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In a first for the US Food and Drug Administration (FDA) and Drug Enforcement Administration (DEA), the agencies came together to warn four online networks operating 10 websites that illegally market unapproved and misbranded versions of opioids. FDA notes that the illegal online pharmacies may put people at risk because there is no guarantee that the medicines are safe and because several of these websites sell opioids online without a prescription. In the warning letters, dated 6 September, the agencies cited companies for selling unapproved versions of tramadol, marketed as “Top-Tram” or “Tramadol (Ultram) 100 mg” or “Tramadol 200mg Tablets,” and another opioid known as tapentadol, among others. In addition, the online networks violated the Controlled Substances Act (CSA) by failing to register their online pharmacies with the DEA despite knowingly or intentionally advertising the sale of controlled substances, including opioids. “While the FDA partners regularly with the DEA, this ...

Scientists have confirmed for the first time that bacteria can change form to avoid being detected by antibiotics in the human body. Studying samples from elderly patients with recurring urinary tract infections, the Newcastle University team used state-of-the-art techniques to identify that bacteria can lose their cell wall - the common target of many groups of antibiotics. The research by the Errington lab which turns on its head current thinking about the bacteria's ability to survive without a cell wall, known as "L-form switching", is published today in Nature Communications. The World Health Organisation has identified antibiotic resistance as one of the biggest threats to global health, food security, and development today. Lead author, Dr Katarzyna Mickiewicz researcher at Newcastle University said: "Imagine that the wall is like the bacteria wearing a high-vis jacket. This gives them a regular shape (for example a rod or a sphere), making them strong and pro...

The Therapeutic Goods Administration (TGA) has today released the findings of its review into breast implants and breast tissue expanders following reports of around 100 cases of Breast Implant Associated Anaplastic Large Cell Lymphoma in Australia, including four deaths. The TGA undertakes its role in balancing patient safety with the availability of medical devices for patients very seriously. The TGA has decided to take regulatory action on all breast implant and breast tissue expanders currently included in the Australian Register of Therapeutic Goods (ARTG). Eight models of breast implants are to be suspended from supply in Australia for six months, while a number of safety and performance concerns are addressed. This means that these devices will not be able to be imported, exported, or supplied within Australia while the TGA works with industry sponsors to ensure the devices meet all the necessary requirements for patient safety. Any stock of these un-implanted devices in the ma...

Pharma major Lupin Limited announced the appointment of Jon Stelzmiller as the president of its US specialty business. Jon brings to Lupin over 30 years of experience in the specialty segment and will be replacing Nicholas Hart. Jon has a proven track record of building high performing teams and launching 18 major brands across 14 different therapeutic areas including women’s health, oncology and anti-infectives. Recently, Jon was SVP & general manager — women’s healthcare at Bayer, where he helped build and lead a billion-dollar women’s health business in the US. Prior to Bayer, Jon spent 12 years at Pfizer Inc. in roles of increasing commercial responsibilities in Specialty areas including Institutional sales and market access. Jon spent his early career at The Upjohn Company and Pharmacia Corporation in various sales and sales leadership positions. Jon holds a Bachelor of Science in Bacteriology from North Dakota State University. Vinita Gupta, chief executive officer, Lupin sai...

Onions and garlic are key ingredients in sofrito, a condiment that's a staple of Puerto Rican cuisine. They may also be a recipe for reducing the risk of breast cancer. That's according to the findings of a study led by University at Buffalo and University of Puerto Rico researchers. It's the first population-based study to examine the association between onion and garlic consumption and breast cancer in Puerto Rico. The results were published in the journal Nutrition and Cancer. "We found that among Puerto Rican women, the combined intake of onion and garlic, as well as sofrito, was associated with a reduced risk of breast cancer," said Gauri Desai, the study's lead author, who is an epidemiology Ph.D. student in UB's School of Public Health and Health Professions. In fact, those who consumed sofrito more than once per day had a 67% decrease in risk compared to women who never ate it. The idea for the study stemmed from previous scientific evidence showin...

Pharma major Lupin Limited announced the completion of the United States Food and Drug Administration (FDA) inspection carried out at its Tarapur manufacturing (API) facility. The inspection was carried out between September 16 to September 20, 2019, the company said. The company further added that inspection at the Tarapur facility closed with three observations. The company is confident of addressing them satisfactorily.

