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Top drugs and pharmaceutical companies of 2019 by revenues
Acquisitions and spin-offs dominated headlines in 2019 and the tone was set very early with Bristol-Myers Squibb acquiring New Jersey-based cancer drug company Celgene in a US$ 74 billion deal announced on January 3, 2019. After factoring in debt, the deal value ballooned to about US$ 95 billion, which according to data compiled by Refinitiv, made it the largest healthcare deal on record. In the summer, AbbVie Inc, which sells the world’s best-selling drug Humira, announced its acquisition of Allergan Plc, known for Botox and other cosmetic treatments, for US$ 63 billion. While the companies are still awaiting regulatory approval for their deal, with US$ 49 billion in combined 2019 revenues, the merged entity would rank amongst the biggest in the industry. View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available) The big five by pharmaceutical sales — Pfizer, Roche, J&J, Novartis and Merck Pfizer continued to lead companies by pharmaceutical sales by reporting annual 2019 revenues of US$ 51.8 billion, a decrease of US$ 1.9 billion, or 4 percent, compared to 2018. The decline was primarily attributed to the loss of exclusivity of Lyrica in 2019, which witnessed its sales drop from US$ 5 billion in 2018 to US$ 3.3 billion in 2019. In 2018, Pfizer’s then incoming CEO Albert Bourla had mentioned that the company did not see the need for any large-scale M&A activity as Pfizer had “the best pipeline” in its history, which needed the company to focus on deploying its capital to keep its pipeline flowing and execute on its drug launches. Bourla stayed true to his word and barring the acquisition of Array Biopharma for US$ 11.4 billion and a spin-off to merge Upjohn, Pfizer’s off-patent branded and generic established medicines business with Mylan, there weren’t any other big ticket deals which were announced. The Upjohn-Mylan merged entity will be called Viatris and is expected to have 2020 revenues between US$ 19 and US$ 20 billion and could outpace Teva to become the largest generic company in the world, in term of revenues.  Novartis, which had followed Pfizer with the second largest revenues in the pharmaceutical industry in 2018, reported its first full year earnings after spinning off its Alcon eye care devices business division that had US$ 7.15 billion in 2018 sales. In 2019, Novartis slipped two spots in the ranking after reporting total sales of US$ 47.4 billion and its CEO Vas Narasimhan continued his deal-making spree by buying New Jersey-headquartered The Medicines Company (MedCo) for US$ 9.7 billion to acquire a late-stage cholesterol-lowering therapy named inclisiran. As Takeda Pharmaceutical Co was busy in 2019 on working to reduce its debt burden incurred due to its US$ 62 billion purchase of Shire Plc, which was announced in 2018, Novartis also purchased the eye-disease medicine, Xiidra, from the Japanese drugmaker for US$ 5.3 billion. Novartis’ management also spent a considerable part of 2019 dealing with data-integrity concerns which emerged from its 2018 buyout of AveXis, the gene-therapy maker Novartis had acquired for US$ 8.7 billion. The deal gave Novartis rights to Zolgensma, a novel treatment intended for children less than two years of age with the most severe form of spinal muscular atrophy (SMA). Priced at US$ 2.1 million, Zolgensma is currently the world’s most expensive drug. However, in a shocking announcement, a month after approving the drug, the US Food and Drug Administration (FDA) issued a press release on data accuracy issues as the agency was informed by AveXis that its personnel had manipulated data which the FDA used to evaluate product comparability and nonclinical (animal) pharmacology as part of the biologics license application (BLA), which was submitted and reviewed by the FDA. With US$ 50.0 billion (CHF 48.5 billion) in annual pharmaceutical sales, Swiss drugmaker Roche came in at number two position in 2019 as its sales grew 11 percent driven by its multiple sclerosis medicine Ocrevus, haemophilia drug Hemlibra and cancer medicines Tecentriq and Perjeta. Roche’s newly introduced medicines generated US$ 5.53 billion (CHF 5.4 billion) in growth, helping offset the impact of the competition from biosimilars for its three best-selling drugs MabThera/Rituxan, Herceptin and Avastin. In late 2019, after months of increased antitrust scrutiny, Roche completed its US$ 5.1 billion acquisition of Spark Therapeutics to strengthen its presence in gene therapy. Last year, J&J reported almost flat worldwide sales of US$ 82.1 billion. J&J’s pharmaceutical division generated US$ 42.20 billion and its medical devices and consumer health divisions brought in US$ 25.96 billion and US$ 13.89 billion respectively.  