Dear FDA: WTF?

World of DTC Marketing

SUMMARY: The FDA wants to look at how certain brand names affect consumer and health care providers’ perceptions about the efficacy and the medical conditions for which they’re indicated. The FDA’s scientists don’t understand marketing because marketing is not a science.

FDA 163

The FDA and Aduhelm: WTF?

World of DTC Marketing

One agency FDA adviser, resigning from his committee post in protest, called it “probably the worst drug approval decision in recent U.S. Biogen’s Aduhelm won FDA approval after discovering that some patients on higher dosages had displayed improvement of.39

FDA 190

New FDA head needs to examine the accelerated approval program

World of DTC Marketing

The FDA’s “accelerated approval” program expedites the evaluation process for new treatments so that patients can have access to them sooner. Between 2011 and 2018, cumulative spending on 44 FDA-approved oral targeted therapy drugs was $3.5 FDA Accelerated Approval

FDA 201

“I don’t trust the FDA anymore”

World of DTC Marketing

SKIMMERS SUMMARY: Health experts, including those on an external advisory committee to the FDA, are skeptical that Biogen’s drug will even successfully slow the progression of Alzheimer’s after late-stage clinical trials yielded mixed results and are angry the FDA approved the product.

FDA 153

Drug companies know how to play the FDA drug approval process

World of DTC Marketing

SUMMARY: The FDA has many puzzled as to why they approve some drugs with questionable data and ask for more data on other drugs. The FDA approves drugs on the potential to save a life, the cost of the drugs is never considered in the process.

FDA 168

Another reason change is needed at FDA? Fair balance

World of DTC Marketing

If the FDA understood consumer behavior like marketers instead of scientists, they would understand how DTC works. More importantly, the FDA needs to work with online sites to eliminate health misinformation. This is normal, and the FDA should take note.

FDA 153

A sad day for us all as the FDA continues to lose credibility

World of DTC Marketing

SUMMARY: The approval of Biogen’s Alzheimer’s drug, after its advisory panel turned it down, begs the Inspector General to open an investigation into the FDA. The FDA gave approval to a medication despite a strong NO vote from their advisory panel of scientific advisers.

FDA 181

FDA warning letter puts maker of nicotine gummies in a sticky situation

MedCity News

The FDA issued a warning letter about nicotine gummies—the first ever notification sent for such a product. BioPharma Daily Legal Pharma SYN Top Story biopharma nl cancer FDA FDA Warning Letter legal nicotine

FDA 81

FDA says pharmacists can prescribe Covid treatment

MedCity News

Daily Legal SYN Top Story American Medical Association biopharma nl FDA Paxlovid PharmacistsThe AMA believes physicians should still be the main prescribers, while advocates for provider status for pharmacists say it’s a win for health equity and will expand treatment access.

FDA 96

Pfizer, BioNTech seek FDA authorization for omicron-adjusted Covid-19 boosters

MedCity News

Pfizer and BioNTech have completed their filing seeking FDA emergency use authorization of their omicron-adapted Covid-19 booster shot. Production of this bivalent vaccine has already begun, enabling the companies to begin distribution as soon as the FDA authorizes the shot.

Pfizer, BioNTech Covid-19 vaccine gets full FDA approval for adolescents

MedCity News

The FDA has granted the Pfizer and BioNTech Covid-19 full approval for use in adolescents. BioPharma Daily Legal Pharma SYN Top Story BioNTech biopharma nl Clinical Trials Covid vaccines COVID-19 FDA legal Pfizer

FDA 90

FDA finally signs off on Fennec Pharma drug for chemo-caused hearing loss in kids

MedCity News

The regulatory decision comes more than two years later than expected, but the company now claims its drug, Pedmark, is the first and only FDA-approved therapy for reducing the risk of chemotherapy-induced hearing loss in pediatric cancer patients.

FDA 70

Better late than never? Axsome depression drug is approved a year after FDA delay

MedCity News

The FDA has approved Axsome Therapeutics drug Auvelity as a treatment for major depressive disorder in adults. BioPharma Daily Legal Pharma SYN Top Story Auvelity Axsome Therapeutics biopharma nl Clinical Trials depression FDA Herriot Tabuteau New York

FDA 92

Merck HIV drug trials paused by FDA will resume under modified plan

MedCity News

BioPharma Daily Legal Pharma SYN Top Story antiviral biopharma nl Clinical Trials FDA HIV drugs Merck New Jersey RahwayA Merck HIV drug placed under multiple full and partial clinical holds last year is now clear to resume testing.

