Pharma Talk

ABOTT TO SHIP 5-MINUTE CORONAVIRUS TEST KIT NATIONWIDE

Abbott to deliver portable, 5-minute coronavirus tests kit nationwide

MORE: https://pharmaquest.wordpress.com/2020/03/29/abbott-to-deliver-portable-5-minute-coronavirus-tests-kit-nationwide/

Emergency Use Authorization issued for Xpert Xpress SARS COVID-2 Test Kit

Emergency Use Authorization issued for Cepheid SARS COVID-2 Test

For More: https://pharmaquest.wordpress.com/2020/03/23/covid-2-test/

USFDA 483 at Cipla Goa

US FDA finds failures at Goa plant of India’s Cipla

The US Food and Drug Administration has released a detailed Form 483 at the Goa injectable facility of Indian drugmaker Cipla, which contained 12 observations. This could impact or delay new drug launches in the USA.

Cipla’s US business contributes 22% of total sales. The Goa unit is an important facility for Cipla (accounting for 20%-25% of US sales; and one source product contributing 2.5% of total sales).

This April, Cipla’s US subsidiary InvaGen recalled an injection used to treat low testosterone from the US markets. It had been manufactured at Cipla’s Goa plant.

The US FDA observations are serious in nature, with the three US FDA inspectors who visited the plant raising questions on cleaning validations, batch failures, quality of drugs, aseptic processing areas, prevention of microbial contamination of the drugs and material specifications.

Resolution of this plant is expected to be time consuming and is expected to take at least 8-10 months, unlike Cipla’s historical track record of resolving US FDA issues within 2-3 months.

Cipla stock has tumbled 36% in the past year, and investors have seen its value erode to a 52-week low from its 52-week high levels.

Cipla has multiple US FDA approved plants. This March, the company faced US FDA inspection for its Kurkumbh plant (API-formulation) with total 18 observations, but closed the issue in three months.

Cipla also received 7 current Good Manufacturing Practice (cGMPs) observations at Virgonangar, Bengaluru active pharmaceutical ingredients (API) plant this July, but closed the pending issues in two months. The Goa facility too has received eight observations (this January), but the company closed the issue in April.

Novartis, aiming to clean up its rep, sets aside $700M for kickback settlement

Novartis, aiming to clean up its rep, sets aside $700M for kickback settlement

With nearly decade-old bribery charges hanging over its head, Novartis has been eager to wriggle out of U.S. prosecutors’ crosshairs. Now, a settlement in the case appears to be in the works—and it could cost Novartis close to a billion dollars.

The Swiss drugmaker has set aside $700 million for a possible settlement in an eight-year-old whistleblower suit accusing the company of bribing U.S. physicians to boost subscriptions of the company’s drugs, including hypertension med Lotrel and diabetes drug Starlix.

“Consistent with our efforts to resolve legacy compliance-related allegations, we are engaged in settlement discussions to resolve a civil suit challenging speaker programs and other promotional events conducted from 2002 through 2011,” Novartis spokesman Eric Althoff said in a statement.

In mid-June, an accidental court filing from federal prosecutors said Novartis was making “significant progress” toward a settlement in the lawsuit, which accused the drugmaker of shelling out millions to doctors through sham educational events.

Among some of the most eyepopping claims in the suit were Novartis sales execs treating doctors to $10,000 dinners at expensive New York seafood restaurants and wild nights out at Ho***rs. In one instance, Novartis held one of its speaker events aboard a fishing boat, allegedly without any educational material in tow.

For improvement of pharmacist future in Gujarat

RX VIJAY N Patel on Twitter “ ફાર્માસીસ્ટ ના ક્વાલીફિકેશન મુજબ ગ્રેડ પે કેટલો હોવો જોઈએ ???”

નમસ્કાર ફાર્માસિસ્ટ સાથીઓ

ગુજરાત સરકારની ભરતીઓમાં ફાર્માસિસ્ટની જગ્યા માટે કમ્પાઉન્ડર શબ્દનો ઉપયોગ થાય છે.
હકીકતમાં આ શબ્દનો ઉપયોગ કરી શકાય નહીં. આટલી મહત્વપૂર્ણ ડિગ્રી મેળવ્યા પછી આવો શબ્દપ્રયોગ કરવો એ ફાર્માસિસ્ટ માટે શરમજનક બાબત છે. આ વિશે "ગુજરાત ફાર્માસિસ્ટ એસોસિએશન (GPA)" દ્વારા વારંવાર રજુઆત કરવા છતાં પ્રશાસનના પેટનું પાણી હલતું નથી. આથી ત્રસ્ત થઈને પ્રશાસન અને ફાર્મસીસ્ટને જગાડવા માટે રજનીકાંત સોલંકી નામનો જાંબાઝ ફાર્માસિસ્ટ જે ફાર્માસીસ્ટના હક માટે 3 વર્ષથી અમારી સાથે લડી રહ્યો છે એ પોતાની ફાર્મસીની *ડિગ્રી પરત* કરવા જઈ રહ્યો છે. તો દરેક ફાર્માસીસ્ટને અને એમાંય કમ્પાઉન્ડર તરીકે નોકરી કરતા અને આ શબ્દથી અપમાન અનુભવતા દરેકને વિનંતી કે આત્મ સન્માન માટેની આ લડાઈમાં હાજરી આપી સહભાગી થાઓ...

જો નર્સિંગની પોસ્ટ માટે નર્સિંગ ઓફિસર શબ્દ આ સરકાર ઉપયોગ કરતી હોય તો ફાર્માસિસ્ટ માટે કમ્પાઉન્ડર કેમ?

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DRUG DELIVERY -- 'Onion' drug delivery vehicle has concentric layers for consistent dosing

A new type of drug delivery vehicle from the University of Pennsylvania is made up of several membranes layered upon each other to protect the drug at its core or possibly deliver a few different drugs over time.

With a structure based on models from nature, including myelin sheaths and the concentric layout of onions, the scientists created vesicles with as many as 20 layers, consistently spaced. The consistency is important to maintain the size of the vesicles and to ultimately load them with drugs for a predictable timed release.

They accomplished the design via two-faced membranes comprising amphiphilic Janus dendrimers, which have layers themselves to ensure protection of the drugs carried inside, according to a report from UPenn.

It has been difficult up until now to produce such vesicles on a practical level.

"The only way it has been achieved in the past was through a complicated mechanical process, which was a dead end," lead author Virgil Percec said in a statement. "This was not a viable option for mass-producing multilayered vesicles, but, with our library of amphiphilic Janus dendrimers, we were lucky to find some molecules that have in their chemicals instructions needed to self-assemble into these very BEAUTIFUL structures."

And their delivery potential lies in their stability in the bloodstream.

"If you want to deliver a single drug over the course of 20 days," Percec said, "you could think about putting one dose of the drug in each layer and have it released over time. Or you might put one drug in the first layer, another drug in the second and so on. Being able to control the diameter of the vesicles may also have clinical uses; target cells might only accept vesicles of a certain size."

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