App News Updates

A new tool designed to help guide preventive care for heart disease, cancer, and seasonal flu was launched in the United States Monday by Facebook. The Preventive Health tool -- which is accessed by either searching for it on Facebook or clicking on a promotion that pops up -- was created in partnership with the American Cancer Society, American College of Cardiology, American Heart Association, and U.S. Centers for Disease Control and Prevention, CNN reported. The tool makes recommendations based on age and sex. After receiving personalized recommendations, a user can choose to get more information, mark recommendations as completed, or set reminders to get suggested tests. Most of the preventive measures are covered by insurance, but the feature also provides a map of federally qualified health care centers in underserved areas across the United States that provide services regardless of patients' ability to pay, CNN reported. In terms of the flu, the tool offers a way to find wh...

Pyrimethamine (WHOAPI-371) manufactured by Macleods Pharmaceuticals Ltd has been prequalified by the WHO Prequalification Team: medicines under its API prequalification procedure. WHOAPI-371 - Pyrimethamine - Macleods Pharmaceuticals Ltd - INDIA FPPs containing pyrimethamine are used in the therapeutic area of malaria Good-quality APIs are vital to the production of good-quality medicines. WHO prequalification of APIs facilitates production of quality medicines by identifying such APIs for use by manufacturers of finished pharmaceutical products (FPPs). API prequalification consists of a comprehensive evaluation procedure that has two components: assessment of the API master file (APIMF) to verify compliance with WHO norms and standards, and evaluation of the sites of API manufacture to verify compliance with WHO Good Manufacturing Practice requirements.

A revised version of Ph. Eur. chapter 3.2.2. Plastic containers and closures for pharmaceutical use has been published in Pharmeuropa, Issue 31.4. The deadline for comments is 31 December 2019. In the revised version the list of commonly used polymers has been replaced with a cross-reference to "Materials used for the manufacture of containers" (Ph. Eur. 3.1 and subsections) to take into account additional materials that will be included in the future (e.g. 3.1.17 "Cyclo-olefin copolymers (COC)" and 3.1.18 "Styrene block copolymers for containers and closures for parenteral preparations and ophthalmic preparations", as previously announced in the Ph. Eur. Work Programme of March 2019). In addition, editorial changes have been made throughout the general chapter, including a change in the French title. Furthermore, in August 2019, a new Ph. Eur. Chapter with the title: 2.4.35 "Extractable elements in plastic materials for pharmaceutical use" has b...

ISO 22519 is a new available international standard dealing with the pretreatment and the production of purified water (PW) and water for injection (WFI). According to the text of the new ISO standard, while there are many guidelines dealing with pharmaceutical water, there is no document that fully describes the different methods of producing PW and WFI. The new document aims to fill this gap and provide guidance on specifying a pretreatment and purification system for pharmaceutical water. The new 42-page standard contains the following chapters: Scope Normative references Terms, definitions and abbreviated terms Design and practices Selecting materials, methods and system components Sampling Instruments System design Operation Maintenance Specific GMP requirements Control philosophy Alarms Recommended engineering documentation Annex A: Examples of PQ productions systems Annex B: Examples of feed water categories Annex C: System selection table Annex D: Configur...

EMA's human medicines committee (CHMP) has recommended granting a conditional marketing authorization in the European Union for Ervebo (rVSVΔG-ZEBOV-GP), the first vaccine for active immunization of individuals aged 18 years and older at risk of infection with the Ebola virus. "This is an important step towards relieving the burden of this deadly disease," said Guido Rasi, EMA's Executive Director. "The CHMP's recommendation is the result of many years of collaborative global efforts to find and develop new medicines and vaccines against Ebola. Public health authorities in countries affected by Ebola need safe and efficacious medicines to be able to respond effectively to outbreaks and save lives." Ebola virus disease is a rare but severe illness caused by the Ebola virus. Death rates in patients who have contracted the disease have varied from 25% to 90% in past outbreaks. The largest outbreak to date occurred in West Africa in 2014-2016 with more than ...

Alkem Laboratories Ltd has announced that the US Food and Drug Administration (FDA) had conducted an inspection at the company's bioequivalence center located at Taloja, Maharashtra from 14th October, 2019 to 18th October, 2019. At the end of the inspection, no Form 483 was issued, the company said.

The guidance document on amendments to an Active Pharmaceutical Ingredient Master File (APIMF) submitted in support of a Prequalified Pharmaceutical Product (FPP) or Prequalified Active Pharmaceutical Ingredient (API) has been revised to include the following changes: Change 2a regarding change in name or address of a manufacturer has been split into two subcategories: 2a.1 if the change refers to a manufacturer of an intermediate or the API and 2a.2 if the changes refers to a manufacturer of a starting material. Addition of change 11g [AIN] for the submission of the risk assessment for elemental impurities. The document relating to the use of ICHQ3D guideline for APIs has been revised accordingly. The wording of the declaration regarding the submission of a new APIMF version has been revised to clarify that the 24-month period should be calculated from the date of acceptance of the APIMF or the date of acceptance of the latest APIMF version. Document Link:  Guidance on amendm...

