STAT

JANUARY 27, 2023

After weeks of deliberation, Pfizer was scolded by a U.K. pharmaceutical industry trade group after its chief executive officer made misleading statements in a media interview about the need to vaccinate young children against Covid-19. The fracas began when the Pfizer chief, Albert Bourla, gave an interview to the BBC and discussed the idea of vaccinating children between five and 11 years old, a course of action that had not yet been approved by regulators in the U.K.

Vaccines 363

Vaccines 363

PharmaVoice

JANUARY 24, 2023

A longtime leader in the respiratory space, AstraZeneca has hammered another stake in the ground with its newest asthma treatment, Airsupra.

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pharmaphorum

JANUARY 27, 2023

AstraZeneca’s revenue boost from COVID-19 therapy Evusheld looks set to be curbed early, as the FDA withdraws authorisation for the antibody on the grounds that it is ineffective against most subvariants now circulating in the US. Evusheld (tixagevimab and cilgavimab) was cleared by the FDA towards the end of 2021, becoming the first antibody to be authorised for prevention of COVID-19 infection, and it rapidly found use among people with compromised immune systems, such as cancer chemothe

Chemotherapy 132

Chemotherapy Immunity Immunization Vaccines 132

PhRMA

JANUARY 26, 2023

Mental illness represents a broad spectrum of health conditions affecting mood, thinking and behavior. These conditions include depression, bipolar disorder, schizophrenia, substance use disorder, anxiety disorders, eating disorders, obsessive compulsive disorder and post-traumatic stress disorder, among others. Each of these illnesses often varies in its degree of severity, ranging from mild to moderate to severe, and may occur together.

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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.

STAT

JANUARY 23, 2023

Scientists at the Food and Drug Administration propose making Covid vaccination a regular, once-a-year shot that is updated to match current strains of the SARS-CoV-2 virus, according to documents posted by the FDA on Monday. For people who are older or immunocompromised, the FDA would recommend two annual doses of the revised shot.

Documentation 334

Documentation Vaccines 334

PharmaVoice

JANUARY 26, 2023

Elon Musk’s takeover of Twitter has upended the ways pharma companies communicate with doctors online. Now new social strategies are emerging.

Communication 148

Communication 148

pharmaphorum

JANUARY 26, 2023

2022 was a banner year for genomics. In March, the collaborative T2T consortium published the first complete telomere-to-telomere sequence of the human genome, filling in the last 8% of the 3 billion base pairs that make up our DNA. And in the UK specifically, genomics remained high on the national agenda, with several significant government programmes and investments announced – including the Newborn Genomes Programme in healthcare and the Precision Breeding Bill in the agricultural sector.

Adverse Reactions 119

Adverse Reactions Vaccines 119

STAT

JANUARY 26, 2023

Fasten your seat belts, folks. We’re about to hit some turbulence. If you’re reading this, you’re interested in the discussion on the future of Covid-19 vaccination that’s going to take place today in a meeting of the Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee. We at STAT can’t predict the outcome, but we know enough to expect that this meeting will feature some heated debate.

Vaccines 327

Vaccines 327

PharmaVoice

JANUARY 26, 2023

At SFA Therapeutics, patients are the “focus” of Ira Spector’s approach to changing the course of autoimmune disease.

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European Pharmaceutical Review

JANUARY 26, 2023

Yescarta ® ▼(axicabtagene ciloleucel; axi-cel) is now the first chimeric antigen receptor (CAR) T-cell therapy and first personalised immunotherapy to be recommended for routine use on the NHS in England. This is based on final draft guidance from the National Institute for Health and Care Excellence (NICE). The therapy by Gilead Sciences and Kite is indicated for eligible adults with diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL) who have already bee

Chemotherapy 120

Chemotherapy Immunity Immunization 120

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Pharmaceutical Technology

JANUARY 23, 2023

Systemic lupus erythematosus (SLE) is a systemic, inflammatory, chronic autoimmune disease that can affect multiple organs simultaneously or sequentially, with a relapsing and remitting nature. While SLE can affect multiple major organ systems in the body, one of its most severe manifestations is renal (kidney) involvement, known as lupus nephritis (LN).

Labelling 111

Labelling Immunity Immunization 111

STAT

JANUARY 26, 2023

A loophole in prescription drug regulation exposes American consumers to false and misleading claims of drug ads via on-line businesses promoting potent drugs without accurate information about their risks and benefits. Many countries prohibit direct-to-consumer advertising of prescription drugs. The United States allows it, but only if pharmaceutical companies comply with standards for accuracy and balance established and enforced by the Food and Drug Administration.

