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 watchdogs in the pharmaceutical industry

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updated Thu. February 21, 2019

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While that may often be the case with first-generation pharmaceutical patents, follow-on patents covering blockbuster drugs more-often exhibit substantially less genius. As a first example, consider the Humira patents. Humira was first approved by the FDA in 2002, and the first Humira patent expired in 2016 ...
... a price point that would be considered cost-effective by cost-effectiveness watchdog the National Institute for Health and Care Excellence (NICE), the annual overall cost to the NHS of one of the hypothetical treatments is £420 million ($588 million) – a third of the total cost of all cardiovascular medicines.

New Delhi: The central government seems all set to change the character of the National Pharmaceutical Pricing Authority after moving its powerful and controversial chief Bhupendra Singh on 1 March – it wants to turn the drug price watchdog into a 'market research agency'. The Department of ...
Dr. Michelsohn's recent post on this blog takes issue with pharmaceutical patenting practices and urges us to police drug patents more vigorously, perhaps “with a fury,” to ensure that drugmakers receive patent protection only for true innovation. Dr. Michelsohn is particularly concerned about secondary, ...
The CPS is also concerned about the impact on access to new drugs post-Brexit— even if, as Prime Minister Theresa May hopes, the UK successfully negotiates associate membership of the European Medicines Agency (EMA), the drug's safety watchdog. Barclay said he hoped that, post-Brexit, access to ...
Benin is fighting against its reputation for being the crossroads for trafficking in expired and counterfeit drugs in West Africa — a business that has deeply alarmed health watchdogs. President Patrice Talon, elected in 2016, has vowed to crack down on the practice. Over the past year, dozens of people have ...

Pharmacists have laid most of the blame for the price hike on manufacturers, but at least one pharmaceutical company is pushing back, saying it made no changes to pricing since the rescheduling, brought in to restrict access to addictive codeine pills. Sanofi, which produces Mersyndol and Prodeine, says ...
“In recent years the Legislature has abdicated its role as a public watchdog, and that needs to change. Senator Hansen and Rep. Anderson are to be commended for offering common sense legislation empowering the Attorney General to intervene on the public's behalf when the greed of pharmaceutical ...
The regulatory body will have oversight of registration, licensing, manufacturing and importing of active pharmaceutical ingredients, medicines and medical devices. It will also regulate clinical trials in line with national policy. The body will generate feeds from the pharmaceutical and health products ...
Last month the pharmaceutical watchdog said all women must be warned of the risks of taking it while of child-bearing age. It followed a European Medicines Agency study on sodium valproate, sold in Ireland as Epilim. In 2014 a group of parents whose children had been born with malformations after they ...
PSEG, seeking $300M nuclear subsidy, defends keeping ratepayer watchdog in the dark ... of critics, uniting an unlikely opposition force that now includes groups ranging from the Sierra Club and AARP to the Chemistry Council of New Jersey, which represents pharmaceutical and chemical manufacturers.
Mr Bailey was warned he risks making a “mockery” of the City watchdog if it continues to delay publication, with Stewart Hosie MP adding the hold-up risks “reputational damage” to the FCA. “Time is important here. If you don't publish, others will,” he said. Mr Bailey said publishing the report without the ...
For Instance: India's largest drug maker Sun Pharma reported a 59 per cent drop in second-quarter profit due to price erosion of generics in the US. ... Apart from the challenges of operating in the US market, domestic drug makers have faced a string of actions by the American health watchdog, Food and ...
The founder and head of Sun Pharmaceutical Industries, Shanghvi has seen his net worth fall to $12.8 billion on the Bloomberg Billionaires Index in January against $13.1 billion in 2017. ... Also, US health watchdog, FDA, has come down heavily on the company in the inspection of approved plants.
The lawsuit from Teva Pharmaceutical Industries Ltd. accuses Barinder Sandhu, who worked as a senior director of regulatory affairs for Teva's U.S. generics division, of leaking trade secrets and other confidential ... Federal watchdog closes review of Barry Sherman fundraisers for Trudeau Liberals.
Many of the world's leading drug manufacturers may be leaking antibiotics from their factories into the environment, according to a new report from a drug industry watchdog. This risks creating more superbugs. The report surveyed household-name pharmaceutical giants like GSK, Novartis and Roche as ...
... pharmaceutical industry came from key committees, including the Senate Committee on Health, Education, Labor and Pensions (HELP) and the House Energy and Commerce Committee, which in 2016 shepherded the 21st Century Cures Act into law. The law faced criticism from watchdogs who feared it ...

