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'It's too soon': In small towns and big cities, Georgia's experiment in reopening moves slowly

A week after Georgia Gov. Brian Kemp plunged Georgia into the middle of a national social experiment — rolling back restrictions on businesses in an effort to restart the economy after a monthlong shutdown to halt the spread of COVID-19 — some restaurants, salons and tattoo parlors remain shuttered. Most that are opening are proceeding cautiously.




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As weather warms amid coronavirus outbreak, states face new challenges

Governors across the U.S. are encouraging people to continue practicing social distancing amid summer weather




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'You could literally kill someone': Masks become a new COVID-19 battleground

As more states reopen their economies, officials say fighting the coronavirus outbreak means wearing a face covering. But some are balking at restrictions.




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Missing Major League Baseball? Here's Korean baseball to the rescue

While much of the world is under lockdown, baseball returned to South Korea on a day when the country reported just three new cases of COVID-19.




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Trump calls Americans 'warriors' in fight to open the economy

As COVID-19 deaths keep rising, Trump's message has shifted from 'one is too many' to praising Americans as warriors fighting to open the economy.




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A coronavirus debate on the apple orchard: Should migrant workers be allowed to sleep in bunk beds?

Washington state fruit growers say that a ban on bunk beds in farmworker housing would cut their seasonal work force in half, likely leading to food shortages and price hikes.




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Syrian President Bashar Assad faces rare dissent from a top financial ally, cousin Rami Makhlouf

Syria's Bashar Assad faces dissent from his rich cousin Rami Makhlouf




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Next to open beauty halls in former Debenhams stores

The retail chain will expand its online beauty concept to shopping centres when the lockdown ends.




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Coronavirus: What could a socially-distanced bar look like?

How bars and restaurants could look when coronavirus restrictions are eased.




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Sally Rooney's novel Normal People adapted for TV

On location in Dublin with the stars of Normal People Paul Mescal and Daisy Edgar-Jones.




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Michael Rubin Applauds Chris Pratt, David Blaine For All In Challenge

Michael Rubin is applauding Chris Pratt and David Blaine for going above and beyond with the All In Challenge, and says it's beautiful to see celebs commit their time to the cause. The Philadelphia 76ers partner, and creator of the Challenge,…




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David Walliams' £10k donation to Britain's Got Talent golden buzzer act

The star gave his support to five-year-old Christian Kilduff, who is raising money for the NHS




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Alan Halsall looks 'petrified' as his girlfriend Tisha Merry cuts his hair

It's four years since the Corrie star had his first hair transplant




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Union health minister directs all states to ensure uninterrupted voluntary blood donation




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Maharashtra FDA allays fears of shortage of HCQ tabs either in govt hospital pharmacies or in retail pharmacies




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Maharashtra FDA issues licenses to 7 more cos to produce medical oxygen for treating critically ill COVID─19 patients




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Indian pharma & machinery sector sees Smart Factory model to mitigate future challenges of COVID─19 like lockdowns




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Union health minister calls upon all scientific depts to develop enhanced synergy for better results




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Allmpus Labs to focus on increasing R&D in new drug discovery and development




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EU MDR: Officially delayed

The European Medical Device Regulation (EU MDR) will come into effect on 26th May 2021, a year later than originally planned.




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Support terminated for four devices in the Ventilator Challenge

The UK government has announced it will be ending support for four devices in the Ventilator Challenge.




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Manufacturer forms alliance to cope with the demand for PPE

Manufacturer and designer, Placon, has introduced the Face Shield Alliance to provide healthcare workers and first responders with adequate Personal Protective Equipment (PPE) during the Covid-19 pandemic.




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JEDI launches billion molecules agains COVID19 challenge

The Billion Molecules against Covid19 Grand Challenge aims to screen billions of molecules with blocking interactions on SARS-CoV-2




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US regulators permit AbbVie/Allergan merger

The closing of the acquisition remains subject to other customary closing conditions




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Pallone, Wyden Slam Trump Admin for Excluding Medicaid Providers from COVID-19 Relief Fund

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. ###




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Pallone and Neal Demand Transparency into Methodology and Distribution of COVID-19 Health Care Provider Relief Funds

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. ###




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Alligator Bioscience hires Chief Financial Officer in interim capacity

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.

read more




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How To Really Take Medical Conflicts Of Interest Seriously

If we’re going to have a central database of conflict of interest disclosures in medicine – and there is one, created by law – it’s high time that people start using it.




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In Blowout, Amarin’s Fish-Oil-Derived Drug Dramatically Cuts Heart Risk In Study

The results, if they hold up, are likely to result in many patients getting the medicine, and could upend decades of orthodoxy among cardiologists.




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Elsevier: Challenges and Trends to Watch in 2020 (Guest Post)

Today’s guest post comes from Trygve Anderson, Vice President of Commercial Pharmacy at Elsevier.

Trygve discusses trends and challenges to watch in 2020, including drug pricing transparency, the approval and interchangeability of biosimilars, and stakeholder access to timely and accurate data.

Learn more about Elsevier’s information analytics capabilities from its video: Evaluating Drug Data Yields Business Value.

