Tom Hoover, senior medical business development manager – Americas, assembly technologies, at global technology and manufacturing company, Emerson, explains how ultrasonic plastic welding is improved through improved force control.

MPN editor Laura Hughes reached out to Blake Teipel (BT), CEO and co-founder of Essentium, and Gurvinder Singh (GS), global product director, injection moulding at Protolabs, to find out how the companies were helping with the pandemic.

Adhesives specialist Intertronics has launched a new campaign to highlight the ways that assembly companies can simplify processes, improve output and reduce waste.

Roche’s antibody test for Covid-19 has been given the CE mark and has been issued Emergency Use Authorisation from the US Food and Drug Administration.

Engineers from the University of Glasgow are responding to the coronavirus pandemic by producing up to 1,000 pieces of Personal Protective Equipment (PPE) each day.

John Dogru, CEO of 3DPrinterOS, spoke to MPN’s editor Laura Hughes about the pivotal role of 3D printing during the Covid-19 pandemic.

AdvaMed has announced the launch of a new platform, which will attempt to connect ventilator companies with component suppliers to ensure quick scale production and distribution of these devices during the Covid-19 pandemic.

To help with the increased demand for Personal Protective Equipment (PPE), Suffolk based manufacturer Broadwater Mouldings have turned over its 3D printer to produce protective shield frames for healthcare workers.

Manufacturer Atermit has begun producing face shields to protect users from Covid-19 using Expanded Polypropylene Particle (EPP) foam - Arpro.

New era for lymphoma, leukemia, possibly other cancers

Agency moves toward more accelerated reviews

Posted by Stephanie Fischer on June 10, 2011 at 3:29pm EDT on BIOtech Now The U.S. Supreme Court issued a favorable decision yesterday in the critical case of Microsoft v. i4i, in which Microsoft challenged the “clear and convincing evidence” standard traditionally used by courts in determining whether to invalidate an issued U.S. patent.   Microsoft argued for a lower “preponderance […]

The charity's Centre for Drug Development will sponsor and fund a future Phase I clinical trial for CB213

NHS England has expanded access to targeted hormone therapies for advanced prostate cancer

The Scottish government has given funds £101,903 to support the project

The approval gives NSCLC patients whose tumours carry the MET exon 14 skipping mutation a new treatment option

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

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. ###

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. ###

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. ###

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.   ###

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. ###

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.”  

Kura Oncology is discontinuing development of one of its three clinical-stage cancer drug candidates amid pandemic-related impacts to its clinical trial plans. The decision to end work on the drug, KO-947, comes after San Diego-based Kura (NASDAQ: KURA) was successful in lifting a partial clinical hold placed on a Phase 1 trial of the drug […]

As cancer research reveals the genetic basis of the disease, pharmaceutical companies are pursuing targeted therapies that address certain groups of patients. One such drug from Novartis won FDA approval Wednesday, making it the first therapy cleared by the agency to treat patients whose non-small cell lung cancer (NSCLC) carries a certain genetic mutation. The […]

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 […]

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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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).

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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.

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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.

In this video explainer, Christopher Robertson discusses the Right to Try Act and off-label use of pharmaceuticals with Alison Bateman-House.

The post Access to Drugs Before FDA Approval: Video Explainer with Christopher Robertson appeared first on Bill of Health.

Today’s guest post comes from Rob Brown, Vice President and General Manager of RxCrossroads by McKesson and Biologics by McKesson.

Rob discusses the importance of access, adherence, and affordability for specialty therapy patients who are uninsured, underinsured, or low-income. He describes three criteria companies should use to evaluate patient assistance program solutions.

Click here to learn more about program pharmacy solutions for biopharma from RxCrossroads by McKesson.

Read on for Rob’s insights.
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The U.S. economy is in a medically-induced coma. Unemployment is soaring. Companies are teetering on the brink of bankruptcy. It is unclear when our lives will return to their pre-pandemic state.

One thing seems apparent: As people lose jobs and health insurance, Medicaid enrollment will jump, perhaps by as much as 20% to 30%. This will have profound implications for the drug channel.

Today, I focus on how this increase will affect retail pharmacies and pharmacy benefit managers (PBMs). Below, I review Medicaid enrollment trends, how states manage prescriptions, and the factors driving the coming boom in Medicaid enrollment.

As I explain, many (but not all) retail pharmacies will benefit from Medicaid growth. PBMs, however, will not fare as well. Read on and see if you agree.

In early May, Drug Channels Institute will host two live video webinars: Industry Update and COVID-19 Impact: Retail & Specialty Pharmacies (May 1) and Industry Update and COVID-19 Impact: PBMs & Payers (May 8). CLICK HERE TO LEARN MORE AND SIGN UP. DCI will donate 20% of all profits from these events to The Center for Disaster Philanthropy’s COVID-19 Response Fund.