Since J&J’s consumer health division sells analgesics, digestive health along with beauty and oral care products, the US$ 5.43 billion in consumer health sales from over-the-counter drugs and women’s health products was only used in our assessment of J&J’s total pharmaceutical revenues. With combined pharmaceutical sales of US$ 47.63 billion, J&J made it to number three on our list. While the sales of products like Stelara, Darzalex, Imbruvica, Invega Sustenna drove J&J’s pharmaceutical business to grow by 4 percent over 2018, the firm had to contend with generic competition against key revenue contributors Remicade and Zytiga. US-headquartered Merck, which is known as MSD (short for Merck Sharp & Dohme) outside the United States and Canada, is set to significantly move up the rankings next year fueled by its cancer drug Keytruda, which witnessed a 55 percent increase in sales to US$ 11.1 billion. Merck reported total revenues of US$ 41.75 billion and also announced it will spin off its women’s health drugs, biosimilar drugs and older products to create a new pharmaceutical company with US$ 6.5 billion in annual revenues. The firm had anticipated 2020 sales between US$ 48.8 billion and US$  50.3 billion however this week it announced that the coronavirus  pandemic will reduce 2020 sales by more than $2 billion. View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available)  Humira holds on to remain world’s best-selling drug AbbVie’s acquisition of Allergan comes as the firm faces the expiration of patent protection for Humira, which brought in a staggering US$ 19.2 billion in sales last year for the company. AbbVie has failed to successfully acquire or develop a major new product to replace the sales generated by its flagship drug. In 2019, Humira’s US revenues increased 8.6 percent to US$ 14.86 billion while internationally, due to biosimilar competition, the sales dropped 31.1 percent to US$ 4.30 billion. Bristol Myers Squibb’s Eliquis, which is also marketed by Pfizer, maintained its number two position and posted total sales of US$ 12.1 billion, a 23 percent increase over 2018. While Bristol Myers Squibb’s immunotherapy treatment Opdivo, sold in partnership with Ono in Japan, saw sales increase from US$ 7.57 billion to US$ 8.0 billion, the growth paled in comparison to the US$ 3.9 billion revenue increase of Opdivo’s key immunotherapy competitor Merck’s Keytruda. Keytruda took the number three spot in drug sales that previously belonged to Celgene’s Revlimid, which witnessed a sales decline from US$ 9.69 billion to US$ 9.4 billion. Cancer treatment Imbruvica, which is marketed by J&J and AbbVie, witnessed a 30 percent increase in sales. With US$ 8.1 billion in 2019 revenues, it took the number five position. View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available) Vaccines – Covid-19 turns competitors into partners This year has been dominated by the single biggest health emergency in years — the novel coronavirus (Covid-19) pandemic. As drugs continue to fail to meet expectations, vaccine development has received a lot of attention.  GSK reported the highest vaccine sales of all drugmakers with total sales of US$ 8.4 billion (GBP 7.16 billion), a significant portion of its total sales of US$ 41.8 billion (GBP 33.754 billion).   US-based Merck’s vaccine division also reported a significant increase in sales to US$ 8.0 billion and in 2019 received FDA and EU approval to market its Ebola vaccine Ervebo. This is the first FDA-authorized vaccine against the deadly virus which causes hemorrhagic fever and spreads from person to person through direct contact with body fluids. Pfizer and Sanofi also reported an increase in their vaccine sales to US$ 6.4 billion and US$ 6.2 billion respectively and the Covid-19 pandemic has recently pushed drugmakers to move faster than ever before and has also converted competitors into partners. In a rare move, drug behemoths  — Sanofi and GlaxoSmithKline (GSK) —joined hands to develop a vaccine for the novel coronavirus. The two companies plan to start human trials in the second half of this year, and if things go right, they will file for potential approvals by the second half of 2021.  View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available)  Our view Covid-19 has brought the world economy to a grinding halt and shifted the global attention to the pharmaceutical industry’s capability to deliver solutions to address this pandemic.  Our compilation shows that vaccines and drugs for infectious diseases currently form a tiny fraction of the total sales of pharmaceutical companies and few drugs against infectious diseases rank high on the sales list. This could well explain the limited range of options currently available to fight Covid-19. With the pandemic currently infecting over 3 million people spread across more than 200 countries, we can safely conclude that the scenario in 2020 will change substantially. And so should our compilation of top drugs for the year. View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available)   

