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New Drugs Approvals by FDA and EMA: 2020 Recap
The year 2020 was an eventful year for the pharmaceutical industry, with several companies across the world working at a feverish pace to find a treatment or a vaccine for the raging Covid-19, which has so far taken over 1.79 million lives worldwide. With countries imposing lockdowns and regulators putting on-site inspections on hold, we were expecting far lower new drug approvals in mid-2020. But our mid-2020 recap published in July, which looked at new drug approvals by the US Food and Drug Administration (FDA) and European Medical Agency (EMA), found that the FDA had approved 33 new drugs by the end of June. This put the approvals within the ballpark of the past two years.  This week, we bring you a roundup of 2020, a tumultuous year when 58 drugs (53 approvals by the Center for Drug Evaluation and Research and 5 by the Center for Biologics Evaluation and Research) bagged FDA’s new drug approvals. While this number is lower than the number of drugs approved in 2018 (62), it is higher than the number for 2019 (54). Out of this, while 23 approvals were in the field of oncology, 9 were for infectious diseases and infections, 8 for genetic diseases, 7 for neurology, 3 for immunology and 2 for gastroenterology. View New Drug Approvals in 2020 with Estimated Sales (Free Excel Available) A year marked by EUA With the pandemic raging across the world, emergency use authorizations (EUAs) dominated news headlines in 2020 — the FDA issued 10 EUAs, with the most prominent being those issued to Pfizer-BioNTech and Moderna for their Covid-19 vaccines. EMA was busy as well since they issued 75 positive opinions with Novartis leading the pack with 8, followed by Pfizer and Sanofi which received 4 each. The EUAs came with their own set of controversies. In March, the FDA had issued an EUA “for oral formulations of chloroquine phosphate and hydroxychloroquine sulfate for the treatment of” Covid-19. However, by June, FDA had revoked the EUA, as the agency determined that chloroquine and hydroxychloroquine were not likely to be effective in treating Covid-19 for the authorized uses in the EUA. Amongst treatments for Covid-19, in May the FDA authorized the emergency use of Gilead’s antiviral drug remdesivir. In our mid-2020 recap, Gilead’s remdesivir was on top of our list of top-selling drugs after it received an EUA from the FDA. In October, remdesivir became the first drug to be approved by the FDA for treatment of Covid-19 patients requiring hospitalization. While analysts predicted US$ 3.5 billion in revenue in early October, the future of this drug as a treatment for Covid-19 in hospitalized patients remains uncertain, especially in wake of results from the World Health Organization (WHO)-led Solidarity Trial that said Gilead’s remdesivir had little or no effect on the 28-day mortality or length of hospital stays for Covid-19 patients. The FDA approved remdesivir for hospitalized patients a week after the WHO results.  View New Drug Approvals in 2020 with Estimated Sales (Free Excel Available) Gilead US$ 21 billion Immunomedics acquisition Immunomedics' antibody-drug conjugate (ADC) — Trodelvy (sacituzumab govitecan-hziy) — was approved by the FDA in April this year for the treatment of adult patients with metastatic triple-negative breast cancer who have received at least two prior therapies for the disease. Such tumor types account for 15 to 20 percent of breast cancers. Trodelvy follows remdesivir in our list of FDA approved drugs in 2020 with the highest sales potential. The current forecast for Trodelvy sales is US$ 2.151 billion by 2026.  In September, Gilead made a big move and acquired biotech company Immunomedics Inc for US$ 21 billion. The transaction, which was completed in October, will strengthen Gilead’s cancer portfolio and add another potential blockbuster to it. Immunomedics plans to submit a supplemental Biologics License Application (BLA) to support full approval of Trodelvy in the US over the next quarter. According to a statement, Immunomedics is also on track to file for regulatory approval of the drug in Europe in the first half of 2021. Moreover, ongoing studies are also evaluating the potential of Trodelvy as a treatment for non-small cell lung cancer and other types of solid tumors. View New Drug Approvals in 2020 with Estimated Sales (Free Excel Available) Roche-PTC Therapeutics’ risdiplam bags approval Following Troveldy in sales potential for drugs approved by the FDA is Roche and PTC Therapeutics’ drug Evrysdi (risdiplam), the first oral medicine approved for the rare genetic disease, spinal muscular atrophy, which until four years ago had no available treatments. The approval of Evrysdi presents patients and their families with a unique choice between a one-time gene therapy, an RNA-based drug infused three times a year at the doctor’s office and a daily medicine taken at home. Roche priced the drug by patient weight, with a maximum cost of US$ 340,000 per year — substantially lesser than the competing (and approved) therapies from Biogen and Novartis. View New Drug Approvals in 2020 with Estimated Sales (Free Excel Available) Vertex’s Kaftrio bags EMA approval Earlier this year, PharmaCompass had published its compilation of sales forecasts for the new drugs approved by the FDA in 2019. The list was led by Vertex’s cystic fibrosis treatment — Trikafta — which was expected to have sales of US$ 3.935 billion by 2024.  