pharmaphorum

DECEMBER 29, 2022

The FDA granted full approval to Par’s generic on 28 March, 2013. Plaintiffs – in this case direct purchasers, indirect purchasers and retailers including CVS Health, Kroger, Rite Aid and Walgreens Boots Alliance according to Reuters – filed suit against Novartis and Par in 2018 alleging violation of federal antitrust laws.

Retail 52

Retail Marketing Doctors Government 52

Pharmaceutical Technology

FEBRUARY 24, 2023

Amivantamab is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.

Retail 40

Retail Distribution Pharmaceutical Pharmaceutical products 40

European Pharmaceutical Review

NOVEMBER 8, 2022

For example, the US recently passed the Inflation Reduction Act, 1 which requires the Secretary of Health and Human Services (HHS) to negotiate prices for certain physician-administered and retail prescription drugs covered under Medicare Parts B and D. Citizen Petitions before the FDA. 5) monitoring access to biosimilars.

Food and Drug Administration 52

Food and Drug Administration Pharma Manufacturing Prescription 52

Pharmaceutical Technology

JANUARY 6, 2023

In the case of Novartis’ antihypertensive drug Exforge (amlodipine and valsartan), retail pharmacies including CVS, Walgreens, and two other plaintiff groups accused Novartis and Endo International’s Par Pharmaceutical unit of forming an illegal “reverse payment” agreement to delay the launch of less expensive generic versions of the drug.

Pharmaceutical 97

Pharmaceutical Doctors Healthcare Provider Prescription 97

Rep-Lite

FEBRUARY 26, 2021

It will probably be hiring substantially this year too – it has an FDA-authorised Covid-19 diagnostic which helped plug the Cologuard sales shortfall in the second quarter. Covid-19 will not help: the group has suspended sales to new patients in its retail treatment centers owing to the pandemic.

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Sales Retail Government Medical 52

Clarify Health

DECEMBER 13, 2022

Question: What’s the FDA’s approach to unlocking the full promise of real-world evidence? Mr. Gohil said, “When we look at the FDA, since 2016, the industry overall has seen a good amount of adoption. It’s not just the FDA,” he said. I think the pandemic sped that up a bit.

Recruitment 52

Recruitment Retail Patients FDA 52

pharmaphorum

OCTOBER 26, 2022

We promptly discussed this need with the FDA and the agency agreed to a proposed amendment of the protocol to accommodate, in a safe manner, the patient access to the EAP.”. Previously he was with Accenture where he led large teams in outsourcing projects across Europe and US for clients in the transportation and retail businesses.

Patients 95

Patients Pharma Consulting Transportation 95

Clarify Health

DECEMBER 13, 2022

Question: What’s the FDA’s approach to unlocking the full promise of real-world evidence? Mr. Gohil said, “When we look at the FDA, since 2016, the industry overall has seen a good amount of adoption. It’s not just the FDA,” he said. I think the pandemic sped that up a bit.

Recruitment 40

Recruitment Retail Patients FDA 40

pharmaphorum

JANUARY 4, 2023

Retail pharmacies in the US will be able to dispense mifepristone-based therapies to end pregnancies after the FDA introduced changes to its regulatory framework for the products. The American College of Obstetricians and Gynaecologists (ACOG) said the FDA’s decision was a victory for women’s health.

Retail 96

Retail FDA Sales Healthcare Provider 96

Pharmacy Times

JANUARY 12, 2023

Although the FDA has now allowed retail pharmacies to dispense mifepristone, a drug used for medicated abortions, questions still remain about the requirements for pharmacies and the availability of the drug.

Retail 48

Retail FDA Medical 48

Pharmacy Times

JANUARY 4, 2023

The changes will almost certainly widen access for patients seeking medicated abortions in states without legal obstacles.

Retail 49

Retail FDA Medical Patients 49

PM360

NOVEMBER 21, 2022

The two retail pharmacy giants have announced their intention to settle lawsuits regarding inappropriate opioid prescriptions at $5 billion each. Ketamine is FDA approved for anesthesia and pain management but not for depression or any other psychiatric disorder. CVS and Walgreens Announce Opioid Settlements. Local and U.S.

Government 52

Government Prescription FDA Patients 52

Pharmaceutical Technology

APRIL 21, 2023

The company has said its goal is to have an out-of-pocket retail price that is in line with its publick interest pricing strategy. Additionally, its pricing for both public interest groups and retailers going forward would be less than the current Wholesale Acquisition Cost (WAC) price of $125.

Food and Drug Administration 52

Food and Drug Administration Retail Prescription Management 52

Pharmaceutical Technology

MARCH 2, 2023

Merck sells medicines to drug wholesalers, retailers, hospitals, government agencies and managed health care providers; and animal health products to veterinarians, distributors and animal producers. The company provides animal health products such as vaccines, poultry products, livestock products and aquaculture products.

Patients 40

Patients FDA Prescription Retail 40

pharmaphorum

JANUARY 12, 2023

The Attorney General of Alabama has threatened to use an obscure law passed in 2006 to prosecute women who terminate a pregnancy using pharmacological means, shortly after the FDA made access to the drugs easier.

Pharmacology 52

Pharmacology Retail Healthcare Provider FDA 52

Cadensee

JULY 14, 2021

They've been involved in major clinical studies; they've been working with the FDA as consultants. Then if it that's going to be the case, you're going to sit there for the FDA approval. So not only M&As, the tech, the retail, the pharma that are buying. Because guess what? It's not always going to happen.

Marketing 52

Marketing Doctors Medical Management 52

Nixon Gwilt Law

NOVEMBER 5, 2021

health care support services not performed in a health care setting, telehealth services performed outside of a setting where direct patient care occurs, dispensing of prescriptions by pharmacists in retail settings). Consequently, there is a significant gap in ensuring the vaccination of our entire healthcare workforce under the ETS.

Healthcare 52

Healthcare Healthcare Training Safety 52

World of DTC Marketing

DECEMBER 9, 2020

There are 14 FDA inspectors to cover the whole country. Can you imagine the chaos that’s going to ensue when retail pharmacies announce that they have a minimal supply of Covid vaccine? Pfizer is having supplier issues, some people who received the vaccine are reporting side effects like Bell’s Palsy.

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Side effects Retail FDA Media 272

Pharmaceutical Technology

APRIL 26, 2023

The US Food and Drug Administration (FDA) has granted Atea Pharmaceuticals’ bemnifosbuvir a Fast Track designation for Covid-19 as the landscape continues to change. Atea projects the annual retail demand for oral antiviral therapeutics for Covid-19 to be worth more than $10 billion, according to the same presentation.

Food and Drug Administration 52

Food and Drug Administration Retail Food Patients 52