A history of Johnson & Johnson

By most measures the single largest pharma company in the world, US-based Johnson & Johnson (J&J) is also arguably one of the most well-known drugmakers among the general public. 

Both these factors can be tied in part to J&J’s strong presence in the consumer sector – but behind household name products is a strong pharmaceutical backbone that has emerged over the company’s long and varied history.

Johnson & Johnson was founded over 125 years ago in the year 1886. However, it wasn’t until 1959 – 73 years and two major acquisitions later – that J&J developed its significant presence in the pharmaceutical industry.

Where it all began

In 1886, three brothers – Robert Wood Johnson, James Wood Johnson and Edward Mead Johnson – founded Johnson & Johnson, in New Brunswick, New Jersey in the United States. It’s said that the Johnson brothers were inspired to start the business in order to create a line of ready-to-use surgical dressings, after hearing a speech by antiseptic advocate Joseph Lister in 1885. Robert Wood Johnson served as the first president – the company became incorporated in 1887 and throughout the nineteenth century, Robert worked to improve sanitation practices.

“J&J pioneered the first commercial first aid kits, which were initially designed to help railroad workers, but soon became the standard practise in treating injuries”

 

A year later, J&J pioneered the first commercial first aid kits, which were initially designed to help railroad workers, but soon became the standard practise in treating injuries. In 1894, J&J’s heritage baby business began, by the launch of maternity kits. These kits had the aim of making childbirth safer for mother and babies. Johnson’s Baby Powder also went on sale during this year and was extremely successful. Robert Wood’s granddaughter, Mary Lea, was the first baby to be used on the baby powder label.

Between 1896 and 1897, J&J enabled a huge step forward for women’s health when it manufactured the first mass-produced sanitary protection products.

When Robert Wood died in 1910, his brother James Wood became president, before James’ son, Robert Wood Johnson II became president in 1932.

One of J&J’s subsidiaries is Ethicon, which is a manufacturer of surgical sutures and wound closure devices. It was incorporated as a separate company in 1949 so as to expand and diversify the J&J product line. Following World War II, Ethicon’s market share in surgical sutures rose from 15% to 70% worldwide.

In 1959, J&J acquired McNeil Laboratories in the US and also Cilag Chemie, AG in Europe. These two acquisitions enabled the company to gain a significant presence in the field of pharmaceutical medicines for the first time. One McNeil product was the first prescription aspirin-free pain reliever, Tylenol (acetaminophen) elixir for children.

The joining of Janssen

It was in 1961 that Belgium’s Janssen Pharmaceutica N.V. joined the J&J Family of Companies. Its founder, Dr Paul Janssen, is recognised as one of the most innovative and prolific pharmaceutical researchers of the 20th century.

Today, Janssen is one of the world’s leading research-based pharma companies and markets prescription medicines in the areas of gastroenterology, women’s health, mental health, neurology and HIV/AIDS, to name a few.

“Dr Paul Janssen is recognised as one of the most innovative and prolific pharmaceutical researchers of the 20th century”

 

United under the common name of J&J, Janssen is now split into three different businesses – Janssen Research & Development, Janssen Healthcare Innovation and Janssen Diagnostics. Some of the most well-known Janssen products include diarrhoea treatment, Immodium (loperamide), antipsychotic Risperdal (risperidone) and Alzheimer’s disease drug, Reminyl (galantamine).

Risperdal is well-known due to the controversy in the US following its product launch in 1994. Juries in several US states found J&J guilty of hiding information about adverse effects of the antipsychotic medication. In 2012, J&J agreed to pay US $181 million to 26 states in order to settle these claims – though another lawsuit related to the drug (for $8 billion, eventually reduced to $6.8 billion) hit the company in 2019.

Litigation & controversy

This is not the only controversy J&J has had to deal with in recent years. 

The company has also faced claims that it did not adequately communicate the risks of its opioid painkillers in its marketing, contributing to the US’ ‘opioid epidemic’, and that its talc products could contain small amounts of asbestos and lead to cancer.

The company has been hit with billions of dollars in lawsuits relating to these charges, 

J&J has been bullish in both its insistence that the claims are inflated or false and that it can easily deal with the lawsuits, but the company has both won and lost existing cases, with many still caught up in appeals processes, and it remains to be seen how the balance will eventually play out.

Acquisitions post-Janssen

Between 1976 and 1989, James E. Burke was chairman and CEO of J&J. During this tenure, J&J entered into the areas of vision care, mechanical wound closure and diabetes management. It was also during this time that J&J opened the first operating companies in China and Egypt.

During the 1990s, Ethicon’s Endo-Surgery pioneered minimally invasive surgery, which uses very small incisions and helps patients recover faster than with traditional surgery.

In 1994, the first coronary stent was created by J&J and was called the Palmaz-Schatz stent. This move revolutionised cardiology – coronary stents keep vessels open so blood can flow to the heart. Later, another of J&J’s companies, Cordis Corporation, introduced the first drug-eluting stent, which helped prevent the arteries from re-clogging. Cordis was founded in Miami in 1959 and develops and produces medical equipment to treat patients who suffer from cardiovascular disease.

AlexGorsky-CEO-Johnson-Johnson-Wall

CEO Alex Gorsky, who was appointed in 2012

Beginning in 2003, J&J became involved in a series of litigations with Boston Scientific involving patents covering heart stent medical devices. Both parties claimed that the other had infringed upon their patents. The litigation was settled in 2009, when Boston Scientific agreed to pay $716 million in September and an additional $1.73 billion the following February.

William C. Weldon became the Chairman and CEO of J&J in 2002. Under his leadership, the company entered new therapeutic areas. One of these new areas was HIV/AIDS, which came about through the acquisition of Tibotec-Virco BVBA, to help address the vast unmet needs of patients with these diseases and other infectious diseases like tuberculosis.

In 2006, J&J acquired Pfizer Consumer Healthcare for $16.6 billion in cash. The acquisition included worldwide leading brands such as Listerine oral care products and the Nicorette line of smoking cessation treatments.

2017 saw J&J make its biggest ever acquisition deal after fighting off competition from Sanofi to acquire Swiss biotech Actelion for $30 billion. The company brought with it a group of medicines that treat pulmonary arterial hypertension – well-established blockbuster Tracleer (bosentan), and the more recently-approved Opsumit (macitentan) and Uptravi (selexipag), as well as a slew of pipeline products. 

And at the tail end of 2020, a $6.5 billion deal to buy Momenta meant that J&J added potential inflammatory disease blockbuster nipocalimab to the pipeline at Janssen.

COVID and beyond

J&J’s size meant that it had the resources to bring to bear against COVID-19 as the pandemic ravaged the world in 2020 and 2021, and the company soon began work on its own vaccine in partnership with the US government.

The vaccine was pipped to the post in approval by Pfizer and AstraZeneca’s offerings, and showed lower efficacy in trials, but the company is hoping for an advantage with its single shot dosing, as opposed to the double shot approach of many of its key rivals, as well as its comparatively easier storage. 

As with most of the pharma industry, J&J’s financials were hit by COVID uncertainty in 2020, the impacts of which may be felt for years to come.

The company has many interesting drugs in its pipeline, including a CAR-T therapy developed in partnership with Legend Biotech. But like many of its big pharma peers, it faces increased pressure on some of its biggest brands, as expiring patents pave the way for generic competition while biosimilars undercut sales of biologics.

Products whose sales have taken a hit include prostate cancer drug Zytiga and inflammatory diseases drug Remicade.

But ultimately these dips are likely to only be blips on the radar for J&J. It still easily holds the position of largest pharma company in the world by revenue, and there’s little that is likely to change that in the foreseeable future. 

For all the latest pharma news on Johnson & Johnson, follow pharmaphorum’s J&J and Janssen tags.

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AbbVie’s Humira (adalimumab) Receives the US FDA’s Approval to Treat Pediatric Patients with Ulcerative Colitis

Shots:

  • The approval is based on P-III ENVISION I study that involves assessing Humira (SC) vs PBO in pediatric patients aged 4-17yrs. with mod. to sev. UC
  • The study demonstrated that 60% of patients taking the higher dosage achieved clinical remission per PMS @8wks induction period and 45% of patients who responded @8wks, achieved remission per FMS @52wks.
  • Humira is the 1st and only SC biologic treatment option for pediatric patients with the mod. to sev. active UC. The approval marks the 11 indication in the US which includes 5 approval in pediatric populations

Click here ­to­ read full press release/ article | Ref: Abbvie | Image: Abbvie

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WeylChem

WeylChem Group of Companies is the fine chemicals platform of International Chemicals Investors Group.
Posted in US

The Importance of Titrations in Pharmaceutical Analysis: From the Basics to the Modern Method

***Live: Wednesday, February 24, 2021, 1pm EST | 10am PST | 6pm GMT | 7pm CET*** Titration plays an important role in pharmaceutical analysis. Despite the recent attention given to chromatographic methods, several applications are only feasible by titration, making it a fit-for-purpose method for many analytes. For example, distinguishing between carbonate and bicarbonate or monobasic and dibasic phosphate salts can only be accomplished by titration. *** On demand available after final airing until Feb. 24, 2022.***
Posted in US

Pfizer Reports the US FDA’s Acceptance and Priority Review of BLA for Ticovac (Tick-Borne Encephalitis Vaccine)

Shots:

  • The US FDA has accepted the PR of BLA for TicoVac to prevent TBE in patients aged ≥1year with an anticipated PDUFA date in Aug 2021. If approved, the vaccine may help reduce the risk of TBE for people traveling to endemic areas
  • The BLA is based on clinical trials that assess TicoVac across two age groups (aged 1-15yrs. and 16-65yrs.). The studies showed pooled seropositivity rates 99-100% and 94-99% following three doses respectively
  • The real-world studies demonstrated that the vaccine is 96-99% effective in people who have received at least 2 doses of the vaccine and 2-3 doses of the vaccine were shown to be sufficient to provide a long-lasting immune memory

Click here ­to­ read full press release/ article | Ref: Pfizer | Image: Pfizer

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Top Pitfalls to Avoid When Deploying a Quality and Compliance Management Solution

***Live: Tuesday, February 23, 2021, 11am EST | 8am PST | 4pm GMT | 5pm CET*** The combination of Quality 4.0 and a global pandemic created a pressing need for organizations to automate quality and compliance processes by deployment a digital quality management system. Learn about the technologies that are creating a paradigm shift within the quality and compliance space and common pitfalls to avoid when automating quality and compliance processes.*** On demand available after final airing until Feb. 23, 2022.***
Posted in US

Amgen Reports sNDA Submission of Otezla (apremilast) to The US FDA’s for Adults with Mild to Moderate Plaque Psoriasis

Shots:

  • The sNDA filing is based on P-III ADVANCE trial data, assessing Otezla (30 mg, bid) vs PBO in 595 patients in a ratio (1:1) with mild-to-moderate plaque psoriasis
  • The P-III ADVANCE study results: @16wks., improvement in its 1EPs of sPGA score; achieve 2EPs i.e, 75% improvement in BSA, change in PASI score
  • Otezla is a selective PDE4 inhibitor, approved therapy for mod. to sev. plaque psoriasis who are candidates for phototherapy or systemic therapy, for active PsA, and for with oral ulcers associated with Behçet’s Disease

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: Conejo Valley Guide

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Incyte Reports the US FDA’s Acceptance of sNDA for Priority Review of Jakafi (ruxolitinib) to Treat Chronic Graft Versus Host Disease

Shots:

  • The sNDA submission is based on the P-III REACH3 study assessing ruxolitinib vs best available therapy in adult and pediatric patients ≥12yrs. with steroid-refractory chronic GVHD. The findings were recently presented at the 62nd ASH Annual Meeting & Exposition
  • The study showed greater ORR @24wks. i.e 1EPs (49.7% vs 25.6%); @24wks. mFFS (not reached vs 5.7 mos.); greater symptom improvement per mLSS (24.2% vs 1.0%); no new safety signals were observed while AEs were consistent
  • The PR shortens the review period from 10 to 6mos. The anticipated PDUFA date is Jun 22, 2021

Click here ­to­ read full press release/ article | Ref: Businesswire | Image: The Business Journals

The post Incyte Reports the US FDA’s Acceptance of sNDA for Priority Review of Jakafi (ruxolitinib) to Treat Chronic Graft Versus Host Disease first appeared on PharmaShots.

Regeneron and Sanofi’s Libtayo (cemiplimab-rwlc) Receive the US FDA’s Approval as 1L Treatment for Advanced NSCLC

Shots:

  • The approval is based on the P-III EMPOWER-Lung 1 trial assessing Libtayo (350mg, q3w) monothx. vs platinum doublet CT in 710 patients for the 1L treatment with advanced NSCLC who tested positive for PD-L1 in ≥50% of tumor cells and without EGFR, ALK or ROS1 aberrations
  • The study showed a 32% reduction in the risk of death; mOS (22mos. vs 14mos.); mPFS per BICR (6.2 vs 5.6mos.). An additional prespecified analysis was performed in 563 patients with proven PD-L1 expression of ≥50% and showed a 43% reduction in risk of death
  • Libtayo is a fully human mAb targeting the immune checkpoint receptor PD-1 on T-cells. This approval marks the third approval in the US

Click here ­to­ read full press release/ article | Ref: GlobeNewswire | Image: STAT

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AstraZeneca to Withdraw Imfinzi Indication in Advanced Bladder Cancer in the US

Shots:

  • The company reported the voluntary withdrawal of the Imfinzi (durvalumab) indication in the US for prior treated adult patients with LA or metastatic bladder cancer. The withdrawal was made in consultation with the US FDA
  • The withdrawal is aligned with FDA guidance for evaluating indications with accelerated approvals that did not meet post-marketing requirements
  • In May’2017, Imfinzi has received accelerated approval in the US based on Study 1108 while the continued approval was contingent on results from the P-III DANUBE study in the 1L metastatic bladder cancer setting, which did not meet its 1EPs in 2020

Click here ­to­ read full press release/ article | Ref: AstraZeneca | Image: Healthline

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Incyte Reports the US FDA’s Acceptance of NDA for Priority Review of Ruxolitinib Cream to Treat Atopic Dermatitis

Shots:

  • The NDA is based on two P-III TRuE-AD 1 & 2 assessing ruxolitinib cream (0.75%/1.5%, bid) vs vehicle (non-medicated cream) in 600 patients aged ≥12yrs. in a ratio (2:2:1) diagnosed with AD for at least 2yrs. and who were candidates for topical therapy
  • Patients who completed an assessment @8wks. were offered participation in the 44wks. long-term safety treatment extension period with ruxolitinib cream (0.75%/1.5%, bid)
  • The company submitted PRV along with NDA to the FDA which shortens the review period by 4mos. The anticipated PFUFA date is Jun 21, 2021

Click here ­to­ read full press release/ article | Ref: BusinessWire | Image: BusinessWire

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Immunocore’s Tebentafusp Receives the US FDA’s Breakthrough Therapy Designation for Unresectable or Metastatic Uveal Melanoma

Shots:

  • The US FDA has granted BTD to the tebentafusp (IMCgp100) for the treatment of HLA-A*02:01-positive adult patients with unresectable/ mUM
  • The pre-planned interim analysis of a P-III study (IMCgp100-202) in prior untreated muM demonstrated superior OS as monothx. Immunocore will be working with the FDA to facilitate the submission of a BLA for the therapy
  • Tebentafusp is a novel bispecific protein comprised of a soluble T cell receptor fused to an anti-CD3 immune-effector function and has received the US FDA’s ODD and FTD and Promising Innovative Medicine designation under the UK Early Access to Medicines Scheme. If approved, tebentafusp would be the first new therapy in this space

Click here ­to­ read full press release/ article | Ref: GlobeNewswire | Image: Linkedin

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Drug Development

Ensure the success of your drug development program with Recipharm. We have the expertise and capability to support your drug development project from the early stages through to manufacturing.
Posted in US

Migration to Prefabricated Cleanrooms

In nearly all industries, there has been a general shift away from on-site construction to prefabricated solutions. Specifically, the requirement in the biopharmaceutical industry to address speed to market and lower the total cost of ownership for facilities has accelerated this movement. More recently, the impact of COVID on our society has placed a strain on how we operate while also creating an immense need for additional capacity.
Posted in US

Astellas and Seagen Reports Submission of Two BLA to the US FDA for Padcev (enfortumab vedotin) in Locally Advanced or Metastatic Urothelial Cancer

Shots:

  • The first BLA submission is based on P-III EV-301 trial which involves assessing of Padcev vs CT in 600 patients with locally advanced or metastatic urothelial cancer who were previously treated with platinum-based CT and a PD-1/L1 inhibitor. The 1EP of the study was OS
  • The second BLA submission is based on P-II cohort 2 of EV-201 trial which involves assessing of Padcev in 128 patients with locally advanced or metastatic urothelial cancer who had received prior immunotherapy treatment but not eligible for cisplatin. The 1EP’s study was ORR
  • The submissions will be reviewed under RTOR for both the trials and results were presented at the ASCO GU’ 2021

Click here ­to­ read full press release/ article | Ref: Astellas | Image: Astellas

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The US FDA New Drug Approvals in January 2021

The US FDA has approved 4 NDAs in Jan 2021, leading to treatments for patients and advances in the health care industry.

The Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 4 novel products in 2021.