Watchdog groups are becoming alarmed at what they deem a revolving door between the federal government and the pharmaceutical industry, according to a report by Kaiser Health News and Legistorm, a nonpartisan congressional research company. The article notes that approximately 340 former ...
Alex Azar's job hop from drugmaker Eli Lilly and Co. to the Trump administration reflects ever-deepening ties between the pharmaceutical industry and the federal ... The law faced criticism from watchdogs who feared it would make drug approval cheaper and easier but could lead to unsafe approvals.
Nearly 340 former congressional staffers now work for pharmaceutical companies or their lobbying firms, according to data analyzed by KHN and provided by ... The law faced criticism from watchdogs who feared it would make drug approval cheaper and easier but could lead to unsafe approvals.
Ontario's pharmacist watchdog is investigating two of its former presidents over questionable payments they collected from a pharmaceutical company that supplies their stores with prescription drugs. The College of Pharmacists received complaints about Mark Scanlon and Esmail Merani after a Star ...
Many of the world's leading drug manufacturers fail to disclose how much antibiotic discharge they release from factories, according to a new report from a drug industry watchdog. Such discharge risks creating more superbugs. The report surveyed household-name pharmaceutical giants like GSK, Novartis ...
Pharmaceutical companies, doctors and clinics, and even the DEA have come under fire in what many say is the worst public health crisis in modern U.S. .... Zohydro came with strong warnings and there's no indication it's been widely abused, but to watchdogs like Kolodny and Manchin, the FDA action ...
Miklos advises biotechnology and pharmaceutical companies on the development and execution of global patent strategy. He is experienced in U.S. and international patent procurement, invalidity, noninfringement, and patentability opinions, as well as freedom-to-operate and due diligence investigations.
ASHINGTON — It looked like the watchdog had found something big — in December 2017, a government report 1 proclaimed that drug companies might ... of any of that finger-pointing,” said Bill Sarraille, a partner with the law firm Sidley Austin LLP, who has represented pharmaceutical manufacturers.
... the latest—whether to continue her office's high-profile investigation into Apotex founder Barry Sherman, the pharmaceutical billionaire who was discovered dead five weeks ago alongside his wife Honey. The chairman of Canada's largest drug firm, Sherman was the target of Ottawa's lobbying watchdog ...
Finland's pharmaceutical watchdog Fimea has ordered hospital staff across the country to stop using a suspect batch of the cancer medication Velcade ... Finnish pharmaceutical regulator Fimea has ordered hospital staff to stop the use of a suspect shipment of the cancer drug Velcade because it found that ...
6,335,031 was upheld as not invalid in district court after defendant Noven Pharmaceuticals challenged the patent's validity on grounds of obviousness, once in a trial opinion from August 2015 and then again in a final judgment issuing from the court a few weeks later. Noven and fellow pharmaceutical firm ...
The amount of patent filings skyrocketed ever since, as patents were now available to fields not previously patentable, such as pharmaceutical technologies. Hence, in a 15 years period, the amount of applications rose up to about 200%, without a correspondent increase in the number of examiners within ...
In pursuing the most efficient production of a drug material (i.e., the active pharmaceutical ingredient in a drug product) exhibiting optimal potency for the therapeutic endpoint of interest, chemists and drug companies explore strategies for removing or minimizing impurities in that drug material that do not ...
The Zambia Pharmaceuticals Business Forum (ZPBF) has raised a red flag against the Minister Health for exclusively awarding tenders for the supply of drugs to companies of personal interests, against the public procurement guidelines. And ZPBF has written to Ministry of Health Permanent Secretary, ...
Over the period between 1990 and 2015, development times for pharmaceuticals have increased by more than two years on average, while the same period also corresponds to a drop of 1.4 years in the lag between the first global launch and the first EU launch. Accordingly, the remaining patent term is ...
The Zambia Pharmaceuticals Business Forum (ZPBF) has raised a red flag against the Minister Health for exclusively awarding tenders for the supply of drugs to companies of personal interests, against the public procurement guidelines. And ZPBF has written to Ministry of Health Permanent Secretary, ...
As the watchdog for lobbying, she is responsible for enforcing the Lobbying Act — which, among other things, requires lobbyists to register with her office and ... Canadian pharmaceutical giant Apotex is challenging an investigation Shepherd opened into a 2015 political fundraiser its chairman, a registered ...