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Pharmaceutical Companies Pharmaceutical Companies 264

PharmaVoice

JANUARY 26, 2023

With a rapidly expanding oncology pipeline and a new approval in HIV, Johanna Mercier discusses Gilead’s quest to transform.

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European Pharmaceutical Review

JANUARY 23, 2023

There are major concerns about microbial contamination in cannabis, US Food and Drug Administration (FDA) researchers observed in a study. Multiple cases have been reported of infections associated with cannabis use caused by fungi and bacteria in immunocompromised individuals using inhaled cannabis material. Investigational New Drug (IND) applications for cannabis as therapeutics tested in clinical trials must comply with FDA’s requirements and standards for drug products.

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Compounding 115

Pharmaceutical Technology

JANUARY 22, 2023

Eli Lilly and Company and Boehringer Ingelheim have announced that the US Food and Drug Administration (FDA) accepted a supplemental New Drug Application (sNDA) for Jardiance (empagliflozin) tablets for chronic kidney disease (CKD) in adult patients. Jardiance is currently being evaluated as a potential therapy for reducing kidney disease progression and cardiovascular death risk in CKD adult patients.

Diabetes 105

Diabetes 105

STAT

JANUARY 26, 2023

WASHINGTON — The FDA is giving up on trying to figure out a way to regulate CBD on its own. The agency announced Thursday that it is formally calling on Congress for help — and, according to one official, looking for guidance on other hemp products like Delta 8 THC, too. For nearly four years, the Food and Drug Administration has been laboring to craft a solution that would allow CBD to be legally sold in capsules, gummy vitamins, and various foods, even though the agency also cons

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pharmaphorum

JANUARY 27, 2023

Johnson & Johnson has been cleared to continue a lawsuit filed last year against drug benefit programme SaveOnSP, which claims it defrauded a payment assistance programme for patients out of “at least $100 million.” The complaint – originally filed in May 2022 in a New Jersey federal court – alleges that SaveOnSP took advantage of J&J’s Janssen CarePath programme, which covers eligible patients’ out-of-pocket expenses for 44 of its more expensive prescription drug

Health Insurance Companies 104

Health Insurance Companies Specialty Pharmacies Documentation 104

PhRMA

JANUARY 25, 2023

Earlier this month, the American Cancer Society (ACS) released its annual report, Cancer Statistics 2023, finding the overall cancer mortality rate has declined 33% since peaking in 1991, leading to an estimated 3.8 million averted cancer deaths over this period. The report notes the continued decline in death rates since 1991, including a 1.5% decrease between 2019 and 2020 alone, increasingly reflects advances in prevention and treatment—including new medicines which have improved survival acr

Documentation 101

Documentation 101

Pharmaceutical Technology

JANUARY 26, 2023

Health Canada has accepted for review Valeo Pharma partner Veru’s new drug submission (NDS-CV) for Covid-19 therapy sabizabulin. The new dual antiviral and anti-inflammatory agent Sabizabulin is being developed to treat hospitalised adult patients with moderate to severe Covid-19 who are at high acute respiratory distress syndrome (ARDS) and mortality risk.

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STAT

JANUARY 26, 2023

WASHINGTON — It’s not every day that the pharmaceutical industry, the NAACP, a cancer center, and a nonpartisan think tank are all lobbying to achieve the same policy goal. But an effort to expand Medicare coverage for obesity drugs has managed to unite them all, and many more groups across the health care industry, too.

Drug Pricing 258

Drug Pricing 258

pharmaphorum

JANUARY 27, 2023

The emergence of COVID-19 resulted in staffing challenges that have continued to have a sustained, negative impact on clinical trial workflows. In fact, 76% of healthcare professionals have recently cited feelings of burnout, leading to a turnover rate twice as high as before the pandemic and increased levels of vacant positions across clinical research sites.

Medical Records 102

Medical Records Hospitals 102

Med Ed 101

JANUARY 25, 2023

In this article, we lay out our top 5 all-time hypertension clinical trials. If you remember previously, we covered the top 5 landmark clinical trials in hyperlipidemia. It was a tough call with many options, but here’s our list of hypertension clinical trials. Feel free to comment below if you feel we missed one! DASH […] The post Top 5 All-Time Hypertension Clinical Trials appeared first on Med Ed 101.

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Pharmafile

JANUARY 23, 2023

Indian biotech company Bharat Biotech plans to launch its new intranasal COVID-19 vaccine iNCOVACC on the 26 January 2023 ‒ the vaccine is the first of its kind to be developed in India.