Additionally, last year in 2020, the US FDA has approved 105 novel products. PharmaShots has compiled a list of a total of 4 new drugs approved by the US FDA in Jan 2021

Bayer and Merck’s Verquvo (vericiguat) Received the US FDA’s Approval to Treat Chronic Heart Failure

Published: Jan 21, 2021 | Tags: Bayer, Merck, Verquvo (vericiguat), Receives, US, FDA, Approval ,Treat, Chronic Heart Failure

  • The approval is based on pivotal P-III VICTORIA trial involves assessing of Verquvo (2.5mg, 5mg & 10mg) vs PBO in 5,050 adult patients with symptomatic CHF and LVEF less than 45%, following a worsening HF event
  • The study met the primary efficacy objective based on a time-to-event analysis & showed a 4.2% reduction in annualized absolute risk. The 1EPs is time to the first event of CV death or hospitalization for HF @median follow-up of 11 mos.
  • Verquvo is the first soluble guanylate cyclase stimulator, approved to treat HF

ViiV’s Cabenuva (cabotegravir and rilpivirine) Received the US FDA’s Approval as the First and Only Complete Long-Acting Regimen for HIV treatment

Published: Jan 22, 2021 | Tags: ViiV, Cabenuva (cabotegravir and rilpivirine), Receives, US, FDA, Approval, First, Only, Complete, Long-Acting Regimen, HIV treatment

  • The approval is based on pivotal phase III ATLAS and FLAIR study assessing Cabenuva in 1,100+ HIV-1 adults to replace the current ARV regimen in those who were virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable regimen
  • Prior to initiating treatment of Cabenuva, oral dosing of cabotegravir and rilpivirine should be administered for ~1mos. to assess the tolerability of each therapy. The therapy reduces the treatment dosing days from 365 days to 12days/ yr
  • The company will begin shipping of Cabenuva to wholesalers and specialty distributors in the US in Feb’2021

ViiV’s Vocabria (cabotegravir, tablet formulation) Received the US FDA’s Approval for the Treatment of HIV-1 infection

Published: Jan 22, 2021 | Tags: ViiV, Vocabria (cabotegravir, tablet formulation), Receives, US, FDA, Approval, Treatment, HIV-1 infection

  • The US FDA approved Vocabria (30mg, tablet formulation) in combination with oral rilpivirine (Edurant) for one month prior to starting treatment with Cabenuva to ensure the medications are well-tolerated before switching to the extended-release injectable formulation
  • Additionally, changes to the Edurant (rilpivirine) tablet label were revised to reflect the oral lead-in recommendations for use with Vocabria
  • The oral therapy is for the patients who will miss planned injection dosing with Cebenuva

Aurinia’s Lupkynis (voclosporin) Received US FDA’s Approval to Treat Adult Patients with Active Lupus Nephritis

Published: Jan 25, 2021 | Tags: Aurinia, Lupkynis (voclosporin), Receives, US, FDS, Approval, Treat Adult, Patients, Active Lupus Nephritis

  • The approval is based on the pivotal AURORA P-III study and AURA-LV P-II study involves assessing of Lupkynis + SoC in 533 patients to treat adult patients with LN
  • The study demonstrated significantly improved renal response rates vs SoC, improved response rates in all parameters across immunologically-active classes, 50 % reduction in UPCR twice as fast as SoC, complete renal response @24 wks vs SoC @1year
  • Lupkynis is the 1st FDA-approved oral therapy for LN and is now commercially available in the US

Related Post: The US FDA New Drug Approvals in December 2020

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BeiGene Reports the US FDA’s Acceptance of sNDA for Brukinsa (zanubrutinib) in Waldenström’s Macroglobulinemia

Shots:

  • The sDNA submission is based on a P-III APSEN study assessing Brukinsa vs ibrutinib in 351 patients with WM and includes a pivotal P-II trial of zanubrutinib in r/r WM conducted in China and P- I/II trial in patients with B-cell malignancies
  • Additionally, safety data from 779 patients in 6 trials of Brukinsa were included in the submission with the anticipated PDUFA date as Oct 18, 2021. Brukinsa is also under regulatory review in the EU, Canada, Australia, China, Taiwan, and South Korea
  • Currently, 20+ marketing applications of Brukinsa have been submitted covering 45 countries globally including the US, EU & China

Click here ­to­ read full press release/ article | Ref: BusinessWire | Image: Switzerland Global Enterprise

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Haven: The strategy that didn’t fix healthcare

John Singer discusses the disbanding of Haven, the joint healthcare venture by Amazon, JP Morgan and Berkshire Hathaway, and the strategies that can help fix US healthcare. 

“The market” was terrified when Warren Buffett, Jamie Dimon and Jeff Bezos got together to disrupt healthcare three years ago with the launch of Haven – in response to that news, healthcare stocks comprising a significant chunk of the $3.5 trillion health economy in the United States shed billions in value overnight.

CVS Health, Walmart, Cardinal Health and Express Scripts were among those affected. Few details about Haven emerged after the new venture was announced to the public in January 2018 and the Haven brand name did not appear until about a year later.

Haven kept its cards close to its chest, saying only that it was going to “explore a wide range of healthcare solutions, as well as pilot new ways to make primary care easier to access, insurance benefits simpler to understand and easier to use, and prescription drugs more affordable”.

The fact that three companies came together to say they’d had enough with the status quo was a big deal, argued Matthew Holt, a managing director who specialised in health system vision and market innovation at private equity firm New Mountain Capital. “These execs have influence in the market by simply standing up and talking about inefficiency and cost,” he explained.

At JP Morgan’s annual health care conference in January 2018, Dimon hosted a private dinner for about 25 top executives from pharmaceutical companies and advocated for lower drug prices. He told his guests, “We are not happy with healthcare costs and want to help.” Dimon was peppered with questions about the end state vision for the joint-venture and its roadmap to get there, especially after Amazon purchased online pharmacy PillPack.

“America is flailing to reshape healthcare because the storyline of ‘cost’ and ‘simplifying insurance’ is perpetuating feedback loops that have not changed in more than 50 years.”

In January 2021, Haven announced it is shutting down. Little information came from the company on the reason for ending operations, merely stating that its founding companies would collaborate further in the future. Among the galaxy of analysis speculating about why ‘Project Haven’ didn’t work, a headline from Barron’s seemed to capture the root issue: ‘JP Morgan, Amazon, and Berkshire Hathaway’s Health-Care Venture Dies. Costs Remain a Problem.’

“Cost” is not the problem. The ‘production of health’ is.

The unmet need: a new conceptual framework

There is a perpetual short circuit in thinking about ‘the next healthcare’. In the early summer of 1967, President Lyndon B. Johnson convened a National Conference on Medical Costs. It brought together more than 300 US health leaders, representing providers of health services, as well as the ultimate consumers of health care services, patients themselves (the birth of “patient-centred” health care).

The membership of the conference included healthcare professionals specialising in medicine, dentistry, pharmacy, economics, administration, and in other relevant disciplines. They were the leading American medical minds and scientists the world had to offer at the time, representing a significant proportion of the men and women in the nation who studied the rising costs of healthcare and the effect of these costs “on the availability of medical care to all Americans”. Then, as now, “urgency” and “crisis” dominated the storyline.

In its final report delivered to America’s executive leadership at the time, the members of the conference said there was “an urgent need for a wide range of actions to deal with the rising costs of medical care”. There were projections of structural and supply chain problems arising from increasing demands for health manpower; how best to expand and strengthen the availability of health personnel was the subject of deep discussion and analysis, as it still is today (Some of the states hardest hit by COVID-19 are turning to retired healthcare workers and medical students to fill gaps left by an already tight labour supply and an influx of patients).

Their assessment: “Even the most optimistic estimates of future manpower in the health services indicate chronic shortages for the foreseeable future. Emphasis was placed not only on the need for more physicians, dentists, nurses and other health personnel, but for the development of new and better ways to utilise the available and future supplies.”

The US health economy is little changed since then – it is still organised as inputs for niche impacts, not outcomes from a coherent whole. We are governed by the logic of market fragmentation. At an individual level, the story is everyone doing the “right thing” to protect and grow their businesses, brands, and shareholders. At a system level, the story is collapse, a function of the design flaw in the orientation of the economics. The centre of gravity is value extraction for shareholder benefit, not value creation for stakeholder benefit.

America is flailing to reshape healthcare because the storyline of “cost” and “simplifying insurance” is perpetuating feedback loops that have not changed in more than 50 years. If the ambition is to “disrupt” the status quo, to transcend the current state and leap into a new orbit for action and imagination, we need different words to think different thoughts. Until then, we are flailing in a vacuum of new energy and ideas.

Recurring revenue from 75% of the US Population

‘Continuous health engagement’ is the real disruption in healthcare. Which is where the “old” Amazon already excels – the company is managing a growing economic system that generates $322 billion in recurring revenue a year from approximately 75 percent of the US population. Strategy and innovation at a system level is the story behind all other stories about what it means to “transform” the dominant perceptions constraining healthcare (+ life sciences). It means adapting to a massive shift underway in how the world works and thinks, and what consumers expect.

Positioning business models for value-based success comes from thinking outside the clinical setting – less “patient engagement” and “patient adherence” to a drug or device, more “consumer engagement” and experience within a larger context of health system innovation. Less about “cost”, more about ‘the production of health’ over time.

Shortly before the news of Haven’s disbanding came out, Atul Gawande, the ex-CEO of the venture, talked with Fast Company about his experience at Haven and the evolving business of healthcare in the US. He shared this perspective: “Places like a Walmart or an Amazon or others who are in the services side have paid a huge amount of attention to the experiences of the person who comes through to make it a better experience for them, with a lot of discipline around cost and a recognition of how important it is to drive for scale. Those are the things we do not bring in healthcare.

“They need to marry that with a deep understanding of the complexities in healthcare and building relationships that are not just about the momentary transaction, but the reality that people need someone who will stay with them for years of their life. You can create incredible outcomes for people when you enable that relationship.”

The roadmap is about creating and competing with durable systems of engagement. Like Amazon and Apple (and Epic), the end state is positioning yourself as an infrastructural technology, to become the dominant design for healthcare delivery in the United States, the backbone to match clinical outcomes with business and administrative processes. New Strategy starts with interoperability at a national level. The complex reality of the current chaos of collapse – including that of Haven – is that we all are going to have to re-examine some of our dearest shibboleths. The rules governing and constraining mindsets no longer work for multiple shifting paradigms. The unmet need is a new science of synthesis, a new conceptual frame to solve for market fragmentation.

Which is to say the “Strategy That Will Fix Healthcare” will have little to do with fixing healthcare; it has more to do with large-scale system change to invent an economy from new source material. We are standing astride a stark rupture in the historical timeline. The world is in motion, searching for an alternative equilibrium, a different consciousness from which to see, think and act. “Haven’s [demise], and the fact that its anticipated disruption of the health care insurance space never materialised, also underlines the difficulty inherent lowering healthcare costs for employers,” wrote Josh Nathan-Kazis, a reporter at Barron’s covering the healthcare industry. “Even with some of the best minds in the business on staff, and the resources of three of America’s largest corporations at their disposal, Haven doesn’t seem to have cracked the problem.”

“Costs remain a problem.” Perhaps everyone is trying to crack the wrong problem. If we have learned anything in 2020, it should be that public health is not separate and distinct from economic health. “Healthcare” is a meta-market around which $142 trillion in global GDP is linked and flows. New strategy comes from the ability to artfully see and select combinations of capabilities from across a vast assemblage of resources, and then intentionally cohere them on a market shaping roadmap to achieve desired effects across multiple domains simultaneously and interactively. It is about creating, managing, and leading with an ecological sensibility.

The gap between computation and culture is not just a gulf between different systems of symbolic logic, of representation and meaning: it is also a gap between different modes of imagination. The next healthcare (+ life sciences) will emerge in the zone where human and computational assemblages can do extraordinary things.

Which is what Amazon already knows how to do better than anyone.

About the author

John G. Singer advises business and government on large-scale system change. He is the managing partner of Blue Spoon Consulting.

The post Haven: The strategy that didn’t fix healthcare appeared first on .

Novartis’s Entresto Receives US FDA’s Approval for Chronic Heart Failure

Shots:

  • The approval is based on P-III PARAGON-HF study involves assessing of Entresto (sacubitril/valsartan) in the treatment of patients with preserved ejection fraction HFpEF
  • The expanded indication enables potential treatment of adults with left ventricular ejection fraction (LVEF) below normal, benefits are most clearly evident
  • Entresto is the 1st and only therapy approved in the US to treat patients diagnosed with guideline defined heart failure to include both those with HFrEF and many with HFpEF

Click here ­to­ read full press release/ article | Ref: Novartis | Image: Penn Medicine

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Targovax Receives US FDA’s Fast Track Designation for ONCOS-102 for Malignant Pleural Mesothelioma

Shots:

  • The US FDA has granted FT designation for ONCOS-102 based on pre/clinical efficacy associated with broad immune activation observed to date
  • The designation is granted to therapies with the potential to address unmet medical needs in serious diseases and allows for more frequent interactions with the FDA to expedite clinical development as well as the regulatory review processes
  • The FT designation follows ONCOS-102’s ODD with both US FDA and EMA in the mesothelioma indication providing market exclusivity for 7 and 10yrs in the US and EU from the date of BLA grant

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: Targovax

The post Targovax Receives US FDA’s Fast Track Designation for ONCOS-102 for Malignant Pleural Mesothelioma first appeared on PharmaShots.

Roche’s Receives the US FDA’s Clearance for Urine Sample Type for BK Virus Quantitative Test

Shots:

  • The US FDA 510K clearance for stabilized urine samples to be used with the cobas BKV test on the cobas 6800/8800 systems. It is also approved for use in CE markets with EDTA plasma and urine stabilized in cobas PCR media as sample types
  • The cobas BKV test provides an alternative to LDTs or ASR combinations, reducing variability and complexity in testing as well as workload and risk alleviation for labs
  • The test previously received the US FDA’s BTD and cleared for use with EDTA plasma samples to aid in the management of BKV in transplant patients and also delivers enhanced diagnosis of disease via non-invasive, easily collected, prepared and stored urine samples

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: Cladding Corp

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Pfizer’s Panzyga Receives the US FDA’s Approval of sBLA for Chronic Inflammatory Demyelinating Polyneuropathy

Shots:

  • The approval is based on the P-III study that involves assessing Panzyga (IVIg) in 142 patients with CIDP. The study evaluated more than one maintenance dosing option while the efficacy, safety, and tolerability were observed during 7 maintenance infusions @3wks. intervals over a 6mos. period
  • The study met 1EPs i.e. 80% of patients achieved INCAT response with 1.0 g/kg dose. Dose-dependent responses demonstrate 1.0 g/kg and 2.0 g/kg dose arms in grip strength, I-RODS, and MRC sum scores and were well tolerated
  • Panzyga is the only IVIg with two FDA-approved maintenance dosing options for CIDP and has received the US FDA’s approval in 2018 for PI and cITP in adults

Click here ­to­ read full press release/ article | Ref: Pfizer | Image: Pfizer

The post Pfizer’s Panzyga Receives the US FDA’s Approval of sBLA for Chronic Inflammatory Demyelinating Polyneuropathy first appeared on PharmaShots.

G1 Therapeutics’ Cosela (trilaciclib) Receives US FDA’s Approval as the First Myeloprotection Therapy for Extensive-Stage Small Cell Lung Cancer

Shots:

  • The approval is based on three clinical trials involves assessing Trilaciclib +carboplatin/etoposide (+/- atezolizumab) and topotecan CT regimens in patients with ES-SCLC. 90% of all patients with ES-SCLC will receive at least one of these regimens
  • The result show reductions in the incidence and duration of severe neutropenia, positive impact on RBC transfusions and other myeloprotective measures, and impacted anemia and the need for rescue interventions such as growth factors
  • Trilaciclib is the 1st therapy designed to help protect bone marrow during CT and has received the US FDA’s BTD in 2019 and expected to be commercially available in Mar’2021

Click here ­to­ read full press release/ article | Ref: Globenewswire | Image: Linkedin

The post G1 Therapeutics’ Cosela (trilaciclib) Receives US FDA’s Approval as the First Myeloprotection Therapy for Extensive-Stage Small Cell Lung Cancer first appeared on PharmaShots.

Visby’s POC COVID-19 Test Receives the US FDA’s EUA for Use in CLIA Waived Settings

Shots:

  • The US FDA has granted EUA for rapid PCR COVID-19 test use at the POC and authorized for use in CLIA waived settings
  • Visby device is easy to use with the potential capability of running pooled tests in the future. The test is contained on a small, palm-sized device that plugs into a power outlet and is designed to deliver results within 30mins.
  • Visby Medical’s test is able to provide fast, accurate and actionable results at the point of need. The company will continue to work to expand authorized use cases to help provide a sense of security to critical areas and allow people to return to work safely

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: PRNewswire

The post Visby’s POC COVID-19 Test Receives the US FDA’s EUA for Use in CLIA Waived Settings first appeared on PharmaShots.

Regeneron’s Evkeeza (evinacumab-dgnb) Receives the US FDA’s Approval for Patients with Homozygous Familial Hypercholesterolemia

Shots:

  • The approval is based on P-III ELIPSE trial that involves assessing Evkeeza (15 mg/kg, IV, q4w) + vs PBO in 65 patients aged ≥12yrs. with HoFH for 24wks.
  • The study met 1EPs i.e. 49% reduction in LDL-C (47% vs 2%), patients also experienced a reduction in the level of ApoB, non-HDL-C. Reductions in LDL-C were observed as early as weeks 2 and maintained throughout week 24 and open-label trial period (through week 48).
  • Evinacumab is a mAb targeting ANGPTL3 and is under FDA’s PR following the BTD granted in 2017

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: Barron’s

The post Regeneron’s Evkeeza (evinacumab-dgnb) Receives the US FDA’s Approval for Patients with Homozygous Familial Hypercholesterolemia first appeared on PharmaShots.

