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.

FDA 96

FDA Patients Electronics Medical 96

PM360

SEPTEMBER 15, 2022

Patient Pages: Patients Refuse Prescription Use After Recalls. adults are unlikely to use a prescription drug that has experienced a recall, regardless of whether that issue was fixed. FDA Update. BrainsWay’s coils are housed in a cushioned helmet and have been used to stimulate one portion of the brain to treat OCD since 2018.

Healthcare 52

Healthcare Healthcare Doctors Physicians 52

World of DTC Marketing

FEBRUARY 4, 2021

Amgen CEO Bob Bradway racked up a 2018 pay package of $18.6 prescriptions of finasteride, as the drug is known, for hair loss increased to over 2.4 Food and Drug Administration (FDA) is meant to help patients and warn of potential drug side effects but a Vice report indicates something more. ” Ouch. Annual U.S.

Pharma 180

Pharma Food and Drug Administration Side effects Safety 180

Clarivate

MARCH 17, 2022

Experts at a November 2021 Food and Drug Administration (FDA) meeting also wrestled with this theme of clinical trials and pregnancy. Ahead of the meeting, the FDA highlighted nonclinical findings (i.e., We look at the outcome of a recent Food and Drug Administration meeting and their draft guidance for more information.

Food and Drug Administration 10

Food and Drug Administration Safety FDA Ethics 10

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. When Coherus BioSciences received FDA approval for Cimerli , a biosimilar to Roche’s eye disease medicine Lucentis , it was also granted drug interchangeability without requiring a switching study.

Medical 52

Medical Manufacturing Healthcare Healthcare 52

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.

Prescription 52

Prescription FDA Food and Drug Administration Medical 52

Pharmaceutical Technology

JANUARY 6, 2023

Last week, Novartis announced plans to pay $245 million to end a pay-for-delay legal battle that started in 2018. Last year, Novartis began with a win in January, as the US Court of Appeals affirmed the validity of Gilenya’s patent, allowing the company to sue a competitor generics company for filing for FDA approval for its Gilenya generic.

Pharmaceutical 97

Pharmaceutical Doctors Healthcare Provider Prescription 97

Pharmaceutical Technology

DECEMBER 4, 2022

There are seven FDA-approved Humira biosimilars, of which Amgen’s Amjevita will be launched in January. Humira biosimilars became available in the EU in October 2018. While small molecule drugs can be remade into identical generics, biologics are more complex.

Marketing 104

Marketing Physicians Competition Patients 104

World of DTC Marketing

APRIL 7, 2022

Food and Drug Administration (FDA). Thirty-seven thousand three hundred forty-eight patients who received one or more of 44 new oral targeted cancer drugs, the proportion of patients receiving medications without documented overall survival benefit increased from 13% in 2011 to 59% in 2018, accounting for 52% of the $3.5

Healthcare 215

Healthcare Healthcare Food and Drug Administration Government 215

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.

Pharma 185

Pharma Food and Drug Administration Government Insurance 185

Clarivate

OCTOBER 17, 2024

Since the government first created a Part D benefit with the Medicare Modernization Act of 2003 (MMA) , Democrats have agitated for greater governmental input into the cost of prescription drugs for Medicare beneficiaries. It allowed the largest healthcare merger in history – that of CVS and Aetna in 2018 – requiring only minimal divestment.

Healthcare 52

Healthcare Healthcare Government Insurance 52