PhRMA

AUGUST 16, 2022

Innovative biopharmaceutical research companies have been dedicated to fighting COVID-19 for over two years. Since the start of the pandemic, America’s biopharmaceutical companies have worked around the clock to research, develop and manufacture treatments and vaccines to fight COVID-19. We’ve made unprecedented progress in a short time thanks to decades of experience having produced over 14 billion vaccines globally to date.

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Vaccines 196

Pharmacy Times

AUGUST 16, 2022

Insurer and pharmacy benefit manager policies used to cut the cost of drugs could be so time consuming that they could put newly diagnosed atrial fibrillation patients at risk of stroke.

Insurance 139

Insurance 139

pharmaphorum

AUGUST 16, 2022

AstraZeneca and Merck & Co’s PARP inhibitor Lynparza is already used to treat prostate cancer associated with a specific genetic mutation, but could see its use broadened if a new marketing application is approved by the FDA. The US regulator has started a priority review of Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone as a first-line treatment for metastatic castration-resistant prostate cancer (mCRPC) based on the results of the PROpel trial.

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FDA Labelling 110

Pharmacy Times

AUGUST 16, 2022

Investigators aimed to determine how individuals with and without concomitant NSP differ in characteristics and in their perception of treatment responses to analgesics.

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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.

Outsourcing Pharma

AUGUST 16, 2022

The AI and QC specialists have joined to use AI and QC in order to discover biological pathways relevant to the treatment of triple-negative breast cancer.

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Pharmacy Times

AUGUST 16, 2022

A new study warns that fluoroquinolone could increase the risk of altered mental status and hospitalizations for advanced chronic kidney disease patients, though it is rare.

Hospitals 123

Hospitals 123

Pharmacy Times

AUGUST 16, 2022

The Preventing Addiction Related Suicide module was found to better improve suicide knowledge, increase help-seeking behaviors, and reduce maladaptive attitudes compared with usual care for patients with substance use disorders.

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European Pharmaceutical Review

AUGUST 16, 2022

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved an updated version of Moderna’s COVID-19 vaccine, Spikevax, that targets two coronavirus variants as a booster. The regulator confirmed that the vaccine meets its standards of safety, quality and effectiveness. The decision was also endorsed by the government’s independent expert scientific advisory body, the Commission on Human Medicines, after a careful review of the evidence.

Vaccines 101

Vaccines Immunization 101

Pharmacy Times

AUGUST 16, 2022

Pharmacies can play a key role in supporting patients with opioid use disorder and helping diminish stigma for patients treated with methadone, who are told by some they are still addicts despite trying to receive help.

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The FDA Law Blog

AUGUST 16, 2022

By Douglas B. Farquhar — Those of us who work frequently on FDA inspections of drug and medical device manufacturing facilities have noticed an uptick in regular inspections after a dramatic falloff during the first two years of COVID. That impression was corroborated this week at the GMP by the Sea conference when Douglas Throckmorton, Deputy Director for Regulatory Programs at FDA’s Center for Drug Evaluation and Research, stated that domestic FDA inspections of facilities have been performed

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FDA 98

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.

FDA

Pharmacy Times

AUGUST 16, 2022

The FDA has issued a rule that will grant millions of Americans access to OTC hearing aids in pharmacies or online without a prescription or medical exam required.

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FDA 123

pharmaphorum

AUGUST 16, 2022

Merck & Co has ramped up its involvement in the RNA category, partnering with US biotech Orna Therapeutics in a deal valued at up to $3.5 billion, including $150 million upfront. It has also invested another $100 million in the three-year-old Cambridge, Massachusetts-based biotech, by participating in a $221 million Series B round. One of the unexpected consequences of the COVID-19 vaccine race was that some top-tier vaccine companies like Merck, GSK and Sanofi ended up trailing the field, a

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Vaccines Packaging 96

Pharmacy Times

AUGUST 16, 2022

A potential public health benefit of 13-valent pneumococcal conjugate vaccine is the reduction of acute chest syndrome among children with sickle-cell disease.

Vaccines 123

Vaccines 123

European Pharmaceutical Review

AUGUST 16, 2022

The Phase III RATIONALE 301 study evaluated the efficacy and safety of tislelizumab versus sorafenib as a first-line systemic treatment in participants with unresectable hepatocellular carcinoma. . Hepatocellular carcinoma, or HCC, is the sixth most common type of cancer worldwide. HCC accounted for more approximately 85 percent of the 900,000 new liver cancer cases in 2020, according to the Globocan 2020 database. .

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Labelling Immunization 97

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Pharmacy Management Software

PharmaVoice

AUGUST 16, 2022

In balancing two roles — Lexitas CEO and practicing physician — George Magrath brings a patient-first perspective to developing and advancing eye treatments.

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NICE

AUGUST 16, 2022

The UK’s new valuation study for the EQ-5D-5L questionnaire, designed to understand how people prioritise different aspects of their quality of life, gets underway in October. The study is an important contribution to the evidence NICE uses to decide whether treatments offer good value. The results of this study will allow better interpretation of the results of the EQ-5D-5L questionnaire, informed by up-to-date information about the public's preferences.

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Pharmacy Times

AUGUST 16, 2022

Guidelines provide information on the management and treatment of this common skin condition.

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Outsourcing Pharma

AUGUST 16, 2022

The National Institute for Health and Care Excellence is weighing the viability of PD Neurotechnologyâs PDMonitor system for Parkinsonâs disease patients.