Impressions: 54764

https://www.pharmacompass.com/radio-compass-blog/top-drugs-and-pharmaceutical-companies-of-2019-by-revenues

#PharmaFlow by PHARMACOMPASS
29 Apr 2020
Mylan’s President, Emcure’s CEO named in US drug price-fixing probe; Novartis buys French biotech for US$ 3.9 billion
This week in Phispers, we look at how Mylan’s president Rajiv Malik and Emcure’s CEO Satish Mehta, along with 12 major generic drug players, got added to an expanded investigation into the drug price-fixing case in the US. While Trump declared the opioid crisis a health emergency, pharma companies Celgene and Gilead saw their third quarter results and guidance get impacted by a drug trial failure and competition. Meanwhile, there was news on Novartis buying AAA, CVS Health showing interest in buying health insurer Aetna and Merck cutting jobs and withdrawing its application for Keytruda as treatment for advanced lung cancer. Mylan’s president, Emcure’s CEO, 12 firms to be probed in price-fixing case   This week, attorneys general from 45 US states named Mylan’s president Rajiv Malik and Emcure’s billionaire CEO Satish Mehta as they expanded their three-year old investigation into price-fixing in the generic pharmaceuticals industry. In addition to the two individuals, 12 major generic drug companies and 13 drugs were added to the expanded investigation. This week’s filing alleges collusion of 18 defendant companies, as well as two individual executives, involving a total of 15 drugs.  (To view the complete list of companies and drugs, click here) The states allege multiple conspiracies that restrained trade, artificially inflated and/or maintained prices and reduced competition in the generic drug industry. According to the expanded complaint, Mehta and Malik were “directly involved in conceiving an illegal agreement and taking affirmative steps to ensure it was executed by their subordinates.” Earlier this year, a federal criminal investigation resulted in the convictions of former Heritage Pharmaceuticals CEO Jeffrey Glazer and former Heritage President Jason Malek. Heritage is a wholly-owned subsidiary of Emcure. Both Glazer and Malek pleaded guilty and have been cooperating in the anti-trust investigations being conducted by federal and state prosecutors. PharmaCompass had covered the illegal practices at Heritage Pharmaceuticals that had come to light when Emcure had filed a lawsuit against Glazer. It now remains to be seen if Glazer acted on his own or colluded with his bosses in India to fix generic drug prices in the United States. As Trump declares opioid crisis an emergency, Insys founder gets arrested   Last week, the US President Donald Trump hardened his stand on the opioid crisis, blaming it on factors like criminals, drug companies, Mexico and China. In the US, the crisis claimed over 30,000 lives in 2015. He termed abuse of opioids a public health emergency and outlined steps to fight it — such as new efforts to curb prescription abuse, reduction in import of certain drugs and educating children on the risks. “We must stop the flow of all types of illegal drugs into our communities,” Trump said. Blaming pharmaceutical companies for over-prescribing pain medications, he said the US Food and Drug Administration (FDA) will provide more training to doctors who prescribe drugs to prevent abuse. Moreover, he has requested that one opioid drug, Opana ER, no longer be sold. According to Trump, a border wall with Mexico will “greatly help” reduce this problem. He also talked about China’s role in the production of fentanyl. Meanwhile, John Kapoor, the founder of Insys Therapeutics, was arrested last week on charges of participating in a scheme to bribe doctors to prescribe a fentanyl-based cancer pain drug. Kapoor has resigned from the company’s board of directors, and his arrest is being seen as a step towards fighting the opioid epidemic. The charges against Kapoor marked a major escalation of probes into Subsys, an under-the-tongue spray that contains fentanyl, an addictive synthetic opioid. Celgene’s Crohn’s disease drug fails trial; Gilead reports weak Hep C sales   Two companies have not had a good going — Celgene and Gilead. The former announced that its drug mongersen — a potential treatment for Crohn’s disease — had failed. Celgene had purchased the drug four years ago for US$ 710 million from a private company in Dublin — Nogra Pharma Limited. The New Jersey-headquartered biotech firm had promised that if mongersen gets approved, Nogra would get another US$ 815 million. But that was not to be. What was worse, Celgene’s third-quarter financial announced last week spooked its investors. The company missed analysts’ sales projections for the third quarter by 4 percent, cut its guidance for 2020 by 5 to 10 percent, and announced that sales of a key (plaque psoriasis) drug — Otezla — had missed forecasts by US$ 