Eli Lilly and AbCellera’s Bamlanivimab (LY-CoV555) and Etesevimab (LY-CoV016) Receive the US FDA’s EUA for COVID-19

Shots:

  • The FDA authorized EUA for bamlanivimab (700 mg) and etesevimab (1400 mg) for the treatment of mild to mod. COVID-19 patients aged ≥12yrs. who are at high risk for progressing to severe COVID-19 and/or hospitalization
  • The EUA is based on P-III BLAZE-1 trial in ≥1,000 COVID-19 patients showed 70% reduction in hospitalizations. Lilly plans to manufacture 250,000+ doses in Q1’ 21 and up to 1M doses by mid-2021
  • The FDA authorizes new protocols for infusion of bamlanivimab as monothx. and bamlanivimab and etesevimab together in as few as 16 and 21 min respectively

Click here ­to­ read full press release/ article | Ref: Businesswire | Image: Genetic Engineering and Biotechnology News

The post Eli Lilly and AbCellera’s Bamlanivimab (LY-CoV555) and Etesevimab (LY-CoV016) Receive the US FDA’s EUA for COVID-19 first appeared on PharmaShots.

Regeneron and Sanofi’s Libtayo (cemiplimab-rwlc) Receives US FDA’s Approval for Patients with Advanced Basal Cell Carcinoma

Shots:

  • The FDA approval is based on P-II trial involves assessing Libtayo (350mg, q3w) in patients with locally advanced BCC & metastatic BCC (nodal or distant)
  • Results: median follow-up (9.5 & 15.1mos.); ORR (21% & 29%); PR (21% & 23%); D0R @≥6mos. (100% & 79%); with longer follow up, 0RR with LA BCC (31%) as reported at ESMO 2020
  • Libtayo is a mAb targeting PD-1 on T-cells, currently under the US FDA’s PR for advanced NSCLC with an expected PDUFA date as Feb 28, 2021. EMA is assessing Libtayo in advanced NSCLC with ≥50% PD-L1 expression & LA BCC following treatment with HHI with anticipated EC’s decision in mid 2021

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: The Print

The post Regeneron and Sanofi’s Libtayo (cemiplimab-rwlc) Receives US FDA’s Approval for Patients with Advanced Basal Cell Carcinoma first appeared on PharmaShots.

Signifier’s eXciteOSA Receives US FDA’s Approval for the Treatment of Mild Obstructive Sleep Apnea and Snoring

Shots:

  • The FDA has approved eXciteOSA to treat mild obstructive sleep apnea and snoring by using for only 20 min./day for a period of 6 wks. and then twice per week
  • In a study of 65 mild obstructive sleep apnea patients, 79% responded to therapy with 52% mean reduction in AHI, 50% reduction in ODI, 3.9point reduction in ESS. In a pivotal study, eXciteOSA achieved nearly a 40% reduction in snoring time across 115 patients
  • eXciteOSA is the first and only daytime intraoral neuromuscular stimulation device for treating mild obstructive sleep apnea and snoring will be available in the US imminently

Click here ­to­ read full press release/ article | Ref: Businesswire | Image: Businesswire

The post Signifier’s eXciteOSA Receives US FDA’s Approval for the Treatment of Mild Obstructive Sleep Apnea and Snoring first appeared on PharmaShots.

Roche’s Elecsys GDF-15 Assay Receives the US FDA’s Breakthrough Device Designation as a CDX in Cancer Treatment

Shots:

  • The US FDA grants the BDD for Elecsys GDF-15 assay that is intended for measurement of Growth Differentiation Factor-15 (GDF-15) in cachectic patients aged≥18yrs. with solid tumors for treatment with Pfizer’s PF-06946860
  • GDF-15 assay helps to identify patients suitable for innovative treatment addressing unintentional weight loss in cancer patients and may provide a precision medicine approach to identifying patients likely to respond to a GDF-15 treatment
  • Elecsys GDF-15 is a quantitative serologic, two-incubation step ECLIA using the sandwich test format for the detection of GDF-15 in human serum

Click here ­to­ read full press release/ article | Ref: GlobeNewswire | Image: GlobeNewswire

The post Roche’s Elecsys GDF-15 Assay Receives the US FDA’s Breakthrough Device Designation as a CDX in Cancer Treatment first appeared on PharmaShots.

BMS’ Breyanzi (lisocabtagene maraleucel) Receives the US FDA’s Approval for Adults With R/R Large-B-Cell Lymphoma

Shots:

  • The approval is based on pivotal TRANSCEND NHL 001 (017001) study assessing Breyanzi in 268 patients with 3L+R/R LBCL including patients with a broad range of histologies and high-risk disease. Breyanzi was administered in the inpatient & outpatient settings
  • Results: ORR (73%); CR (54%); PR (19%); mDOR (16.7mos.) in all responders; patients with best response or PR, mDOR (1.4mos.); patients achieving CR, 65% had remission lasting at least 6mos. and 62% had remission lasting at least 9mos.
  • Breyanzi is a CD19-directed CAR T cell therapy with defined composition and 4-1BB costimulatory domain. Additionally, the US FDA has granted ODD, RMAT and BT Designation to the therapy

Click here, Click here ­to­ read full press release/ article | Ref: PRNewswire, BMS | Image: PRNewswire, BMS

The post BMS’ Breyanzi (lisocabtagene maraleucel) Receives the US FDA’s Approval for Adults With R/R Large-B-Cell Lymphoma first appeared on PharmaShots.

Johnson & Johnson Reports EUA Submission to US FDA’s for its Single Shot COVID-19 Vaccine Candidate

Shots:

  • The EUA submission is based on P-III ENSEMBLE trial assessing the safety and efficacy of the COVID-19 vaccine in protecting adults aged ≥18yrs. against both mod. and sev. COVID-19 disease with assessment of efficacy as of day 14 and as of day 28 as co-1EPs
  • The study demonstrated that single-dose vaccine met all 1EPs & 2EPs. The company has initiated rolling submissions with several health agencies outside the US, and will submit a cMAA with the EMA in the coming weeks
  • The company intends to distribute vaccine to the US government imminently, following the authorization, and expects to supply 100M doses to the US in the H1’21

Click here ­to­ read full press release/ article | Ref: J&J | Image: Yahoo Finance

The post Johnson & Johnson Reports EUA Submission to US FDA’s for its Single Shot COVID-19 Vaccine Candidate first appeared on PharmaShots.

Merck KGaA’s Tepmetko (tepotinib) Receives the US FDA’s Approval for Patients with Metastatic NSCLC with METex14 Skipping Alterations

Shots:

  • The approval is based on pivotal P- II VISION study that involves assessing of Tepmetko (450mg, qd) as monothx. in 152 patients with a median age of 73 years with advanced/ m-NSCLC with METex14 skipping alterations
  • Results: treatment-naïve patients & previously treated patients, ORR (43% & 43%); mDoR (0.8 and 11.1mos.); DoR @6mos. (67% & 75%); DoR @9mos. (30% & 50%) respectively
  • Tepmetko is an oral MET inhibitor that inhibits the oncogenic MET receptor signaling caused by MET (gene) alterations and approved for both treatment naïve and previously treated METex14 positive NSCLC patients

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: Business Insider

The post Merck KGaA’s Tepmetko (tepotinib) Receives the US FDA’s Approval for Patients with Metastatic NSCLC with METex14 Skipping Alterations first appeared on PharmaShots.

Compact Granulation Line

Romaco Innojet’s IGL 100 granulation line is intended for production-scale processing applications and combines high-shear mixing and granulation, fluid bed drying, fluid bed granulation, fluid bed pellet coating, and fluid bed hot melt coating into one unit.
Posted in US

Medtronic Receives the US FDA’s Approval for DiamondTemp Ablation System to Treat Atrial Fibrillation

Shots:

  • The approval is based on DIAMOND-AF trial assessing the safety and efficacy of the DTA system vs contact force-sensing ablation system in 482 patients with recurrent, symptomatic, PAF whose condition is unresponsive to drug therapy
  • Results: patient complication rate (96.7% vs 93.4%); primary effectiveness (79.1% vs 75.7%); procedural efficiencies with shorter total RF times, individual RF ablation duration and reduction in volume of infused saline
  • The DTA system is the 1st FDA-approved, temperature-controlled, irrigated RF ablation system with diamonds currently available to deliver ablations

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: Mission Statement Academy

The post Medtronic Receives the US FDA’s Approval for DiamondTemp Ablation System to Treat Atrial Fibrillation first appeared on PharmaShots.

Gan & Lee Receives the US FDA’s Fast Track Designation for GLR2007 for the Treatment of Patients with Glioblastoma

Shots:

  • The US FDA has granted FTD for GLR2007 for the treatment of patients with glioblastoma and application is eligible for Rolling Review and for Accelerated Approval and Priority Review
  • The Designation evaluate to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need
  • GLR2007 is a cyclin-dependent kinase 4/6 (CDK 4/6) inhibitor for the treatment of advanced solid tumors including glioblastoma, an aggressive form of brain cancer with a low survival rate

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: Gan & Lee

The post Gan & Lee Receives the US FDA’s Fast Track Designation for GLR2007 for the Treatment of Patients with Glioblastoma first appeared on PharmaShots.

Bio-Thera Solutions Reports the US FDA’s Acceptance of BLA for BAT1706 (Proposed Biosimilar to Avastin)

Shots:

  • The BLA submission is based on data from P-III clinical comparison study that demonstrated BAT1706 is highly similar to reference bevacizumab in clinical efficacy, safety, and immunogenicity. The anticipated BsUFA date is Nov 27, 2021
  • The BLA seeks approval of BAT1706 for mCC in combination with fluorouracil-based CT, 1L treatment for nsq. NSCLC, recurrent glioblastoma, mRCC in combination with interferon alfa and persistent, recurrent or metastatic cervical cancer
  • The FDA’s acceptance brings Bio-Thera closer to providing cancer patients in the US with a high-quality, low-cost treatment option

Click here ­to­ read full press release/ article | Ref: Business Wire | Image: Business Wire

The post Bio-Thera Solutions Reports the US FDA’s Acceptance of BLA for BAT1706 (Proposed Biosimilar to Avastin) first appeared on PharmaShots.

Enabling Streamlined Formulation Development of Amorphous Solid Dispersion Drug Products

***Live: Thursday, January 28, 2021 at 11am EST | 8am PST | 4pm GMT | 5pm CET*** Amorphous solid dispersions (ASDs) are a critical technology for bioavailability enhancement. In this webcast Lonza’s Deanna Mudie and Aaron Stewart discuss Lonza’s best practices for ASD formulation development and in vitro testing.*** On demand available after final airing until Jan. 28, 2022.***
Posted in US

Aurinia Lupkynis (voclosporin) Receives US FDA’s Approval to Treat Adult Patients with Active Lupus Nephritis

Shots:

  • The approval is based on the pivotal AURORA P-III study and AURA-LV P-II study involves assessing of Lupkynis + SoC in 533 patients to treat adult patients with LN
  • The study demonstrated significantly improved renal response rates vs SoC, improved response rates in all parameters across immunologically-active classes, 50 % reduction in UPCR twice as fast as SoC, complete renal response @24 wks vs SoC @1year
  • Lupkynis is the 1st FDA-approved oral therapy for LN and is now commercially available in the US

Click here ­to­ read full press release/ article | Ref: Businesswire | Image: Aurinia Pharmaceuticals

The post Aurinia Lupkynis (voclosporin) Receives US FDA’s Approval to Treat Adult Patients with Active Lupus Nephritis first appeared on PharmaShots.

Exelixis Cabometyx (cabozantinib) + Opdivo (nivolumab) Receives US FDA’s Approval as a 1L Treatment for Patients with Advanced Renal Cell Carcinoma

Shots:

  • The approval is based on results from CheckMate -9ER, P-III pivotal trial involves assessing of Cabometyx + Opdivo vs sunitinib in 651 patients previously untreated advanced or metastatic RCC.
  • Results: @ median follow-up of 18.1 mos. patients treated with the combination achieved PFS of 16.6 mos vs 8.3 mos for Sutent arm. Opdivo + Cabometyx also significantly reduced the risk of death by 40% vs Sutent alone , ORR 56% in combination and 27% sunitinib
  • Application approved prior to PDUFA action date of Feb 20, 2021 and reviewed under the Real-Time Oncology Review pilot program

Click here ­to­ read full press release/ article | Ref: Businesswire | Image: Fierce Pharma

The post Exelixis Cabometyx (cabozantinib) + Opdivo (nivolumab) Receives US FDA’s Approval as a 1L Treatment for Patients with Advanced Renal Cell Carcinoma first appeared on PharmaShots.

ViiV’s Cabenuva (cabotegravir and rilpivirine) Receives the US FDA’s Approval as the First and Only Complete Long-Acting Regimen for HIV treatment

Shots:

  • The approval is based on pivotal phase III ATLAS and FLAIR study assessing Cabenuva in 1,100+ HIV-1 adults to replace the current ARV regimen in those who were virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable regimen
  • Prior to initiating treatment of Cabenuva, oral dosing of cabotegravir and rilpivirine should be administered for ~1mos. to assess the tolerability of each therapy. The therapy reduces the treatment dosing days from 365 days to 12days/ yr
  • The company will begin shipping of Cabenuva to wholesalers and specialty distributors in the US in Feb’2021

Click here ­to­ read full press release/ article | Ref: Businesswire | Image: ViiV Healthcare

The post ViiV’s Cabenuva (cabotegravir and rilpivirine) Receives the US FDA’s Approval as the First and Only Complete Long-Acting Regimen for HIV treatment first appeared on PharmaShots.

Novo Nordisk Report Submission of label Expansion Application to US FDA’s for Ozempic (semaglutide) for T2D

Shots:

  • The approval is based on SUSTAIN FORTE trial assessing Ozempic (2.0mg, qw) vs Ozempic (1.0mg) in 961 people with T2D in need of treatment intensification
  • Result: 2.0 mg dose achieved significant and superior reduction in HbA1c, both doses are safe and well-tolerated profiles
  • Ozempic is a glucagon-like peptide-1 (GLP-1) analogue and is currently approved in the US for 0.5 mg and 1.0 mg doses to treat T2D in adults and to reduce the risk of MACE in adults with T2D mellitus and established CV disease

Click here ­to­ read full press release/ article | Ref: GlobeNewswire| Image: Business Medical Dialogues

The post Novo Nordisk Report Submission of label Expansion Application to US FDA’s for Ozempic (semaglutide) for T2D first appeared on PharmaShots.

Roche Reports the US FDA’s Acceptance of sNDA and Granted Priority Review for Esbriet (pirfenidone) to Treat UILD

Shots:

  • The sNDA submission is based on a P-II study that involves assessing Esbriet vs PBO in patients aged ≥18-85yrs. with progressive fibrosing UILD for 24wks. The anticipated PDUFA date is May’2021
  • Results: Over 24wks. predicted median change in FVC measured by home spirometry (-87.7 vs -157.1 mL); change in percent predicted DLco and 6MWD are in favor of Esbriet. Additionally, less loss to lung function and exercise capacity was observed
  • Esbriet is an oral therapy for IPF and is available in more than 60+ countries globally. FDA has granted ODD and BTD to the therapy in 2020

Click here ­to­ read full press release/ article | Ref: Roche| Image: The Indian Express

The post Roche Reports the US FDA’s Acceptance of sNDA and Granted Priority Review for Esbriet (pirfenidone) to Treat UILD first appeared on PharmaShots.

Bayer and Merck’s Verquvo (vericiguat) Receives the US FDA’s Approval to Treat Chronic Heart Failure

Shots:

  • The approval is based on pivotal P-III VICTORIA trial involves assessing of Verquvo (2.5mg, 5mg & 10mg) vs PBO in 5,050 adult patients with symptomatic CHF and LVEF less than 45%, following a worsening HF event
  • The study met the primary efficacy objective based on a time-to-event analysis & showed a 4.2% reduction in annualized absolute risk. The 1EPs is time to the first event of CV death or hospitalization for HF @median follow-up of 11 mos.
  • Verquvo is the first soluble guanylate cyclase stimulator, approved to treat HF

Click here ­to­ read full press release/ article | Ref: Business Wire| Image: Financial Times

The post Bayer and Merck’s Verquvo (vericiguat) Receives the US FDA’s Approval to Treat Chronic Heart Failure first appeared on PharmaShots.

Omeros Reports the US FDA’s Acceptance and Priority Review of BLA for Narsoplimab (OMS721) to Treat HSCT-TMA

Shots:

  • The US FDA has accepted the BLA and granted the PR with an anticipated PDUFA date as Jul 17, 2021
  • The BLA filing marks the milestone on the path to commercialization of narsoplimab
  • Narsoplimab is an investigational mAb targeting MASP-2 has received the US FDA’s BTD and ODD to the FDA for each of HSCT-TMA and IgA nephropathy

Click here ­to­ read full press release/ article | Ref: Businesswire | Image: Omeros

The post Omeros Reports the US FDA’s Acceptance and Priority Review of BLA for Narsoplimab (OMS721) to Treat HSCT-TMA first appeared on PharmaShots.

Genmab’s Darzalex Faspro (daratumumab and hyaluronidase-fihj) Receives the US FDA’s Approval for Patients with Newly Diagnosed Light-chain (AL) Amyloidosis

Shots:

  • The approval is based on P-III ANDROMEDA (AMY3001) study involves assessing of Darzalex Faspro + bortezomib, cyclophosphamide, and dexamethasone (VCd) vs VCd alone in 388 patients with newly diagnosed AL amyloidosis
  • Genmab to receive $30M as milestones with the first commercial sale of Darzales faspro in this indication. The US FDA reviewed the submission of data for approval in this indication under RTOR pilot program and Project Orbis
  • Darzalex faspro is the SC formulation of daratumumab and is the only therapy for newly diagnosed Light-chain (AL) amyloidosis in the US

Click here ­to­ read full press release/ article | Ref: GlobeNewswire | Image: Medwatch

The post Genmab’s Darzalex Faspro (daratumumab and hyaluronidase-fihj) Receives the US FDA’s Approval for Patients with Newly Diagnosed Light-chain (AL) Amyloidosis first appeared on PharmaShots.

