* Salt Lake City, Utah-based PolarityTE Inc. fired its CEO, John Stetson, after the healthcare executive was charged with fraud by the U.S. Securities and Exchange Commission. The SEC charged 10 individuals, including Stetson and Opko Health Inc. chairman and CEO Phillip Frost, as well as several associated companies for allegedly facilitating market manipulation schemes.
Meanwhile, Opko Health said the SEC's complaint contained "serious factual inaccuracies," adding that it was confident the matter will be resolved favorably for the Miami-based diagnostic instrument maker and Frost once a proper investigation is completed.
* Merck & Co. Inc. said the European Commission approved Keytruda in combination with Eli Lilly and Co.'s Alimta and chemotherapy for the first-line treatment of a certain type of lung cancer. The combination can now treat metastatic nonsquamous non-small cell lung cancer in adults whose tumors have no EGFR or ALK-positive mutations.
* Top U.S. cancer researcher José Baselga, a chief medical officer at the prestigious U.S. cancer research institution Memorial Sloan Kettering Cancer Center in New York, failed to disclose millions of dollars of financial payments from drug companies in his published research papers, The New York Times reported. In response, Memorial Sloan CEO Craig Thompson told the institution's employees that its members "need to do a better job" at disclosing financial ties, the newspaper added.
On the policy front
* Former President Barack Obama gave the so-called "Medicare for all" single-payer platform being proposed by some Democrats a boost, calling it a "good idea." But the head of the Center for Medicare and Medicaid Services, Seema Verma, quickly pushed back, calling the single-payer concept "More government control [that] leads to higher premiums and fewer choices."
* The House Commerce Energy and Commerce Health Subcommittee voted to advance legislation that would ban so-called gag clauses, which prevent pharmacists from telling customers when they can pay less in out-of-pocket costs for their prescription medicines by not using their insurance plans.
* At the Research!America forum, National Institutes of Health Director Francis Collins said to expect a draft blueprint by summer 2019 of the next stage of the Brain Research through Advancing Innovation Neurotechnologies, or BRAIN, Initiative — a collaborative project between the U.S. government and the private and academic sectors, which is aimed at finding new ways to treat, cure and prevent neurological diseases and disorders, like Alzheimer's, Parkinson's, autism, schizophrenia and epilepsy.
M&A and capital markets
* Kodiak Sciences Inc., a Palo Alto, Calif.-based biopharmaceutical company that develops drugs to treat eye diseases, plans to raise up to $100 million in an IPO.
* Private equity firm Boyu Capital Fund III LP and two affiliates of Chinese billionaire Jack Ma are reconsidering the acquisition of iKang Healthcare Group Inc. The buyers, which include Ma's Yunfeng Capital and Alibaba Group Holding Ltd., had proposed acquiring the Beijing-based medical services provider for $41.20 per common share, or $20.60 for every American depositary stock, in a deal that was originally announced in March.
* Pediapharm Inc., which makes treatments for children, agreed to buy Canada's Medexus Inc. for C$23 million and the U.S. business of Germany's medac GmbH for up to US$50 million. Medexus is focused on joint treatments, women's health and dermatology. Medac's U.S. unit, called Medac Pharma Inc., sells the rheumatoid arthritis therapy Rasuvo.
* San Francisco-based Clarify Health Solutions Inc., which uses data analytics to help doctors and insurers identify the most cost-effective treatments, said it raised $57 million in a series B funding round led by New York-based investment firm KKR & Co.
Drug and product pipeline
* U.K.-based GlaxoSmithKline PLC said the U.S. Food and Drug Administration rejected Nucala as an add-on treatment for patients with a certain type of lung disease. The drugmaker is seeking approval for Nucala, or mepolizumab, as an add-on to corticosteroid-based maintenance therapy to lessen the severity of symptoms of the chronic obstructive pulmonary disease. The agency asked for more clinical data.
* New York's Bristol-Myers Squibb Co. said the U.K. National Institute for Health and Care Excellence rejected its drug Opdivo for the treatment of skin cancer. The U.K. watchdog said in a draft guidance that it was uncertain about the effectiveness of the therapy because of a lack of clinical trials comparing Opdivo with the current standard of care.
The U.K. watchdog rejected Opdivo for use in Britain's National Health Service as a single therapy, or administered after other therapies, for patients with stage 3 or stage 4 melanoma with lymph node involvement or which has spread across the body and whose cancers have been removed through surgery.
* Tokyo-based Astellas Pharma Inc. terminated its exclusive license and collaboration agreement with Aquinox Pharmaceuticals Inc. for a bladder pain drug that failed a late-stage study.
* India's Sun Pharmaceutical Industries Ltd. said the U.S. Food and Drug Administration issued six observations on its Halol facility in Gujarat as part of a pre-approval inspection. The company, which has previously gained FDA clearance for the embattled plant, said it will submit its response to the US FDA within 15 days.
* U.K.'s Consort Medical PLC said it is partnering with Santa Monica, Calif.-based Opiant Pharmaceuticals Inc. to develop a nasal spray for treating opioid overdoses, with a new drug application expected to be filed for the treatment in 2020, Reuters reported.
* A Japanese court upheld a patent ruling against Shionogi & Co. Ltd. covering one of its HIV medicines. The Japanese company had filed a lawsuit against Merck & Co. Inc. for allegedly infringing on the patent, but Japan's Patent Office ended up invalidating the patent in a follow-up, prompting Shionogi to file an appeal.
Cannabis companies double down on research, clinical trials in expanding field: With the first marijuana-based treatment approved in the U.S. and set to launch this fall, the stage is set for further developments in cannabis-related medicines, with a wide range of therapeutic potentials.
* The maker of compounded drugs such as Buffalo, N.Y.-based Athenex Inc. and San Diego-based Imprimis Pharmaceuticals Inc., who produce custom-made medicines by adjusting their main ingredients, have come under criticism from drugmakers and regulators in the U.S. for selling cheaper versions of the original medicines that do not need the FDA's approval, the Wall Street Journal reported.
* The Wall Street Journal wrote that after shutting down his healthcare-focused hedge fund over an insider trading scandal, Jacob Gottlieb is planning to enter the market again by raising funds from his existing clients.
The day ahead
Early morning futures indicators pointed to a higher opening for the U.S. market.
In Asia, the Hang Seng was down 1.33% to 26,613.42. The Nikkei 225 rose 0.30% to 22,373.09.
In Europe as of midday, the FTSE 100 was up 0.36% to 7,304.01, and the Euronext 100 was up 0.48% to 1,034.28.
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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