Pharmaceutical Technology

MAY 31, 2023

The US Food and Drug Administration (FDA) has accepted Bristol Myers Squibb’s new drug application (NDA) for repotrectinib for priority review. Repotrectinib is a tyrosine kinase inhibitor (TKI) intended to treat patients with ROS1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC).

Food and Drug Administration 52

Food and Drug Administration FDA Safety Prescription 52

World of DTC Marketing

DECEMBER 23, 2020

Among the 26% of respondents who talked to a health care provider about a specific prescription drug they saw advertised, 16% said they received a prescription for the advertised drug. Online research is used to evaluate new prescription drugs. What are other patients saying about it? Is TV the best channel?

Prescription 249

Prescription Doctors Side effects Marketing 249

Pharmaceutical Technology

JUNE 14, 2023

Ipsen has received US Food and Drug Administration (FDA) approval for Bylvay (odevixibat) to treat patients aged 12 months and above with cholestatic pruritus caused by Alagille syndrome (ALGS). More than 90% of patients who received treatment with odevixibat were pruritus responders.

Food and Drug Administration 52

Food and Drug Administration FDA Transportation Prescription 52

Pharmaceutical Technology

APRIL 19, 2023

The US Food and Drug Administration (FDA) has accepted Arcutis Biotherapeutics ’ new drug application (NDA) for roflumilast foam 0.3% to treat patients aged nine years and above with seborrheic dermatitis. in patients with seborrheic dermatitis. in patients with seborrheic dermatitis.

Food and Drug Administration 52

Food and Drug Administration FDA Safety Prescription 52

pharmaphorum

SEPTEMBER 30, 2022

Patient organisations have been celebrating the FDA approval yesterday of Amylyx’ amyotrophic lateral sclerosis (ALS) therapy Relyvrio, after not one but two advisory committee meetings that arrived at different conclusions about the drug. An oral version of edaravone was cleared this year.

FDA 88

FDA Doctors Patients Prescription 88

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

Pharmaceutical Technology

FEBRUARY 8, 2023

The US Food and Drug Administration (FDA) has accepted Aldeyra Therapeutics’ new drug application (NDA) for topical ocular reproxalap to treat signs and symptoms of dry eye disease. The regulator has assigned 23 November 2023 as the Prescription Drug User Fee Act (PDUFAs) date for its decision.

Food and Drug Administration 52

Food and Drug Administration FDA Prescription Food 52

Pharmaceutical Technology

JULY 25, 2022

AstraZeneca and Daiichi Sankyo have received Priority Review for their supplemental Biologics License Application (sBLA) from the US Food and Drug Administration (FDA) of antibody-drug conjugate (ADC), Enhertu (trastuzumab deruxtecan), to treat unresectable or metastatic HER2-low breast cancer in adults.

Food and Drug Administration 52

Food and Drug Administration FDA Safety Prescription 52

Pharmaceutical Technology

JUNE 1, 2023

Additionally, when asked whether the FDA should consider a potential accelerated approval, panellists voted 15 to one against that regulatory pathway for the drug. Additionally, when asked whether the FDA should consider a potential accelerated approval, panellists voted 15 to one against that regulatory pathway for the drug.

FDA 52

FDA Side effects Prescription Patients 52

Nixon Gwilt Law

FEBRUARY 27, 2023

If this data isn’t available, the practitioner must limit the prescription to a 7-day supply; Keeps detailed records regarding prescriptions written based on telemedicine encounters. Records can be kept in digital or paper form, and the proposed rule includes specific data points (e.g.,

Prescription 105

Prescription Medical Patients Specialization 105

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

PM360

SEPTEMBER 15, 2022

The term “patient centricity” has been around for over a decade, and since its first utterance the buzzword has been praised, dissected, criticized, and everything in between. The concept has always been worthwhile, but people within and outside of the industry have wondered whether the industry was truly becoming more patient centric?

Patients 98

Patients Healthcare Healthcare Marketing 98

pharmaphorum

JANUARY 5, 2023

Addiction treatment specialist Spero Health has expanded an agreement to use Pear Therapeutics’ prescription digital therapeutics (DTx) in its network of US clinics. We believe having access to patient-reported data via Pear’s clinician dashboard gives us better insight into patient behaviours.”. billion.

Prescription 52

Prescription Specialization FDA Networking 52

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. Qualio surveyed 2,002 U.S.

Healthcare 52

Healthcare Healthcare Doctors Physicians 52

pharmaphorum

DECEMBER 22, 2022

The life sciences industry is flexing towards innovation in new areas, faster than ever before, and increasing patient care in astonishing ways. We can now measure patient activity, steps, and movement continuously and in real time, which serves as a new potential indicator of treatment effectiveness.

FDA 86

FDA Patients Electronics Medical 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. Challenges in Working with Label Data.

Food and Drug Administration 98

Food and Drug Administration Competition Safety Pharmacology 98

PM360

OCTOBER 13, 2023

HCPs need pharma, and pharma needs HCPs—so let’s make sure that this next chapter of engagement is one of partnership, in pursuit of the interest of patients.” Only 15% of prescribers think the drugs come at reasonable cost to patients or have decent insurance coverage eligibility. Three quarters of U.S.

Healthcare 59

Healthcare Healthcare Doctors Pharma 59

European Pharmaceutical Review

NOVEMBER 8, 2022

In the current US Congressional session, Congress has focused heavily on legislation directed at reducing prescription drug prices. Citizen Petitions before the FDA. 2 Submission of a Citizen Petition to the FDA obligates the regulator to address the arguments raised. 5) monitoring access to biosimilars. Senate Bill 562 (S.