Trikafta is a combination of ivacaftor, tezacaftor and elexacaftor and its stellar clinical data made the FDA approve the drug within three months of Vertex’s application filing and five months before FDA’s action date.  In June 2020, EMA’s CHMP adopted a positive opinion, recommending the granting of a marketing authorization for Vertex’s combination, which will be marketed as Kaftrio.  View New Drug Approvals in 2020 with Estimated Sales (Free Excel Available) A year of multiple setbacks Not everything went smoothly in 2020. In fact, the year saw several setbacks — almost 44 drugs were not granted approval by the FDA. Bristol Myers Squibb was one such company that received setbacks. As part of Bristol’s US$ 74 billion acquisition of Celgene, the New York-headquartered drug company offered Celgene shareholders Contingent Value Rights or CVRs. But to realize the US$ 9-a piece payment, approvals for three ex-Celgene drugs must meet their pre-specified deadlines. While in March, the FDA approved Bristol’s ozanimod, a sphingosine-1-phosphate receptor agonist for the treatment of relapsing multiple sclerosis, well ahead of the December 31, 2020 deadline,  in May, Bristol Myers Squibb and bluebird bio, Inc announced that they have received a Refusal to File letter from FDA regarding the Biologics License Application (BLA) for their CAR-T therapy — idecabtagene vicleucel (ide-cel) — for patients with heavily pre-treated relapsed and refractory multiple myeloma, which was submitted in March 2020. Upon preliminary review, the FDA determined that the Chemistry, Manufacturing and Control (CMC) module of the BLA requires further details to complete the review. This was followed by Bristol Myers announcing that the FDA has extended the action date by three months for the BLA for lisocabtagene maraleucel (liso-cel), a CD19-directed CAR-T therapy for the treatment of adults with relapsed or refractory (R/R) large B-cell lymphoma after at least two prior therapies. The FDA had then set the new Prescription Drug User Fee Act (PDUFA) action date as November 16, 2020. However, on that day, FDA informed the company that its review of the BLA for liso-cel will not be completed by November 16. The FDA approval of liso-cel by December 31, 2020 is one of the required remaining milestones of the CVRs issued upon the close of the Celgene acquisition in the fourth quarter of 2019. The other is FDA approval of ide-cel by March 31, 2021. FDA declines approval to Novartis’ inclisiran: Recently, there was news that the FDA declined to approve Swiss drugmaker Novartis AG’s lipid-lowering therapy, inclisiran (branded as Leqvio). The drug came to Novartis' fold through the US$ 9.7 billion acquisition of The Medicines Company last year. The drug has been cleared by the European Commission. In a statement, Novartis said the FDA has not raised any concerns related to the efficacy or safety of inclisiran. The complete response letter (CRL) is due to unresolved facility inspection-related conditions. No onsite inspection was conducted by the FDA, the company said. View New Drug Approvals in 2020 with Estimated Sales (Free Excel Available) Our view Like the drug companies, regulators across the world also worked at a frenetic pace in order to accelerate EUAs and drug approvals, especially for treatments and vaccines for Covid-19. Apart from Covid-19, the year saw wider adoption and approvals for cell and gene therapies along with approvals of several innovative medicines like relugolix (the first oral gonadotropin-releasing hormone receptor antagonist for the treatment of adult patients with advanced prostate cancer), berotralstat the first oral once daily plasma kallikrein inhibitor to prevent attacks of hereditary angioedema in adults and pediatric patients 12 years and older, lumasiran (an HAO1-directed small interfering ribonucleic acid indicated for the treatment of primary hyperoxaluria type 1 to lower urinary oxalate levels in pediatric and adult patients) and osilodrostat for the treatment of adults with Cushing’s disease). Moreover, there were several interesting ‘non-Covid’ medical breakthroughs that took place during 2020. One such breakthrough is a single pill that combines four medications meant to lower blood pressure and cholesterol and aspirin that was found to cut the risk of heart disease. While the agility shown by pharma companies and regulators was undoubtedly quite impressive, with many countries granting EUA to vaccines for Covid-19, the ongoing pandemic did put mankind in a bind for several months. And if the words of the WHO director general Tedros Adhanom Ghebreyesus are to be believed, the coronavirus crisis will not be the last pandemic and attempts to improve human health are “doomed” without tackling climate change and animal welfare. If that really proves to be the case, the pharma industry has a lot to learn from this pandemic, and science has a lot to demonstrate if mankind is to emerge unscathed from such adversities. View New Drug Approvals in 2020 with Estimated Sales (Free Excel Available)  

