
EMA’s Executive Director has asked the human medicines committee (CHMP) to provide guidance for avoiding the presence of nitrosamine impurities in human medicines containing chemically synthesised active substances.
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EMA’s Executive Director has asked the human medicines committee (CHMP) to provide guidance for avoiding the presence of nitrosamine impurities in human medicines containing chemically synthesised active substances.
Pregnant women who are exposed to higher air pollution levels during their second pregnancy, compared to their first one, may be at greater risk of preterm birth, according to researchers at the National Institutes of Health.

Their study appears in the International Journal of Environmental Research and Public Health.
The Pan American Health Organization (PAHO) is requesting an initial USD 3.5 million from donors to cover short-term health care and other needs for the population in the Bahamas affected by Hurricane Dorian.

The devastating category 5 storm made landfall exactly one week ago in northwest Bahamas, and severely affected the health sector, with significant destruction of equipment and medical supplies and electrical and water supplies in Abaco and Grand Bahama. Some 73,000 persons were affected by the storm, and there are hundreds of people in shelters in the disaster zone. While 43 deaths have been officially reported thus far, mass casualty numbers are expected to rise significantly as more areas become accessible and search and rescue operations continue.
Dr. Ciro Ugarte, PAHO’s Director of Health Emergencies, said, “Our priority concerns are to restore access to essential health services and continued medical care delivery, to ensure water quality in affected communities and health facilities, and to restore proper hygiene and sanitation.” He said adequate waste management and control of disease-causing vectors such as mosquitoes is key, along with increasing epidemiological surveillance to support early detection and timely management of disease outbreaks.
The 3.5 million being requested by PAHO is a preliminary estimate to cover short- term healthcare, water and sanitation, epidemiological surveillance and vector-control needs in the Bahamian Islands most affected by Hurricane Dorian for the next six months, Dr. Ugarte said, adding that needs will likely increase as damage assessments are completed.
PAHO/WHO activated its emergency teams for surge capacity and had pre-deployed Rapid Response Team experts to the Bahamas before Hurricane Dorian struck to support health authorities and humanitarian response as needs were identified. So far, 14 PAHO experts are in the disaster zone to provide surge capacity in logistics, civil and military coordination, information management, epidemiological surveillance, communications, and coordination.
Dr. Ugarte said PAHO is acting quickly to support the Bahamas Ministry of Health in the response, setting up an Incident Management system and co-leading the health cluster with the national health authorities to coordinate health and humanitarian support to the affected population.
The funding requests includes USD 1.3 million to restore healthcare delivery in affected areas, USD 500,000 for surveillance to detect and manage disease outbreaks, USD 800,000 for safe access to water, emergency sanitation and control of disease vectors, and well as USD 671,000 to coordinate humanitarian assistance and manage information to address the most urgent humanitarian needs.
Indoco Remedies announced that the Inspection Action Group (IAG) of the United Kingdom has confirmed that the GMP status for its Goa Plant I has been fully re-instated by UK regulator, The Medicines and Healthcare Products Regulatory Agency of the United Kingdom (UK-MHRA). This is an outcome of the full GMP inspection conducted by the MHRAfrom May 21 - 23, 2019.
Biocon Ltd announced that it has signed a License and Supply Agreement with a subsidiary of China Medical System Holdings Ltd. (CMS) for three Generic Formulation products in Greater China.

Biocon Ltd announced that it has signed a License and Supply Agreement with a subsidiary of China Medical System Holdings Ltd. (CMS) for three Generic Formulation products in Greater China.
India has joined the Global Antimicrobial Resistance (AMR) Research and Development (R&D) Hub as a new member. This was announced by the Department of Biotechnology, Ministry of Science & Technology in New Delhi.

India has joined the Global Antimicrobial Resistance (AMR) Research and Development (R&D) Hub as a new member. This was announced by the Department of Biotechnology, Ministry of Science & Technology in New Delhi. This expands the global partnership working to address challenges and improve coordination and collaboration in global AMR R&D to 16 countries, the European Commission, two philanthropic foundations and four international organisations (as observers).
To spur innovation to meet the challenges of complex care management for people with Alzheimer’s disease and related dementias (AD/ADRD) and their families, the National Institute on Aging (NIA), part of the National Institutes of Health, has funded a new effort designed to test care interventions in real-world settings.

To spur innovation to meet the challenges of complex care management for people with Alzheimer’s disease and related dementias (AD/ADRD) and their families, the National Institute on Aging (NIA), part of the National Institutes of Health, has funded a new effort designed to test care interventions in real-world settings. Brown University, Providence, Rhode Island, will partner with Hebrew Senior Life, a Harvard Medical School Affiliate, Roslindale, Massachusetts, to manage the Imbedded Pragmatic AD/ADRD Clinical Trials (IMPACT) Collaboratory with funding from NIA that is expected to total $53.4 million over five years. IMPACT Collaboratory researchers will team with scientists at other universities with health care and long-term care systems to guide research to develop and test novel ways to care for people with AD/ADRD.
Methotrexate and the more expensive mycophenolate mofetil performed similarly in a head-to-head clinical trial that compared the two drugs for treating noninfectious uveitis, an eye disease that accounts for up to 15% of blindness in the U. S. In cases of more severe disease, posterior uveitis and panuveitis, the international trial showed that methotrexate was more effective in controlling inflammation.

Methotrexate and the more expensive mycophenolate mofetil performed similarly in a head-to-head clinical trial that compared the two drugs for treating noninfectious uveitis, an eye disease that accounts for up to 15% of blindness in the U. S. In cases of more severe disease, posterior uveitis and panuveitis, the international trial showed that methotrexate was more effective in controlling inflammation. Investigators published results from the trial today in the Journal of the American Medical Association. The National Eye Institute, part of the National Institutes of Health, funded the trial.
The ceiling price of Tenofovir 300mg tablet has been increased by 4.2662% on the basis of the annual increase in Wholesale Price Index (WPI), and has been notified at Rs. 46.18.

Department of Pharmaceuticals (DoP) has rejected Cipla's plea against decision of National Pharmaceutical Pricing Authority (NPPA) for fixing the retail prices of Emtricitabine+ Tenofovir Alafenamide tablet (brand Tafmune - EM) containing Emtricitabine IP 200mg, Tenofovir Alafenamide Hemifumarate eq. to Tenofovir Alafenamide 25mg.
Eminence Business Media’s “Pharma Brand Protection & Packaging 2019” concluded on August 29 th & 30 th , 2019 at Hotel Novotel, Mumbai.The theme of the summit was “Trends that have revolutionized the Pharma Packaging World”.The event was an outstanding success with 150+ delegates attending the conference with Karomi Technologies, Autoprint Machinery Manufacturers Pvt. Ltd, Condot Systems, Original 4 Sure, Great Four Systems Pvt. Ltd., Bobst India, Novel Automation Ltd., Bullion Flexipack Pvt. Ltd, Pharma Secure, Aptar Pharma, Nipro Pharma Packaging, Systech International, Immer Group, Sun Packaging, Nuplas Industries, Pharma Mantra, GS1 India, PCRI & ASPA partnering the event.