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Q&A: How SweynTooth medical device hackers can be thwarted

Ian Bolland spoke to Chris Risley, CEO at Bastille Networks, about medical devices at risk of being compromised by SweynTooth vulnerabilities, highlighting how hackers can be combatted from targeting devices and healthcare systems.




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Winner announced for Red Dot Design Award

LoFric Elle – an intermittent catheter with an L-shaped handle – has won the 2020 Red Dot Design Award.




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USPTO Biotechnology/Chemical/Pharmaceutical Customer Partnership Meeting

Biotechnology/Chemical/Pharmaceutical Customer Partnership   Wednesday, June 8, 2011 Meeting  Madison Auditorium   Starting Time of 10:00 AM  United States Patent and Trademark Office Alexandria, Virginia  600 Dulany Street, Alexandria, VA,  Accessing the event: Double click on the link below (or copy it into your internet browser) https://uspto.connectsolutions.com/r80345544/ Click here   for detailed login instructions in MS Word.   […]




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Debunking the Myth: ‘Gene Patents’ are not necessary for healthcare innovation.

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 […]




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Newron drops development of sarizotan in Rett syndrome

The experimental 5-HT1A receptor agonist and D2 receptor antagonist was not effective on primary or secondary endpoints




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Rebiotix, Ferring's microbiome-based therapy RBX2660 shows promise

RBX2660 may bring an innovative therapeutic option to patients suffering from C. diff




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House Health Leaders Oppose Rule to Roll Back ACA Nondiscrimination Protections

Today, Chairs of the House Committees that oversee the Department of Health and Human Services (HHS) voiced their strong opposition to a harmful Trump Administration rule that would roll back Affordable Care Act (ACA) nondiscrimination protections. In a letter, House Energy and Commerce Committee Chairman Frank Pallone, Jr. (D-NJ), House Ways and Means Committee Chairman Richard E. Neal (D-MA), House Education and Labor Committee Chairman Bobby Scott (D-VA), and House Oversight and Reform Committee Chairwoman Carolyn B. Maloney (D-NY) urged HHS Secretary Alex Azar not to finalize this troubling rule and to instead focus on responding to the COVID-19 pandemic. The rule would overturn core protections for marginalized communities including LGBTQ+ people, women, individuals with limited English proficiency, and individuals with disabilities, and eliminate many health care programs and activities from coverage of the Affordable Care Act’s nondiscrimination requirements. “At a time when the United States is grappling with the 2019 coronavirus (COVID-19) pandemic and access to health care services is so critical, we are disappointed that this Administration is once again taking steps to limit access to health care and embolden discrimination against some of the most vulnerable among us,” the Chairs wrote. “If finalized, this dangerous rule would open the door to discrimination against patients in express contradiction to the plain language and intent of the law, and would therefore be illegal. Undermining protections for marginalized individuals at any time is unacceptable, but it is particularly egregious to do so during the worst global pandemic in over a century.” Read the full letter to Secretary Azar HERE. ###




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E&C Announces Hearing on Protecting Scientific Integrity in COVID-19 Response

The Energy and Commerce Committee today announced a Health Subcommittee Hearing for Thursday, May 14, entitled “Protecting Scientific Integrity in the COVID-19 Response.”  The hearing notice follows this note to the media.   NOTE TO THE MEDIA: Due to COVID-19, the Committee will make every effort to adhere to the safety recommendations from the Centers for Disease Control and Prevention (CDC) and the Attending Physician.  Therefore, media access will be limited.  Please contact your respective gallery for details.  As always, congressional press credentials will be required.   May 7, 2020   HEARING  NOTICE   TO:                      Members of the Subcommittee on Health FROM:                Anna G. Eshoo, Chairwoman SUBJECT:           Subcommittee Hearing on “Protecting Scientific Integrity in the COVID-19 Response” The Subcommittee on Health of the Committee on Energy and Commerce will hold a hearing on Thursday, May 14, 2020, at 10 a.m. in the John D. Dingell Room, 2123 of the Rayburn House Office Building.  The hearing is entitled, “Protecting Scientific Integrity in the COVID-19 Response.”  Witnesses will be by invitation only.  Among the witnesses invited to testify is Dr. Rick A. Bright, former Director of the Biomedical Advanced Research and Development Authority. The logistics of this hearing will be different due to the current circumstances of conducting a public hearing during the COVID-19 pandemic.  Members will be advised regarding specifics on hearing procedures and briefings as soon as they become finalized. If you have any questions, please contact Meghan Mullon with the Committee staff at (202) 225-2927. The U.S. House of Representatives Office Buildings and the U.S. Capitol Complex are currently closed to the public.  Official meetings of the Committee and its subcommittees are broadcast and available on the Committee’s website:  www.energycommerce.house.gov. ###