Countries must increase spending on primary healthcare by at least 1% of their gross domestic product (GDP) if the world is to close glaring coverage gaps and meet health targets agreed in 2015, says a new report from the World Health Organization and partners on the eve of a UN General Assembly high-level meeting on Universal Health Coverage. They must also intensify efforts to expand services countrywide. The world will need to double health coverage between now and 2030, according to the Universal Health Coverage Monitoring Report. It warns that if current trends continue, up to 5 billion people will still be unable to access health care in 2030 – the deadline world leaders have set for achieving universal health coverage. Most of those people are poor and already disadvantaged. Primary health care key to health for all “If we are really serious about achieving universal health coverage and improving people’s lives, we must get serious about primary health care,” says Dr Tedros Adha...

Researchers from Duke-NUS Medical School (DukeNUS), in collaboration with the Agency for Science, Technology and Research (A*STAR)'s Bioinformatics Institute (BII), and the University of Texas Medical Branch (UTMB), USA, have discovered that the dengue virus changes its shape through mutations in Envelope (E) protein to evade vaccines and therapeutics. The study also gives insights on the types of treatment strategies to use at different stages of infection. This could give rise to new approaches in vaccine development and treatment for dengue disease. Dengue virus (DENV) infects about 400 million people annually around the world, with a high prevalence in tropical and sub-tropical regions. The virus causes diseases ranging from mild dengue fever to severe dengue haemorrhagic fever and dengue shock syndrome. DENV2 exists as smooth spherical surface particles while growing at the mosquito's physiological temperature (29 degrees Celsius). It then changes to bumpy surfaced particl...

Pharma major Lupin Limited announced that it has received approval for its sANDA for Levothyroxine Sodium Tablets USP, 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg, from the United States Food and Drug Administration (U.S. FDA), to market a generic equivalent of UNITHROID 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg, manufactured by Jerome Stevens Pharmaceuticals Inc. Lupin's Levothyroxine Sodium Tablets USP, 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg was originally approved on January 18, 2019 as generic equivalent of SYNTHROID 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150O mcg, 175 mcg, 200 mcg, and 300 mcg, manufactured by ABBVIE Inc. With this sANDA approval, Lupin's Levothyroxine Sodium Tablets USP, 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 m...

The U.S. Food and Drug Administration today approved Rybelsus (semaglutide) oral tablets to improve control of blood sugar in adult patients with type 2 diabetes, along with diet and exercise. Rybelsus is the first glucagon-like peptide (GLP-1) receptor protein treatment approved for use in the United States that does not need to be injected. GLP-1 drugs are non-insulin treatments for people with type 2 diabetes. “Patients want effective treatment options for diabetes that are as minimally intrusive on their lives as possible, and the FDA welcomes the advancement of new therapeutic options that can make it easier for patients to control their condition,” said Lisa Yanoff, M.D, acting director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research. “Before this approval, patients did not have an oral GLP1 option to treat their type 2 diabetes, and now patients will have a new option for treating type 2 diabetes without injections.” ...

In order to address the gap between the strategic vision and operational realities of the pharma manufacturing sector, Eminence Business Media will be holding the 2nd Annual Pharma Manufacturing & Automation Convention 2019 in Hyderabad on October 17 and 18, 2019. The past 10 years have been crucial for the Indian pharma landscape. From 2005-2015, the revenue of the top 10 companies grew at 19 percent which is almost at par with the industry growth of 18 percent. Things have significantly changed now with US markets capping prices of crucial drugs that have impacted the overall profit margins. Indian pharma companies have to nimbly navigate contingencies by expanding the number of FDA approved sites to secure a dominant position in the US market. The US contributes about one-third of the total Indian pharma exports. Furthermore, Indian pharma manufacturing companies accounted for 34 percent of the total ANDA approvals by the US in 2016. Growth of the Indian pharma industry pivots o...

