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Pharma majors under Chinese scrutiny; AstraZeneca seeks successor for chairman

Top news

* China has randomly chosen 77 major pharmaceutical companies, including Sanofi, Eli Lilly and Co. and Bristol-Myers, to face auditing, after one of its largest drugmakers — Kangmei Pharmaceutical Co. — was found to have overstated its cash holding by about 29.9 billion Chinese yuan, Bloomberg News reported. China's Ministry of Finance said the companies will be audited in June and July.

* AstraZeneca is on the lookout for a successor for its Chairman, Leif Johansson, Sky News reported. The U.K.-based drug giant has set no scheduled timetable for Johansson's departure, who has been with the company for seven years, the report said.

* Results from clinical trials in patients with advanced melanoma highlighted the ongoing rivalry between best-selling cancer immunotherapies Keytruda and Opdivo — from Merck & Co. Inc. and Bristol-Myers Squibb Co., respectively — at the 2019 annual meeting of the American Society of Clinical Oncology on June 3. In a five-year analysis of what began as an early-stage trial, Bristol-Myers found that 57% of patients receiving the combination of Opdivo-Yervoy were alive for four years or longer.

Whereas, a phase 2 study of Merck's Keytruda in combination with Dynavax Technologies's experimental drug SD-101 showed that 72% of patients receiving the combination lived for 18 months without their disease getting worse.

* A phase 3 study, dubbed SOLO3, evaluating AstraZeneca PLC and Merck's Lynparza showed that 72% of ovarian cancer patients responded to the therapy compared to just over half of patients on chemotherapy. Patients receiving Lynparza also lived 4.2 months longer with no disease progression. The companies presented the results during the 2019 ASCO meeting.

* Immigrants accounted for 18.2% of health care workers in the U.S in 2017, filling some gaps created by a shortage of healthcare workers in the country, Bloomberg News reported citing a study. Migrants are filling up key shortage roles such as rural physicians, said the report.

On the policy front

* The U.S. Supreme Court ruled June 3 that the U.S. Department of Health and Human Services did not legally change the funding formula for hospitals that serve a high volume of uninsured patients. The department is required to notify the public and seek comment when a “substantive legal standard” is changed. However, the department did not follow this legal requirement, according to the ruling. The court ruled 7-1 against HHS, with Justice Neil Gorsuch writing the decision. Justice Stephen Breyer was the lone dissenter, and Justice Brett Kavanaugh did not take part in the decision.

* The U.S. Food and Drug Administration said that a new program called Project Facilitate will help physicians seeking access to unapproved therapies for cancer patients. Project Facilitate will be a single point of contact where the FDA oncology staff will help physicians submit an Expanded Access request for a patient. The move is part of the agency's efforts into directing critically ill patients who want to try experimental medicines to the agency's expanded-access program and away from using unproven therapies outside of regulators' control.

* The National Academy of Sciences, a private, nonprofit institution that provides advice to the federal government and other organizations, said it made changes to its bylaws to permit the NAS Council to rescind membership for the most egregious violations to a new code of conduct, including for proven cases of sexual harassment.

* The U.S District Court for the Southern District of Florida ruled that the FDA has authority to regulate a Sunrise, Fla.-based stem cell clinic that blinded three patients after injecting a fat extract into their eyes, The New York Times reported.

M&A and capital markets

* Irish conglomerate DCC PLC agreed to sell its generic drug units — Kent Pharmaceuticals Ltd., and Athlone Laboratories Ltd. — to London-based private equity firm Duke Street LLP.

ASCO conference

* Takeda Pharmaceutical Company Ltd.'s drug TAK-788 showed that 43% of patients with a type of non-small cell lung cancer experienced a reduction in cancer. TAK-788 — a next-generation, small-molecule tyrosine kinase inhibitor — also stopped the progression of the disease for an average time of 7.3 months into treatment, noted the Japanese drugmaker in the results presented at the 2019 ASCO meeting.

* Sanofi said its cancer drug isatuximab prolonged multiple myeloma patient's lives without the disease worsening by five months in a late-stage study. The phase 3 results presented at 2019 ASCO meeting showed that when combined with Celgene Corp.'s Pomalyst and the steroid dexamethasone, isatuximab prompted a response in patients 60% of the time. Without isatuximab, the other drugs showed a 35% response rate.

* MERCK KGaA said a phase 2 study of its drug tepotinib showed the therapy reduced advanced non-small cell lung cancer in certain patients who had a type of mutation in their genes.

* Gilead Sciences Inc. said a follow-up study showed that its cell therapy Yescarta curbed cancer in patients with lymphoma, and older patients were more likely to see a benefit.

* Meanwhile, Celgene's drug fedratinib showed promise in a mid-stage study in patients with a rare form of bone marrow cancer called myelofibrosis who were previously with Incyte Corp.'s Jakafi. The phase 2 trial, dubbed JAKARTA2, showed 31% of patients exhibited a 35% or greater reduction in spleen volume after six one-month treatment cycles.

* An early study, CheckMate –040, showed that a combination of Bristol-Myers' Opdivo and Yervoy helped shrink liver tumors in about 31% of patients who had been previously treated with Bayer AG's Nexavar.

* Moving on, Amgen Inc. said its KRAS inhibitor AMG 510 stopped tumor growth in patients with lung and colorectal cancer in a small, phase 1 study. Amgen said that all 35 patients — of which 14 had non-small cell lung cancer, 19 had colorectal cancer and two had other types — had received other therapies before being treated with KRAS.

* Blueprint Medicines Corp. said that a phase 1 study of its drug BLU-667 showed a reduction in cancer in patients with RET-fusion non-small cell lung cancer and RET-mutant medullary thyroid cancer.

* Also at the 2019 ASCO meeting, BerGenBio ASA's treatment bemcentinib combined with chemotherapy helped control acute myeloid leukemia in certain patients in a small phase 2 trial.

Drug and product pipeline

* Roche Holding AG's antiviral drug Xofluza was effective in preventing influenza in those exposed to patients infected with the disease, a phase 3 trial showed. The study, which was conducted in Japan, showed that those preventatively treated with Xofluza were significantly less likely to develop the flu compared to those in the placebo group.

* The FDA approved Merck & Co.'s Zerbaxa to treat patients 18 years and older with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by certain susceptible gram-negative microorganisms.

* Avenue Therapeutics Inc.'s injectable, opioid-based drug tramadol significantly reduced pain in patients following surgery compared to placebo, meeting the main goal in a phase 3 trial. Tramadol is a synthetic, dual-acting opioid with less potential for abuse and a lower risk of dependence than conventional narcotics.

The day ahead

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

In Asia, Hang Seng fell 0.49% at 26,761.52, while the Nikkei 225 dropped 0.01% to 20,408.54.

In Europe, around midday, the FTSE 100 lifted 0.12% to 7,193.65, and the Euronext 100 gained 0.09% to 1,027.18.

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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