Sat.Aug 06, 2022 - Fri.Aug 12, 2022

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Woman of the Week: COTA’s Miruna Sasu

PharmaVoice

Miruna Sasu is on a mission to use real world data to help wipe out cancer. She believes this audacious goal is within reach, and as president and CEO of COTA, she is inspiring her team to create a “path to care” for oncology patients.

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Digital health app linked to better outcomes in heart failure

pharmaphorum

A study of a mobile health app used to support patients hospitalised with heart failure has concluded that it provided a modest improvement in quality-of-life scores, as well as better clinical outcomes. The finding comes from the large-scale CONNECT-HF cluster study, which looked at various patient engagement and education interventions to see if they could help patients with heart failure do better after discharge from hospital.

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The potential of virtual reality-based therapy for serious mental disorders

Pharmaceutical Technology

In June this year, it was announced that the US Food and Drug Administration (FDA) had granted UK-based OxfordVR a breakthrough device designation for its gameChangeVR treatment to deliver immersive cognitive behaviour therapy (CBT) to people suffering from schizophrenia and other mental illnesses. The FDA’s breakthrough device programme is for medical devices or device-led combination products that provide more effective treatment or diagnosis of diseases.

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The 5 Stages of Hashimoto’s Thyroiditis

The Thyroid Pharmacist

Did you know that most cases of thyroid disease are autoimmune in nature? (1). Hashimoto’s thyroiditis is an autoimmune condition that happens to affect the thyroid gland. This means that our immune system recognizes the thyroid gland as a foreign invader and begins to attack it, eventually leading to the destruction of our thyroid tissue. When this destruction goes on long enough, the person will lose their ability to produce thyroid hormone.

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Position Your Pharmacy for Expansion

Speaker: Chris Antypas and Josh Halladay

Access to limited distribution drugs and payer contracts are key to pharmacy expansion. But how do you prepare your operations to take the next step? Meaningful data: Collect and share clinical data regarding outcomes, utilization, and more Reporting: Limited distribution models require efficient tracking and reporting systems Workflows: Align workflows with specific pharma and payer contractual requirements For in-depth, expert insights on pharmacy expansion, watch this webinar from Inovalon.

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As pharma M&A ramps up, U.S. execs are bullish on more deals

PharmaVoice

What top executives at Merck, Pfizer and more are saying about M&A as they move into the second half of the year.

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The Price of Innovation: ‘Paying for a Cure’ Remains Costly Proposition

PharmExec

Curative-type therapies offer great hope in further transforming treatments for cancer and other diseases, but addressing the economics of these products—and ultimately the cost-benefit equation—is daunting. What is being done to smooth the path for pricing and reimbursement?

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More Trending

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US FDA approves Daiichi Sankyo-AstraZeneca’s Enhertu for lung cancer

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted approval for Daiichi Sankyo and AstraZeneca ’s Enhertu (fam-trastuzumab deruxtecan-nxki) to treat unresectable or metastatic non-small cell lung cancer (NSCLC) in adults. The treatment is indicated for such patients whose tumours have activating HER2 (ERBB2) mutations and previously received systemic therapy. .

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Turning harp seal contraceptives into a ‘new genre’ of cancer treatments

PharmaVoice

With Andrew Hall at its helm, IMV has evolved an animal contraceptive into a unique drug delivery platform aimed at creating targeted cancer immunotherapies for humans.

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A World of Opportunity

PharmExec

Marie-France Tschudin, president, innovative medicines international, and chief commercial officer at Novartis, taps into life lessons to help bring therapies to people in novel ways­.

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Pfizer vaults into sickle cell market as GBT deal confirmed

pharmaphorum

Pfizer’s reported interest in acquiring sickle cell disease specialist Global Blood Therapeutics (GBT) has been confirmed, with the $68.50-per-share deal valuing GBT at $5.4 billion. As we reported this morning, the deal gives Pfizer already-approved SCD therapy Oxbryta (voxelator) – which industry watchers reckon could see a dramatic uptick in sales with Pfizer’s marketing muscle – plus a phase 3 antibody candidate, a phase 1 follow-up to Oxbryta that could offer improved dosing.

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5 Reasons to Upgrade Your Pharmacy Management Software

Are you still using workarounds to manage your daily operations? To achieve peak performance, it's time to explore other options for specialty and infusion pharmacy software. Streamline pharmacy operations and improve clinical performance with automated processing, real-time data exchange, and electronic decision support. Download this helpful infographic to: Drive efficiency and patient adherence from referral receipt to delivery and ongoing care – all with our Pharmacy Cloud.