Read on for Trygve’s insights.
Read more »
        




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Scientist Mothers Face Extra Challenges in the Face of COVID-19

The pandemic is amplifying nearly every disadvantage that women in STEM already face. But institutions and the scientific community can help

-- Read more on ScientificAmerican.com




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British MP Benn talks Brexit challenges and the future of UK clinical research industry

The Association of Clinical Research Organizations (ACRO) highlights contributions to health and economy (Leeds, UK) – Facing unprecedented challenges associated with Brexit,...




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ACRO Opposes Fatally-Flawed Right-To-Try Legislation

In May of 2017 the Board of Directors of the Association of Clinical Research Organizations, which represents the world’s leading clinical research...




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UK Government focus on strengthening clinical research amidst unique challenges of Brexit

The Association of Clinical Research Organizations (ACRO) convenes discussion series that seeks to advance an industry with important health and economic impacts...




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ACRO offers unique insights on risk-based monitoring of clinical trials, calls for adoption of RBM as a best practice

Following meetings with then-Commissioner Scott Gottlieb and senior leadership from the Center for Drug Evaluation and Research on the role of CROs and technology companies in designing and implementing risk-based monitoring (RBM) of clinical trials, ACRO this week submitted extensive comments on recent FDA Guidance.Increasing the use of innovative RBM technologies helps make clinical trials safer, more efficient and higher quality. ACRO’s comments offer unique insights into the recent expansion of RBM implementation and call for further increasing the use of these oversight technologies.




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ACRO Members Heed the UK Government’s Call for Volunteers in Response to the COVID-19 Pandemic

May 6, 2020 – (Washington, DC) – In an effort to fight the global COVID-19 pandemic, over 150 employees from clinical research...




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The world needs a coronavirus vaccine. But it will take time | Patrick Vallance

Any vaccine has to work, but it also has to be safe. Making it happen is one of the government’s biggest priorities

• Patrick Vallance is the UK government chief scientific adviser

Covid-19 has made fundamental and long-lasting changes to the way we live our lives, not just in the UK, but across the world.

As we continue with social-distancing measures and deal with the most immediate issue of reducing the number of cases to protect the NHS and save lives, and keeping R, which is the average infection rate per person, below one, we also need to progress ways to tackle the disease in the longer term.

The vaccines taskforce will be working in lockstep with the public and private sector

Related: New UK taskforce to help develop and roll out coronavirus vaccine

Continue reading...




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Australia calls for investigation into China’s coronavirus response

Scott Morrison, the Australian Prime Minister, has called for an investigation into the origins of the COVID-19 coronavirus, as Australia becomes one of China’s most vocal critics of its response to the pandemic.




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Phase 3 Libtayo monotherapy trial halted early due to strong benefit in advanced non-small cell lung cancer

A Phase 3 study of Sanofi and Regeneron’s Libtayo (cemiplimab) as a monotherapy for advanced or metastatic non-small cell lung cancer (NSCLC) has been stopped early after showing strong overall survival benefit, it has emerged.




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Mike Pompeo says there is evidence COVID-19 was made in a lab, despite US intelligence saying it occurred naturally

US Secretary of State Mike Pompeo claimed that there is evidence the COVID-19 coronavirus was created in a lab, despite US intelligence officials stating it probably occurred naturally.




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South Korea says Ebola drug remdesivir may not be suitable for all coronavirus patients

South Korea says that remdesivir, traditionally used in treating Ebola, may not be effective enough in treating COVID-19 patients.




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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.




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FTC clears AbbVie’s $63bn Allergan takeover

US regulator satisfied that antitrust concerns are remediated




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Endo, Allergan Nearing Deals to Limit Ohio Litigation Over Opioids - Report

Click to view a price quote on AGN.




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Study reveals most critically ill patients with COVID-19 survive with standard treatment

Clinicians from two hospitals in Boston report that the majority of even the sickest patients with COVID-19 - those who require ventilators in intensive care units - get better when they receive existing guideline-supported treatment for respiratory failure. The clinicians, who are from Massachusetts General Hospital (MGH) and Beth Israel Deaconess Medical Center, published their findings in the American Journal of Respiratory and Critical Care Medicine.




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Mallinckrodt’s INOmax successful in trial of neonates with pulmonary hypertension

UK-based Mallinckrodt Pharmaceuticals has ended a trial of INOmax (nitric oxide) gas early due to positive…



  • Drug Trial/Inomax/Mallinckrodt/Nitric Oxide/Pharmaceutical/Research/Respiratory and Pulmonary/UK

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US FTC clears AbbVie’s buy of Allergan, but with divestments

Almost a year after the original announcement, the US Federal Trade Commission (FTC) has accepted the…



  • AbbVie/Allergan/Companies
  • mergers and acquisitions/Endocrinology/Federal Trade Commission/Ireland/Legal/Management/Pancrelipase/Pharmaceutical/USA/Viokace/Zenpep

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BRIEF—AbbVie finally completes acquisition of Allergan

US pharma major AbbVie has finally completed its $63 billion acquisition of Ireland-incorporated Allergan,…



  • AbbVie/Allergan/Companies
  • mergers and acquisitions/Ireland/Legal/Pharmaceutical/USA

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AbbVie CEO: Don't worry, Allergan's aesthetics clients still have money—and 'strong desire' for treatment

AbbVie may be working through COVID-19, but it's pressing ahead with its Allergan merger, too—and taking stock of products hit by pandemic lockdowns. That puts Allergan’s aesthetics business top of mind, but AbbVie CEO Rick Gonzalez figures customers are ready and able to return quickly for treatment.




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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.