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

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This week’s reading list: All the reasons the Senate-passed drug pricing bill is bad policy

PhRMA

Last weekend, the Senate passed the Inflation Reduction Act which includes dangerous price-setting provisions. The bill now heads to the House for consideration, where it is not too late for them to stand up for patients and medical innovation by opposing the bill.

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Study: Green Tea Extract Reduces Blood Sugar Levels, Improves Gut Health

Pharmacy Times

Investigators found that the health risks linked to the condition known as metabolic syndrome could be diminished by green tea’s anti-inflammatory benefits in the gut.

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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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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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Making coupons count for patients with HIV

PhRMA

Despite having insurance, too many patients with HIV face high out-of-pocket costs for brand medicines. This is largely driven by insurer-imposed barriers that shift the cost of life-saving care onto patients.

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Hormone Therapy for Prostate Cancer May Increase Risk of Mortality From Cardiovascular Disease

Pharmacy Times

Use of hormone therapy to treat prostate cancer may require more consideration by health care providers as new study shows the therapy may increase the risk of heart disease.

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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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New survey: Voters seriously concerned about fine print in reconciliation bill

PhRMA

With a final vote in Congress expected on a reconciliation spending bill, a new Morning Consult survey explores what this legislation actually does – and does not do – and finds that voters are skeptical of its impact on inflation, worried about the consequences of Medicare “negotiation” and concerned the bill doesn’t do enough to help make medicines affordable for patients.

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Study to Evaluate Efficacy of Telehealth Cognitive Behavioral Therapy for Migraine

Pharmacy Times

Study will analyze whether cognitive behavioral therapy telehealth can lower headache days and disability as effectively as cognitive behavioral therapy plus a preventive medication for migraine.

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Pharma Distribution: Carving New Ground

Pharmaceutical Commerce

Pharmaceutical distribution today is anything but monolithic. While companies in this space are grappling with issues ranging from inflation and supply chain disruption to workforce scarcity and DSCSA implementation, there’s still plenty of room for smaller players to stake out part of the terrain to call their own.

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

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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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Value assessment should include all aspects of value that matter to patients

PhRMA

We need to move toward a more value-driven health care system that centers around patients’ needs. Sound evidence can help guide us toward that, and we’re committed to developing tools to help patients, physicians and others make informed decisions.

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Second Booster Protects Against Breakthrough COVID-19 Variant Infections in Health Care Workers

Pharmacy Times

Health care workers who got 4 total doses against COVID-19, 2 doses of which are boosters, experienced more than 10% lower breakthrough infection rate than those with only 3 total doses.

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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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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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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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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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New Study Suggests Potential for Heterologous COVID-19 Boosters

Pharmacy Times

A recent study suggests that homologous and heterologous vaccines protect against the Omicron variant of COVID-19, but the heterologous appears more durable.

Vaccines 139
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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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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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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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New Binding Mechanism Science Driving Therapeutic Insight in Immune-Mediated Diseases

Pharmacy Times

The ability of an anti-interleukin-23 antibody to bind to key immune system components may help neutralize a key driver of inflammation right at its cellular source.

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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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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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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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Regeneron’s REGM5678 Combination Shows Positive Results for Prostate Cancer

Pharmacy Times

Preliminary data from the ongoing dose-escalation portion of the clinical trial, show dose-dependent anti-tumor activity when combined with standard-dose Libtayo.

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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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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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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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Overcoming Barriers to Adopting Effective Organizational Culture in Pharmacy

Pharmacy Times

Organizational culture is determined by how the organizational leadership responds to a crisis, how they adapt to new demands and how they correct an employee when mistakes happen.

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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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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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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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Clinical Overview: Certain Antihypertensive Drugs Can Lower Risk for New Onset Type 2 Diabetes

Pharmacy Times

Meta-analysis of randomized controlled trials adds to growing evidence around certain antihypertensive drug classes showing promise for primary or secondary prevention of diabetes.

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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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