Daiichi Sankyo and AstraZeneca’s Enhertu Receive the US FDA’s Approval for Previously Treated HER2-Positive Advanced Gastric Cancer

Shots:

  • The approval is based on pivotal P-II DESTINY-Gastric01 trial involves assessing of Enhertu (6.4 mg/kg, q3w) vs CT in a ratio (2:1) in adult patients with LA or metastatic HER2 positive gastric or GEJ adenocarcinoma who have received a prior trastuzumab-based regimen
  • In a pre-specified interim analysis, it showed 41% reduction in the risk of death vs patients with mOS (12.5 vs 8.4mos); PFS (5.6 vs 3.5mos); ORR (40.5% vs 11.3%); CR (7.9% vs 0%); PR (32.5% vs 11.3%); DoR (11.3 vs 3.9mos.)
  • Enhertu is a HER2-directed ADC and has received the US FDA’s PR & BTD for HER2+ m-gastric cancer and ODD for gastric cancer

Click here ­to­ read full press release/ article | Ref: Businesswire | Image: BioSpace

The post Daiichi Sankyo and AstraZeneca’s Enhertu Receive the US FDA’s Approval for Previously Treated HER2-Positive Advanced Gastric Cancer first appeared on PharmaShots.

US eyes permanent change to digital health regulatory path

Developers of digital health tools have benefited from a truncated route to market during the COVID-19 crisis, and that could be made permanent if new FDA guidance is adopted.

Pandemic emergency provisions were put in place in March last year to allow certain medical devices to be launched for use by patients without having to go through the FDA’s usual premarket notification requirements – also known as the 510(k) process.

That included some low-risk (Class IIa) digital health apps under the software as a medical device (SaMD) category, which can be used to minimise direct contact between patients and healthcare professionals at a time when non-essential visits are best avoided.

Now, the FDA is seeking comment on plans to make that emergency regulatory flexibility permanent, by doing away with the premarket review requirements altogether  “for some or all of [these] devices”, according to a Federal Register notice (0991–ZA52).

The document is likely to be one of the last signed by Health and Human Services (HHS) Secretary Alex Azar, who has resigned from the role as preparations continue for the start of the new administration under President-elect Joe Biden on Wednesday.

Last April, the FDA temporary waiver covered digital health tools used specifically for psychiatric disorders, along with low-risk general wellness and digital health products for mental health or psychiatric conditions. The discretion also covered digital pathology tools and other medical devices like thermometers and ventilators.

Pandemic lockdowns mean patients with mental illness are less able to maintain contact with healthcare and support workers, placing them under added strain, and when it announced the measure the FDA said remote tools could help them cope until some degree of normal life can be restored.

The waiver meant that a number of apps were launched earlier than expected in the US, including Pear Therapeutics’ smartphone-based Pear-004 for people living with schizophrenia and Akili Therapeutics’ attention deficit hyperactivity disorder (ADHD) app Endeavor (AKL-T01), as well as computerised cognitive assessment aids.

The experience so far seems to have been a success, given the FDA is considering making the exemption permanent for 91 devices and SaMD tools out of 221 Class I and Class II medical device types covered by the waiver categories.

“The exemptions provided for and proposed under this notice for these 91 device classes could eliminate anywhere from $9.1 to $364 million in startup costs if there were one new entrant into each device market,” says the guidance.

“At the same time, should these waivers go into effect as proposed, patients stand to gain more immediate access to new products that would otherwise be required to obtain a 510(k) clearance prior to marketing.”

The proposal would also spare FDA’s “scarce review resources” as a result of the pandemic and allow it to redeploy these elsewhere, including devices intended for use in managing CPOVID-19 patients.

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Novartis’ Ligelizumab (QGE031) Receives the US FDA’s Breakthrough Designation for Patients with Chronic Spontaneous Urticaria

Shots:

  • The US FDA has granted BTD for Ligelizumab for the treatment of CSU in patients with an inadequate response to H1-antihistamine treatment
  • The therapy is currently being evaluated in ongoing P-III program including PEARL 1 & -2 that assess Ligelizumab vs Xolair (omalizumab) in ~2000 patients across the globe with its anticipated results in H2’21
  • Ligelizumab is a next generation monoclonal anti-IgE Ab, that demonstrated more patients experienced complete resolution of wheals (hives) in a P-IIb dose-finding trial. The company is anticipating the US regulatory submission in 2022

Click here ­to­ read full press release/ article | Ref: Novartis | Image: Medical, Marketing and Media

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Pfizer’s Xalkori (crizotinib) Receives the US FDA’s Approval for ALK-Positive Anaplastic Large Cell Lymphoma In Children And Young Adult

Shots:

  • The approval is based on the ADVL0912 study assessing Xalkori in 121 patients aged 1-21yrs. that included 26 patients with r/r, systemic ALK+ ALCL prior treated with at least one systemic treatment
  • The study showed 88% ORR. Among 23 patients, who achieved a response, 39% maintained their response for at least 6mos. and 22% maintained their response for at least 12mos.
  • Xalkori is a TKI and has received the FDA’s BTD for ALK+ ALCL in May’2018. Additionally, EMA has agreed to a PIP for the therapy to treat pediatric patients with r/r systemic ALK+ ALCL

Click here ­to­ read full press release/ article | Ref: Pfizer | Image: The Bangkok Post

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Amgen’s Enbrel heads ICER list of unjustified US price rises

US cost effectiveness watchdog ICER found 10 examples of substantial price rises for top-selling medicines in 2019, and concluded that seven of those were not backed by any clinical evidence.

The cost to the American taxpayer from those increases? Around $1.2 billion for the seven drugs alone, says the organisation, which also found that for all but one the list price increase was at least double the US rate of inflation in that year.

Amgen’s venerable TNF inhibitor Enbrel (etanercept) for arthritis and other inflammatory conditions topped the list of offenders in terms of the added cost to the healthcare system, which ICER – the Institute for Clinical and Economic Review – estimated to be $403 million.

Enbrel’s list price rose 5.4%, but the net price was up almost 9% once adjusted for other factors, which could include rebates, wholesale fees and other variables like patient assistance programmes.

Second place was Johnson & Johnson’s schizophrenia treatment Invega Sustenna/Invega Trinza (paliperidone), with a 6.8% increase in the list price – and 10.7% net – which added $203 million to US drug spending.

The biggest price increases were seen with Salix’ irritable bowel syndrome therapy Xifaxan (rifaximin) – up 8.4% and 13.3% respectively – which added $173 million to the national spend.

The rest of the seven were: Bristol-Myers Squibb’s arthritis drug Orencia (abatacept) at a cost of $145 million; Biogen’s multiple sclerosis therapy Tecfidera (dimethyl fumarate) at $118 million; AbbVie’s TNF drug Humira (adalimumab) at $66 million; and UCB’s Vimpat (lacosamide) for epilepsy which swelled spending by $58 million.

“Several of these treatments have been on the market for many years, with scant evidence that they are any more effective than we understood them to be years ago,” said ICER’s chief medical officer David Rind.

The increases came against a backdrop of relatively modest price increases overall in 2019, a time when the US administration had recently published a series of proposals to tackle high prescription drug prices, although many of those failed to come to fruition.

It’s worth noting that the scale of the increase identified in the latest report is considerably lower than was seen in ICER’s last edition in 2019. That also identified seven hefty price hikes for products – including Humira and Tecfidera – but cumulatively they all added a massive $4.8 billion to the US drugs bill.

According to a 2019 report by the OECD group of industrialised nations, the US spends roughly twice the average amount spent by other member countries on pharmaceuticals per head.

Three drugs also saw sizeable price increases, but ICER says those may have been justified by new clinical evidence – although the organisation notes it hasn’t run a full cost-effectiveness analysis.

The three were Novartis’ heart failure therapy Entresto (sacubitril/valsartan), Takeda’s Entyvio (vedolizumab) for ulcerative colitis and Astellas’ prostate cancer therapy Xtandi (enzalutamide).

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Astellas Reports the US FDA’s Acceptance of Priority Review for its NDO Therapy

Shots:

  • The US FDA has accepted the PR for NDA of mirabegron (oral suspension) and sNDA for Myrbetriq (mirabegron, tablets) for neurogenic detrusor overactivity (NDO) in pediatric patients aged ≥ 3yrs. with anticipated PDUFA date as Mar 28, 2021
  • The NDA & sNDA is based on P-III study assessing efficacy, safety, tolerability and PK of mirabegron in children and adolescents aged 3-<18yrs. with NDO and using clean intermittent catheterization
  • In 2012, Myrbetriq tablets were initially approved in the US for adults with overactive bladder with symptoms of urge urinary incontinence, urgency and urinary frequency

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: Financial Times

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ViewPoints Interview: Genentech’s Ted Omachi Shares Insight on the US FDA’s Approval of Xolair in Nasal polyps

In a recent interview with PharmaShots, Ted Omachi, Global Development Leader for Xolair, and Senior Medical Director of Product Development for Immunology, Genentech shared his views on the approval of Xolair in the US.

Shots:

  • The approval is based on P-III POLYP 1 & 2 trials assessing Xolair vs PBO in 138 & 127 adult patients with nasal polyps who had an inadequate response to nasal corticosteroids respectively
  • Results: @24wks. improvement in NPS (-1.1 vs 0.1 & -0.9 vs -0.3); improvement in NCS (-0.9 vs -0.4 & -0.7 vs -0.2); no new or unexpected safety signals were identified respectively
  • Xolair is the first biologic for the treatment of nasal polyps that targets and blocks IgE. In the US, Novartis & Genentech work together to develop and co-promote Xolair

Tuba: Can you please shed some light on Nasal Polyps? (causes, symptoms, epidemiology, etc.)

Ted: Approximately 13 million people in the U.S. are impacted by nasal polyps, a commonly occurring condition in adults that may be refractory to treatments such as nasal corticosteroids and even surgery. Nasal polyps present as noncancerous growths on the lining of the nasal sinuses or nasal cavity associated with irritation and inflammation and, as such, they can block normal airflow. Nasal polyps may also co-occur with other respiratory conditions, such as allergies and asthma. They may become quite large and develop in both nostrils, leading to a loss of smell, nasal congestion, chronic runny nose, and post-nasal drip. This condition can cause significant long-term symptoms and impact on patients’ lives. While the pathophysiology of nasal polyps is not entirely elucidated, we know that it is an inflammatory condition in which immunoglobulin E (IgE) plays an important role.

Tuba:  A quick highlight of clinical data submitted for the approval of Xolair in nasal polyps to the U.S. FDA.

Ted: The FDA’s approval is based on results from the Phase III POLYP 1 and POLYP 2 pivotal trials conducted in adult patients. To be enrolled in the study, patients needed to have large polyps in both nostrils and significant symptoms, with persistent symptoms and large polyps even after treatment with nasal steroids. Patients were then given either Xolair or placebo, in a blinded fashion, while continuing to receive nasal steroids. Patients who received Xolair had statistically significantly greater improvements, as compared to placebo, over the approximate six-month duration of the study, from baseline to Week 24, in both of the co-primary endpoints: Nasal Polyp Score (NPS) and Nasal Congestion Score (NCS). NPS is an objective measure of the size of the polyps, as determined by endoscopy, while NCS is a measure of the degree of nasal blockage, as determined by patients’ assessment of their own symptoms. The greater improvements in NPS and NCS in the Xolair group as compared to the placebo group were observed as early as the first assessment at Week 4 in both studies. They also had statistically significant improvements in smell, post-nasal drip, and runny nose. The safety profile in POLYP 1 and POLYP 2 was consistent with the established safety profile for Xolair, which is based on more than 17 years of real-world experience in allergic asthma and more than 1.3 million patient-years of usage in clinical practice. 

Tuba: Can you explain how Xolair works for nasal polyps (mechanism of action)?

Ted: Xolair is the first biologic for the treatment of nasal polyps that targets and blocks immunoglobulin E (IgE), a key driver of inflammation. By reducing free IgE, down-regulating high-affinity IgE receptors and limiting mast cell degranulation, Xolair minimizes the release of mediators throughout the allergic inflammatory cascade.

Tuba: Can you provide some insights on RoA for Xolair in Nasal Polyps?

Ted: We do not comment on sales forecasts or projections.

Tuba:  Can our readers have more details on any ongoing and upcoming patients support programs and efforts for patient adherence?

Ted: As a physician, I know firsthand that adherence and access to medicines are some of the most important factors to ensure the safety and effectiveness of treatment for patients. At Genentech, we are committed to helping patients access to the medicines prescribed by their physician, even if they can’t afford them. For more than 20 years, we have helped more than 2.2 million people get the medicine they need through patient assistance programs like Genentech Access Solutions and the Genentech Patient Foundation.

Tuba: Xolair is now approved in multiple indications including allergic asthma, CIU and nasal polyps. What’s next?

Ted: We are committed to exploring the full potential of Xolair across a range of respiratory diseases.

In August 2020, the FDA accepted our sBLA for a new self-injection option for Xolair prefilled syringe formulation across all approved US indications, with a decision on approval anticipated in Q1 2021.

Additionally, in 2018 the FDA granted Breakthrough Therapy Designation to Xolair as a potential treatment for food allergies. Xolair is currently being investigated as a potential treatment for multiple food allergies in Phase III clinical trial, Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen Oral Immunotherapy in Food Allergic Children and Adults, or OUtMATCH trial. The trial is supported by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, Genentech, and Novartis. We are hopeful about the potential to address this area of the significant need for patients as there are limited FDA-approved treatments that help prevent severe reactions due to food allergies.

Tuba: Are you focusing on approvals in different countries?

Ted: Xolair is approved for nasal polyps-related conditions in several countries outside of the U.S. In August 2020, the European Commission approved Xolair as add-on therapy with intranasal corticosteroids for the treatment of adults with severe chronic rhinosinusitis with nasal polyps (CRSwNP) for whom therapy with intranasal corticosteroids does not provide adequate disease control. Additionally, Xolair is approved in more than 10 other countries throughout the world for nasal polyps or CRSwNP. Further regulatory reviews of Xolair to treat patients with CRSwNP (often referred to as nasal polyposis) are currently underway in multiple countries.

Tuba: What kind of pricing difference shall be expected for Xolair for Nasal Polyps vs. Xolair for other indications?

Ted: When determining the prices of our medicines, we take into consideration a number of factors including clinical benefit, patient access, investments required for future medications, and our responsibility to patients, society, and shareholders. The dosing of Xolair for nasal polyps and allergic asthma depends on the patient’s weight and serum IgE levels, which affects the cost of therapy.

About Ted Omachi:

Ted Omachi is a Medical Director in the Product Development Immunology group at Genentech, focusing on late-stage development in respiratory and allergic diseases. He joined Genentech in 2013, starting in the Medical Affairs group before transitioning to Product Development in 2015.

Related Post:  ViewPoints Interview: Genentech’s Ted Omachi Shares Insights on Xolair (omalizumab) PFS

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Nirmidas Receives the US FDA’s EUA for its COVID-19 Rapid Antibody Fingerstick Test

Shots:

  • The US FDA has granted EUA to Nirmidas’ COVID-19 rapid antibody IgG/IgM test for use in POC settings, delivering results in 15-20min
  • Using a fingerstick serology test, the MidaSpot COVID-19 Ab combo detection kit checks for Ab against the RBD antigen and showed 100% sensitivity for IgG after 14 days post symptom onset and 100% sensitivity for IgM after 7 days post symptom onset
  • With this, Nirmidas became the first US company to receive EUA for a COVID-19 POC fingerstick Ab test. The kit can now be administered in CLIA-waived settings for POC testing such as doctor’s offices, pharmacies, ERs

Click here ­to­ read full press release/ article | Ref: Businesswire | Image: Yahoo Finance

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Provention Bio Reports Submission of BLA and Priority Review to the US FDA for Teplizumab to Prevent T1D

Shots:

  • The BLA for teplizumab to delay or prevention of clinical T1D in at-risk individuals has been filed to the US FDA. The FDA has also granted Provention’s request for Priority Review and assigned anticipated PDUFA date as Jul 02, 2021
  • The company is actively working with the FDA to support their review while planning to launch the therapy in Q3’21
  • Teplizumab is an investigational anti-CD3 mAb and has previously received the US FDA’s BT designation. If approved, teplizumab will be the first disease-modifying therapy for T1D

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: ProventionBio

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Biocon has Launched Tacrolimus Capsules in the US

Shots:

  • The launch of Tacrolimus capsules follows the approval of the US FDA in Nov’20 and emphasizes Biocon activity to make affordable healthcare accessible
  • Tacrolimus is particularly effective in treating patients of renal transplant
  • Tacrolimus, a calcineurin inhibitor immunosuppressant used to treat organ transplant patients, reduces the body’s ability to reject a transplanted organ

Click here ­to­ read full press release/ article | Ref: Biocon | Image: Business Standard

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Biocon Launches Tacrolimus Capsules in the US

Shots:

  • The launch of Tacrolimus capsules follows from approval of US FDA in Nov. 2020 and underscores Biocon relentless pursuit to make affordable healthcare accessible
  • It has particularly effective in treating patients of renal transplant for more than 2 decades
  • Tacrolimus, a calcineurin inhibitor, is an immunosuppressant used in the treatment of organ transplant patients, which reduces the body’s ability to reject a transplanted organ

Click here ­to­ read full press release/ article | Ref: Biocon | Image: Business Standard

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Moderna’s mRNA-1273 Receives the US FDA’s EUA Against COVID-19

Shots:

  • The US FDA has authorized EUA of mRNA-1273 vaccine against COVID-19 in individuals ≥18yrs. The delivery to the US govt. will begin imminently while Moderna will continue to gather additional data and plans to file BLA for full licensure in 2021
  • Allocation and distribution will be prioritized according to populations identified by the CDC’s ACIP. The Company expects to have b/w 100-125M doses available globally in the Q1’21, with 85-100M of those available in the US
  • The US govt. ordered total 200M doses to date & retains an option to purchase up to an additional 300M doses, ~20M doses will be delivered by the end of Dec 2020

Click here ­to­ read full press release/ article | Ref: Moderna | Image: CTech

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GSK’s Benlysta (belimumab) Receives the US FDA’s Approval as the First Therapy for Active Lupus Nephritis (LN)

Shots:

  • The approval follows BTD and PR & is based on P-lll BLISS-LN study involves assessing Benlysta (IV, 10 mg/kg) + SOC vs PBO + SOC in 448 adult patients with active LN
  • The study met its 1EPs demonstrating a greater number of patients who achieved PERR @2yrs. (43% vs 32%., all 2EPs were achieved while safety results are consistent with the known safety profile of Benlysta
  • Benlysta is a mAb that binds to soluble BLyS and does not bind B cells directly. The approval extends the current indication in the US to include both SLE and LN for both the IV and SC formulations

Click here ­to­ read full press release/ article | Ref: GSK | Image: Euronews

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Moderna’s mRNA-1273 Receives the US FDA’s Advisory Committee Vote Supporting EUA Against COVID-19

Shots:

  • The VRBPAC voted 20-0, with one abstention that the benefits of the Moderna’s vaccine outweighed its risks for use in people aged ≥18yrs
  • The recommendation is based on data analysis from the pivotal P-III clinical study that demonstrated 94.1% efficacy
  • The US FDA’s committees provide non-binding recommendations. The FDA will take the VRBPAC’s recommendation into consideration in making a final decision on approval

Click here ­to­ read full press release/ article | Ref: Moderna | Image: Pharmaphorum

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Pfizer/BioNTech COVID-19 vaccinations start across the US

Hospitals in the US have started vaccinating their front-line staff against COVID-19, as deaths in the country crossed the 300,000 threshold with more than 200,000 new cases reported yesterday.

