Saturday, February 29, 2020

First Person Dies Of Coronavirus In U.S. February 29, 20201:06 PM ET

Number of US coronavirus cases with unknown origin rises to 4 BY MARTY JOHNSON - 02/29/20 07:48 AM EST

Maverick Funds Sue Bausch Claiming Valeant Price-Gouging

Some People Stockpiling Supplies Due To Coronavirus Fear, Pharmacists Say NEW YORK (CBSNewYork) – As the coronavirus keeps spreading, some people worry that basic goods will be hard to find, so they're stockpil ... By CBS New York City, News Partner Feb 28, 2020 3:38 pm ET

Pharmacy Owners Convicted For Medicinal Scheme Worth $11.8 Million By Alondra Arana -Feb 28, 202

Pharmacy Owner Found Guilty Of Health Care Fraud, Money Laundering For Role in Billing Scheme

House bills take aim at pharmacy benefit managers By Andy Miller Feb 29, 2020 Updated 5 hrs ago

Senate bill would force Virginia to reveal sources of lethal injection drugs By Kate Masters -February 27, 202

FDA: Compounding Research

3 days ago - FDA is engaged with the following institutions to conduct research to help inform the public and the agency's policies regarding compounded drugs.
2 days ago - The United States has its first novel coronavirus-related drug shortage, according to the US Food and Drug Administration. The maker of an unnamed drug that has recently been added to the FDA Drug Shortages list told the agency that the shortage is due to the novel coronavirus.
22 hours ago - The agency cited confidential commercial information in not revealing the name of the drug, but critics say releasing details is vital in a public health crisis.

5 days ago - About 150 prescription drugs — including antibiotics, generics and some branded drugs without alternatives — are at risk of shortage if the coronavirus outbreak .
11 hours ago · Sterile Compounding Self Inspection Addendum. DOH

Coronavirus (COVID-19) Update: FDA Issues New Policy to Help Expedite Availability of Diagnostics

Today, as part of the U.S. Food and Drug Administration’s ongoing and aggressive commitment to address the coronavirus outbreak, the agency issued a new policy for certain laboratories seeking to develop diagnostic tests for coronavirus in order to achieve more rapid testing capacity in the U.S.

“We believe this policy strikes the right balance during this public health emergency,” said FDA Commissioner Stephen M. Hahn, M.D. “We will continue to help to ensure sound science prior to clinical testing and follow-up with the critical independent review from the FDA, while quickly expanding testing capabilities in the U.S. We are not changing our standards for issuing Emergency Use Authorizations. This action today reflects our public health commitment to addressing critical public health needs and rapidly responding and adapting to this dynamic and evolving situation.”

There is currently an outbreak of respiratory disease caused by a novel coronavirus that was first detected in Wuhan City, Hubei Province, China and which has now been detected in 50 locations internationally, including cases in the United States. The virus has been named “SARS-CoV2” and the disease it causes has been named “Coronavirus Disease 2019” (COVID-19). SARS-CoV-2 has demonstrated the capability to rapidly spread, leading to significant impact on health care systems and causing societal disruption. The potential public health threat posed by COVID-19 is high, both globally and to the U.S. To effectively respond to the COVID-19 outbreak, rapid detection of cases and contacts, appropriate clinical management and infection control, and implementation of community mitigation efforts are critical. This can best be achieved with ...

Wednesday, February 26, 2020

Big Pharma and politics in an election year: Ad spending soars in efforts to influence the influencers

Coronavirus Update: FDA steps to ensure quality of foreign products

This statement is attributed to: FDA Commissioner Stephen M. Hahn, M.D., and Judy McMeekin, Pharm.D., Acting Associate Commissioner for Regulatory Affairs 
Recently, we provided an update on FDA-wide activities we are engaged in related to the novel coronavirus outbreak:  COVID-19. We continue to take a multi-pronged approach to this public health emergency, including focusing on actively facilitating efforts to diagnose, treat and prevent the disease; surveilling the medical product supply chain for potential shortages or disruptions and helping to mitigate such impacts, as necessary; and leveraging the full breadth of our public health tools, including enforcement tools to stop fraudulent activity as we oversee the safety and quality of FDA-regulated products for American patients and consumers.

