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Sep
15
ragupathyrenganathan
Mylan introduces generic Brevibloc in US markets
Drug Discovery, Formulation Discussion, Pharma News
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Hertfordshire, England
Saturday, September 15, 2018, 12:00 Hrs  [IST]

Global pharmaceutical company Mylan N.V. announced the US launch of esmolol hydrochloride in sodium chloride injection, 2,500 mg/250 mL (10 mg/mL) single-dose plastic bag and 2,000 mg/100 mL (20 mg/mL) single-dose plastic bag, the first generic version of the reference listed drug, Baxter’s Brevibloc.

Mylan is offering esmolol hydrochloride in sodium chloride injection, 2,500 mg/250 mL (10 mg/mL) single-dose plastic bag and 2,000 mg/100 mL (20 mg/mL) single-dose plastic bag to its institutional customers after an Abbreviated New Drug Application (ANDA) for the product was approved by the US Food and Drug Administration (FDA). Esmolol hydrochloride in sodium chloride injection is indicated for the short-term treatment of control of ventricular rate in supraventricular tachycardia including atrial fibrillation and atrial flutter and control of heart rate in noncompensatory sinus tachycardia and control of perioperative tachycardia and hypertension.

US sales for sodium chloride injection, 2,500 mg/250 mL (10 mg/mL) single-dose plastic bag and 2,000 mg/100 mL (20 mg/mL) single-dose plastic bag were approximately US$ 126 million for the 12 months ending June 30, 2018, according to IQVIA.

Currently, Mylan has 189 ANDAs pending FDA approval representing approximately US$ 91.5 billion in annual brand sales, according to IQVIA. Forty-three of these pending ANDAs are potential first-to-file opportunities, representing US$ 50.6 billion in annual brand sales, for the 12 months ending June 30, 2018, according to IQVIA.

Courtesy – Pharnabiz

Sep
15
ragupathyrenganathan
Researcher admits plot to steal GSK secrets to sell in China!!!!!
Intellectual Property Rights, Pharma News
0

 

Sep – 01-2018

Prosecutors have described the 48-year-old US citizen as one of the top protein biochemists in the world. She had worked at GlaxoSmithKline’s research facility in suburban Philadelphia for about a decade and had become a senior manager.

A cancer researcher pleaded guilty on Friday to conspiring to steal biopharmaceutical trade secrets from GlaxoSmithKline in what prosecutors said was a scheme that involved plans to set up companies in China to market them.Yu Xue entered a guilty plea in federal court on Friday to a single conspiracy count. The government dropped more than two dozen other pending counts against the researcher as part of the plea.

In court on Friday, Xue said she didn’t understand that the material she was emailing to her private account then to others including portions of her own patent application for certain research was considered trade secrets. “A trade secret to me is not publicly available. The patents I sent to them is publicly available,” she said, noting that she sent the preliminary application for a patent on her research.

Judge Joel Slomsky noted that prosecutors did not have to prove that she understood it was a trade secret, but that she knew she was sharing confidential materials. Slomsky said he believed federal prosecutors had met that burden of proof.

Prosecutors have described the 48-year-old US citizen as one of the top protein biochemists in the world. She had worked at GlaxoSmithKline’s research facility in suburban Philadelphia for about a decade and had become a senior manager. She was fired shortly after charges were brought against her in early 2016.

Prosecutors had accused her of downloading and emailing confidential information including research on specific cancer drugs and working with four others, including two people in China, charged in connection with the scheme.

Another research scientist at GlaxoSmithKline, Tao Li, was also charged as part of the five. She has a change of plea hearing scheduled before the court in a few weeks, but it was unclear if she would be pleading to the same charge as Xue.

Slomsky set a sentencing hearing for December 18, but agreed to hold an evidentiary hearing prior to that date that will largely focus on the difference between prosecutors’ and defense attorneys’ arguments about how serious the crime was and how much potential financial damage was caused.

“There are vast differences between the parties as to the value and importance of the information stolen,” Assistant US Attorney Robert Livermore said.

Federal prosecutors have had to drop charges or withdraw cases in several other high-profile trade secret cases in recent years, including that of Temple University professor Xiaoxing Xi, who was accused of stealing sensitive technology involving superconductivity in 2015.

Charges were dropped when investigators realized the information shared did not amount to trade secrets.

