- Unlike FDA, European regulators refuse to clear chloroquine for COVID-19 without data (fiercepharma.com)
...days after the FDA gave them (chloroquine and hydroxychloroquine) an emergency approval to treat COVID-19...European regulators are limiting their COVID-19 use to clinical trials only...The decision comes as limited data—some of it questionable—rolls in about the drugs and their potential as COVID-19 therapies. A French study that's made headlines continues to draw fire, but brand-new data from China add to the positive case...In guidance...the European Medicines Agency restricted general use of the drugs—already approved to treat malaria and autoimmune diseases—to patients taking them for approved indications. COVID-19 patients can receive the drugs as part of clinical trials or through national emergency use programs...READ MORE
- Which drug makers do a good job getting poor patients access to their medicines? (statnews.com)
The pharmaceutical industry is regularly chastised for failing to do enough to ensure that people in low and middle-income countries have access to its medicines. Yet the real picture is actually more nuanced, according to a newly released report that finds some — but not all — drug makers are making headway...Some companies...are partnering to develop needed medicines. Others are pledging to waive or abandon patent rights and granting licenses so that generic versions of their drugs become available. At the same time, the report finds that much more can be done…“...progress is slower than many of us would like,”...executive director of the Access to Medicine Foundation…The foundation...compiled an index...Here are some key findings: GlaxoSmithKline led the index for the fifth time and was followed by Johnson & Johnson and Novartis, while Astellas had the poorest showing...the number of companies using equitable pricing strategies increased from 16 in 2012, to 18 in 2014, to 19 in 2016. Ischemic heart disease replaced HIV/AIDS as the disease with the most products with equitable pricing...As for drugs being developed...420 R&D projects that address specific needs of people in low and middle-income countries, up from 93 in 2014. The pipeline focuses heavily on five diseases —lower respiratory infections, diabetes, malaria, viral hepatitis and HIV/AIDS — that cause relatively large burdens and either have large commercial markets or are high priorities.
- Drugmaker Abbott to buy Alere for $5.8 bln (cnbc.com)
Drugmaker Abbott Laboratories said it would acquire Alere for $5.8 billion in a deal that would expand its diagnostics business and make it a leader in point-of-care testing...Point-of-care tests help increase the speed of treatment by bringing test results to doctors in a matter of minutes as they can be conducted in the physician's office, an ambulance or even at home...Alere, which has annual sales of $2.5 billion, makes tests for infections such as HIV, tuberculosis, malaria and dengue...Abbott, which had annual sales of $20.4 billion in 2015, said its total diagnostics sales would exceed $7 billion after the close of the deal...Alere's net debt, currently $2.6 billion, will be assumed or refinanced by Abbott.
- 300 million child-friendly antimalarial treatments supplied without profit by Novartis (malaria.novartis.com)
Novartis announced today that it has reached a delivery milestone of 300 million pediatric antimalarial treatments supplied without profit since 2009, helping to reduce the disease burden for children in more than 30 malaria-endemic countries. Coartem® Dispersible is the first artemisinin-combination therapy developed by Novartis in collaboration with Medicines for Malaria Venture specifically to meet the needs of children. Never before have so many pediatric treatments been distributed in such a short timeframe to children suffering from malaria…"This milestone underscores our long-standing commitment to the fight against malaria and to the children who are most at risk from the disease…"We are proud of the part we have played in helping to reduce childhood deaths from malaria. And we continue to provide medicine at no profit to people who need it, contributing to the goal of a world free from the disease."
- UN: About 11 percent of drugs in poor countries are fake (ktvn.com)
About 11 percent of medicines in developing countries are counterfeit and likely responsible for the deaths of tens of thousands of children from diseases like malaria and pneumonia every year, the World Health Organization said...It's the first attempt by the U.N. health agency to assess the problem. Experts reviewed 100 studies involving more than 48,000 medicines. Drugs for treating malaria and bacterial infections accounted for nearly 65 percent of fake medicines... Between 72,000 and 169,000 children may be dying from pneumonia every year after receiving bad drugs. Counterfeit medications might be responsible for an additional 116,000 deaths from malaria mostly in sub-Saharan Africa...Counterfeit drugs include products that have not been approved by regulators, fail to meet quality standards or deliberately misrepresent an ingredient...In 2013, WHO set up a voluntary global monitoring system for substandard and fake drugs and has received reports of about 1,500 problematic medicines including drugs that claim to treat heart problems, diabetes, fertility problems, mental health issues and cancer. WHO also reported problems of fake vaccines for diseases including yellow fever and meningitis...