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AstraZeneca-Daiichi Sankyo’s Enhertu gets US FDA approval for breast cancer

Pharmaceutical Technology

AstraZeneca and Daiichi Sankyo ’s Enhertu (trastuzumab deruxtecan) has received expanded approval from the US Food and Drug Administration (FDA) to treat adults with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer. The treatment is indicated for patients who have previously received chemotherapy in the metastatic setting or recurred during or within six months of receiving adjuvant chemotherapy.

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Despite AbbVie’s Botox prowess, underdog Galderma has leveraged soft skills to succeed in aesthetics

PharmaVoice

Galderma may not have the biggest name in aesthetics, but as the sector grows past pandemic lows, the company is relying on its people to build a loyal customer base.

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Samsung Biologics recognised for sustainable growth

European Pharmaceutical Review

The Frost & Sullivan Institute stated that it is proud to present Samsung Biologics with the 2022 Enlightened Growth Leadership Award for not only demonstrating growth excellence but also social responsibility. In announcing the award, the Institute asserted that it “believes that all organisations must either create or become part of a solution that addresses threats to humanity,” highlighting Samsung’s strong environmental, social and governance (ESG) and sustainability initiatives the rea

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Regions On Rise: Life Sciences Across US

Pharmaceutical Commerce

Exploring the competitive and unique offerings in three of the US’s lower-cost economic development regions—and how success in these areas has been boosted by COVID.

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SMC approve Johnson & Johnson’s systemic light chain amyloidosis therapy

Pharma Times

Newly diagnosed patients will become the first to access systemic light chain amyloidosis treatment in the UK

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Are Big Pharma CEOs earning their pay?

PharmaVoice

While compensation packages at the top may not always reflect value, it’s not necessarily an industry-wide problem.

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GSK, Sanofi and Haleon ‘facing billions of dollars in Zantac liability’

pharmaphorum

GSK, its consumer health spin-off Haleon and Sanofi could be on the hook for billions of dollars in potential damages over Zantac, a gastrointestinal drug pulled from the market in 2020 after it was linked to cases of cancer. That’s the conclusion of analysts at Morgan Stanley, Deutsche Bank and UBS, who have all issued research notes drawing attention to the issue, which has remained largely off the radar since sales of Zantac (ranitidine) were halted.

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Greater Than One Names New Executive Creative Director

PharmExec

Mindy will be the creative voice of the agency, responsible for providing Greater Than One clients with strategic creative direction and oversight from inception through execution.

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FDA makes moves to advance ALS research ahead of upcoming Amylyx AdCom

Pharmaceutical Technology

In the lead-up to a critical meeting that will influence the approval of a new drug for amyotrophic lateral sclerosis (ALS), the US Food and Drug Administration (FDA) has detailed its plans to advance rare neurodegenerative disease research. The plan, which was released in late June, outlines a science strategy to improve research efforts for ALS. Its content is pertinent given the upcoming FDA Advisory Committee (AdCom) for Amylyx Pharmaceuticals’ ALS drug AMX0035 on 7 September.

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How real world evidence is impacting rare disease drug development

PharmaVoice

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The drugs don’t work (and other mental health myths)

The Guardian - Pharmaceutical Industry

Our attitudes to mental health are changing but much of the stigma that surrounds conditions such as schizophrenia remains – along with some enduring and often damaging untruths There can be little doubt that public attitudes to mental health have already turned a corner. Just consider the sheer number of public figures – from Robbie Williams and Lady Gaga to Baroness Davidson – who have opened up about their struggles.

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Environmental Sustainability: An Imperative for the Life Sciences Sector

Pharmaceutical Commerce

Recognizing the sustainability issue is an important step, but the biopharmaceutical sector encompasses a complex set of networks and supply chains, so it is not straightforward to shift towards net zero across all operations.

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Health Canada accepts Paladin’s NDS for epilepsy-linked seizure therapy

Pharmaceutical Technology

Health Canada has accepted the New Drug Submission (NDS) of Endo International subsidiary Paladin Labs for cenobamate tablets as an adjunctive treatment to manage partial-onset seizures in adult epilepsy patients. The treatment is intended for such patients who are not well-controlled with standard therapy. The regulatory agency is anticipated to provide a decision on whether cenobamate tablets can be commercialised and sold in Canada under this NDS in the middle of next year.

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Texas Shows Us Where PBMs’ Rebates Go

Drug Channels

Over the weekend, the U.S. Senate passed a massive overhaul of the Medicare Part D program. If passed into law, these changes will have many unintended consequences , but will not address the warped incentives baked into our current rebate system. This makes it a good time to review the murky, little-seen economics of how commercial plan sponsors and payers access the billions of dollars in manufacturer rebates and fee that are negotiated by their pharmacy benefit managers (PBMs).

