Press review

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Merck KGaA/Pfizer's Bavencio in competition with Merck's Keytruda in advanced renal cell carcinoma

Country : Germany, Greece, Italy, Switzerland, U.S., UK

Keywords :
BERLIN, 15 Feb (APM) - Germany's Merck KGaA and Pfizer are competing head-to-head against U.S. Merck & Co on an extension of indication in advanced renal cell carcinoma, reported Frankfurter Allgemeine Zeitung (FAZ) on Wednesday (p21).
Merck KGaA and Pfizer announced that the U.S. Food and Drug Administration has accepted to review cancer drug Bavencio (avelumab) in combination with Pfizer's Inlyta (axitinib) in this indication (APMHE 61829) one day after Merck & Co published positive study data of its flagship drug Keytruda (pembrolizumab) in combination with Inlyta in the same indication (APMHE 61845).
With its recent U.S. approval in recurrent locally advanced or metastatic Merkel cell carcinoma (MCC) (APMHE 61155), Keytruda already competes with Bavencio, which was approved in the U.S. in 2017 in metastatic MCC, FAZ noted.

Roche chose Germany to transfer UK-based licences and trials

Roche has chosen Germany to transfer all licences and clinical trials initially registered in the UK in preparation for the UK leaving the European Union, head of Roche Pharma Germany Hagen Pfundner told FAZ on Tuesday (p18) (APMHE 61831).
Several employees from the UK and Switzerland have been relocated to Germany, where a company has been established for this purpose.

Medigene appoints new CFO

German biotech Medigene has appointed Axel-Sven Malkomes as its new chief finance officer from 1 April, FAZ reported on Tuesday (p20).
Malkomes, who will also be responsible for corporate development and IT, succeeds Thomas Taapken, who resigned last summer for personal reasons.
Malkomes has been active in the pharmaceutical and healthcare industry for more than 25 years. Most recently, he held a senior position in healthcare banking for the British bank Barclays.

Gaps remain in EU anti-counterfeit system

The EU anti-counterfeit system, started last weekend, has important gaps that put into question its efficacy, FAZ on Saturday (p17 and 21).
Greece and Italy, two countries from which counterfeit or stolen medicines had been distributed in the past, will only participate in the security system in 2025.
In addition, German hospitals are exempted from a complete scan of every package as it would be too expensive to individually scan thousands of packs that come directly from the manufacturer.

J&J's nasal spray Spravato for depression backed by FDA panel

Advisers to the U.S. Food and Drug Administration have voted in favour of Johnson & Johnson's experimental nasal spray Spravato (eketamine) for treatment-resistant depression, Die Welt reports on Friday (p9) (APMHE 61843).
FDA approval for fast-acting Spravato is expected at the beginning of March; Johnson & Johnson's Janssen has also filed for approval in the EU, Die Welt says.
Analysts have estimated sales potential of $3 billion a year for Janssen's psychiatry and neurology pipeline consisting of Spravato and two other drugs.

Statins too often recommended in guidelines

Swiss epidemiologist Milo Puham has published a review of statins in primary stroke prevention in the Annals of Internal Medicine, saying that cardiology guidelines are recommending statin therapy far too often, Die Welt reports on Friday (p20).
Young adults with hypercholesterolaemia benefit more if they quit smoking or start exercising than if they receive statins therapy, chair of German general practitioners' association Erika Baum DEGAM is quoted as saying.

Harvard professor gained $400 million through Moderna's IPO

Harvard professor Timothy Springer might have become the richest U.S. scientist after receiving shares of worth $400 million when Massachusetts-based biotech Moderna Therapeutics went public in December 2018, Sueddeutsche Zeitung (SZ) reported in a portrait published on Monday (p17).
Springer founded the biotech Leukosite, which developed leukaemia drugs and was acquired by Millennium Pharmaceuticals in 1999. He has invested his profits in more companies since, SZ reported.

Melatonin available as prescription drug and dietary supplement in Germany

While Lundbeck's Circadin is the only prescription melatonin drug that is approved in Europe, other melatonin products are available for German patients as dietary supplements in drugstores or online pharmacies, Die Welt reported on Tuesday (p20) and FAZ on Wednesday (p29).
The effect of drugs based on sleep hormone melatonin is limited. However, their benefit-risk-ratio is positive as they do not show severe side-effects, FAZ said.
Manufacturers of melatonin products have obtained before German courts that their products would not need drug approval as patients could as well take in a therapeutic dose of melatonin by eating pistachios or cranberries, Die Welt said.
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