Impressions: 6847

https://www.pharmacompass.com/radio-compass-blog/new-drugs-approvals-by-fda-and-ema-2020-recap

#PharmaFlow by PHARMACOMPASS
31 Dec 2020
New Drug Approvals by FDA & EMA (Mid-2020 Recap)
In case you thought Covid-19 had slowed down US Food and Drug Administration’s New Drug Approvals, you’re in for a pleasant surprise — the FDA appears to be more active than ever before. By the end of June, the FDA had already approved 33 new drugs which put the approval activities within the ballpark of the past two years — 62 novel drugs were approved in 2018, while 54 were approved in 2019.  FDA’s Center for Drug Evaluation and Research (CDER) approved 25 new molecular entities and new therapeutic biological products, of which almost half — 12 out of 25 — were oncology drugs, while the rest of the novel therapies were approved by the Center for Biologics Evaluation and Research. The European Medical Agency (EMA) was also busy as the regulator issued a positive opinion for 41 drugs, of which 27 were classified as novel treatments. View New Drug Approvals by June 2020 with Estimated Sales (Free Excel Available) Conditional Approval for Gilead’s Remdesivir Gilead’s Remdesivir has certainly been one of the most talked about drugs this year. While it is still under clinical evaluation, the FDA, EMA and the Japanese Ministry of Health, Labour and Welfare (MHLW) found ways of providing market access to this drug as a treatment against Covid-19.  On May 1, 2020, based on the totality of scientific evidence available to the FDA, the agency issued an Emergency Use Authorization (EUA), as it believed that remdesivir may be effective in treating Covid-19 and that the known and potential benefits of remdesivir, when used to treat Covid-19, outweigh the known and potential risks of such products. On June 25, 2020, EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of conditional marketing authorization for Veklury (remdesivir). The demand for remdesivir is such that the US bought more than 500,000 doses, which is all of Gilead’s production for July and 90 percent of production for August and September, leaving almost no stock of remdesivir for the UK and Europe.  In 127 poor or middle-income countries, Gilead is allowing generic drugmakers to supply remdesivir. It has signed non-exclusive voluntary licensing agreements with generic pharmaceutical manufacturers based in Egypt, India and Pakistan to further expand the supply of the antiviral drug. View New Drug Approvals by June 2020 with Estimated Sales (Free Excel Available) Vertex’s Kaftrio bags EMA approval Earlier this year, PharmaCompass published its compilation of the sales forecasts for the new drugs approved by the FDA in 2019. The list was led by Vertex’s cystic fibrosis treatment — Trikafta — which is expected to have sales of US$ 3.935 billion by 2024.  Trikafta is a combination of ivacaftor, tezacaftor and elexacaftor and its stellar clinical data made the FDA approve the drug within three months of Vertex’s application filing and five months before FDA’s action date.  In June 2020, EMA’s CHMP adopted a positive opinion, recommending the granting of a marketing authorization for Vertex’s combination which will be marketed as Kaftrio.  EMA also adopted positive opinions on other drugs which were previously approved by the FDA in 2019, such as Novartis’ Zolgensma and Piqray, Pfizer’s Staquis and Daurismo among many others. Immunomedic’s antibody-drug conjugate (ADC) — Trodelvy (sacituzumab govitecan-hziy) — was approved by the FDA for the treatment of adult patients with metastatic triple-negative breast cancer who have received at least two prior therapies for metastatic disease. Trodelvy follows remdesivir in our list of FDA approved drugs in 2020 with the highest sales potential. The current forecast for Trodelvy sales is US$ 2.151 billion by 2026.  FDA’s approval of Lundbeck’s Vyepti (eptinezumab) and Biohaven’s Nurtec ODT (rimegepant) for migraine headaches brought additional CGRP-targeted products to the market. It will be interesting to see how Nurtec ODT is accepted given it is a small molecule drug, which makes administration easier. It was recently promoted on social media by Khloe Kardashian. View New Drug Approvals by June 2020 with Estimated Sales (Free Excel Available) Covid-19 impacts drug launches The pandemic has, however, started taking a toll on drug launches. One of the most anticipated drug approvals of the year, Bristol-Myers Squibb’s multiple sclerosis (MS) treatment — Zeposia (ozanimod) — was approved in both the US and Europe. However, the launch of the drug would be delayed due to the coronavirus outbreak. The drug was added to BMS’s portfolio through its US$ 74 billion acquisition of Celgene last year. Its approval was one of the three conditions set for a potentially higher payout for Celgene investors.  