100 million. In a note, Geoffrey Porges, a biotech analyst at Leerink, said: “Investors are likely to ask whether the company’s good fortune has run out, with disappointments (mongersen) and negative revisions (Otezla) left and right.” Gilead, on the other hand, is trying hard to move away from hepatitis C. Its hepatitis C drugs generated US$ 2 billion during the last quarter — just US$ 300 million short of Wall Street’s projections. However, investors were cautioned about AbbVie’s new launch —Mavyret — which is expected to have a “big impact” on Gilead’s fourth-quarter results. Gilead’s hepatitis C drugs have been facing competition from new rivals who have eaten into its market share and driven down prices over the last few quarters. However, we could expect some M&A action soon. “Gilead noted that it is in a ‘constant state of valuation and opportunities’ and that it is very, very active,” said an analyst. Novartis buys radiopharmaceutical firm AAA for US$ 3.9 billion   In July, PharmaCompass had covered news on how Lutathera — a nuclear medicine targeted at the type of cancer that killed former Apple Inc co-founder and CEO Steve Jobs — got a nod from the European Medicines Agency (EMA), boosting prospects for its developer Advanced Accelerator Applications (AAA). Well, last week the French biotech — AAA — got bought over by Novartis for US$ 3.9 billion. Novartis is paying a 44 percent premium over AAA’s market valuation from September 28. The deal further strengthens Novartis’ oncology business, which had got a shot in the arm in 2015, when it acquired GlaxoSmithKline’s marketed cancer drugs. And in August, its gene-modifying leukemia treatment (a chimeric antigen receptor T-cell therapy or CAR-T therapy) — Kymriah — got approved. This was the first CAR-T therapy to bag an FDA approval. With AAA, Novartis will now have a technology that deploys trace amounts of radioactive compounds to not only diagnose a disease (by creating images of organs and lesions), but also to fight cancer. Lutathera is a radiopharmaceutical — it uses radioisotopes to target neuroendocrine tumors. Along with Lutathera, Novartis also gets a pipeline of drugs from AAA with some near-term potential.  US Merck to cut 1,800 jobs, withdraws EU application of cancer wonder drug   Late last week, Merck announced it had withdrawn its application for Keytruda (pembrolizumab) as a combination treatment for an advanced stage of non-small cell lung cancer (NSCLC) from the European Medicines Agency (EMA). An analyst with Evercore ISI, Umer Raffat, said in a note that EMA was reluctant to approve drugs based on Phase II data, even though the FDA regularly does so in oncology. The company is also moving to a new sales team structure in the US, and plans to cut 1,800 sales positions, while adding 960 jobs to a new chronic care salesforce. According to a Fox Business report, three of Merck’s US sales teams will be cut: primary care, disease-focused endocrinology and hospital chronic care. This is “to better support changes in our business in the United States,” Merck’s spokeswoman said. Merck’s new chronic care team will focus on Januvia (a diabetes drug), other primary care products such as sleep medication Belsomra, and products for respiratory conditions and women's health, she added. Releasing its third quarter numbers in the US, Merck was also forced to concede that the NotPetya cyber attack had cost the company US$ 135 million in lost sales along with US$ 175 million in related costs. That extra US$ 310 million in costs will be repeated in Q4 as overall damages inch up to the US$ 1 billion mark, the company said. As Amazon threat looms over US pharmacy biz, CVS eyes health insurer Aetna   Amazon has been trying to get into the US$ 412 billion pharmacy business in the US. Every year, pharmacies in the US dispense about 4.5 billion prescriptions. Patients pick up about 9 out of 10 prescriptions at a retail pharmacy. Amazon’s entry into online prescription drug sales, therefore, poses an existential threat to brick-and-mortar pharmacies. And that’s the reason why news about US pharmacy operator CVS Health Corp reportedly evincing interest in buying health insurer Aetna Inc is important. This potential acquisition could trigger another round of deal making in an industry that is fearing Amazon’s arrival. According to news reports, CVS Health is expected to buy Aetna for US$ 66 billion in what would be the biggest deal of the year. If the deal goes through, it would also be the biggest of its kind ever in healthcare. “A potential combination would diversify CVS profit streams ahead of an Amazon entry and set the stage for a new healthcare-retail delivery model,” Morgan Stanley analysts wrote in a note. A deal would make CVS-Aetna a one-stop shop for customers’ healthcare needs — which could range from employer healthcare and government plans to managing benefits and running drug stores.  