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Consumer Protection and Commerce Subcommittee Announces Teleconference Forum with FTC Chairman Simons on May 11

Washington, D.C. – Consumer Protection and Commerce Subcommittee Chair Jan Schakowsky (D-IL) and Ranking Member Cathy McMorris Rodgers (R-WA) today announced that the Subcommittee will hold a teleconference forum on Monday, May 11, at 12 p.m. (EDT) with Federal Trade Commission (FTC) Chairman Joseph J. Simons to discuss critical consumer protection issues related to the COVID-19 pandemic. “The COVID-19 pandemic has brought about significant consumer protection concerns that fall under the purview of the FTC, including COVID-19 related scams, price gouging, privacy and data security issues, and more,” Schakowsky and McMorris Rodgers said.  “We look forward to hearing from Chairman Simons about the steps FTC is taking to ensure consumers are protected during this pandemic.”      This forum is open to the press.  Credentialed reporters interested in listening to the forum live should RSVP to Evan.Gilbert@mail.house.gov by 5 pm on Friday, May 8.   ###




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Hearing on Protecting Scientific Integrity in the COVID-19 Response

The Subcommittee on Health of the Committee on Energy and Commerce will hold a hearing on Thursday, May 14, 2020, at 10 a.m. in the John D. Dingell Room, 2123 of the Rayburn House Office Building. The hearing is entitled, “Protecting Scientific Integrity in the COVID-19 Response.”  




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Trovagene Rebrands as Cardiff Oncology, Promotes Longtime Exec to CEO

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 […]




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Vertex promote chief medical officer to CEO as Jeffrey Leiden steps down

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.

read more




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Troy Robinson promoted to managing director of Chugai Pharma Europe

Troy Robinson has been taken on as the new managing director of Chugai Pharma Europe. Mike Crosher will succeed him in his current role as managing director of Chugai Pharma UK.

Chugai Pharma Europe (CPE) has promoted Troy Robinson and Mike Crosher into the positions of managing director of CPE and managing director of the firm’s UK subsidiary, Chugai Pharma UK (CPU).

read more




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General Pharmaceutical Council appoints Laura Fraser as director for Scotland

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.

read more




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Dr John C. McKew promoted to Chief Operating Officer at Lumos Pharma

Lumos Pharma, Inc. has promoted Dr John McKew to the position of Chief Operating Officer effective 1 April 2020.

McKew is already Chief Scientific Officer and he will do both roles simultaneously. With his new role, he will lead Lumos’s clinical development plan as the company looks toward adding additional assets to its pipeline.

read more




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How States are Protecting Health Care Providers from Legal Liability in the COVID-19 Pandemic

Clinicians and policymakers alike are raising the alarm about potential legal liability for following crisis standards of care during the COVID-19 pandemic.

The post How States are Protecting Health Care Providers from Legal Liability in the COVID-19 Pandemic appeared first on Bill of Health.




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Semiautomatic Rifles May Make Mass Shootings Deadlier, Study Says

Mass shooters appear to injure and kill more people when the use semiautomatic rifles instead of handguns, other types of rifles, or shotguns, according to a new analysis in the Journal of The American Medical Association. But the research has significant limitations.




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A $100 Million Biotech Deal Is Also A Tale Of Two Executives Facing Their Kids’ Deadly Diseases

“John, I’m very aware of your family’s journey, Twelve years ago I was one of the producers considering bidding on your life rights.”




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At Joe Biden’s Urging, Airbnb, WeWork, And Others Commit To Help Cancer Patients

The companies are committing to find ways to use their businesses to help patients with cancer.




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Bioclinical, VivaLNK unveil remote patient monitoring technology

The solutions enable continuous remote monitoring of body temperature and other vitals, either at home or in care centers, for clinical trials.




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Veeva launches free remote monitoring

The companyâs SiteVault Free tool, designed to enable collaborating between sites and study monitors, now has a remote monitoring feature.




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Novartis acquires digital therapeutics specialist Amblyotech

The pharmaceutical firm has purchased the company, which specializes in advancing treatments and diagnostics for ocular disorders.



  • Markets & Regulations

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'Breakthrough' COVID-19 Tests Are Currently Cheap, Fast--and Not Very Accurate

Antigen-based assays could be used in the home, but critics say their error rates are still an issue

-- Read more on ScientificAmerican.com




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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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FTSE 100 boosted amid optimism over potential coronavirus drug

Stock index up more than 3% in early trading on the back of hopes for remdesivir treatment

Optimism about a potential treatment for Covid-19 gave a shot in the arm to stock markets around the world, amid claims that a drug called remdesivir has spurred rapid recovery in 113 patients.