FDA 79

FDA turns down Acadia Pharma drug for Alzheimer’s psychosis; new trial needed

MedCity News

Acadia Pharmaceuticals drug Nuplazid failed to win FDA approval for the treatment of psychosis in Alzheimer’s disease patients. BioPharma Daily Legal Pharma SYN Top Story Acadia Pharmaceuticals alzheimer's disease anti-psychotic drug Clinical Trials FDA Nuplazid San Diego

FDA 94

Turmoil at FDA or just another day?

World of DTC Marketing

SUMMARY: Marion Gruber, director of the FDA’s Office of Vaccines Research & Review, and deputy director Phil Krause will exit the agency because the White House is getting ahead of the agency on COVID booster shots. The FDA has to earn the trust of both HCPs and the public.

FDA 154

FDA backs pharmacist prescribing of Paxlovid for COVID

Pharma Phorum

Some patients with COVID-19 will be able to get easier access to Pfizer’s oral antiviral therapy Paxlovid, after the FDA ruled that pharmacists would be able to prescribe the drug. The FDA’s amendment to the EUA comes as Pfizer has just filed for full approval of Paxlovid.

FDA 96

FDA Authorizes Bivalent COVID-19 Boosters

PharmaTech

FDA has issued an emergency use authorization for both the Pfizer-BioNTech and Moderna bivalent COVID-19 boosters.

FDA 52

FDA approval of AstraZeneca drug is first for a new group of breast cancer patients

MedCity News

Enhertu, a breast cancer drug from AstraZeneca and Daiichi Sankyo, is now FDA approved for treating patients whose tumors express low levels of the protein HER2. BioPharma Daily Legal Pharma SYN Top Story AstraZeneca biopharma nl breast cancer Clinical Trials Daiichi Sankyo FDA legal

FDA 91

FDA rejection of Spero’s tebipenem ‘raises resistance threat’

Pharma Phorum

The FDA’s decision not to approve Spero Therapeutics’ oral antibiotic tebipenem Hbr for adults with complicated urinary tract infections (cUTI) further increases the threat of antibiotic resistance, according to a GlobalData analyst.

FDA 97

FDA setback leads women’s health biotech ObsEva to give up on uterine fibroids drug

MedCity News

ObsEva’s uterine fibroids drug linzagolix has hit a snag at the FDA, portending a likely delayed regulatory decision. BioPharma Daily Legal News Pharma SYN Top Story biopharma nl FDA Geneva ObsEva Switzerland uterine fibroids Women's Health

Leads 98

FDA hits pause on Beam Therapeutics’ off-the-shelf cell therapy for blood cancers

MedCity News

Beam Therapeutics’ application to begin human testing of a cell therapy made with base-editing technology is now under an FDA clinical hold. In other clinical hold news, the FDA lifted a hold on a Celyad Oncology cell therapy clinical trial that was halted in March.

FDA 88

Who do you trust? The FDA vs. Pfizer

World of DTC Marketing

The FDA and CDC say “not so fast.” ” However, the FDA and CDC say, “Americans who have been fully vaccinated do not need a booster shot at this time,” the agencies said in a joint statement.”

FDA 239

FDA authorizes updated Covid-19 boosters to protect against omicron this fall, winter

MedCity News

The FDA has authorized mRNA Covid-19 booster shots designed to protect against the original strain of the novel coronavirus, as well as the two omicron subvariants that are currently driving U.S.

FDA 81

Hearing experts applaud FDA approval of over the counter hearing aids

MedCity News

The FDA’s final rule could make hearing aids available as soon as October. Devices & Diagnostics Legal SYN Top Story audiology FDA hearing aids

FDA 82

New funding fuels device-maker’s pursuit of FDA approval

MedCity News

Daily Devices & Diagnostics News SYN Top Story Advent Life Sciences FDA Approval Moximed osteoarthritisMoximed snagged $40 million as it works to secure approval for its device, an implantable shock absorber for the knee designed to put off the need for full joint replacement.

