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Affimed halts blood cancer therapy trials; Celgene's Otezla passes phase 3 study

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Top news

* German drug developer Affimed N.V. put on hold two early stage clinical studies testing its immunotherapy AFM11 to treat certain types of blood cancer following the death of one of the patients and other life-threatening events. The immunotherapy, a CD19/CD3-targeting T cell engager, is being studied to treat CD19 positive B cell non-Hodgkin lymphoma, or NHL, in patients whose cancer came back or was unresponsive to treatment and to treat acute lymphoblastic leukemia, or ALL.

* Celgene Corp.'s Otezla met its main goal in a late-stage study in patients with scalp psoriasis, a type of skin disease. Under the phase 3 trial, Otezla, when administered twice daily, achieved a highly statistically significant improvement in patients with moderate to severe scalp psoriasis at week 16 when compared to placebo.

M&A and capital markets

* Stada Arzneimittel AG and European buyout firms BC Partners, CVC Capital Partners Ltd. and PAI Partners are joining the race to acquire UPSA SAS, Bristol-Myers Squibb Co.'s French over-the-counter drugs business, Reuters reported yesterday. UPSA, which manufactures painkillers Dafalgan and Efferalgan, could potentially fetch up to €1 billion, according to the Reuters report, which cited sources familiar with the matter.

The potential sale is part of Bristol-Myers' efforts to focus on high-margin prescription drugs, especially on its immuno-oncology franchise.

* Clinigen Group PLC completed its €7.5 million acquisition of Switzerland-based specialty pharmaceutical business iQone Healthcare Holding. The acquisition, which is being made on a cash-free, debt-free basis, expands U.K.-based Clinigen's unlicensed and commercial divisions.

* MeiraGTx Holdings plc acquired Vector Neurosciences Inc. in an all-stock deal. With the transaction, MeiraGTx expands its portfolio to include adeno-associated virus encoding glutamic acid decarboxylase, a gene therapy candidate for Parkinson's disease.

Drug and product pipeline

* Menlo Therapeutics Inc. will no longer develop serlopitant as a potential treatment for chronic cough after the drug failed to significantly help patients in a midstage study. The phase 2 trial evaluated serlopitant in 185 patients with chronic cough that was unresponsive to previous treatments.

* Bausch Health Cos. Inc. and its dermatology unit, Ortho Dermatologics Inc., said the U.S. Food and Drug Administration tentatively approved Bryhali, a lotion intended to treat plaque psoriasis in adults. The FDA's approval is backed by the results of clinical studies in which Bryhali, a highly potent steroid also known as halobetasol propionate, achieved treatment success with no increase in epidermal atrophy despite being administered for up to eight weeks.

Operational activity

* Generic-drug maker Lannett Co. Inc. is seeking help from its existing advisers to evaluate options to address the company's debt and capital structure. CEO Tim Crew said in a press release that the company is aiming to "add revenues, reduce costs and more closely analyze financing options."

* CSPC Pharmaceutical Group Ltd signed a licensing and commercialization agreement to advance SCT400, Sinocelltech Ltd.'s investigational treatment for non-Hodgkin lymphoma, a group of blood cancers that begin in the white blood cells called lymphocytes. The deal grants CSPC the exclusive right to apply for SCT400's approval in China, including Hong Kong, Macau and Taiwan.

Our features

Novo Nordisk shares slide as competition intensifies in diabetes, hemophilia: Shares in Novo Nordisk A/S continued to slide as investors digested news that Roche Holding AG's rival hemophilia drug Hemlibra received expanded approval on the same day that Eli Lilly and Co. released positive data for its experimental diabetes medicine.

Other features

* Bloomberg News has features about the effect of Bose's entry into the hearing aid market and about Roche Holding's attempt to better understand multiple sclerosis through its phone app Floodlight.

Bloomberg News also writes about how Novartis AG looks to keep up with Apple Inc., Google and Inc. — tech giants advancing into the healthcare market — by strengthening its partnerships with startups.

* The Financial Times has a feature about a clinical trial — funded by the U.K.'s National Institute for Health Research — for a potential therapy for Alzheimer's disease and another about how a squeeze in National Health Service funding may not have brought the intended efficiency result.

The day ahead

Early morning futures indicators pointed to a lower opening for the U.S. market.

In Asia, the Hang Seng slipped 0.11% to 26,172.91, and the Nikkei 225 declined 1.32% to 23,469.39.

In Europe, around midday, the FTSE 100 was down 0.32% to 7,209.38, and the Euronext 100 was down 0.39% to 1,024.09.

Click here to read about today's financial markets, setting out the factors driving stocks, bonds and currencies around the world ahead of the New York open.

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