Courtesy – Business Today

Jul
11
ragupathyrenganathan
US FDA updates warnings for fluoroquinolone antibiotics on risks of mental health & low blood sugar adverse reactions
Pharma News
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Maryland
Wednesday, July 11, 2018, 18:00 Hrs  [IST]

The US Food and Drug Administration (FDA) is requiring safety labeling changes for a class of antibiotics called fluoroquinolones to strengthen the warnings about the risks of mental health side effects and serious blood sugar disturbances, and make these warnings more consistent across the labeling for all fluoroquinolones taken by mouth or given by injection.

“The use of fluoroquinolones has a place in the treatment of serious bacterial infections — such as certain types of bacterial pneumonia — where the benefits of these drugs outweigh the risks, and they should remain available as a therapeutic option. The FDA remains committed to keeping the risk information about these products current and comprehensive to ensure that health care providers and patients consider the risks and benefits of fluoroquinolones and make an informed decision about their use,” said Edward Cox, M.D., director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research.

FDA-approved fluoroquinolones include levofloxacin (Levaquin), ciprofloxacin (Cipro), ciprofloxacin extended-release tablets, moxifloxacin (Avelox), ofloxacin, gemifloxacin (Factive) and delafloxacin (Baxdela). There are more than 60 generic versions. The safety labeling changes the FDA is requiring were based on a comprehensive review of the FDA’s adverse event reports and case reports published in medical literature.

Across the fluoroquinolone antibiotic class, a range of mental health side effects are already described in the Warnings and Precautions section of the drug labeling, but differed by individual drug. The new class-wide labeling changes will require that the mental health side effects be listed separately from other central nervous system side effects and be consistent across the labeling of the fluoroquinolone class. The mental health side effects to be included in the labeling across all the fluoroquinolones are disturbances in attention, disorientation, agitation, nervousness, memory impairment and delirium.

Additionally, the recent FDA review found instances of hypoglycemic coma where users of fluoroquinolones experienced hypoglycemia. As a result, the Blood Glucose Disturbances subsection of the labeling for all systemic fluoroquinolones will now be required to explicitly reflect the potential risk of coma with hypoglycemia.

Today, the FDA also published a drug safety communication about safety information regarding hypoglycemic coma and mental health side effects with fluoroquinolones.

The FDA first added a Boxed Warning to fluoroquinolones in July 2008 for the increased risk of tendinitis and tendon rupture. In February 2011, the risk of worsening symptoms for those with myasthenia gravis was added to the Boxed Warning. In August 2013, the agency required updates to the labeling to describe the potential for irreversible peripheral neuropathy (serious nerve damage).

In 2016, the FDA enhanced warnings about the association of fluoroquinolones with disabling and potentially permanent side effects involving tendons, muscles, joints, nerves and the central nervous system. Because the risk of these serious side effects generally outweighs the benefits for patients with acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis and uncomplicated urinary tract infections, the FDA determined that fluoroquinolones should be reserved for use in patients with these conditions who have no alternative treatment options.

The patient Medication Guide that is required to be given to the patient with each fluoroquinolone prescription describes the safety issues associated with these medicines.

The FDA, an agency within the US Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.

Courtesy – Pharmabiz

Jul
10
ragupathyrenganathan
Which Healthcare Stakeholders Puts Patients Interests before Profits?
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May
29
ragupathyrenganathan
Henan Roshn Packaging Material – A Brief Introduction
Pharma Packaging
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Apr
4
ragupathyrenganathan
US FDA grants Kitova a waiver for new drug application filing fee
Drug Discovery, Pharma News, Pharmaceutical & Drug Delivery Journals
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Feb
20
ragupathyrenganathan
AstraZeneca’s Lynparza meets primary endpoint in phase III study in BRCA-mutated metastatic breast cancer
Pharma News
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Feb
13
ragupathyrenganathan
US$55bn pharma by 2020 – fii-news.com
Pharma News
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Feb
8
ragupathyrenganathan
Indian Pharmaceutical Alliance demands streamlining of approval of new drugs, biosimilars & revamping of CDSCO
Pharma News
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Feb
6
ragupathyrenganathan
US FDA issues draft norms on reference listed drug standards for ANDA submissions, industry to comment before April
Pharma News
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