Pharma Leaders

JUNE 21, 2023

The US Food and Drug Administration (FDA) has accepted bluebird bio’s Biologics License Application (BLA) for lovotibeglogene autotemcel (lovo-cel) gene therapy and granted priority review for the product’s use in the treatment of sickle cell disease (SCD). It is claimed to be the longest follow-up of any gene therapy programme for SCD.

Food and Drug Administration 52

Food and Drug Administration FDA Prescription Food 52

World of DTC Marketing

DECEMBER 23, 2020

According to a study in the Journal for American Board of Family Medicine “respondents (76%) said they were likely to ask a health care provider about advertised drugs; 26% said they had already done so. Online research is used to evaluate new prescription drugs. A great example of poorly timed DTC is Humira.

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Prescription Doctors Side effects Marketing 249

Pharmaceutical Technology

JANUARY 31, 2023

FDA director Robert Califf gave his prognosis for the pharma industry at this year’s JP Morgan Healthcare Conference in San Francisco over January 9–12. This “skinny” bill passed just in time to continue funding the FDA, with few of the planned amendments. billion in funding, a $226 million increase on the previous year.

FDA 52

FDA Prescription Medicine Biopharma 52

pharmaphorum

OCTOBER 27, 2022

The FDA has accepted for review Seres Therapeutics’ Biologics License Application (BLA) for SER-109, an investigational oral microbiome therapeutic for the prevention of recurrent Clostridium difficile infection (rCDI). If approved, SER-109 would be the first-ever FDA-approved oral microbiome therapeutic. Now at $6.79

FDA 44

FDA Prescription Food Medical 44

European Pharmaceutical Review

DECEMBER 6, 2022

The European Medicines Agency (EMA) has accepted the marketing authorisation application (MAA) for tofersen, to treat superoxide dismutase 1 (SOD1) amyotrophic lateral sclerosis (ALS). The MAA also contains recent results from the studies, which were published in The New England Journal of Medicine.

Marketing 86

Marketing Food and Drug Administration Medicine Prescription 86

PM360

NOVEMBER 29, 2022

Drug labels hold value for life sciences companies because they are rich, extensive documents that can be used across labeling, regulatory, safety, and medical affairs. Typically, a drug label refers to any information provided with prescription drugs, as requested by regulators such as the U.S.

Food and Drug Administration 98

Food and Drug Administration Competition Safety Pharmacology 98

PM360

SEPTEMBER 15, 2022

In many of the states where abortion is banned, strictly regulated, or soon to be restricted, the procedure is legal only in instances of a life-threatening situation, but no regulations define what such a situation may be, leaving 70% of physicians unclear about when to intervene for maternal safety. FDA Update. Drug Approvals.

Healthcare 52

Healthcare Healthcare Doctors Physicians 52

pharmaphorum

OCTOBER 12, 2018

The development of software applications that are available with a prescription took a major step forward last year with the first FDA approval for a mobile medical application with both a safety and efficacy label.

Healthcare 52

Healthcare Healthcare Prescription Doctors 52

European Pharmaceutical Review

NOVEMBER 15, 2022

As ISPE GAMP 5 Second Edition notes in the preface “Operating in a highly regulated industry may lead practitioners to apply prescriptive and rigid compliance-based approaches that are not commensurate with and not effective in managing any actual risk to the product and the patient.” Takeaways from ISPE’s GAMP 5 Second Edition update.

Manufacturing 83

Manufacturing Pharma Food and Drug Administration Safety 83

PM360

AUGUST 9, 2022

The combined solution enables health plans and self-insured employers to realize immediate pharmacy cost savings and near-term medical cost reductions by integrating Levrx’s plan-specific and real-time prescription insights into the Adhere Platform medication optimization offerings. The Andaman7 Platform Solution. Vincent Keunen.

Prescription 105

Prescription Medical Side effects Patients 105

pharmaphorum

AUGUST 11, 2022

More than 60 percent of all American adults take prescription drugs , amounting to approximately 131 million individuals. Many FDA-cleared drugs have pharmacogenomics data on the label, which indicate the biomarker information to help guide decisions regarding the use of the therapeutic in individual patients.

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Side effects Medical Prescription Patients 78

pharmaphorum

DECEMBER 22, 2022

Prediction 1: the FDA will become more directive and collaborative on guidelines for DCTs. The risk of not having these discussions is to conduct expensive trials only to discover too late that they were measuring the wrong endpoint, in the wrong way, or with a tool or technology the FDA does not accept.

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FDA Patients Electronics Medical 73

Pharmaceutical Technology

OCTOBER 28, 2022

It aims to ensure the quality of medicines by employing statistical, analytical, and risk-management methodology in the design, development, and manufacturing processes of medicines. They may be therapeutically as effective, but the safety aspect is a key concern in approving biosimilarity.”.