- Engineers develop a pill for long-term drug release (news.mit.edu)
Researchers from MIT and Brigham and Women’s Hospital have designed a new type of pill that, once swallowed, can attach to the lining of the gastrointestinal tract and slowly release its contents. The tablet is engineered so that one side adheres to tissue, while the other repels food and liquids that would otherwise pull it away from the attachment site...Such extended-release pills could be used to reduce the dosage frequency of some drugs...The ability to precisely engineer the adhesiveness of a particle opens up possibilities of designing particles to selectively adhere to specific regions of the GI tract, which in turn can increase the local or systemic concentrations of a particular drug...In addition to delivering antibiotics, the two-sided material may help to simplify drug regimens for malaria or tuberculosis, among other diseases...The researchers may also further pursue the development of tablets with omniphobic coatings on both sides, which they believe could help patients who have trouble swallowing pills...Texturing the surfaces really opens up a new way of thinking about controlling and tuning how these drug formulations travel...
- We Can Beat Zika And Malaria–If The FDA Allows (forbes.com)The Emerging Zika PandemicEnhancing Preparedness (jama.jamanetwork.com)
Zika virus infection, the scary new disease for which there is no vaccine or treatment, is “spreading explosively” from Africa and Southeast Asia...The United States and 20 other countries...have reported cases of the virus since Brazil reported the first cases of local transmission last May. Delivered by varieties of mosquitoes...it has boosted interest in mosquito-borne diseases...What’s needed is...modern genetic engineering techniques to more effectively prevent mosquitoes from delivering the viruses and parasites that cause disease….The FDA has long delayed the approval of a November 2011 application for a field trial to test a new biological control agent for the mosquito species Aedes aegypti. Although that field trial is concerned specifically with dengue fever, A. aegypti...also transmits Zika...Oxitec has created a new way to control Aedes aegypti. Male mosquitoes are bred in the laboratory with a specific genetic mutation that, in the absence of a certain chemical, causes their offspring to die before reaching maturity...This safe and effective control technique has been approved in Brazil and open field trials of these mosquitoes have been conducted in Brazil, the Cayman Islands, Panama and Malaysia...Eight months have passed since FDA promised last May to publish for public comment a routine environmental assessment of the Oxitec field trial in Florida. Only after FDA reviews the comments will FDA consider whether to grant approval. This delay is unnecessary and unconscionable.
- Top 5 Things to Know About Future Drug Spending (drugtopics.modernmedicine.com)
The United States and other countries will continue to spend more on specialty medications, and less will be spent on brand-name drugs...spending on drugs in the U.S. will grow at a much slower rate, according to the Quintiles IMS Institute report, "Outlook for Global Medicines Through 2021: Balancing Cost and Value."...
- THE GROWTH RATE for U.S. spending on medicines will decline by half, from 12% in 2015 to between 6% and 7% in 2017. Plus, prescription drug spending is forecast to grow between 6% and 9% through 2021…
- U.S. BRAND DRUG PRICES will increase at a slower rate, due both to competition from generics and Congressional backlash over soaring brand prices...Brand prices will increase at 8% to 11% — more slowly than the 12% to 15% in the past three years….
- SPECIALTY MEDICINES will lift the share of global heathcare spending from 30% in 2016 to 35% in 2021, driven by the adoption of new breakthrough medicines...
- PATIENT OUT-OF-POCKET COSTS are forecast to decline, despite rising brand prescription costs, as patients shift to newly available generics and receive co-pay assistance for brands…
- SEVERAL NEW THERAPIES are moving through the registration process around the world and are expected to come to market soon. In the anti-infectives and antivirals category, new treatments for HIV, bacterial disease, anthrax, hepatitis C, and malaria will be launched...
- Zika update: Vaccine race swells, PaxVax CEO on how to stop ‘chasing epidemics’
As the Zika virus continues to spread, more biotechs are announcing their Zika vaccine programs. Meriden,.. Protein Sciences,..GeoVax Labs and.. PaxVax are the latest...Getting caught off-guard by epidemics like this has happened time and time again. And "chasing" outbreaks instead of anticipating them rarely results in a vaccine being developed in time. Witness the most recent Ebola epidemic: Merck's experimental vaccine, the furthest along in a crowded field, won't be submitted for regulatory approval until 2017, more than two years after the outbreak started...we had known about Ebola for decades...Companies got a head start in 2014 from partly developed candidates that had been shelved away. It is not so with Zika. "Almost everyone is pretty much starting from scratch...To avoid this and have programs in place before an outbreak hits...governments and nongovernmental organizations...should create economic incentives for companies to make vaccines for neglected diseases like Zika...the FDA's priority review voucher system, in which a company developing a vaccine for a neglected tropical disease receives a transferable voucher for expedited FDA review. Malaria and dengue have been on the list of neglected diseases for years, but Zika is not yet on the list
- 3 Exotic Diseases Pharmacists Should Know (pharmacytimes.com)
Pharmacists should learn how to properly diagnose foreign-acquired diseases in order to optimize outcomes for infected patients...these diseases are rarely seen in US emergency departments, health-system pharmacists might nevertheless encounter them during their careers...It’s important to recognize these diseases and know what you need to help them, [but] you don’t need to be an expert...Pharmacists can also play a role in preventing these diseases by reminding patients that they must follow their entire prescribed regimen when taking drugs prior to travel...The following are some exotic diseases primarily coming from Southeast Asia that pharmacists should know:
- Malaria
- Dengue Fever
- Typhoid Fever