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Roche hemophilia drug gets FDA nod; biotech leaders call for women in top roles


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Roche hemophilia drug gets FDA nod; biotech leaders call for women in top roles

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Top news

* Roche Holding AG said the U.S. Food and Drug Administration approved Hemlibra to treat a bleeding disorder known as hemophilia A in patients who have developed a resistance to a certain blood clotting therapy. The therapy, also called emicizumab-kxwh, is being co-developed globally by the Swiss drugmaker and its majority-owned Japanese unit Chugai Pharmaceutical Co. Ltd.

The therapy was also approved by the U.S. FDA in November 2017 to treat patients with hemophilia A with factor VIII inhibitors. Roche said Hemlibra is now the only preventive treatment for hemophilia A among patients with and without factor VIII inhibitors that can be delivered through the skin in multiple doses.

* The heads of the Biotechnology Innovation Organization told their member companies this week it was time to put more women in top-level positions and ensure their businesses' actions, including the events they hold or support, meet the group's principles of equality and anti-sexism.

BIO President and CEO Jim Greenwood, BIO Chairman John Maraganore, who is the president and CEO of Alnylam Pharmaceuticals Inc., and BIO Workforce Development, Diversity and Inclusion Committee Chairwoman Helen Torley, who leads Halozyme Therapeutics Inc., want women to represent 50% of "functional leader" and C-suite positions in the biotech industry by 2025. They also called for improved racial diversity and increased LGBTQ representation, though the biotech leaders did not set a measure for companies to meet for those groups.

On the policy front

* The U.K.'s Medicines and Healthcare products Regulatory Agency warned that the country's residents may have trouble getting access to new medicines at the event of a no-deal Brexit, Financial Times (London) reported, citing a consultation paper by the drug regulator. MHRA also said there would be costs to companies due to additional regulatory requirements to sell medicines in the U.K.

M&A and capital markets

* Gaithersburg, Md.-based Emergent BioSolutions Inc. completed its acquisition of PaxVax Corp., a specialty vaccines developer, for about $270 million. Emergent BioSolutions said the acquisition broadens its development pipeline and sales capabilities.

* GlaxoSmithKline PLC-backed biotech Orchard Therapeutics Ltd expects to raise up to $172.5 million in its IPO of American depositary shares on the Nasdaq Global Market. Net proceeds from the offering will go toward developing Orchard Therapeutics' lead product candidates and EU commercialization of Strimvelis — the gene therapy for "bubble baby syndrome" it acquired from GlaxoSmithKline.

* Generex Biotechnology Corp. said it completed the acquisition of the first tranche of certain assets from an undisclosed business involved in healthcare supplies. The Miramar, Fla.-based diagnostics company said the purchased assets generated more than $66 million in unaudited revenues in the past 12 months.

* Certain Takeda Pharmaceutical Co. Ltd. shareholders requested for more transparency regarding the Japanese company's $62 billion acquisition of Dublin-based Shire PLC — the largest takeover ever by a Japanese company — in an open letter to Takeda President Christophe Weber, Nikkei Asian Review reported. Regulators in China, U.S. and Brazil have approved the acquisition, while the European Commission is expected to decide whether to approve the deal by November.

Drug and product pipeline

* The European Medicines Agency accepted a marketing authorization application for Paratek Pharmaceuticals Inc.'s Nuzyra to treat a type of bacterial pneumonia and a certain skin infection. Nuzyra was approved by the U.S. FDA earlier in October to treat adult patients with community-acquired bacterial pneumonia and acute skin and skin structure infections.

* The EMA also accepted a marketing authorization application for bluebird bio Inc.'s LentiGlobin gene therapy for treating certain adolescents and adults with transfusion-dependent beta-thalassemia, a blood disorder leading to severe anemia. The therapy was previously granted accelerated assessment by the EMA's Committee for Medicinal Products for Human Use in July.

* Horizon Pharma PLC's thyroid eye disease drug maintained its effectiveness in patients for nearly a year after completing therapy, according to new follow-up data from a phase 2 trial.

Our features

Radius Health CEO talks company vision, ups and downs of Tymlos launch: Radius Health Inc. President and CEO Jesper Høiland reflects on his first year with the company and discusses new additions to the company's pipeline, including treatments for metastatic breast cancer.

Old antibiotic may selectively kill lethal skin cancer cells, researchers find: Despite the lack of research being undertaken by large pharmaceutical companies into new antibiotics, scientists have discovered that by repurposing older versions, progress has been made against a type of aggressive skin cancer.

Other features

* A new way of analyzing CT scan images can be used as an early warning system for a patient's heart attack risk, Reuters reported, citing researchers from Oxford University and institutions in Germany and the U.S. Reuters also has a report about how vitamin D supplements may not improve bone health in adults.

* Financial Times (London) has a feature about how online drug sales of China's e-commerce companies Alibaba and may be evading regulations through loopholes.

* Silicon Valley startup Mindstrong has an idea for an app that can detect troubling mental health patterns, but researchers are skeptical about how the technology will work, STAT reported.

The day ahead

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

In Asia, the Hang Seng slipped 0.19% to 26,572.57, and the Nikkei 225 declined 0.80% to 23,783.72.

In Europe, around midday, the FTSE 100 was down 0.49% to 7,382.69, and the Euronext 100 was down 0.31% to 1,044.33.

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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