Pharma stocks posted gains in the past week with the BJP retaining power in the Gujarat assembly elections. ... and needles are likely to come down sharply as domestic manufacturers have decided to cap trade margins at 75% after the country's drug price watchdog asked companies to regulate prices.
Plans are being drawn up to redistribute the European work of the UK's medicines safety watchdog in the run up to Brexit. ... base — which will support the needs of EU clinical research, and which it describes as “the most ambitious IT development project…required by the EU pharmaceutical legislation”.
Canada's lobbying watchdog said she is “assessing” the fate of an investigation she opened into a political fundraiser hosted by Apotex founder Barry Sherman after the pharmaceutical magnate and his wife were found dead in their Toronto home last Friday. Lobbying Commissioner Karen Shepherd was ...
Ontario banned the payments in 2006, stating that pharmaceutical companies were incorporating the cost of rebates into their medications' regulated price and the province's public drug plan was paying inflated amounts for drugs. The government eventually cracked down on “professional allowances,” ...
But in the winter of 2009, one of the top pharmaceutical sales representatives selling it, Allison Zayas, began to have her doubts. According to Zayas, one of her best clients, a doctor at a New York City outpatient clinic, told her that a patient had died while taking the drug and that the combination of Seroquel ...
Law360, New York (January 31, 2018, 8:27 PM EST) -- Denmark's competition authority on Wednesday accused pharmaceutical distributor CD Pharma of abusing its dominance by hiking the price of a drug used during childbirth by more than 2,000 percent, making it the latest enforcer to crack down on prescription drug ...
ello, everyone, and how are you today? We are just fine, thank you, despite the miserable downpour that is turning the Pharmalot grounds into a soggy mess. Our short person successfully navigated the path to the local schoolhouse and our official mascots are resting comfortably in their corners.
... father, Leander Shaw, served as a justice and chief justice for two decades, Shaw promised to be a consumer watchdog if voters elect him in November. ... He faulted Bondi for turning “a blind eye” to the abuses by pharmaceutical companies that have worsened the opioid epidemic and for squandering ...
The Liberal government's proposed changes would overhaul the Patented Medicines Prices Review Board, Canada's brand name drug price watchdog, and the way it reviews drug prices and sets their ceilings. In December, Health Minister Ginette Petitpas Taylor said the changes will improve the ...
Finland's pharmaceutical watchdog Fimea has ordered hospital staff across the country to stop using suspect batches of the cancer medication Velcade ... Finnish pharmaceutical regulator Fimea has ordered hospital staff to stop the use of suspect batches of the cancer drug Velcade because it found that ...
Finland's pharmaceutical watchdog Fimea has ordered hospital staff across the country to stop prescribing the cancer medication Velcade due to ... Finnish pharmaceutical regulator Fimea has ordered hospital staff to stop the use of the cancer drug Velcade because it found that several batches of the drug ...
In April 2016, the District of New Jersey entered a stipulation and an order of dismissal in a patent infringement case after a consent judgment was entered by plaintiff Jazz Pharmaceuticals and defendant Wockhardt Bio. In that consent judgment, defendant Wockhardt had admitted that an abbreviated new ...
MUNCIE, Ind. — Delaware County, ravaged by opioid abuse and drug overdoses in recent years, might join a lawsuit against drug makers and distributors. The county commissioners on Monday heard a presentation from attorneys from Cohen and Malad, an Indianapolis firm that already represents the city ...
Ontario banned the payments in 2006, stating that pharmaceutical companies were incorporating the cost of rebates into their medications' regulated price and the province's public drug plan was paying inflated amounts for drugs. The government eventually cracked down on “professional allowances,” ...
Toronto billionaire and philanthropist Barry Sherman and his wife were found dead in their mansion Friday, and police said they were investigating the deaths as suspicious. Const. David Hopkinson would not identify the two bodies found at the home of Apotex founder Bernard "Barry" Sherman and his wife ...
But in the winter of 2009, one of the top pharmaceutical sales representatives selling it, Allison Zayas, began to have her doubts. According to Zayas, one of her best clients, a doctor at a New York City outpatient clinic, told her that a patient had died while taking the drug and that the combination of Seroquel ...


 

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