A University of Chicago hospital participating in a study of the antiviral medication, made by US firm Gilead Sciences, found that nearly all patients suffering severe fever and respiratory symptoms were discharged within a week. A report of the study, issued by specialist healthcare publication Stat News shortly after Wall Street closed on Thursday night, spurred hopes among investors that lockdowns around the world could soon be eased.

Continue reading...




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Africans facing coronavirus must not suffer the injustices they saw with Aids | Lydia Namubiru

Patients were used as guinea pigs but denied access to resulting therapies. This time, Big Pharma must be held to account

The year I turned 11, my uncle Josiah Ssesanga was admitted to a hospital in Uganda with meningitis. It was 1994, and he was HIV positive. Between him and death stood a tattered post-civil war health system.

Treatments for HIV and Aids existed in other parts of the world, but in Uganda they were mostly limited to those used in clinical trials. For my uncle’s particular infection – cryptococcal meningitis – there was a drug called Fluconazole. But he didn’t know it existed; regardless, he wouldn’t have been able to afford it. and even among patients who took it, only 12% survived beyond six months.

Related: Macron calls for clinical trials of controversial coronavirus 'cure'

Related: Fear, bigotry and misinformation – this reminds me of the 1980s Aids pandemic | Edmund White

Continue reading...




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Researchers studying heartburn drug as potential coronavirus treatment

Researchers in America have been studying famotidine, the active ingredient in Pepcid, as a potential treatment for COVID-19.




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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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Arizona GOP lawmakers and AAPS say hydroxychloroquine has 90% chance of helping COVID-19 patients, but data is not based on clinical trials

The Association of American Physicians and Surgeons (AAPS) wrote a letter to Republican Arizona Governor Doug Ducey urging the wider use of hydroxychloroquine, based on data they have collected.




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Two studies reveal "positive" data for Gilead's remdesivir in hospitalised COVID-19 patients

The first findings of two new studies have been revealed detailing the efficacy of Gilead’s antiviral therapy remdesivir in the treatment of patients hospitalised with COVID-19.




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AstraZeneca joins forces with University of Oxford to develop and manufacture potential coronavirus vaccine

A “landmark” partnership has been struck between AstraZeneca and the University of Oxford in the ongoing battle against COVID-19, with the former agreeing to aid in the development and large-scale manufacture of the latter’s potential recombinant adenovirus vaccine for the prevention of novel coronavirus infection.



  • Research and Development
  • Manufacturing and Production

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Teva’s cancer drug Bendeka protected from generics until 2031, judge rules

A US federal judge has ruled that generic versions of the cancer treatment Bendeka infringe on four separate patents, and has delayed them from launching until 2031.




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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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Amgen adds Otezla to the COVID-19 candidate list

Psoriasis therapy may be a potential treatment for COVID-19




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Sanofi, Regeneron set up another niche use for PD-1 drug Libtayo

Drug has shown “clinically meaningful responses” for basal cell carcinoma




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Glutagenic Virus Protection Kit

The U.S. Food and Drug Administration posted a photo:

This product is promoted with unapproved claims to prevent, treat, mitigate, or cure COVID-19. FDA warns consumers to avoid unproven and potentially unsafe products. See the Warning Letter for more information:

www.fda.gov/inspections-compliance-enforcement-and-crimin...

More information is available at www.fda.gov/consumers/health-fraud-scams/fraudulent-coron...

Photo by FDA's Office of Regulatory Affairs, Health Fraud Branch

This photo is free of all copyright restrictions and available for use and redistribution without permission. Credit to FDA's Office of Regulatory Affairs, Health Fraud Branch is appreciated but not required.




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CBD Product - Patriot Hemp Company

The U.S. Food and Drug Administration posted a photo:

This product is promoted with unapproved claims to prevent, treat, mitigate, or cure COVID-19. FDA warns consumers to avoid unproven and potentially unsafe products. See the Warning Letter for more information:

CBD Product – Patriot Hemp Company: www.fda.gov/inspections-compliance-enforcement-and-crimin...

More information is available at www.fda.gov/consumers/health-fraud-scams/fraudulent-coron...

Photo by FDA's Office of Regulatory Affairs, Health Fraud Branch

This photo is free of all copyright restrictions and available for use and redistribution without permission. Credit to FDA's Office of Regulatory Affairs, Health Fraud Branch is appreciated but not required.




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Protection Blend

The U.S. Food and Drug Administration posted a photo:

This product is promoted with unapproved claims to prevent, treat, mitigate, or cure COVID-19. FDA warns consumers to avoid unproven and potentially unsafe products. See the Warning Letter for more information:

www.fda.gov/inspections-compliance-enforcement-and-crimin...