Analysts have high hopes from ozanimod. Its average peak sales for 2024 have been predicted to be at US$ 1.62 billion by Cortellis, though the Covid-19 pandemic may weigh in there as well. View New Drug Approvals by June 2020 with Estimated Sales (Free Excel Available) First non-statin cholesterol drug bags FDA approval This year also witnessed the first non-statin treatment to be cleared for sale in the US in nearly 20 years. The drug, bempedoic acid, is made by Esperion Therapeutics Inc. This cholesterol-lowering drug is aimed at helping millions of people who can’t tolerate or don’t get enough help from widely used statin pills like Lipitor and Crestor. This new drug is to be used as an add-on treatment with statins. It lowers bad cholesterol or low-density lipoprotein (LDL) by inhibiting its synthesis in the liver. It targets patients with high cardiovascular risk. Esperion also won approval of bempedoic acid in combination with ezetimibe, another cholesterol-lowering drug.  In January last year, Daiichi Sankyo Europe had entered into an exclusive licensing agreement with Esperion Therapeutics for Daiichi Sankyo Europe to market bempedoic acid and bempedoic acid/ezetimibe combination tablet in the European Economic Area and Switzerland. View New Drug Approvals by June 2020 with Estimated Sales (Free Excel Available) Approvals not granted to almost 20 drugs  There were setbacks too, and not everything rolled smoothly. This year, almost 20 drug approvals were not granted. Among the major setbacks were Bristol Myers Squibb and bluebird bio, Inc announcing that they have received a Refusal to File letter from the FDA regarding the Biologics License Application (BLA) for their CAR-T therapy, idecabtagene vicleucel (ide-cel), for patients with heavily pre-treated relapsed and refractory multiple myeloma, which was submitted in March 2020. Upon preliminary review, the FDA determined that the Chemistry, Manufacturing and Control (CMC) module of the BLA requires further detail to complete the review. No additional clinical or non-clinical data have been requested or are required. Two years after Intarcia Therapeutics received a CRL for its matchstick-sized, long-term drug implant for type 2 diabetes, the FDA issued a second CRL to the company for its ITCA-650 implant. The implant is designed to be a small, osmotic pump which can be slipped under the skin and deliver a continuous, six-month dose of the GLP-1 agonist exenatide. The FDA also did not approve Intercept Pharmaceuticals’ obeticholic acid to treat NASH (or nonalcoholic steatohepatitis, a liver condition in which the buildup of fat progressively scars the organ), as it wasn’t convinced that its benefits outweighed the potential risks. After acquiring Allergan for US$ 63 billion, one of the first drugs which AbbVie was expecting approval for was Abicipar pegol, their experimental DARPin therapy for patients with neovascular (wet) age-related macular degeneration (nAMD). However, FDA’s review indicated the rate of intraocular inflammation observed following administration of Abicipar pegol 2mg/0.05 mL results in an unfavorable benefit-risk ratio in the treatment of wet AMD.  View New Drug Approvals by June 2020 with Estimated Sales (Free Excel Available) Our view While everyone’s attention is on the Covid-19 pandemic, the industry is certainly busy working towards getting new drugs to market. At the halfway mark, the FDA and EMA seem to be on track to set approval records this year, since the number of drugs approved by June are almost twice the number that were approved at the same time last year. However, it remains to be seen how companies adapt their sales and marketing strategies in a world where mobility is likely to get restricted and interpersonal contact is set to reduce dramatically. View New Drug Approvals by June 2020 with Estimated Sales (Free Excel Available)  

Impressions: 69865

https://www.pharmacompass.com/radio-compass-blog/new-drug-approvals-by-fda-ema-mid-2020-recap

#PharmaFlow by PHARMACOMPASS
23 Jul 2020
World looks for effective treatment to coronavirus, as drugmakers, regulators race ahead to find vaccines, cure