Shipments of Pfizer/BioNTech’s mRNA vaccine BNT-162b are being shipped to hundreds of hospitals and other distribution facilities across the US, with the first three million doses earmarked for  healthcare workers and elderly.

Just three days after the FDA granted Emergency Use Authorisation for the shot, the first dose administered outside a clinical trial was given yesterday to intensive care nurse Sandra Lindsay at the Long Island Jewish Medical Center in Queens, New York.

It’s likely to be months before all eligible healthcare workers for the first wave receive vaccinations. Hopeful eyes are already turning to the Moderna’s mRNA-1273 vaccine, which is scheduled to be reviewed by FDA advisors on Thursday, to help boost available supplies.

The first nursing home residents aren’t expected to start receiving their doses until next week, according to Army General Gustave Perna, chief operating officer for Operation Warp Speed, the US vaccination task force.

The immunisation programme comes as hospitals around the country say they are already struggling to cope with the influx of COVID-19. The US has the highest death toll from the disease worldwide, ahead of Brazil, India and Mexico, and there are fears of a further spike as the holiday season gathers pace.

The US government is predicting that 20 million Americans will have received at least one of the two doses of the vaccines by the end of the year, with another 30 million set to be immunised during January and another 50 million by the end of March.

President Trump took a break from his relentless tweeting about alleged election fraud to briefly acknowledge the milestone on the path to recovery from the pandemic.

Canada also gave the first doses of BNT-162b to healthcare workers yesterday, a week after the UK started the ball rolling on its own vaccination programme – the first to get started in the world.

Because BNT-162b is made from RNA, it has strict temperature requirements and has to be stored at -70 C in dry ice to prevent it from breaking down, although it can be kept at regular refrigeration temperatures temporarily – around three days – after being defrosted for administration.

That will pose a logistical challenge for all countries, requiring a massive and carefully controlled shipping operation as doses come off the production line at Pfizer’s facility in Michigan.

Around 5 million doses of Moderna’s vaccine could be ready to ship straightaway if the FDA gives a green light, possibly as soon as Friday, with distributor McKesson handling that roll-out. Moderna’s shot is a little easier to handle as it only needs to be kept at -20 C.

Meanwhile, Operation Warp Speed’s chief executive Dr Moncef Slauoi also suggested yesterday that Johnson & Johnson could get approval for its shot in late January or early in February, while AstraZeneca may be in a position to seek FDA approval as early as February.

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AstraZeneca’s Trixeo Aerosphere Receives EU’s Approval for the Maintenance Treatment of COPD

Shots:

  • The approval is based on P-lll ETHOS involve the assessing of Trixeo Aerosphere (formoterol fumarate/glycopyrronium bromide/budesonide) vs Bevespi Aerosphere and PT009 in adult patients with mod. to sev. COPD. P-III KRONOS study also supported the approval
  • The study showed a reduction in rate of mod. or sev. exacerbations. EMA’s CHMP has recommended the MAA for Trixeo Aerosphere in Oct’2020
  • Trixeo Aerosphere is a single-inhaler, fixed-dose triple-combination of formoterol fumarate LABA, LAMA, with budesonide, an ICS, and delivered in a pressurized metered-dose inhaler. The approval marks the fourth major approval of the therapy

Click here ­to­ read full press release/ article | Ref: AstraZeneca | Image: Global Justice Now

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Medtronic Launches Carpediem as the First Pediatric and Neonatal Acute Dialysis Machine in the US

Shots:

  • Following the US FDA’s approval granted in early 2020, the first Carpediem (Cardio-Renal Pediatric Dialysis Emergency Machine) were installed & use at Cincinnati Children’s HMC in the US
  • Carpediem system is indicated for acute kidney injury or fluid overloaded patients requiring hemodialysis or hemofiltration therapy
  • The system is intended to provide CRRT to patients weighing 2.5 to 10kg

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: BioWorld

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As COVID-19 cases swell, US extends telehealth to acute care

The US government has introduced a scheme to allow hospitals to reduce the number of inpatients they see through a telehealth platform that would helps deliver acute care at home.

The move comes as the number of new cases of COVID-19 have been climbing to around 180,000 a day, with deaths since the start of the pandemic now rising above 260,000, and concerns that some hospitals could become overwhelmed over the winter months.

The Centres for Medicare & Medicaid Services (CMS) announced the plans as part of  broad plan to free up hospital capacity amid the COVID-19 surge, although it stressed patients won’t have to use the service unless they want to, and the first assessment by a physician must take place in person.

It said that treatment for more than 60 different acute conditions, including asthma, heart failure, pneumonia and chronic obstructive pulmonary disease (COPD), can be carried out “appropriately and safely in home settings with proper monitoring and treatment protocols.”

The new telehealth scheme applies to patients with conditions that require at least daily visits by a physician and ongoing medical team monitoring.

Six health systems across the country have already been approved to participate in the programme, getting the necessary Medicare waivers to allow them to treat patients at home.

They are Brigham and Women’s Hospital in Massachusetts, Massachusetts General Hospital, Huntsman Cancer Institute in Utah, Mount Sinai Health System in New York City, Presbyterian Healthcare Services in New Mexico, and Iowa’s UnityPoint Health.

Participating hospitals must have screening protocols in place before care at home begins, to assess that patients have access to working utilities, ensure there are no other physical barriers to care, and rule out welfare concerns such as a risk of domestic violence.

The US healthcare system has rapidly adopted telehealth and remote patient monitoring during the response to the coronavirus pandemic, with some suggesting it will transform the future of health care delivery, although there are dissenting voices.

In March 13, President Trump made an emergency declaration that empowered the CMS to issue waivers to Medicare programme requirements to support healthcare providers and patients during the crisis.

Since then, the CMS has added dozens of services to the list of telehealth services it will reimburse during the public health emergency, including emergency department visits, initial nursing facility and discharge consultations, home visits, and physical, occupational and speech therapy services.

Some of the changes have found their way into the proposed 2021 Physician Fee Schedule, which will make reimbursement for some telehealth and digital services permanent.

“We’re at a new level of crisis response with COVID-19 and CMS is leveraging the latest innovations and technology to help healthcare systems that are facing significant challenges to increase their capacity to make sure patients get the care they need,” said CMS Administrator Seema Verma.

“With new areas across the country experiencing significant challenges to the capacity of their health care systems, our job is to make sure that CMS regulations are not standing in the way of patient care for COVID-19 and beyond,” she added.

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Baxter’s Homechoice Claria APD System Receives the US FDA’s 510 (k) Clearance for Kidney Failure

Shots:

  • Baxter has received the FDA’s clearance for its APD system designed for home use, combining it with Sharesource that aims to help patients with kidney disease manage their care remotely
  • The Homechoice Claria system was cleared for both adults and children. Its interface is available in 38 languages and features step-by-step, voice-activated instructions through an app to guide the user through therapy
  • The clearance follows the recent finalization of the ESRD ETC payment model aims to increase the number of new patients with kidney failure who receive home dialysis and organ transplants. Homechoice Claria with Sharesource will be available in the US in the coming weeks

Click here ­to­ read full press release/ article | Ref: Baxter | Image: BusinessWire

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Insights+: The US FDA New Drug Approvals in October 2020

The US FDA has approved 4 NDAs and 1 BLA in Oct 2020, leading to treatments for patients and advances in the health care industry. The Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 90 novel products so far in 2020, including 5 in Oct 2020. Additionally, last year in 2019, the US FDA has approved 48 novel products. We have compiled a list of a total of 5 new drugs approved by the US FDA in Oct 2020.

Regeneron’s Inmazeb (atoltivimab, maftivimab, and odesivimab) Received the US FDA’s Approval as the First Treatment for Ebola

Published: Oct 15, 2020 | Tags: Approval, Atoltivimab, Ebolavirus, Firs,t Inmazeb, Maftivimab, Odesivimab, Receives, Regeneron, Treatment, US FDA

  • The approval is based on the PALM trial assessing Inmazeb vs Zmapp and remdesivir in 681 adult and pediatric patients including newborns of mothers who have tested positive for the infection. The study demonstrated 1EPs of mortality @28days (33.5% vs 51.3%) and 2EPs of reduction in days until the virus was undetectable in the bloodstream
  • As per the agreement signed in Jul’2020, Regeneron will deliver a number of Inmazeb treatment doses for 6yrs. to the BARDA
  • Inmazeb is a triple antibody cocktail consisting of 3 mAbs (atoltivimab, maftivimab & odesivimab, 50 mg each /kg) that bind to different, non-overlapping epitopes on Zaire ebolavirus glycoprotein

Nevakar’s Ephedrine Sulfate Injection Received the US FDA’s Approval as Ready-To-Use Vials

Published: Oct 22, 2020 | Tags: Nevakar, Ephedrine Sulfate, Injection, Receives, US FDA, Approval, Ready to Use, Vials

  • Nevakar received US FDA’s approval to market Ephedrine Sulfate Injection (50mg/10 ml) in a ready to use vial presentation and it is the 1st approval under collaboration bw Nevakar and Endo for the development of sterile injectable product in the US and Canada
  • Nevakar to develop and obtain FDA approval for these products and Par Pharmaceuticals Sterile Products division will launch and distribute the products
  • The company is focused on developing and commercializing innovative products to address unmet medical needs, thereby improving patient care and quality of life

Gilead’s Veklury (remdesivir) Received the US FDA’s Approval as the First Treatment for COVID-19

Published: Oct 23, 2020 | Tags: COVID-19, Gilead, Receives, Remdesivir, US FDA, Approval, Veklury

  • The approval is based on three studies including P-lll ACTT-1 study assessing the efficacy and safety of a 10-day treatment course of Veklury vs PBO in 1063 hospitalized patients with confirmed SARS-CoV-2 infection and mild, moderate or severe COVID-19 receiving the treatment with SOC. The other two studies include two P-II OLE studies (SIMPLE-Severe trial & SIMPLE-Moderate trial)
  • ACTT-1 trial results: improvement in time to recovery in overall study population & in patients who required oxygen (10 vs 15days & 11 vs 18days); reduction in disease progression in patients needing oxygen, reduction in new mechanical ventilation or ECMO (13% vs 23%)
  • Additionally, FDA also issued a new EUA for the use of Veklury to treat hospitalized pediatric patients aged <12yrs. weighing at least 3.5 kg or hospitalized pediatric patients weighing 3.5 kg to <40 kg with suspected or laboratory confirmed COVID-19 for whom use of an IV agent is clinically appropriate. Veklury is now the 1st and only approved COVID-19 treatment in the US

Kala Pharmaceuticals’ Eysuvis (loteprednol etabonate ophthalmic suspension) Received US FDA’s Approval for Dry Eye Disease

Published: Oct 27, 2020 | Tags: Kala Pharmaceuticals, Eysuvis, Loteprednol, Etabonate, Ophthalmic, Suspension, US FDA, Dry Eye Disease

  • The approval is based on results from four clinical trials, including three P-III trials and one P-II trial, that demonstrated significant improvements in both the signs and symptoms of dry eye disease
  • The approval has made Eysuvis, the 1st ocular corticosteroid for the treatment of dry eye disease and the 1st drug approved specifically for the short-term (up to 2 wks.) treatment of the signs and symptoms of dry eye disease
  • Eysuvis utilizes Kala’s Ampplify mucus-penetrating particle (MPP) drug delivery technology to enhance penetration of loteprednol etabonate into target tissue on the ocular surface. The company plans to launch Eysuvis in the US by the end of the year 2020

Chiesi’s Bronchitol (mannitol) Inhalation Powder Received US FDA’s Approval for Cystic Fibrosis

Published: Oct 30, 2020 | Tags: Chiesi, Bronchitol, Mannitol, Inhalation, Powder, Receives, US FDA, Approval, Cystic Fibrosis, Pulmonary

  • In the three large-scale global clinical trials assessing Bronchitol in 761 patients, sustained improvement in FEV1 (Forced Expiratory Volume) with Bronchitol use vs. control group was observed
  • Bronchitol is currently approved and marketed in Australia, Italy, Germany, Russia, and several other countries. Additionally, the company anticipates launching Bronchitol in the US in Mar 2021
  • Bronchitol (mannitol) inhalation powder is a sugar alcohol and also the 1st and only inhaled dry powder indicated as add-on maintenance therapy to improve pulmonary function in CF patients aged 18 yrs. of age and older

Related Post: Insights+: The US FDA New Drug Approvals in September 2020

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Pfizer Launches US Pilot Programme for Delivery and Distribution of COVID-19 Vaccine, BNT162b2

Shots:

  • Pfizer launched a pilot program to support the state’s planning, deployment & administration of the COVID-19 vaccine candidate, to build on coordination with the relevant US agencies
  • Pfizer has been working with US officials in OWS & the US CDC to help ensure that after potential authorization or approval, the Pfizer-bioNtech COVID-19 vaccine can reach those in most need as quickly and equitably as possible
  • The BNT162b2 COVID-19 vaccine is not currently approved for distribution anywhere in the world, both collaborators are committed to developing these novel vaccines with preclinical & clinical data at the forefront of all their decision making

Click here ­to­ read full press release/ article | Ref: Pfizer | Image: Pfizer

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Qiagen Launches Portable Digital SARS-CoV-2 Antigen Test in the US

Shots:

  • Qiagen has initiated the commercialization of the portable digital QIAreach SARS-CoV-2 antigen test in the US that can be used by laboratories to detect active infections in 2-15mins.
  • The test provides a higher throughput testing for SARS-CoV-2 antigen by processing up to 8 tests/ hub. The digital results do not need subjective interpretation and enable Ab tests to run simultaneously with Ag tests
  • QIAreach SARS-CoV-2 Ag test is a fast, digital, and easy to use a test that utilizes sensitive nanoparticle technology and is developed in partnership with Ellume. The company anticipate receiving CE-IVD registration for the EU and other markets by the end of 2020

Click here­ to­ read full press release/ article | Ref: Qiagen | Image: Holland One

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Abbott Launches IonicRF Generator for Patients with Chronic Pain in the US

Shots:

  • Abbott has launched the IonicRF Generator, which is used to deliver a non-surgical, minimally invasive treatment for the management of pain in the nervous system
  • Radiofrequency ablation uses an electric current to heat up a small area of nerve tissue to stop it from sending pain signals. Studies showed that pain relief following a single radiofrequency ablation treatment can last from 6-12mos.
  • The IonicRF generator is the first Abbott-developed radiofrequency ablation device that uses heat to target specific nerves & block pain signals from reaching the brain, currently approved in the US & EU

Click here ­to­ read full press release/ article | Ref: Abbott | Image: Abbott Neuromodulation

The post Abbott Launches IonicRF Generator for Patients with Chronic Pain in the US first appeared on PharmaShots.

Biomarin Reports the US FDA’s Acceptance of Vosoritide’s NDA to Treat Children with Achondroplasia

Shots:

  • The acceptance marks the first marketing application accepted for achondroplasia in the US with an anticipated PDUFA date as of Aug 20, 2021. The US FDA is not planning to hold an advisory committee meeting to discuss the application
  • Additionally, the company is expecting to complete enrollment in a P-II study assessing vosoritide in ~70 infants and young children with achondroplasia, aged 0-<60mos., for 52wks.
  • Vosoritide (qd) is an investigational injection analog of C-type Natriuretic Peptide (CNP) for children with achondroplasia and has received the US FDA’s & EMA’s ODD for the same

Click here to­ read the full press release/ article | Ref: PRNewswire | Image: BioMarin Careers

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US buys Lilly COVID antibody, as effectiveness questions remain

The US government said it will buy 300,000 doses of Eli Lilly’s COVID-19 therapy bamlanivimab for $375 million if the drug gets Emergency Use Authorisation (EUA) – despite the fact its effectiveness has been called into question.

