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The aftermath from the Brexit vote in the United Kingdom is only first being digested the world over. As with so many other sectors, there are implications for the pharmaceutical industry. Some 70,000 people in the UK work for drug makers, including AstraZeneca and GlaxoSmithKline, which are based there. Will companies want to shift substantial portions of their operations elsewhere? The European Medicines Agency, which oversees product approvals, is also headquartered in London, raising questions about the ability of the UK’s own regulator, the Medicines and Healthcare products Regulatory Agency, to fill that role. Then there is concern about government support for basic research. We spoke with Michael Thompson, who heads the Association of the British Pharmaceutical Industry, the large trade group, about these unknowns...

In an unusual step, the pharmaceutical industry trade group in the United Kingdom has suspended Astellas for a year after discovering the drug maker disguised the true purpose of a meeting held for doctors, and then senior executives compounded the infraction by withholding crucial information when asked to explain the arrangements..."There was an institutional failure," an oversight panel for the Association of British Pharmaceutical Industries (Prescription Medicines Code of Practice Authority) concluded in a harshly worded...report. "This was one of the worst cases (the panel) ever had to consider…Very senior staff at Astellas Europe had lied and there was deception on a grand scale which was appalling and shocking."...The suspension had its roots in a meeting that the Astellas division in the UK held in...February 2014 for more than 100 physicians. The company billed the gathering as an educational event to obtain advice about prostate cancer when, in fact, it was more of a promotional stunt designed to woo doctors who were targeted to become high prescribers for Xtandi (enzalutamide)...it is rare...for the ABPI to suspend a company from its membership...

For the third time...congressional lawmakers have introduced a bill designed to end a practice that generic drug makers say is used by brand-name rivals to thwart competition...Known as the Creating and Restoring Equal Access to Equivalent Samples Act, the bipartisan legislation comes amid ongoing complaints that brand-name drug makers sometimes refuse to provide samples to generic companies. They need samples to prove their copycat versions are equivalent to the brand-name drugs in order to pass regulatory muster...The legislation would allow the secretary of Health and Human Services to vet the request for samples and create a "cause of action," presumably making it easier for a generic company to go to court in hopes of forcing a brand-name rival to make samples available...Whether the legislation will gain any traction is unclear...

The latest skirmishes over drug take-back programs yielded a mixed outcome this week for the pharmaceutical industry, which has been battling local governments that want drug makers to pick up the tab...officials in Snohomish County, Wash., voted unanimously to require drug companies to run a program that would allow consumers to dispose of unwanted and unused medicines. At the same, the Los Angeles County Board of Supervisors delayed passing a similar ordinance until November...The actions...underscore the growing challenge that the pharmaceutical industry faces as more local governments consider such programs...Local officials are pursuing these laws in the face of rising disposal costs, growing concerns about contaminants in water supplies, and a desire to reduce the threat of drug abuse stemming from medicines lingering in cabinets...the Pharmaceutical Research and Manufacturers of America...objected to the effort, saying that maintaining the program would be unwieldy and require the added burden of adhering to US Drug Enforcement Administration regulations because controlled substances would likely be turned in by consumers..."Siding with corporate interests over public health and safety can be a dangerous political position, and the people will have the final say," said Heidi Sanborn, the executive director of the California Product Stewardship Council. "This is not over,"....

Drug makers complained bitterly...after the Supreme Court left intact a controversial procedure for reviewing patent disputes, arguing that the decision threatens valuable research efforts and that patients will eventually suffer. But the truth of those claims is debatable...The ruling upheld a process Congress created...for challenging patents outside the courts. It allows the Patent and Trademark Office to issue the "broadest reasonable interpretation" of patents. The case at hand had nothing to do with pharmaceuticals, but drug makers believe it will make their patents more easily challenged, and more likely to be overturned...The companies believe the procedure, known as inter partes review, is riskier than patent disputes decided in federal courts... Without the promise of effective patent rights, investments [in new medicines] would be far more difficult — if not impossible — to undertake...

Britain's vote to leave the European Union spells regulatory uncertainty for drug companies, with the London-based European Medicines Agency, which approves treatments for all EU countries, expected to have to relocate...The association of Germany's pharmaceuticals industry said on Friday that Europe's equivalent of the U.S. Food and Drug Administration would need to move to a city within the EU...EMA...said it was premature to comment on its future...It is too early to foresee the implications of this decision and at this stage we are waiting for further guidance from the European Commission...Drug companies and healthcare officials in Sweden, Denmark, Italy and Germany have all expressed interest in hosting the EMA instead of London, since firms in these countries are keen to be located close to the region's...The pharmaceuticals industry employs more than 70,000 people in the UK and accounts for 25 percent of all business research and development spending in the country...Many scientists are concerned that funding for academic research, which has been well supported by the EU in recent decades, will now be jeopardized, along with important UK-European research collaborations...

Manufacturing problems at a factory in Italy have disrupted production of some GlaxoSmithKline medicines, leading to shortages of a commonly used opioid anaesthetic in Denmark...The..drugmaker said...it had temporarily suspended manufacturing at its Parma site, which makes sterile products, to investigate environmental monitoring...The factory has now recommenced manufacturing. However, a spokeswoman said a small number of countries had experienced shortages of certain products since April...Denmark, doctors said they were running out of the anaesthetic Ultiva (remifentanil)...

Indonesian lawmakers...urged authorities to seize from hospitals and health clinics all vaccines made by unapproved manufacturers, after police exposed a syndicate selling fake child vaccines for more than a decade...In a country where counterfeit drugs are widespread, the case deals a blow to government health regulators whom many believed to have kept a tight leash on the distribution of vaccines...Authorities have shut some private health facilities after police smashed a drug-making ring last week that sold fake and potentially harmful booster vaccines for measles, hepatitis B and other viruses in Jakarta and the island of Java...Police uncovered the syndicate after a pharmacist in Bekasi...was arrested in May for selling medicine without a license. The drugs turned out to be fake and led to the arrest of 14 distributors and makers of the fake vaccines, whose ingredients included the antibiotic gentamicin and saline...

Drug and biotechnology stocks surged...after the U.S. government said a cost-cutting mechanism created under Obamacare, known as the Independent Payment Advisory Board, or IPAB, will likely be triggered in 2017, not this year as some investors had feared...The 2017 projection is in line with estimates from last year by Medicare’s Board of Trustees, which...released its annual report on the U.S. health-care program’s long-term finances. The trustees also said that Medicare’s hospital insurance trust fund, which finances some care under the program, will be unable to meet all of its obligations in 2028, two years earlier than projected...Investors had been watching nervously for news of the determination, concerned that it could trigger this year and set in motion reductions in Medicare payments to biotech and pharmaceutical companies, as well as other health-care firms. The Nasdaq Biotechnology Index of 189 stocks had fallen for 11 of the past 12 trading days as of Tuesday’s close...The IPAB is a 15-member panel that would be appointed by the president and has broad authority to propose cuts to payments made through Medicare. Its proposals could affect drugmakers, biotechnology companies, hospitals and insurers, with some restrictions. Congress, which has typically controlled many aspects of Medicare’s payments through legislation, has limited oversight of the IPAB, which was set up specifically to make reductions to U.S. health spending, at a distance from lawmakers and lobbyists...

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