Now that the World Health Organization (WHO) has declared the new coronavirus (2019-nCoV) as a public health emergency of international concern, some of the biopharma industry’s biggest names are taking important steps to combat the disease. The death toll from the coronavirus outbreak is rising each day. As many as 563 people have died in China, and the virus has now spread to nearly 30 countries across the world, including Japan, Thailand, Singapore, Hong Kong, South Korea, Australia, Malaysia, Germany, India and the US. In fact, infectious disease specialists and scientists say the new coronavirus may be more contagious than what the current data suggests. The virus has spread from about 300 people on January 21 to over 28,000 people across the world. The numbers may be even higher as there is limited testing capacity. “The rapid acceleration of cases is of concern,” Dr. Mike Ryan, executive director of the WHO’s emergencies program said last week. Health authorities all over the world are trying to contain the outbreak. In the US, nearly 200 Americans were placed under quarantine at a US air base in California after being evacuated from Wuhan, China. Under the new restrictions, US citizens who have traveled to China within the last 14 days will be directed to one of the 11 airports designated for screening. The FDA is halting travel of all its employees to China and recalling its inspectors from the country. Shortage of face masks, body suits   The fear of the fast spreading coronavirus has led to an acute shortage of face masks in Asia, the US and the UK. Manufacturers are increasing production to meet surging demand. In fact, China is the source of most of the world’s masks and respirators. However, today it is using more masks than it ever has. As a result, fewer masks and respirators will be available to the countries that have been importing them from China. In fact, former FDA commissioner Scott Gottlieb tweeted that China is witnessing a shortage of protective body suits. “Since much of supply chain for masks, gowns, gloves is through China; we should prepare for potential of stretched supply chains and increased demand here in US in event of outbreaks or epidemic spread in America,” Gottlieb tweeted quoting a Bernstein analysis Meanwhile, India has banned the export of personal protection equipment such as masks and clothing amid the global coronavirus outbreak. In Hong Kong, which has been struggling with a shortage of face masks, toilet rolls became unavailable in some supermarkets. Social media posts showed empty shelves and shoppers lining up to buy rolls. Success of flu, HIV drugs on coronavirus: Though there is no formal cure discovered to treat the virus, the treatment protocol established in China and confirmed by physicians in Thailand shows that a combination of Lopanvir and Ritonavir, old generation drugs used to treat HIV, along with flu medication Oseltamivir, has worked on patients. Thai doctors have seen success of such a treatment. “This is not the cure, but the patient’s condition has vastly improved. From testing positive for 10 days under our care, after applying this combination of medicine the test result became negative within 48 hours,” Dr. Kriangska Atipornwanich, a lung specialist at Rajavithi Hospital in Bangkok said. Thailand has recorded 19 cases of coronavirus. Of the Thai patients, eight have recovered and gone home while 11 are still under treatment in hospitals. Meanwhile, Indian drug companies say they are ready with supply of anti-retrovirals (ARVs) that seem to work in treating the novel coronavirus. Rise in screening tests: Roche has developed a test that can tell whether or not someone has the 2019-nCoV infection within a couple of hours. Roche’s coronavirus test hasn’t been approved for marketing as yet. Co-Diagnostics Inc has also said that the initial verification of its screening test designed to identify the presence of the coronavirus was successful. Healthcare company Novacyt has also launched a new molecular test for the Wuhan coronavirus. The company said its Primerdesign coronavirus test could detect the 2019 strain of the virus, adding it believed this would differentiate it from other current tests which it said were less specific. New coronavirus projects   There are multiple drugmakers and diagnostics companies making noise about their coronavirus projects. Here are some noteworthy projects: Gilead’s remdesivir: Gilead’s experimental anti-viral treatment — remdesivir — has shown some positive results as a patient in the US with worsening symptoms of a confirmed 2019-nCoV infection has been treated with the drug. Remdesivir appeared effective as a throat swab was tested negative for the virus just a few days after receiving the infusion. Incidentally, Gilead is developing remdesivir to combat the Ebola virus, not 2019-nCoV. Success from a single patient is great news, but the company needs more evidence to prove its case. Gilead is also expediting laboratory testing of remdesivir against samples of the new coronavirus. Last week, Anthony Fauci, director of the US National Institute of Allergy and Infectious Diseases, said his agency was working with Gilead to test remdesivir. Gilead is also working with Chinese authorities to begin a controlled, randomized study. However, such a study is bound to take months. Meanwhile, China has kick-started a clinical trial to speedily test remdesivir for 2019-nCoV. In fact, the virology institute in Wuhan has applied for a patent on this experimental Gilead drug. Scientists have found remdesivir and chloroquine, an 