Vaccines 98

Vaccines Communication 98

STAT

JANUARY 27, 2023

LOS ANGELES – California cities are supposed to be cracking down on sales of flavored vapes, which are now illegal across the state. But even cities that have banned such vapes for years are unwilling — or unable — to police the sellers. STAT visited 24 vape shops earlier this month in Oxnard, Ventura, Pasadena, El Monte, Carson and West Hollywood — all of which have had bans on flavored vapes on the books for at least a year; most for two or more years.

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pharmaphorum

JANUARY 26, 2023

Guidance on the way pharma companies communicate about prescription medicines has been updated in the UK to cover use of social media channels for the first time. The document from the Prescription Medicines Code of Practice Authority (PMCPA) arrives in the wake of several cases where drugmakers made promotional statements on social media platforms – including LinkedIn and Instagram – that were deemed to have breached the code of practice laid down by the Association of British Pharmaceutical In

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Communication Documentation 99

Drug Patent Watch

JANUARY 25, 2023

Annual Drug Patent Expirations for JANUMET Janumet is a drug marketed by Merck Sharp Dohme and is included in two NDAs. It is available from two suppliers. There are four… The post New patent expiration for Merck Sharp drug JANUMET appeared first on DrugPatentWatch - Make Better Decisions.

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European Pharmaceutical Review

JANUARY 26, 2023

Typical extractables and leachables (E/L) studies aim to identify, quantify and ultimately minimise any impurities that can migrate from packaging into a final product or drug. Gas or liquid chromatography-mass spectrometry (LC/MS) or (GC/MS) have been widely used in extractables studies however, there are several challenges associated with E&L analyses including: Detection and quantification of unknowns Sensitivity and detection at trace levels Reducing uncertainty factors Increasing s

Packaging 98

Packaging 98

STAT

JANUARY 26, 2023

If the buzz is to be believed, ChatGPT seems poised to upend everything from high school essays and news articles to computer coding and scientific research. The program has generated huge interest for its ability to write nearly anything it’s asked to write and to answer questions. Microsoft has announced a “multiyear, multibillion dollar” investment — rumored to be as high as $10 billion   — into its maker, the artificial intelligence company OpenAI.

Hospitals 252

Hospitals 252

pharmaphorum

JANUARY 27, 2023

Late last year, pharmaphorum caught up with Dr Karen Mullen, chief medical officer and VP of clinical & medical affairs at global drug development consultancy Boyds. Having previously spoken with Dr Mullen three years ago when she was country medical director for the UK & Ireland at GSK – on the topic of patient centricity and embedding that focus within the core of a pharmaceutical company – our recent interview provided some interesting insights into the changing landscape of the indus

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Vaccines Pharmaceutical Companies Pharmaceutical Companies Documentation 99

Pharma Times

JANUARY 27, 2023

Therapy involves patients with paediatric-onset hypophosphatasia – a rare bone disease

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Drug Patent Watch

JANUARY 25, 2023

Annual Drug Patent Expirations for JANUVIA Januvia is a drug marketed by Merck Sharp Dohme and is included in one NDA. It is available from three suppliers. There are three… The post New patent expiration for Merck Sharp drug JANUVIA appeared first on DrugPatentWatch - Make Better Decisions.

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STAT

JANUARY 25, 2023

Two new studies published Wednesday report good news about the updated Covid-19 vaccine, with one suggesting it is more effective than the previous monovalent vaccine and the other showing that even though it targeted an earlier strain of the SARS-CoV-2 virus, its protection is holding up against current variants. The findings suggest the updated vaccine, which targets both the original SARS-2 virus and the Omicron subvariants BA.4 and BA.5, is performing better than some critics of the decision

Vaccines 252

Vaccines 252

The Thyroid Pharmacist

JANUARY 27, 2023

There are common underlying root causes in Hashimoto’s, including nutrient deficiencies , food sensitivities , an impaired ability to handle stress, intestinal permeability, chronic infections , and an impaired ability to handle toxins. [1] Many people have more than just one root cause, and addressing all of these elements can help us feel better.

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Diabetes Immunity Immunization Packaging 97

PhRMA

JANUARY 23, 2023

2022 marked another year of significant progress by biopharmaceutical research companies conducting lifesaving research and development for innovative medicines with a total of 45 new medicine approvals by the U.S. Food and Drug Administration (FDA). According to a new report released by the FDA’s Center for Drug Evaluation and Research (CDER), 37 novel medicines were approved by CDER last year.

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Drug Patent Watch

JANUARY 25, 2023

Annual Drug Patent Expirations for JUVISYNC Juvisync is a drug marketed by Merck Sharp Dohme and is included in one NDA. There are four patents protecting this drug and three… The post New patent expiration for Merck Sharp drug JUVISYNC appeared first on DrugPatentWatch - Make Better Decisions.

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