This warning letter is issued for significant violations of current good manufacturing practice (cGMP) regulations for finished pharmaceuticals. Read Full Warning Letter

This warning letter is issued for significant violations of current good manufacturing practice (cGMP) regulations for finished pharmaceuticals. Read Full Warning Letter

The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) on Thursday allowed the marketing of the first rapid diagnostic test for the Ebola virus that has not been authorized via the agency’s Emergency Use Authorization (EUA) pathway. OraSure Technologies’ OraQuick Ebola Rapid Antigen Test, which provides a rapid, presumptive diagnosis that must be confirmed, gained market entry via CDRH's De Novo review pathway less than five months after its request for classification was submitted (FDA's De Novo performance goal review time is 150 days). The test was also granted a Breakthrough device designation. “This marketing authorization may provide additional assurances to health care professionals seeking to use these types of rapid diagnostics. The ability to use this test to promptly make a presumptive Ebola diagnosis could help providers to more quickly isolate patients and begin treatments that can be potentially life-saving,” acting FDA Com...

Pharma major Lupin Limited announced the appointment of Johnny Mikell as president and global head of quality. Johnny will be based out of Lupin’s US offices and will lead the company’s quality function globally; he will help steer the company towards enhanced standards of quality and compliance. Johnny is a very competent quality leader and brings to Lupin over 35 years of rich pharmaceutical industry experience and expertise. He has significant experience in global quality operations and compliance in the generics, branded and API segments. In his most recent engagement, Johnny was the global head of quality and compliance at Apotex. Prior to that, he served as the global head of quality and compliance at Amneal. Johnny has also held leadership positions at UCB, Novartis and Bausch & Lomb. Johnny holds a Bachelor of Science degree in Biology and Master of Science in Microbiology. He has attained his academic qualifications from leading institutions like Duke University, London’s ...

Rabies is an entirely preventable disease, yet close to 60 000 people fall victim its wrath each year. These deaths reflect a shortcoming in care, rather than an inevitability. The fact is, lifesaving rabies vaccines have existed for over a century, and their strategic use in disadvantaged communities can eliminate human rabies entirely. The United Against Rabies (UAR) collaboration aims to achieve just this. They have set a goal to eliminate human rabies deaths by 2030. And, at the center of this goal, is the necessity for increased access and availability of vaccines in rabies-endemic areas. Impoverished communities in low to middle income countries bear the majority of the global rabies burden. More than 95% of human rabies fatalities come from the continents of Asia and Africa alone. These people, many of whom are children, live in rural and underserved areas where access to vaccines is often limited and treatment results in catastrophic out-of-pocket expenses for those exposed. T...

The breast cancer death rate is continuing to decline, although the decline has slowed in recent years, according to a report published online Oct. 2 in CA: A Cancer Journal for Clinicians. Carol E. DeSantis, M.P.H., from the American Cancer Society in Atlanta, and colleagues present statistics for the incidence, mortality, survival, and screening of female breast cancer in the United States. The researchers found that from 2012 to 2016, there was a slight increase in the breast cancer incidence rate by 0.3 percent per year, mainly due to increased rates of local stage and hormone receptor-positive disease. The breast cancer death rate continued to decrease, with a 40 percent reduction from 1989 to 2017, translating to 375,900 breast cancer deaths averted. There was a slowing in the pace of decline, from an annual decrease of 1.9 percent during 1998 to 2011 to 1.3 percent during 2011 through 2017, mainly due to trends in white women. After widening in the past three decades, the black-...

On the International Day of Older Persons – 1 October – the World Health Organization (WHO) is launching a package of tools, including a digital application to help health and social workers provide better care for older people. The innovative interactive digital application known as WHO ICOPE Handbook App provides practical guidance to address priority conditions including mobility limitations, malnutrition, vision and hearing loss, cognitive decline, depressive symptoms and social care and support. Used in conjunction with a package of tools including a new handbook, the app will accelerate training of health and social workers to better address the diverse needs of older people. “It is essential that services for older people are included in universal health care packages. At the same time there needs to be good coordination between the health and social services to provide optimal care when needed. The new package of tools supports healthy ageing with a person-centred and coordin...

Natco Pharma Limited has announced successful closure of inspection with the receipt of an Establishment Inspection Report (EIR) from the US Food and Drug Administration (FDA) for the inspection conducted at its Active Pharmaceutical Ingredient (API) facility in Mekaguda Village, near Hyderabad. The inspection was conducted during the period August 5-9, 2019, the company said.

Washington has become the fourth state to ban flavored vaping products, joining Michigan, New York, and Rhode Island, CBS News reports. If the state's health department uses its emergency power, the sale of all flavored electronic cigarettes, including those that contain cannabinoid, will be stopped for 120 days. The ban can be extended after that. The ban, initiated by Governor Jay Inslee, comes amid a spate of lung infections and deaths from vaping. Washington has had seven such cases. In a similar executive action, Massachusetts Governor Charlie Baker has banned all vaping products for four months, CBS News reports. To date, more than 800 people have developed lung injury from vaping and there have been 12 vaping-related deaths reported, according to the U.S. Centers for Disease Control and Prevention.