FDA 75

FDA delay means BeiGene, Novartis must wait longer for cancer drug decision

MedCity News

The FDA has deferred a regulatory decision on an esophageal cancer drug from partners BeiGene and Novartis, citing the need to complete inspections of the China-based facilities where the drug is made.

FDA 91

FDA panel shoots down Spectrum, Oncopeptides’ cancer drugs

Pharma Phorum

Chances of FDA approval for Spectrum Pharma’s lung cancer candidate poziotinib and Oncopeptides’ Pepaxto for multiple myeloma have taken a dive, after the regulator’s expert advisors voted that the drugs were not ready to reach the market.

Undeterred by FDA setback, GSK snaps up Spero antibiotic

Pharma Phorum

GSK is paying $66 million upfront to license rights to Spero Therapeutics novel antibiotic tebipenem Hbr, unswayed by the FDA’s decision earlier this year not to approve the drug for adults with complicated urinary tract infections (cUTI).

FDA 52

AstraZeneca & Daiichi drug wins another FDA approval, this time in lung cancer

MedCity News

On the heels of receiving a landmark FDA approval in breast cancer, AstraZeneca and Daiichi Sankyo drug Enhertu won an additional approval in non-small cell lung cancer.

FDA 78

FDA and NIH partner for neurodegenerative disease treatment development

Pharmaceutical Technology

The US Food and Drug Administration (FDA) and the US National Institutes of Health (NIH) have unveiled a public-private partnership (PPP) to understand and develop treatments for neurodegenerative diseases.

Novartis pays $100M to get Mallinckrodt’s ticket for a speedier FDA drug review

MedCity News

Novartis is acquiring an FDA priority review voucher from Mallinckrodt Pharmaceuticals. BioPharma Legal Pharma SYN Top Story biopharma nl FDA Ireland Mallinckrodt Pharmaceuticals Novartis rare diseases Switzerland

FDA 88

Bluebird Bio gene therapy wins first FDA approval for rare blood disorder

MedCity News

FDA approval of Bluebird Bio’s Zynteglo makes it the first gene therapy in the U.S. BioPharma Daily Legal Pharma SYN Top Story bluebird bio Clinical Trials FDA legal Massachusetts rare diseases Somerville Zynteglo

FDA 78

Liver injury leads FDA to pause Sanofi’s tests of MS drug acquired in $3.7B deal

MedCity News

The FDA placed a partial clinical hold on late-stage tests of Sanofi multiple sclerosis drug tolebrutinib after some patients developed drug-induced liver injury. BioPharma Daily Legal Pharma SYN Top Story biopharma nl Clinical Trials FDA legal multiple sclerosis Paris Sanofi tolebrutinib

Congress Slated to Reauthorize User Fees without FDA “Improvements”

PharmaTech

Legislative leaders are looking to approve a bare-bones measure to fund FDA operations as part of a short-term government funding bill.

Do patients care about accelerated approval drugs?

World of DTC Marketing

Accelerated Approval was developed in 1992 in response to the HIV/AIDS crisis and has led to expedited drug and biologic approvals in several disease areas across the FDA. Of course, they should, but in the end, it’s going to come down to trust in their doctor and the FDA.

FDA lifts partial clinical hold on Curis cancer drug in lymphoma study

MedCity News

BioPharma Daily Legal Pharma SYN Top Story cancer Clinical Trials Curis FDA leukemia Lexington lymphoma MassachusettsWhile the lymphoma study is now clear to resume enrolling patients, the status of a partial hold on a separate leukemia study remains unchanged so far.

FDA 78

With new gene therapy data in hand, Sarepta talks with FDA about approval pathways

MedCity News

BioPharma Daily Pharma SYN Top Story biopharma nl Cambridge Clinical Trials Doug Ingram duchenne muscular dystrophy FDA Massachusetts Sarepta Therapeutics

GSK’s daprodustat will have to face FDA advisory committee

Pharma Phorum

GSK has said that its daprodustat for anaemia associated with chronic kidney disease (CKD) will have to face an FDA advisory committee before the US regulator delivers a verdict on the drug early next year.

FDA and NIH partner to understand ALS

European Pharmaceutical Review

The partnership we are announcing today will leverage the shared expertise of all participants to create a path towards new breakthroughs in treating these diseases,” commented FDA’s Chief Medical Officer, Dr Hilary Marston.