Press review

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Germany's EU presidency programme plans self-sufficiency in drug supply

Country : Africa, China, Europe, France, Germany, U.S.

Keywords :
BERLIN, 26 June (APM) - Germany's programme for the EU council presidency plans to overcome the coronavirus crisis in a sustainable way, for example through self-sufficiency in drug supply, FAZ reported on Thursday (p2).
As a "lesson learned" from the coronavirus crisis, Europe is planning to become more independent in matters of critical drugs, medical devices and protective equipment, FAZ said.
During the presidency, which starts on 1 July, the EU should become more independent in matters of digital technologies (APMHE 67903).

Munich start-up hub hopes for better visibility for biotechs

Munich-based start-up hub IZB, one of Europe's hotspots for Covid-19 research, hopes to attract more attention from investors after the crisis, Handelsblatt said on Thurdsay (p20).
Politicians had focused strongly on the energy transition and the digitalisation of the industry in the past. "Now the focus is shifting more towards pharmaceuticals, biotech and medical technology," IZB managing director Peter Hanns Zobel told Handelsblatt.
Several of the 60 start-ups located at IZB in Martinsried, have launched projects in the field of coronavirus, said
Immunic has just started a Phase II trial with IMU-838, Leukocare, together with partners ReiThera and Univercells, is developing a novel adenoviral, vector-based vaccine against Covid-19, while GNA Biosolutions has developed a test that delivers a result in 15 minutes.
Even before Covid-19, the IZB was considered a success story, having already hosted 200 start-ups. The close links with the Bavarian government, Munich's universities and medical research centres, help partnerships and collaborations, made in an unbureaucratic way

Criticisms against state participation in CureVac

The federal government's stake in CureVac has been criticised by politicians and economists, FAZ reported on Sunday (p26) and Die Welt on Monday (p9).
Such an industrial policy "serves mainly protectionist purposes" and might lead to reaction from other states in retaliation, Lars Feld, chairman of the German Council of Economic Experts told Die Welt.
The government has massively intervened in free competition, the president of the Kiel economic Institute IfW, Gabriel Felbermayr told Die Welt.
The move is a "political stance" from the German government to show that it is doing "everything possible to ensure that the population is supplied with a vaccine".
The budget committee of Germany's lower chamber of Parliament Bundestag has criticised the Economy Ministry for not disclosing its plans to the Bundestag, FAZ said.
FAZ pointed out that CureVac's main investor Dietmarr Hopp himself has warned against "overzealous industry politics" in the past.
The participation in CureVac "is a risky bet on the future and a regulatory sin", Otto Fricke from opposition party FDP told Die Welt, pointing out that the government has not supported the other German biotech developing an mRNA vaccine, BioNTech. Selecting CureVac was "an arbitrary decision" and the government has given no valid justification.

CureVac Phase I testing started

Germany's CureVac has started a Phase I study into its Covid-19 mRNA vaccine candidate in 30 volunteers and Phase II is expected to start later this summer, SZ reported on Wednesday (p31).
Participants will receive two shots with a delay of two weeks betweeen shots. A 29-year-old woman has already received the vaccine candidate and did not experience any adverse events. Study centres are in Munich, Tübingen, Hannover and the Belgian cities of Gent and Antwerp.

Germany well placed in Covid-19 vaccine race thanks to BioNTech and CureVac

Germany is well placed in the Covid-19 vaccine race thanks to biotech companies BioNTech and CureVac, Die Welt said on Sunday (p2-3).
BioNTech and CureVac's candidates, both a messenger RNA vaccine, belong to 13 projects which have started clinical trials, out of 140 projects.
"Currently, I see 10 to 20 promising approaches to corona vaccines worldwide. At least three of these are mRNA-based, including the vaccines developed by CureVac and BioNTech," Peter Gottfried Kremsner, director of the Institute of Tropical Medicine at the university hospital of Tübingen and in charge of the clinical trial of the CureVac vaccine, told Die Welt.
Cristina Niculescu, vaccine expert at the European Investment Bank (EIB), shares his view: mRNA vaccines can be produced "faster, safer and in larger quantities than conventional vaccines", she told Die Welt.
BioNTech's alliance with Pfizer is "a stroke of luck" as this allows to "take production to a whole new level", said former CureVac executive and co-founder Steve Pascolo.
CureVac has conducted its project alone so far but received huge support with the state's participation. It is likely to make an initial public offering in July in the U.S. and is negotiating €75 million funding by the EIB.
Der Spiegel reported in a lengthy article (p90-94) that the billion-dollar research race between the U.S. and China is escalating. The U.S. has the best pharma companies and the most powerful pharmaceutical industry in the world but the corona crisis now offers China the chance to catch up with the U.S. in the biotech sector.