Impressions: 3113

https://www.pharmacompass.com/radio-compass-blog/mylan-s-president-emcure-s-ceo-named-in-us-drug-price-fixing-probe-novartis-buys-french-biotech-for-us-3-9-billion

#Phispers by PHARMACOMPASS
02 Nov 2017
Teva to sell assets to reduce debt, lay-off 7,000 workers; Shkreli awaits sentence
This week in Phispers, we look at the growing troubles at Teva. The company plans to divest non-core assets to reduce debt and lay-off 7,000 workers. The FDA approved AbbVie’s Mavyret, a drug that poses considerable challenge to Gilead’s Harvoni and Sovaldi. Meanwhile, Martin Shkreli was found guilty in three out of eight charges; diabetes drug exenatide showed benefit to Parkinson’s disease patients in a study; and in the US, the Senate passed key FDA funding bill.   Teva in dire straits: To lay off 7,000 workers, to sell non-core assets to repay debt   Teva has been in trouble for quite sometime now. It’s a classic case of a company taking on more debt to spur growth. But it’s fallen into hard times, as three CEOs changed guard this decade. Last week, the world’s largest manufacturer of generic medicines said it would divest non-core assets to shed a part of its US$ 35 billion debt load. While debt may be historically cheap, it still has to be repaid. And if revenues don’t keep up with payments, the downfall can be rapid for Teva.  Teva had taken on the debt in order to dominate all facets of generic drugs, including a US$ 40.5 billion acquisition of Allergan’s generics business last year. The Allergan deal added more pressure on drug prices and margins. Teva also slashed its earnings goals for the second time this year. It warned investors it may have to renegotiate some debt agreements if cash flow worsens. Teva reduced its dividend by 75 percent. The company also mentioned that it is in the process of laying off 7,000 workers. Greater competition in the generic drug business due to increased approvals (of generic drugs) by the US Food and Drug Administration (USFDA) has led to poor results, the company said. The continued deterioration of its business environment in Venezuela has made matters worse. The plight of Teva has been worsened due to the leadership crisis — the company has been without a CEO and a CFO for months. Activist shareholder Benny Landa blamed acting CEO Yitzhak Peterburg and the board of directors for leading Teva to disaster. Landa said what is happening in the company is no less than a catastrophe. “I've been saying this for three or four years: the company board of directors is incapable of making big decisions and getting the company back on track,” he said. Price-gouging Shkreli awaits sentence; found guilty on three out of eight charges    Martin Shkreli — the co-founder of Elea Capital, MSMB Capital, Retrophin and the former CEO of Turing Pharmaceuticals who is more famous for price gouging and for defrauding investors — could spend years in prison due to last week’s investor fraud conviction if the judge focuses on the intended impact of his crime and on his antics on the social media, say legal experts. Back in 2015, Shkreli had raised the price of an infection treatment by 5,000 percent to avoid prison due to an unusual twist to his case — defrauded investors suffered no loss from his crime. That could work in Shkreli’s favor, because investor harm is the main factor in determining a sentence for securities fraud in the US. However, a report quotes a law enforcement source as saying that prosecutors will challenge Shkreli's underlying assumption of how to calculate the losses of investors. While Shkreli was convicted on three securities fraud and conspiracy counts, he was acquitted of other charges, including the charge that he conspired to steal US$ 11 million in assets from Retrophin. What’s caught the public eye though is Shkreli’s social media antics. Hours after his conviction, Shkreli declared the mixed verdict by the federal jury on YouTube as an “astounding victory.”  Without showing any sign of remorse, 34-year old Shkreli said: “I’m one of the richest New Yorkers there is, and after today's outcome it's going to stay that way.” According to lawyers, such a conduct on social media could backfire at the time of sentencing. “He lacked any remorse, and the judge may avoid appearing lenient when she sentences him,” James Cox, a law professor at Duke University, said. Diabetes drug exenatide could stop the progress of Parkinson’s disease      In future, clinicians may be able to stop the progress of Parkinson’s disease with a drug normally used in type 2 diabetes. At present, the drugs used to treat Parkinson’s disease only help in managing the symptoms. They do not prevent brain cells from dying. In Parkinson’s, the brain is progressively damaged and the cells that produce the hormone dopamine are lost. Legendary boxer Muhammad Ali had died last year at