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UK decision not to buy Covid drug Evusheld disappoints charities

The Guardian - Pharmaceutical Industry

Drug can help prevent infection in people who are immunocompromised but government says data is lacking The UK will not buy the drug Evusheld, which can help prevent Covid infections in people with weakened immune systems, the government has said. The decision, revealed on Friday in an official statement to BBC Radio 4’s Today programme, has been met with criticism from a host of charities who say it means many people who are immunocompromised will be left with no option but to avoid contact wit

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Key blood clotting protein could be ‘warning light’ for COVID-19 cases

Pharma Times

University of Aberdeen team suggest results indicate that protein PAI-1 could be an early indicator of severe COVID-19

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US FDA grants approval for Orion-Bayer’s Nubeqa combo for prostate cancer

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted approval for a supplemental New Drug Application (sNDA) of Orion and its partner Bayer ’s Nubeqa (darolutamide) plus docetaxel to treat metastatic hormone-sensitive prostate cancer (mHSPC) patients. The latest approval is based on positive data from the multicentre, double-blind, randomised, placebo-controlled Phase III ARASENS clinical trial that analysed the safety and efficacy of oral darolutamide plus androgen deprivation therapy (ADT) an

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Is albumin the key to successful nasal vaccines?

European Pharmaceutical Review

According to researchers, binding nasal vaccine antigens to albumin enables them to bypass mucosal barriers, and could lead to better protection against pathogens like HIV and Severe Acute Respiratory Syndrome coronavirus 2 (SARS-CoV-2; the virus that causes COVID-19). The University of Minnesota researchers tested the technology on mice and non-human primates and found that the vaccine generated strong immune responses, paving the way for further study and development of nasal vaccines.

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Walgreens played ‘substantial’ role in San Francisco opioid crisis, judge finds

The Guardian - Pharmaceutical Industry

The pharmacy chain failed to properly investigate suspicious opioid orders, according to federal ruling Walgreens “substantially contributed” to San Francisco’s opioid epidemic by failing to perform due diligence on prescriptions that flooded into the city for 15 years, a federal judge has found. The city won what local media has called a “ landmark trial ” against Walgreens, with the judge, Charles Breyer, finding that the pharmacy chain had failed to properly investigate suspicious opioid orde

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How Pharmacogenomics may finally realise its promise

pharmaphorum

More than 60 percent of all American adults take prescription drugs , amounting to approximately 131 million individuals. These drugs have been rigorously tested by regulatory bodies around the world before they’re made available to ensure they work as labelled, but despite that, adverse events crop up. In 2016, the estimated annual cost of drug-related morbidity and mortality resulting from non-optimised medication therapy was $528.4 billion in the United States alone.

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Preparing for Back to School at Your Pharmacy

Digital Pharmacist

Back to school can be a crazy time. With shopping for supplies, possibly moving a college-aged student, and trying to soak in the last few days of summer – it can be a lot on families. So, what can we do at the pharmacy to help ease this burden? How can we help our communities have a smooth back to school transition? In today’s blog, we’re going to provide you with a few tips. .

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Lilly to pay more than $180mn for defrauding US Medicaid Program

European Pharmaceutical Review

Eight years after the whistle was blown on Eli Lilly for allegedly underpaying the rebates required of drug manufacturers under the US Medicaid Drug Rebate Program, a jury has ordered the company to pay more than $61 million in damages. However, as the whistleblower Ronald J Streck filed a False Claims Act lawsuit, the damages will be trebled and the final judgment will be over $183 million, according to Streck’s legal team.

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Cerevance and Merck partner to detect new Alzheimer’s targets

Pharmaceutical Technology

Cerevance has entered a multi-year strategic research partnership with Merck (MSD outside North America) to discover new targets for Alzheimer’s disease. Under the alliance, the companies will use the Nuclear Enriched Transcript Sort sequencing (NETSseq) technology platform of Cerevance to identify the targets. Furthermore, Cerevance will simultaneously out-license a discovery-stage programme to Merck under the partnership.

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AI Opens Door To Improving Patient Experience

PharmExec

The technology is not just about digital enablement anymore.

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Pfizer to acquire sickle cell disease specialist for $5.4b USD

Outsourcing Pharma

Biopharmaceutical company Global Blood Therapeutics specializes in conditions that often disproportionately impact underrepresented communities, such as SCD.

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