The initial agreement is for delivery over the two months following an EUA, and provides the option for the government to purchase up to an additional 650,000 vials through 30 June 2021.

Lilly filed for emergency use authorisation (EUA) of bamlanivimab for the treatment of recently diagnosed mild to moderate COVID-19 illness in high-risk patients in early October.

The US has said that patients will have no out-of-pocket costs for the medicine – echoing a promise by Lilly CEO Dave Ricks – although healthcare facilities may charge a fee for the product’s administration. 

The federal government, in partnership with state health departments, is developing a government allocation program for bamlanivimab.

Ricks has said that the company “must work with global health systems to ensure equitable access to our medicine at a fair price”.

“Our goal is to ensure that Lilly antibody treatments are available to patients who need them, no matter where they live.

“As long as supply of neutralising antibodies is constrained, we believe the only way to ensure equitable access is for Lilly to contract directly with governments and pan-national philanthropic organisations. These institutions are best positioned to direct our antibody treatments to the patients who need them most.”

He added that treatment allocation will be based on unmet medical needs globally and that  equitable government pricing will be tiered based on a country’s ability to pay.

But the news might be dampened somewhat by this week’s announcement that no more patients will be treated with bamlanivimab in a trial run by the National Institute of Allergy and Infectious Diseases (NIAID), as results to date suggest it is unlikely to be effective.

The ACTIV-3 study was comparing bamlanivimab (also known as LY-CoV555 or LY3819253) and placebo when added to therapy with Gilead Sciences’ Veklury (remdesivir), which is already approved to treat COVID-19 requiring hospitalisation.

According to Lilly, the NIAID took its decision on the strength of trial data  which indicated that bamlanivimab – an antibody that neutralises the SARS-CoV-2 coronavirus – was unlikely to help hospitalised patients recover from advanced-stage COVID-19.

The drugmaker stressed however that other trials of its drug in COVID-19 are still continuing, and it pointed out that the earlier BLAZE-1 study of bamlanivimab showed a reduced rate of hospitalisation in patients treated with the antibody in the outpatient setting.

It also said it “remains confident…that bamlanivimab monotherapy may prevent progression of disease for those earlier in the course of COVID-19.

ACTIV-3 is a substudy of a larger, 10,000-patient trial that is putting a series of COVID-19 drugs through their paces, and Lilly’s drug is the only arm to include an antibody targeting SARS-CoV-2. In each case, 300 patients are enrolled initially before a decision is taken whether to expand the trial to 1,000 subjects.

In a statement, the NIAID said enrolment of patients into the bamlanivimab was paused on 13 October after 326 had been recruited, “out of an abundance of caution”, and terminated on 26 October.

There were no safety issues – the decision was “driven by lack of clinical benefit for LY-CoV555,” according to the agency – and the patients will continue to be followed for 90 days’ follow-up.

The NIAID is also running another study of Lilly’s antibody, ACTIV-2, which involves outpatients with mild-to-moderate COVID-19 symptoms, and that is continuing as planned.

BLAZE-1 is also continuing – looking at bamlanivimab alone and in combination with etesevimab (LY-CoV016) another Lilly antibody targeting SARS-CoV-2 – and the company is also running the BLAZE-2 trial of bamlanivimab as prophylaxis against COVID-19 in nursing home residents and staff.

The post US buys Lilly COVID antibody, as effectiveness questions remain appeared first on .

AstraZeneca Resumes P-III Study of AZD1222 Against COVID-19 in the US

Shots:

  • The US FDA authorizes the restart of the P-III clinical study in the US following the resumption of trials in other countries in recent weeks. The FDA reviewed all safety data from studies globally and concluded it was safe to resume the trial
  • A voluntary pause across all global studies was triggered on Sept 06, 2020, to allow the examination of safety data by independent monitoring committees. AstraZeneca has resumed the clinical trials across the globe with regulators in the US, UK, Brazil, South Africa, and Japan confirming that it was safe to do so
  • While trials are ongoing, AstraZeneca and Oxford University will continue to provide information to regulators, study investigators, and participants according to clinical trial and regulatory standards

Click here ­to­ read full press release/ article | Ref: AstraZeneca | Image: The Indian Express

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Pharma Middle East Virtual Congress (Dec 07 – 08, 2020)

Pharma Middle East Virtual Congress (PPMC2020) layout many new ideas to resolve the most important problems related to the health and wellbeing of humanity. With all the scientific experts and professionals around the world focused on novel trends and advanced strategies emerging in the areas of pharma & chemistry, it provides unique learning and career-building opportunities in your profession to encourage the nascent research that you just can’t find anywhere else.

Conference Central Topics to be discussed:
1. Pharmacy and Pharmaceutical Sciences
2. Pharmaceutics and Novel Drug Delivery Systems
3. Biosimilars and Biopharmaceuticals
4. Pharmaceutical Microbiology and Biotechnology
5. Bioavailability and Bioequivalence
6. Medicinal Chemistry and Drug Discovery
7. Pharmaceutical Chemistry and Drug Design
8. Industrial Pharmacy and Drug Development
9. Pharmacology and Toxicology
10. Clinical Pharmacy and Pharmacy Practice
11. Pharmaceutical Nanotechnology
12. Drug Delivery Technologies and Medical Devices
13. Pharmacovigilance and Regulatory Affairs

Key Speakers of the Event:

Yavuz Selim Silay, Chairman ICG, Turkey

Ahmed Hegazy, Pvigilant Health, UAE

Zareen Delawar Hussain, CEO, Integro Pharma, Bangladesh

Nitin Kaik, Frost & Sullivan, US

To register online visit our website: PPMC Virtual 2020

For 3 or more members group, contact us to avail discounts
Abstract Submission Deadline: November 27, 2020 Participation Confirmation Deadline: December 03, 2020

The post Pharma Middle East Virtual Congress (Dec 07 – 08, 2020) first appeared on PharmaShots.

Purdue to pay $8.3bn after admitting criminal charges in opioid case

After years of legal wrangling, Purdue Pharma has agreed a deal to resolve litigation about its role in the US opioid epidemic that will cost it up to $8.3 billion.

As part of the criminal and civil settlement, the manufacturer of opioid painkiller OxyContin (oxycodone) pleaded guilty to a three-count felony, including two counts of violating anti-kickback laws and one of conspiracy to defraud the US government.

Purdue faces a criminal fine of $3.54 billion, $2 billion in forfeited assets, and $2.8 billion in civil damages to states affected by the opioid crisis, which the Department of Justice said was the largest penalties ever levied against a pharmaceutical manufacturer.

In a related settlement, the billionaire Sackler family that own the company agreed to pay $225 million to resolve civil claims.

There was however opposition to the plea deal even before it was formally announced. Late last week, 38 Democrat lawmakers delivered a letter to US Attorney General William Barr saying it wasn’t right that  the criminal liabilities would be resolved “without a single person serving a day in prison.”

“If the only practical consequence of your Department’s investigation is that a handful of billionaires are made slightly less rich, we fear that the American people will lose faith in the ability of the Department to provide accountability and equal justice under the law,” they wrote.

The DoJ insists the deals don’t release any executives or employees of Purdue or members of the Sackler family from any future criminal liability.

Meanwhile, they are still facing thousands of lawsuits brought by local governments across the US claiming that aggressive marketing of OxyContin fuelled an epidemic in addiction that has claimed hundreds of thousands of lives.

Purdue filed for bankruptcy last year, after it proposed a separate $10 to $12 billion settlement package to resolve those lawsuits.

The DoJ resolution still has to be approved by the bankruptcy court, and one stipulation is that Purdue will stop operating in its current form and emerge from the procedure as a public health organisation functioning “entirely in the public interest,” according to prosecutors.

Another condition is that the Sackler family give up control of Purdue, which is intended to re-emerge after the bankruptcy process with a focus on developing drugs to treat opioid addiction and reverse overdoses that would be provided at very low cost.

In a statement, the drugmaker said the latest agreement brings it closer to the goal of “delivering more than $10 billion in value to address the opioid crisis,” adding that the “overwhelming majority” of the pay-out will be directed to state, local and tribal governments that have been left to deal with the consequences of the epidemic.

Abuse of opioid drugs “remains a significant public health challenge that impacts the lives of men and women across the country,” said Gary Cantrell, deputy inspector general for investigations at the Department of Health and Human Services (DHHS) Office of Inspector General.

“Unfortunately, Purdue’s reckless actions and violation of the law senselessly risked patients’ health and well-being,” he added.

Purdue’s admission of criminal activity centres on its insistence to the US government that it was operating an anti-diversion programme for opioids, when in reality it was continuing to sell them to doctors who were clearly over-prescribing and diverting the drugs between May 2007 and March 2017.

It admitted to bribing two doctors to write more prescriptions of OxyContin as well as other drugs between June 2009 and March 2017.

The Sackler family also released a statement after the news emerged, claiming that the “proposed resolution includes relinquishing our ownership of Purdue and has been valued at $10-$12 billion – more than double all Purdue profits the Sackler family retained since the introduction of OxyContin.”

The family says it will contribute $3 billion to the proposed settlement offered to state, local and tribal governments as well as handing over Purdue itself, but there still seems to be considerable opposition to the package.

Image by Gerd Altmann from Pixabay

The post Purdue to pay $8.3bn after admitting criminal charges in opioid case appeared first on .

AstraZeneca’s Tagrisso (osimertinib) Receives the US FDA’s Priority Review for the Adjuvant Treatment of Patients with Early-Stage EGFR-Mutated Lung Cancer

Shots:

  • AstraZeneca’s Tagrisso has received sNDA’s acceptance and has been granted PR in the US for the adjuvant treatment of patients with early-stage (IB, II, and IIIA) EGFRm NSCLC after complete tumor resection with curative intent
  • The sNDA is based on the P-III ADAURA trial assessing Tagrisso (80mg, qd, PO) vs PBO for 3yrs. or until disease recurrence in the adjuvant treatment of 682 patients with stage IB, II, IIIA EGFRm NSCLC following complete tumour resection & adjuvant CT as indicated. Unprecedented results showed reduction in the risk of disease recurrence or death by 80% and improvement in DFS
  • Tagrisso is an irreversible EGFR-TKI with clinical activity against CNS metastases with its expected PDUFA date in Q1’21

Click here ­to­ read full press release/ article | Ref: AstraZeneca | Image: The Print

The post AstraZeneca’s Tagrisso (osimertinib) Receives the US FDA’s Priority Review for the Adjuvant Treatment of Patients with Early-Stage EGFR-Mutated Lung Cancer first appeared on PharmaShots.

Eli Lilly Seeks the US FDA’s EUA for its COVID-19 Antibody Treatment

Shots:

  • Eli Lilly reports additional data on its SARS-CoV-2 neutralizing Ab programs including interim data on combination therapy in diagnosed patients with mild-to-mod. COVID-19 and plans to make therapies available to patients
  • The new analysis P-II BLAZE-1 study assessing LY-CoV555 (2800mg) + LY-CoV016 (2800mg) vs PBO demonstrated reduced viral [email protected] meeting its 1EPs, reduction in symptoms and COVID-related hospitalization and ER visits
  • Based on the combination regimen data, along with the previous findings for LY-CoV555, Lilly has submitted the initial EUA for LY-CoV555 monothx. and plans to initiate a large open-label pragmatic study in COVID-19 outpatients in Oct’2020. Additionally, Lilly anticipates the data supporting BLA submission for dual regimen as early as Q2’21

Click here ­to­ read full press release/ article | Ref: Eli Lilly | Image: GMP News

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Taysha Gene Therapies’ TSHA-101 Receives the US FDA’s Orphan Drug Designation and Rare Pediatric Disease Designation for GM2 Gangliosidosis

Shots:

  • The US FDA has granted ODD and RPD to the Taysha Gene Therapies’ TSHA-101 for GM2 Gangliosidosis. The company expects the therapy to enter the clinic by the end of 2020
  • The US FDA’s two designations demonstrated the strength of the translational data package supporting TSHA-101 for GM2 Gangliosidosis
  • TSHA-101 is an AAV9-based gene therapy, currently under development for rare, neurodegenerative disease that causes a progressive dysfunction of the CNS

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: Nordic Life Science

Galecto’s GB0139 Receives the US FDA’s and EMA’s Orphan Drug Designations for Idiopathic Pulmonary Fibrosis

Shots:

  • The US FDA and EMA has received ODD to Galecto’s GB0139 for the treatment of IPF. GB0139 showed significant reduction of YKL-40 biomarker in fibrosis, inflammation, tissue remodeling diseases in its first clinical study after 14 days of treatment
  • The EMA cited GB0139’s clinically relevant biomarker data in IPF patients which provides financial incentives, encouraging the development of drugs targeting rare diseases
  • GB0139 (formerly TD139) is an inhaled galectin-3 inhibitor, being evaluated in P-IIb GALACTIC-1 study in 450 patients with IP across 100 centers in the US the EU and Canada

Click here, ­to­ read full press release/ article | Ref: PRNewswire | Image: Galecto

Abbott’s BinaxNOW COVID-19 Ag Card Receives the US FDA’s EUA to Detect SARS-CoV-2 Infection

Shots:

  • The US FDA has issued EUA for Abbott’s BinaxNOW COVID-19 Ag Card rapid test for the detection of COVID-19. The test will be available at $5 and can deliver results in 15mins.
  • The test utilizes lateral flow technology and has demonstrated a sensitivity of 97.1% and specificity of 98.5% in a clinical study. Additionally, the company has launched the complementary phone app (NAVICA), allowing people to display their BinaxNOW test results in any organizations where people gather like workplaces and schools
  • The BinaxNOW COVID-19 Ag Card can be used as a 1L of defense to identify infected people. The company anticipates shipping of ~10M tests in Sept, ramping to 50M tests/ month at the beginning of Oct’2020

Click here ­to­ read full press release/ article | Ref: Abbott | Image: Alere

Philips and B. Braun’s Onvision Needle Tip Tracking Technology Receive the US FDA’s 510 (k) Clearance for Regional Anesthesia

Shots:

  • Onvision needle tip tracking technology will be exclusively available on the latest version of the B. Braun and Philips’ Xperius ultrasound system together with the Stimuplex Onvision needle, empowering anesthesiologists to embrace regional anesthesia as a viable and effective alternative to general anesthesia.
  • It allows anesthesiologists the confidence to accurately position the needle tip inside the body for PNBs and helps the user to align the needle with the probe in a user-friendly interface leading to a reduction in procedural time
  • Onvision needle tip tracking technology indicates the position of the needle tip in relation to the ultrasound viewing plane to an accuracy of 3mm and is expected to be available in the US in Q4’20. The solution is CE marked and is available for sale across the EU and Chile

Click here ­to­ read full press release/ article | Ref: Philips | Image: StraitTimes

Teva charged in US price-fixing investigation

The US Department of Justice has charged Teva with conspiring with other pharma companies to fix prices for generic drugs.

According to an indictment filed on Tuesday, the company participated in three counts of conspiracy from at least May 2013 until around December 2015, which could have resulted in customers being overcharged by at least $350 million.

The Department alleges that Teva conspired with companies including Sandoz, Glenmark Pharmaceuticals, Apotex and Taro USA to increase prices, rig bids, and allocate customers for generic drugs including medicines for arthritis, brain cancer, cystic fibrosis, seizures, pain, skin conditions, and blood clots, as well as the cholesterol medicine pravastatin.

Sandoz, Apotex and Taro USA have admitted to their roles in these conspiracies and agreed to pay fines. Glenmark is awaiting trial.

Four pharma company executives have also been charged, three of whom have entered guilty pleas. The fourth, Apotex’s former executive Ara Aprahamian, is awaiting trial.

Each of the charged offenses carry a statutory maximum penalty of $100 million for companies, but the maximum fine may be increased to twice the gain derived from the crime or twice the loss suffered by the victims if either amount is greater than $100 million.

“Today’s charge reaffirms that no company is too big to be prosecuted for its role in conspiracies that led to substantially higher prices for generic drugs relied on by millions of Americans,” said assistant attorney general Makan Delrahim of the Department of Justice’s Antitrust Division.

“The division will continue to work closely with our law enforcement partners to ensure that companies that blatantly cheat consumers of the benefits of free markets are prosecuted to the full extent of the law.”

In a statement Teva said it was “deeply disappointed” that the government had chosen to proceed with this prosecution.

“The Company has been investigating this matter for over four years and has concluded that Teva did not participate in price fixing,” it said. “Based on our internal review, Teva firmly rejects the allegations and will vigorously defend the Company in court.

“Teva has fully cooperated throughout the course of the Department of Justice (DOJ) investigation and has attempted to reach a resolution in the best interest of the Company, its stakeholders and the patients the company serves. The DOJ has shown an unwillingness to consider alternatives that would not deeply impact Teva and the stakeholders who depend on the Company, including the patients who benefit from our medicines.”

The post Teva charged in US price-fixing investigation appeared first on .

