Pharma News

FDA and CBP bolster collaboration to protect public health and safety

  • Posted on: 6 April 2019
  • By: Shalini.Sharma

The U.S. Food and Drug Administration and the U.S. Customs and Border Protection (CBP) leaders signed an agreement to maximize inspection and detection capabilities in order to prevent illegal and harmful products entering the U.S. through the nation’s International Mail Facilities (IMFs) and Ports of Entry that pose a threat to public health.

Cholera vaccination campaign begins in Mozambique

  • Posted on: 6 April 2019
  • By: Shalini.Sharma

An oral cholera vaccination campaign to protect survivors of Cyclone Idai begins today in Beira, Mozambique. Funded by Gavi, the Vaccine Alliance, the campaign will be carried out by the Mozambique Ministry of Health, with support from WHO and other partners, including UNICEF, the International Federation of the Red Cross and Red Crescent Societies (IFRC), Médecins Sans Frontières (MSF) and Save the Children.

Opioid epidemic is increasing rates of some infectious diseases

  • Posted on: 4 April 2019
  • By: Shalini.Sharma

The United States faces a converging public health crisis as the nation’s opioid epidemic fuels growing rates of certain infectious diseases, including HIV/AIDS, hepatitis, heart infections, and skin and soft tissue infections. Infectious disease and substance use disorder professionals must work together to stem the mounting public health threat, according to a new commentary in the Journal of Infectious Diseases. The article was co-authored by officials from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, and the Institute of Human Virology at the University of Maryland School of Medicine in Baltimore.

FDA-approved drug effectively treats rare chronic immune disorder

  • Posted on: 4 April 2019
  • By: Shalini.Sharma

A drug approved to treat a severe form of asthma dramatically improved the health of people with rare chronic immune disorders called hypereosinophilic syndromes (HES) in whom other treatments were ineffective or intolerable. This finding comes from a small clinical trial led by scientists at the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, and conducted through a partnership with the global biopharmaceutical company AstraZeneca. The results were published online today in the New England Journal of Medicine.

Acute flaccid myelitis requires galvanized research response

  • Posted on: 4 April 2019
  • By: Shalini.Sharma

Acute flaccid myelitis (AFM) presents significant challenges not only to patients but also to researchers, and efforts must be accelerated to learn more about the condition, experts from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, write in a new perspective published in mBio.

General, non-pharmacovigilance fees payable to EMA by applicants and marketing-authorisation holders are increasing by 1.7% on 1 April 2019

  • Posted on: 4 April 2019
  • By: admin

General, non-pharmacovigilance fees payable to EMA by applicants and marketing-authorisation holders are increasing by 1.7% on 1 April 2019. Full details of the new fee levels are available in Commission Regulation (EU) No 2019/480 amending Council Regulation (EC) No 297/95 , its implementing rules and the corresponding explanatory note on fees , published on 1 April 2019.

FDA steps toward a new, tailored review framework for artificial intelligence-based medical devices

  • Posted on: 4 April 2019
  • By: Shalini.Sharma

Artificial intelligence and machine learning have the potential to fundamentally transform the delivery of health care. As technology and science advance, we can expect to see earlier disease detection, more accurate diagnosis, more targeted therapies and significant improvements in personalized medicine.

Indoco Remedies clears USFDA inspection

  • Posted on: 1 April 2019
  • By: PharmaTutor News

US Food and Drug Administration (USFDA), has cleared the sterile manufacturing facility of Indoco Remedies Limited, for Finished Dosages, located at Verna Industrial Area, Goa (Plant II). This inspection was carried out by USFDA in November 2018.

 

FDA approves new oral testosterone capsule for treatment of men with certain forms of hypogonadism

  • Posted on: 29 March 2019
  • By: Shalini.Sharma

The U.S. Food and Drug Administration approved Jatenzo (testosterone undecanoate), an oral testosterone capsule to treat men with certain forms of hypogonadism. These men have low testosterone levels due to specific medical conditions, such as genetic disorders like Klinefelter syndrome or tumors that have damaged the pituitary gland.

New EudraVigilance system improves reporting of side effects and detection of safety signals

  • Posted on: 29 March 2019
  • By: Shalini.Sharma

The new and improved EudraVigilance, the European system for managing and analysing information on suspected adverse reactions to medicines that are authorised or being studied in clinical trials in the EU, received more than 2 million reports of suspected side effects in 2018.

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