Sanofi expects approval of Covid-19 vaccine in first half of 2021

Sanofi is optimistic that its Covid-19 vaccine candidate, developed under a partnership with GlaxoSmithKline, will be approved in the first half of 2021 and not in next year's second half, predicted in earlier statements, FAZ reported on Wednesday (p21) (APMHE 67864).
Sanofi plans to start clinical testing of its recombinant protein-based vaccine in September, while Moderna expects to start Phase III for its mRNA vaccine candidate in July. AstraZeneca and Oxford University expect results from Phase III testing in the autumn.
Sanofi is also developing an mRNA vaccine in a partnership with Translate Bio, under which Sanofi has taken a $125 million stake in the U.S. biotech and made additional payments of $300 million to it, FAZ said.

Risk of worldwide shortage of HIV anti-retroviral therapies

The United Nations programme on HIV/AIDS UNAIDS has called on governments to ensure the supply of HIV drugs, as the Covid-19 pandemic might lead to a global shortage, Die Welt said on Tuesday (p20).
Lockdowns and border closures led to bottlenecks in the supply of HIV drugs it said. UNAIDS estimated that a six-month disruption in anti-retroviral therapy in sub-Saharan Africa could lead to 500,000 additional AIDS-related deaths.

Bayer closes 'a difficult chapter' with Roundup settlement

Bayer is closing "a difficult chapter" after agreeing to a $10.9 billion settlement of the U.S. glyphosate lawsuits, chief executive Werner Baumann told Handelsblatt, reported on Friday (p1,6-7, 24).
Bayer will pay "a large sum of money" despite the fact that "all major regulatory authorities confirm that glyphosate is not carcinogenic", Baumann said.
"We can now focus our full attention on the issues ahead of us,… on our contribution to making the world a better and more sustainable place in terms of nutrition and health," Baumann said.
First elements on the settlement were aired in Handelsblatt's Wednesday edition (p1, 4-5). The full agreement was commented on Thursday by FAZ (p15) and on Friday by Handelsblatt and Die Welt (p12).
However, the plan bears several risks on its financing and on the management of potential future claims, said FAZ Handelsblatt and Die Welt.

France urges its pharma companies to manufacture paracetamol at home

France's president Emmanuel Macron has urged French pharma companies, such as Sanofi, Seqens and Upsa, to relocate their manufacturing of painkiller paracetamol to France, FAZ reported on Saturday (p22+28).
Macron plans to get back paracetamol manufacturing to the country within the next three years to reach "self-sufficiency in the health and pharma sector", while it would seem a more cost-effective solution to diversify international supply chains instead, FAZ said.

EMA recommends approval of Gilead's remdesivir in severe Covid-19

The European Medicines Agency (EMA)'s CHMP has recommended approval of Gilead's antiviral remdesivir in severe cases of Covid-19 and the European Commission is expected to grant approval next week, FAZ (p23) and SZ (p6) report on Friday (APMHE 67900).
The conditional approval would be granted for patients over 12 years with a Covid-19 pneumonia who need supplemental oxygen based on data from a study sponsored by the U.S. National Institute of Allergy and Infectious Diseases (NIAID).
Remdesivir has been approved for emergency use in the U.S. since May and available in Europe under compassionate use programmes (APMHE 67892).

Innoplexus launches cancer app

German tech start-up Innoplexus is about to launch cancer app Curia based on artificial intelligence (AI), in which patients can find medical knowledge, information on therapies and drugs and can enrol in clinical studies, FAZ reported on Tuesday (p34).
Innoplexus' AI platform is trawling the internet to collect as much information as possible to find answers to the questions on treatment options, ongoing clinical studies and experts' names - and to make these answers available on mobile devices.
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