80-year-old malaria drug, to be highly effective in laboratory settings to thwart the novel coronavirus. However, the two drugs’ efficacies on humans required further clinical tests, the institute said. Remdesivir will also be tested by a medical team from Beijing-based China-Japan Friendship Hospital for efficacy in treating the deadly new strain of coronavirus. Gilead said the drug was shown to be active in animals with Severe Acute Respiratory Syndrome (SARS) and Middle East Respiratory Syndrome (MERS), which are closely related to the current virus. Moderna, J&J, GSK work on vaccines: Moderna, a Massachusetts-headquartered biotechnology firm, is developing a vaccine to prevent the coronavirus from spreading. Though there isn’t any accomplishment as yet, the Coalition for Epidemic Preparedness Innovations (CEPI) has agreed to fund the manufacturing of a 2019-nCoV vaccine that uses the company’s proprietary messenger RNA (mRNA) platform. Last week, Johnson & Johnson also said it would begin work on developing a vaccine for the virus. GlaxoSmithKline and CEPI also said they would work to accelerate the creation of a vaccine. The goal is then to provide many vaccine doses rapidly, a statement said. The project will rely on GSK’s adjuvant system, designed to enhance the body’s immune response and create a stronger and longer lasting protection against infection. However, developing a preventive and confirming that it is safe and useful in humans could take 12 to 18 months Regulators, WHO prepare for new cures   The European Medicines Agency (EMA), US Food and Drug Administration (FDA) and the WHO have taken various precautions and are preparing themselves for new medicines, vaccines and in-vitro diagnostics (IVDs). FDA has issued an Emergency Use Authorization (EUA) to authorize the emergency use of Centers for Disease Control and Prevention's (CDC) 2019-Novel Coronavirus (2019-nCoV) Real-Time Reverse Transcriptase (RT)-PCR Diagnostic Panel for the “presumptive qualitative detection of nucleic acid from the 2019-nCoV in upper and lower respiratory specimens (such as nasopharyngeal or oropharyngeal swabs, sputum, lower respiratory tract aspirates, bronchoalveolar lavage, and nasopharyngeal wash/aspirate or nasal aspirate) collected from individuals who meet CDC criteria for 2019-nCoV testing.” To date, this test has been limited to use at CDC laboratories, but FDA said today’s authorization allows the use of the test at any CDC-qualified lab nationwide. Similarly, EMA said it is ready to support drug developers with all available regulatory tools (i.e., scientific advice, the PRIME scheme, the accelerated assessment and conditional marketing authorization) to advance and expedite the development of ways to fight and prevent the spread of this virus. WHO says ‘no effective treatment’ yet   The WHO has played down reports that talk of effective drugs that could treat the new coronavirus. Television reports in China have pointed to an effective drug for the virus. And Britain’s Sky News said researchers had made a “significant breakthrough” in developing a vaccine. WHO spokesman Tarik Jasarevic said: “There are no known effective therapeutics against this 2019-nCoV (virus) and the WHO recommends enrollment into a randomized controlled trial to test efficacy and safety.” “Even at the accelerated pace enabled by new technologies, the earliest that scientists hope to be able to start initial human trials of a new coronavirus vaccine is by June this year,” a Reuters news report said. Our view   According to the WHO website, there have been multiple disease outbreaks over the last 20 years, including diseases like dengue, avian flu, zika virus, SARS, MERS and many others. Till date, most of these diseases don’t have a cure or a vaccine. These diseases are being treated by various antiviral drugs, and the treatments are largely symptomatic. “The process of developing and testing drugs or vaccines against a new pathogen normally takes many years and is often fraught with pitfalls and failures,” a Reuters report said.Most of the viruses are mutating at a fast pace, creating newer strains each year. Scientists are concerned that the 2019-nCoV has mutated to adapt to its new human hosts far more quickly than SARS. Data on the virus is changing by the day, and some infectious disease specialists say it will take weeks before they can see just how contagious it is. Scientists believe the virus is more contagious than what the current data suggests.Clearly then, this is a race between a fast-spreading and fast-mutating virus and the skills of the biopharmaceutical industry to contain its spread. This time though, the pharmaceutical industry is showing a lot of urgency in finding a vaccine as well as a cure. 

Impressions: 2131

https://www.pharmacompass.com/radio-compass-blog/world-looks-for-effective-treatment-to-coronavirus-as-drugmakers-regulators-race-ahead-to-find-vaccines-cure

#Phispers by PHARMACOMPASS
06 Feb 2020
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