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Akebia anemia drug misses safety goals; Amarin loses appeal on Vascepa patents

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Akebia anemia drug misses safety goals; Amarin loses appeal on Vascepa patents

TOP NEWS

* Akebia Therapeutics Inc.'s vadadustat worked as well as Amgen Inc.'s Aranesp in treating anemia in patients with chronic kidney disease but failed to mimic the reference drug's safety in two late-stage studies. Cambridge, Mass.-based Akebia's stock closed in the red on Thursday, slipping more than 70%, following the news.

* The U.S. Court of Appeals for the Federal Circuit has upheld a patent dispute ruling and cleared the way for Hikma Pharmaceuticals PLC and others to manufacture a generic version of Amarin Corp. PLC's fish oil-derived heart drug. Hikma and India's Dr. Reddy's Laboratories Ltd. can now move forward with marketing their copycat versions of the therapy.

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Groups urge sunlight to immunize COVID-19 vaccine work against political shadows

Concerns that politics are overshadowing biopharmaceutical makers' pursuit of successfully delivering safe and effective vaccines against COVID-19 prompted even members of the drug industry to call on their colleagues to be more transparent.

US acute care hospitals to get 2.9% Medicare pay increase in FY'21

The U.S. Centers for Medicare and Medicaid Services increased Medicare payment rates for acute care hospitals and continued supporting price transparency policies as part of a finalized rule.

Some US hospitals may see increased profits in 2020 despite COVID-19 pandemic

The Medicare Payment and Access Commission said during a Sept. 3 meeting that some hospitals may see 2020 profit growth despite the ongoing coronavirus pandemic, largely due to federal relief funds.

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PHARMACEUTICALS

* The U.S. Food and Drug Administration granted emergency use authorization to Roche Holding AG's cobas SARS-CoV-2 & Influenza A/B test for use on its cobas 6800/8800 systems. The test is also available in markets accepting the CE mark.

* S&P Global Ratings downgraded Teva Pharmaceutical Industries Ltd.'s long-term issuer credit rating to BB- from BB due to increased risks of material liabilities from multiple lawsuits alleging misconduct. The outlook on the ratings is stable.

* Novo Nordisk A/S is investigating a new class of weight-reducing diabetes drugs for treating COVID-19, Bloomberg News reported. Research suggests that GLP-1 drugs, which aim to control blood sugar levels, could be a "very meaningful therapy" against the coronavirus in diabetic patients, Novo Nordisk Chief Scientific Officer Mads Krogsgaard Thomsen told Bloomberg.

* The Philippines is meeting with officials from Pfizer Inc. and the Russian embassy to discuss potential COVID-19 vaccine supply deals, Reuters reported, citing the Southeast Asian nation's health undersecretary, Maria Vergeire. The country intends to purchase 40 million doses worth $400 million, the news outlet added.

BIOTECHNOLOGY

* Savara Inc. discontinued a mid-stage study of Molgradex — the company's drug for treating nontuberculous mycobacteria lung infection in patients with cystic fibrosis — after preliminary results showed it had no impact on infection growth after 20 weeks.

* Novacyt SA launched a two-gene test for COVID-19 that has CE Mark approval in the EU. The Anglo-French company said the polymerase chain reaction test addresses the need of certain countries, including France, Belgium, Croatia, Poland and the UAE, which require a two-gene target testing approach for the coronavirus.

* Alphamab Oncology's KN046 was granted orphan-drug designation by the U.S. Food and Drug Administration for treating thymic epithelial tumors, a range of hard-to-treat cancers.

* Private research and manufacturing company Albany Molecular Research Inc. signed a supply agreement to manufacture AstraZeneca PLC's AZD1222 vaccine for treating COVID-19. Cambridge, U.K.-based AstraZeneca is co-developing the vaccine with researchers at the University of Oxford.

HEALTHCARE EQUIPMENT

* Siemens Healthineers AG raised about €2.73 billion in gross proceeds in a share placement with institutional investors to partly fund its previously announced $16.4 billion acquisition of Varian Medical Systems Inc.

HEALTHCARE SUPPLIES

* 28 manufacturers across 10 countries could produce an unprecedented amount of vaccines for treating COVID-19, Reuters reported. The United Nations Children's Fund, or UNICEF, said it will help distribute the doses as part of the COVAX program it is jointly leading with the World Health Organization.

MARKETS

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