Manufacturing 52

Manufacturing Safety Medicine Pharmaceutical products 52

PM360

DECEMBER 20, 2023

Three Categories of Drugs Medicines entering the Chinese market will be classified into three categories: Category 1 refers to medicines listed on the “National Essential Medicine List” and are eligible for full reimbursement by BMI. The drugs in the list are both Western medicines and traditional Chinese medicines.

Marketing 105

Marketing Insurance Medical Manufacturing 105

PM360

AUGUST 9, 2022

The industry has been limited in its ability to implement creative solutions to engage and motivate patients because the FDA has strict guidelines for what pharma companies can communicate with patients. Measuring and monitoring adherence in clinical trials would add valuable information about the effectiveness and safety of drugs.

Medical 105

Medical Electronics Patients Healthcare 105

Clarivate

MARCH 17, 2022

How feasible is it to establish a drug’s safety for use in a population that may be unwilling or unable to participate in clinical trials? Experts at a November 2021 Food and Drug Administration (FDA) meeting also wrestled with this theme of clinical trials and pregnancy. Medicine use during pregnancy: balancing risks.

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Food and Drug Administration Safety FDA Ethics 10

Pharmaceutical Technology

MAY 31, 2023

The Janssen Pharmaceutical Companies of Johnson & Johnson has submitted a new drug application (NDA) for its investigational single-tablet combination therapy of macitentan 10mg and tadalafil 40mg (M/T STCT) to the US Food and Drug Administration (FDA), to treat pulmonary arterial hypertension (PAH).

Food and Drug Administration 98

Food and Drug Administration FDA Medicine Prescription 98

European Pharmaceutical Review

JANUARY 5, 2023

The US Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) has accepted the Biologics License Application (BLA) for nirsevimab for the prevention of respiratory syncytial virus (RSV) lower respiratory tract infection (LRTI) in all infants. The safety profile of nirsevimab was similar to placebo.

Food and Drug Administration 59

Food and Drug Administration FDA Safety Prescription 59

Pharmaceutical Technology

AUGUST 8, 2022

In 2017, the US Food and Drug Administration (FDA) broke ground by approving the first drug with an embedded biosensor to track its use. Yet, despite the landmark FDA approval, digital pills have not exploded in pharma. Proteus Health’s Abilify MyCite had an ingestible sensor that could track if a patient consumed the drug.

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Food and Drug Administration FDA Medicine Patients 122

PM360

DECEMBER 14, 2022

From hair loss to allergies and acne, Amazon Clinic allows patients to message clinicians for a diagnosis, treatment, and medication prescription. is the major contributor to this rise with 30 states having legalized the use of cannabis, medicinally or for general adult use. billion in 2019. While projections are global, the U.S.

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Manufacturing Medical Healthcare Healthcare 52

PM360

JUNE 11, 2022

For example, everyone must be steeped in both FDA and FTC guidelines. Then, the MRL team and the influencer must align on where there is flexibility within messaging while still abiding to brand safety guidelines, as you don’t want to lose the authenticity that the influencer brings.

Patients 59

Patients Pharma Education Media 59

Pharmaceutical Technology

OCTOBER 10, 2022

The company plans to submit a request for advice from the FDA at the end of this year or the start of 2023, he adds. In 2015, the FDA approved Sprout Pharmaceuticals’s Addyi, also known under the generic name flibanserin, for use by pre-menopausal women with hypoactive sexual desire disorder (HSDD).

Pharmacology 59

Pharmacology Side effects FDA Safety 59

Pharmaceutical Technology

MAY 31, 2023

The US Food and Drug Administration (FDA) has proposed a new model for prescription medication guides for brand name and generic drugs, to increase accessibility and reduce medication nonadherence. The FDA said that the proposed revamp should help limit preventable adverse drug reactions and improve health outcomes.

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Prescription FDA Food and Drug Administration Medical 52

Pharmaceutical Technology

MAY 4, 2023

After a winter marked by a rise in hospitalisations due to the RSV, the FDA has granted its first approval for an Respiratory Syncytial Virus (RSV) vaccine to GSK’s Arexvy for adults ages 60 years and above. These recommendations and the FDA approval were based on positive AReSVi-006 Phase III trial data.

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FDA Safety Medicine Prescription 64

Pharmaceutical Technology

MAY 1, 2023

After a US Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) Advisory Committee (AdCom) meeting in March 2023 voted unanimously in support of GSK’s respiratory syncytial virus vaccine, the odds for an approval have increased. Even in LICs, they do yearly checks or catch up campaigns.

Food and Drug Administration 52

Food and Drug Administration Medicine Pharmaceutical Marketing 52

World of DTC Marketing

MAY 6, 2021

Some commercially insured patients who pay only prescription drug copayments appear to be insulated from increases in drug prices. A study published in JAMA Internal Medicine examined the costs of developing 10 cancer drugs approved by the FDA from 2006 to 2015 and provided a strong contrast to the Tufts study from a year before.

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Pharma Food and Drug Administration Government Insurance 185