Today, we are providing updated and more detailed information about the status of FDA inspections in China and the agency’s oversight of imported products from China, which have been impacted by this outbreak. While we are not able to conduct inspections in China right now, this is not hindering our efforts to monitor medical products and food safety. We have additional tools we are utilizing to monitor the safety of products from China, and in the meantime, we continue ....
8 hours ago - In the U.S., there are 12 cases of people with the novel coronavirus who had traveled to China. Two of their spouses were infected upon their return. In additio
8 hours ago - Public health officials, experts and members of Congress this week sounded new alarms about the spread of a coronavirus that broke out in China late last year, 
5 hours ago - See the number of people under investigation (PUIs) in the United States and states with confirmed cases of Coronavirus Disease 2019 (COVID-19).

Airport officials say 200 travelers coming through Atlanta's airport have shown potential symptoms of the coronavirus.

4 hours ago - Airport officials say 200 travelers coming through Atlanta's airport have shown potential symptoms of the coronavirus.
18 hours ago - South Korea has emerged as a hot spot for the virus, with infections surging to more than 1,200. Italy reported an 11th fatality, while Iran has seen 15. A Brazilian ...
18 hours ago - His wife, who works in a kindergarten, was also confirmed to have contracted the virus. Germany, which has now reported 19 confirmed cases, has been braced ...
20 hours ago - As of Wednesday midday, there are 374 confirmed cases of the virus and 12 deaths. Towns in the northern region of Lombardy and Veneto remain under ...

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9 hours ago - The number of new COVID-19, or coronavirus, infections outside China has outpaced those inside the country for the first time, according to the World Health Organization (WHO). “The sudden increases of cases in Italy, the Islamic Republic of Iran and the Republic of Korea are ...

CDC confirms first 'unknown' coronavirus case in California that could raise concerns about the threat of the virus Jorge L. Ortiz John Bacon USA TODAY
4 hours ago - Hope for treating the novel coronavirus could be on the horizon, as the first US study of a drug to treat the illness is underway. So far, there is no cure or vaccine for the virus, which has infected more than 80,000 people and killed more than 2,700 worldwide in the past few ...

Trump urges calm even as US reports worrisome new virus case President Donald Trump says the U.S. is “very, very ready” for whatever the new coronavirus threat brings, even as health authorities warn Americans that more infections are coming By LAURAN NEERGAARD and RICARDO ALONSO-ZALDIVAR Associated Press

World battles virus epidemic as cases multiply outside China By KIM TONG-HYUNG and MATT SEDENSKY

365 Houston-area jobs affected by closure of AmerisourceBergen's compounding pharmacy business

FDA, India Act to Prevent Shipments of Illegal Medicine from Entering U.S. India-West Staff Reporter 7 hrs ago

Prosecutors appeal acquittals of 2 in deadly fungal meningitis case Walter F. Roche Jr., Special to Nashville TennesseanPublished 11:08 a.m. CT Feb. 25, 2020

February 25, 2020 Update To FDA’s Guidance #256 On Compounded Animal Drugs

What are APIs and how they threaten India’s status of a ‘pharmacy to the world’ Despite being a leading supplier of medicines to several countries, India is highly dependent on China for raw materials even to produce medicines as basic as Crocin. HIMANI CHANDNA 26 February, 2020 12:07 pm IST

February 26, 2020 Pioneer Drug Maker Throws First Punch At Pharmacy Outsourcing Facilities (503b)

"Azurity Pharmaceuticals, Inc. — a pioneer drug company that markets its FDA-approved oral vancomycin hydrochloride solution, FIRVANQ® — has sued Edge Pharma, LLC, an outsourcing facility operating pursuant to section 503B of the Federal Food, Drug, and Cosmetic Act (FDCA), for compounding an oral vancomycin hydrochloride solution that is identical or nearly identical to FIRVANQ."  More Here