More information is available at www.fda.gov/consumers/health-fraud-scams/fraudulent-coron...

Photo by FDA's Office of Regulatory Affairs, Health Fraud Branch

This photo is free of all copyright restrictions and available for use and redistribution without permission. Credit to FDA's Office of Regulatory Affairs, Health Fraud Branch is appreciated but not required.




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Oligonucleotide Therapeutics and Delivery Conference 2020

16 - 17 September 2020, London, UK.
Oligonucleotide therapeutics - the emerging medicine class - are harnessing the therapeutic benefit of targeting genetic material via antisense, mRNA, RNAi, saRNA and siRNA. Their market growth: CAGR of 13.7% projected to reach USD 8.2 billion by 2024 is driven by their potential to provide more efficacious and less toxic alternatives to small molecules.




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Supercomputer simulations present potential active substances against coronavirus

Several drugs approved for treating hepatitis C viral infection were identified as potential candidates against COVID-19, a new disease caused by the SARS-CoV-2 coronavirus. This is the result of research based on extensive calculations using the MOGON II supercomputer at Johannes Gutenberg University Mainz (JGU). One of the most powerful computers in the world,




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Otezla’s impact shown in milder psoriasis

Amgen’s Otezla (apremilast), a drug divested by Celgene ahead of its acquisition by Bristol-Myers Squibb,…



  • Amgen/Biotechnology/Dermatologicals/Drug Trial/Inflammatory diseases/Otezla/Research/USA

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Global pharma and biotech’s fight against COVID-19: an investment perspective

Mark Brewer, who heads up the life sciences team at UK broker and M&A advisory company, finnCap, gives…



  • Actemra/Anti-virals/Avacta/Avigan/Biotechnology/Business Financing/Chloroquine/Coronavirus/Cytiva/Expert View/Faron Pharmaceuticals/favipiravir/Focus On/Fujifilm/Gilead Sciences/Hydroxychloroquine/In Depth/Medical Devices and Diagnostics/Novacyt/Remdesivir/Roche/SNG001/Synairgen/UK

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Amgen ramps up Otezla expansion effort with positive data in mild psoriasis

Amgen is planning to file for FDA approval of Otezla in mild to moderate plaque psoriasis based on new data showing patients on the drug experienced significant improvements in their symptoms. The label expansion will be key to Amgen's ability to recoup the $13.4 billion it paid to acquire the drug from Celgene last year.




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Teva generics benefit from COVID-19 bump––but the boom may not last

With its multibillion-dollar restructuring plan in the rearview mirror, Teva is pinning its future growth on two of its branded meds with high hopes. But generics are still central to the Israeli drugmaker's business, and increased demand due to COVID-19 gave Teva a welcome gift in the first three months of the year.




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Biogen gears up Swiss manufacturing facility for potential aducanumab rollout

Biogen has had a rocky road with its controversial Alzheimer's disease candidate aducanumab, resurrected late last year. But despite postponing the drug's FDA filing half a year, Biogen is still moving forward with plans to scale up production if aducanumab eventually passes muster.




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Singapore reports 753 new coronavirus cases, taking total to 22,460

Singapore registered 753 new coronavirus infections, its health ministry said on Saturday, taking the city-state's total to 22,460 cases.




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Best of the Best Biotech Book Recommendations

As you may know, I maintain an extensive list of book recommendations for the biotech enthusiast on a "Amazon Influencer" page. After the latest update there are well over 100 titles! I recently analyzed the data to come up with the most popular titles among my followers (perhaps the full list is a bit intimidating):​Genentech: The Birth of BiotechThe Biotech Trader HandbookThe Pharmagellan Guide to Biotech Forecasting & ValuationValuation in Life Sciences: A Practical GuideThe Antidot [...]




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Biotech Reading List

I Thought Being a Health Care Reporter Would Make Cancer Easier. I Was Wrong.Alexandra Glorioso (Politico Magazine)Meet the pigs that could solve the human organ transplant crisisKaren Weintraub (MIT Technology Review)The Director of the NIH Lays Out His Vision of the Future of Medical ScienceFrancis Collins (Time)In a rural Wisconsin village, the doctor makes house calls — and sees some of the rarest diseases on EarthMark Johnson (Milwaukee Journal Sentinel)‘I just want to live [...]



  • biotech reading list

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Three Men Indicted for Racially-Motivated Church Arson in Springfield, Mass.

Three individuals were indicted today by a federal grand jury in the District of Massachusetts for conspiring to interfere with the civil rights of members of the Macedonia Church of God in Christ, a Springfield, Mass., church with a predominantly African-American congregation.



  • OPA Press Releases