the age of 74 after battling for years with Parkinson’s disease. In the trial, half the patients were given the diabetes drug exenatide and the rest were given a placebo (dummy treatment). All the patients stayed on their usual medication. Those on just their usual medication declined over 48 weeks of treatment. But those given exenatide were stable. And three months after the experimental treatment stopped, those who had been taking exenatide were still better off. Exenatide, derived from the saliva of Gila monster, is a glucagon-like peptide-1 (GLP-1) agonist. It treats type 2 diabetes by mimicking the hormone GLP-1, which triggers insulin secretion. According to University College London (UCL) researchers, Parkinson’s patients treated with exenatide did better on movement tests than patients who received a placebo. If they can prove the drug changes the disease itself, it could transform the way we treat Parkinson’s. Though the UCL team is “excited”, it has urged caution as any long-term benefit is uncertain and the drug needs more testing. FDA approves AbbVie’s Mavyret — a drug that cures Hepatitis C in eight weeks    Last week, the USFDA approved the first-ever drug that can treat all six major strains of hepatitis C (or HCV) in just eight weeks — AbbVie’s Mavyret. For competitors like Gilead, Mavyret spells bad news. Mavyret is also being considered a ‘steal’ in the world of HCV drugs, with a price tag of US$ 26,400 for an eight-week treatment course. In comparison, Gilead’s Harvoni costs about US$ 63,000 for eight weeks, though the discounts bring the net price down to US$ 30,000. Gilead also has its own ‘pan-genotype’ hepatitis C medicine, Epclusa, in addition to its blockbuster HCV drugs Sovaldi and Harvoni, that have been at the centre of a controversy around their steep prices.  With a combination of two new direct-acting antivirals — glecaprevir and pibrentasvir — Mavyret treats adult Hepatitis C patients with genotype 1 through 6 who don’t have cirrhosis or with mild cirrhosis, or those who are on dialysis. According to the FDA, it’s the first pan-genotypic HCV drug with an eight-week treatment duration. Other options cure the disease in 12 weeks or longer. J&J’s Invokana is CVS Caremark’s preferred diabetes drug   Close on the heels of Express Scripts’ 2018 formulary release, rival pharmacy benefit management (PBM) giant CVS Caremark has published its own list of drugs that are in, and those that are out. Express Scripts Holding is the largest PBM organization in the US. In the SGLT2 class of drugs to treat diabetes, CVS removed Eli Lilly and Boehringer Ingelheim’s Jardiance and added Johnson & Johnson’s Invokana as a preferred option. This, despite the fact that Invokana came with an increased risk for amputations in a cardiovascular outcomes study finished earlier this year. A Boehringer Ingelheim spokesperson said the company is “very disappointed” with the formulary move “and the potential treatment disruption” and the impact this could have on patients. This decision restricts treatment options for patients who could benefit from Jardiance’s life-saving cardiovascular benefit, the spokesperson added. CVS removed 17 drugs in 10 classes, with Merck’s Zetia, Daiichi Sankyo’s Benicar and Teva’s Nuvigil among them. Despite the removals, the company expects 99.76 percent of members will be able to keep using their current treatments. US Senate overwhelmingly passes reauthorization of FDA’s user fees   In the US last week, Senators voted overwhelmingly to pass a key Food and Drug Administration (FDA) funding bill. The bill is now with President Trump, for his approval. The Senate passed a five-year reauthorization of the FDA’s user fees in a 94-1 vote, with only Senator Bernie Sanders voting against the measure. The move is in major contrast to the recent rancor surrounding the Senate’s efforts to repeal ObamaCare. The funding reauthorizations are based on recommendations from industry groups. This bill renews FDA’s authority to collect fees from the prescription drug and medical device industries. Together, they account for 25 percent of all FDA funding; and should amount to around US$ 8-9 billion over the next five years. The fee helps speed up the approval of new drugs and devices. This funding reauthorization of FDA’s user fee comes about a month before the current user fee agreement expires. The White House hasn’t said if it will sign the user fee bill. In a statement of administrative policy issued in July after the bill passed the House, the White House expressed concern with some minor provisions, though it did not threaten a veto.    

Impressions: 2380

https://www.pharmacompass.com/radio-compass-blog/teva-to-sell-assets-to-reduce-debt-lay-off-7-000-workers-shkreli-awaits-sentence

#Phispers by PHARMACOMPASS
10 Aug 2017
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