Press review

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German Parliament opposes EU joint HTA

Country : China, Germany, U.S.

Keywords :
BERLIN, Mar 16 (APM) - The German Parliament is preparing an objection to the European Commission draft legislation on joint health technology assessment (HTA), reported the Frankfurter Allgemeine Zeitung (FAZ) on Thursday (p17).
Conservative CDU party health spokeswoman Karin Maag told FAZ that the Bundestag would vote on issuing a subsidiarity objection on Friday March 23 (APMHE 57290). The primary concern is that EU regulation could undermine German standards.
According to the paper, France, Hungary, the Czech Republic, Sweden, Denmark, Spain and the UK have also criticised the draft legislation.

New health minister chooses team

New health minister Jens Spahn (CDU/CSU), appointed on Wednesday, has chosen two parliamentary state secretaries, Sabine Weiss and Thomas Gebhart, reported FAZ on Wednesday (p20).
Weiss is a social expert and Gebhart is totally new to health issues as he formerly worked on environmental policy, FAZ said.
Lutz Stroppe, who has been state secretary since 2013, will continue in this position.
Before his appointment, Spahn's comments on poverty had triggered outrage from social democrat leaders, reported FAZ on Tuesday (p17). Spahn had said that recipients of unemployment benefit were not poor because their basic needs were met.

MorphoSys expects U.S. launch of MOR208 in first half of 2020

Biotech MorphoSys plans to launch its MOR208 against a form of lymphoma in the first half of 2020, reported FAZ on Wednesday (p22).
"Our main focus in 2018 will be on MOR208," said CEO Simon Moroney.
Last autumn, MOR208 was granted breakthrough status by the U.S. Food and Drug Administration (FDA). Discussions are under way to bring it to market and to prepare for commercialisation.

China conditionally approves Bayer's acquisition of Monsanto, U.S. asks for more divestments

China's commerce ministry has conditionally approved Bayer's planned acquisition of U.S. seed company Monsanto but U.S. authorities have requested more divestments, reported FAZ (p22) and Sueddeutsche Zeitung (SZ) (p19) on Wednesday and SZ on Friday (p20).
Divestments requested by the Chinese authorities were covered by the sale of businesses to Germany's chemicals group BASF or are currently being discussed, Bayer said.
However, the U.S. Justice Department’s antitrust division does not think Bayer’s proposal to sell businesses goes far enough, according to Bloomberg. The government wants Bayer to divest more assets to resolve its concerns that the merger could hurt competition.

Too many painkiller ads in Germany

The number of prescriptions for addictive painkillers in Germany has increased in recent years because of the aggressive advertising and marketing practices of pharmaceutical companies, Die Welt wrote on Thursday (p9).
"The per capita consumption of opioids in Germany is already alarmingly high and hardly differs from that in the U.S.," Christoph Stein, director of the clinic for anaesthesiology and surgical intensive care medicine at the Charité hospital in Berlin, told the paper.
According to Stein, manufacturers focus on doctors: "Concealed advertising for prescription opioids is a problem, especially in medical literature," he said.
While adverts for prescription drugs are banned in Germany, the same does not apply to over-the-counter drugs. The pharmaceutical industry spends around 600 million euros a year on advertising for non-prescription drugs, the paper said. A large part of this is accounted for by drugs with potential for abuse, it concluded.

Sanofi's huge setback with dengue vaccine

Sanofi is facing a huge setback with its dengue vaccine Dengvaxia, reported FAZ on Saturday (p27).
Several deaths occurred among children vaccinated in the Philippines, and Sanofi has advised that only people with previous exposure to the disease should be vaccinated, the paper said.
Sanofi is now accused of being hasty in the vaccine's development because the results of the Phase II study were not finalised before the Phase III began (APMHE 57203).

U.S. SEC charges Theranos with massive fraud

The Securities and Exchange Commission (SEC) charged U.S. diagnostics firm Theranos, its founder and CEO Elizabeth Holmes, and former President Ramesh Balwani with "massive fraud", Handelsblatt reports on Friday (p76) and SZ on Thursday (p18).
The SEC said that Theranos made "numerous false and misleading statements in investor presentations, product demonstrations and media articles” about its key product.
Holmes agreed to the settlement but Balwani did not agree, the papers said.
As part of the settlement, Holmes will pay a $500,000 penalty, be barred from serving as a director or officer of a public company for 10 years, return her remaining 18.9 million shares obtained during the alleged fraud, and relinquish her voting control of Theranos.
Theranos, which was once seen as a Silicon Valley star with a $9 billion valuation, raised over $700 million by saying that its portable blood analyser could generate accurate test results from just a few drops of blood.
A 2015 investigation by The Wall Street Journal unearthed technical problems with the company’s proprietary technology before federal prosecutors started an investigation on alleged fraud (APMHE 47449).
The SEC said that these sanctions may serve as a warning for private companies that they must tell investors the truth about their technology.
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