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Pharmacy Times

AUGUST 16, 2022

Specialty pharmacies are well positioned to address disparities that affect outcomes.

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Specialty Pharmacies 118

European Pharmaceutical Review

AUGUST 16, 2022

The Queen’s Award for Enterprise is the UK’s highest accolade for business success and recognises the strength of Quay Pharma’s export sales, which, according to SGS, have comprised at least 55 percent of its business since 2010. The enterprise also noted that in the last three years its overseas sales had more than doubled. The International Trade category recognises those who have had a clear business strategy for entering new markets abroad, have overcome the challenges faced by exporte

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Immunization 76

Pharmacy Times

AUGUST 16, 2022

High rates of HIV can decrease with community-based support.

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Pharmaceutical Commerce

AUGUST 16, 2022

Three of the authors of a new EY study exploring the evolution of industry supply chain strategies and the long-term implications for healthcare delivery across three major trade regions discuss the report’s key findings and share their predictions as we move into Q3.

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Pharmacy Times

AUGUST 16, 2022

Both ibrutinib (Imbruvica) and venetoclax (Venclexta) carry an approved indication for use in chronic lymphocytic leukemia but do not often lead to complete remission, and therapy routinely continues indefinitely or until disease progression.

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Pharmaceutical Technology

AUGUST 16, 2022

Even giant pharma companies with large internal production capabilities are leaning on outsourcing to meet market demand for huge numbers of injectables, including high-value biologics and Covid-19 vaccines, according to a GlobalData analysis. Large (market cap $10–100bn) and mega-cap (market cap >$100bn) sponsors also require contract manufacturers and packagers with specialist injectable capabilities in the case of cell and gene therapies, as shown in the report titled Contract Injectable Pack

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Packaging Vaccines FDA 64

pharmaphorum

AUGUST 16, 2022

The UK’s Joint Committee on Vaccinations and Immunisations (JCVI) has said that Moderna’s bivalent COVID-19 vaccine should be used for the autumn booster campaign in adults. The new recommendations came hard on the heels of the authorisation of the new shot, which provides protection against the original strain of the virus and the Omicron variant, by the Medicines and Healthcare products Regulatory Agency (MHRA).

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Vaccines Immunization 59

Pharmaceutical Technology

AUGUST 16, 2022

In 2019, Daiichi Sankyo entered a global development and commercialisation agreement with AstraZeneca for Daiichi Sankyo’s lead antibody-drug conjugate (ADC), Enhertu (trastuzumab deruxtecan), in a deal worth $6.9bn. This was followed by a further deal for the global development and commercialisation of another ADC, datopotamab deruxtecan (DS-1062) in 2020, with a deal value of up to $6bn.

Chemotherapy 59

Chemotherapy Immunization FDA 59

pharmaphorum

AUGUST 16, 2022

The FDA has started a review of Roche’s Polivy for people with previously untreated diffuse large B-cell lymphoma (DLBCL), as the drugmaker tries to move the drug further up the treatment pathway in the US. Polivy (polatuzumab vedotin) – an antibody-drug conjugate targeting CD79b – was cleared by the European Commission for the new indication in May, building on its earlier approval as a third-line treatment for DLBCL alongside rituximab and bendamustine.

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FDA Chemotherapy 59

Pharmacy Times

AUGUST 16, 2022

University of Missouri analyzes social, structural determinants of health that worsen health disparities.

Vaccines 73

Vaccines 73

The Guardian - Pharmaceutical Industry

AUGUST 16, 2022

As with Covid, corporate interests are taking priority over getting vaccines to people and areas that most need them Two weeks ago I queued for more than five hours outside a London hospital to receive a monkeypox vaccination. But I’m one of the lucky ones; thousands of people in at-risk groups haven’t been so fortunate, and it’s about to get worse.

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Vaccines Immunization Hospitals 62

Pharmacy Times

AUGUST 16, 2022

Febuxostat) Uloric is a xanthine oxidase inhibitor indicated for the chronic management of hyperuricemia in patients with gout.

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PharmExec

AUGUST 16, 2022

Wed, Aug 17, 2022 2:00 PM EDT Recent advances in both oncology drug development and novel digital technologies provide a ripe opportunity to enhance the clinical trial process. Join Colin Weller and Musaddiq Khan from Medable as they discuss the key considerations around these innovations.

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Pharmacy Times

AUGUST 16, 2022

With costs for blood and blood products continuing to rise, appropriate blood use by hospitals is more important than ever.

Hospitals 65

Hospitals 65

Pharmaceutical Technology

AUGUST 16, 2022

Q32 Bio has signed a partnership and option agreement with Horizon Therapeutics for developing ADX-914 to treat autoimmune ailments. According to the deal, Horizon will provide the funding to develop the therapy until the conclusion of its two Phase II clinical trials. Furthermore, Q32 will oversee the conduct of all programme-linked works. Under the agreement, Horizon will hold an option for the acquisition of the ADX-914 programme, which is exercisable through a period after concluding the Pha

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Immunization FDA 52

pharmaphorum

AUGUST 16, 2022

The LNP Development Europe Summit is the only European conference solely dedicated to?LNP formulation?and process development to enable seamless scale-up , keeping GMP compliance and manufacturing. Given the rapid developments in the field and the success of Pfizer / BioNTech’s mRNA vaccine, lipid nanoparticles have finally reached an inflection point.?

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Vaccines 52