As Stoptober, a national campaign to get people to stop smoking over the month of October, looms, figures show that smoking rates in England are dropping at the fastest rate in over a decade. Currently there are around 200 fewer smokers an hour, according to the University College London (UCL), and Public Health England (PHE) is encouraging all smokers to follow suit and join in with the nation’s biggest quit attempt, which begins on 1 October 2019. Research by the National Centre for Smoking Cessation and Training has shown that while many smokers want to quit, they face common barriers including procrastination and a fear of failure. To help smash these common barriers, smokers can get expert face-to-face support from local stop smoking services. As a result, those who do are three times as likely to quit successfully than those who try to quit using willpower alone. Adult smoking rates fell 2.2% from January to July 2019, and not smoking is now the norm in England, but despite smoki...

Researchers at the US Food and Drug Administration (FDA) have developed a new computational tool to predict whether the body will mount an immune response that blocks the activity of biological drugs. Specifically, the tool, dubbed TCPro, simulates how the body's CD4+ T cells will respond to biotherapeutics, and predicts whether the body will produce anti-drug antibodies. "TCPro can be used to assess the potential for antibody formation even before the laboratory testing on biotherapeutics that is routinely done to screen for this risk," FDA writes, noting that traditional immunogenicity tests "can be expensive and time consuming." This is due to the fact that major histocompatibility (MHC) class II molecules, which are found on the surface of antigen presenting cells (APCs) "are the most diverse in the human genome," making it challenging to collect cell samples that "accurately reflect the presence of all possible MHC-II proteins in a patient...

About a dozen drugmakers and industry groups recently offered their opinions on a revised US Food and Drug Administration (FDA) draft guidance related to population pharmacokinetics (PK) analyses submitted as part of new drug applications and biologic license applications. The comments largely seek specific tweaks to the 23-page revised draft, which was released in July, although some of the comments also seek further clarity and new additions to the guidance. Industry group PhRMA, for instance, recommends that FDA add more specific examples or literature references throughout “to provide detail to the high-level recommendations and to support the technical statements.” FDA also should provide specific examples of where population PK data may alleviate the need for a postmarketing requirement or postmarketing commitment, PhRMA says. Bayer, meanwhile, takes issue with FDA’s inclusion of an executive summary in the population PK report that should focus on the key findings affecting appr...

The US Food and Drug Administration (FDA) on Tuesday unveiled a new initiative whereby its Oncology Center of Excellence (OCE) will work to approve new cancer drugs alongside Australia’s Therapeutic Goods Administration (TGA) and Health Canada. The collaboration, dubbed Project Orbis , was launched with FDA’s decision with TGA and Health Canada to grant accelerated approval to Eisai's Lenvima (lenvatinib) in combination with Merck's Keytruda (pembrolizumab) for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), and who have disease progression following prior systemic therapy but are not candidates for curative surgery or radiation. All three regulators said they collaboratively worked to review the application, which allows for simultaneous decisions in all three countries, although the labels in each country will differ. “The aim of this collaborative review was to identify any...

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) on Monday provided an update on its strategy for pharmacopoeial quality standards for biological medicines. The agency's five-year strategy for pharmacopoeial quality standards for biologics was released in 2017 following a public consultation earlier that year. For its 2019 update, MHRA said it reviewed its strategy and work program and made editorial changes to the strategy document to bring it in line with its Corporate Plan 2018-2023. The work program remains unchanged from previous versions. The update does, however, set out steps the agency plans to take over the next year in order to implement the strategy. Over the next 12 months, MHRA says it will convene its working party on alternative approaches for biotechnologically produced proteins "to develop deeper understanding of performance and class-based concepts" and establish a new working party for advanced therapy medicinal products (A...

Abbott announced that new research, published in the journal Circulation, found its algorithm could help doctors in hospital emergency rooms more accurately determine if someone is having a heart attack or not, so that they can receive faster treatments or be safely discharged. (1) In this study, researchers from the U.S., Germany, U.K., Switzerland, Australia and New Zealand looked at more than 11,000 patients to determine if Abbott's technology developed using artificial intelligence (AI) could provide a faster, more accurate determination that someone is having a heart attack or not. The study found that the algorithm provided doctors a more comprehensive analysis of the probability that a patient was having a heart attack or not, particularly for those who entered the hospital within the first three hours of when their symptoms started. "With machine learning technology, you can go from a one-size-fits-all approach for diagnosing heart attacks to an individualized and more...