BioMarin Reports NDA Submission to the US FDA for Vosoritide to Treat Children with Achondroplasia

Shots:

  • BioMarin has submitted an NDA to the US FDA for vosoritide to treat children with achondroplasia
  • The company also reported that EMA has begun validation of MAA for the therapy on 13 Aug, 2020
  • Vosoritide is an investigational, once-daily injection analog of C-type Natriuretic Peptide (CNP) and is potentially the first treatment for achondroplasia in the US

Click here ­to­ read full press release/ article | Ref: Biomarin | Image: Fierce Biotech

The US FDA Approves Kyprolis (carfilzomib) + Darzalex (daratumumab) + Dexamethasone in Two Dosing Regimens for R/R Multiple Myeloma

Shots:

  • The US FDA has approved Janssen’s Darzalex + Amgen’s Kyprolis (carfilzomib) and dexamethasone (DKd)  in two dosing regimen (70 mg/m2 , qw and 56 mg/m2 , q2w) for the treatment of adult patients with r/r MM who have received 1-3L therapies
  • The approval of q2w dosing regimen is based on P-III CANDOR study assessing DKd (q2w) vs Kd in 466 patients with r/r MM and has met its 1EPs of PFS after a median follow-up of 16.9 & 16.3 mos. respectively
  • The inclusion of carfilzomib (qw) as an approved DKd regimen is based P-Ib EQUULEUS study assessing Darzalex in combination with multiple treatment regimens. Carfilzomib (qw) was evaluated with a starting dose of 20 mg/m2, which was increased to 70 mg/m2 on Cycle 1, Day 8 and onward

Source 1, Source 2 ­to­ read full press release/ article | Ref: Janssen, Amgen  | Image: Revlimid

Novartis’ Kesimpta (ofatumumab) Receives the US FDA’s Approval as the First Self-Administered Therapy for Relapsing Multiple Sclerosis

Shots:

  • The approval is based on P-III ASCLEPIOS I & II studies assessing Kesimpta (20mg, monthly, SC) vs teriflunomide (14mg, qd) in 1,882 patients aged 18-55yrs. with RMS with an EDSS b/w 0 and 5.5 across 37 countries. Additionally, P-II APLIOS study determine the bioequivalence of subcutaneous delivery of Kesimpta via a prefilled syringe and a Sensoready pen in patients with RMS
  • ASCLEPIOS I & II studies results: reduction in ARR 51% & 59% (0.11 vs 0.22) & (0.10 vs 0.25), 34% reduction in 3mos CDP, reduction in number of Gd+ T1 (98% & 94%) and new/ enlarging T2 lesions (82% & 85%) respectively
  • In a post hoc analysis, Kesimpta may halt new disease activity in RMS with 47.0% & 7.8% of patients achieved (NEDA-3) within (0–12mos.) and (12–24 mos.) of treatment, respectively. The therapy is expected to be available in the US in early Sept’2020 along with its anticipated EU approval in Q2’21

Click here ­to­ read full press release/ article | Ref: Novartis | Image: KRCU

G1 Therapeutics Reports the US FDA Acceptance and Priority Review of NDA for Trilaciclib to Treat SCLC

Shots:

  • The NDA submission is based on three clinical studies in which Trilaciclib was administered prior to chemotherapy treatment in patients with SCLC and has demonstrated robust myelopreservation benefits. The company anticipates the PDUFA date as Feb 15, 2021
  • G1 is making Trilaciclib available to SCLC patients in the US, who are unable to enter clinical trials while the NDA for the therapy is under regulatory review, pursuant to FDA’s EAP
  • Trilaciclib is an investigational therapy designed to preserve bone marrow and immune system function during CT and improve patient outcomes and has received the US FDA’s BT designation in 2019

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: Outlook India

AstraZeneca’s Imfinzi (durvalumab) Receives the US FDA’s Priority Review for Less Frequent Fixed-Dose Use in NSCLC and Bladder Cancer

Shots:

  • The US FDA has accepted sBLA and granted PR to Imfinzi (1500mg) for a new 4wks. FD regimen to treat patients with unresectable Stage III NSCLC after CT and prior treated advanced bladder cancer, consistent with the approved dosing in ES-SCLC
  • The company anticipates the PDUFA date in Q4’20. The sBLA is based on multiple clinical trials, including results of P-III CASPIAN trial in ES-SCLC which used the 4wks., FD regimen during maintenance
  • If approved, the new dosing will be available as an alternative to the approved weight-based dosing of 10mg/kg q2w

Click here ­to­ read full press release/ article | Ref: AstraZeneca | Image: Fierce Pharma

Related News: AstraZeneca Reports Results of Imfinzi + Tremelimumab in P-III CASPIAN Study as 1L Treatment for Extensive-Stage Small Cell Lung Cancer

Roche’s Enspryng (satralizumab-mwge) Receives the US FDA’s Approval for Neuromyelitis Optica Spectrum Disorder

Shots:

  • The approval is supported by P-III SAkuraStar and SAkuraSky studies involve assessing Enspryng (120mg, SC, q4w) as a monothx. & as an add-on therapy to baseline IST vs PBO in 95 & 83 patients aged 20-70 &  13-73yrs. in a ratio (2:1) & (1:1) administered at week 0,2 & 4 in patients with NMOSD respectively
  • The studies demonstrated robust efficacy and a favorable safety profile in adults with AQP4 Ab positive NMOSD. relapse-free patients @96wks. (76.5% & 91.1% vs 41.1% & 56.8%)
  • Enspryng is the first and only FDA-approved SC treatment option for AQP4 Ab positive NMOSD that can be self-administered by a patient or a caregiver every four weeks. The therapy is mAb targeting IL-6 that utilizes recycling antibody technology and will be available in the US in two wks.

Click here ­to­ read full press release/ article | Ref: Roche | Image: HKU E-Learning Platform

Related Post: Roche’s Enspryng (satralizumab) Receives MHLW’s Approval for Neuromyelitis Optica Spectrum Disorder in Japan

Roche Reports the US FDA’s Acceptance of sBLA for Xolair (omalizumab) Prefilled Syringe for Self-Administration Across All Indications

Shots:

  • The US FDA has accepted the sBLA for a new self-administration option for Xolair across all approved indications in the US. The company anticipates the approval of the therapy in Q1’21
  • The acceptance is based on the efficacy and safety profile of Xolair in allergic asthma and chronic idiopathic urticaria (CIA)
  • If approved, Xolair’s prefilled syringe will become available for either self-administration by select patients or administration by their caregivers.  Genentech and Novartis work together to develop and co-promote Xolair in the US

Click here ­to­ read full press release/ article | Ref: Roche | Image: Pinterest

Regeneron Reports the US FDA’s Acceptance of Evinacumab’s BLA for Priority Review as a Treatment for Patients with HoFH

Shots:

  • The BLA is based on P-III study evaluating the efficacy and safety of evinacumab (15 mg/kg, IV, q4w) in 65 patients aged ≥12yrs. with HoFH. The 1EPs of the study is reduction of LDL-C from baseline
  • The expected PDUFA date for the therapy as Feb 11, 2021. The US FDA has granted BT designation to the therapy for the treatment of hypercholesterolemia in patients with HoFH in 2017
  • Evinacumab is an investigational mAb that binds to and blocks the function of ANGPTL3 and is currently being studied in patients with HoFH (ongoing P-III extension trial), refractory hypercholesterolemia (P-II) and severe hypertriglyceridemia (P-II)

Click here to­ read full press release/ article | Ref: Regeneron  | Image: CNN

Anger at US deal for Moderna’s ‘taxpayer-funded’ COVID-19 vaccine

The US government has signed another big coronavirus vaccine supply deal, snapping up 100 million doses of Moderna’s mRNA jab for a little over $1.5 billion –around $15 per dose or $30 per course.

That’s a steep discount on the $32 to $37 price per dose in its earlier smaller deals, revealing that purchasing power will be a big factor as supplies of COVID-19 vaccines become available – and also that countries with deep pockets will be at the front of the queue.

Nevertheless, consumer advocacy group Public Citizen has slammed the amount Moderna is charging the US for the mRNA-1273 vaccine, saying that as taxpayer money had funded 100% of the work done to bring it to market the US is “paying twice” for the shot.

“When the president bragged on the campaign trail about his deal-making prowess, this isn’t what people had in mind,” said the organisation.

“It is absurd that Trump and [Health and Human Services Secretary Alex Azar] are touting $30 per course as a good deal for the American people, in light of the consistent and ongoing support from the US government towards mRNA-1273 research, development and manufacturing.”

The $1.525 billion order includes $300 million in incentive payments for swift delivery, in other words if the vaccine is approved for marketing or gets an emergency-use green light on or before 31 January next year.

It takes the total amount allocated to the vaccine by the US government to $2.48 billion, including $955 million previously awarded to Moderna to fund clinical development and manufacturing of mRNA-1273.

The shot is in a phase 3 trial called COVE which started last month with the help of the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).

Moderna has previously said it is on track to deliver up to 500 million doses per year, and possibly up to a billion doses per year beginning in 2021, thanks to a manufacturing collaboration with Lonza.

The company also has a large-scale fill and finish contract with Catalent’s biologics facility in Indiana, following $1.3 billion in funding from investors in a public equity offering in May.

Shares in Moderna spiked up around 5% on the announcement, but fell back just as quickly to end the day only fractionally up.

Analysts said the US deal could lead to others being signed quickly as other countries try to snap up available stocks, once again raising fears of “vaccine nationalism” that will leave lower-income countries at the back of the queue when it comes to access.

The US government previously signed deals – all for 100 million doses – of a vaccine from Pfizer/BioNTech at a cost of $39 per course, $21 per dose for a Sanofi/GlaxoSmithKline shot, and $10 per dose for a Johnson & Johnson candidate.

It also has deals in place to supply vaccines from Novavax and AstraZeneca/University of Oxford for 100 million doses at $16 and 300 million doses at $4, respectively.

“The Trump Administration is increasing the likelihood that the US will have at least one safe, effective vaccine by 2021,” said Azar in a statement.

The post Anger at US deal for Moderna’s ‘taxpayer-funded’ COVID-19 vaccine appeared first on .

Gilead Reports NDA Submission to the US FDA for Veklury (Remdesivir) to Treat COVID-19

Shots:

  • The NDA filing is based on P-III studies evaluating Veklury vs PBO, conducted by NIAID. The studies demonstrated that Veklury led to faster time to recovery and that a 5-day or 10-day treatment duration led to similar clinical improvement
  • Across multiple studies, Veklury was generally well-tolerated in both the 5-day and 10-day treatment groups, with no new safety signals identified
  • Veklury (remdesivir) is an investigational nucleotide analog with broad-spectrum antiviral activity both in vitro/ in vivo in animal models against multiple emerging viral pathogens. The therapy has been approved by multiple regulatory authorities across the globe, including the EU and Japan

Click here ­to­ read full press release/ article | Ref: Gilead  | Image: The Wire Science

The US FDA Approves Guardant360 CDx as the First Liquid Biopsy NGS Assay to Identify EGFR Mutations in Non-Small Cell Lung Cancer

Shots:

  • The FDA has approved Guardant360 CDx as a liquid biopsy companion diagnostic that uses NGS to identify EGFR mutations in patients with metastatic NSCLC
  • The assay utilizes two technologies- i) liquid biopsy that uses a blood sample to provide HCPs with genetic information about the patient’s tumor and ii) NGS that uses large-panel genetic sequencing, allowing clinicians to better assess tumor composition
  • Today’s approval is specific to its use in identifying NSCLC patients with EGFR alterations who may benefit from AstraZeneca’s Tagrisso. The assay has also received FDA’s breakthrough device designation

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: Medpage Today

Roche’s Evrysdi (risdiplam) Receives the US FDA’s Approval for SMA in Adults and Children

Shots:

  • The US FDA has approved Evrysdi to treat SMA in adults and children ≥ 2mos. The approval is based on two clinical studies designed to represent a broad spectrum of people living with SMA: FIREFISH in symptomatic infants aged 2-7 mos, and SUNFISH in children and adults aged 2-25yrs.
  • The two studies demonstrated improvements in motor function in people with varying ages and levels of disease severity, including Types 1, 2, and 3 SMA. The filing of MAA to EMA for the therapy is imminent while the therapy has been filed in Brazil, Chile, China, Indonesia, Russia, South Korea, and Taiwan
  • Roche leads the clinical development of Evrysdi as part of a collaboration with the SMA Foundation and PTC Therapeutics and is the only therapy for SMA that can be taken at home. It will be available in the US within 2wks. for direct delivery to patients’ homes through Accredo Health Group

Click here ­to­ read full press release/ article | Ref: Roche | Image: PharmaShots

Vela Diagnostics’ ViroKey SARS-CoV-2 RT-PCR Test Receives the US FDA’s Emergency Use Authorization

Shots:

  • The US FDA has granted EUA to the Vela’s PCR test that detects SARS-CoV-2 in nasopharyngeal and oropharyngeal swabs
  • The manual version of the ViroKey enables flexible sample processing and quick adoption of the test by laboratories with existing ABI 7500 Fast Dx instruments but for high throughput testing, an automated version of the assay is used for the optimization  of a workflow consisting of the Sentosa SX101 instrument, in conjunction with ABI 7500 Fast Dx PCR instrument or the Sentosa SA201 instrument
  • ViroKey SARS-CoV-2 RT-PCR Test has also received the CE mark and provisional approval from the Singapore Health Sciences Authority

Click here ­to­ read full press release/ article | Ref: Vela Diagnostic | Image: Biospectrum Asia




Johnson & Johnson Signs an Agreement with the US Government to Supply 100M Doses of COVID-19 Vaccine Worth ~$1B

Shots:

  • The US government will pay over $1B for 100M doses of its potential COVID-19 vaccine, Ad26.COV2.S, for use in the US following the US FDA’s EUA
  • The government may also purchase additional 200M doses of Ad26.COV2.S under a subsequent agreement. The company is evaluating one- and two-dose regimens, in its clinical program for the global access of the vaccines
  • J&J expects to meet its goal to supply 1B doses globally through the course of 2021, provided the vaccine is safe and effective. The vaccine will be provided at a global not-for-profit basis for emergency pandemic use

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: PharmaShots

Related News: Johnson & Johnson Initiates P-I/IIa Study of its Ad26.COV2.S Against COVID-19 in the US and Belgium




Teva and Alvotech Collaborate to Commercialize Five Biosimilar Candidates in the US

Shots:

  • Alvotech will lead the development, registration, and supply of the biosimilars, while Teva will be exclusively commercializing the products in the US. Alvotech will receive upfront with subsequent milestone payments over the next several years
  • The companies will share the profit from the commercialization of the biosimilars. The collaboration leverages Teva’s commercial presence and extensive infrastructure in the US along with Alvotech’s experience and state-of-the-art biologics manufacturing
  • The collaboration will improve patient access for high-quality biosimilar medicines in the US

Click here ­to­ read full press release/ article | Ref: Teva | Image: PharmaShots




Roche’s cobas Epstein-Barr Virus Test Receives the US FDA’s Authorization for Transplant Patients

Shots:

  • The US FDA has granted de novo class II for cobas EBV test, providing HCPs a tool for monitoring transplant patients at risk for complications from infections or reactivations of EBV
  • The cobas EBV test is a PCR viral load test that runs on the fully automated and widely available cobas 6800/8800 systems and has been calibrated to WHO’s international standard
  • The test has received the FDA’s BDD and has robust coverage with a limit of detection of 18.8 IU/mL and an expanded linear range from 35 IU/mL-1E+08 IU/mL in EDTA plasma

Click here ­to­ read full press release/ article | Ref: Roche | Image: Fedaiisf




LEO Pharma Receives the US FDA’s Fast Track Designation for Delgocitinib Cream to Treat Moderate-to-Severe Chronic Hand Eczema

Shots:

  • The US FDA has granted FT designation to LEO’s delgocitinib cream as the potential treatment for adults with moderate-to-severe CHE. There are currently no treatment options available in the US specifically developed and approved for CHE
  • The FDA’s FT designation facilitates the development and expedites the regulatory review of drugs to treat serious conditions and demonstrate the potential to address an unmet medical need
  • Delgocitinib (bid, topical formulation) acts by inhibiting the activation of the JAK-STAT pathway, currently being evaluated in two P-IIb studies for mild-to-severe CHE & AD. The company plans to submit the results of P-IIb CHE study in late 2020

Click here ­to­ read full press release/ article | Ref: LEO Pharma | Image: LEO Pharma




Sanofi and GSK Receive $2.1B from the US Government to Supply 100M Doses of COVID-19 Vaccine

Shots:

  • The US government will provide ~$2.1B to support the development of the vaccine, including clinical trials with some amount to be used for ramping up the manufacturing and delivery of an initial 100M dose of the vaccine
  • The US government has an option to supply an additional 500M dose and helps the government’s Operation Warp Speed goals for providing millions of doses of a safe and effective COVID-19 vaccine
  • Additionally, the companies are in discussion with the EC for the supply of up to 300M doses of a COVID-19 vaccine. Both the companies are committed to making their COVID-19 vaccine affordable and available globally

Click here, Click here ­to­ read full press release/ article | Ref: GSK, GSK | Image: WorldPharma Today

Related News: Sanofi and GSK Sign an Agreement with the UK Government to Supply ~60M Doses of COVID-19 Vaccine




Johnson & Johnson Initiates P-I/IIa Study of its Ad26.COV2.S Against COVID-19 in the US and Belgium

Shots:

  • J&J’s Ad26 vector-based vaccine demonstrated robust immune response in the pre-clinical study by neutralizing Abs, preventing infection and provide complete/ near-complete protection in the lungs from the virus in NHPs
  • Based on the preclinical studies, the company has commenced the P-I/IIa study of Ad26.COV2.S, in healthy volunteers in the US and Belgium with expected initiation of P-III study in Sept’2020. The P-I/IIa study will evaluate the safety, reactogenicity, and immunogenicity of Ad26.COV2.S in ~1,000 healthy adults aged 18-55yrs. and 65+ yrs.
  • Additionally, the company is planning to initiate P-III clinical trial program, will evaluate both one/two-dose regimens of Ad26.COV2.S initiate in parallel studies while the P-IIa study in the Netherlands, Spain, and Germany and a P-I study in Japan in underway

