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Novartis seeks US, EU nods for MS drug; US FDA expands use of Merck HPV vaccine

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Novartis seeks US, EU nods for MS drug; US FDA expands use of Merck HPV vaccine

Top news

* Novartis AG is seeking U.S. Food and Drug Administration and European Medicines Agency approval for its drug siponimod to treat secondary progressive multiple sclerosis, an aggressive form of the autoimmune disease. The U.S. and EU drug regulators are expected to decide on siponimod's approval by March 2019 and late 2019, respectively.

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* Merck & Co. Inc.'s human papillomavirus, or HPV, vaccine Gardasil 9 received the U.S. FDA's expanded approval to treat women and men aged 27 through 45. Gardasil 9, which prevents certain cancers and diseases caused by the nine HPV types, was previously approved to treat patients aged 9 through 26.

* The Alliance to Protect Medical Innovation, a new pro-brand-name biopharmaceutical industry group that drew much speculation after its initial launch, revealed that former journalist Patrick O'Connor, a partner at CGCN Group, was running the organization, but details about its funding remain unclear.

* The Pharmaceutical Research and Manufacturers of America and the Biotechnology Innovation Organization weighed in on President Donald Trump's new trade deal with Mexico and Canada, with the former calling it a "significant step toward leveling the playing field with our trading partners by delivering strong [intellectual property] protections for American manufacturers and innovators."

* After years of trying to repeal and replace the Affordable Care Act, some Republicans are now backtracking and trying to convince their constituents ahead of the November 2018 midterm elections that the lawmakers were not out to end the law's insurance protections for patients with pre-existing conditions.

* Mexican President-elect Andrés Manuel López Obrador, during a speech in the country's city of Morelia, called on local drugmakers to keep medicine costs down or face losing out to foreign competitors, Reuters reported.

M&A and capital markets

* Swedish startup Lobsor Pharmaceuticals AB — a company developing a treatment for Parkinson's disease — is considering options, including an IPO on Stockholm's First North Premium marketplace, Bloomberg News reported, citing an interview with Ulf Rosen, the company's chairman.

Drug and product pipeline

* The U.K. National Health Service reached a deal with Gilead Sciences Inc. to make Yescarta available on the national public health system to adult patients with a form of blood cancer. With the deal, Gilead's Yescarta becomes the first chimeric antigen receptor T cell therapy available to adult patients on the NHS, beating rival Novartis' Kymriah.

* An EMA panel has recommended restricting the use of a class of antibiotics called fluoroquinolones and has recommended removing quinolone antibiotics from the market entirely, due to potentially long-lasting and disabling side effects. The agency's Pharmacovigilance Risk Assessment Committee issued the Oct. 5 ruling on fluoroquinolone and quinolone antibiotics taken by mouth, injection or inhalation, following a review initiated in 2017.

* Loxo Oncology Inc. said LOXO-292 demonstrated durable efficacy in a phase 1/2 trial in certain patients with thyroid cancer. Data from the phase 2 portion covered 38 heavily pretreated patients — 29 with medullary thyroid cancer and nine with thyroid cancer.

* Akcea Therapeutics Inc. and Ionis Pharmaceuticals Inc. said the U.S. FDA approved Tegsedi to treat polyneuropathy — nerve damage outside the brain and central nervous system — caused by hereditary transthyretin-mediated amyloidosis in adults. The FDA's approval is based on a phase 3 study, called Neuro-TTR, which showed that the drug substantially reduced the production of transthyretin protein among the patients.

* Blueprint Medicines Corp. said its investigational drug BLU-667 shrank the tumors of patients with papillary thyroid cancer or medullary thyroid cancer in an early stage trial. Updated data from the ongoing phase 1 study, called Arrow, showed that 90% of patients saw radiographic tumor reductions after treatment with BLU-667.

* Scientists at the U.S. FDA found no concerns in the data submitted by Celltrion Pharm Inc. to support the approval of its biosimilar version of Roche Holding AG's non–Hodgkin lymphoma drug Rituxan, according to documents posted on the agency's website. Biosimilars are intended to be lower-cost versions of biologic therapies — drugs derived from natural sources, such as microorganisms or plant or animal cells.

* Xencor Inc. said its medicine XmAb5871 did not show the desired efficacy in treating a certain form of lupus compared to placebo in a midstage trial, but the results support further study of the medicine.

Our features

Healthcare equipment companies drive M&A activity in Q3: Deals for healthcare equipment companies largely drove M&A activity in the third quarter as companies shored up their core business with acquisitions.

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Global healthcare IPOs fetch $19.18B year-to-date, topping 2017 proceeds: Gross proceeds from global healthcare IPOs year-to-date in 2018 exceeded amounts raised the year before, according to data compiled by S&P Global Market Intelligence.

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Other features

* Illumina Inc.-backed startup Luna DNA Inc. is seeking approval from the U.S. Securities and Exchange Commission to pay consumers with company shares in exchange for sharing their DNA data, Bloomberg News writes in a feature.

* Bloomberg News has a feature about how the mental health of U.K. workers is being negatively affected by financial concerns; another feature looks at how Tencent Holdings Ltd. is teaming up with Medopad Ltd. to use artificial intelligence for the treatment of Parkinson's disease.

* Type 1 diabetes patients who maintain good control of their blood sugar may cut their long-term risk of developing dementia, Reuters reported, citing a U.S. study.

* The Financial Times (London) has a feature about respiratory treatment innovations from companies hVIVO PLC, Circassia Pharmaceuticals PLC and Verona Pharma PLC.

The day ahead

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

In Asia, the Hang Seng was down 1.39% to 26,202.57.

In Europe as of midday, the FTSE 100 slipped 0.56% to 7,277.39 and the Euronext 100 slipped 0.74% to 1,031.23.

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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