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Today’s guest post comes from Miranda Gill, Senior Director of Provider Network at CoverMyMeds.

Miranda reviews how the pandemic affects the ability of healthcare workers to complete administrative responsibilities like prior authorization. She then outlines how electronic automation is helping patients get needed medications while face-to-face interactions are restricted.

Learn more about healthcare IT solutions for providers and patients in CoverMyMeds’ 2020 Medication Access Report, or schedule a virtual meeting.
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This week, I’m rerunning some popular posts while I prepare for this Friday’s video webinar: Industry Update and COVID-19 Impact: PBMs & Payers.

Life was very different when I originally published today’s article. 2020 is not turning out to be quite what any of us expected. However, the pandemic has exposed some intriguing pros and cons of vertical consolidation. Click here to see the original post and comments from December 2019.

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The largest insurers, PBMs, and specialty pharmacies have now combined into vertically-integrated organizations. As I explain below, these companies have also been rapidly integrating with healthcare providers.

I also provide an updated look at these companies and highlight strategies that they are using—or could use—to control the channel. I believe that these insurer / PBM / specialty pharmacy / provider organizations are poised to restructure U.S. drug channels by exerting greater control over patient access, sites of care/dispensing, and pricing.

If they can effectively coordinate their sprawling business operations, they will pose a substantial threat of disruption to the existing commercial strategies of pharma companies.

Will they succeed by better managing care and costs, or merely by extracting higher profits from our convoluted system?
Read more »

With cars off the roads, scientists can study how smog and other types of pollution change  

-- Read more on ScientificAmerican.com

Originally published in February 1967

-- Read more on ScientificAmerican.com

On Monday, March 25, 2019 ACRO provided testimony at a public hearing held by the Internal Revenue Service (IRS) and Treasury Department...

Developing, executing and overseeing clinical trials is a complex process. Yet it is essential to gain reliable evidence from clinical trials to...

Firm’s recent success could have been very different had it been bought out by Pfizer in 2014

It’s perhaps not surprising that the worth of healthcare companies should emerge during a global pandemic, but we should offer thanks for the UK’s big pharma twins – AstraZeneca and GlaxoSmithKline.

The former, with its share price at all-time high, is now jostling with Shell and Unilever for the title of biggest company in the FTSE 100 index. Successful research bets, especially on cancer drugs, have transformed Astra.

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Trial of remdesivir shows fewer deaths and shorter hospital stays

• Coronavirus – latest updates
• See all our coronavirus coverage

The first drug against Covid-19 to show promise in trials, reducing the time seriously ill people take to recover in hospital, is unlikely to be available widely in the UK soon, it has emerged.

Forty-six people in the UK have received remdesivir as part of the European arm of an international trial. Researchers would like to have given the drug to more patients but did not have the supplies.

Related: Coronavirus: what do scientists know about Covid-19 so far?

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Drugmaker will manufacture and distribute vaccine if human trials are successful

• Coronavirus – latest updates
• See all our coronavirus coverage

AstraZeneca, the Cambridge-based pharmaceutical group, is teaming up with Oxford University to manufacture and distribute a coronavirus vaccine if clinical trials currently under way show it is effective.

News of the partnership boosted AstraZeneca’s share price, helping it to become Britain’s most valuable company by market capitalisation.

Related: The hunt for a coronavirus vaccine – a perilous and uncertain path

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The partnership between AstraZeneca and the Jenner Institute should jolt our industry and banks

• Coronavirus latest updates
• See all our coronavirus coverage

There was some good news last week. Oxford University’s Jenner Institute announced it was teaming up with AstraZeneca to take a promising prototype of coronavirus vaccine into volume production by the autumn. Of course there are caveats – the institute’s confidence in its vaccine may not be validated by the trials that began last week.

Still it was heartening, after so much tragic incompetence, that a British university and a British company could forge a relationship of such potential national importance.

The piping through which emergency credit must flow is atrophied and weak

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Gilead’s remdesivir, which has been hailed as one of the few truly promising treatments for COVID-19 at this early stage of the ongoing pandemic, has failed in its first randomised clinical trial, leaked data has revealed.

Sanofi’s MedQuadfi Meningococcal Conjugate Vaccine has scored FDA approval for the prevention of invasive meningococcal disease, becoming the first and only product available in the US for this indication in patients of at least two years old.

NICE has recommended Janssen’s Stelara (ustekinumab) for the treatment of moderately to severely active ulcerative colitis (UC), a move which rows back on the Institute’s decision to reject the drug last year.

Novartis has revealed that the European Commission has moved to approve Cosentyx (secukinumab) for the treatment of active non-radiographic axial spondyloarthritis (nr-axSpA) in adult patients.

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.