Food and Drug Administration 52

Food and Drug Administration Pharma Prescription Manufacturing 52

Pharmaceutical Technology

JULY 14, 2022

Avrobio has received orphan drug designation for its gene therapy, AVR-RD-05, from the US Food and Drug Administration (FDA) to treat mucopolysaccharidosis type II (MPSII) or Hunter syndrome. AVR-RD-05 had previously obtained rare pediatric disease designation from the FDA.

Food and Drug Administration 52

Food and Drug Administration FDA Prescription Food 52

PM360

AUGUST 9, 2022

How can we help ensure patients continue to take their medications as prescribed? The reasons why a patient may not take their medication are plentiful, and as a result so are the solutions now available to attempt to solve this issue. But it is not a simple answer. Furthermore, it is estimated to reach $6.5 Vincent Keunen.

Prescription 105

Prescription Medical Side effects Patients 105

World of DTC Marketing

FEBRUARY 4, 2021

prescriptions of finasteride, as the drug is known, for hair loss increased to over 2.4 The company decided there were too few reports of serious depression and suicidal behavior and not enough specifics about those cases to warrant more than “routine” monitoring of safety data. Newly unsealed court documents show that Merck and U.S.

Pharma 180

Pharma Food and Drug Administration Side effects Safety 180

pharmaphorum

AUGUST 11, 2022

More than 60 percent of all American adults take prescription drugs , amounting to approximately 131 million individuals. There have been great strides made in genomics to refine tools that determine the safest, most effective course of treatments for patients across a number of disease states. billion in the United States alone.

Side effects 91

Side effects Medical Prescription Patients 91

World of DTC Marketing

FEBRUARY 9, 2021

Consistently we heard that they like images of real patients or a REAL doctor with one key message communicated. 6ix: Safety information needs context. 7even: Real patient stories. They wanted to know why pharma didn’t communicate that their websites had to meet FDA guidelines? 6ix: Lack of drug comparisons.

Pharma 180

Pharma Side effects Medical FDA 180

PM360

JUNE 11, 2022

Only 5% of patients ranked pharma companies as the most trusted player in the healthcare space, according to a 2021 survey of 500 patients from Accenture. But 71% also want publicly shared information about how patients’ perspectives were incorporated into the development of products and services. Noël Moossa.

Patients 59

Patients Pharma Education Media 59

pharmaphorum

OCTOBER 12, 2018

Digital technology is transforming the way that healthcare is practiced and delivered, with areas like digital therapeutics forging ahead to complement traditional medical approaches and augment patient care. We’ll be looking at how digital and traditional approaches to medicine are being combined to improve patient outcomes.

Healthcare 52

Healthcare Healthcare Prescription Doctors 52

pharmaphorum

AUGUST 11, 2022

Zantac was originated by GSK and launched by the company in the early 1908s, which sold it as a prescription and over-the-counter (OTC) product for indications like heartburn and acid indigestion over the years. Some voluntarily took their products off the market as soon as the NDMA finding was reported by the FDA.

Sales 100

Sales Prescription FDA Marketing 100

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 85

Manufacturing Pharma Food and Drug Administration Safety 85

pharmaphorum

DECEMBER 7, 2022

Pharma companies involved in the sale of heartburn therapy Zantac have won a key battle in litigation brought by patients who claim the drug caused them to develop cancer.

Prescription 73

Prescription Sales FDA Pharma 73

Legacy MEDSearch

OCTOBER 25, 2023

Theranica , a neuromodulation therapeutics company, announced the publication of a comprehensive clinical study in Advances in Therapy examining the long-term utilization, clinical efficacy, and safety of Nerivio ® , a Remote Electrical Neuromodulation (REN) device for the treatment of migraine. As for clinical efficacy, 74.1%

Side effects 52

Side effects Recruitment Networking Management 52

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. Today, we still can’t easily discern whether a patient took their pill or not and the reason why. Michael Oleksiw.

Medical 105

Medical Electronics Patients Healthcare 105

Pharmaceutical Technology

OCTOBER 28, 2022

They inform industrial scientists what is necessary to ensure that their product meets the safety and efficacy requirements to get a product approved in humans. For companies in the US, if the results show bioequivalence, an abbreviated new drug application (ANDA) containing the results is sent to the FDA to review and potentially approve.

Manufacturing 52

Manufacturing Safety Medicine Pharmaceutical products 52

pharmaphorum

JANUARY 25, 2023

Digital therapeutics company Woebot Health has announced enrolment of the first patient in a pivotal clinical trial to evaluate the safety and efficacy of WB001, an investigational therapeutic for postpartum depression (PPD), granted Breakthrough Device designation by the US Food and Drug Administration (FDA) in 2021.

Food and Drug Administration 93

Food and Drug Administration Prescription Media FDA 93

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.

Food and Drug Administration 10

Food and Drug Administration Safety FDA Ethics 10

PM360

DECEMBER 20, 2023

Medicines that are not listed in either Category 1 or 2, such as over the counter (OTC) and other prescription therapies (pembrolizumab, CAR-T therapy, etc.), FDA or EMA) and if the “Lecheng Medical Products Administration Bureau” recognizes the status of “clinical urgency.” The GBA gives patients access to innovative drugs (e.g.,

Marketing 105

Marketing Insurance Medical Manufacturing 105

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

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. Proteus Health’s Abilify MyCite had an ingestible sensor that could track if a patient consumed the drug. Yet, despite the landmark FDA approval, digital pills have not exploded in pharma.

Food and Drug Administration 122

Food and Drug Administration FDA Medicine Patients 122

Medgadget

MAY 2, 2023

The system uses the patient’s EEG data to calculate a value for the amygdala-derived-EFP biomarker, and meanwhile the patient tries various mental strategies that may help to reduce the value. These treatments at times come with a long list of side effects, leaving many patients in search of an effective long-term solution.

Side effects 87

Side effects Prescription Healthcare Healthcare 87