex’s Chief Medical Officer Dr Kewalramani will succeed current CEO Jeffrey Leiden who has is now stepping aside from the role after seven years as Chief executive at the Boston-based firm. In stepping down Leiden will serve as executive chairman until the first quarter of 2023.     

Fourty-six year old Dr Kewalramani, who has been at Vertex since 2017, will thus become the first woman to head the firm. Prior to joining Vertex, Kewalramani spent more than 12 years at Amgen.

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Immunotherapy-focused pharmaceutical company Midatech Pharma has appointed Stephen Stamp as Chief Financial Officer (CFO) with immediate effect.

He will be replacing Nick Robbins-Cherry, who has stepped down after five years since joining in 2014. Robbins will nevertheless remain at Midatech until October to facilitate Stamp’s handover in an orderly fashion.

Stamp has most recently served as CEO of pharmaceutical firm Ergomed for two years, stepping down in January citing health reasons. Prior to this he was CFO at Ergomed for a year beginning in 2016.

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Chief Executive of Gulf Pharmaceutical Industries, Jerome Carle, is stepping down from his post at the United Arab Emirates drug manufacturer facing mounting pressure.

Julphar, one of the biggest generic drugs manufacturers in the Middle East and North Africa said Jerome Carle has “tendered his resignation” and the board has accepted it. His last working day will be December 8th.

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Sir Mark Walport, Chief Executive of UK Research and Innovation (UKRI), the national funding agency responsible for science and research investment in the UK, has announced he is to retire for the role next year.

The decision to leave the organisation in 2020 will mark the end of a three-year tenure at its helm, beginning in 2017 when Walport was appointed to “create a single, ambitious organisation and provide the UK with a world class funding system to keep it at the forefront of global research and innovation”.

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London consultant and public health professor, Chris Whitty, has begun his role as England’s Chief Medical Officer, taking over from Dame Sally Davies, who has now stepped down from the position.

Whitty has served as the Department of Health and Social Care’s Chief Scientific Adviser since 2016 and was announced as Dame Sally Davies successor earlier in June this year.

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Gilead Sciences have announced that Merdad Parsey will join the company as Chief Medical Officer, effective November 1st.

Dr Parsey will be responsible for and oversee the company’s global clinical development and medical affairs organisations – reporting directly to Daniel O’Day, Gilead’s Chairman and Chief Executive Officer.

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The Association of the British Pharmaceutical Industry (ABPI) has appointed Dr Richard Torbett as its new Chief Executive. He will assume the position on 1 January 2020.

The appointment comes after his predecessor, Mike Thompson, stepped down in June. He had served in the role since March 2016. Torbett was unanimously selected by the ABPI board after an external recruitment process with an executive search agency.

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Saniona has announced that Rami Levin will take over as the Chief Executive Officer of the company as it seeks to transition into a fully-fledge biopharmaceuticals company, with a focus on rare diseases.

Levin was appointed by the Board of Directors and the company’s founders. His appointment takes immediate effect.

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Ipsen has named Dr Steven Hildemann as its new Executive Vice President, Chief Medical Officer, Head of Global Medical Affairs and Pharmacovigilance.

In his new role, which begins on 1 March 2020 and will be based in Paris, he will report directly to Ipsen CEO Aymeric Le Chatelier. His remit will include the provision of medical strategy to the company’s scientific, clinical and business teams, while also working in tandem with its R&D operations to design and direct clinical trials efforts to generation of post-launch data.

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Khondrion has revealed that Dr Rob van Maanen has joined the company as its new Chief Medical Officer (CMO).

Dr van Maanen’s career has spanned more than 20 years and seen him take on roles at major industry names such as Roche, Astellas and Eisai. In the role, he will manage the company’s medical operations and clinical strategy.

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Galecto has announced Bertil Lindmark as their new Chief Medical Officer. He began his posting on 1 February 2020.

Lindmark joins from the eTheRNA immunotherapies, which is a Belgian mRNA immunotherapy company. He has also had an extensive and successful career in the pharmaceutical industry.

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Nordic Nanovector has appointed Dr Lars Nieba as the interim Chief Executive Officer. He is currently the company’s Chief Technology Officer and replaces Eduardo Bravo who as of today has left Nordic to pursue other career opportunities.

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Andreas Johannesson has been announced as Alligator Bioscience’s new interim Chief Financial Officer (CFO), replacing ex-CFO Per-Olof Schrewelius who it was previously confirmed will no longer serve the company.

Johannesson’s career has spanned 15 years in the consumer goods sector, with him managing the finances of firms including TeamOlmed, Stenqvist, Fitness23Seven and Haldex.

He spent a further nine years of his career as a strategic consultant with a focus on consumer goods, five of which were spent at global consulting firm McKinsey & Company.

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