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Pfizer back in hot seat over pricing; valsartan recall has FDA playing catchup


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Pfizer back in hot seat over pricing; valsartan recall has FDA playing catchup

Top news

* The top Democrat on the Senate Finance Committee, Sen. Ron Wyden of Oregon, wants Pfizer Inc. to justify the price increases of its fibromyalgia drug Lyrica — a medicine whose costs have significantly risen in the past decade.

Wyden also pressed Health and Human Services Secretary Alex Azar over concerns about financial conflicts of interest with members of a task force charged with reviewing best practices for prescribing pain medications and making recommendations about what opioid-use disorder treatments should be covered by the government's healthcare programs for seniors, the disabled and low-income Americans.

* The U.S. Food and Drug Administration is playing catch-up in its efforts to temper the entrance of tainted drugs like valsartan from foreign sources into the U.S. market, a problem that poses risks to public health as well as to worldwide pharmaceutical markets.

* The U.S. Food and Drug Administration approved AstraZeneca PLC and Merck & Co. Inc.'s Lynparza as maintenance therapy for women with certain types of ovarian, fallopian tube and peritoneal cancer. Lynparza, or olaparib, is the first in a class of medicines known as PARP inhibitors to garner U.S. regulatory approval as first-line maintenance therapy for advanced ovarian cancer featuring a mutation in the BRCA gene.

The companies said separately that Lynparza shrunk tumors and extended survival in a late-stage study, the fourth trial to show a benefit for the drug. The companies evaluated Lynparza tablets in a phase 3 trial, called Solo-3, in 266 patients with ovarian cancer that tested positive for the BRCA mutation and which came back after two or more lines of treatment.

On the policy front

* The Drug Enforcement Administration failed for more than a decade to stop distributors of opioids from flooding West Virginia with millions of pills, many of which are ending up at rogue pharmacies, a congressional panel reported.

* Meanwhile, HHS unveiled new prescribing guidelines for the opioid-overdose reversal agent naloxone after an advisory panel from the U.S. FDA voted 12 to 11 in favor of prescribing naloxone with prescription opioid painkillers.

* Medicaid expansion in Virginia is set to take effect Jan. 1, 2019, and more than 182,000 people have gained coverage under the new policy, according to Gov. Ralph Northam.

* Former chief medical officer of Memorial Sloan Kettering Cancer Center, José Baselga, resigned as editor-in-chief of the journal Cancer Discovery following previous reports that he failed to disclose conflicts of interests with pharmaceutical companies, The New York Times reported.

M&A and capital markets

* Pfizer's decision to form a consumer health joint venture with British drugmaker GlaxoSmithKline PLC is credit negative for the New York-based company, Moody's said.

Drug and product pipeline

* Merck & Co.'s blockbuster cancer drug has notched another FDA approval, this time for the treatment of a rare type of skin cancer called Merkel cell carcinoma. The Kenilworth, N.J.-based company said Keytruda has been approved for use in adults and children with Merkel cell carcinoma whose cancer has grown or spread to other parts of the body but has not previously been treated for advanced disease.

* Denmark-based Veloxis Pharmaceuticals A/S said the U.S. FDA approved its medicine Envarsus XR to prevent organ rejection in new kidney transplant patients.

* Equillium Inc. said the FDA granted fast-track designation to its drug EQ001 for treating a complication of stem cell transplants. EQ001 is under development to treat acute graft versus host disease, or aGVHD, which occurs after stem cell transplant procedures and causes diarrhea, skin rashes and liver damage.

* Montrouge, France-based DBV Technologies SA voluntarily withdrew its application seeking U.S. FDA approval for peanut allergy therapy Viaskin Peanut after discussions with the regulator.

* ADMA Biologics Inc. said the U.S. FDA rejected its application to market its lead product candidate RI-002. The Ramsey, N.J.-based company's intravenous drug is used to treat primary humoral immunodeficiency, which comprises over 350 disorders involving a compromised or incomplete immune system.

* Spectrum Pharmaceuticals Inc. said the FDA declined to grant breakthrough therapy designation for poziotinib, a therapy for a hard-to-treat lung cancer. Poziotinib is being investigated for use in heavily pretreated patients with non-small cell lung cancer whose disease has spread across the body and with a mutation in proteins known as EGFR or HER2.

* AVROBIO Inc. said the U.S. Food and Drug Administration granted its gene therapy AVR-RD-01 the orphan drug designation to treat Fabry disease.

* AstraZeneca and San Francisco-based FibroGen Inc.'s roxadustat showed effectiveness in treating anemia in patients with chronic kidney disease under late-stage trials called Olympus and Rockies.

Operational activity

* Johnson & Johnson has lost a motion to reverse a jury verdict from July ordering the company to pay $4.69 billion in damages to 22 women who claim its talc product contained asbestos that led to their ovarian cancer, Reuters reported.

* Novartis AG said Susanne Schaffert, president of its unit Advanced Accelerator Applications SA, will become CEO of Novartis Oncology, replacing Liz Barrett. Schaffert has been with the Swiss pharmaceutical giant for over 20 years and has held leadership roles in the oncology unit for the past six years.

* Gilead Sciences Inc. has teamed up with Scholar Rock Holding Corp. to discover and develop treatments for fibrosis, a disease that scars tissues and vital organs and can be fatal. Under the agreement, Gilead will pay $80 million up front for exclusive access to results of Scholar Rock's research in transforming growth factor beta, an inhibitor that targets what is thought to be a central regulator of fibrosis.

* U.S. drug retailer Walgreens Boots Alliance Inc. teamed up with Alphabet Inc.-owned Verily Life Sciences LLC to collaborate on new projects aimed at improving health outcomes for patients with chronic conditions.

* Belgium-based brewer Anheuser-Busch Inbev SA/NV is partnering with cannabis company Tilray Inc. to research cannabis-based beverages. Each company will invest up to $50 million in the venture, which will study nonalcoholic beverages containing two cannabinoids: tetrahydrocannabinol and cannabidiol.

Our features

Kaiser Permanente executive talks environmental goals, impacts of climate change: Kaiser Permanente has set a goal of being carbon neutral by 2020 and carbon positive by 2025. Rame Hemstreet, the company's chief sustainable resource officer, talked about the company's energy projects and efforts to mitigate climate change.

Other features

* Nearly 30 drugmakers, including Bayer AG and Novartis, are in the midst of raising their drug prices in January, lifting a voluntary embargo on the price increases in 2018 due to pressure from the Trump administration, Reuters reported.

The day ahead

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

In Asia, the Hang Seng fell 0.94% to 25,623.53, while the Nikkei 225 was down 2.84% to 20,392.58.

In Europe, around midday, the FTSE 100 fell 0.26% to 6,748.23, and the Euronext 100 was down 1.14% to 917.00.

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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