Click here ­to­ read full press release/ article | Ref: Johnson & Johnson | Image: StraitTimes




Roche Receives the US FDA’s Approval for VENTANA HER2 Dual ISH Test as CDx to Identify Breast Cancer

Shots:

  • The US FDA has approved the new VENTANA HER2 Dual ISH DNA Probe Cocktail assay to detect HER2 biomarker in BC and as a CDx for Herceptin (trastuzumab) therapy. The assay was launched as a CE IVD in Apr’2019
  • The assay is designed to be completed within the same day, enabling clinicians to get results back faster than with other common methods of confirmatory testing for HER2
  • The assay is optimized for use with the VENTANA Silver ISH DNP detection kit and the VENTANA Red ISH DIG detection kit on the fully automated BenchMark ULTRA and is the enhanced version of the previous-generation test

Click here ­to­ read full press release/ article | Ref: Roche | Image: StraitTimes




Takeda’s Pevonedistat Receives the US FDA’s Breakthrough Therapy Designation to Treat Patients with Higher-Risk Myelodysplastic Syndrome

Shots:

  • The BT designation is based on the final analysis of the Pevonedistat-2001 P-II study assessing pevonedistat + azacitidine vs azacitidine as monothx. in patients with rare leukemias, including HR-MDS
  • The 1EPs of the study include OS, EFS, CR and transfusion independence, and AE profile. The designation addresses the needs of people living with HR-MDS, for whom few therapies exist, and the benefits are limited
  • Pevonedistat is a first in class NEDD8-activating enzyme (NAE) inhibitor. The pre-clinical studies demonstrated the inhibition of NAE, blocked the modification of select proteins, which resulted in the disruption of cell cycle progression and cell survival, leading to cancer cell death

Click here ­to­ read full press release/ article | Ref: Takeda | Image: Future Medicine India




Roche’s Tecentriq + Cotellic and Zelboraf Receives the US FDA’s Approval for Patients with Advanced Melanoma

Shots:

  • The approval is based on P-III IMspire150 study assessing Tecentriq (atezolizumab) + Cotellic  (cobimetinib) + Zelboraf (vemurafenib) vs  PBO + Cotellic +   Zelboraf in patients with BRAF V600 mutation-positive advanced melanoma
  • Results: mPFS (15.1 vs 10.6mos.); the safety profile of the Tecentriq combination was consistent with the known safety profiles of the individual medicines. The review was conducted under Project Orbis
  • Tecentriq is a mAb targeting PD-L1, acts by blocking is its interactions with both PD-1 and B7.1 receptor. Cotellic is a MEK1/2 inhibitor in a cell signaling pathway that helps control cell growth and survival while Zelboraf is a prescription medicine for melanoma that has spread to other parts of the body or cannot be removed by surgery and has a BRAF V600 mutation

Click here ­to­ read full press release/ article | Ref: Roche | Image: StraitTimes




Merck’s MK-6482 Receives the US FDA’s Breakthrough Therapy Designation to Treat Patients With Von Hippel-Lindau Disease-Associated Renal Cell Carcinoma

Shots:

  • The designation is based on P-II study evaluating MK-6482 in patients with VHL-associated RCC with nonmetastatic RCC tumors >3cms in size, unless immediate surgery is required
  • The FDA’s BT designation is granted to expedite the development and review of medicines that are intended to treat serious or life-threatening conditions and have demonstrated preliminary clinical evidence indicating that the medicine may provide a substantial improvement over available therapy on at least one clinically significant endpoint
  • MK-6482 (formerly PT2977) is an investigational oral HIF-2α inhibitor, currently being evaluated in a P-III  trial in advanced RCC (NCT04195750), a P-II trial in VHL-associated RCC (NCT03401788), and a P-I/II dose-escalation and dose-expansion trial in advanced solid tumors, including advanced RCC (NCT02974738)

Click here ­to­ read full press release/ article | Ref: Merck | Image: Market Watch




Zebra Medical Receives the US FDA’s Approval for its HealthMammo Mammography Tool

Shots:

  • The US FDA has granted 510 (k) clearance to HealthMammo for boosting early detection of breast cancer in mammograms
  • The tool utilizes the AI to prioritize and identify suspicious mammograms and is automatically sent to Zebra’s platform, where it gets processed and analyzed for suspected breast lesions. The HealthMammo product then returns its result to the radiologist
  • Zebra Medical’s HealthMammo may help radiologists deal with the screening management strategy of the post COVID backlog and triaging. The tool is the first solution for oncology to receive FDA clearance, as part of the company’s AI1 “All-In-One” bundle

Click here ­to­ read full press release/ article | Ref: Business wire | Image: Business wire




After final $600M opioid settlement, Indivior looks to the future

UK drugmaker Indivior looks finally to have put years of uncertainty over its exposure to opioid litigation in the US behind it, after agreeing a $600 million settlement.

The deal resolves criminal and civil liabilities faced by the company related to charges it engaged in an illicit nationwide scheme to increase prescriptions of opioid addiction drug Suboxone Film (buprenorphine/naloxone).

It follows a guilty plea by former chief executive Shaun Thaxter last month, and a $1.4 billion settlement agreed with its former parent company Reckitt Benckiser last year.

There had been speculation after the indictment in the case in April 2019 that it could bankrupt the company, wiping three quarters of the value off its share price, but the stock has firmed since and rocketed 38% after the settlement was announced, with further gains today.

Under the terms of the agreement, the Department of Justice will move to dismiss all charges returned by the jury in the lawsuit, according to Indivior.

“We believe the agreement provides greater certainty for all Indivior stakeholders, including the patients around the world who are prescribed our medicines,” said new CEO Mark Crossley and interim chair Daniel Tassé in a statement.

An Indivior subsidiary – Indivior Solutions – pleaded guilty on Friday to one felony count in connection with making false statements to promote the Suboxone Film to the Massachusetts Medicaid programme, namely that the product had a lower risk of children taking the drug by accident.

As a result, MassHealth agreed to provide access to Suboxone Film for patients with children under the age of six.

The settlement includes a $100 million payment as soon as it gets the go-ahead from a judge, plus six annual payments of $50 million between 2022 and 2027. The final balance will be due in December 2027.

Indivior also has to disband its Suboxone sales force and remove medical providers from its promotional programmes who pose a high risk of inappropriate prescribing.

The actions “hold accountable entities and individuals that unlawfully marketed opioid-addiction products,” said principal deputy associate attorney general Claire Murray.

“When a drug manufacturer claims to be part of a solution for opioid addicts, we expect honesty and candour to government officials, as well as to the physicians and patients making important treatment decisions based on those representations,” she added.

The settlement comes after a difficult couple of years for Indivior in which it also suffered a major defeat in the US courts over patent protection for Suboxone Film, opening the door to early generic competition for the drug – which accounts for most of its sales.

It is trying to compensate with the launch of new products such as long-acting schizophrenia therapy Perseris (risperidone), but sales of that product have been modest so far at just $3 million in the first three months of 2020.

It also sells another buprenorphine-based opioid withdrawal product called Sublocade in the US, and recently claimed approval for the drug as Subutex in Sweden, its first European market.

“The incident to which the agreement relates occurred well in the past and does not reflect the values Indivior has strived to demonstrate and uphold during our long history of partnering with healthcare providers, policymakers, and communities to fight the opioid crisis,” said Crossley.

The post After final $600M opioid settlement, Indivior looks to the future appeared first on .

Kite’s Tecartus (brexucabtagene autoleucel) Receives the US FDA’s Approval as the First Cell-Based Gene Therapy for Relapsed or Refractory MCL

Shots:

  • The accelerated approval follows FDA’s PR and BT designation and is based on ZUMA-2 study assessing Tecartus (formerly KTE-X19) in 74 patients with r/r MCL prior treated with  anthracycline/ bendamustine-containing CT, an anti-CD20 Ab therapy and a BTK inhibitor (ibrutinib or acalabrutinib)
  • Results: 87% patients responded to Tecartus (single infusion), including 62 % patients achieved CR, 18% experienced Grade 3 or higher CRS and 37% experienced Grade 3 or higher neurologic toxicities
  • Tecartus is an autologous, anti-CD19 CAR T cell therapy, currently under EC review and has received EMA’s PRIME designation for r/r MCL. The therapy will be manufactured in Kite’s commercial manufacturing facility in El Segundo, California

Click here to read full press release/ article | Ref: Kite | Image:  Stat News




AstraZeneca’s Breztri Aerosphere Receives the US FDA’s Approval for the Maintenance Treatment of COPD

Shots:

  • The approval is based on P-III ETHOS study assessing of Breztri Aerosphere (budesonide/glycopyrronium/formoterol fumarate) vs dual therapies [Bevespi Aerosphere (glycopyrronium/formoterol fumarate) and PT009 (budesonide/formoterol fumarate)] with mod. to sev. COPD and a history of exacerbation(s) in the previous year
  • The P-III ETHOS study demonstrated a reduction in the rate of moderate or severe exacerbations. Additionally, the P-III KRONOS study also support the approval of the therapy
  • Breztri Aerosphere is an approved therapy in Japan and China for patients with COPD and is under regulatory review in the EU. As per the agreement to acquire Pearl Therapeutics, AstraZeneca paid $150M as a milestone on US approval of the therapy for COPD

Click here to read full press release/ article | Ref: AstraZeneca | Image: 

Related News: AstraZeneca Reports Results of Breztri Aerosphere in P-III ETHOS Study to Treat COPD




Abbott’s IOS-Compatible App Receives the US FDA’s Approval for Patients with Neurological Disorder

Shots:

  • The US FDA approves Abbott’s patient controller app for use on Apple’s smartphone devices, allowing patients with neurological conditions such as chronic pain or movement disorders to manage their therapy directly from their smartphone
  • The company plans to integrate the app into Abbott’s NeuroSphere Digital Care, launched in May’2020 which is compatible with Infinity DBS System for patients with PD or essential tremor, Proclaim XR SCS system and Proclaim DRG Neurostimulation system for patients with chronic pain and chronic pain in the lower limbs caused by complex regional pain syndrome or causalgia respectively
  • The integration across all Abbott neuromodulation technologies allows physicians to treat patients more easily within their practice who have an Abbott device and Apple smartphone. The patient controller app with personalized access to therapy will be available imminently

Click here to read full press release/ article | Ref: Abbott | Image: Twaku




US places $1.95 billion order for Pfizer/BioNTech’s COVID-19 vaccine

The US government has agreed to pay Pfizer and BioNTech $1.95 billion to secure access to 100 million doses of their coronavirus vaccine on approval, just days after promising results in a clinical trial.

The deal – part of the Trump administration’s Operation Warp Speed that aims to deliver 300 million coronavirus vaccines in early 2021 – has ignited fears of “vaccine nationalism” – wealthy nations buying up potential COVID-19 vaccines and restricting available supplies to countries without the same spending power. 

Last month, for example, hackles were raised after the US acquired most of the global supply of Gilead’s COVID-19 drug remdesivir until September, and there are concerns that vaccines will follow a similar path.

Along with the initial order for 100 million doses of BNT162, the federal government has also agreed a facility to acquire another 500 million, and says it will make them available for free to US citizens.

It is the largest deal to be signed under Warp Speed, and comes after the UK placed an order for 30 million doses of BNT162 for delivery this year and next.

Pfizer and BioNTech said in May they expected to have capacity to make “millions” of doses of the shot in 2020, rising to “hundreds of millions” next year, so at face value the UK and US orders seem to cover most of the near-term supply.

BioNTech chief executive Ugur Sahin said however that the partners “are also in advanced discussions with multiple other government bodies and we hope to announce additional supply agreements soon.”

The two partners say they also intend to start supply discussions with the COVAX programme – run by Gavi, the Coalition for Epidemic Preparedness Innovations (CEPI), and the World Health Organization (WHO) – which has been set up to enable equitable access to coronavirus vaccines around the globe.

In the meantime, the US has also placed big orders for coronavirus vaccines developed by Oxford University/AstraZeneca and Novavax as part of agreements that also include clinical development funding, and has provided development funding to Johnson & Johnson and Moderna under Operation Warp Speed.

The BNT162 programme, which is based on BioNTech’s mRNA technology, is currently testing at least four different vaccine candidates in clinical trials. A large-scale trial of the front-runner shot in 30,000 is due to start this month and could form the basis of an emergency-use approval, perhaps as early as October.

Price ceiling?

The size of the deal puts a nominal price per vaccine dose of around $19.50, which Bloomberg notes will likely set a price ceiling on what other vaccine developers can charge for their candidates if approved. Pfizer and BioNTech are testing one- and two-dose regimens of BNT162.

It still allows profit to be made on the vaccines, and Bloomberg analyst  Sam Fazeli says that it could allow Pfizer to make a windfall of more than $15 billion, assuming the vaccine confers protection with one dose.

Earlier this week, pharma executives told a congressional hearing in the US that they could not commit to providing coronavirus vaccines at cost over the long-term, but would do so during the pandemic.

The US currently has more than 4 million confirmed cases of COVID-19, with more than 145,000 deaths

The post US places $1.95 billion order for Pfizer/BioNTech’s COVID-19 vaccine appeared first on .

Boston Scientific Receives the US FDA’s Approval for Next-Generation WATCHMAN FLX Left Atrial Appendage Closure Device

Shots:

  • The approval is based on 12mos. results of PINNACLE FLX study assessing the WATCHMAN FLX device as an alternative to NOACs and other OAC medications. The study met its 1EPs demonstrating a low rate of major procedure-related safety events (0.5% @7days post-procedure) and high rate of effective LAAC (100% with peri-device flow < 5mm @12mos. post-procedure) and showed a high implant success rate of 98.8%
  • The company is also evaluating the device in OPTION study for patients with NVAF undergoing cardiac ablation procedure comparing it to oral anticoagulants as well as in the CHAMPION-AF trial that assess the device against NOACs in a broader OAC-eligible patient population
  • The WATCHMAN FLX device is indicated to reduce the risk of stroke in patients with NVAF by permanently closing off the left atrial appendage and is available in broader size options to treat a wider range of patient anatomies. The device receives CE mark in Mar’2019 and will immediately commence a launch of the device in the US

Click here to read full press release/ article | Ref: Businesswire | Image: Boston Scientific




Paige Receives the US FDA’s 510(k) Clearance for its FullFocus Viewer to Use in Digital Pathology

Shots

  • The FullFocus viewer allows pathologists to view and navigate images when used together with the Philips’ Ultra-Fast scanner. The AI firm is working to expand the 510(k) clearance to include the use of FullFocus with additional scanners and monitors in future
  • In Nov’2019, FullFocus received the CE Mark, making it available to use in the EU. Paige has early access trials across the US, EU, and Brazil with healthcare organizations to serve patients and maintains a business continuity
  • FullFocus operates within the Paige Platform and allows users, meaning researchers and pathologists to view any digital image, regardless of the scanning platform used to generate the image

Click here to read full press release/ article | Ref: Businesswire | Image: Paige




Quest Diagnostic Receives the US FDA’s First EUA for Sample Pooling in COVID-19

Shots:

  • The US FDA has authorized Quest SARS-CoV-2 rRT-PCR test for use with pooled samples containing up to 4 individual swab specimens collected under observation. The Quest test is the first COVID-19 diagnostic test to be authorized for use with pooled samples
  • Quest Diagnostic expects to deploy the technique at its laboratories in Chantilly, VA and Marlborough, Mass., by the end of next week with additional laboratories to follow
  • The company has received the FDA’s EUA for use of self-collection molecular diagnostic kit on the Hologic and Roche’s platforms, expanding use with healthcare provider supervision via telemedicine

Click here to read full press release/ article | Ref: PRNewswire | Image: Glassdoor




Kiniksa’s Rilonacept Receives the US FDA’s Orphan Drug Designation to Treat Pericarditis

Shots:

  • The US FDA has granted ODD for Kiniksa’s Rilonacept to treat pericarditis, which includes recurrent pericarditis. The company plans to submit sBLA in recurrent pericarditis to the US FDA in late 2020
  • Earlier, the company has reported the results of P-III RHAPSODY study that met its all 1EPs & 2EPs showing that the therapy improved clinical outcomes associated with the unmet medical need in recurrent pericarditis
  • Rilonacept (SC, qw) is a recombinant fusion protein that blocks IL-1α and IL-1β signaling and has received the US FDA’s BT designation in 2019. In 2017, Regeneron out-licensed rilonacept to Kiniksa for recurrent pericarditis under which Regeneron will receive equal profit on sales of the therapy, if approved in the US

Click here to read full press release/ article | Ref: Kiniksa | Image: Kiniksa




Merck and Bayer Receive the US FDA’s Priority Review for Vericiguat to Reduce the Risk of CV Death in Patients with Symptomatic Chronic Heart Failure with HFrEF

Shots:

  • The NDA is based on P-III VICTORIA study assessing vericiguat (qd, (titrated up to 10mg) vs PBO when given in combination with available HF therapies in ~5,050 patients with worsening CHF, reduced left VEF of <45% within 12mos. prior to randomization following a decompensation event
  • The 1EPs is the composite of time to the first occurrence of HF hospitalization or CV death. 2EPs included time to occurrence of CV death, time to the first occurrence of HF hospitalization, time to total HF hospitalizations (including first and recurrent events), time to the composite of all-cause mortality and time to all-cause mortality
  • Vericiguat is an orally administered soluble guanylate cyclase (sGC) stimulator with its anticipated PDUFA date as Jan 20, 2021

Click here to read full press release/ article | Ref: Businesswire | Image: USA Today