June and her late husband Leon were among the original stars of the Channel Four reality show

The pair shared video of people gathering in the sunshine

The music legend was credited with changing the face of music

For businesses serving the hospitality sector, growth relies on implementing and capitalizing modernized systems to improve processes and increase guest satisfaction. These are the four most important strategies to achieve this goal in 2020.

Keep on reading: 4 Tech Trends for the New Hotel Age

CEO at Datrium, Tim Page has a sharpness for how enterprises can protect and prepare their data and operations for disaster recovery - especially when it comes to ransomware.

Keep on reading: M.R. Asks 3 Questions: Tim Page, CEO, Datrium

By: Stacy Ehrlich and Justine E. Johnson On March 18, 2020, the Food and Drug Administration (FDA) published a final rule (21 C.F.R. Part 1141) requiring textual and graphic health warnings to be included on all cigarette packages and advertisements.[1]  FDA simultaneously published two related guidance documents: (1) Required Warnings for Cigarette Packages and Advertisements,

The post FDA ISSUES FINAL RULE ON GRAPHIC WARNINGS FOR CIGARETTE PACKAGES AND ADVERTISEMENTS appeared first on Kleinfeld Kaplan & Becker LLP.

By: Suzan Onel FDA issued a Press Release on March 28, 2020, reiterating what we all have seen in the news, there is a severe shortage of personal protective equipment (PPE) in health care facilities across the country.  In response to the shortages, FDA has issued Emergency Use Authorizations (EUAs) for respirators, ventilators, ventilator tubing

The post Shortage of PPE and other Devices During COVID-19 Pandemic – Is 3D Printing the Answer? appeared first on Kleinfeld Kaplan & Becker LLP.

By: Daniel Logan and Justine Johnson The Coronavirus Aid, Relief, and Economic Security Act, or “CARES” Act (Pub. L. No. 116–136) makes numerous changes to the Federal Food, Drug, and Cosmetic Act (FDCA).  The CARES Act made substantial changes related to the regulation of over-the-counter (OTC) drugs (see KKB’s alert here dedicated to summarizing these

The post Changes Made to the Federal Food, Drug, and Cosmetic Act by the CARES Act appeared first on Kleinfeld Kaplan & Becker LLP.

#TTB just made changes to modernize the way that #wine, #distilledspirits, and #maltbeverages are labeled and advertised. KKB associate Dan Logan and partner Dan Dwyer highlight some of the key changes (and proposals that were rejected).

The post TTB Finalizes Portions of Modernization of Advertising and Labeling Regulations for Wine, Distilled Spirits, and Malt Beverages Rule appeared first on Kleinfeld Kaplan & Becker LLP.

ZOLL Medical, a part of the Asahi Kasei Group, won EU clearance for its SuperSaturated Oxygen (SSO2) Therapy System to be used to minimize the damage that heart attacks cause within heart muscle. Approved about a year ago in the United States, SSO2 is the only option beyond percutaneous coronary intervention (stenting) that can help […]

VitalConnect announced that it has received FDA Emergency Use Authorization status for use of its VitalPatch to detect changes in the QT interval of hospitalized patients undergoing drug treatment for COVID-19. Hydroxychloroquine and chloroquine, used to treat some COVID-19 patients, are associated with risk of prolonged QT interval that can lead to life-threatening arrhythmias. VitalPatch allows […]

The Dyson CoVent ventilators are no longer required in the UK, according to a statement from Sir James Dyson.

Small to medium-sized (SME) manufacturers are calling for greater and faster financial support from the government as they confront plummeting sales, production volumes, and the prospect of job cuts amid the ongoing Covid-19 pandemic.

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

Mitsubishi Chemical America has entered into a definitive agreement to acquire all of the issued and outstanding shares of Gelest Intermediate Holdings, the parent of Gelest, and a portfolio company of New Mountain Capital.

Health news and commentary from around the Web gathered by the ALLMedPage Today staff

Also, CMS chief vows to lessen docs' record-keeping burden

Says the evidence is equivocal

Huffington Post: Data Exclusivity: Getting the Balance Right      A great article on the downsides of cutting or removing data exclusivity provisions for biologics.  The article points out that data protection is needed to enhance safety and create incentives to research and produce new innovative drugs that cost billions of dollars.  However, the author argues that the period must be […]

  MYTH: YOUR GENES ARE PATENTED. FACTS:  IT IS NOT POSSIBLE TO PATENT YOUR GENES The term “gene patent” is a misnomer, because genes as they exist in the body cannot be patented. Because a naturally-occurring gene – even a newly-discovered one – cannot be patented, patents don’t provide ownership rights over our genes, and […]

Myth: ‘Gene Patents’ are not necessary for health care innovation. Facts: Patents on DNA preparations or sequences are often the first patents upon which a later technology platform or portfolio is built.  These patents are often in-licensed from universities by small start-up companies for the purpose of additional R&D, evidencing that the public/non-profit university sector cannot bear […]

by Stephanie D. Fischer BIO has issued a strong letter of support for the Manager’s Amendment to H.R. 1249, the America Invents Act.  The letter is posted on our website and the text is below: “On behalf of the Biotechnology Industry Organization (BIO), I am writing to express our strong support for your Manager’s Amendment […]

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

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

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

More than 6,000 visors have already been delivered to Charing Cross Hospital

Dr Mike England joins as medical director for UK & ROI

Regulators on Friday afternoon granted emergency authorization for the Gilead Sciences drug remdesivir as a treatment for patients hospitalized with severe COVID-19 infections. The decision makes the antiviral drug, which is delivered via intravenous infusion, the second drug to receive authorization under the FDA’s emergency guidelines for use against the novel coronavirus. The first was […]

An AstraZeneca diabetes drug that brought in more than $1.5 billion in sales last year has won an FDA nod expanding its use to adults with systolic heart failure, a condition in which the heart struggles to pump with enough force to push enough blood into circulation. The drug, the once-daily pill dapagliflozin (Farxiga), was […]

PTC Therapeutics has reached an agreement to acquire Censa Pharmaceuticals and its lead asset, an experimental metabolic disorder therapy that is now being prepared for a pivotal study. The deal, announced after the market close Wednesday, will bring South Plainfield, NJ-based PTC (NASDAQ: PTCT) another compound for its pipeline of rare disease drugs. Wellesley, MA-based […]

Trovagene (NASDAQ: TROV), which started out as a diagnostics company, has renamed itself Cardiff Oncology to better reflect its focus on the cancer drug it is advancing in three clinical trials. In 2017 the San Diego area-based biotech made the first step in its transformation into a drug development-focused organization, licensing rights to an investigational […]

Eil Lilly received accelerated FDA approval Friday for a drug that treats advanced cancers carrying a certain genetic signature. It’s the latest targeted cancer therapy to pass the regulatory bar and the first that addresses tumors characterized by aberrations in one particular gene. The gene in question, RET, produces a protein involved in cell signaling. […]

The General Pharmaceutical Council has appointed Laura Fraser, former clinical fellow for the Scottish Chief Pharmaceutical Officer as the new Director for Scotland.

Fraser has held leadership roles in community pharmacy across Scotland including board member of Community Pharmacy Scotland. She has also worked for the Scottish Government as Clinical Leadership Fellow. Prior to her position as board member she was area and regional manager for nearly nine years.

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Biogen have announced updates to it senior leadership team with Alfred Sandrock being named Executive Vice President of Research and Development in addition to his responsibilities as Chief Medical Officer. Additionally Alphonse Galdes has been appointed as Executive Vice President of Pharmaceutical Operations and Technology.

In a statement, Michel Vounatsos, Chief Executive Officer at Biogen, said: “Both AI and Alphonse are seasoned and respected leaders at Biogen. Their accomplishment in the scientific community is well-recognised.

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Eli Lilly veteran Enrique Conterno has been revealed as the new Chief Executive Officer of FibroGen following the unexpected death of its previous long-term Chief Thomas Neff in August last year.

Neff passing took the company off-guard, bringing a sad and abrupt end to his 26 years of service. In the wake of the loss, FibroGen appointed Board member James Schoeneck to lead the company until a permanent replacement could be found.

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Data science firm Genomics Plc, which lays claim to “the world’s largest genomic database”, has welcomed Mitchell Harris to the company and its senior leadership team as its Chief Strategy Officer.

Joining from his previous role as Global Head, Emerging Business Lines at Abcam, Harris’ career has given him ample experience in commercial strategy and operations. Prior to his most recent role at Abcam, he acted as the company’s Head of Proteins Portfolio Commercial and Business Development.

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Genmab has announced the establishment of the new position of Chief Operating Officer at the company, and has furthermore named Anthony Mancini to the post. In this new role, he will oversee the company’s commercial strategies, including corporate development, business development and information technology functions

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Ophthalmology specialist Alimera Sciences has announced that Steven T Gill is to return to the company in the newly created role of Vice President, Thought Leader Engagement.

Gill had previously served at Alimera as its Senior Director, Thought Leader Liaison, before leaving the company for Novartis, where he most recently held the position of Associate Director, Thought Leader Liaison at Novartis US.

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The question must be: can we accommodate non-emergent/non-urgent care safely or not, and if yes, which care do we address first as we re-open?

The post When and How to Resume Non-Urgent Care During COVID-19 appeared first on Bill of Health.

Miami’s Phillip Frost, who built a $2.8 billion fortune in the generic drug business, was allegedly involved in a tawdry stock promotion scheme, the Securities and Exchange Commission says.